Generic Name and Formulations:
Dantrolene sodium 25mg, 50mg, 100mg; caps.
Par Pharmaceutical, Inc.
Indications for DANTRIUM:
Chronic spasticity due to upper motor neuron disorders (eg, spinal cord injury, stroke, cerebral palsy, multiple sclerosis).
Use lowest effective dose. 25mg once daily for 7 days, then 25mg 3 times daily for 7 days, then 50mg 3 times daily for 7 days, then 100mg 3 times daily; max 100mg 4 times daily.
<5yrs: not established. ≥5yrs: Use lowest effective dose. 0.5mg/kg once daily for 7 days, then 0.5mg/kg 3 times daily for 7 days, then 1mg/kg 3 times daily for 7 days, then 2mg/kg 3 times daily; max 100mg 4 times daily.
Active hepatic disease. Spasticity utilization to sustain upright posture/balance in locomotion or to obtain increased function.
Risk of hepatotoxicity (esp. females or patients >35 years, or concomitant other drugs); monitor liver function at baseline and during therapy; discontinue if hepatitis or liver abnormalities develop. History of liver disease. Pulmonary dysfunction. Severely impaired cardiac function. Discontinue if no improvement after 45 days of treatment. Avoid exposure to sunlight. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Muscle relaxant (local).
Estrogens may increase risk of hepatotoxicity. Potentiates CNS depressants (eg, sedatives, tranquilizers). Avoid concurrent verapamil (cardiovascular collapse). May potentiate vecuronium.
Drowsiness, dizziness, weakness, fatigue, diarrhea, urinary changes, tachycardia, seizures, depression; hepatotoxicity, hepatitis, photosensitivity, pleural effusion with associated eosinophilia.