DROTAVERINE (amp)
-
Chemical Name:
Drotaverine HCl -
Therapeutic Category:
Gastro-intestinal drugs -
Pharmacologic Category:
Antispasmodic -
Pharmaceutical Form:
Ampoule -
Composition:
Drotaverine HCl 40mg/2ml
DROTAVERINE
Tablets, Injection (Ampoule)
Drotaverine HCl
1. PHARMACOLOGY:
DROTAVERINE relieves or prevents the development of spasms of the various smooth muscle organs regardless of their function and innervation.
The spasmolytic action of Drotaverine is many times stronger and much less toxic than that of papaverine and perparin which also act on smooth muscles. This effect furthermore lasts longer and absorption of the drug is favourable.The action dose not involve the autonomic nervous system, hence Drotaverine is free from anticholinergics like side effects and can be administered to patients suffering from glaucoma and prostatic hypertrophy when other anticholinergics are contraindicated.
2. INDICATIONS:
DROTAVERINE is indicated for:
- Spasms associated with cholecystopathy, cholelithiasis and cholecystitis.
- Spasms associated with nephrolithiasis, pyelitis and cystitis.
- Spastic conditions of the gastrointestinal system.
- Furthermore, it is used in severe dysmenorrhoea.
- Hastening cervical dilatation during normal delivery.
3. CONTRAINDICATIONS:
DROTAVERINE should not be used in hepatic and nephritic insufficiency nor in acute heart failure.
4. USE IN PREGNANCY:
DROTAVERINE has no mentioned effect on the fetus.
5. SIDE EFFECTS:
Rarely headache, nausea, hypotension, vertigo and heart palpitation.
Avoid rapid intravenous injection to prevent arterial blood pressure lowering.
In rare cases, rapid I.V injection leads to nausea and dizziness.
6. DRUG INTERACTIONS:
The antiparkinson effect of Levodopa may be decreased.
7. DOSAGE AND ADMINISTRATION:
Tablets:
Adults: 1 tablet 80 mg 3 times daily.
Children: The dosage is determined according to age and body weight:
1 to 6 years children: ½ tablet 40 mg three times daily.
6 to 12 years children: 1 tablet 40 mg three times daily.
Injection:
Acute Colics: 40 to 80 mg by IM or slow IV injection up to 3 times daily.
Labor: 40 mg by IM injection in 2 hours interval.
8. PACKAGING & COMPOSITION:
- DROTAVERINE 40 – Tablets: A pack of 20 tablets. Each tablet contains Drotaverine HCl 40 mg.
- DROTAVERINE 80 – Tablets: A pack of 10 tablets. Each tablet contains Drotaverine HCl 80 mg.
- DROTAVERINE 40 – Injection: A pack of 5 or 25 or 100 ampoules of 2 mL. Each 2 mL ampoule contains Drotaverine HCl 40 mg.
10. STORAGE CONDITIONS:
Store DROTAVERINE Tablets at temperature between (20-25) C, do not store above 25°C. Protect from light.
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