International generic name Papaverine
Drug form and composition Solution for injection. One ampoule of 1 ml (2%) contains 20 mg Papaverine hydrochloride (20 mg/ml).
Indications The preparation is used as a muscular relaxant in acute peripheral arterial spasms; acute renal, biliary, and gastrointestinal colic; in erection dysfunctions (as a monotherapy or in combination with α-adrenergic blockers, including phentolamine).
Dosage and administration The solution is applied intravenously or intramuscularly. In adults the dosage is 20-40 mg, 1-2 times daily. If necessary the dose could be repeated every 3 hours - up to 120 mg maximal 24 hours dose. In impotence the preparation could be applied in the cavernous body in single dose 20-40 mg, but no more than 60 mg. In children the preparation is applied intramuscularly or intravenously in dose 1.5 mg per kg body weight, 4 times daily.
Contraindications Papaverine is contraindicated in hypersensitivity to the preparation; atrioventricular block; acute myocardial infarction; recent stroke; liver function disorders; glaucoma.
Special warnings and precautions In patients with liver diseases the preparation should be used with care. In patients with Parkinson’s disease, treated with levodopa, a risk of worsening of the disease exists. In pregnancy and nursing women the preparation should be used only after careful assessment of the risk-benefit ratio for the mother and the fetus. The preparation should be used with care in drivers and machinery operating persons, as it possesses some sedative effect.
Drug interactions Concomitant administration with hypotensive medicines leads to potentiation of their hypotensive effect. The spasmolytic effect of Papaverine on the smooth muscles is abolished by simultaneous application of morphine. The preparation could be combined successfully with other medicines, including phenobarbital, diolan, novphyllin, atropin, etc.
Adverse reactions During the treatment with Papaverine following adverse reactions may be seen: tachycardia; premature heart contractions; atrioventricular block; xerostomia; constipation; elevation of the liver enzymes serum level; fatigue; dizziness; somnolence; headache.
Pharmacological mechanisms Papaverine is a synthetic opium alkaloid with prominent spasmolytic and anticholinergic action. It exerts a direct effect on the smooth muscles; reduces the blood vessel tone, particularly of the coronary, intracranial and pulmonary arteries and arterioles. The preparation reduces the tone of the smooth muscles, bronchi, stomach, biliary tract, ureter and uterus also. The mechanism of its action is related to inhibition of the enzyme phosphodiesterase and elevation of the intracellular concentration of cAMP. In higher doses it exerts a weak sedative effect.
Supplied 100 ampoules of 1 ml (20 mg).
Expiry 2 years. |