Papaverine

Overdose

No information provided.

Contraindications

Large doses can depress atrioventricular and intraventricular conduction and thereby produce serious arrhythmias.

Undesirable effects

Although occurring rarely, the reported side effects of papaverine include nausea, abdominal distress, anorexia, constipation, malaise, drowsiness, vertigo, sweating, headache, diarrhea, skin rash, flushing of face, increase in heart rate and depth of respiration and slight increase in blood pressure.

Therapeutic indications

For the relief of cerebral and peripheral ischemia associated with arterial spasm and myocardial ischemia complicated by arrhythmias.

Name of the medicinal product

Papaverine

Qualitative and quantitative composition

Papaverine Hydrochloride Sustained Release Capsules are supplied as: 150 mg brown and clear capsules, imprinted E 5156 and are available in bottles of 100, 500 and 1000.

Storage

Store at 20° to 25°C (68° to 77°F).

Protect from moisture.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for: Sandoz Inc. Princeton, NJ 08540. Manufactured by: Epic Pharma, LLC. Laurelton, NY 11413. Rev. 11/08.

Special warnings and precautions for use

WARNINGS

No information provided.

PRECAUTIONS

Use with caution in patients with glaucoma. Hepatic hypersensitivity has been reported with gastrointestinal symptoms, jaundice, eosinophilia and altered liver function tests. Discontinue drug if these occur.

Dosage (Posology) and method of administration

One capsule every 12 hours. In difficult cases administration may be increased to one capsule every 8 hours or two capsules every 12 hours.

Interaction with other medicinal products and other forms of interaction

SIDE EFFECTS

Although occurring rarely, the reported side effects of papaverine include nausea, abdominal distress, anorexia, constipation, malaise, drowsiness, vertigo, sweating, headache, diarrhea, skin rash, flushing of face, increase in heart rate and depth of respiration and slight increase in blood pressure.

DRUG INTERACTIONS

No information provided.