RYANODEX dantrolene sodium 250 mg/5mL

dantrolene sodium · INJECTION, SUSPENSION · Eagle Pharmaceuticals, Inc.

No Recall History

Plain English

RYANODEX dantrolene sodium is a injection, suspension containing dantrolene sodium at 250 mg/5mL, taken intravenous. Manufactured by Eagle Pharmaceuticals, Inc..

Key Facts

Brand Name: RYANODEX dantrolene sodium
Generic Name: dantrolene sodium
NDC Code (Product): 42367-540
Manufacturer: Eagle Pharmaceuticals, Inc.
Strength: 250 mg/5mL
Dosage Form: INJECTION, SUSPENSION
Route: INTRAVENOUS
Marketing Status
Application #: NDA205579
Marketing Start: 07/23/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

neuroleptic malignant syndrome44 reports

respiratory failure35 reports

drug ineffective29 reports

muscular weakness29 reports

asthenia28 reports

pyrexia27 reports

convulsion26 reports

diarrhoea24 reports

vomiting22 reports

off label use20 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see Dosage and Administration ( 2.1 )] Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. ( 1 ) Prevention of malignant hyperthermia in patients at high risk. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Treatment of Malignant Hyperthermia (MH) ( 2.1 ) Administer by intravenous push at a minimum of 1 mg/kg. If signs continue, administer additional intravenous boluses up to maximum cumulative dosage of 10 mg/kg. Institute supportive measures (e.g., discontinue MH-triggering agents, manage metabolic acidosis, cooling if necessary, administer diuretics) Prevention of MH in Patients at High Risk ( 2.2 ) Administer 2.5 mg/kg intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery. Avoid agents that trigger MH. Administer additional individualized doses during anesthesia and surgery if surgery is prolonged. Pediatric Patients : recommended weight-based dose is the same as for adults ( 2.3 ) Reconstitution : With 5 mL of sterile water for injection (without a bacteriostatic agent) prior to administration ( 2.4 ) 2.1 Dosage for Treatment of Malignant Hyperthermia In addition to RYANODEX treatment, institute the following supportive measures: Discontinue use of malignant hyperthermia (MH)-triggering anesthetic agents (i.e., volatile anesthetic gases and succinylcholine). Manage the metabolic acidosis Institute cooling …

Contraindications

4 CONTRAINDICATIONS None None ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 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 )] .

Adverse Reactions

6 ADVERSE REACTIONS Administration to conscious subjects is associated with loss of grip strength and weakness in the legs, drowsiness and dizziness. Other common adverse reactions are: nausea, thrombophlebitis, tissue necrosis secondary to extravasation, urticaria and erythema, and injection site reactions (pain, erythema, swelling) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eagle at 1-855-318-2170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a study designed to evaluate the safety and tolerability of RYANODEX, healthy volunteers were randomly assigned to receive treatment with RYANODEX or an active comparator at doses ranging from 1 mg/kg to 2.5 mg/kg. The RYANODEX dose was infused over the course of 1 minute for each of the doses evaluated. The active comparator was an injectable formulation of dantrolene sodium that differed from RYANODEX in that it contained dantrolen…

Frequently Asked Questions

What is RYANODEX dantrolene sodium used for?

RYANODEX dantrolene sodium contains dantrolene sodium. It is a injection, suspension taken intravenous. Consult your doctor for specific uses.

Is RYANODEX dantrolene sodium a controlled substance?

RYANODEX dantrolene sodium is not classified as a controlled substance by the DEA.

What is the generic name for RYANODEX dantrolene sodium?

The generic name for RYANODEX dantrolene sodium is dantrolene sodium. There are 12 other brand versions of dantrolene sodium.

What is the NDC code for RYANODEX dantrolene sodium 250 mg/5mL?

The NDC (National Drug Code) for RYANODEX dantrolene sodium 250 mg/5mL is 42367-540, listed by Eagle Pharmaceuticals, Inc..

Product NDC

42367-540

Package NDC

42367-540-32

Other Dantrolene Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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