Balo Tablet

Balo Tablet is used for: Pain, Chronic muscle spasticity, Multiple sclerosis, Spasm, Stiffness, Low back pain

Oral Spasticity Indicated for spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity 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 the desired effect is obtained. Max: The maximum dosage is 80 mg daily (20 mg four times a day).

Oral Spasticity Child: 0.75-2 mg/kg daily. May initiate with 2.5 mg 4 times daily, increased gradually every 3 days until the 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 impairment: Dose reduction may be required.

Take with or without food

Hypersensitivity. Active peptic ulcer disease.

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when Baclofen is discontinued. Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue Baclofen before delivery. Baclofen can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of Baclofen may be additive to those of alcohol and other CNS depressants. Baclofen can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions Use with caution in patients who have had a stroke; baclofen has not significantly benefited patients with stroke; patients have also shown poor tolerability to the drug Not indicated for spasm with rheumatic disease, stroke, Parkinson May take with food to avoid stomach upset Not significantly beneficial for patients with stroke Use with caution in seizure disorders and renal impairment Abrupt drug discontinuation has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death May cause acute urinary retention that may be related to underlying disease; use caution in patients with urinary obstruction Animal studies have shown increased incidence in ovarian cysts; effect in humans inconclusive Use with caution in patients with decreased GI motility, peptic ulcer disease, and/or gastrointestinal obstructive disorders Use with caution in patients with a history of autonomic dysreflexia; presence of nociceptive stimuli or abrupt withdrawal may cause autonomic dysreflexia episode Possible exacerbation of psychotic disorders, schizophrenia or confusional state Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue oral baclofen before delivery Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them; advise patients that the central nervous system effects may be additive to those of alcohol and other CNS depressants Use with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function

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 the 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

Hypotensive effects may be increased with antihypertensives. Concomitant use with levodopa in Parkinson patients may result in confusion, agitation, hallucinations. Baclofen may cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol Potentially Fatal: CNS depressants and alcohol may potentiate CNS effects. Contraindicated (0) Serious - Use Alternative (18) benzhydrocodone/acetaminophen buprenorphine subdermal implant buprenorphine transdermal buprenorphine, long-acting injection calcium/magnesium/potassium/sodium oxybates fentanyl fentanyl intranasal fentanyl iontophoretic transdermal system fentanyl transdermal fentanyl transmucosal hydrocodone methohexital metoclopramide intranasal olopatadine intranasal selinexor sodium oxybate sufentanil SL zuranolone

Side effects of Baclofen : >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.

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

Balo 5mg Tablet manufactured by Medicon Pharmaceuticals Ltd.. Its generic name is Baclofen. Balo is availble in Bangladesh. Farmaco BD drug index information on Balo Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.