Piperal

Piperal may be available in the countries listed below.

Ingredient matches for Piperal

Piperacillin

Piperacillin is reported as an ingredient of Piperal in the following countries:

• Tunisia

International Drug Name Search

Fexodine

Fexodine may be available in the countries listed below.

Ingredient matches for Fexodine

Fexofenadine

Fexofenadine hydrochloride (a derivative of Fexofenadine) is reported as an ingredient of Fexodine in the following countries:

• Bahrain


• Oman

International Drug Name Search

Pizotifen Malate

Pizotifen Malate may be available in the countries listed below.

Ingredient matches for Pizotifen Malate

Pizotifen

Pizotifen Malate (BANM) is also known as Pizotifen (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.

Pulmo-Timelets

Pulmo-Timelets may be available in the countries listed below.

Ingredient matches for Pulmo-Timelets

Theophylline

Theophylline is reported as an ingredient of Pulmo-Timelets in the following countries:

• Indonesia

International Drug Name Search

PVP-Jod Hexal

PVP-Jod Hexal may be available in the countries listed below.

Ingredient matches for PVP-Jod Hexal

Povidone Iodine

Povidone-Iodine is reported as an ingredient of PVP-Jod Hexal in the following countries:

• Germany

International Drug Name Search

Piperital

Piperital may be available in the countries listed below.

Ingredient matches for Piperital

Piperacillin

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

• Italy

International Drug Name Search

Betoptic S

betaxolol hydrochloride

Dosage Form: ophthalmic suspension
FULL PRESCRIBING INFORMATION

Indications and Usage for Betoptic S

Betoptic S® Ophthalmic Suspension 0.25% is indicated for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Betoptic S Dosage and Administration

Instill one drop of Betoptic S® Ophthalmic Suspension 0.25% in the affected eye(s) twice daily. It may be used alone or in combination with other intraocular pressure lowering medications.

Dosage Forms and Strengths

Bottle filled with 2.5, 5, 10, and 15 mL of 0.25% sterile ophthalmic suspension

Contraindications

Betoptic S® Suspension is contraindicated in patients with:

• sinus bradycardia

• greater than a first degree atrioventricular block

• cardiogenic shock

• patients with overt cardiac failure

• hypersensitivity to any component of this product.

Warnings and Precautions

General

As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported with topical application of beta-adrenergic receptor inhibitors.

Cardiac Failure

Betoptic S® Suspension has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betoptic S® should be discontinued at the first signs of cardiac failure.

Diabetes Mellitus

Beta-adrenergic receptor inhibitors should be administered with caution in patients subject to hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. 


Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis

Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic receptor inhibitors, which might precipitate a thyroid storm.

Muscle Weakness

Beta-adrenergic receptor inhibitors have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

Surgical Anesthesia

The necessity or desirability of withdrawal of beta-adrenergic receptor inhibitors prior to major surgery is controversial. Beta-adrenergic receptor inhibitors impair the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor inhibitors have experienced protracted, severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. In patients undergoing elective surgery, consider gradual withdrawal of beta-adrenergic receptor inhibitors. If necessary during surgery, the effects of beta-adrenergic receptor inhibitors may be reversed by sufficient doses of adrenergic agonists.

Bronchospasm and Obstructive Pulmonary Disease

Caution should be exercised in the treatment of glaucoma patients with excessive restriction of pulmonary function. There have been reports of asthmatic attacks and pulmonary distress during betaxolol treatment. Although re-challenges of some such patients with ophthalmic betaxolol has not adversely affected pulmonary function test results, the possibility of adverse pulmonary effects in patients sensitive to beta-adrenergic receptor inhibitors cannot be ruled out.

Atopy/Anaphylaxis

While taking beta-adrenergic receptor inhibitors, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Angle-Closure Glaucoma

In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle. This may require constricting the pupil. Betaxolol has little or no effect on the pupil and should not be used alone in the treatment of angle-closure glaucoma.

Cerebrovascular Insufficiency

Because of potential effects of beta-adrenergic receptor inhibitors on blood pressure and pulse, these inhibitors should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Betoptic S®, alternative therapy should be considered.

Bacterial Keratitis

Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products when these containers are inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Instruct patients on appropriate instillation techniques. [see Patient Counseling Information (17)].

Choroidal Detachment

Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.

Adverse Reactions

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, the most frequent adverse reaction associated with the use of Betoptic S® Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients:

Ocular: blurred vision, corneal punctuate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes.

Systemic adverse reactions include:

Cardiovascular: Bradycardia, heart block and congestive failure.

Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure.

Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis.

Other: Hives, toxic epidermal necrolysis, hair loss and glossitis. Perversions of taste and smell have been reported.

In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of Betoptic S® Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.

Additional Potential Adverse Reactions Associated with Betaxolol

Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctuate staining which may appear in dendritic formations, edema and anisocoria.

Drug Interactions

Oral Beta-Adrenergic Receptor Inhibitors

Patients who are receiving a beta-adrenergic receptor inhibitor orally and BETOPTIC S® Ophthalmic Suspension 0.25% should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade.

Catecholamine-Depleting Drugs

Close observation of the patient is recommended when a beta–adrenergic receptor inhibitor is administered to patients receivingcatecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia which may result in vertigo, syncope, or postural hypotension.

Concomitant Adrenergic Psychotropic Drugs

Betaxolol is an adrenergic receptor inhibitor; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic effects

Pregnancy Category C: Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. Betaxolol HCl was not shown to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels. There are no adequate and well-controlled studies in pregnant women.

Betoptic S® Ophthalmic Suspension 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether betaxolol HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BETOPTIC S® Ophthalmic Suspension 0.25% is administered to nursing women.

Pediatric Use

Safety and IOP-lowering effect of Betoptic S® Ophthalmic Suspension 0.25% has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.

Geriatric Use

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

Overdosage

No information is available on overdosage in humans. The oral LD50 of the drug ranged from 350-920 mg/kg in mice and 860-1050 mg/kg in rats. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic receptor inhibitor are bradycardia, hypotension and acute cardiac failure.

A topical overdose of Betoptic S® Ophthalmic Suspension 0.25% may be flushed from the eye(s) with warm tap water.

Betoptic S Description

Betoptic S® Ophthalmic Suspension 0.25% contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89. The chemical structure is presented below.

Empirical Formula:

C18H29NO3•HCl

Chemical Name:

(±)-1-[p-[2-(cyclopropylmethoxy) ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.

Each mL of Betoptic S® Ophthalmic Suspension 0.25% contains: Active: betaxolol HCl 2.8 mg equivalent to 2.5 mg of betaxolol base. Preservative: benzalkonium chloride 0.01%. Inactives: mannitol, poly(styrene-divinyl benzene) sulfonic acid, carbomer 934P, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.

