TRADE NAME: Vasorin ampoules This product contains benzyl alcohol, Not for Use In Neonates up to 4 weeks old. GENERIC NAME: Papaverine hydrochloride COMPOSITION: Each 2 ml ampoule contains: Active ingredient: Papaverine hydrochloride 0.06 gm : Excipients Disodium edetate, benzyl alcohol, water. PHARMACEUTICAL FORM: Ampoule. PHARMACOLOGICAL ACTION: PHARMACODYNAMICS: The most characteristic effect of Vasorin is relaxation of the tonus of all smooth muscle, especially when it has been spasmodically contracted. Papaverine Hydrochloride apparently acts directly on the muscle itself. This relaxation is noted in the vascular system and bronchial musculature and in the gastrointestinal, biliary and urinary tracts. The main actions of Vasorin are exerted on cardiac and smooth muscle. Vasorin relaxes various smooth muscles, especially those of larger arteries; this relaxation may be prominent if spasm exists. The antispasmodic effect is a direct one and unrelated to muscle innervation, and the muscle still responds to drugs and other stimuli causing contraction. Vasorin has minimal actions on the central nervous system, although very large doses tend to produce some sedation and sleepiness in some patients. In certain circumstances, mild respiratory stimulation can be observed, but this is therapeutically inconsequential. Vasorin stimulates respiration by acting on carotid and aortic body chemoreceptors. Vasorin relaxes the smooth musculature of the larger blood vessels, including the coronary, cerebral, peripheral, and pulmonary arteries. This action is particularly evident when such vessels are in spasm, induced reflexly or by drugs, and it provides the basis for the clinical use of Vasorin in peripheral or pulmonary arterial embolism. PHARMACOKINETICS: Vasorin is effective by all routes of administration. A considerable fraction of the drug localizes in fat deposits and in the liver, with the remainder being distributed throughout the body. It is metabolized in the liver. About 90% of the drug is bound to plasma protein. The drug is excreted in the urine in an inactive form. INDICATIONS AND USAGE: Vasorin is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic. DOSAGE AND ADMINISTRATION: Vasorin may be administered intravenously or intramuscularly. The intravenous route is recommended when an immediate effect is desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid uncomfortable or alarming side effects. Parenteral administration of Vasorin in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment of cardiac extrasystoles, 2 doses may be given 10 minutes apart. CONTRAINDICATIONS: Intravenous injection of Vasorin is contraindicated in the presence of complete atrioventricular heart block. When conduction is depressed, the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia. Vasorin is not indicated for the treatment of impotence by intracorporeal injection. The intracorporeal injection of papaverine hydrochloride has
