Category: Tablets
Classification: GIT Drug
Product English Name: Spamed
Product Arabic Name: سباميد
Scientific Name English: Drotaverine
Scientific Name Arabic: دروتافيرين
Product Unit:20 Tablet
Product Strength: 40
Clinical Pharmacology
Mechanism of Action & Pharmacodynamics:
Drotaverine, a benzylisoquinoline derivative, is an analogue of papaverine with smooth muscle relaxant properties. Its antispasmodic activity is achieved by a selective phosphodiesterase enzyme IV inhibition, which is an enzyme responsible for the degradation of cyclic adenosine monophosphate (cAMP). Inhibition of PDE4 & elevated levels of cAMP lead to smooth muscle relaxation.
| Pharmacokinetics | Absorption: Although therapeutic serum levels have not been established, peak concentrations occur approximately 1 to 3 hours after an oral dose. Oral bioavailability of drotaverine ranges from 24.5% to 91%. Distribution: Drotaverine and its metabolites are 80% to 95% protein bound and it has a volume of distribution of 193 to 195 litres. Metabolism: Drotaverine appears undergo extensive first pass metabolism. Excretion: Drotaverine is excreted in the urine and faeces. The half-life of drotaverine ranges from 7 to 12 hours. |
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| Indications and dosage | Primary & Secondary Dysmenorrhoea. Post Surgical Uterine Spasm. Uterine irritability and pain associated with IUCD insertion, dilatation and curettage, pelvic inflammatory disease or HSG. Gastro-intestinal colic, renal colic, biliary colic. |
| Dosage and Administration | For Spamed 40 mg Tablet: Adult: 1 to 2 tablets, three times a day. Children (over 6 years): ½ or 1 tablet 1–2 times daily. Children (1–6 years): ¼ or ½ tablet 1–2 times daily. For Spamed 80 mg Tablet: Adult: ½ or 1 tablet 1–2 times daily. Children (over 6 years): ¼ or ½ tablet 1–2 times daily. |
| Contraindications | Hypersensitivity to drotaverine or any component of the formulation. Pre-existing renal disease. Rhinitis, urticaria, asthma, or allergic reactions to aspirin or other anti-inflammatory agents. Ulceration or chronic inflammation of the upper or lower GI tract. Porphyria. Neonates. |
| Warnings and Precautions | Use with caution in patients with renal, hepatic, cardiac dysfunction, and elderly people. |
| Adverse Reactions | Cardiovascular: Hypotension, Tachycardia. CNS: Headache and Vertigo. Metabolic effects: Acute attacks of Porphyria have been associated with Drotaverine use. |
| Drug Interactions | Drotaverine intensifies the effect of other spasmolytics. Drotaverine intensifies the hypotension caused by tricyclic antidepressants, quinidine and novocainamid. Drotaverine reduces smogenic morphine activity. Drotaverine reduces antiparkinsonian levodopa activity. When administered together rigidity and tremor may increase. Concurrent use of analgesics, antimuscarinics or benzodiazepines has additive beneficial effects. |
| Use in Specific Population | Pregnancy: Reproduction toxicology studies conducted in animals shows no teratogenic and embryotoxic effects. Drotaverine has been widely in labour induction in pregnant women. According to data from surveillance of congenital anomalies in Hungary (1980–1991), whose analysis focuses on 30,663 pregnant women, no detectable teratogenic effect was observed during the administration of drotaverine. However, the use of Drotaverine should be avoided during pregnancy and lactation. Effects on ability to drive and use machines: |
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