Betoptic S® Ophthalmic Suspension 0.25% has pH of approximately 7.6 and an osmolality of approximately 290 mOsmol/kg.

Betoptic S - Clinical Pharmacology

Mechanism of Action

Betaxolol HCl, a cardioselective (beta-1-adrenergic) receptor inhibitor, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic receptor inhibitors reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function.

When instilled in the eye, Betoptic S® Ophthalmic Suspension 0.25% has the action of reducing elevated intraocular pressure, whether or not accompanied by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.

Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Betaxolol has the action of reducing elevated as well as normal intraocular pressure and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry.

Pharmacodynamics

The onset of action with betaxolol can generally be noted within 30 minutes and the maximum effect can usually be detected 2 hours after topical administration. A single dose provides a 12-hour reduction in intraocular pressure. In some patients, the intraocular pressure lowering responses to BETOPTIC S® may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.

Ophthalmic betaxolol solution at 1% (one drop in each eye) was compared to placebo in a crossover study challenging nine patients with reactive airway disease. Betaxolol HCl had no significant effect on pulmonary function as measured by Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC and was not significantly different from placebo. The action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol.

No evidence of cardiovascular beta adrenergic-blockade during exercise was observed with betaxolol in a double-masked, crossover study in 24 normal subjects comparing ophthalmic betaxolol and placebo for effects on blood pressure and heart rate.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies with betaxolol HCl have been completed in mice at oral doses of 6, 20 or 60 mg/kg/day and in rats at 3, 12 or 48 mg/kg/day; betaxolol HCl demonstrated no carcinogenic effect. Higher dose levels were not tested.

In a variety of in vitro and in vivo bacterial and mammalian cell assays, betaxolol HCl was nonmutagenic.

Clinical Studies

In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of Betoptic S® Ophthalmic Suspension 0.25% and BETOPTIC® Ophthalmic Solution 0.5% were clinically equivalent. BETOPTIC S® Suspension was significantly more comfortable than BETOPTIC® Solution.

How Supplied/Storage and Handling

Betoptic S® Ophthalmic Suspension 0.25% is supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER® dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER® package.

5 mL: NDC0065-0246-05

10 mL: NDC0065-0246-10

15 mL: NDC0065-0246-15

Storage and Handling

Store upright at 2° - 25°C (36° - 77°F).

Shake well before using.

Patient Counseling Information

How to Use The DROP-TAINER® Bottle

The DROP-TAINER® bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER® bottle, read the complete instructions carefully.

1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before BETOPTIC S®.

2. Wash hands before each use.

3. Before using the medication for the first time, be sure the Safety Seal on the bottle isunbroken.

4. Tear off the Safety Seal to break the seal.

5. Before each use, shake well and remove the screw cap.

6. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you.

7. Tilt your head back and position the bottle above the affected eye. DO NOT TOUCH THE EYE WITH THE TIP OF THE DROPPER.

8. With the opposite hand, place a finger under the eye. Gently pull down until a “V” pocket is made between your eye and lower lid.

9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication. DO NOT SQUEEZE THE SIDES OF THE BOTTLE.

10. Repeat 6, 7, 8 and 9 with other eye if instructed to do so.

11. Replace screw cap by turning until firmly touching the bottle.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions.

Patients should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container.

Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 10 minutes before instilling BETOPTIC S® Suspension.

© 2003, 2007, 2008, 2009 Alcon, Inc.

Alcon Laboratories, Inc.

Fort Worth, Texas76134

9002808-0109

PRINCIPAL DISPLAY PANEL

NDC 0065-0246-05


Alcon®

Betoptic S®

(betaxolol HCl ophthalmic suspension)

0.25% as base


5 mL Sterile

Betoptic S   betaxolol hydrochloride  suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0246 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Betaxolol Hydrochloride (Betaxolol) Betaxolol Hydrochloride 2.8 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Mannitol   Edetate Disodium   Hydrochloric Acid   Sodium Hydroxide   Benzalkonium Chloride   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0246-10 10 mL In 1 BOTTLE, PLASTIC None 2 0065-0246-05 5 mL In 1 BOTTLE, PLASTIC None 3 0065-0246-15 15 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019845	01/15/1996

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 05/2008Alcon Laboratories, Inc.

More Betoptic S resources

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

• Betoptic S Concise Consumer Information (Cerner Multum)


• Betoptic S eent Monograph (AHFS DI)


• Betoptic S Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Betoptic S with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Paraderma

Paraderma may be available in the countries listed below.

Ingredient matches for Paraderma

Lindane

Lindane is reported as an ingredient of Paraderma in the following countries:

• Portugal

International Drug Name Search

Combantrin-1

Combantrin-1 may be available in the countries listed below.

Ingredient matches for Combantrin-1

Mebendazole

Mebendazole is reported as an ingredient of Combantrin-1 in the following countries:

• Australia


• New Zealand

International Drug Name Search

Yodoxin

Generic Name: iodoquinol (eye oh DOE quih nol)

Brand Names: Diquinol, Yodoxin

What is Yodoxin (iodoquinol)?

Iodoquinol is an amebicidal drug. The exact way that iodoquinol works is not known.

Iodoquinol is used to treat intestinal infections caused by amoebae.

Iodoquinol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Yodoxin (iodoquinol)?

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Iodoquinol may cause dizziness or visual disturbances. Report any vision changes to your doctor.

What should I discuss with my healthcare provider before taking Yodoxin (iodoquinol)?

Do not take iodoquinol without first talking to your doctor if you have

• liver disease;


• 
  

  optic neuritis (inflammation of the optic nerve) or other vision problems;

  
  


• 
  

  nerve problems (peripheral neuropathy, numbness or tingling); or

  
  


• 
  

  thyroid disease.

  
  

You may not be able to take iodoquinol, or you may require a dosage adjustment or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether iodoquinol will be harmful to an unborn baby. Do not take iodoquinol without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known if iodoquinol will affect a nursing infant. Do not take iodoquinol without first talking to your doctor if you are breast-feeding a baby.

How should I take Yodoxin (iodoquinol)?

Take iodoquinol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take iodoquinol after a meal.

It is important to take iodoquinol regularly to get the most benefit.

Store iodoquinol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an iodoquinol overdose have not been reported.

What should I avoid while taking Yodoxin (iodoquinol)?

Use caution when driving or performing other hazardous activities until you know how this medication affects you. Iodoquinol may cause dizziness or visual disturbances. Report any vision changes to your doctor.

Yodoxin (iodoquinol) side effects

Seek emergency medical attention or contact your doctor immediately if you experience any of the following uncommon but serious side effects:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  vision problems;

  
  


• 
  

  numbness or tingling; or

  
  


• 
  

  skin rash.

