Ife-Bimix 30/1 (papaverine HCl/phentolamine mesylate in water)

The usual adult oral dosage of papaverine hydrochloride is 150 mg (as extended-release capsules) every 8-12 hours. Alternatively, 300 mg (as extended-release capsules) may be given every 12 hours. A dosage of 75-300 mg (as conventional tablets (no longer commercially available in the US)) 3-5 times daily also has been used.

The usual adult parenteral dose of papaverine hydrochloride is 30 mg; however, a dosage of 30-120 mg may be repeated every 3 hours as necessary. In the treatment of cardiac extrasystoles, 2 doses may be administered 10 minutes apart. Children may receive 6 mg/kg daily, divided into 4 IM or IV doses.

Papaverine hydrochloride may be administered orally, or by IM or slow IV injection. The IV route is recommended when an immediate effect is desired, but the drug must be injected slowly over a 1- to 2-minute period to avoid serious adverse effects. (See Cautions: Precautions and Contraindications.)

Papaverine hydrochloride, alone or combined with phentolamine mesylate, also has been administered by intracavernous+ injection for the treatment of erectile dysfunction. (See Uses: Erectile Dysfunction.) Patients receiving the drug via intracavernosal injection should be advised of the potential for prolonged erections (priapism) and informed of steps to take in the event that this potentially serious adverse effect occurs. (See Adverse Effects: Adverse Intracavernosal Effects, in Cautions.)

No dosing information is available for this tab.

No dosing information is available for this tab.

The effects of papaverine hydrochloride may be slightly potentiated by CNS depressants and a synergism may result from combination with morphine.

Papaverine may interfere with the therapeutic effects of levodopa in patients with Parkinson's disease when the drugs are administered concomitantly. The mechanism of this interaction is not known, but it has been suggested that papaverine may block dopamine receptors. Use of papaverine in patients with Parkinson's disease should probably be avoided, particularly if the patients are receiving levodopa.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Complete atrioventricular block

• Hypotension

• Disease of liver
• Glaucoma
• Sinus tachycardia

There is no enhanced messaging for this drug.

More Frequent

• Cardiac arrhythmia
• Tachycardia

Less Frequent

• General weakness

Rare or Very Rare

• Acute myocardial infarction
• Cerebrovascular occlusion
• Hepatitis
• Hypertension
• Hypotension
• Jaundice
• Spasm of cerebral arteries
• Tachycardia
• Torsades de pointes

More Frequent

• Abdominal pain with cramps
• Diarrhea
• Nausea
• Orthostatic hypotension
• Vomiting

Less Frequent

• Acute abdominal pain
• Anorexia
• Constipation
• Diarrhea
• Dizziness
• Flushing
• Nasal congestion
• Nausea

Rare or Very Rare

• Accidental fall
• Flushing
• Headache disorder
• Hyperhidrosis
• Malaise
• Sedation
• Skin rash
• Vertigo

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No enhanced messaging available.

Reproduction studies in rats and mice using oral phentolamine mesylate dosages 24-30 times the usual daily human dosage (based on a 60-kg individual) have shown slightly decreased fetal growth and slight fetal skeletal immaturity (manifested by an increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae). In rats receiving oral dosages 60 times the usual human daily dosage (based on a 60-kg individual), a slightly decreased rate of implantation occurred. In rabbits receiving oral dosages 20 times the usual human daily dosage (based on a 60-kg individual), embryonic and fetal development were not affected. No teratogenic or embryotoxic effects were observed in reproduction studies in rats, mice, and rabbits. At least one human death has been reported following the phentolamine test during pregnancy. There are no adequate and well-controlled studies using phentolamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits outweigh the possible risks to the fetus.

It is not known whether phentolamine mesylate is distributed into milk. Because of the potential for serious adverse reactions to phentolamine mesylate in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

It is not known whether papaverine distributes into human milk. Because many drugs are distributed into milk, papaverine hydrochloride should be used with caution in nursing women.

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