Tri-Mix (PAPVRN-PHNTLMN-PGE1) (papaverine HCl/phentolamine mesylate/alprostadil)
Alprostadil Intracavernosal Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Phentolamine is an imidazoline alpha-adrenergic blocking agent.
Papaverine hydrochloride is a vasodilating agent.
Alprostadil, the naturally occurring prostaglandin E1, is a vasodilating agent and a platelet-aggregation inhibitor.
Alprostadil, the naturally occurring prostaglandin E1, is a vasodilating agent and a platelet-aggregation inhibitor and is prepared synthetically for commercial use. Parenteral alprostadil is commercially available as a sterile powder for injection with (Caverject(R) Impulse(R)) or without alfadex (alpha-cyclodextrin) (Caverject(R)), as an alcoholic solution (Prostin VR Pediatric(R)), and as a lyophilized powder with alfadex (Edex(R)). The inclusion complex enhances the water solubility of alprostadil.
Alprostadil also is available as a urethral (micro) suppository, measuring 1.4 mm in diameter and 3 or 6 mm in length (Muse(R)). Prostaglandins of the E series occur naturally in the seminal vesicles and cavernous tissues of males and in the placenta and ductus arteriosus of the fetus. Alprostadil relaxes the smooth muscles of the corpus cavernosum and the ductus arteriosus.
Alprostadil is absorbed through the urethral mucosa and then distributed to corpus spongiosum and corpus cavernosum when administered as a urethral suppository.
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/alprostadil
Drug class: Alprostadil
Therapeutic class: Drugs to treat Erectile Dysfunction
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Tri-Mix (PAPVRN-PHNTLMN-PGE1)
Indications
No indications are available for this drug.
Dosing
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.)
Alprostadil is administered by intracavernosal injection for the treatment and diagnosis of erectile dysfunction, by urethral suppository for the treatment of erectile dysfunction, or by continuous IV or intra-arterial infusion to maintain the patency of the ductus arteriosus in neonates.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
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.
Contraindications
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- Complete atrioventricular block
- Deformity of erection of the penis
- Fibrosis of corpus cavernosum
- Leukemia
- Lymphoid leukemia
- Multiple myeloma
- Penile angulation
- Peyronie's disease
- Sickle cell disease
- Sickle cell trait
- Hypotension
- Increased risk of bleeding due to coagulation disorder
- Disease of liver
- Glaucoma
- Sinus tachycardia
Adverse reactions
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More Frequent
- Cardiac arrhythmia
- Tachycardia
Less Frequent
- Fibrosis of corpus cavernosum
- General weakness
- Infection
- Priapism
Rare or Very Rare
- Acute myocardial infarction
- Cerebrovascular occlusion
- Hepatitis
- Hypertension
- Hypotension
- Hypotension
- Jaundice
- Peyronie's disease
- Spasm of cerebral arteries
- Supraventricular premature beats
- Tachycardia
- Testicular swelling
- Torsades de pointes
More Frequent
- Abdominal pain with cramps
- Diarrhea
- Injection site sequelae
- Nausea
- Orthostatic hypotension
- Pain in penis
- Painful erection
- Vomiting
Less Frequent
- Acute abdominal pain
- Anorexia
- Back pain
- Constipation
- Diarrhea
- Dizziness
- Dizziness
- Ecchymosis
- Edema of penis
- Flu-like symptoms
- Flushing
- Headache disorder
- Hemorrhage
- Hyperhidrosis
- Hypertension
- Injection site inflammation
- Leg pain
- Nasal congestion
- Nausea
- Penile angulation
- Penile hematoma
- Prostatitis
- Sinusitis
- Skin rash
- Upper respiratory infection
Rare or Very Rare
- Accidental fall
- Disorder of ejaculation
- Flushing
- Headache disorder
- Hematospermia
- Hyperhidrosis
- Increased urinary frequency
- Malaise
- Pelvic pain
- Pruritus of skin
- Sedation
- Skin rash
- Testicular pain
- Vasodilation of blood vessels
- Vertigo
Precautions
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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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ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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