United States - English - NLM (National Library of Medicine)
BACLOFEN- baclofen tablet
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 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.
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
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
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual
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.
Hypersensitivity to baclofen.
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.
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
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.
Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
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
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.
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.
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
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 bottles of 100 , 500 and 1000 .
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 bottles of 100 and 500
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].
Lannett Company, Inc.
Philadelphia, PA 19136
Made in the USA
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:6 19 19 -0 9 5(NDC:0 527-1337)
Route of Administration
Active Ingredient/Active Moiety
Basis of Strength
Stre ng th
BACLO FEN (UNII: H78 9 N3FKE8 ) (BACLOFEN - UNII:H78 9 N3FKE8 )
Stre ng th
STARCH, CO RN (UNII: O8 232NY3SJ)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
S hap e
ROUND ((ro und))
S iz e
Marketing Start Date
Marketing End Date
NDC:6 19 19 -0 9 5-30
30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 7/29 /20 19
NDC:6 19 19 -0 9 5-8 6
270 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 7/29 /20 19
Marke ting Cate gory
Application Numbe r or Monograph Citation
Marke ting Start Date
Marke ting End Date
0 7/29 /20 19
Ad d re s s
Busine ss Ope rations
Dire c t_Rx
0 79 254320
re pa c k(6 19 19 -0 9 5)