Uses of Bacloflex: - Muscle relaxation Pain, Chronic muscle spasticity, Multiple sclerosis, Spasm, Stiffness, Low back pain Hypersensitivity. Active peptic ulcer disease.

Centrally acting Skeletal Muscle Relaxants

Baclofen is an effective muscle relaxant and antispastic agent that primarily acts at the spinal level. While its exact mode of action is not fully understood, Baclofen works by stimulating GABAB receptors, which inhibits the release of glutamate and aspartate, thereby affecting both monosynaptic and polysynaptic reflexes.

It may also have central nervous system (CNS) depressant effects at intraspinal sites. Notably, Baclofen does not impact neuromuscular transmission. Baclofen exhibits an antinociceptive (pain-relieving) effect, although its clinical significance remains uncertain.

How to use Baclofen: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Baclofen is to be taken with food. Administration: Should be taken with food. Adult Dose: Oral Spasticity Adult: Initially, 5 mg tid for 3 days increased to 10 mg tid for 3 days, then in similar increments and intervals until either 20 mg tid is reached or until desired effect is obtained. Max: 80 mg daily. Elderly: Initiate with lower doses. Child Dose: Oral Spasticity Child: 0.75-2 mg/kg daily. May initiate with 2.5 mg 4 times daily, increased gradually every 3 days until desired effect is obtained. Maintenance: 6-10 yr: 30-60 mg daily; 2-6 yr: 20-30 mg daily; 12 mth-2 yr: 10-20 mg daily. Max: >10 yr: 2.5 mg/kg daily. Renal Dose: Renal impairment: Dose reduction may be required.

Hypotensive effect may be increased with antihypertensives. Concomittant use with levodopa in Parkinson patients may result in confusion, agitation, hallucinations. Potentially Fatal: CNS depressants and alcohol may potentiate CNS effects.

Hypersensitivity. Active peptic ulcer disease.

Common - Fatigue - Weakness - Drowsiness - Dizziness >10% Drowsiness, transient (10-63%),Dizziness (5-15%),Nausea (4-12%),Confusion (1-11%) 1-10% Headache (4-8%),Insomnia (2-7%),Constipation (2-6%),Urinary frequency (2-6%),Fatigue (2-4%) <1% Abdominal pain,Ankle edema,Anorexia,Ataxia,Blurred vision,Chest pain,Coordination disorder,Depression,Diarrhea,Dry mouth,Diplopia,Dysarthria,Dyspnea,Dystonia,Enuresis,Euphoria,Excitement,Hallucinations,Hematuria,Hypotension,Impotence,Miosis,Muscle pain,Mydriasis,Nasal congestion,Nocturia,Nystagmus,Palpitation,Paresthesia,Excessive perspiration,Pruritus,Rash,Rigidity,Seizure,Strabismus,Slurred speech,Syncope,Tinnitus,Tremor,Urinary retention,Vomiting,Weight gain Potentially Fatal: Respiratory or CV depression, seizures.

Pregnancy category B3. The safety of using Baclofen during pregnancy has not been established, as it can cross the placental barrier. Administration to pregnant women should only occur when the physician concludes that the potential benefits outweigh the possible risks. Baclofen is excreted in breast milk, but available evidence suggests that the quantities are so minimal that no adverse effects on the infant are expected.

Precaution: Cerebrovascular disorders, epilepsy, severe psychotic disorders, confusional states, history of peptic ulcer, resp depression, diabetes (DM), hepatic or renal impairment, elderly, pregnancy. Avoid sudden withdrawal. Lactation: Enters breast milk in small amounts; not recommended

Gastric lavage is important in case of severe overdose.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Centrally acting Skeletal Muscle Relaxants

Baclofen is an antispastic. It inhibits both monosynaptic and polysynaptic reflexes at spinal level.

Pregnancy There are no adequate data on the developmental risk associated with the use in pregnant women Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose which was also associated with maternal toxicity Clinical considerations May increase the risk of late-onset neonatal withdrawal symptoms Animal data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given ~13 times on a mg/kg basis, or 3 times on a mg/m2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams This abnormality was not seen in mice or rabbits Lactation At recommended oral doses, baclofen is present in human milk There are no human data on the effects of baclofen on milk production There are no adequate data on the effects of baclofen on the breastfed infant Withdrawal symptoms can occur in breastfed infants when maternal administration is stopped, or when breastfeeding is stopped Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition