kemstro- baclofen tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Baclofen (UNII: H789N3FKE8) (Baclofen - UNII:H789N3FKE8)

Available from:

Schwarz Pharma

INN (International Name):

baclofen

Pharmaceutical form:

TABLET, ORALLY DISINTEGRATING

Composition:

10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KEMSTRO™ 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 treatment with KEMSTRO™ will aid in restoring residual function. KEMSTRO™ may also be of some value in patients with spinal cord injuries and other spinal cord diseases. KEMSTRO™ is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of KEMSTRO™ in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions. KEMSTRO™ is contraindicated in patients who are hypersensitive to any component of this product. Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure th

Product summary:

KEMSTRO™ (baclofen orally disintegrating tablets) 10 mg are white, round, orange-flavored, scored and engraved “10” on the unscored side and “SP” above and “351” below the score on the other side. They are supplied as follows: Bottles of 100NDC 0091-3351-01 KEMSTRO™ (baclofen orally disintegrating tablets) 20 mg are white, round, orange-flavored, scored and engraved “20” on the unscored side and “SP” above and “352” below the score on the other side. They are supplied as follows: Bottles of 100NDC 0091-3352-01 Dispense in a tight container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20º- 25º (68º- 77º); excursions permitted between 15º- 30º (59º- 86º). Protect from moisture. Manufactured for: Schwarz Pharma

Summary of Product characteristics

KEMSTRO- BACLOFEN TABLET, ORALLY DISINTEGRATING
SCHWARZ PHARMA
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KEMSTRO™ (BACLOFEN ORALLY DISINTEGRATING TABLETS)
DES CRIPTION
KEMSTRO™ (baclofen orally disintegrating tablets) is a muscle
relaxant and antispastic. 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.
Its chemical name is 4-amino-3-
(4-chlorophenyl)-butanoic acid. The molecular weight of baclofen is
213.66 and the empirical formula
is C
H CINO . The structural formula is represented below:
KEMSTRO™ is available as 10 mg and 20 mg orally disintegrating
tablets. Each orally disintegrating
tablet also contains as inactive ingredients: aspartame, colloidal
silicon dioxide, crospovidone,
magnesium stearate, mannitol, microcrystalline cellulose, natural and
artificial orange flavor and
povidone.
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.
_PHARMACOKINETICS_
Absorption
Baclofen is rapidly and extensively absorbed. Absorption may be
dose-dependent, being reduced with
increasing doses. KEMSTRO™ given with or without water is
bioequivalent to the baclofen
conventional tablet. Thus KEMSTRO™ can be placed on the tongue until
it disintegrates and then be
swallowed with or without water. Followi