DANTROLENE SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR)

Available from:

American Health Packaging

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dantrolene sodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage titration (see DOSAGE AND ADMINISTRATION ), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolene sodium capsules. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium capsule therapy. In such instances, information regarding im

Product summary:

Dantrolene Sodium Capsules USP, 25 mg are rich yellow opaque bodies and light green opaque caps. Each cap and body imprinted in black with G441. They are available as follows: Unit dose packages of 30 (3 x 10) NDC 68084-300-21 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DANTROLENE SODIUM- DANTROLENE SODIUM CAPSULE
AMERICAN HEALTH PACKAGING
----------
DANTROLENE SODIUM CAPSULES, USP
8230021/0721
RX ONLY
Dantrolene sodium has a potential for hepatotoxicity, and should not
be used in
conditions other than those recommended. Symptomatic hepatitis (fatal
and non-
fatal) has been reported at various dose levels of the drug. The
incidence reported
in patients taking up to 400 mg/day is much lower than in those taking
doses of
800 mg or more per day. Even sporadic short courses of these higher
dose levels
within a treatment regimen markedly increased the risk of serious
hepatic injury.
Liver dysfunction as evidenced by blood chemical abnormalities alone
(liver enzyme
elevations) has been observed in patients exposed to dantrolene sodium
for
varying periods of time. Overt hepatitis has occurred at varying
intervals after
initiation of therapy, but has been most frequently observed between
the third and
twelfth month of therapy. The risk of hepatic injury appears to be
greater in
females, in patients over 35 years of age, and in patients taking
other medication(s)
in addition to dantrolene sodium. Spontaneous reports suggest a higher
proportion
of hepatic events with fatal outcome in elderly patients receiving
dantrolene
sodium. However, the majority of these cases were complicated with
confounding
factors such as intercurrent illnesses and/or concomitant potentially
hepatotoxic
medications (see GERIATRIC USE subsection). Dantrolene sodium should
be used
only in conjunction with appropriate monitoring of hepatic function
including
frequent determination of SGOT or SGPT. If no observable benefit is
derived from
the administration of dantrolene sodium after a total of 45 days,
therapy should be
discontinued. The lowest possible effective dose for the individual
patient should be
prescribed.
DESCRIPTION
The chemical formula of dantrolene sodium is hydrated
1-[[[5-(4-nitrophenyl)-2-
furanyl]methylene] amino]-2, 4-imidazolidinedione sodium salt. It is
an orange powder,
slightly soluble in wate