Online Article Directory Marshall Islands: 2016

Thursday, 29 September 2016

Fozitec

Fozitec may be available in the countries listed below.

Ingredient matches for Fozitec

Fosinopril

Fosinopril is reported as an ingredient of Fozitec in the following countries:

France

International Drug Name Search

Globamox

Globamox may be available in the countries listed below.

Ingredient matches for Globamox

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Globamox in the following countries:

Philippines

International Drug Name Search

Ingredient matches for Feiba

Coagulation Factor VIII , Human (rDNA)

Coagulation Factor VIII , Human (rDNA) Octocog Alfa (a derivative of Coagulation Factor VIII , Human (rDNA)) is reported as an ingredient of Feiba in the following countries:

Bulgaria

Prothrombin Complex, Activated

Prothrombin Complex, Activated is reported as an ingredient of Feiba in the following countries:

Austria

Belgium

Croatia (Hrvatska)

Czech Republic

Denmark

Finland

France

Georgia

Germany

Hungary

Israel

Italy

Latvia

Lithuania

Malta

Serbia

Slovakia

Spain

Sweden

Turkey

United Kingdom

United States

International Drug Name Search

Wednesday, 28 September 2016

Féprazone

Féprazone may be available in the countries listed below.

Ingredient matches for Féprazone

Feprazone

Féprazone (DCF) is also known as Feprazone (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Formotop Novolizer

Formotop Novolizer may be available in the countries listed below.

Ingredient matches for Formotop Novolizer

Formoterol

Formoterol fumarate (a derivative of Formoterol) is reported as an ingredient of Formotop Novolizer in the following countries:

Germany

International Drug Name Search

Trusopt Ocumeter

Generic Name: dorzolamide (Ophthalmic route)

dor-ZOLE-a-mide

Commonly used brand name(s)

In the U.S.

Trusopt Ocumeter

Trusopt Ocumeter Plus

Available Dosage Forms:

Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Carbonic Anhydrase Inhibitor

Uses For Trusopt Ocumeter

Dorzolamide ophthalmic (eye) drops is used to treat increased pressure in the eye caused by open-angle glaucoma or a condition called hypertension of the eye. Both eye conditions are caused by high pressure in your eye and can lead to pain from pressure in your eye and then can eventually harm your vision. This medicine can help you keep your sight by reducing the pressure in your eye and stopping eye pain.

This medicine is available only with your doctor's prescription.

Before Using Trusopt Ocumeter

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dorzolamide eye drops in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dorzolamide eye drops in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of dorzolamide

This section provides information on the proper use of a number of products that contain dorzolamide. It may not be specific to Trusopt Ocumeter. Please read with care.

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

If you normally wear soft contact lenses, remove them before you use dorzolamide eye drops. Wait at least for 15 minutes before putting the contact lenses back in.

To use the eye drops:

Wash your hands with soap and water.

Before using this medicine for the first time, make sure that the safety strip on the bottle is unbroken.

Tear off the safety strip to break the seal and open the bottle by unscrewing the cap by turning as indicated by the arrows on the top of the cap. Do not pull the cap directly up and away from the bottle.

Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the eyelid away from the eye to make a space. Drop the medicine into this space.

Invert the bottle, and press lightly the "finger push area" using your thumb or index finger.

Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to cover the eye.

If you think you did not get the drop of medicine into your eye properly, replace the cap on the bottle and tighten. Then, remove by turning the cap in the opposite direction as indicated by the arrows on the top of the cap and repeat the process with another drop.

Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.

Wash your hands after using the eye drops to remove any medicine.

Never touch the applicator tip to any surface, including the eye, and keep the container tightly closed. This will keep the medicine as germ-free as possible.

If your doctor ordered two different eye drops to be used together, wait at least 10 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic dosage form (eye drops):
- For glaucoma or hypertension of the eye:
  - Adults and teenagers—Use one drop in the affected eye three times a day.
  - Children—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Trusopt Ocumeter

It is very important that your doctor check the progress of you or your child at regular visits. Your doctor may want to do certain tests to see if the medicine is working properly or to see if certain side effects may be occurring without you or your child knowing it.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you or your child are allergic to dorzolamide eye drops.

This medicine may cause some people to have blurred vision for a short time. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you cannot see properly. Also, since blurred vision may be a sign of a side effect that needs medical attention, check with your doctor if it continues.

Ophthalmic dorzolamide may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort. If the discomfort continues, check with your doctor.

If you hurt your eye, develop an eye infection, or need to have eye surgery, talk with your doctor right away. You or your child may need to get a new bottle of the eye drops to help prevent an eye infection or keep an infection from getting worse.

Serious allergic reactions may occur while using this medicine. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms: black, tarry stools; blistering, peeling, or loosening of the skin; chills; dark urine; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; unusual bleeding or bruising; unusual tiredness or weakness; or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Trusopt Ocumeter Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Burning, stinging, or discomfort when medicine is applied

itching, redness, swelling, or other sign of the eye or eyelid irritation

Less common

Burning, dry, or itching eyes

discharge from the eye

excessive tearing

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Rare

Blood in the urine

blurred vision

nausea or vomiting

pain in the side, back, or abdomen

skin rash

tearing

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

change in vision

chills

cough

diarrhea

difficult or labored breathing

flashes of light

floaters in vision

hives or welts

itching skin

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

redness of the skin

shortness of breath

sore throat

sores, ulcers, or white spots in the mouth or on the lips

tightness in the chest

unusual tiredness or weakness

wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion

irregular heartbeat

muscle cramps or pain

numbness, tingling, pain, or weakness in the hands or feet

seizures

trembling

weakness and heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bitter taste

feeling of something in the eye

Less common

Changes in color vision

difficulty seeing at night

dryness of the eyes

eyelid reactions

headache

increased sensitivity of the eyes to sunlight

Incidence not known

Bloody nose

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in distance vision

difficulty in focusing the eyes

dizziness

dry mouth

eyelid crusting

lack or loss of strength

scaling of the skin

severe redness, soreness, or swelling of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Trusopt Ocumeter side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Trusopt Ocumeter resources

Trusopt Ocumeter Side Effects (in more detail)
Trusopt Ocumeter Use in Pregnancy & Breastfeeding
Trusopt Ocumeter Drug Interactions
Trusopt Ocumeter Support Group
0 Reviews for Trusopt Ocumeter - Add your own review/rating

Compare Trusopt Ocumeter with other medications

Glaucoma, Open Angle
Intraocular Hypertension

Foucacillin

Foucacillin may be available in the countries listed below.

Ingredient matches for Foucacillin

Cefuroxime

Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Foucacillin in the following countries:

Greece

International Drug Name Search

Fluoxetin Streuli

Fluoxetin Streuli may be available in the countries listed below.

Ingredient matches for Fluoxetin Streuli

Fluoxetine

Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetin Streuli in the following countries:

Switzerland

International Drug Name Search

Tuesday, 27 September 2016

Hipotensil

Hipotensil may be available in the countries listed below.

