Drug: Baclofen

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below: C10H12ClNO2             M.W. 213.66 Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn).

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

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The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 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 (see WARNINGS, Abrupt Drug Withdrawal).

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No information provided. Last reviewed on RxList: 11/20/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) treatment will aid in restoring residual function. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

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Hypersensitivity to baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) .Last reviewed on RxList: 11/20/2007
This monograph has been modified to include the generic and brand name in many instances.

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Signs and symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. 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.

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Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 10 mg are scored, round, white tablets imprinted DAN 5730 and 10 supplied in bottles of 100 and 500. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 20 mg are scored, round, white tablets imprinted DAN 5731 and 20 supplied in bottles of 100 and 500. Dispense in a tight container with a child-resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Watson Laboratories, Inc. Corona, CA 92880 USA. Revised: January 2004. FDA rev date: Last reviewed on RxList: 11/20/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Safe use of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) in pediatric patients under age 12 has not been established, and it is, therefore, not recommended for use in pediatric patients. 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) may be additive to those of alcohol and other CNS depressants. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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. In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) . 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. A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) . Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.Last reviewed on RxList: 11/20/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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