API

Tolperisone (450mg) + Diclofenac (100mg)

Drug classification

Skeletal muscle relaxant (Tolperisone) and nonsteroidal anti-inflammatory drug—NSAID (Diclofenac).

Dosage form

Film-coated oral tablet containing Tolperisone and Diclofenac.

API strength per dosage

Dose

Standard adult dosing for Myotop-DSR Tablet is typically one tablet twice daily after meals. Safety and efficacy in children have not been established; use in paediatric patients is not recommended. Caution is advised in patients with renal or hepatic impairment; dose adjustment or avoidance may be necessary. Always follow prescribing information and consult a healthcare professional.

Mechanism of action

Tolperisone is a centrally acting muscle relaxant that inhibits voltage-gated sodium and calcium channels, reducing neuronal excitability and muscle spasticity. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, thereby reducing inflammation and pain.

Indications

Pain due to muscle spasm

Side effects

Nausea Vomiting Sleepiness Dizziness Dryness in mouth Fatigue Muscle weakness Abdominal discomfort Abdominal pain

Pregnancy category

Safety in pregnancy is not established; use only if clearly needed and potential benefits outweigh risks. Consult a healthcare provider before use.

Precautions

Monitor for gastrointestinal bleeding, renal and hepatic function, allergic reactions, CNS effects (drowsiness, dizziness), blood pressure, avoid in pregnancy and lactation unless essential, caution in elderly, avoid alcohol, assess for drug interactions, discontinue if serious adverse effects occur, use lowest effective dose for shortest duration.

Contraindications

Hypersensitivity to tolperisone, diclofenac, or excipients, active peptic ulcer, severe hepatic or renal impairment, severe heart failure, history of asthma or allergic reactions to NSAIDs, pregnancy, lactation, children.