Baclofen by Endo USA, Inc. BACLOFEN tablet

Baclofen by

Drug Labeling and Warnings

Baclofen by is a Prescription medication manufactured, distributed, or labeled by Endo USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

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: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

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-amino-butyric 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.

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.

CONTRAINDICATIONS

Hypersensitivity to baclofen.

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 benefitted 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 or 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.

PRECAUTIONS

Safe use of baclofen in children under age 12 has not been established, and it is, therefore, not recommended for use in children.

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.

ADVERSE REACTIONS

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: Confusion (1–11%), headache (4–8%), insomnia (2–7%); 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 (0–9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: Nausea (4–12%), constipation (2–6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.

Genitourinary: Urinary frequency (2–6%); 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.

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.

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).

HOW SUPPLIED

Baclofen Tablets, USP 10 mg are off-white, scored, oval-shaped tablets debossed “2265” on one side and debossed “V” on the reverse side; and supplied as follows:

• Bottles of 100: NDC: 0603-2406-21
• Bottles of 500: NDC: 0603-2406-28
• Bottles of 1000: NDC: 0603-2406-32

Baclofen Tablets, USP 20 mg are off-white, scored, capsule-shaped tablets debossed “2266” on one side and debossed “V” on the reverse side; and are supplied as follows:

• Bottles of 100: NDC: 0603-2407-21
• Bottles of 500: NDC: 0603-2407-28
• Bottles of 1000: NDC: 0603-2407-32

STORAGE AND HANDLING

Dispense in a tight container with child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

SPL UNCLASSIFIED SECTION

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam - 603 103.
Made in India

Mfg. Lic. No.: TN00002121
OS2406H-01-74-01
Issued: 01/19

PRINCIPAL DISPLAY PANEL - 10 mg

PRINCIPAL DISPLAY PANEL - 20 mg

INGREDIENTS AND APPEARANCE

BACLOFEN 
baclofen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0603-2406
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)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (off-white)	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	2265;V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0603-2406-02	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005	03/31/2016
2	NDC: 0603-2406-21	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005
3	NDC: 0603-2406-28	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005
4	NDC: 0603-2406-32	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005
5	NDC: 0603-2406-30	2500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005	10/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077156	08/30/2005

BACLOFEN 
baclofen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0603-2407
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)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (off-white)	Score	2 pieces
Shape	OVAL (capsule-shaped)	Size	16mm
Flavor		Imprint Code	2266;V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0603-2407-21	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005
2	NDC: 0603-2407-28	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005
3	NDC: 0603-2407-32	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077068	08/30/2005

Labeler - Par Pharmaceutical (011103059)

Establishment
Name	Address	ID/FEI	Business Operations
Generics Bidco II LLC d/b/a Prinston Laboratories		968329537	ANALYSIS(0603-2406, 0603-2407) , MANUFACTURE(0603-2406, 0603-2407)

Establishment
Name	Address	ID/FEI	Business Operations
Generics Bidco II LLC d/b/a Prinston Laboratories		151228897	LABEL(0603-2406, 0603-2407) , MANUFACTURE(0603-2406, 0603-2407) , PACK(0603-2406, 0603-2407)

Establishment
Name	Address	ID/FEI	Business Operations
Par Formulations Private Limited		676159161	ANALYSIS(0603-2406, 0603-2407) , MANUFACTURE(0603-2406, 0603-2407) , PACK(0603-2406, 0603-2407)

Establishment
Name	Address	ID/FEI	Business Operations
Par Pharmaceutical Inc.		092733690	PACK(0603-2406, 0603-2407)