Dantrium (dantrolene sodium), capsules
Dantrium® (dantrolene sodium), capsules
Product Summary
Therapeutic Class: Skeletal Muscle Relaxant This product is manufactured and distributed by MCP Pharmaceuticals, LLC
Product Profile:
- Latex Free
- Preservative Free
- Bar Coded
For additional detailed information on product and resources, please visit the Dantrium® Capsules Product Website at www.dantrium.com
| WARNING
Dantrium (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 Dantrium 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 Dantrium (dantrolene sodium). Dantrium 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 Dantrium after a total of 45 days, therapy should be discontinued. The lowest possible effective dose for the individual patient should be prescribed. |
Description
Dantrium® is supplied in capsules of 25 mg, 50 mg, and 100 mg.
Indications and Usage
In Chronic Spasticity: Dantrium® 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.Dantrium® is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
In Malignant Hyperthermia: Oral Dantrium® 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 Dantrium® should be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
Contraindications
Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of Dantrium®. Dantrium® 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.
Warnings See Boxed Warning.
Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium® therapy. At the start of Dantrium® 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. Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during Dantrium® therapy. If such studies reveal abnormal values, therapy should generally be discontinued. Only where benefits of the drug have been of major importance to the patient, should reinitiation or continuation of therapy be considered. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, Dantrium® should be discontinued. Dantrium® should be used with particular caution in females and in patients over 35 years of age in view of apparent greater likelihood of drug-induced, potentially fatal, hepatocellular disease in these groups.
Adverse Events
The most frequently occurring side effects of Dantrium® have been drowsiness, dizziness, weakness, general malaise, fatigue, and diarrhea. These are generally transient, occurring early in treatment, and can often be obviated by beginning with a low dose and increasing dosage gradually until an optimal regimen is established. Diarrhea may be severe and may necessitate temporary withdrawal of Dantrium® therapy. If diarrhea recurs upon readministration of Dantrium®, therapy should probably be withdrawn permanently.
Other less frequent side effects, listed according to system, are:
Gastrointestinal: Constipation, rarely progressing to signs of intestinal obstruction, GI bleeding, anorexia, swallowing difficulty, gastric irritation, abdominal cramps, nausea and/or vomiting.
Hepatobiliary: Hepatitis (see WARNINGS).
Neurologic: Speech disturbance, seizure, headache, light-headedness, visual disturbance, diplopia, alteration of taste, insomnia, drooling. Cardiovascular: Tachycardia, erratic blood pressure, phlebitis, heart failure.
Hematologic: Aplastic anemia, anemia, leukopenia, lymphocytic lymphoma, thrombocytopenia.
Psychiatric: Mental depression, mental confusion, increased nervousness.
Urogenital: Increased urinary frequency, crystalluria, hematuria, difficult erection, urinary incontinence and/or nocturia, difficult urination and/or urinary retention.
Integumentary: Abnormal hair growth, acne-like rash, pruritus, urticaria, eczematoid eruption, sweating.
Musculoskeletal: Myalgia, backache. Respiratory: Feeling of suffocation, respiratory depression.
Special Senses: Excessive tearing.
Hypersensitivity: Pleural effusion with pericarditis, anaphylaxis.
Other: Chills and fever.
The published literature has included some reports of Dantrium® use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrium® capsules are not indicated for the treatment of NMS and patients may expire despite treatment with Dantrium® capsules.
Please see the full prescribing information link above for additional information.
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