  
  

Other, less serious side effects may be more likely to occur. Continue to take iodoquinol and talk to your doctor if you experience

• 
  

  nausea, vomiting, or abdominal cramps;

  
  


• 
  

  diarrhea;

  
  


• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  fever or chills;

  
  


• 
  

  itching; or

  
  


• 
  

  enlargement of the thyroid gland.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Yodoxin (iodoquinol)?

Before taking iodoquinol, talk to your doctor if you are taking any of the following drugs:

• 
  

  bortezomib (Velcade);

  
  


• 
  

  didanosine (Videx);

  
  


• 
  

  lamivudine (Epivir, Epivir-HBV, Trizivir);

  
  


• 
  

  stavudine (Zerit, Zerit XR); or

  
  


• 
  

  zalcitibine (Hivid).

  
  

You may not be able to take iodoquinol, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with iodoquinol. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor.

More Yodoxin resources

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

• Yodoxin Monograph (AHFS DI)


• Yodoxin Advanced Consumer (Micromedex) - Includes Dosage Information


• Yodoxin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Yodoxin with other medications

• Amebiasis
• Balantidium coli
• Blastocystis Infection
• Dientamoeba fragilis

Where can I get more information?

• Your pharmacist has more information about iodoquinol written for health professionals that you may read.

See also: Yodoxin side effects (in more detail)

Pentacarinat Ready-to-Use Solution

1. Name Of The Medicinal Product

Pentacarinat Ready-to-Use solution

2. Qualitative And Quantitative Composition

In terms of the active ingredient

Pentamidine Isetionate 300mg

(Equivalent to 172.4mg Pentamidine base)

3. Pharmaceutical Form

Nebuliser Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Pentacarinat Ready-to-Use Solution is indicated in the treatment of Pneumocystis carinii pneumonia (PCP) in patients infected by the human immunodeficiency virus

(HIV).

Pentacarinat Ready-to-Use Solution is also indicated for the prevention of Pneumocystis carinii pneumonia in patients infected by the human immunodeficiency virus who have experienced a previous episode of PCP.

4.2 Posology And Method Of Administration

Adults

Treatment of Pneumocystis carinii pneumonia

600mg, (two bottles) given once daily for 3 weeks, administered by a suitable nebuliser.

Prevention of Pneumocystis carinii pneumonia

300mg given once a month or 150mg given every two weeks, administered using a suitable nebuliser.

There are no specific dosage recommendations for the elderly.

Hepatic failure

No information is available.

4.3 Contraindications

The drug should not be administered to patients with a known hypersensitivity to pentamidine.

4.4 Special Warnings And Precautions For Use

Fatalities due to severe hypotension, hypoglycaemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isetionate, by both the intramuscular and intravenous routes. Therefore patients receiving pentamidine by inhalation should be closely monitored for the development of severe adverse reactions.

Pentamidine isetionate should be used with particular caution in patients with hepatic and/or renal dysfunction, hypertension, hyperglycaemia, hypoglycaemia, leucopenia, thrombocytopenia or anaemia. Bronchospasm has been reported to occur following the use of the nebuliser. This has been particularly noted in patients who have a history of smoking or asthma. This can be controlled by prior use of bronchodilators.

The benefit of aerosolised pentamidine therapy in patients at high risk of a pneumothorax should be weighed against the clinical consequences of such a manifestation.

Pentamidine isetionate may prolong the QT interval. Cardiac arrhythmias indicative of QT prolongation, such as Torsades de Pointes, have been reported in isolated cases with administration of pentamidine isetionate. Therefore, pentamidine isetionate should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (<50 bpm), or during concomitant administration of pentamidine isetionate with QT prolonging agents.

Particular caution is necessary if the QTc exceeds 500 msec whilst receiving pentamidine isetionate therapy, continuous cardiac monitoring should be considered in this case.

Should the QTc-interval exceed 550 msec then an alternative regimen should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Caution is advised when pentamidine isetionate is concomitantly used with drugs that are known to prolong the QT interval such as phenothiazines, tricyclic antidepressants, terfenadine and astemizole, IV erythromycin, halofantrine, and quinolene antibiotics (see Warnings section).

4.6 Pregnancy And Lactation

There is no evidence on the safety of aerosolised pentamidine in human pregnancy. A miscarriage within the first trimester of pregnancy has been reported following aerosolised prophylactic administration. Pentamidine isetionate should not be administered to pregnant patients unless considered essential. The use of pentamidine isetionate is contraindicated in breast feeding mothers unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Pentamidine has no known effect on the ability to drive and use machines.

4.8 Undesirable Effects

Cases of pneumothorax have been reported in patients with a history of PCP. Although the aetiology of the pneumothorax was not linked primarily to the aerosolised administration of pentamidine in the majority of cases, a causal relationship cannot be ruled out. Local reactions involving the respiratory tract can occur, ranging in severity from cough, shortness of breath and wheezing, bronchospasms to eosinophilic pneumonia. Other adverse effects reported with the use of aerosolised pentamidine are rash, hypotension, hypoglycaemia, acute pancreatitis, renal insufficiency, fever, decrease in appetite, taste disturbances, fatigue, lightheadedness and nausea.

Pentamidine isetionate may prolong the QT interval. Isolated cases of Torsades de Pointes have been reported with the administration of pentamidine isetionate.

4.9 Overdose

Should overdosage occur, treatment is symptomatic.

Cardiac rhythm disorders, including Torsades de Pointes, have been reported following overdose of pentamidine isetionate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pentamidine isetionate is an aromatic diamine. It is an antiprotozoal agent which acts by interfering with DNA and folate transformation, and by the inhibition of RNA and protein synthesis.

5.2 Pharmacokinetic Properties

When administered by the use of a nebuliser, human kinetic studies revealed significant differences when compared to parenteral administration. Aerosol administration resulted in a 10-fold increase in bronchial alveolar lavage (BAL) supernatant fluid and an 80-fold increase in BAL sediment concentrations in comparison with those seen with equivalent parenteral doses.

Limited data suggests that the half life of pentamidine in BAL fluid is greater than 10-14 days.

Long term pulmonary parenchymal effects of aerosolised pentamidine are not known. Lung volume and alveolar capillary diffusion, however, have not been shown to be affected by high doses of pentamidine administered by inhalation to AIDS patients.

5.3 Preclinical Safety Data

No additional data of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glucose

Sodium acetate

Glacial acetic acid

Water for Injections

6.2 Incompatibilities

Pentamidine nebuliser solution should not be mixed with any other solution.

6.3 Shelf Life

12 months.

