API

Paracetamol, Tramadol hydrochloride

Drug classification

Paracetamol: Analgesic; Tramadol: Opioid analgesic; Combination: Analgesics.

Dosage form

Tablet

API strength per dosage

Paracetamol Ph.Eur ........ 325 mg Tramadol…

Dose

Adults: 1–2 tablets every 4–6 hours as needed (maximum 8 tablets/24 hours). Not recommended for children under 12 years. Use with caution in hepatic or renal impairment; dose adjustment may be required. Avoid in severe impairment. Each tablet contains paracetamol 325 mg and tramadol hydrochloride 37.5 mg.

Mechanism of action

Paracetamol inhibits prostaglandin synthesis via central cyclooxygenase (COX), primarily COX-2, reducing pain and fever. Tramadol acts as a μ-opioid receptor agonist and inhibits neuronal reuptake of serotonin (5-HT) and norepinephrine, modulating pain transmission in the central nervous system.

Indications

Moderate to severe pain, acute pain, chronic pain, pain associated with musculoskeletal disorders, postoperative pain, dental pain, pain unresponsive to non-opioid analgesics.

Side effects

Nausea, vomiting, constipation, dizziness, drowsiness, headache, dry mouth, sweating, respiratory depression, hepatotoxicity, allergic reactions, dependence, serotonin syndrome, hypotension, confusion.

Pregnancy category

Category C

Precautions

Hepatic impairment, renal impairment, respiratory depression, history of seizures, head injury, alcohol use, concurrent CNS depressants, risk of dependence or abuse, elderly patients, pregnancy, breastfeeding, hypersensitivity to components, monitoring for serotonin syndrome, avoid exceeding recommended dose, caution in patients with gastrointestinal disorders.

Contraindications

Hypersensitivity to paracetamol or tramadol, acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs, severe respiratory depression, uncontrolled epilepsy, acute asthma, severe hepatic impairment.