Dantrolene
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Manage the metabolic acidosis Institute cooling when necessary Administer diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX is insufficient to maintain diuresis) [see Description] Administer RYANODEX by intravenous push at a minimum dose of 1 mg/kg. If the physiologic and metabolic abnormalities of MH continue, administer additional intravenous boluses up to the maximum cumulative dosage of 10 mg/kg.
Preparation and administration
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Reconstitution and Administration Instructions The supplied lyophilized powder must be reconstituted prior to administration: (a) Reconstitute each vial of RYANODEX lyophilized powder by adding 5 mL of sterile water for injection (without a bacteriostatic agent). Do not reconstitute with any other solution (e.g., 5% dextrose injection, 0.9% sodium chloride injection). (b) Shake the vial to ensure an orange-colored uniform suspension.
Visually inspect the vial for particulate matter and discoloration prior to administration. (c) Must use the contents of the vial within 6 hours after reconstitution. Store reconstituted suspensions at controlled room temperature (68°F to 77°F or 20°C to 25°C). Do not dilute or transfer the reconstituted RYANODEX suspension to another container to infuse the product.
Administer the reconstituted RYANODEX suspension either: Into the intravenous catheter while an intravenous infusion of 0.9% sodium chloride injection, or 5% dextrose injection is freely running; or Into the indwelling catheter - after assuring its patency - without a freely running infusion. Flush the line to assure that there is no residual RYANODEX remaining in the catheter [see Warnings and Precautions].
Drug interactions
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Calcium Channel Blockers : Concomitant use can cause cardiovascular collapse in association with marked hyperkalemia ( 7.1 ) Muscle Relaxants : Concomitant use with muscle relaxants may potentiate their effects ( 7.2 ) Sedatives : Concomitant use with sedative agents may potentiate their effects ( 7.3 )
7.1 Calcium Channel Blockers Cardiovascular collapse in association with marked hyperkalemia has been reported in patients receiving dantrolene in combination with calcium channel blockers. The concomitant use of RYANODEX and calcium channel blockers is not recommended during the treatment of malignant hyperthermia.
7.2 Muscle Relaxants The concomitant administration of RYANODEX with muscle relaxants may potentiate the neuromuscular block.
7.3 Antipsychotics and Antianxiety Agents The concomitant administration of RYANODEX with antipsychotic and antianxiety agents may potentiate their effects on the central nervous system [see Warnings and Precautions ( 5.2 )] .
Contraindications
None None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from published case reports with RYANODEX use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Dantrolene readily crosses the placenta; however, no serious adverse events have been reported in the neonate following maternal administration of dantrolene prior to delivery. There are risks to the pregnant woman and fetus associated with untreated malignant hyperthermia ( see Clinical Considerations ).
In animal reproduction studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated maternal and embryo/fetal risk Malignant hyperthermia is a medical emergency which can be fatal for the pregnant woman and fetus if left untreated. Life-sustaining therapy should not be withheld due to pregnancy. Labor or Delivery In one uncontrolled study, 100 mg per day of prophylactic oral dantrolene sodium was administered to term pregnant patients awaiting labor and delivery. Dantrolene readily crossed the placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply.
No neonatal respiratory and neuromuscular side effects were observed in this study. Data Animal Data Animal reproduction studies have been conducted with dantrolene sodium. In these studies, dantrolene sodium administered to rats and rabbits produced embryolethality (rabbits) and decreased pup survival (rats) at doses seven times the human oral dose.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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