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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.
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