The white round pill debossed with 024 is an oral prescription medication containing Baclofen (10 mg), a central nervous system (CNS) muscle relaxant and antispastic agent.
Pill Identification
Attribute – Specification
- Active Ingredient – Baclofen, USP (10 mg)
- Imprint – 024 on one side; score line on reverse
- Color & Shape – White to off-white, round, flat-faced with beveled edge
- Size – Approximately 7 mm
- Primary Distributors/Manufacturers – TruPharma LLC / Advagen Pharma Ltd
- Drug Class – Skeletal muscle relaxant receptor agonist
Mechanism of Action
Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid . It acts primarily at the spinal cord level:
- Receptor Activation: Baclofen selectively binds to pre- and post-synaptic receptors.
- Hyperpolarization & Inhibition: Binding inhibits calcium influx into presynaptic terminals and stimulates potassium efflux postsynaptically, leading to membrane hyperpolarization.
- Suppression of Reflexes: This reduces the release of excitatory neurotransmitters (such as glutamate and aspartate), thereby inhibiting both monosynaptic and polysynaptic spinal reflexes that drive muscle stiffness, involuntary spasms, and clonus.
Indications and Clinical Uses
- Multiple Sclerosis: Alleviates spasticity, flexor or extensor spasms, and concomitant pain or clonus.
- Spinal Cord Pathology: Treats spasticity resulting from spinal cord injury, transverse myelitis, or other non-degenerative spinal diseases.
- Off-Label Uses: Occasionally used under specialist care for conditions like alcohol withdrawal/dependence, intractable hiccups, and trigeminal neuralgia.
General Dosage and Administration
Dosage is individualized and titrated slowly to avoid extreme sedation and muscle weakness.
- Initial Adult Dosing: Typically started at 5 mg (half of a 10 mg tablet) taken orally three times daily for 3 days.
- Titration Schedule: Increased gradually by 5 mg per dose every 3 days until optimal response is reached:
- Days 4–6: 10 mg three times daily
- Days 7–9: 15 mg three times daily
- Days 10–12: 20 mg three times daily
- Maintenance & Maximum Dose: The typical therapeutic range is 40 to 80 mg/day divided across 3–4 doses. Total daily dose generally should not exceed 80 mg/day.
- Renal Adjustment: Baclofen is excreted primarily by the kidneys; patients with impaired renal function require reduced dosages.
Side Effects
Common Side Effects:
- Transient drowsiness and sedation (up to 63%)
- Dizziness and lightheadedness
- Muscle weakness and hypotonia
- Nausea, dry mouth, or constipation
- Headache, confusion, and insomnia
Serious Adverse Reactions:
- Severe CNS or respiratory depression
- Hallucinations, acute psychosis, or severe confusion
- Hypotension or bradycardia
- Seizures (particularly with overdose or abrupt cessation)
Warnings and Precautions
- Abrupt Discontinuation (Black Box Warning Category for Intrathecal; Severe Risk for Oral): Never stop baclofen suddenly. Abrupt cessation can trigger life-threatening withdrawal symptoms, including high fever, severe rebound spasticity, hallucinations, delirium, seizures, rhabdomyolysis, and autonomic instability. Discontinuation must be done via a gradual taper under medical supervision.
- CNS Depression & Additive Effects: Combining baclofen with alcohol, opioids, benzodiazepines, or other sedatives significantly increases the risk of profound sedation, respiratory arrest, coma, or fatal overdose.
- Impaired Coordination: Patients should refrain from driving, operating heavy machinery, or engaging in hazardous tasks until tolerance to sedative effects is established.
- Special Populations:
- Renal Impairment: Higher risk of toxicity due to decreased clearance; close monitoring of creatinine clearance is required.
- Elderly Patients: Heightened susceptibility to confusion, dizziness, and fall-related injuries.
- Pregnancy & Lactation: Crosses the placenta and enters breast milk; used only when clinical necessity clearly outweighs fetal/neonatal risks.