Ingredient matches for Hipotensil

Captopril

Captopril is reported as an ingredient of Hipotensil in the following countries:

Portugal

International Drug Name Search

Felbinac

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

M02AA08

CAS registry number (Chemical Abstracts Service)

0005728-52-9

Chemical Formula

C14-H12-O2

Molecular Weight

212

Therapeutic Categories

Analgesic, antipyretic and anti-inflammatory agent

Non-steroidal anti-inflammatory drug, NSAID

Topical agent

Chemical Name

[1,1'-Biphenyl]-4-acetic acid

Foreign Names

Felbinacum (Latin)
Felbinac (German)
Felbinac (French)
Felbinaco (Spanish)

Generic Names

Felbinac (OS: BAN, USAN, DCF, JAN)
BPAA (IS)
CL 83544 (IS: Lederle)
LJC 10141 (IS)
LY 61017 (IS)
Felbinac (PH: Ph. Eur. 6, BP 2010)
Felbinacum (PH: Ph. Eur. 6)

Brand Names

Aszes
Toko Pharmaceutical, Japan

Dolinac
Teofarma, Italy

Falzy
Nipro PatchNipuropatchi, Japan

Felbinac P
Kyukyu Yakuhin, Japan

Felbis
Toko Pharmaceutical, Japan

Flex
Hisamitsu, Japan

Flexfree
Omega, Belgium; Omega, Luxembourg

Mulchnes
Oishi Koseido, Japan

Napageln
Wyeth KK, Japan

Sebtet
Medisa Shinyaku, Japan

Selspot
Ohara Yakuhin, Japan

Seltouch
Teikoku Seiyaku, Japan

Sumilu
Mikasa Seiyaku, Japan

Tramax
Goldshield, Ireland

Traxam
Goldshield, United Kingdom; Goldshield, Ireland; Wyeth, Italy

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

FML

fluorometholone

Dosage Form: ophthalmic suspension
FML®

(fluorometholone ophthalmic suspension, USP) 0.1%

Sterile

DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:

Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.

Structural Formula:

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

CLINICAL PHARMACOLOGY

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

INDICATIONS AND USAGE

FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

CONTRAINDICATIONS

FML® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. FML® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.

Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Corticosteroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.

PRECAUTIONS

General:

The initial prescription and renewal of the medication order beyond 20 milliliters of FML® suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

Information for Patients:

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

The preservative in FML® suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® suspension to insert soft contact lenses.

Carcinogenesis, mutagenesis, impairment of fertility:

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy:

Teratogenic effects. Pregnancy Category C: Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in infants below the age of 2 years have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.

Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical steroids.

Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS).

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of FML® suspension. Other adverse events reported with the use of FML® suspension include: allergic reactions, visual disturbance (blurry vision), and taste perversion.

DOSAGE AND ADMINISTRATION

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

The dosing of FML® suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

HOW SUPPLIED

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

     5mL in 10mL bottle NDC 11980-211-05

   10mL in 15mL bottle NDC 11980-211-10

   15mL in 15mL bottle NDC 11980-211-15

Note: Store between 2° and 25°C (36° - 77°F); protect from freezing. Shake well before using.

Rx Only

Revised June 2003

ALLERGAN

NDC 11980-211-15

Rx Only

FML®

(fluorometholone

ophthalmic suspension,

USP) 0.1%

15 mL sterile

ALLERGAN

NDC 11980-211-15 Rx Only

FML®

(fluorometholone

ophthalmic suspension,

USP) 0.1%

15 mL sterile

FML
fluorometholone suspension/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	11980-211
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
fluorometholone (fluorometholone)	fluorometholone	1 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride
edetate disodium
polysorbate 80
polyvinyl alcohol
water
sodium chloride
sodium phosphate, dibasic
sodium phosphate, monobasic
sodium hydroxide

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11980-211-05	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
1		5 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (11980-211-05)
2	11980-211-10	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
2		10 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (11980-211-10)
3	11980-211-15	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
3		15 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (11980-211-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016851	02/01/1972

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		362898611	MANUFACTURE

Revised: 10/2010Allergan, Inc.

More FML resources

FML Side Effects (in more detail)
FML Dosage
FML Use in Pregnancy & Breastfeeding
FML Drug Interactions
0 Reviews for FML - Add your own review/rating

Compare FML with other medications

Eye Dryness/Redness
Eye Redness/Itching
Eyelash Hypotrichosis

Uniket

Uniket may be available in the countries listed below.

Ingredient matches for Uniket

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Uniket in the following countries:

Spain

International Drug Name Search

Istalol

Generic Name: timolol (Ophthalmic route)

TIM-oh-lol

Commonly used brand name(s)

In the U.S.

Betimol

Istalol

Timoptic Ocudose

Timoptic Ocumeter

Timoptic Ocumeter Plus

Timoptic-XE Ocumeter

Timoptic-XE Ocumeter Plus

Available Dosage Forms:

Solution

Gel Forming Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For Istalol

Timolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .

This medicine is available only with your doctor's prescription .

Before Using Istalol

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of timolol in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of timolol in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Albuterol

Amiodarone

Arformoterol

Bambuterol

Bitolterol

Broxaterol

Clenbuterol

Clonidine

Colterol

Diltiazem

Dronedarone

Epinephrine

Fenoldopam

Fenoterol

Formoterol

Hexoprenaline

Indacaterol

Isoetharine

Levalbuterol

Metaproterenol

Pirbuterol

Procaterol

Reproterol

Rimiterol

Ritodrine

Salmeterol

Terbutaline

Timolol

Tretoquinol

Tulobuterol

Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose

Aceclofenac

Acemetacin

Acetohexamide

Alclofenac

Alfuzosin

Amlodipine

Apazone

Arbutamine

Benfluorex

Benoxaprofen

Bromfenac

Bufexamac

Bunazosin

Carprofen

Chlorpropamide

Cimetidine

Clometacin

Clonixin

Dexketoprofen

Diclofenac

Diflunisal

Digoxin

Dipyrone

Doxazosin

Droxicam

Etodolac

Etofenamate

Felbinac

Felodipine

Fenbufen

Fenoprofen

Fentiazac

Floctafenine

Flufenamic Acid

Flurbiprofen

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Guar Gum

Ibuprofen

Indomethacin

Indoprofen

Insulin

Insulin Aspart, Recombinant

Insulin Glulisine

Insulin Lispro, Recombinant

Isoxicam

Ketoprofen

Ketorolac

Lacidipine

Lercanidipine

Lornoxicam

Manidipine

Meclofenamate

Mefenamic Acid

Meloxicam

Metformin

Methyldopa

Mibefradil

Miglitol

Moxisylyte

Nabumetone

Naproxen

Nicardipine

Nifedipine

Niflumic Acid

Nilvadipine

Nimesulide

Nimodipine

Nisoldipine

Nitrendipine

Oxaprozin

Oxyphenbutazone

Phenoxybenzamine

Phentolamine

Phenylbutazone

Pirazolac

Piroxicam

Pirprofen

Pranidipine

Prazosin

Propyphenazone

Proquazone

Quinidine

Repaglinide

St John's Wort

Sulindac

Suprofen

Tamsulosin

Tenidap

Tenoxicam

Terazosin

Tiaprofenic Acid

Tolazamide

Tolbutamide

Tolmetin

Trimazosin

Troglitazone

Urapidil

Zomepirac

Interactions with Food/Tobacco/Alcohol

Proper Use of timolol

This section provides information on the proper use of a number of products that contain timolol. It may not be specific to Istalol. Please read with care.

Shake the regular eye drops well just before each use. If you are using the gel-forming eye drops, turn the bottle upside down and shake it once. You do not need to shake the gel-forming eye drops more than once .

To use the eye drops (solution and gel):

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

Immediately after using the medicine, wash your hands to remove any medicine that may be on them.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .

