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Bacolfen
Overview
What is Bacolfen?
Baclofen 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 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:
Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn).
What does Bacolfen look like?
What are the available doses of Bacolfen?
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What should I talk to my health care provider before I take Bacolfen?
Sorry No records found
How should I use Bacolfen?
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.
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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see ).
What interacts with Bacolfen?
Hypersensitivity to baclofen.
What are the warnings of Bacolfen?
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What are the precautions of Bacolfen?
Safe use of baclofen 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 may be additive to those of alcohol and other CNS depressants.
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.
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.
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. 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.
What are the side effects of Bacolfen?
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 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:
Cardiovascular:
Gastrointestinal:
Genitourinary:
Other:
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.
What should I look out for while using Bacolfen?
Hypersensitivity to baclofen.
What might happen if I take too much Bacolfen?
Signs and symptoms:
Treatment:
How should I store and handle Bacolfen?
Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and 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 USARev: January 2004
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism of action of baclofen is not fully known. 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. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.
Non-Clinical Toxicology
Hypersensitivity to baclofen.Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Safe use of baclofen 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 may be additive to those of alcohol and other CNS depressants.
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.
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.
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. 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.
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 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:
Cardiovascular:
Gastrointestinal:
Genitourinary:
Other:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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