BACLOFEN tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)

Dostupné s:

Unichem Pharmaceuticals (USA), Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 tablets treatment will aid in restoring residual function. Baclofen tablets 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 tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions. Hypersensitivity to baclofen.

Přehled produktů:

Baclofen tablets USP, 5 mg are available as white to off white, round, flat-faced, beveled-edge, uncoated tablets debossed with "B1" on one side and "U" on the other side, containing 5 mg baclofen, USP and are supplied as follows: Bottles of 100………………..….NDC 29300-474-01 Baclofen tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "343" on one side of score line and "U" on the other side of score line on one side of tablet and plain on other side, containing 10 mg baclofen, USP and are supplied as follows: Bottles of 90………………..….NDC 29300-343-19 Bottles of 100………………….NDC 29300-343-01 Bottles of 500………………….NDC 29300-343-05 Bottles of 1000………………...NDC 29300-343-10 Baclofen tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "344" on one side of score line and "U" on the other side of score line on one side of tablet and plain on other side, containing 20 mg baclofen, USP and are supplied as follows: Bottles of 90………………..….NDC 29300-344-19 Bottles of 100………………….NDC 29300-344-01 Bottles of 500………………….NDC 29300-344-05 Bottles of 1000………………...NDC 29300-344-10 Store at 20º to 25ºC (68º to 77ºF) [see USP controlled Room Temperature]. Manufactured by: UNICHEM LABORATORIES LTD. Ind. Area, Meerut Road, Ghaziabad – 201 003, India Manufactured for: East Brunswick, NJ 08816 13014182 05-R-10/2022

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BACLOFEN - BACLOFEN TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
----------
BACLOFEN TABLETS, USP
5 MG
10 MG
20 MG
MUSCLE RELAXANT,
ANTISPASTIC
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Baclofen USP, is a muscle relaxant and antispastic, available as 5-mg,
10-mg and 20-mg
tablets for oral administration. Its chemical name is
4-amino-3-(4-chlorophenyl)-
butanoic acid, and its structural formula is
Baclofen USP is a white or creamy white powder, with a molecular
weight of 213.66. It is
slightly soluble in water, insoluble in organic solvents, dissolves in
dilute mineral acids
and alkali hydroxides.
_Inactive Ingredients._ colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose, povidone, 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-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