Dantrolene Sodium 25 mg/1
Dantrolene Sodium · CAPSULE · Amneal Pharmaceuticals of New York LLC
Dantrolene Sodium is a capsule containing dantrolene sodium at 25 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.
Key Facts
- Brand Name
- Dantrolene Sodium
- Generic Name
- Dantrolene Sodium
- NDC Code (Product)
0115-4411- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076856
- Marketing Start
- 03/01/2005
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
US Worldmeds LLC
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE In Chronic Spasticity: Dantrolene sodium 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. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium is 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. Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolene sodium therapy. In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of dantrolene sodium for a period of 2…
Dosage & Administration
DOSAGE AND ADMINISTRATION For Use in Chronic Spasticity: Prior to the administration of dantrolene sodium , 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 . 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 therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated. Usual Dosage: It is important that the dosage be titrated and individualized for maximum effect. The lowest dose compatible with optimal response is recommended. In view of the potential for liver damage in long-term dantrolene sodium use, therapy should be stopped if benefits are not evident within 45 days. Adults: The following gradual titration schedule is suggested. Some patie…
Warnings
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. If baseline liver abnormalities exist and are confirmed, there is a clear possibility that the potential for dantrolene sodium hepatotoxicity could be enhanced, although such a possibility has not yet been established. Liver function studies (e.g., SGOT or SGPT) should be performed at appropriate intervals during dantrolene sodium 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. Some patients have revealed a return to normal laboratory values in the face of continued therapy while others have not. If symptoms compatible with hepatitis, accompanied by abnormalities in liver function tests or jaundice appear, dantrolene sodium sho…
Contraindications
CONTRAINDICATIONS Active hepatic disease, such as hepatitis and cirrhosis, is a contraindication for use of dantrolene sodium . Dantrolene sodium 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.
Drug Interactions
Drug Interactions: Drowsiness may occur with dantrolene sodium therapy, and the concomitant administration of CNS depressants such as sedatives and tranquilizing agents may result in further drowsiness. While a definite drug interaction with estrogen therapy has not yet been established, caution should be observed if the two drugs are to be given concomitantly. Hepatotoxicity has occurred more often in women over 35 years of age receiving concomitant estrogen therapy. Cardiovascular collapse in patients treated simultaneously with verapamil and Dantrolene Sodium is rare. The combination of therapeutic doses of intravenous Dantrolene Sodium and verapamil in halothane/ α -chloralose anesthetized swine has resulted in ventricular fibrillation and cardiovascular collapse in association with marked hyperkalemia. Until the relevance of these findings to humans is established, the combination of Dantrolene Sodium and calcium channel blockers is not recommended during the management of malignant hyperthermia. Administration of dantrolene sodium may potentiate vecuronium-induced neuromuscular block.
Adverse Reactions
ADVERSE REACTIONS The most frequently occurring side effects of dantrolene sodium 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 dantrolene sodium therapy. If diarrhea recurs upon readministration of dantrolene sodium , 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 depre…
Frequently Asked Questions
What is Dantrolene Sodium used for?
Dantrolene Sodium contains Dantrolene Sodium. It is a capsule taken oral. Consult your doctor for specific uses.
Is Dantrolene Sodium a controlled substance?
Dantrolene Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Dantrolene Sodium?
The generic name for Dantrolene Sodium is Dantrolene Sodium. There are 8 other brand versions of Dantrolene Sodium.
What is the NDC code for Dantrolene Sodium 25 mg/1?
The NDC (National Drug Code) for Dantrolene Sodium 25 mg/1 is 0115-4411, listed by Amneal Pharmaceuticals of New York LLC.