BACLOFEN tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)
Available from:
Eywa Pharma Inc
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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.  Hypersensitivity to baclofen.
Product summary:
For 10 mg strength : White to off-white, round flat-faced beveled edged tablets debossed with 'E' and '6' on one side and scored on the other side.                           They are supplied as follows: NDC 71930-006 -12 bottles of 100 tablets  NDC 71930-006 -13 bottles of 1000 tablets  For 20 mg strength: White to off-white, round flat-faced beveled edged tablets debossed with 'E' and '9' on one side and scored on the other side.                                       They are supplied as follows: NDC 71930-007 -12 bottles of 100 tablets  NDC 71930-007 -13 bottles of 1000 tablets  Storage   Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children Distributed by: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540   Made in India. Rev. January 2020
Authorization status:
Abbreviated New Drug Application
Authorization number:
71930-006-12, 71930-006-13, 71930-007-12, 71930-007-13

BACLOFEN - baclofen tablet

Eywa Pharma Inc

----------

BACLOFEN TABLETS USP

Rx only

DESCRIPTION

Baclofen USP, is a muscle relaxant and antispastic.

Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is:

H ClNO M.W. 213.66

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder, with a

molecular weight of 213.66. 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, USP. In addition, each tablet

contains the following inactive ingredients: Microcrystalline Cellulose, Mannitol, Pre-Gelatinized

Starch, Hypromellose, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate.

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, 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.

CONTRAINDICATIONS

Hypersensitivity to baclofen.

WARNINGS

a. Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days

after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The

symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and

seizure. If the potential benefit justifies the potential risk to the fetus and oral baclofen is continued

during pregnancy, gradually reduce the dose and discontinue baclofen before delivery. If slow

withdrawal is not feasible, advise the parents or caregivers of the potential for neonatal withdrawal.

b. 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.

c. 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.

d. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown

poor tolerability to the drug.

e. 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

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.

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 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 WARNINGSAbrupt

Drug Withdrawal).

HOW SUPPLIED

For 10 mg strength:

White to off-white, round flat-faced beveled edged tablets debossed with 'E' and '6' on one side and

scored on the other side.

They are supplied as follows:

NDC 71930-006-12 bottles of 100 tablets

NDC 71930-006-13 bottles of 1000 tablets

For 20 mg strength:

White to off-white, round flat-faced beveled edged tablets debossed with 'E' and '9' on one side and

scored on the other side.

They are supplied as follows:

NDC 71930-007-12 bottles of 100 tablets

NDC 71930-007-13 bottles of 1000 tablets

Storage

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

closed container as defined in the USP, with a child-resistant closure (as required).

Keep this and all medications out of the reach of children

Distributed by:

Eywa Pharma Inc.

2 Research Way, Floor 3

Princeton, NJ 08540

Made in India.

Rev. January 2020

Package/Label Display Panel

Baclofen Tablets USP 10 mg 100s Label Text

Baclofen

Tablets, USP

10 mg

Rx only

100 TABLETS EYWA PHARMA

Baclofen Tablets USP 10 mg 1000s Label Text

Baclofen

Tablets, USP

10 mg

Rx only

1000 TABLETS EYWA PHARMA

Baclofen Tablets USP 20 mg 100s Label Text

Baclofen

Tablets, USP

20 mg

Rx only

100 TABLETS EYWA PHARMA

Baclofen Tablets USP 20 mg 1000s Label Text

Baclofen

Tablets, USP

20 mg

Rx only

1000 TABLETS EYWA PHARMA

BACLOFEN

baclofen tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:719 30 -0 0 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACLO FEN (UNII: H78 9 N3FKE8 ) (BACLOFEN - UNII:H78 9 N3FKE8 )

BACLOFEN

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MANNITO L (UNII: 3OWL53L36 A)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

2 pieces

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:719 30 -0 0 6 -12

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/10 /20 20

2

NDC:719 30 -0 0 6 -13

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/10 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA211555

0 1/10 /20 20

BACLOFEN

baclofen tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:719 30 -0 0 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACLO FEN (UNII: H78 9 N3FKE8 ) (BACLOFEN - UNII:H78 9 N3FKE8 )

BACLOFEN

20 mg

Eywa Pharma Inc

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MANNITO L (UNII: 3OWL53L36 A)

STARCH, CO RN (UNII: O8 232NY3SJ)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

2 pieces

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:719 30 -0 0 7-12

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/10 /20 20

2

NDC:719 30 -0 0 7-13

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/10 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA211555

0 1/10 /20 20

Labeler -

Eywa Pharma Inc (080465609)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Recipharm Pharmaservices

Private Limited

8 7140 19 27

LABEL(719 30 -0 0 6 , 719 30 -0 0 7) , MANUFACTURE(719 30 -0 0 6 , 719 30 -0 0 7) ,

PACK(719 30 -0 0 6 , 719 30 -0 0 7)

Revised: 12/2019

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