Baclofen

The US label lists baclofen for spasticity from multiple sclerosis, especially to relieve flexor spasms and the pain, clonus and muscle stiffness that go with them.

The label adds that it may also be of some value in spinal cord injuries and other spinal cord diseases.

The label says it is not meant for muscle spasm caused by rheumatic disorders.

In the National List of Essential Medicines 2022, baclofen appears under medicines used in anaesthesia, for preoperative medication. The label we reviewed does not describe that use.

• Spasticity from multiple sclerosis
• Possibly spinal cord injury and other spinal cord diseases
• Not for muscle spasm from rheumatic conditions

The label says the exact way baclofen works is not fully understood. It reduces reflexes at the level of the spinal cord, possibly by lowering the release of excitatory signals from nerve endings.

It is a structural relative of the calming brain chemical GABA and may act on GABA-B receptors.

The US label for adults says to start with a low dose, preferably divided through the day, and raise it gradually based on response and tolerance.

The suggested steps in the suspension label go up every three days, from 5 mg three times a day to 20 mg three times a day. The label gives a ceiling of 80 mg a day, as 20 mg four times a day.

The suspension is a concentrated liquid. The label asks for a calibrated measuring device and not a household spoon, and for the bottle to be shaken well.

The label warns that baclofen should be lowered slowly when stopped. Do not stop it suddenly unless your doctor says so.

This is label information, not a prescription. Indian pack labels may differ from the US label, and your prescriber's instruction always comes first.

Sudden stopping: the label says abrupt discontinuation has caused hallucinations, seizures, high fever, worse spasticity and, rarely, muscle breakdown, organ failure and death.

Drowsiness and alcohol: baclofen can impair alertness. The label advises avoiding driving or dangerous machinery until you know how it affects you, and says alcohol and other sedating medicines add to the effect.

Pregnancy: the label says there are no adequate human data and that animal studies showed fetal abnormalities at doses that also harmed the mother. Newborns can show withdrawal after birth, so doctors may lower the dose before delivery.

Breastfeeding: baclofen is present in breast milk, and the label notes that infants can show withdrawal when the mother stops it.

Kidneys: baclofen leaves the body mostly through the kidneys, so the dose may need lowering in kidney impairment. Elderly patients are more prone to this.

Other conditions: use with caution after a stroke, and in psychotic disorders, schizophrenia, confusional states, epilepsy and autonomic dysreflexia.

Children: the label says safety and effectiveness below the age of 12 are not established.

• Alcohol
• Other sedating medicines, such as sleep medicines or some anxiety medicines
• The label names one main interaction.
• Baclofen adds to the sedating effect of alcohol and other medicines that depress the central nervous system.
• Ask your doctor or pharmacist to check your full medicine list.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says an overdose can cause coma, deepening drowsiness, dizziness, breathing problems, seizures or floppy muscles that progress to loss of consciousness.

Treatment described includes emptying the stomach, keeping the airway open and supporting breathing.

The label says to store the suspension at 20 to 25 degrees C.

The label asks to throw away any unused liquid 2 months after the bottle is first opened.

In the Drugs Rules schedules we checked, baclofen is listed under the prescription-only schedule (Schedule H) (Schedule H, serial 47). Schedule H medicines are sold only on a doctor's prescription.

Baclofen appears in the National List of Essential Medicines 2022 on page 61. Forms in the list are tablets of 5 mg, 10 mg and 20 mg.

NPPA lists ceiling prices for several baclofen formulations. The table shows the rows we found. Check NPPA directly for the current list.

Banned combinations: we found no mention of baclofen in the banned-combination list we checked. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. Check the pack and the seller.

Jan Aushadhi (PMBJP) lists baclofen 10 mg tablets and a baclofen 20 mg extended-release tablet. We have not shown a brand price here.

• Baclofen Tablets IP 10 mg (pack 10's)
• Baclofen 20mg Extended Release (Gastric Retentive System) Tablets (pack 10's)