BACLOFEN by Advagen Pharma Limited / Rubicon Research Private Limited BACLOFEN tablet
BACLOFEN by
Drug Labeling and Warnings
BACLOFEN by is a Prescription medication manufactured, distributed, or labeled by Advagen Pharma Limited, Rubicon Research Private Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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DESCRIPTION
Baclofen, USP is a muscle relaxant and antispastic.
Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is:
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: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.
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CLINICAL 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.
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INDICATIONS AND USAGE
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.
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WARNINGS
a. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
b. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
c. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
d. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits.
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.
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PRECAUTIONS
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.
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ADVERSE REACTIONS
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.
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OVERDOSAGE
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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DOSAGE AND ADMINISTRATION
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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HOW SUPPLIED
Baclofen Tablets, USP 5 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with "023" on one side and plain on other side, containing 5 mg baclofen USP packaged in bottles of 100 tablets.
NDC: 72888-009-01 100s count
Baclofen Tablets, USP 10 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with "024" on one side and score on other side, containing 10 mg baclofen USP packaged in bottles of 100, 500 and 1000 tablets.
NDC: 72888-010-01 100s count
NDC: 72888-010-05 500s count
NDC: 72888-010-00 1000s count
Baclofen Tablets, USP 20 mg are available as a White to off white, round flat-faced, beveled edge tablets debossed with "025" on one side and score on other side, containing 20 mg baclofen USP packaged in bottles of 100, 500 and 1000 tablets.
NDC: 72888-011-01 100s count
NDC: 72888-011-05 500s count
NDC: 72888-011-00 1000s count
PHARMACIST: Dispense in a well closed container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Distributed by:
Advagen Pharma Ltd
666 Plainsboro Road
Plainsboro Suite 605,
Plainsboro, NJ, 08536, USAManufactured by:
Rubicon Research Private Limited,
Ambernath, Dist: Thane, 421506
India
Rev: 00, 08/2019 - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BACLOFEN
baclofen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 72888-009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (White to off white) Score no score Shape ROUND Size 5mm Flavor Imprint Code 023 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 72888-009-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209102 09/13/2019 BACLOFEN
baclofen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 72888-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (White to off white) Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code 024 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 72888-010-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 2 NDC: 72888-010-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 3 NDC: 72888-010-00 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209102 09/13/2019 BACLOFEN
baclofen tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 72888-011 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (White to off white) Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 025 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 72888-011-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 2 NDC: 72888-011-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 3 NDC: 72888-011-00 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209102 09/13/2019 Labeler - Advagen Pharma Limited (051627256) Registrant - Rubicon Research Private Limited (918629544) Establishment Name Address ID/FEI Business Operations Rubicon Research Private Limited 677604197 manufacture(72888-009, 72888-010, 72888-011) , analysis(72888-009, 72888-010, 72888-011)
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