If your doctor ordered two different eye medicines to be used together, wait at least 10 minutes after the regular eye drops before using the second medicine. This will help prevent the second medicine from “washing out” the first one. The gel-forming eye drops should always be the last medicine used if two medicines are ordered. Wait 10 minutes before using the gel-forming eye drops .

You should not use the regular eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 15 minutes after you use the medicine before putting the contact lenses back in .

Dosing

For glaucoma or ocular hypertension:
- For ophthalmic gel-forming solution dosage form (eye drops):
  - Adults—One drop in the affected eye(s) once a day.
  - Children—Use and dose must be determined by your doctor .
- For ophthalmic solution dosage form (eye drops):
  - Adults—One drop in the affected eye(s) two times a day.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Istalol

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .

Timolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

The gel-forming eye drops may cause blurred vision or other vision problems that last about 30 seconds to 5 minutes after you put them in your eye. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these eye changes are bothersome, check with your doctor .

Istalol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

burning or stinging in eye

Less common

Arm, back, or jaw pain

blisters, hives, welts, or itching

blue lips, fingernails, or skin

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in vision

chest pain or discomfort

chest tightness or heaviness

confusion about identity, place, and time

continuing ringing or buzzing or other unexplained noise in ears

coughing that sometimes produces a pink frothy sputum

depression

difficult, fast, noisy breathing, sometimes with wheezing

difficulty in chewing, swallowing, or talking

dilated neck veins

discharge, excessive tearing

disturbed color perception

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

double vision

drooping eyelids

dry or itching eyes

extreme fatigue

false sense of well-being

fast, slow, irregular, pounding, or racing heartbeat or pulse

fear, nervousness

feeling of having something in the eye

fever and chills

flashes of light, floaters in vision

general feeling of discomfort or illness

hair loss

halos around lights

headaches

inability to speak

increased sweating

irregular, fast or slow, or shallow breathing

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lightheadedness, dizziness, or fainting

loss of vision

memory loss

mood swings

muscle or joint pain

muscle weakness

nausea

night blindness

no blood pressure or pulse

overbright appearance of lights

pain, tension, and weakness upon walking that subsides during periods of rest

pale skin

paleness or cold feeling in fingertips, toes, hands, and feet

personality changes

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of skin

redness, pain, swelling or irritation of eye, eyelid, or inner lining of eyelid

seeing double

seeing, hearing, or feeling things that are not there

seizures

severe numbness, especially on one side of the face or body

severe or sudden headache

severe tiredness

shortness of breath or troubled breathing

skin irritation or rash, including rash that looks like psoriasis

slurred speech

sore throat

stopping of heart

sweating

swelling of face, fingers, feet, lower legs, and ankles

swollen glands

temporary blindness

tingling or pain in fingers or toes when exposed to cold

tunnel vision

unconsciousness

unusual tiredness or weakness

weakness in arm and/or leg on one side of the body, sudden and severe

weight gain

wheezing

Less common

Acid or sour stomach

belching

body aches or pain

diarrhea

dry mouth

ear congestion

hearing loss

heartburn

indigestion

lack or loss of strength

loss of appetite

loss of voice

nightmares

runny nose

sleepiness or unusual drowsiness

sleeplessness

sneezing

stomach discomfort, upset, or pain

stuffy nose

trouble sleeping

unable to sleep

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Istalol side effects (in more detail)

More Istalol resources

Istalol Side Effects (in more detail)
Istalol Use in Pregnancy & Breastfeeding
Istalol Drug Interactions
Istalol Support Group
0 Reviews for Istalol - Add your own review/rating

Istalol Prescribing Information (FDA)

Istalol Consumer Overview

Istalol Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Timolol Ophthalmic Prescribing Information (FDA)

Betimol Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Betimol Prescribing Information (FDA)

Compare Istalol with other medications

Glaucoma, Open Angle
Intraocular Hypertension

Propafenone

In the US, Propafenone (propafenone systemic) is a member of the drug class group I antiarrhythmics and is used to treat Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia and Wolff-Parkinson-White Syndrome.

US matches:

Propafenone

Propafenone Sustained-Release Capsules

Propafenone Hydrochloride

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

C01BC03

CAS registry number (Chemical Abstracts Service)

0054063-53-5

Chemical Formula

C21-H27-N-O3

Molecular Weight

341

Therapeutic Category

Antiarrhythmic agent

Chemical Name

1-Propanone, 1-[2-[2-hydroxy-3-(propylamino)propoxy]phenyl]-3-phenyl-

Foreign Names

Propafenonum (Latin)
Propafenon (German)
Propafénone (French)
Propafenona (Spanish)

Generic Names

Propafenone (OS: BAN, DCIT)
Propafénone (OS: DCF)
Propafenone Hydrochloride (OS: BANM, USAN, JAN)
Fenopraine hydrochloride (IS)
SA 79 (IS)
WZ 88462-3 (IS)
Propafenone Hydrochloride (PH: BP 2010, Ph. Eur. 6, USP 32)
Propafenoni hydrochloridum (PH: Ph. Eur. 6)

Brand Names

Polfenon
Polpharma, Poland

Propafenon Hexal
Hexal, Luxembourg

Propafenonã
Arena, Romania

Propafenon-Hexal
Hexal, Luxembourg

Rytmonorm
Abbott, Germany

Apo-Propafenone
Apotex, Canada

Arythmol
Abbott, United Kingdom; Abbott, Ireland

Cardiofenone
Polifarma, Italy

Cuxafenon
TAD, Germany

Fenorit
Scharper, Italy

Gen-Propafenone
Genpharm, Canada

Nistaken
Kendrick, Mexico

Normorytmin
Abbott, Argentina

Profenan
Slaviamed, Serbia

Profex
Taro, Israel

Prolekofen
Lek, Czech Republic; Sandoz, Slovakia

Pronon
Astellas, Japan

Propafen
Heimdall, Colombia; Zorka, Serbia

Propafenon AL
Aliud, Czech Republic; Aliud, Germany; Aliud, Hungary; Aliud, Romania

Propafenon Alkaloid
Alkaloid, Croatia (Hrvatska)

Propafenon Genericon
Genericon, Croatia (Hrvatska)

Propafenon HCl PCH
Pharmachemie, Netherlands

Propafenon Heumann
Heumann, Germany

Propafenon Hexal
Hexal, Germany

Propafenon Pharmavit
Walmark, Hungary

Propafenon Sandoz
Sandoz, Germany

Propafenon Siga
Sigapharm, Germany

Propafenon Stada
Stada, Germany

Propafenon
Alkaloid, Serbia; Alkaloid, Slovenia; Genericon, Austria

Propafenon-CT
CT Arzneimittel, Germany

Propafenone Alter
Alter, Italy

Propafenone DOC
DOC Generici, Italy

Propafenone Hydrochloride
Ethex, United States; KV Pharmaceutical, United States; Mutual, United States; Pliva, United States; Qualitest, United States; United Research, United States; URL, United States; Vintage, United States; Watson, United States

Propafenone Pensa
Pensa, Italy

Propafenone ratiopharm
Ratiopharm, Italy

Propafenone Sandoz
Sandoz, Italy

Propafenon-ratiopharm
Ratiopharm, Germany

Propanorm
Pro.Med.CS, Bosnia & Herzegowina; Pro.Med.CS, Czech Republic; Pro.Med.CS, Estonia; Pro.Med.CS, Georgia; Pro.Med.CS, Lithuania; Pro.Med.CS, Russian Federation; Pro.Med.CS, Slovakia

