Drotaverine Hydrochloride

Drotaverine Hydrochloride is a potent synthetic antispasmodic drug that acts directly on smooth muscle fibers. It inhibits phosphodiesterase-IV to correct cyclic AMP and calcium imbalance at the spastic site, relieving smooth muscle spasm and pain. It is indicated for gastric spasm, intestinal spasm, pyloric spasm, cholelithiasis, spastic constipation, dysmenorrhoea, peripheral vascular disorders, coronary insufficiency and angina pectoris. It is free from cardiotoxic and hypotensive effects.

• Gastric spasm
• Intestinal spasm or pyloric spasm
• Cholelithiasis (gallbladder stones)
• Spastic constipation
• Relief of tenesmus in dysentery
• Dysmenorrhoea (menstrual pain)
• Peripheral vascular disorders
• Coronary insufficiency and angina pectoris
• Abdominal pain

Drotaverine HCl is a potent synthetic antispasmodic drug readily absorbed from the intestine. Like papaverine, it acts directly on smooth muscle fibers, exceeding the antispasmodic effect of standard preparations. It is characterized by rapid onset of action, advantageous in acute painful spastic conditions. In addition to spasmolytic and vasodilatory actions, Drotaverine HCl elicits selective blockage of cardiac beta-receptors.

Drotaverine has antispasmodic effect mediated via inhibition of phosphodiesterase-IV, specific for smooth muscle. It has rapid and direct action on smooth muscle, correcting cyclic AMP and Ca imbalance at the spastic site, relieving smooth muscle spasm and pain.

Adult Dose (Oral): 1-2 tablets, 3 times daily.

Adult Dose (Injection): 1-2 ampoules, intramuscularly or subcutaneously, 1-3 times daily. For acute stone colic: 1-2 ampoules by slow intravenous injection.

Child Dose (>6 years): 1/2-1 tablet, 1-2 times daily (40 mg).

Child Dose (1-6 years): 1/4-1/2 tablet, 1-2 times daily (20 mg).

Oral tablet. Take in the dose and duration as advised by your doctor. Swallow whole. Do not chew, crush or break. May be taken with or without food, but better to take at a fixed time.

If you miss a dose of Drotaverine Hydrochloride, skip it and continue with your normal schedule. Do not double the dose.

Common Side Effects:

• Nausea
• Vomiting
• Dryness in mouth
• Vertigo

• Drotaverine Hydrochloride helps relieve pain due to smooth muscle spasms such as menstrual pain, kidney stone, and colicky pain.
• Take as per dose and duration suggested by your doctor.
• It may cause a drop in blood pressure. Monitor blood pressure regularly and inform doctor if you have history of low blood pressure.
• Use caution while driving as it may cause dizziness.
• Inform doctor if you have severe kidney, liver, or heart disease.

• Severe renal/hepatic/cardiac dysfunction
• Porphyria
• Hypersensitivity to Drotaverine HCl

May attenuate the action of levodopa. Concurrent use of analgesics, antimuscarinics or benzodiazepines has additive beneficial effect.

It is not known whether it is safe to consume alcohol with Drotaverine Hydrochloride. Please consult your doctor.

Information regarding the use of Drotaverine Hydrochloride during pregnancy is not available. Please consult your doctor.

Information regarding the use of Drotaverine Hydrochloride during breastfeeding is not available. Please consult your doctor.

Children should be given smaller doses according to age and body weight.

Limited information available regarding dose adjustment for elderly patients.

Renal impairment: Limited information available on use in kidney disease. Consult your doctor.

Hepatic impairment: Limited information available on use in liver disease. Consult your doctor.

Overdose may cause severe nausea, vomiting, vertigo and allergic reactions. Provide symptomatic treatment.

Store in a cool, dry place. Keep out of reach of children.

Drotaverine Hydrochloride