6.4 Special Precautions For Storage

Store below 25°C. Do not refrigerate. See 6.6 (lnstructions for Use/Handling)

6.5 Nature And Contents Of Container

Low density polyethylene bottles and plug with yellow high density polyethylene tamper evident caps

6.6 Special Precautions For Disposal And Other Handling

Any solid material evident in the polyethylene bottle should be re-dissolved by gentle warming in the hand before use. The solution placed in the nebuliser reservoir should be visually inspected prior to use. Any solution containing particulate matter should be discarded and the nebuliser reservoir rinsed with sterile water prior to re-use.

The optimal particle size for alveolar deposition is between 1 and 2 microns.

The solution containing the required dosage should be administered by inhalation using a suitable nebuliser such as a Respirgard II (trade mark of Marquest Medical Products inc.), modified Acorn system 22 (trade mark of Medic-Aid) or an equivalent device with either a compressor or piped oxygen at a flow rate of 6 to 10 litres/minute.

The nebuliser should be used in a vacated well ventilated room. Only staff wearing adequate protective clothing (mask, goggles, gloves) should be in the room when nebulisers are being used.

A suitable well fitted one way system should be employed such that the nebuliser stores the aerosolised drug during exhalations and disperses exhaled pentamidine into a reservoir. A filter should be fitted to the exhaust line to reduce atmospheric pollution. It is advisable to use a suitable exhaust tube which vents directly through a window to the external atmosphere. Care should be taken to ensure that passers-by will not be exposed to the exhaust. All bystanders including medical personnel, women of child bearing potential, pregnant women, children and people with a history of asthma should avoid exposure to atmospheric pentamidine resulting from nebuliser usage.

Dosage equivalence: 4 mg pentamidine isetionate contain 2.3 mg pentamidine base. 1 mg pentamidine base is equivalent to 1.74 mg pentamidine isetionate.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

PL 04425/0571

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st September 1997

10. Date Of Revision Of The Text

21^st December 2006

Legal Category: POM

Propanolol LCH

Propanolol LCH may be available in the countries listed below.

Ingredient matches for Propanolol LCH

Propranolol

Propranolol is reported as an ingredient of Propanolol LCH in the following countries:

• Peru

International Drug Name Search

Propranolol Eurogenerics

Propranolol Eurogenerics may be available in the countries listed below.

Ingredient matches for Propranolol Eurogenerics

Propranolol

Propranolol is reported as an ingredient of Propranolol Eurogenerics in the following countries:

• Luxembourg

International Drug Name Search

Lorastyne

Lorastyne may be available in the countries listed below.

Ingredient matches for Lorastyne

Loratadine

Loratadine is reported as an ingredient of Lorastyne in the following countries:

• Australia


• Taiwan

International Drug Name Search

DuraHist Sustained-Release Tablets

Pronunciation: KLOR-fen-IR-a-meen/SOO-doe-e-FED-rin/METH-skoe-POL-a-meen
Generic Name: Chlorpheniramine/Pseudoephedrine/Methscopolamine
Brand Name: Examples include Dallergy PSE and Relcof PSE

DuraHist Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

DuraHist Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use DuraHist Sustained-Release Tablets if:

• you are allergic to any ingredient in DuraHist Sustained-Release Tablets


• you are pregnant or breast-feeding


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding


• you are unable to urinate or are having an asthma attack

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

Before using DuraHist Sustained-Release Tablets:

Some medical conditions may interact with DuraHist Sustained-Release Tablets. 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 a history of diabetes, an enlarged prostate, bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

Some MEDICINES MAY INTERACT with DuraHist Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased


• Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of DuraHist Sustained-Release Tablets's side effects


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by DuraHist Sustained-Release Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by DuraHist Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if DuraHist Sustained-Release Tablets 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 DuraHist Sustained-Release Tablets:

Use DuraHist Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take DuraHist Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take DuraHist Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after you take DuraHist Sustained-Release Tablets.


• Swallow DuraHist Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of DuraHist Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of DuraHist Sustained-Release Tablets and you are taking it regularly, 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 DuraHist Sustained-Release Tablets.

Important safety information:

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


• If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor.


• DuraHist Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.


• DuraHist Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• DuraHist Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Do not take diet or appetite control medicines while you are taking DuraHist Sustained-Release Tablets without checking with your doctor.


• DuraHist Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take DuraHist Sustained-Release Tablets.


• DuraHist Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking DuraHist Sustained-Release Tablets.


• Tell your doctor or dentist that you take DuraHist Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - DuraHist Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use DuraHist Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using DuraHist Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: It is not known if DuraHist Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using DuraHist Sustained-Release Tablets while you are pregnant. DuraHist Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking DuraHist Sustained-Release Tablets.

Possible side effects of DuraHist Sustained-Release Tablets:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

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: DuraHist 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 deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of DuraHist Sustained-Release Tablets:

Store DuraHist Sustained-Release Tablets in a tightly closed container 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 DuraHist Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about DuraHist Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• DuraHist Sustained-Release Tablets are 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 DuraHist Sustained-Release Tablets. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More DuraHist resources

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

Compare DuraHist with other medications

• Hay Fever
• Nasal Congestion
• Sinus Symptoms

Propanta

Propanta may be available in the countries listed below.

Ingredient matches for Propanta

Pantoprazole

Pantoprazole is reported as an ingredient of Propanta in the following countries:

• Bangladesh

International Drug Name Search

Alka-Seltzer Classic

Alka-Seltzer Classic may be available in the countries listed below.

Ingredient matches for Alka-Seltzer Classic

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Alka-Seltzer Classic in the following countries:

• Germany

International Drug Name Search

Tempra

In the US, Tempra (acetaminophen systemic) is a member of the drug class miscellaneous analgesics and is used to treat Fever, Muscle Pain, Pain and Sciatica.

US matches:

• Tempra 1 Drops


• Tempra Quicklets oral/rectal


• Tempra oral/rectal

Ingredient matches for Tempra

Paracetamol

Paracetamol is reported as an ingredient of Tempra in the following countries:

• Canada


• Ethiopia


• Indonesia


• Luxembourg


• Mexico


• Philippines


• Venezuela

International Drug Name Search

Flupirtine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N02BG07

CAS registry number (Chemical Abstracts Service)

0056995-20-1

Chemical Formula

C15-H17-F-N4-O2

Molecular Weight

304

Therapeutic Category

Analgesic and antipyretic

Chemical Name

Carbamic acid, [2-amino-6-[[(4-fluorophenyl)methyl]amino]-3-pyridinyl]-, ethyl ester

Foreign Names

• Flupirtinum (Latin)
• Flupirtin (German)
• Flupirtine (French)
• Flupirtina (Spanish)

Generic Names

• Flupirtine (OS: DCF, BAN)
• Flupirtine Maleate (OS: BANM, USAN)
• D 9998 (IS)
• W 2964 M (IS: Carter-Wallace)

Brand Names

• Katadolon
  AWD.pharma, Latvia



• Awegal
  AWD.pharma, Germany



• Katadolon
  AWD.pharma, Germany



• Efiret
  Meda, Italy



• Katadolon
  Aché, Brazil; AWD Pharma, Estonia; AWD Pharma, Slovakia; AWD.pharma, Germany; AWD.pharma, Lithuania; Pliva, Russian Federation



• Metanor
  Meda, Portugal



• Trancolong
  Kade, Germany



• Trancopal Dolo
  Kade, Germany

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
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.