Ritmocor
Drugtech-Recalcine, Chile

Ritmonorm
Knoll, Brazil

Ropaful
Choseido Pharmaceutical, Japan

Rythmex
Teva, Israel

Rythmol
Abbott, Canada; Abbott, France; Abbott, South Africa; GlaxoSmithKline, United States

Rytmocard
Abbott, Philippines; Sopharma, Bulgaria

Rytmonorm
Abbott, Bosnia & Herzegowina; Abbott, Belgium; Abbott, Bulgaria; Abbott, Switzerland; Abbott, China; Abbott, Colombia; Abbott, Costa Rica; Abbott, Czech Republic; Abbott, Germany; Abbott, Denmark; Abbott, Estonia; Abbott, Spain; Abbott, Finland; Abbott, Georgia; Abbott, Guatemala; Abbott, Hong Kong; Abbott, Honduras; Abbott, Croatia (Hrvatska); Abbott, Hungary; Abbott, Indonesia; Abbott, Iceland; Abbott, Italy; Abbott, Lithuania; Abbott, Luxembourg; Abbott, Latvia; Abbott, Nicaragua; Abbott, Netherlands; Abbott, New Zealand; Abbott, Panama; Abbott, Peru; Abbott, Poland; Abbott, Portugal; Abbott, Romania; Abbott, Russian Federation; Abbott, Sweden; Abbott, Singapore; Abbott, Slovenia; Abbott, Slovakia; Abbott, El Salvador; Abbott, Thailand; Abbott, Turkey; Abbott, Taiwan; Abbott, Venezuela; Ebewe, Bulgaria; Ebewe, Romania; Knoll, United Arab Emirates; Knoll, Bahrain; Knoll, Egypt; Knoll, Iran; Knoll, Jordan; Knoll, Kuwait; Knoll, Lebanon; Knoll, Qatar; Knoll, Saudi Arabia

Rytmonorma
Abbott, Austria

Rytmo-Puren
Actavis, Germany

Sobiral
Ohara Yakuhin, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Efalizumab

In the US, Efalizumab (efalizumab systemic) is a member of the drug class selective immunosuppressants and is used to treat Psoriasis.

US matches:

Efalizumab

Efalizumab Subcutaneous

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

L04AA21

CAS registry number (Chemical Abstracts Service)

0214745-43-4

Therapeutic Category

Selective immunosuppressant

Chemical Name

Immunoglobulin G1, anti - (human antigen CD 11a) (human-mouse monoclonal hu 1124 gamma 1 - chain), disulfide with human-mouse monoclonal hu 1124 light chain, dimer (WHO)

Foreign Names

Efalizumabum (Latin)
Efalizumab (German)
Efalizumab (French)
Efalizumab (Spanish)

Generic Names

Efalizumab (OS: USAN)
anti - CD 11a (IS)
anti - CD 11a MAb (IS)
hu 1124 (IS)
Humanized MHM 24 (IS)

Brand Names

Raptiva
EMD Serono, Canada; Genentech, Bulgaria; Genentech, United States; Merck, Croatia (Hrvatska); Merck Serono, Australia; Merck Serono, Denmark; Serono, Argentina; Serono, Brazil; Serono, Hong Kong; Serono, Israel; Serono, Iceland; Serono, Norway; Serono, Oman; Serono, Serbia; Serono, Singapore; Serono, Slovenia; Serono, Turkey

International Drug Name Search

Glossary

IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Monday, 26 September 2016

Mumps Pancreatitis Medications

There are currently no drugs listed for "Mumps Pancreatitis".

Definition of Mumps Pancreatitis: Mumps Pancreatitis is a complications of mumps, which causes pain in the upper abdomen.

Learn more about Mumps Pancreatitis

Micromedex Care Notes:

Mumps

Medical Encyclopedia:

Acute pancreatitis

Drug List:

Alfuzosina EG

Alfuzosina EG may be available in the countries listed below.

Ingredient matches for Alfuzosina EG

Alfuzosin

Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosina EG in the following countries:

Italy

International Drug Name Search

Flucloxin

Flucloxin may be available in the countries listed below.

Ingredient matches for Flucloxin

Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Flucloxin in the following countries:

Bangladesh

New Zealand

Taiwan

International Drug Name Search

Pentazocine and Naloxone Hydrochloride

Ingredient matches for Pentazocine and Naloxone Hydrochloride

Naloxone

Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Pentazocine and Naloxone Hydrochloride in the following countries:

United States

Pentazocine

Pentazocine hydrochloride (a derivative of Pentazocine) is reported as an ingredient of Pentazocine and Naloxone Hydrochloride in the following countries:

United States

International Drug Name Search

Furosemid Helvepharm

Furosemid Helvepharm may be available in the countries listed below.

Ingredient matches for Furosemid Helvepharm

Furosemide

Furosemide is reported as an ingredient of Furosemid Helvepharm in the following countries:

Switzerland

International Drug Name Search

Friday, 23 September 2016

Pamine Forte

Pronunciation: meth-skoe-POL-uh-meen
Generic Name: Methscopolamine
Brand Name: Pamine and Pamine Forte

Pamine Forte is used for:

Treating peptic ulcers in combination with other medicines. It also may be used for other conditions as determined by your doctor.

Pamine Forte is an anticholinergic. It works by decreasing stomach acid production and by relaxing the muscles in the stomach and intestines.

Do NOT use Pamine Forte if:

you are allergic to any ingredient in Pamine Forte

you have glaucoma, blockage of the bladder, certain problems with your esophagus (eg, decreased esophageal motility, severe irritation caused by reflux), certain stomach or intestinal problems (eg, blockage, lack of muscle tone, or ulcerative colitis), heart problems caused by blood loss, or muscle problems (eg, myasthenia gravis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pamine Forte:

Some medical conditions may interact with Pamine Forte. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have nerve problems, severe bowel problems, prostate problems, heart problems, heart failure, a hernia, a predisposition of glaucoma or open-angle glaucoma, or urinary retention

Some MEDICINES MAY INTERACT with Pamine Forte. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticholinergic medicines (eg, benztropine, hyoscyamine, or trihexyphenidyl), certain medicines for mental or mood disorders (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Pamine Forte's side effects

Beta-blockers (eg, propanolol) or digoxin because the risk of their side effects may be increased by Pamine Forte

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pamine Forte may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pamine Forte:

Use Pamine Forte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Pamine Forte by mouth 30 minutes before meals and at bedtime, or as directed by your health care provider.

Do not take an antacid within 1 hour before or 2 hours after you take Pamine Forte.

If you miss a dose of Pamine Forte, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pamine Forte.

Important safety information:

Pamine Forte may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pamine Forte with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Pamine Forte may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Pamine Forte may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pamine Forte without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Antacids may decrease the effectiveness of Pamine Forte. Talk to your doctor before taking any antacids while taking Pamine Forte.

Use Pamine Forte with caution in the ELDERLY; they may be more sensitive to its effects, especially if they have weak intestines or constipation.

Pamine Forte should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pamine Forte while you are pregnant. It is not known if Pamine Forte is found in breast milk. Do not breast-feed while taking Pamine Forte.

