Dantrolene Sodium

Indications

INDICATIONS AND USAGE In Chronic Spasticity 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION For Use in Chronic Spasticity Prior to the administration of dantrolene sodium capsules, consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with dantrolene sodium capsules. Refer to INDICATIONS AND USAGE section for description of response to be anticipated. It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilization of braces, transfer maneuvers, etc.) before beginning dantrolene sodium capsule therapy.

Contraindications

CONTRAINDICATIONS Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium capsules. Dantrolene sodium capsules are contraindicated where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain or maintain increased function.

Warnings and precautions

WARNINGS It is important to recognize that fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy. At the start of dantrolene sodium therapy, it is desirable to do liver function studies (SGOT, SGPT, alkaline phosphatase, total bilirubin) for a baseline or to establish whether there is pre-existing liver disease.

Pregnancy

Pregnancy Adequate animal reproduction studies have not been conducted with dantrolene sodium. It is also not known whether dantrolene sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dantrolene sodium should be given to a pregnant woman only if clearly needed.

Storage and supply

Store at 20°C to 25°C (68°F to 77°F) . Protect from moisture and humidity. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Source: Dantrolene Sodium (Dantrolene Sodium) — US FDA prescribing information, 2024-10-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.