Plasminex

Plasminex may be available in the countries listed below.

Ingredient matches for Plasminex

Tranexamic Acid

Tranexamic Acid is reported as an ingredient of Plasminex in the following countries:

• Indonesia

International Drug Name Search

Permit Ungeziefershampoo

Permit Ungeziefershampoo may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Permit Ungeziefershampoo

Permethrin

Permethrin is reported as an ingredient of Permit Ungeziefershampoo in the following countries:

• Switzerland

International Drug Name Search

Loftyl

Loftyl may be available in the countries listed below.

Ingredient matches for Loftyl

Buflomedil

Buflomedil hydrochloride (a derivative of Buflomedil) is reported as an ingredient of Loftyl in the following countries:

• Austria


• Belgium


• Greece


• Indonesia


• Italy


• Luxembourg


• Netherlands


• Portugal


• Switzerland


• Taiwan


• Venezuela

International Drug Name Search

Penagrand

Penagrand may be available in the countries listed below.

Ingredient matches for Penagrand

Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penagrand in the following countries:

• Argentina

International Drug Name Search

Pramipexol-Mepha

Pramipexol-Mepha may be available in the countries listed below.

Ingredient matches for Pramipexol-Mepha

Pramipexole

Pramipexole dihydrochloride monohydrate (a derivative of Pramipexole) is reported as an ingredient of Pramipexol-Mepha in the following countries:

• Switzerland

International Drug Name Search

Pipoxolan

Scheme

Prop.INN

CAS registry number (Chemical Abstracts Service)

0023744-24-3

Chemical Formula

C22-H25-N-O3

Molecular Weight

351

Therapeutic Category

Antispasmodic agent

Chemical Name

1,3-Dioxolan-4-one, 5,5-diphenyl-2-[2-(1-piperidinyl)ethyl]-

Foreign Names

• Pipoxolanum (Latin)
• Pipoxolan (German)
• Pipoxolan (French)
• Pipoxolan (Spanish)

Generic Names

• Pipoxolan (OS: BAN)
• Pipoxolan Hydrochloride (OS: USAN, BANM)

Brand Names

• Rowapraxin
  Chin Teng, Taiwan; Rowa, Luxembourg; Rowa, Oman

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
OS	Official Synonym
Prop.INN	Proposed International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Penicilinã G Sodicã

Penicilinã G Sodicã may be available in the countries listed below.

Ingredient matches for Penicilinã G Sodicã

Benzylpenicillin

Benzylpenicillin sodium (a derivative of Benzylpenicillin) is reported as an ingredient of Penicilinã G Sodicã in the following countries:

• Romania

International Drug Name Search

Omeprazol-Zys

Omeprazol-Zys may be available in the countries listed below.

Ingredient matches for Omeprazol-Zys

Omeprazole

Omeprazole is reported as an ingredient of Omeprazol-Zys in the following countries:

• Netherlands

International Drug Name Search

OmeHennig

OmeHennig may be available in the countries listed below.

Ingredient matches for OmeHennig

Omeprazole

Omeprazole is reported as an ingredient of OmeHennig in the following countries:

• Germany

International Drug Name Search

Prolastin

In the US, Prolastin (alpha 1-proteinase inhibitor systemic) is a member of the drug class miscellaneous respiratory agents and is used to treat Alpha-1 Proteinase Inhibitor Deficiency.

US matches:

• Prolastin


• Prolastin-C

Ingredient matches for Prolastin

Alpha1-protease inhibitor

Alpha1-protease inhibitor is reported as an ingredient of Prolastin in the following countries:

• Austria


• Canada


• Germany


• Ireland


• Netherlands


• Switzerland

International Drug Name Search

Morniflumato

Morniflumato may be available in the countries listed below.

Ingredient matches for Morniflumato

Morniflumate

Morniflumato (DCIT) is also known as Morniflumate (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Primperan

Primperan may be available in the countries listed below.

Ingredient matches for Primperan

Metoclopramide

Metoclopramide is reported as an ingredient of Primperan in the following countries:

• Belgium


• Finland


• Greece


• Japan


• Luxembourg


• Netherlands


• Oman


• Peru


• Portugal


• Singapore


• Sweden


• Tunisia


• Turkey

Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Primperan in the following countries:

• Belgium


• Denmark


• Ecuador


• Finland


• Hong Kong


• Iceland


• Indonesia


• Japan


• Luxembourg


• Malaysia


• Netherlands


• Peru


• Spain


• Sweden


• Switzerland


• Taiwan


• Vietnam

International Drug Name Search

Piperacillin Sodium

Piperacillin Sodium may be available in the countries listed below.

Ingredient matches for Piperacillin Sodium

Piperacillin

Piperacillin Sodium (BANM, JAN, USAN) is known as Piperacillin in the US.

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
JAN	Japanese Accepted Name
USAN	United States Adopted Name

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

Keityl

Keityl may be available in the countries listed below.

Ingredient matches for Keityl

Sulpiride

Sulpiride is reported as an ingredient of Keityl in the following countries:

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International Drug Name Search

fluphenazine decanoate

Class: Phenothiazines
Note: This monograph also contains information on fluphenazine hydrochloride
VA Class: CN701
CAS Number: 5002-47-1
Brands: Prolixin

Special Alerts:

[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 .

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .

Introduction

Phenothiazine antipsychotic agent.^{a b c d f g i}

Uses for fluphenazine decanoate

Psychotic Disorders

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.

