BACLOFEN- baclofen tablet 
Mylan Pharmaceuticals Inc.

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DESCRIPTION

Baclofen is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid with a molecular formula of C10H12ClNO2 and a molecular weight of 213.66.  The structural formula is:

Baclofen Structural Formula

Baclofen, USP is a white to almost 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 of baclofen. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone and yellow iron oxide.

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.

INDICATIONS AND USAGE

Baclofen tablets 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 may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets 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.

CONTRAINDICATIONS

Hypersensitivity to baclofen.

WARNINGS

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.

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.

Stroke

Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

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.

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% 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.

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 mg 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).

HOW SUPPLIED

Baclofen Tablets, USP are available containing 10 mg or 20 mg of baclofen, USP.

The 10 mg tablets are light yellow, round, scored tablets debossed with MX above the score and 23 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-3023-01
bottles of 100 tablets

NDC 0378-3023-10
bottles of 1000 tablets

The 20 mg tablets are light yellow, round, scored tablets debossed with MX above the score and 24 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-3024-01
bottles of 100 tablets

NDC 0378-3024-05
bottles of 500 tablets

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured in India by:
Mylan Laboratories Limited
Hyderabad—500 034, India
Code No. MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED FEBRUARY 2012
MX:BLFN:R2
75005245

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 0378-3023-01

Baclofen
Tablets, USP
10 mg

Rx only     100 TABLETS

100 TABLETS (Rx only)

Each tablet contains:
Baclofen, USP ................. 10 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

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

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

www.mylan.com

RMX3023A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

BaclofenTablets 10 mg Bottles

PRINCIPAL DISPLAY PANEL - 20 mg

NDC 0378-3024-01

Baclofen
Tablets, USP
20 mg

Rx only     100 TABLETS

100 TABLETS (Rx only)

Each tablet contains:
Baclofen, USP ................. 20 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

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

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

www.mylan.com

RMX3024A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

BaclofenTablets 20 mg Bottles
BACLOFEN 
baclofen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0378-3023
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACLOFEN (BACLOFEN) BACLOFEN10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorYELLOW (light yellow) Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code MX;23
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-3023-01100 in 1 BOTTLE, PLASTIC
2NDC:0378-3023-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09033404/02/2012
BACLOFEN 
baclofen tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0378-3024
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACLOFEN (Baclofen) BACLOFEN20 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorYELLOW (light yellow) Score2 pieces
ShapeROUNDSize11mm
FlavorImprint Code MX;24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-3024-01100 in 1 BOTTLE, PLASTIC
2NDC:0378-3024-05500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09033404/02/2012
Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 2/2012
 
Mylan Pharmaceuticals Inc.