Possible side effects of Pamine Forte:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; difficulty sleeping; dilation of pupils; dizziness; drowsiness; dry mouth; headache; loss of taste; nausea; nervousness; urinary hesitancy or retention.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heartbeat; diarrhea; difficulty focusing your eyes; difficulty urinating; pounding in the chest; rapid heart rate; unusual weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pamine Forte side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal behavior; blurred vision; circulatory problems; coma; difficulty breathing; dilated pupils; disorientation; excessive thirst; excitement; flushing; low blood pressure; muscle weakness; nausea; paralysis; restlessness; seizures; unusual dizziness or drowsiness; unusually dry mouth; vomiting.

Proper storage of Pamine Forte:

Store Pamine Forte between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pamine Forte out of the reach of children and away from pets.

General information:

If you have any questions about Pamine Forte, please talk with your doctor, pharmacist, or other health care provider.

Pamine Forte is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pamine Forte. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Pamine Forte resources

Pamine Forte Side Effects (in more detail)
Pamine Forte Use in Pregnancy & Breastfeeding
Pamine Forte Drug Interactions
Pamine Forte Support Group
3 Reviews for Pamine Forte - Add your own review/rating

Pamine Forte Concise Consumer Information (Cerner Multum)

Methscopolamine Prescribing Information (FDA)

Methscopolamine Bromide Monograph (AHFS DI)

Pamine Prescribing Information (FDA)

Compare Pamine Forte with other medications

Irritable Bowel Syndrome
Peptic Ulcer

Legendal

Legendal may be available in the countries listed below.

Ingredient matches for Legendal

Lactulose

Lactulose is reported as an ingredient of Legendal in the following countries:

Netherlands

Switzerland

International Drug Name Search

Risperidon Streuli

Risperidon Streuli may be available in the countries listed below.

Ingredient matches for Risperidon Streuli

Risperidone

Risperidone is reported as an ingredient of Risperidon Streuli in the following countries:

Switzerland

International Drug Name Search

Fenpipramide Hydrochloride

Fenpipramide Hydrochloride may be available in the countries listed below.

Ingredient matches for Fenpipramide Hydrochloride

Fenpipramide

Fenpipramide Hydrochloride (BANM) is also known as Fenpipramide (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ranitidine-Merck

Ranitidine-Merck may be available in the countries listed below.

Ingredient matches for Ranitidine-Merck

Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidine-Merck in the following countries:

France

Luxembourg

Netherlands

International Drug Name Search

Risperdal

Generic Name: Risperidone
Class: Atypical Antipsychotics
VA Class: CN709
Chemical Name: 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8, 9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
Molecular Formula: C₂₃H₂₇FN₄O₂
CAS Number: 106266-06-2

Special Alerts:

[Posted 06/13/2011] ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.

The FDA determined that the factors contributing to the confusion between the two products include:

Similarities of both the brand (proprietary) and generic (established) names

Similarities of the container labels and carton packaging

Illegible handwriting on prescriptions

Overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.

BACKGROUND: Risperidone (Risperdal) is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autistic disorder. Ropinirole (Requip) is a dopamine agonist used in the treatment of Parkinson’s disease and Restless Legs Syndrome.

RECOMMENDATION: Healthcare Professionals are reminded to clearly print or spell out the medication name on prescriptions and make certain their patients know the name of their prescribed medication and their reason for taking it. For more information visit the FDA website at: and .

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

Increased Mortality in Geriatric Patients

Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., risperidone, aripiprazole, olanzapine, quetiapine) compared with those receiving placebo (2.6%).⁹⁸ ^a ^b

Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).⁹⁸ ^a ^b

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.⁹⁸ ^a ^b (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

Introduction

Atypical or second-generation antipsychotic agent.¹ ² ³ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ⁶⁰

Uses for Risperdal

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Schizophrenia

Symptomatic management of schizophrenia.¹ ⁶⁰ ¹⁰³ ¹⁰⁴

Bipolar Disorder

Short-term management (alone or in combination with lithium or divalproex sodium) of acute manic or mixed episodes associated with bipolar I disorder.¹ ⁹⁹ ¹⁰⁰ ¹⁰¹

Autistic Disorders

Management of severe behavioral problems associated with autistic disorders†; not shown to improve core symptoms of autism (e.g., language deficits, social withdrawal).³¹ ³² ³³ ³⁴

Risperdal Dosage and Administration

Administration

Administer orally or IM.¹ ^b

Establish tolerability with oral risperidone prior to initiating IM therapy.^b

Oral Administration

Administer orally once or twice (in equally divided doses) daily without regard to meals.¹ ¹⁴

Just prior to administration of orally disintegrating tablet, remove blister from aluminum blister pack or child-resistant pouch; with dry hands, peel open blister package, place tablet on tongue to dissolve, and swallow with or without liquids.^a Do not chew or divide orally disintegrating tablet.¹

Oral solution may be administered with compatible beverages.¹ (See Compatibility under Stability.)

When switching from other antipsychotic agents to risperidone, abrupt discontinuance of previous agent may be acceptable for some patients, but gradual discontinuance may be appropriate for others.¹ In all cases, minimize period of overlapping antipsychotic administration.¹

In patients being switched from long-acting (depot) parenteral antipsychotic therapy to oral risperidone therapy, administer first oral dose in place of next scheduled dose of the long-acting preparation.¹

IM Administration

Administer by deep IM injection into upper outer quadrant of the gluteal area every 2 weeks, alternating buttocks.¹⁰³ Do not administer IV.¹⁰³

Administer only with needle and other components of dose pack supplied by manufacturer.¹⁰³

Do not combine 2 different strengths of IM risperidone in a single administration.¹⁰³

Reconstitution

Consult manufacturer’s labeling for instructions for using components of dose pack for reconstitution.¹⁰³

Allow the risperidone dose pack to reach room temperature before reconstituting.¹⁰³

Reconstitute vial containing risperidone extended-release microspheres only with diluent in prefilled syringe supplied by manufacturer.¹⁰³ Inject entire contents of prefilled syringe and shake vial vigorously while holding plunger rod down with thumb for ≥10 seconds to ensure a homogeneous suspension (appears uniform, thick, milky).¹⁰³

Upon suspension in diluent, immediate use is recommended because suspension will settle over time.¹⁰³ If >2 minutes pass before administration, shake vigorously to resuspend.¹⁰³ Must be used within 6 hours of reconstitution.¹⁰³

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

If reinitiated after a drug-free period, titrate oral dosage as with initial therapy.¹

Adults

Schizophrenia

Oral

Initially, 1 mg twice daily, with increases in increments of 1 mg twice daily on second and third day, as tolerated, to target dosage of 6–8 mg daily (once daily or in 2 equally divided doses) recommended by manufacturer.¹ Make subsequent dosage adjustments at intervals of ≥7 days.¹ ²

Alternatively, an initial dosage of 1–2 mg daily, with increases in increments of 0.5–1 mg daily titrated over 6–7 days, as tolerated, to target dosage of 4 mg daily may be more appropriate in most otherwise healthy adult patients.³⁰

Lower initial dosages (e.g., 1 mg daily) and slower dosage titrations to an initial target dosage of 2 mg daily may be appropriate for younger patients and those being treated for their first psychotic episode.³⁰ Titrate dosage up to 4 mg daily depending on clinical response and adverse neurologic effects; 1–3 mg may be optimal.³⁰

Maximal efficacy generally observed in dosage range of 4–8 mg daily; dosages >6 mg daily did not result in greater efficacy, but were associated with more adverse effects (e.g., extrapyramidal symptoms).¹ ¹⁵ ³⁰

Efficacy maintained for up to 2 years, but optimum duration of therapy currently is not known.¹ ²³ In responsive patients, continue as long as clinically necessary and tolerated, but at lowest possible effective dosage; periodically reassess need for continued therapy.¹ ^b

IM

25 mg IM every 2 weeks.¹⁰³

Administer oral risperidone (or another antipsychotic agent) with the first IM risperidone injection and continue oral therapy for 3 weeks thereafter to ensure adequate therapeutic plasma concentrations are maintained prior to main release of risperidone from injection site.¹⁰³ (See Bioavailability and Plasma Concentrations under Pharmacokinetics.)

