RELAXON FORTE 500/MG TAB 30/TAB

Indications

Approved Uses

Relief of discomfort associated with acute, painful musculoskeletal conditions such as muscle spasm, muscle strain, and sprains as an adjunct to rest and physical therapy

Dosage & Administration

Dosing by Condition

Acute painful musculoskeletal conditions: 500 mg orally 3-4 times daily; may increase to 750 mg 3-4 times daily if needed; reduce dose as symptoms improve.

Initial Dose

Usual adult dose: 500 mg three or four times a day.

Maintenance Dose

One 500 mg tablet three or four times daily; may be increased to 1.5 tablets (750 mg) three or four times daily if adequate response is not obtained; dosage can usually be reduced as improvement occurs

Maximum Dose

3000mg per day (750mg four times daily).

Dose Adjustment Notes

Use with caution in hepatic impairment or history of liver disease; discontinue if signs/symptoms of hepatotoxicity occur. No specific renal dose adjustment is typically defined, but use caution in severe renal impairment due to limited data.

Side Effects

Common Side Effects

Drowsiness, dizziness/lightheadedness, nausea/vomiting, stomach upset; urine discoloration (orange/reddish-purple) can occur.

Side Effect Frequency

Common: drowsiness/somnolence, dizziness/lightheadedness, malaise; Less common: GI upset (nausea, vomiting, heartburn), headache, diarrhea/constipation; Rare: urine discoloration, hypersensitivity reactions (rash/angioedema/anaphylaxis), and hepatotoxicity (including hepatocellular injury).

Safety & Warnings

Contraindications

Hypersensitivity to chlorzoxazone or any component; active hepatic disease or significant hepatic impairment; prior chlorzoxazone-associated hepatotoxicity/drug-induced liver injury.

Warnings & Precautions

May cause CNS depression-caution with driving/operating machinery and with other sedatives/alcohol; rare serious/fatal hepatocellular toxicity-avoid in active liver disease and discontinue promptly if symptoms/signs of liver dysfunction occur (e.g., jaundice, dark urine, anorexia, nausea, fever, rash); use as adjunct to rest/physical therapy for acute musculoskeletal spasm.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Additive CNS depression with alcohol and other CNS depressants (e.g., opioids, benzodiazepines, sedating antihistamines, hypnotics); avoid alcohol and use caution with concomitant sedatives. Clinically relevant CYP2E1 interaction management is not routinely recommended, though chlorzoxazone is a CYP2E1 substrate used as a probe and strong CYP2E1 modifiers could theoretically alter exposure.

Food Interaction

May be taken with or without food; taking with food or milk may reduce stomach upset.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Kidney Impairment

No adjustment needed.

Liver Impairment

Avoid/contraindicated in active hepatic disease or significant hepatic impairment; if used in patients with past liver disease, use with caution and monitor, and discontinue immediately if symptoms/signs of hepatotoxicity occur (e.g., jaundice, dark urine, anorexia, nausea, fever, rash).

Storage & Patient Advice

Overdose

Symptoms: prominent CNS depression (drowsiness, dizziness, ataxia, slurred speech), GI upset (nausea/vomiting/diarrhea), and in severe cases respiratory depression/hypotension/coma. Management: immediate medical evaluation/poison center, supportive care with airway/ventilation as needed; consider activated charcoal if early and airway protected; no specific antidote.

Patient Counseling

May cause drowsiness/dizziness-avoid driving or hazardous tasks until effects are known; avoid alcohol and other sedatives; may take with food/milk if stomach upset occurs; urine may discolor (orange/reddish-purple) and is usually harmless; stop and seek medical advice urgently for liver injury symptoms (jaundice, dark urine, RUQ pain, persistent fatigue, nausea).

Monitoring Requirements

Monitor for clinical signs/symptoms of hepatotoxicity (e.g., jaundice, dark urine, RUQ pain, unexplained fatigue); consider baseline and periodic liver function tests if prolonged use or hepatic risk factors are present.

Pharmacology

Mechanism of Action

Centrally acting skeletal muscle relaxant that acts at the spinal cord and subcortical brain areas to inhibit multisynaptic reflex arcs, reducing muscle spasm without direct action at the neuromuscular junction.

Onset of Action

About 30-60 minutes (within 1 hour).

Duration of Effect

Approximately 3-6 hours.

Metabolism

Hepatic metabolism primarily via CYP2E1 to 6-hydroxychlorzoxazone, followed by conjugation (e.g., glucuronidation) and urinary excretion.

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 500mg chlorzoxazone

Generic Availability

Yes

Pain Type

Muscular

Nsaid

No

Opioid

No

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