Generic Name: – Drotaverine Hydrochloride + Mefenamic Acid
Therapeutic Class: – Antispasmodic – Analgesic / Anti-inflammatory
Dosage Form: – Tablets
Each Film Coated MEDSPAS-M Contains Drotaverine Hydrochloride 80 mg + Mefenamic Acid 250 mg.
MEDSPAS (Drotaverine) in MEDSAPS-M is Musculotropic drug acting directly on smooth muscle cells.
Mefenamic Acid is a non-steroidal anti-inflammatory drug (NSAID). Mefenamic Acid is one of the more commonly used NSAIDs in the treatment of dysmenorrhea.
MEDSPAS has a dual mechanism of action: –
MEDSPAS (Drotaverine) inhibits the enzyme Phosphodiesterase IV (PDE IV). This Causes an increase in cyclic adenosine monophosphate level (cAMP), Which results in decrease in concentration of free calcium ion ( Ca+2).
Simultaneously MEDSPAS (Drotaverine) inhibits Calmodulin (CM). The decrease in Ca+2 ions along with the inhibition of “Calcium – Calmodulin Complex” (CM-Ca+2) formation. This process inhibits myosin light chain kinase (MLCK) leading to DE phosphorylation of actomyosin phosphate complex thus causing relaxation of smooth muscles.
The onset of action of MEDSPAS-M (Drotaverine) on oral administration is about 12 Minutes.
Mefenamic Acid inhibits the cyclooxygenase enzyme thus exerts its anti-inflammatory activity by inhibition of prostaglandin synthesis.
Mefenamic Acid also reduces mean menstrual blood loss (MBL) by up to 47%
Absorption: MEDSPAS (Drotaverine) is well quickly absorbed from jejunum and ileum. The peak plasma concentration reaches between 45-60 Minutes. Half-life of absorption of MEDSPAS (Drotaverine) is 12 Minutes.
Distribution: MEDSPAS (Drotaverine) rapidly penetrates into organs after oral administration. The peak concentration of the drug in lungs, kidney etc. appears half a minute after the injection proving very rapid distribution of drug. Passage of MEDSPAS (Drotaverine) its metabolites across the placental barrier is limited.
Metabolism: The route of administration of MEDSPAS (Drotaverine) doesn’t influence its metabolism. The main metabolite of MEDSPAS (Drotaverine) is 4’-desethyl-drotaverine. But 4’-desethyl-drotaverine and 6’-desethyl Drotaverine can also be found besides some minor metabolites. The metabolites of MEDSPAS (Drotaverine) are eliminated in glucoronide form. The glucuronide conjugated metabolites are inactive and inactive and the spasmolytic effect is exerted by unchanged drug in the body.
Excretion: Approximately 51-58% of the drug is eliminated through urine and 39-48 % is eliminated in the feces after oral administration. After intravenous injection of MEDSPAS (Drotaverine), Majority of the drug is eliminated through feces & urine. The metabolites especially the different glucuronide conjugates are excreted mainly in bile. The half-life of MEDSPAS (Drotaverine) is approximately 16 hours, irrespective of the route of administration (oral or parenteral) .
- Biliary Colic
- Renal Colic
- MTP and D&C / PID (Pelvic Inflammatory Disease) / IUCD Insertion / HSG / Lithotripsy
Dosage: – MEDSPAS-M one tablet three times a day.Drug Interactions : – No drug interaction is reported between Drotaverine and Mefenamic acid. Co-administration with levodopa in patients with Parkinson’s disease should be avoided, as it may alleviate the antiparkinsonian effect of levodopa Drotaverine and Mefenamic acid Should be avoided in the patients receiving oral anticoagulant therapy.
Adverse effects : – Both the active ingredients of Drotaverine and Mefenamic acid are well tolerated. Skin rashes, diarrhea, and dyspepsia, have been reported with Mefenamic acid in few patients. Drotaverine is free from anticholinergic side effects like blurring of vision and dryness of mouth. It can be administered to patients suffering from glaucoma and prostatic hypertrophy where anticholinergic antispasmodics are contraindicated.
CONTRAINDICATIONS: – Drotaverine HCl & Mefenamic Acid is contraindicated in patients with peptic ulcer, bronchial asthma or those with hypersensitivity to Drotaverine or Mefenamic acid. It should be avoided in patients with severe renal or cardiac insufficiency.