Symptomatic management of psychotic disorders (i.e., schizophrenia).^{a b c f g i}

The long-acting decanoate ester is used mainly for maintenance therapy in patients with chronic schizophrenic disorder who cannot be relied on to take oral antipsychotic drugs; do not use for acute management of severely agitated patients.^{a b}

Mental Retardation

Efficacy not established for management of behavioral complications in mental retardation.^{a b c f g i}

fluphenazine decanoate Dosage and Administration

General

• 
  

  Use shorter-acting fluphenazine hydrochloride formulations in patients with acute schizophrenic reactions so that dosage can be readily adjusted according to patient’s tolerance and therapeutic response.^{a b}

  
  

Administration

Administer fluphenazine hydrochloride orally or IM.^{a b c f g i}

Administer fluphenazine decanoate IM or sub-Q.^{a b} If used outside of psychiatric institutions, administer under direction of clinician experienced in use of psychotropic drugs, particularly phenothiazine derivatives.^b

Avoid skin contact with elixir, oral concentrate solution, or injection since contact dermatitis rarely occurs.^{a d}

Oral Administration

Fluphenazine hydrochloride: Administer orally every 6–8 hours initially; maintenance therapy can often be administered as a single daily dose.^{a c f g}

When oral concentrate solution is used, dilute dose with at least 60 mL of suitable diluent (e.g., water; uncaffeinated soft drinks [e.g., Seven-Up]; carbonated orange beverage; sodium chloride; milk; V-8; or pineapple, apricot, prune, orange, tomato, or grapefruit juice) just before administration.^{a f} (See Compatibility under Stability.)

IM or Sub-Q Administration

Fluphenazine hydrochloride: Administer IM every 6–8 hours.^{a f}

Fluphenazine decanoate: Administer IM or sub-Q using a dry syringe and needle of at least 21 gauge; use of a wet needle or syringe may cause solution to become cloudy.^b

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.

Available as fluphenazine hydrochloride or fluphenazine decanoate; dosage expressed in terms of the salt.^{b c f g i}

Carefully adjust dosage according to individual requirements and response, using lowest possible effective dosage.^{a c f g}

Because of risk of adverse reactions associated with cumulative effects of phenothiazines, periodically evaluate patients with a history of long-term therapy with fluphenazine and/or other antipsychotic agents to determine whether maintenance dosage may be decreased or drug therapy discontinued.^a

Conversion from oral fluphenazine hydrochloride to long-acting decanoate injection may be indicated for psychotic patients stabilized on a fixed daily oral dosage.^{a c f g} In patients without a history of therapy with phenothiazines, administer shorter-acting form for several weeks prior to instituting therapy with fluphenazine decanoate in order to determine patient’s approximate dosage requirements and susceptibility to adverse effects.^{a b}

Precise formula for converting therapy from fluphenazine hydrochloride to fluphenazine decanoate not established.^a An approximate conversion ratio of 12.5 mg every 3 weeks of fluphenazine decanoate for every 10 mg daily of fluphenazine hydrochloride has been used.^a

Adults

Psychotic Disorders

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.

Oral

Fluphenazine hydrochloride: Initially, 2.5–10 mg daily given in divided doses every 6–8 hours.^{a c f g} Dosage may be gradually increased, if necessary, until desired clinical effects are obtained.^{a c f g}

Optimum therapeutic effect often occurs with oral fluphenazine hydrochloride dosages <20 mg daily.^{a c f g} Dosages up to 40 mg may be required in severely disturbed patients, but safety of prolonged administration of such dosages not established.^{a c f g} Use dosages >20 mg daily with caution.^a

After maximum response attained, reduce fluphenazine hydrochloride dosage gradually to maintenance dosage of 1–5 mg daily, often as a single dose.^{a c f g} To avoid recurrence of psychotic symptoms, continued therapy is required following optimum therapeutic response.^a

IM

Fluphenazine hydrochloride: Generally, IM dose is approximately one-third to one-half the oral dose.^{a i}

Usual initial fluphenazine hydrochloride dose is 1.25 mg.^{a i} Depending on severity and duration of symptoms, initial total IM dosage may range from 2.5–10 mg daily given in divided doses every 6–8 hours; may gradually increase dosage if necessary, until symptoms are controlled.^{a i}

Use fluphenazine hydrochloride dosages >10 mg daily with caution.^{a i}

After symptoms are controlled, oral therapy generally should replace parenteral therapy.^{a i}

IM or Sub-Q

Fluphenazine decanoate: In patients with chronic schizophrenic disorder, usual initial dose is 12.5–25 mg.^{a b}

Carefully adjust subsequent fluphenazine decanoate dose and dosage interval according to patient tolerance and response;^{a b} if doses >50 mg are deemed necessary, increase the next and succeeding doses cautiously in increments of 12.5 mg, but do not exceed 100 mg.^{a b}

When administered as maintenance therapy, a single fluphenazine decanoate injection may be effective in controlling schizophrenic symptoms for up to 4 weeks or longer; response may persist for up to 6 weeks in some patients.^{a b}

Prescribing Limits

Adults

Psychotic Disorders

Oral

Fluphenazine hydrochloride: Safety of prolonged administration of dosages up to 40 mg daily not established.^{a f g} Use dosages >20 mg daily with caution.^a

IM

Fluphenazine hydrochloride: Use dosages >10 mg daily with caution.^{a i}

IM or Sub-Q

Fluphenazine decanoate: Do not exceed 100 mg.^b

Special Populations

Geriatric Patients

Fluphenazine hydrochloride: Initially 1–2.5 mg orally daily.^{a c f g} Increase dosage more gradually in debilitated, emaciated, or geriatric patients.^a

Cautions for fluphenazine decanoate

Contraindications

• 
  

  Suspected or established subcortical brain damage.^{b c f g i}

  
  


• 
  

  Comatose or severely depressed states.^{b c f g i}

  
  


• 
  

  Blood dyscrasia or liver damage.^{b c f g i}

  
  


• 
  

  Concomitant therapy with large doses of hypnotics.^{b c f g i}

  
  


• 
  

  Known hypersensitivity to fluphenazine^{b c f g i} or other phenothiazine derivatives (unless potential benefits outweigh possible risks).^d

  
  

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.

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, may develop in patients receiving antipsychotic agents, including fluphenazine.^{b c f g i} Consider discontinuance.^{b c f g i}

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, may occur in patients receiving antipsychotic agents, including fluphenazine.^{b c f g i}

Sensitivity Reactions

Hypersensitivity

Skin disorders (e.g., pruritus, erythema, urticaria, seborrhea, photosensitivity, eczema, exfoliative dermatitis) reported with phenothiazine derivatives.^{b c f g i} Contact dermatitis reported rarely.^a

Consider possibility of anaphylactoid reactions.^{b c f g i}

Cross-sensitivity

Possible cross-sensitivity with other phenothiazines; use with caution in patients who have developed cholestatic jaundice, dermatoses, or other allergic reactions to phenothiazine derivatives.^{b c f g i}

General Precautions

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.

