DANTROLENE SODIUM capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Dantrolene sodium is 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 is 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. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression. A decision to continue the administration of dantrolene sodium on a long-term basis is justified if introduction of the drug into the patient's regimen: - produces a significant reduction in painful and/or disabling spasticity such as clonus, or - permits a significant reduction in the intensity and/or degree of nursing care required, or - rids the patient of any annoying manifestation of spasticity considered important by the patient himself. Oral dantrolene sodium is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery. Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous Dantrolene Sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for Dantrium ® (dantrolene sodium) Intravenous. Oral dantrolene sodium should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia. Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium . Dantrolene sodium is contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function. Drug abuse and dependency potential has not been evaluated in human or animal studies.

Resumen del producto:

Dantrolene sodium is available in: 50-mg opaque, orange and tan capsules imprinted with DANTRIUM 50 mg on the cap and 0149 0031 with a double bar on the body. NDC  63629-2169-1 bottle of 100 Store between 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature].

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

DANTROLENE SODIUM- DANTROLENE SODIUM CAPSULE
BRYANT RANCH PREPACK
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DANTROLENE SODIUM CAPSULES
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 water, but due to its slightly acidi