Baclofen, Baclo 10mg Tab

Product shot of Baclo 10mg Tab

THERAPEUTIC CATEGORY : Spasmolytic Drug
STRENGTH : 10 mg tablet
SIZE : Box of 100s

FORMULATION
Each uncoated tablet contains 10mg Baclofen

INDICATION
Severe but reversible spasticity of the muscles resulting from multiple sclerosis. Spinal spasticity of infectious, degenerative, traumatic or neoplastic origin.


DOSAGE AND ADMINISTRATION
The optimum daily dosage in adults is 30-75mg baclofen, given in 3-5 divided doses. Doses up to 100 mg/day may also be considered occasionally. In children the usual starting dose is 0.3mg/kg/day.

CONTRAINDICATION
Hypersensitivity to baclofen.

PRECAUTION
Because baclofen is primarily excreted unchanged through the kidneys, it should be be given with caution, and it may be necessary to reduce the dosage.
Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
Psychotic disorders, schizophrenia or confusional states may be exacerbated by treatment with baclofen and patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
Particular caution is indicated in patients with epilepsy since the seizure threshold may be reduced and there have been occasional reports or seizures associated with withdrawal or over dosage of baclofen. Appropriate anti-convulsive therapy should be continued and the patients closely monitored.
Baclofen should be used with caution in patients with peptic ulcer (underlying history of peptic ulcer), cerebrovascular disease, or respiratory, hepatic or renal insufficiency)
Neurogenic disturbances affecting emptying of the bladder may show an improvement under treatment with baclofen, whereas in patients with pre-existing sphincter hypertonia acute retention of urine may occur. The drug should therefore be used with caution in such patients. Since , in rare instances, elevated SGOT, alkaline phosphatase and glucose levels in serum have been reported, appropriate laboratory tests should be performed at regular intervals in patients with liver disease or diabetes mellitus in order to ensure that no drug included changes in the underlying disease have occurred
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. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants

ADVERSE REACTION
The most common is transient drowsiness (10 to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 to 15%), weakness (5 to 15%) and fatigue (2 to 4%)
Other reported: Neuropsychiatric: Confusion (1 to 11%) headache (4 to 8%), insomnia (2 to 7%); 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, dysarthria, epileptic seizure.
Cardiovascular: Hypotension (0 to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
Gastrointestinal: Nausea (4 to 12%), constipation (2 to 6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.
Genitourinary: Urinary frequency (2 to 6%); 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 test have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

AVAILABILITY
Available in 10 blister strip containing 10 Tablets of Baclofen (Baclo-10)

STORAGE
Store at a temperature not exceeding 30º C. Keep out of reach of children.

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