Some patients not responding to 25 mg may benefit from dosages of 37.5 or 50 mg IM every 2 weeks, although dose response for efficacy not established.¹⁰³

Increase dosage at intervals of 4 weeks.¹⁰³

If reinitiating IM risperidone after a drug-free period, administration of oral risperidone (or another antipsychotic agent) for supplementation will be needed.¹⁰³

Bipolar Disorder

Acute Manic or Mixed Episodes

Oral

Initially 2–3 mg once daily.¹⁰⁴ ⁹⁹ ¹⁰⁰ ¹⁰¹

Adjust dosage, if indicated, in increments or decrements of 1 mg daily at intervals of not less than 24 hours.¹⁰⁴ ⁹⁹

Antimanic efficacy demonstrated in dosage range of 1–6 mg daily; dosages >6 mg daily not studied.¹⁰⁴ ⁹⁹

Not studied >3 weeks.¹⁰⁴ If elect to use risperidone for extended periods, periodically reevaluate long-term risks and benefits for the individual patient.¹⁰⁴

Prescribing Limits

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adults

Schizophrenia

Oral

Dosages >6 mg (in 2 divided doses) generally not recommended; safety of dosages >16 mg daily not established.¹

IM

Maximum 50 mg every 2 weeks.¹⁰³

Bipolar Disorder

Acute Manic or Mixed Episodes

Oral

Safety and efficacy of dosages >6 mg not established.¹

Special Populations

Hepatic Impairment

Oral: Initially, 0.5 mg twice daily in patients with severe hepatic impairment; increase dosage in increments of ≤0.5 mg twice daily.¹ If increase in dosage beyond 1.5 mg twice daily is planned, adjust at intervals of at least 1 week; slower titration may be appropriate in some patients.¹

IM: Titrate oral therapy prior to initiation of IM therapy in patients with hepatic impairment; if an oral dosage of ≥2 mg daily is well tolerated, administer 25 mg IM every 2 weeks.¹⁰³ Administer oral risperidone with the first IM risperidone injection and continue oral supplementation for 3 weeks thereafter.¹⁰³

Renal Impairment

Oral: Initially, 0.5 mg twice daily in patients with severe renal impairment; increase dosage in increments of ≤0.5 mg twice daily.¹ If increase in dosage beyond 1.5 mg twice daily is planned, adjust at intervals of at least 1 week; slower titration may be appropriate in some patients.¹

IM: Titrate oral therapy prior to initiation of IM therapy in patients with renal impairment; if an oral dosage of ≥2 mg daily is well tolerated, administer 25 mg IM every 2 weeks.¹⁰³ Administer oral risperidone with first IM risperidone injection and continue oral supplementation for 3 weeks thereafter.¹⁰³

Geriatric, Debilitated, or Hypotensive Patients

Oral: Initially, 0.5 mg twice daily in geriatric or debilitated patients and patients either predisposed to hypotension or for whom hypotension would pose a risk; increase dosage in increments of ≤0.5 mg twice daily.¹ If increase in dosage beyond 1.5 mg twice daily is planned, adjust at intervals of at least 1 week; slower titration may be appropriate in some patients.¹ If a once-daily dosage regimen is considered, titrate on a twice-daily regimen for 2–3 days at the target dosage before switching to a once-daily regimen.¹⁰³

Alternatively, in geriatric patients, initially give 0.25 mg daily; gradually increase dosage as tolerated.³⁰

IM: 25 mg every 2 weeks in otherwise healthy geriatric patients.¹⁰³ Administer oral risperidone with the first IM risperidone injection and continue oral supplementation for 3 weeks thereafter.¹⁰³

Cautions for Risperdal

Contraindications

Known hypersensitivity to risperidone or any ingredient in the formulation.¹ ¹⁰³

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Increased Mortality in Geriatric Patients with Dementia-related Psychosis

Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.⁹⁸ ¹⁰³ ^a

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.⁹⁸ ¹⁰³ ^a (See Boxed Warning and see Geriatric Use under Cautions.)

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported in patients receiving antipsychotic agents.¹

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, has been reported.¹ ²¹ Consider discontinuance of risperidone.¹

Cerebrovascular Effects

Adverse cerebrovascular effects (e.g., stroke, TIA), sometimes fatal, reported in geriatric patients (73–97 years of age) with dementia-related psychosis receiving risperidone.¹ (See Geriatric Use under Cautions.)

Hyperglycemia and Diabetes Mellitus

Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents, including risperidone.¹ ⁴⁴ ⁴⁵ ⁴⁶ ⁴⁷ ⁴⁸ ⁴⁹ ⁵⁰ ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁷¹ ⁷² ⁷³ ⁷⁴ ⁷⁸ ⁹⁷ Closely monitor patients with preexisting diabetes mellitus for worsening of glucose control and perform fasting glucose tests at baseline and periodically for patients with risk factors for diabetes (e.g., obesity, family history of diabetes).¹ ⁴⁵ ⁴⁶ ⁴⁷ ⁴⁸ ⁴⁹ ⁵⁰ ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ If manifestations of hyperglycemia occur, test for diabetes mellitus.¹ ⁴⁵ ⁴⁶ ⁴⁷ ⁴⁸ ⁴⁹ ⁵⁰ ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶

General Precautions

Orthostatic Hypotension

Orthostatic hypotension reported.¹ Use with caution in patients with known cardiovascular or cerebrovascular conditions that would predispose them to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy), in geriatric patients, and in patients with renal or hepatic impairment.¹ ¹⁰³

Nervous System Effects

Possible risk of seizures.¹

Disruption of ability to regulate core body temperature possible; both hypothermia and hyperthermia reported.¹⁰³ ¹⁰⁴ Use caution in patients exposed to temperature extremes.¹⁰³ ¹⁰⁴

Somnolence reported.¹ Potential impairment of judgment, thinking, or motor skills.¹

Antiemetic effect demonstrated in animals; also may occur in humans and mask manifestations of overdosage with certain drugs or of underlying conditions (e.g., intestinal obstruction, Reye’s syndrome, brain tumor).¹

GI Effects

Esophageal dysmotility and aspiration possible; use with caution in patients at risk for aspiration pneumonia (e.g., those with advanced Alzheimer’s dementia).

