INDICATIONS AND CLINICAL USE

Dantrium^® Capsules (Dantrolene Sodium) are indicated for:

Controlling the manifestations of a chronic spasticity of skeletal muscle resulting from such conditions as spinal cord injury, cerebral palsy, multiple sclerosis, and stroke, whenever such spasticity results in a decrease in functional use of residual motor activity.
The pre-operative management of malignant hyperthermia-susceptible surgical patients.
The post-crisis follow-up management of patients stabilized with the intravenous product (for information regarding the intravenous product see the Dosage and Administration Section of the Dantrium Intravenous Product Monograph).

Dantrium is not indicated in the relief of skeletal muscle spasms due to rheumatic disorders.

CONTRAINDICATIONS

Dantrium^® is contraindicated in:

Patients with known hypersensitivity to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING.
Cases where spasticity is needed to maintain function. Skeletal muscle spasticity without suitable volitional activity (residual motor activity) may be of value in rehabilitation programs aimed toward sustaining upright posture and balance, and may assist a patient’s locomotor pattern. Relief of such spasticity would reduce rather than increase function.
Patients with compromised pulmonary function, particularly those with obstructive pulmonary disease.
Patients with active hepatic disease, such as hepatitis and cirrhosis.

WARNINGS AND PRECAUTIONS

Serious Warning and Precautions

Hepatotoxicity
Dantrium (dantrolene sodium) has a potential for hepatotoxicity and symptomatic hepatitis, and should not be used in conditions other than those recommended. Risk of hepatic injury appears to be greater in female patients, in patients over 30 years of age, in patients taking other medication(s), and in patients receiving other hepatotoxic therapies concomitantly. Dantrium may exacerbate pre-existing liver dysfunction. Dantrium should not be used without appropriate evaluation and monitoring of hepatic function before and throughout treatment, including frequent determinations of alanine transferase (ALT) and aspartate transferase (AST) in blood serum. A trial administration of Dantrium is recommended and if after 45 days no observable benefit is evident, Dantrium should be discontinued. The lowest possible effective dose for the individual patient should be prescribed.

Carcinogenicity
There is evidence of low-grade carcinogenicity activity of Dantrium in rats. Thus, potential carcinogenicity in humans cannot be disregarded (see Carcinogenesis and Mutagenesis). Please see complete warnings and full prescribing information for further information.

ADVERSE REACTIONS

Side effects most frequently reported were drowsiness, weakness, dizziness, malaise, fatigue and diarrhoea. These effects were generally transient and may be avoided with initial low doses and a gradual increase to optimal doses. Diarrhoea may be of sufficient severity to warrant temporary or possibly permanent withdrawal of medication.

For additional less commonly reported side effects listed according to the following systems (Cardiovascular, Gastrointestinal, Hepatobiliary, Respiratory, CNS, Urogenital, Musculoskeletal, Integumentrary, Hypersensitivity, Other, Abnormal Hemetologic and Clinical Chemistry Findings), please refer to the Product Monograph.

AVAILABILITY

Dantrium is available in opaque orange and brown capsules of:

25 mg (opaque orange cap and opaque light tan to brown body) coded with 1 black bar and DANTRIUM 25 mg 0149 0030, bottles of 100, and
100 mg (opaque orange cap and opaque light tan to brown body) coded with 3 black bars and DANTRIUM 100 mg 0149 0033, bottles of 100.

Dantrium Capsules: 25 mg
Bottles of 100
DIN 01997602

Dantrium Capsules: 100 mg
Bottles of 100
DIN 01997653

For full prescribing information please refer to the Product Monograph.

JHP acquired the rights to Dantrium^® Capsules (dantrolene sodium) from Procter & Gamble on August 19th 2008 and has now partnered with Methapharm for the product distribution in Canada.