213.66. C 10 H 12 ClNO 2 M.W.
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.
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.
Each tablet, for oral administration, contains 10 mg or 20 mg Baclofen. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate, potato starch, povidone.
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Boxes of 10 x 10 UD 100 NDC.
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Baclofen is a muscle relaxant and antispastic.
Before using this medication, l your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as schizophrenia), brain disorders (such as seizures, stroke).
Before taking baclofen, l your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Talk to your pharmacist for more details. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Please refer to the WARNINGS AND PRECAUTIONS section. No information provided.
Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.
20 mg : White colored, circular, flat, uncoated tablets with 'N030' debossed on one side and scoreline on the other side.
If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal ). The lowest dose compatible with an optimal response is recommended.
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Store at 20° to 25°C (68° to 77°F).
Baclofen tablets are 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.
10 mg : White colored, circular, flat, uncoated tablets with 'N029' debossed on one side and scoreline on the other side.
Use child-resistant closure (as required). PHARMACIST: Dispense in a well-closed container as defined in the USP.
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.).
Boxes of 10 x 10 UD 100 NDC.
Other common adverse reactions are dizziness (5 to 15%), weakness (5 to 15%) and fatigue (2 to 4%). 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. The most common is transient drowsiness (10 to 63%).
Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.
It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder.
Patients should have reversible spasticity so that baclofen tablet treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Cardiovascular: Hypotension (0 to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
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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:
As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. It is not known whether this drug is excreted in human milk.
for 3 days. for 3 days 10 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days 15 mg t.i.d. 5 mg t.i.d.
Ovarian cysts are estimated to occur spontaneously in approximay 1% to 5% of the normal female population. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year.
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Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. This drug may make you dizzy or drowsy. Avoid alcoholic beverages.
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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. Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. No information provided.
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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.
BACLOFEN (Baclofen) Tablets, USP.
Before having surgery, l your doctor or dentist about all the products you use (including prescription drugs.
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.
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks.
Baclofen is rapidly and extensively absorbed and eliminated. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination. The precise mechanism of action of baclofen is not fully known. Absorption may be dose-dependent, being reduced with increasing doses. 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. 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. 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.
Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid. The structural formula is:.
Baclofen Tablets, USP are supplied as:
Maintain adequate respiratory exchange, do not use respiratory stimulants. Hypersensitivity to baclofen. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). In the alert patient, empty the stomach promptly by induced emesis followed by lavage.
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There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximay 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximay 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus. There are no studies in pregnant women.
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. 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.
Concord, NC 28027. Revised: Jun 2013. Distributed by: McKess on Packaging Services a business unit of McKesson Corporation, 7107 Weddington Rd. Manufactured by: Piramal Enterprises Limited, 247 Business Park A-Wing, 6th floor, LBS Marg, Vikrolu (W) Mumbai 400083.Baclofen