Hematologic Effects

Thrombotic thrombocytopenic purpura reported in at least one patient; relationship to risperidone not established.¹

Suicide

Attendant risk with psychotic illnesses; closely supervise high-risk patients.¹ Prescribe oral risperidone in the smallest quantity consistent with good patient management to reduce the risk of overdosage.¹

Sexual Dysfunction

Priapism reported rarely with oral risperidone.¹

Endocrine Effects

Elevated prolactin concentrations possible, which persist during chronic administration.¹

Metabolic Effects

Weight gain possible.¹

Phenylketonuria

Each 0.5, 1, 2, 3, or 4 mg Risperdal M-TAB orally disintegrating tablet contains aspartame (e.g., Nutrasweet), which is metabolized in the GI tract to provide 0.14, 0.28, 0.42, 0.63, or 0.84 mg of phenylalanine per tablet, respectively.³⁹ ⁴⁰ ⁴¹ ⁴² ⁴³ ^a

Osteodystrophy and Tumors in Animals

Osteodystrophy, renal tubular tumors, and adrenomedullary pheocytochromocytomas demonstrated in rats following IM administration of extended-release risperidone; not observed previously with oral risperidone.¹⁰³ Relevance to humans currently not known.¹⁰³

Concomitant Illnesses

Experience in patients with certain concomitant diseases is limited.^a ^b

Possible increased risk of NMS and increased sensitivity to antipsychotic agents in patients with parkinsonian syndrome or dementia with Lewy bodies; manifestations of sensitivity may include confusion, obtundation, postural instability with more frequent falling, or extrapyramidal adverse effects¹⁰⁴ ^a ^b

Patients with recent history of MI or unstable heart disease generally were excluded from premarketing clinical studies.^a ^b Use with caution in patients with altered metabolism or hemodynamics.^a ^b

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.¹ ¹⁰³

Lactation

Risperidone and an active metabolite (9-hydroxyrisperidone) are distributed into milk.¹ ¹⁰³ Women receiving oral risperidone should not breast-feed.¹ Women treated with extended-release IM risperidone should not breast-feed during or for at least 12 weeks after the last injection.¹⁰³

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ¹⁰³ However, has been used in a limited number of children 5–7 years of age for treatment of autistic disorders.³¹ ³³ (See Autistic Disorders under Uses.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹ Use with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly. (See Boxed Warning and see Cerebrovascular Effects under Cautions.)¹

Minimize risk of orthostatic hypotension with lower initial dosage and careful dosage titration; monitor orthostatic vital signs in patients for whom hypotension is a concern.¹ (See Special Populations under Dosage and Administration and see Orthostatic Hypotension under Cautions.)

No differences in tolerance of extended-release IM risperidone were observed in one study in patients ≥65 years of age with schizophrenia or schizoaffective disorder; no dosage adjustment recommended for otherwise healthy geriatric patients.¹⁰³

Increased mortality reported in geriatric patients receiving risperidone concomitantly with furosemide (but not other diuretics) for the management of dementia-related psychosis.^a ^b

Possible increased risk of death in geriatric patients with dementia-related psychosis regardless of concomitant use with furosemide.⁹⁸ ^a ^b Substantial (1.6- to 1.7-fold) increase in mortality rate reported in geriatric patients with dementia who received atypical antipsychotic agents (e.g., risperidone, aripiprazole, olanzapine, quetiapine) for treatment of behavioral disorders; most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).⁹⁸ ^a ^b In addition, adverse cerebrovascular effects, sometimes fatal, reported in geriatric patients with dementia-related psychosis receiving risperidone.¹ (See Cerebrovascular Effects under Cautions.)

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.⁹⁸ ^a ^b (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

Hepatic Impairment

Possible increases in risperidone free fraction, resulting in enhanced effect; dosage adjustment recommended.¹ (See Special Populations under Dosage and Administration.)

Renal Impairment

Possible decreased elimination compared with normal adults; dosage adjustment recommended.¹ (See Special Populations under Dosage and Administration.)

Common Adverse Effects

Anxiety, somnolence, extrapyramidal symptoms, dizziness, constipation, nausea, dyspepsia, rhinitis, rash, tachycardia, dystonia, akathisia, abnormal vision, increased saliva, fatigue, weight increase.¹ ^a ^b

Interactions for Risperdal

Metabolized by CYP2D6 to 9-hydroxyrisperidone, which has similar pharmacologic activity.^a ^b May weakly inhibit CYP2D6.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP2D6; potential pharmacokinetic interaction (altered risperidone metabolism and plasma concentrations of the active moiety [risperidone plus 9-hydroxyrisperidone]).¹ (See Metabolism under Pharmacokinetics.) In vitro, drugs metabolized by CYP1A1, CYP1A2, CYP2C9, CYP2C19, and CYP3A4 only weakly inhibit risperidone metabolism.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Drugs metabolized by CYP2D6; substantial pharmacokinetic interaction unlikely.¹

Specific Drugs¹

Drug	Interaction	Comments
Alcohol	Possible additive CNS effects¹	Advise patients to avoid alcohol¹
Amitriptyline	No effects on pharmacokinetics of risperidone or active antipsychotic moiety^a ^b
Carbamazepine	Decreased plasma risperidone and 9-hydroxyrisperidone concentrations¹	Titrate risperidone dosage accordingly, particularly during carbamazepine initiation or discontinuance¹ Patients receiving IM risperidone may need dosage increase or supplemental oral risperidone when carbamazepine is initiated; consider reducing IM risperidone dosage 2–4 weeks before discontinuance of carbamazepine¹⁰³
Cimetidine	Increased risperidone bioavailability, but no effect on AUC of active antipsychotic moiety^a ^b
Clozapine	Possible decreased risperidone clearance¹
CNS agents	Additive CNS effects¹
Digoxin	No clinically relevant effect on digoxin pharmacokinetics¹
Donepezil	No substantial effects on donepezil pharmacokinetics¹
Dopamine agonists	Possible antagonistic effects¹
Erythromycin	No substantial interactions¹
Fluoxetine	Increased plasma risperidone concentrations; no effect on 9-hydroxyrisperidone concentrations¹ ¹⁰³	Reevaluate risperidone dosage during fluoxetine initiation or discontinuance;¹ consider reducing dosage of IM risperidone 2–4 weeks before initiating fluoxetine¹⁰³
Galantamine	No substantial effects on galantamine pharmacokinetics¹
Hypotensive agents	Additive hypotensive effects¹	Use with caution¹
Levodopa	Possible antagonistic effects¹
Lithium	No effect on lithium AUC or peak plasma concentrations¹
Paroxetine	Increased plasma risperidone concentrations, decreased plasma 9-hydroxyrisperidone (active metabolite) concentrations, and increased plasma concentrations of active antipsychotic moiety¹ ^c ^d Generally well tolerated; possible risk of parkinsonian symptoms^d	Monitor patients carefully and consider possible monitoring of plasma risperidone concentrations;^d reevaluate risperidone dosage during paroxetine initiation or discontinuance¹ Consider lower initial dosage of paroxetine (10–20 mg daily)^d
Phenobarbital	Possible decreased plasma risperidone and 9-hydroxyrisperidone concentrations¹	Decreased risperidone efficacy possible¹ Patients receiving IM risperidone may need dosage increase or supplemental oral risperidone when phenobarbital is initiated; consider reducing IM risperidone dosage 2–4 weeks before discontinuance of phenobarbital¹⁰³
Phenytoin	Possible decreased plasma risperidone and 9-hydroxyrisperidone concentrations¹	Decreased risperidone efficacy possible¹ Patients receiving IM risperidone may need dosage increase or supplemental oral risperidone when phenytoin is initiated; consider reducing IM risperidone dosage 2–4 weeks before discontinuance of phenytoin¹⁰³
Ranitidine	Increased risperidone bioavailability and AUC of active antipsychotic fraction^a ^b
Rifampin	Possible decreased plasma risperidone and 9-hydroxyrisperidone concentrations¹	Decreased risperidone efficacy possible¹ Patients receiving IM risperidone may need dosage increase or supplemental oral risperidone when rifampin is initiated; consider reducing IM risperidone dosage 2–4 weeks before discontinuance of rifampin¹⁰³
Valproate	Possible increase in peak plasma valproate concentration¹

