Dantrolene Sodium
Generic Name: dantrolene sodium
Brand Names:
Revonto
DESCRIPTION Revonto is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Revonto is supplied in 65 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 ml sterile water for injection USP (without a bacteriostatic agent). Dantrolene sodium is classified as a direct-acting skeletal muscle relaxant.
Overview
DESCRIPTION Revonto is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Revonto is supplied in 65 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 ml sterile water for injection USP (without a bacteriostatic agent). Dantrolene sodium is classified as a direct-acting skeletal muscle relaxant.
Uses
INDICATIONS AND USAGE Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Revonto should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).
Dosage
DOSAGE AND ADMINISTRATION As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued; the administration of 100% oxygen is recommended. Revonto should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached. If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to note that administration of Revonto should be continuous until symptoms subside.
Side Effects
ADVERSE REACTIONS 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.
Interactions
Drug Interactions Dantrolene sodium is metabolized by the liver, and it is theoretically possible that its metabolism may be enhanced by drugs known to induce hepatic microsomal enzymes. However, neither phenobarbital nor diazepam appears to affect dantrolene sodium metabolism. Binding to plasma protein is not significantly altered by diazepam, diphenylhydantoin, or phenylbutazone. Binding to plasma proteins is reduced by warfarin and clofibrate and increased by tolbutamide. Cardiovascular collapse in association with marked hyperkalemia has been reported in patients receiving dantrolene in combination with calcium channel blockers.
Warnings
WARNINGS The use of Revonto in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Since the effect of disease state and other drugs on dantrolene sodium-related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive intravenous dantrolene sodium preoperatively should have vital signs monitored. CONTRAINDICATIONS None.
Pregnancy
Pregnancy Pregnancy Category C Dantrolene sodium has been shown to be embryocidal in the rabbit and has been shown to decrease pup survival in the rat when given at doses seven times the human oral dose. There are no adequate and well-controlled studies in pregnant women. Revonto ® (dantrolene sodium for injection) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Storage
Store unreconstituted product between 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and avoid prolonged exposure to light.
Frequently Asked Questions
What is Dantrolene Sodium used for?▼
INDICATIONS AND USAGE Revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Revonto should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).
What are the side effects of Dantrolene Sodium?▼
ADVERSE REACTIONS 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.
Can I take Dantrolene Sodium during pregnancy?▼
Pregnancy Pregnancy Category C Dantrolene sodium has been shown to be embryocidal in the rabbit and has been shown to decrease pup survival in the rat when given at doses seven times the human oral dose. There are no adequate and well-controlled studies in pregnant women. Revonto ® (dantrolene sodium for injection) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What are the important warnings for Dantrolene Sodium?▼
WARNINGS The use of Revonto in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Since the effect of disease state and other drugs on dantrolene sodium-related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive intravenous dantrolene sodium preoperatively should have vital signs monitored. CONTRAINDICATIONS None.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.