Use phenothiazines with caution in debilitated patients, patients with renal or hepatic disease, patients with glaucoma or prostatic hypertrophy, and patients exposed to organophosphate insecticides.^{b c d f g i}

Use phenothiazines with caution in patients with hypocalcemia, since susceptibility to dystonic reactions may be increased.^d

Abrupt Withdrawal

Gastritis, nausea, vomiting, dizziness, and tremulousness reported after abrupt discontinuance of high-dose therapy; minimize symptoms by continuing concomitant antiparkinsonian agents for several weeks after phenothiazine is withdrawn.^{b c f g i}

Cardiovascular Effects

Hypotension occurs rarely.^{a b f g i} Patients with pheochromocytoma, cerebral or vascular insufficiency, or severe cardiac reserve deficiency (e.g., mitral insufficiency), or psychotic patients receiving large doses of phenothiazines who are undergoing surgery may be especially prone to hypotensive effects;^{a b c f g i} closely monitor such patients during therapy.^{a b c f g i}

Hypertension and fluctuations in BP may occur.^{a b c f g i}

Nervous System Effects

Possible risk of seizures; phenothiazines may lower seizure threshold.^d Use with caution in patients with a history of seizures or EEG abnormalities or in those receiving anticonvulsant agents.^{b c d f g i} Maintain adequate anticonvulsant therapy.^d

Drowsiness or lethargy possible; may necessitate dosage reduction.^{b c f g i}

Because of CNS depressant effects of phenothiazines, use with caution in patients with chronic respiratory disorders (e.g., severe asthma, emphysema, acute respiratory tract infections).^d

Neurologic reactions from phenothiazine therapy may be similar to CNS manifestations accompanying certain disorders (e.g., Reye’s syndrome, encephalopathy, meningitis, tetanus); diagnosis of these disorders may be obscured or disease-associated manifestations may be incorrectly diagnosed as drug induced.^d

Antiemetic effect of phenothiazines may mask signs of overdosage of toxic drugs (e.g., antineoplastic agents) or may obscure cause of vomiting in various disorders (e.g., intestinal obstruction, Reye’s syndrome, brain tumor).^d

Phenothiazines depress hypothalamic mechanism for body temperature regulation; use caution in patients exposed to extreme heat or cold.^{b c f g i}

Extrapyramidal symptoms occur frequently and are usually reversible; persistent reactions can usually be controlled by concomitant therapy with an antiparkinsonian drug and subsequent dosage reduction.^{a b c f g i}

Autonomic reactions (e.g., nausea, appetite loss, salivation, polyuria, perspiration, dry mouth, headache, constipation) may occur.^{a b c f g i}

Hematologic Effects

Blood dyscrasias, including leukopenia, agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura, eosinophilia, and pancytopenia reported with phenothiazine derivatives.^{b c d f g i} Perform hematologic evaluations periodically.^{b c d f g i}

If manifestations of blood dyscrasias (e.g., sore throat, fever, weakness) occur, discontinue until possibility of adverse hematologic effect is ruled out; if evidence of cellular depression (i.e., decreased leukocyte and differential counts) occurs, discontinue and institute appropriate therapy.^{b c d f g i}

Hepatic Effects

Liver damage, manifested by cholestatic jaundice may occur, particularly during first months of therapy;^{b c f g i} discontinue immediately if liver damage occurs.^d

Consider possibility of liver damage in patients receiving prolonged therapy.^{b c f g i} Monitor hepatic function periodically.^{b c f g i}

Ocular Effects

Consider possibility of pigmentary retinopathy and lenticular and corneal deposits in patients receiving prolonged therapy.^{b c d f g i} Periodic ophthalmic examinations recommended in patients receiving prolonged phenothiazine therapy with moderate to high dosages.^d

Endocrine Effects

Elevated prolactin concentrations, which persist during chronic administration, possible.^{b c d f g i}

Galactorrhea, amenorrhea, gynecomastia, and impotence reported.^{b c f g i}

Pulmonary Effects

Clinicians should be alert to possible development of “silent pneumonias” in patients receiving phenothiazines, including fluphenazine.^{b c f g i}

Use with caution in patients with chronic respiratory disorders (e.g., severe asthma, emphysema, acute respiratory tract infections).^d

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.^e

Lactation

Phenothiazines are distributed into milk.^{d e} Women receiving phenothiazines should not breast-feed.^d

Pediatric Use

Insufficient experience with fluphenazine hydrochloride to establish safety and efficacy.^{a c f g i}

Safety and efficacy of fluphenazine decanoate not established in children <12 years of age.^{a b}

Geriatric Use

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.

Geriatric patients appear to be particularly sensitive to adverse CNS (e.g., tardive dyskinesia, parkinsonian manifestations, akathisia, sedation), anticholinergic, and cardiovascular (e.g., orthostatic hypotension) effects of antipsychotic agents.^d (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use phenothiazines with caution in patients with hepatic disease.^d Monitor hepatic function periodically.^{b c f g i}

Renal Impairment

Use phenothiazines with caution in patients with renal disease.^d Monitor renal function periodically; if BUN becomes abnormal, discontinue therapy.^{b c f g i}

Common Adverse Effects

Extrapyramidal reactions (e.g., pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia), drowsiness, lethargy, weight gain.^{a b c d f g i}

Interactions for fluphenazine decanoate

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Anticonvulsants	Phenothiazines may lower seizure threshold, but CNS depressant effects do not potentiate anticonvulsant activity of anticonvulsantsd	Dosage adjustment of anticonvulsant may be necessary to maintain seizure control during concomitant used
Atropine	Possible potentiated effects of atropine in some patients receiving fluphenazine because of added anticholinergic effectsb c f g i
CNS depressants (e.g., alcohol, analgesics, antihistamines, barbiturates, general anesthetics, opiates)	Possible additive effects or potentiated action of other CNS depressantsb c d f g i	Use concomitantly with caution to avoid excessive sedation or CNS depressionb c d During surgery in patients receiving high fluphenazine dosages, may need to reduce dosages of anesthetics or other CNS depressantsb c f g i
Epinephrine	Reversal of epinephrine actionb c f g i	Do not use epinephrine for phenothiazine-induced hypotension; further lowering of BP may resultb c f g i
Lithium	An acute encephalopathic syndrome reported occasionally, especially when high serum lithium concentrations presentd	Observe patients receiving combined therapy for evidence of adverse neurologic effects; promptly discontinue if such signs or symptoms appeard
Test for phenylketonuria (PKU)	False-positive test results may occur during phenothiazine used
Tests for pregnancy	False-positive results reported in some patients receiving phenothiazinesb c d f g i
Tests for urobilinogen, amylase, uroporphyrins, porphobilinogens, 5-hydroxyindolacetic acid	Urinary metabolites of phenothiazines may cause urine to darken and result in false-positive test resultsd

fluphenazine decanoate Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract and from parenteral sites.^a Peak serum concentrations were attained within 1.5–2 or 0.5 hours after IM or oral administration, respectively, of fluphenazine hydrochloride.^a