Risperdal Pharmacokinetics

Absorption

Bioavailability

Well absorbed after oral administration, with peak plasma concentrations attained in approximately 1 hour.¹

Absolute bioavailability is 70%; relative oral bioavailability from a tablet is 94% compared with a solution.¹

Commercially available conventional and orally disintegrating tablets and oral solution are bioequivalent.¹

After IM administration, there is a small initial release of the drug (<1% of dose) followed by a 3-week lag time; main drug release starts from 3 weeks onward and is maintained for 4–6 weeks.¹⁰³

Food

Food does not affect rate or extent of absorption.¹

Plasma Concentrations

With IM administration of extended-release injection risperidone every 2 weeks, steady-state plasma concentrations achieved after 4 doses and are maintained 4–6 weeks after the last injection.¹⁰³

Distribution

Extent

Rapidly distributed.¹ Crosses the placenta in rats; not known if crosses the placenta in humans.¹ Risperidone and its active metabolite distribute into milk.¹

Plasma Protein Binding

90% (mainly albumin and α₁-acid glycoprotein); major active metabolite (9-hydroxyrisperidone) is 77% protein bound.¹

Elimination

Metabolism

Extensively metabolized, principally in the liver via CYP2D6, to an active metabolite (9-hydroxyrisperidone); N-dealkylation is minor metabolic pathway.¹

9-Hydroxyrisperidone has similar pharmacologic activity to parent drug; clinical effects result from combined concentrations of risperidone and 9-hydroxyrisperidone.^a ^b

Elimination Route

Excreted principally in urine (70%) and to much lesser extent, in feces (14%).¹

Half-life

After oral administration, overall mean elimination half-life for active moiety (risperidone plus 9-hydroxyrisperidone) is about 20 hours.¹

After IM administration, apparent half-life of active moiety is 3–6 days.¹⁰³ Elimination phase is complete approximately 7–8 weeks after last injection.¹⁰³

Special Populations

In patients with moderate to severe renal impairment, total active moiety clearance (i.e., sum of risperidone and its active metabolite) is decreased by 60% compared with that of young healthy adults.¹ Dosage adjustment recommended.¹ (See Special Populations under Dosage and Administration.)

In patients with hepatic impairment, pharmacokinetics were similar to those in young healthy adults; however, the mean free-fraction of risperidone in plasma was increased by about 35% due to diminished albumin and α₁-acid glycoprotein concentrations.¹ Dosage adjustment recommended.¹ (See Special Populations under Dosage and Administration.)

In geriatric patients receiving oral risperidone, renal clearance was decreased and half-lives were prolonged for both risperidone and its active metabolite compared with younger adults.¹ Adjust dosage accordingly.¹ However, in otherwise healthy patients ≥65 years of age treated with IM risperidone for up to 12 months, pharmacokinetics were similar to younger adults; no dosage adjustment recommended in such patients.¹⁰³

CYP2D6 is subject to genetic polymorphism; extensive metabolizers convert risperidone rapidly into 9-hydroxyrisperidone, while poor metabolizers convert it much more slowly.¹ Although extensive metabolizers have lower risperidone and higher 9-hydroxyrisperidone concentrations, the pharmacokinetics of the active moiety are similar after single and multiple doses in extensive and poor metabolizers.¹

Stability

Storage

Oral

Tablets

15–25°C.¹ Protect from light and moisture.¹

Orally Disintegrating Tablets

15–25°C.¹ Do not remove from manufacturer’s pack.^a

Solution

15–25°C.¹ Protect from light and freezing.¹

Parenteral

Extended-release Injection

Store entire dose pack at 2–8°C; protect from light.¹⁰³ If refrigeration unavailable, store at temperatures not >25°C for ≤7 days prior to administration.¹⁰³

After mixing with diluent, use within 6 hours of suspension; do not expose to temperatures >25°C.¹⁰³

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Solution

May be mixed with water, coffee, orange juice, or low-fat milk.¹ Not compatible with cola or tea.¹

ActionsActions

Exact mechanism of antipsychotic action has not been fully elucidated; may involve antagonism of central type 2 serotonergic (5-HT₂) receptors and central dopamine D₂ receptors.¹ ² ³ ⁸ ¹⁰ ¹² ¹³ ¹⁵

Antagonism at other receptors (e.g., α₁- and α₂-adrenergic receptors, histamine H₁ receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence).¹

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Risk of somnolence.¹ Importance of avoiding driving, operating machinery, or performing hazardous tasks until gain experience with drug’s effects.¹

Risk of orthostatic hypotension.¹ ¹⁰³ Importance of using nonpharmacologic methods (e.g., sitting on edge of bed for several minutes upon waking, slowly rising from sitting to standing position) to minimize effects.¹⁰³

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).^a ^b

Importance of avoiding alcohol during risperidone therapy.¹

Importance of avoiding overheating or dehydration.^a ^b

Importance of informing patients with phenylketonuria that risperidone orally disintegrating tablets contain aspartame.³⁹ ⁴⁰ ⁴¹ ⁴² ⁴³ ^a

Importance of women informing clinicians if they are or plan to become pregnant during oral risperidone therapy or for 12 weeks after last risperidone IM injection.¹ ¹⁰³

Breast-feeding not recommended.¹ ¹⁰³ Importance of women informing clinicians if they are or plan to breast-feed during oral risperidone therapy or for 12 weeks after last IM risperidone IM injection.¹ ¹⁰³

Importance of informing patients of other important precautionary information.¹ ¹⁰³ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Risperidone
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	1 mg/mL	Risperdal	Janssen
	Tablets	0.25 mg	Risperdal (with propylene glycol; scored)	Janssen
		0.5 mg	Risperdal (with propylene glycol; scored)	Janssen
		1 mg	Risperdal (with propylene glycol; scored)	Janssen
		2 mg	Risperdal (with propylene glycol; scored)	Janssen
		3 mg	Risperdal (with propylene glycol; scored)	Janssen
		4 mg	Risperdal (with propylene glycol; scored)	Janssen
	Tablets, orally disintegrating	0.5 mg	Risperdal M-TAB (with aspartame)	Janssen
		1 mg	Risperdal M-TAB (with aspartame)	Janssen
		2 mg	Risperdal M-TAB (with aspartame)	Janssen
		3 mg	Risperdal M-TAB (with aspartame)	Janssen
		4 mg	Risperdal M-TAB (with aspartame)	Janssen
Parenteral	For injectable suspension, extended-release, for IM use	25 mg	Risperdal Consta (available as dose pack containing a SmartSite needle-free vial access device, a Needle-Pro safety needle, and with 2 mL prefilled syringe diluent)	Janssen
		37.5 mg	Risperdal Consta (available as dose pack containing a SmartSite needle-free vial access device, a Needle-Pro safety needle, and with 2 mL prefilled syringe diluent)	Janssen
		50 mg	Risperdal Consta (available as dose pack containing a SmartSite needle-f

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Other Medical Problems

Proper Use of timolol

Dosing

Missed Dose

Storage

Precautions While Using Istalol

Istalol Side Effects

More Istalol resources

Compare Istalol with other medications

Scheme

ATC (Anatomical Therapeutic Chemical Classification)