BACLOFEN- baclofen tablet
American Health Packaging
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Baclofen, USP is a muscle relaxant and antispastic.
Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is:
C 10H 12ClNO 2 M.W. 213.66
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.
Each tablet, for oral administration, contains 5 mg, 10 mg, or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, povidone and sodium starch glycolate.
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.
Baclofen tablets USP 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.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets USP are 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.
There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 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. 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.
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.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
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%).
Others 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 tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
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 mg to 80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. (three times in a day) 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. (four times in a day)).
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).
Baclofen Tablets USP, 5 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "16" on one side and "09" on the other side, containing 5 mg baclofen, USP are supplied as follows:
Unit dose packages of 50 (5 x 10) NDC 60687-804-65
Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1285" on one side and break line on the other side, containing 10 mg baclofen, USP are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-815-01
Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1286" on one side and break line on the other side, containing 20 mg baclofen, USP are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 60687-826-01
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Keep this and all drugs out of the reach of children.
American Health Packaging unit dose blisters (see
How Supplied section) contain drug product from Zydus Pharmaceuticals (USA) Inc. as follows:
(5 mg / 50 UD) NDC 60687-804-65 packaged from NDC 70710-1609
(10 mg / 100 UD) NDC 60687-815-01 packaged from NDC 70710-1285
(20 mg / 100 UD) NDC 60687-826-01 packaged from NDC 70710-1286
Distributed by:
American Health Packaging
Columbus, OH 43217
8480465/1223F
NDC 60687- 804-65
Baclofen
Tablets, USP
5 mg
50 Tablets (5 x 10) Rx Only
Each Tablet Contains:
Baclofen USP.............................................................................. 5 mg
Usual Dosage: See full prescribing information.
Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from
NDC # 70710-1609, Zydus Pharmaceuticals (USA) Inc.
Distributed by: American Health Packaging, Columbus, Ohio 43217
780465
0480465/1223
NDC 60687- 815-01
Baclofen
Tablets, USP
10 mg
100 Tablets (10 x 10) Rx Only
Each Tablet Contains:
Baclofen USP............................................................................10 mg
Usual Dosage: See full prescribing information.
Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from
NDC # 70710-1285, Zydus Pharmaceuticals (USA) Inc.
Distributed by: American Health Packaging, Columbus, Ohio 43217
781501
0481501/1223
NDC 60687- 826-01
Baclofen
Tablets, USP
20 mg
100 Tablets (10 x 10) Rx Only
Each Tablet Contains:
Baclofen USP............................................................................ 20 mg
Usual Dosage: See full prescribing information.
Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
The drug product contained in this package is from
NDC # 70710-1286, Zydus Pharmaceuticals (USA) Inc.
Distributed by: American Health Packaging, Columbus, Ohio 43217
782601
0482601/1223
BACLOFEN
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Labeler - American Health Packaging (929561009) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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American Health Packaging | 929561009 | repack(60687-804, 60687-815, 60687-826) |