BACLOFEN KANAWATI 10 mg
Tablets

Muscle relaxants & cholinesterase inhibitors

  • Chemical Composition

    Baclofen 10 mg

  • Packing

    20Tablets

  • Medical Id

    T109

  • License Number

    291/2016

  • License date

    11/8/2016

Excipients Corn Starch , Cross Povidone , Magnesium Stearate , Microcrystalline Cellulose .
Mechanism Of Action Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression
INDICATIONS Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.
CONTRAINDICATIONS Hypersensitivity to Baclofen.
Side EFFECTS The most common is transient drowsiness. Other common adverse reactions are dizziness, weakness and fatigue. Others repoted: Neuropsychiatric: Confusion, headache, insomnia; and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, epileptic seizure. Cardiovascular: Hypotension. Rare instances of dyspnea, palpitation, chest pain, syncope. Gastrointestinal: Nausea, constipation; and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool. Genitourinary: Urinary frequency; and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria. Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar
WARNINGS Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug. Pregnancy: There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. Use in paediatrics: Safe use of baclofen in children under age 12 has not been established, and it is, therefore, not recommended for use in children. Operating Machineries: Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness
DRUG INTERACTIONS Patients should be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants, such as antihistamines (e.g. cetirizine, diphenhydramine), drugs for sleep or anxiety (e.g. alprazolam, diazepam, zolpidem), other muscle relaxants, and narcotic pain relievers (e.g. codeine). In addition to the risk of depressing brain function, the use of baclofen and tricyclic antidepressants (for example, amitriptyline, doxepin) together may cause muscle weakness. Use of baclofen and monoamine oxidase inhibitors (for example, phenelzine, tranylcypromine) can result in greater depression of brain function as well as low blood pressure. Because baclofen can increase blood sugar, doses of antidiabetic drugs may need to be adjusted when baclofen is begun.
Pregnancy And lactations You should consult a doctor if this drug is prescribed to pregnant or breastfeeding women
Dosage And Administration between 40 to 80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d. for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.). The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug.
OVERDOSE Symptoms: The most common ymptoms of overdosage includevomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizure. Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.
Storage Conditions "Store at room temperature, 20° - 25° C” “Keep out of reach of children” "Prescription only medicine "