Drotaverine Hydrochloride Tablets 40mg Taj Pharma

Drotaverine Hydrochloride Tablets 40mg/80mg Taj Pharma

Name of the product:

Drotaverine Hydrochloride Tablets 40mg/80mg Taj Pharma

Pharmacotherapeutic group

Vasodilators. Myothropic spasmolytics.

Composition:

a) Drotaverine Hydrochloride Tablets 40mg

Each tablet contains:
Drotaverine hydrochloride         40 mg
Excipients                                   q.s

b) Drotaverine Hydrochloride Tablets 80mg

Each tablet contains:
Drotaverine hydrochloride       80 mg
Excipients                                   q.s

Pharmacological effect

Pharmacodynamics

Drotaverine hydrochloride is of spasmolytic, myothropic, vasodilation, hypotensive action.

It decreases ionized active calcium supply to smooth muscle cells due to inhibition of phosphoesterase and intracellular accumulation of adenosine monophosphate. It is of apparent and prolonged action on smooth muscles of inner organs and vessels, it decreases moderately arterial pressure, increases minute volume of heart, is of some antiarrhythmic action. It decreases tone of cerebral vessels and increases their bloof-filling. Practically it does not influence vegetative nervous system and does not penetrate to CNS.

Pharmacokinetics

Rapid and total absorption by gastrointestinal tract. Bioavailability is about 100%. Half-absorption is 12 min. Smooth distribution in tissues of plain muscle cells. Drotaverine is bound with plasma proteins to 95-98%.

Indications for usage

Spasm of smooth muscles of inner organs (cardio- and pylorospasm), chronic gastroduodenitis, stomach and duodenum ulcer, cholelithiasis (biliary colic), chronic cholecystitis, post cholecystectomy syndrome, hypermotoric biliary track dyskinesia, spasmodic intestines dyskinesia, intestines colic caused by gas retard after intervention, colitis, proctitis, tenesmus, meteorism, urolithiasis (renal colic), pyelitis, spasm of brain vessels, of coronary and peripheral arteries, necessary abatement uterus traction in parturition and reversal of spasm of neck of uterus in parturition, spasm of smooth muscles in instrumental intervention.

Administration and dosage

The drug is administered for interior use. 1-2 tablets (0.04—0.08 g) 2—3 time a day. In children under 6 0.01—0.02 g 1—2 times a day, in children of 6—12 years old — 0.02 g 1—2 times a day. In children after 12 the adult dose.

Warnings for special population

Pregnancy

This medicine is not recommended for use by pregnant women unless necessary and the benefits outweigh the risks. Consult your doctor before using this medicine.

Breast-feeding

This medicine is not recommended for use if you are breastfeeding as the risks of adverse effects on the infant are significantly high. Consult your doctor and discuss the risks associated with the use of this medicine.

General warnings

Liver disease

This medicine should be used with caution in patients having a liver function impairment. Appropriate dose adjustments and safety monitoring are advised if the impairment is severe.

Kidney disease

This medicine should be used with caution in patients having a kidney function impairment. Appropriate dose adjustments and safety monitoring are advised if the impairment is severe.

Hypotension

Use of this medicine can cause a fall in blood pressure levels and hence should be used with caution in patients having a disease of the heart and blood vessels.

Other medicines

This medicine is known to interact with many other medicines that you might be consuming. Report the use of all medicines including herbs and supplements to the doctor.

Limitation for usage

Adenoma of prostate, apparent atherosclerosis of coronary arteries. Administerwithcareinpregnancy.

Adverse reaction

Heat sensation, vertigo, arrhythmia, hypotension, tachycardia, hyperhidrosis (often in parenteral introduction), allergic dermatitis.

Contraindications

Hypersensitivity, glaucoma.

Interactions

All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.

Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

This medicine should be used with caution in a patient suffering from this genetic disorder of the blood and skin.

Low cardiac output

This medicine is not recommended for use if you suffer from a condition that impairs the normal blood pumping ability of the heart.

Food interactions

Information not available.

Lab interactions

Information not available.

This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.

Interaction with other drugs

Enhances the affect of other spasmolytics (cholinergic antagonist inclusive), hypotensia caused by tricyclic antidepressants, by quinidine, by procainamide hydrochloride. The secure spasm elimination is enhanced by phenobarbital. It inhibits spasmogenic action of morphine, antiparkinsonian activity of levodopa.

General Instructions

Take Drotaverine as instructed by the doctor. Follow all the instructions mentioned on the label. Do not take in larger or smaller quantities than recommended. This medicine can be taken with or without food. An adequate amount of water should be consumed while taking this medicine.

Side effects

Major & minor side effects for Drotaverine

  • Nausea and Vomiting
  • Dry mouth
  • Change in pulse rate
  • Dizziness
  • Headache
  • Difficulty in breathing
  • Allergic skin reaction
  • Swelling of face, lips, eyelids, tongue, hands and feet
  • Fall in blood pressure.

Overdose

АV block, cardiac arrest, paralysis of respiratory center.

Dosage form

Tablet 40mg/80mg
Blister Packing.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com