Formulary
Baclofen: Indications, Dosing, Side Effects and Interactions
Baclofen clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Baclofen: Indications, Dosing, Side Effects and Interactions
Baclofen clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Pain of muscle spasm in palliative care**
- **Adult** (By Mouth): 5-10 mg 3 times a day.
**Hiccup due to gastric distension in palliative care**
- **Adult** (By Mouth): 5 mg twice daily.
**Chronic severe spasticity resulting from disorders such as multiple sclerosis or traumatic partial section of spinal cord**
- **Adult** (By Mouth): Initially 5 mg 3 times a day, usual maintenance up to 20 mg 3 times a day, dose to be increased gradually to maintenance dose; dose can be increased if necessary up to maximum 100 mg per day, review treatment if no benefit within 6 weeks of achieving maximum dose.
**Chronic severe spasticity of voluntary muscle for baclofen**
- **Child 1 month-7 years** (By mouth): Initially 75 micrograms/kg 4 times a day, usual maintenance up to 0.5 mg/kg 4 times a day, dose to be increased gradually at weekly intervals until satisfactory response, review treatment if no benefit within 6 weeks of achieving maximum dose; maximum 40 mg per day.
- **Child 8-17 years** (By mouth): Initially 75 micrograms/kg 4 times a day, usual maintenance up to 0.5 mg/kg 4 times a day, dose to be increased gradually at weekly intervals until satisfactory response, review treatment if no benefit within 6 weeks of achieving maximum dose; maximum 60 mg per day.
**Severe chronic spasticity of cerebral or spinal origin unresponsive to oral antispastic drugs (or oral therapy not tolerated) (specialist use only) for baclofen**
- **Child 4-17 years** (By intrathecal injection): Test dose 25-50 micrograms, to be given over at least 1 minute via catheter or lumbar puncture, then increased in steps of 25 micrograms (max. per dose 100 micrograms), not more often than every 24 hours to determine initial maintenance dose, then dose-titration phase, most often using infusion pump (implanted into chest wall or abdominal wall tissues) to establish maintenance dose retaining some spasticity to avoid sensation of paralysis; maintenance 25-200 micrograms daily, adjusted according to response.
Cautions
General cautions: Cerebrovascular disease; diabetes; elderly; epilepsy; history of peptic ulcer; history of substance abuse; hypertonic bladder sphincter; Parkinson's disease; psychiatric illness; respiratory impairment Specific cautions: With intrathecal use Coagulation disorders; malnutrition (increased risk of post-surgical complications); previous spinal fusion procedure
Contraindications
With intrathecal use Local infection; systemic infection With oral use Active peptic ulceration
Side effects
Severe chronic spasticity unresponsive to oral antispastic drugs (or where side-effects of oral therapy unacceptable) or as alternative to ablative neurosurgical procedures (specialist use only) for baclofen By intrathecal injection Adult Test dose 25-50 micrograms, to be given over at least 1 minute via catheter or lumbar puncture, then increased in steps of 25 micrograms (max. per dose 100 micrograms), not given more often than every 24 hours to determine appropriate dose, then dose-titration phase , most often using infusion pump (implanted into chest wall or abdominal wall tissues) to establish maintenance dose (ranging from 12 micrograms to 2 mg daily for spasticity of spinal origin or 22 micrograms to 1.4 mg daily for spasticity of cerebral origin) retaining some spasticity to avoid sensation of paralysis.
Interactions
**Severe interactions:**
- Agents reducing renal function Drugs or medicinal products that can significantly affect renal function may reduce baclofen excretion leading to toxic effects (see section 4.4).
**Other interactions (8):**
- Levodopa/dopa decarboxylase (DDC) inhibitor (Carbidopa) In patients with Parkinson's disease receiving treatment with baclofen and levodopa (alone or in combination with DDC inhibitor, carbidopa),...
- Hence, caution should be exercised during concomitant administration of baclofen and levodopa/carbidopa.
- Drugs causing Central Nervous System (CNS) depression Increased sedation may occur when baclofen is taken concomitantly with other drugs causing CNS depression including other muscle relaxants (such...
- In addition, hypotension has been reported with concomitant use of morphine and intrathecal baclofen.
- Antidepressants During concurrent treatment with tricyclic antidepressants, the effect of baclofen may be potentiated, resulting in pronounced muscular hypotonia.
- Lithium Concomitant use of oral baclofen and lithium resulted in aggravated hyperkinetic symptoms.
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk (toxicity in animal studies).
Breast feeding
Present in milk-amount probably too small to be harmful.
Hepatic impairment
With oral use: Manufacturer advises use with caution-no information available.
Renal impairment
Prescribing in renal impairment . Use with caution. M With oral use: Only use if potential benefit outweighs risk if eGFR less than 15 mL/minute/1.73 m 2 . M Dose adjustments With oral use: Use smaller doses (e.g. 5 mg daily) and if necessary increase dosage interval-monitor for signs and symptoms of toxicity. M
Medicinal forms
Solution,Tablet,Solution,Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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