Onset

Fluphenazine hydrochloride: Usually occurs within 1 hour following oral or IM administration.^a

Fluphenazine decanoate: Within 24–72 hours.^{a b}

Duration

Fluphenazine hydrochloride: 6–8 hours following oral or IM administration.^a

Fluphenazine decanoate: Usually 1–6 weeks (average: 2 weeks).^a

Distribution

Extent

Not fully elucidated; reportedly crosses blood-brain barrier.^a

Phenothiazines cross the placenta and are distributed into milk.^e

Elimination

Metabolism

Metabolic fate not fully elucidated.^a

Elimination Route

Excreted in feces and urine as unchanged drug, fluphenazine sulfoxide, and 7-hydroxyfluphenazine following IM administration of fluphenazine decanoate in 1 patient studied; also excreted in urine as metabolite conjugates.^a

Half-life

Fluphenazine hydrochloride: 14.7–15.3 hours following IM or oral administration.^a

Fluphenazine decanoate: 6.8–9.6 days following IM administration.^a

Stability

Storage

Oral

Tablets

15–30°C.^c Protect from light.^c Avoid excessive heat.^c

Elixir

Tightly closed containers at 15–30°C, unless otherwise specified by manufacturer; ^{a d g} avoid freezing.^g Protect from light.^{a g}

Solution, concentrate

Tightly closed containers at <40°C, preferably 15–30°C, unless otherwise specified by manufacturer;^{a d f} avoid freezing.^{d f} Protect from light.^{a f}

Parenteral

Injection

Fluphenazine decanoate: 15–30°C.^b Avoid freezing and excessive heat.^b Protect from light.^b

Fluphenazine hydrochloride: 15–30°C.^{d i} Avoid freezing.^a Protect from light.^{a i}

Compatibility

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

Oral

Do not mix oral concentrate solution with beverages containing caffeine (e.g., coffee, cola), tannic acid (e.g., tea), or pectinates (e.g., apple juice), since physical incompatibility may result.^{a f} (See Oral Administration under Dosage and Administration.)

Parenteral

Drug Compatibility (for Fluphenazine Hydrochloride)

Syringe Compatibilityh

Compatible
Benztropine mesylate
Diphenhydramine HCl
Hydroxyzine HCl

ActionsActions

• 
  

  Precise mechanism(s) of antipsychotic action not determined but may be principally related to antidopaminergic effects.^d

  
  


• 
  

  Exhibits weak anticholinergic and sedative effects and strong extrapyramidal effects; has weak antiemetic activity.^a

  
  

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 drowsiness and impairment of mental and physical abilities required for driving a car or operating heavy machinery.^{a b c f g i}

  
  


• 
  

  Importance of avoiding alcohol during fluphenazine therapy.^{a b c f g i}

  
  


• 
  

  Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.^{a b c f g i}

  
  


• 
  

  Importance of clinicians informing patients of risk of extrapyramidal reactions and providing reassurance that these reactions usually can be controlled by administration of antiparkinsonian drugs (e.g., benztropine) and by subsequent dosage reduction.^{b c f g i}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{a b c f g i}

  
  


• 
  

  Importance of avoiding exposure to temperature extremes.^{b c d f g i}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{a b c f g i}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{a b c f g i} (See Cautions.)

  
  

Preparations

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

Fluphenazine Decanoate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	25 mg/mL	Fluphenazine Decanoate Injection (with benzyl alcohol 1.2% in sesame oil)	Abraxis, Apotex, Bedford, Sicor
			Prolixin Decanoate (with benzyl alcohol 1.2% in sesame oil)	Sandoz

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Fluphenazine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Elixir	2.5 mg/5 mL	Fluphenazine Hydrochloride Elixir	Pharmaceutical Associates, Teva
	Solution, concentrate	5 mg/mL	Fluphenazine Hydrochloride Concentrate	Pharmaceutical Associates, Teva
	Tablets	1 mg*	Fluphenazine Hydrochloride Tablets	Mylan, Par, Sandoz, UDL
		2.5 mg*	Fluphenazine Hydrochloride Tablets	Mylan, Par, Sandoz, UDL
		5 mg*	Fluphenazine Hydrochloride Tablets	Mylan, Par, Sandoz, UDL
		10 mg*	Fluphenazine Hydrochloride Tablets	Mylan, Par, Sandoz, UDL
Parenteral	Injection, for IM use only	2.5 mg/mL	Fluphenazine Hydrochloride Injection (with parabens)	Abraxis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Fluphenazine Decanoate 25MG/ML Solution (APP PHARMACEUTICAL): 5/$69.99 or 10/$130

Fluphenazine HCl 1MG Tablets (SANDOZ): 90/$17.99 or 180/$23.98

Fluphenazine HCl 10MG Tablets (SANDOZ): 60/$24.99 or 180/$74.98

Fluphenazine HCl 2.5MG Tablets (MYLAN): 60/$15.99 or 180/$38.98

Fluphenazine HCl 5MG Tablets (SANDOZ): 60/$18.99 or 180/$45.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Fluphenazine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2314-5.

b. Gensia Sicor Pharmaceuticals, Inc. Fluphenazine decanoate injection prescribing information. Irvine, CA; 1998 Aug.

c. Par Pharmaceutical, Inc. Fluphenazine hydrochloride tablets prescribing information. Spring Valley, NY; 2003 Jul.

d. AHFS drug information 2004. McEvoy GK, ed. Phenothiazines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 2301-11.

e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Baltimore, MD: Williams & Wilkins; 2002:574-5.

f. Pharmaceutical Associates, Inc. Fluphenazine hydrochloride oral solution prescribing information. Greenville, SC; 2000 Oct.

g. Pharmaceutical Associates, Inc. Fluphenazine hydrochloride elixir prescribing information. Greenville, SC; 2002 Nov.

h. Trissel LA. Handbook on injectable drugs. 12th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2003:622-3.

i. American Pharmaceutical Partners. Fluphenazine hydrochloride injection prescribing information. Schaumburg, IL; 2002 Jul.

More fluphenazine decanoate resources

• Fluphenazine decanoate Side Effects (in more detail)
• Fluphenazine decanoate Use in Pregnancy & Breastfeeding
• Drug Images
• Fluphenazine decanoate Drug Interactions
• Fluphenazine decanoate Support Group
• 2 Reviews for Fluphenazine decanoate - Add your own review/rating

• Fluphenazine Professional Patient Advice (Wolters Kluwer)


• Fluphenazine MedFacts Consumer Leaflet (Wolters Kluwer)


• Prolixin Prescribing Information (FDA)


• Prolixin Concise Consumer Information (Cerner Multum)


• Prolixin Decanoate Prescribing Information (FDA)


• fluphenazine Concise Consumer Information (Cerner Multum)

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