Label: BACLOFEN- baclofen tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 14, 2019

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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 Structural formula

    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 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, 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 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.

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  • CONTRAINDICATIONS

    Hypersensitivity to baclofen.

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  • WARNINGS

    1. 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.
    2. 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.
    3. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
    4. 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 to 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, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1330" on one side and plain on the other side, containing 10 mg Baclofen USP. Available in unit dose packaged of 100 (10 x 10) NDC 68084-855-01

    Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1337" on one side and plain on the other side, containing 20 mg Baclofen USP. Available in unit dose packaged of 100 (10 x 10) NDC 68084-868-01

    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.

    Made in the USA

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  • PACKAGING INFORMATION

    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
    (10 mg / 100 UD) NDC 68084-855-01 packaged from NDC 0527-1330
    (20 mg / 100 UD) NDC 68084-868-01 packaged from NDC 0527-1337

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8285501/0217

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  • Package/Label Display Panel – Carton – 10 mg

    10 mg Baclofen Tablets Carton

    NDC 68084- 855-01

    Baclofen
    Tablets, USP

    10 mg

    100 Tablets (10 x 10)               Rx Only

    Each Tablet Contains:
    Baclofen, USP………………………………………………10 mg

    Usual Dosage: See package insert for 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].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    The drug product contained in this package is from
    NDC # 0527-1330, Lannett Company, Inc.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    085501
    0285501/1118

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  • Package/Label Display Panel – Blister – 10 mg

    10 mg Baclofen Tablet Blister

    Baclofen
    Tablet, USP

    10 mg

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  • Package/Label Display Panel – Carton – 20 mg

    20 mg Baclofen Tablets Carton

    NDC 68084- 868-01

    Baclofen
    Tablets, USP

    20 mg

    100 Tablets (10 x 10)               Rx Only

    Each Tablet Contains:
    Baclofen, USP………………………………………………20 mg

    Usual Dosage: See package insert for 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].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    The drug product contained in this package is from
    NDC # 0527-1337, Lannett Company, Inc.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    086801
    0286801/1118

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  • Package/Label Display Panel – Blister – 20 mg

    20 mg Baclofen Tablet Blister

    Baclofen
    Tablet, USP

    20 mg

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  • INGREDIENTS AND APPEARANCE
    BACLOFEN 
    baclofen tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-855(NDC:0527-1330)
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color white (white) Score 2 pieces
    Shape ROUND (flat-faced beveled edge) Size 9mm
    Flavor Imprint Code LCI;1330
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68084-855-01 100 in 1 BOX, UNIT-DOSE 03/04/2015
    1 NDC:68084-855-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077241 03/04/2015
    BACLOFEN 
    baclofen tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-868(NDC:0527-1337)
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color white (white) Score 2 pieces
    Shape ROUND (flat-faced beveled edge) Size 10mm
    Flavor Imprint Code LCI;1337
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68084-868-01 100 in 1 BOX, UNIT-DOSE 03/04/2015
    1 NDC:68084-868-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077241 03/04/2015
    Labeler - American Health Packaging (929561009)
    Establishment
    Name Address ID/FEI Business Operations
    American Health Packaging 929561009 repack(68084-855, 68084-868)
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