PARAXONE 250/300/MG CAP 30/CAP

Indications

Approved Uses

Adjunctive relief of discomfort associated with acute, painful musculoskeletal conditions with muscle spasm (e.g., strains, sprains, low back pain).

Dosage & Administration

Dose Adjustment Notes

Use with caution/consider dose reduction in older adults due to sedation risk; avoid or use extreme caution in hepatic impairment and do not exceed total paracetamol daily maximum from all sources (typically 4 g/day in adults; lower in chronic liver disease/alcohol misuse).

How to Take

Swallow whole with a full glass of water. Can be taken with or without food, but taking with food may reduce stomach upset.

Side Effects

Common Side Effects

Drowsiness/somnolence, dizziness/lightheadedness, nausea, vomiting, gastrointestinal upset (e.g., dyspepsia/heartburn), and urine discoloration (orange to purple-red).

Side Effect Frequency

Common: drowsiness/sedation, dizziness/lightheadedness, nausea/vomiting, GI upset. Uncommon/Rare: hypersensitivity reactions (rash/urticaria; rare severe reactions), hepatotoxicity/hepatocellular injury (rare at therapeutic doses but serious with overdose or risk factors); urine discoloration can occur (not typically categorized as very common).

Safety & Warnings

Contraindications

Hypersensitivity to chlorzoxazone and/or paracetamol (or any excipients); severe hepatic impairment/active liver disease; prior chlorzoxazone-associated hepatotoxicity.

Warnings & Precautions

Hepatotoxicity risk-avoid alcohol/hepatotoxic co-meds when possible, do not exceed total daily paracetamol from all sources, and stop/seek care if jaundice, dark urine, RUQ pain, or unexplained nausea occurs; may cause drowsiness/dizziness-avoid driving/machinery; use caution in elderly and in hepatic or severe renal impairment; limit duration to the shortest necessary.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Additive CNS depression with alcohol, opioids, benzodiazepines, sedating antihistamines; avoid duplicate paracetamol-containing products; increased hepatotoxicity risk with chronic alcohol use and other hepatotoxic drugs (e.g., isoniazid); warfarin-paracetamol can increase INR with repeated/high-dose use; enzyme induction (e.g., carbamazepine, phenytoin, rifampin) may increase paracetamol hepatotoxicity risk.

Interaction Severity

MAJOR: Alcohol (increased CNS depression and increased hepatotoxicity risk); other paracetamol-containing products (risk of overdose/hepatotoxicity). MODERATE: Warfarin (regular/repeated paracetamol may increase INR/bleeding risk); other CNS depressants such as benzodiazepines/opioids (additive sedation).

Food Interaction

May be taken with food to reduce gastrointestinal upset (food is not required).

Alcohol Interaction

Dangerous

Special Populations

Liver Impairment

Severe hepatic impairment/active liver disease: avoid/contraindicated; mild-moderate impairment: use with caution at the lowest effective dose for the shortest duration and monitor for hepatotoxicity.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take a double dose.

Stopping the Medicine

May be stopped without tapering when no longer needed; discontinue immediately if signs of liver injury, rash/hypersensitivity, or excessive sedation occur.

Overdose

Symptoms: nausea/vomiting, abdominal pain, diaphoresis; drowsiness/dizziness/CNS depression; paracetamol overdose may have delayed severe hepatotoxicity (often 24-72 h). Management: urgent emergency evaluation, activated charcoal if early, prompt N-acetylcysteine per protocols, supportive care and monitoring (LFTs/INR).

Patient Counseling

May cause drowsiness/dizziness-avoid driving/operating machinery until effects are known; avoid alcohol; do not combine with other paracetamol-containing products; take with food if stomach upset occurs; urine discoloration can occur and is usually harmless; stop and seek care for signs of liver injury (jaundice, dark urine, severe abdominal/RUQ pain).

Monitoring Requirements

Monitor for hepatotoxicity; consider baseline and periodic liver function tests with prolonged use or in patients with hepatic risk factors, and counsel patients to report jaundice, dark urine, or right upper quadrant pain.

Pharmacology

Mechanism of Action

Chlorzoxazone produces centrally mediated skeletal muscle relaxation (likely via depression of polysynaptic reflexes in the spinal cord/subcortical areas); paracetamol provides analgesic/antipyretic effects primarily via central prostaglandin synthesis inhibition.

Metabolism

Chlorzoxazone: hepatic metabolism primarily via 6-hydroxylation followed by glucuronide conjugation. Paracetamol: hepatic glucuronidation and sulfation (major), minor CYP2E1 pathway producing NAPQI detoxified by glutathione.

Excretion

Both components are eliminated primarily in urine as metabolites: chlorzoxazone mainly as glucuronide-conjugated metabolites; paracetamol >90% as glucuronide and sulfate conjugates (small fraction as cysteine/mercapturate from NAPQI).

Protein Binding

Paracetamol: low protein binding ~10-25% at therapeutic concentrations. Chlorzoxazone: 13-18%.

Product Information

Available Dosage Forms

Capsule (oral).

Composition per Dose

Each capsule: Chlorzoxazone 250mg + Paracetamol 300mg

Generic Availability

Yes

OTC Alternatives

No OTC equivalent for the chlorzoxazone/paracetamol combination; OTC options for pain include paracetamol alone or ibuprofen (if appropriate) for mild pain without significant spasm.

Pain Type

Muscular

Nsaid

No

Opioid

No

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