Dantrium Intravenous Side Effects

Generic Name: dantrolene

Please note - some side effects for Dantrium Intravenous may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Dantrium Intravenous Side Effects - for the Professional

Dantrium Intravenous

There have been occasional reports of death following malignant hyperthermia crisis even when treated with intravenous dantrolene; incidence figures are not available (the pre-dantrolene mortality of malignant hyperthermia crisis was approximately 50%). Most of these deaths can be accounted for by late recognition, delayed treatment, inadequate dosage, lack of supportive therapy, intercurrent disease and/or the development of delayed complications such as renal failure or disseminated intravascular coagulopathy. In some cases there are insufficient data to completely rule out therapeutic failure of dantrolene.

There are reports of fatality in malignant hyperthermia crisis, despite initial satisfactory response to i.v. dantrolene, which involve patients who could not be weaned from dantrolene after initial treatment.

The administration of intravenous Dantrium to human volunteers is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness.

The following adverse reactions are in approximate order of severity:

 

There are rare reports of pulmonary edema developing during the treatment of malignant hyperthermia crisis in which the diluent volume and mannitol needed to deliver i.v. dantrolene possibly contributed.

 

There have been reports of thrombophlebitis following administration of intravenous dantrolene; actual incidence figures are not available. Tissue necrosis secondary to extravasation has been reported.

 

There have been rare reports of urticaria and erythema possibly associated with the administration of i.v. Dantrium. There has been one case of anaphylaxis.

 

Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported.

None of the serious reactions occasionally reported with long-term oral Dantrium use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term Dantrium Intravenous therapy.

The following events have been reported in patients receiving oral dantrolene: aplastic anemia, leukopenia, lymphocytic lymphoma, and heart failure. Capsules for a complete listing of adverse reactions.)

The published literature has included some reports of Dantrium use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrium Intravenous is not indicated for the treatment of NMS and patients may expire despite treatment with Dantrium Intravenous.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Side Effects by Body System

Nervous system

Nervous system side effects have commonly included drowsiness (30%), dizziness (14%), and malaise. Speech disturbances, headache, seizures and hallucinations have been reported less frequently.

Gastrointestinal

Several reports of severe constipation and abdominal distention leading to functional obstruction have been reported.

Gastrointestinal side effects have frequently included diarrhea which may be severe enough to require discontinuation. Constipation, abdominal cramps, nausea, and vomiting have been reported less frequently.

Hematologic

Hematologic side effects have included aplastic anemia, leukopenia, and lymphocytic lymphoma.

Musculoskeletal

Musculoskeletal side effects have commonly included weakness which is usually tolerable. Myalgia and backache have also been reported.

Hepatic

Hepatic side effects have included hepatic injury (1.8%), hepatitis (0.6%), and fatal hepatitis (0.3%).

Risk of hepatic injury is greater in females, patients over 35 years of age, and in patients on concurrent medications. The severity of the reaction appears to increase with increases in dose and duration.

Respiratory

Respiratory side effects have infrequently included pulmonary edema with the use of intravenous dantrolene. Pleural effusion and pneumonitis have also been reported.

Cardiovascular

Cardiovascular side effects have infrequently included pericarditis (both with and without pleural effusion) in patients receiving oral dantrolene.

Local

Local side effects have included thrombophlebitis in patients receiving intravenous dantrolene.

Dermatologic

Dermatologic side effects have included rare reports of acne.

Ocular

Ocular side effects have included visual disturbances.

Other

Other side effects have included one case of bilateral hearing loss which was thought to have been secondary to dantrolene treatment.

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