Please wait while the formulary information is being retrieved.
Drug overview for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water):
Generic name: papaverine HCl/phentolamine mesylate in water
Drug class: Vasodilators
Therapeutic class: Drugs to treat Erectile Dysfunction
Papaverine hydrochloride is a vasodilating agent. Phentolamine is an imidazoline alpha-adrenergic blocking agent.
Phentolamine is used mainly in the diagnosis of pheochromocytoma and to control or prevent paroxysmal hypertension immediately prior to or during pheochromocytomectomy.
Generic name: papaverine HCl/phentolamine mesylate in water
Drug class: Vasodilators
Therapeutic class: Drugs to treat Erectile Dysfunction
Papaverine hydrochloride is a vasodilating agent. Phentolamine is an imidazoline alpha-adrenergic blocking agent.
Phentolamine is used mainly in the diagnosis of pheochromocytoma and to control or prevent paroxysmal hypertension immediately prior to or during pheochromocytomectomy.
DRUG IMAGES
No Image Available
The following indications for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for 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.
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.)
(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 available.
No generic dosing information available.
The following drug interaction information is available for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Complete atrioventricular block |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypotension |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Glaucoma |
| Sinus tachycardia |
The following adverse reaction information is available for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 12 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cardiac arrhythmia Tachycardia |
General weakness |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Cerebrovascular occlusion Hepatitis Hypertension Hypotension Jaundice Spasm of cerebral arteries Tachycardia Torsades de pointes |
There are 21 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal pain with cramps Diarrhea Nausea Orthostatic hypotension Vomiting |
Acute abdominal pain Anorexia Constipation Diarrhea Dizziness Flushing Nasal congestion Nausea |
| Rare/Very Rare |
|---|
|
Accidental fall Flushing Headache disorder Hyperhidrosis Malaise Sedation Skin rash Vertigo |
The following precautions are available for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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 papaverine distributes into human milk. Because many drugs are distributed into milk, papaverine hydrochloride should be used with caution in nursing women. 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.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for IFE-BIMIX 30/1 (papaverine hcl/phentolamine mesylate in water)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
Formulary Reference Tool