Ryanodex is used to prevent or treat a medical problem called malignant hyperthermia that may occur in some patients during or following surgery or anesthesia. Malignant hyperthermia consists of a group of symptoms including very high fever, fast and irregular heartbeat, and breathing problems. It is believed that the tendency to develop malignant hyperthermia is inherited.
This medicine is available only with your doctor's prescription.
Ryanodex indications
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Ryanodex® is indicated for the:
Treatment of malignant hyperthermia in conjunction with appropriate supportive measures
Prevention of malignant hyperthermia in patients at high risk.
Ryanodex dosage
Ryanodex Dosage
Generic name: Ryanodex
Dosage form: injection, suspension
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
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 when necessary
Administer diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX is insufficient to maintain diuresis)
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.
If the physiologic and metabolic abnormalities reappear, repeat RYANODEX dosing by intravenous push starting with 1 mg/kg.
Dosage for Prevention of Malignant Hyperthermia
The recommended prophylactic dose of RYANODEX is 2.5 mg/kg administered intravenously over a period of at least 1 minute, starting approximately 75 minutes prior to surgery. Avoid agents that trigger MH.
If surgery is prolonged, administer additional individualized RYANODEX doses during anesthesia and surgery.
Dosage for Pediatric Patients
The recommended weight-based dose of RYANODEX for pediatric patients in the treatment and prevention of MH is the same as for adults for these indications.
Reconstitution and Administration Instructions
The supplied lyophilized powder must be reconstituted prior to administration:
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).
Shake the vial to ensure an orange-colored uniform suspension. Visually inspect the vial for particulate matter and discoloration prior to administration.
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.
More about Ryanodex (Ryanodex)
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Ryanodex (Advanced Reading)
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Professional resources
Ryanodex (FDA)
Ryanodex Sodium (AHFS Monograph)
Related treatment guides
Malignant Hyperthermia
Ryanodex interactions
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Calcium Channel Blockers
Cardiovascular collapse in association with marked hyperkalemia has been reported in patients receiving Ryanodex in combination with calcium channel blockers. The concomitant use of RYANODEX and calcium channel blockers is not recommended during the treatment of malignant hyperthermia.
Muscle Relaxants
The concomitant administration of RYANODEX with muscle relaxants may potentiate the neuromuscular block.
Antipsychotics And Antianxiety Agents
The concomitant administration of RYANODEX with antipsychotic and antianxiety agents may potentiate their effects on the central nervous system.
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 Ryanodex sodium that differed from RYANODEX in that it contained Ryanodex sodium and mannitol at concentrations of 0.33 mg/mL and 50 mg/mL, respectively, when reconstituted according to the product's prescribing information. The active comparator was infused at a rate that administered 20 mg of Ryanodex per minute for each of the doses evaluated.
Table 1 displays the most common adverse events in this study. These data are not an adequate basis for comparison of the types or frequencies of adverse event types between RYANODEX and the Ryanodex sodium comparator.
Adverse events increased in frequency with increasing doses in the trial, but did not differ in frequency between the two treatment groups. RYANODEX-treated subjects were more likely to report immediate adverse events of flushing, dystonia, and dysphagia than those receiving the active comparator.
In all dose groups, hand grip strength declined after dosing. In general, the decline in hand grip strength was more pronounced and occurred more rapidly in the RYANODEX-treated subjects in the 1.0, 1.75, 2.0 and 2.25 mg/kg treatment groups. In the 2.5 mg/kg treatment group, the decline in hand grip strength both in amount and duration was similar between the two treatment groups.
Table 1: Adverse Events in Healthy Volunteers
Number(%) of subjects
RYANODEX
[N=30]
Ryanodex Sodium Comparator
[N=31]
Flushing
8 (27)
1 (3)
Somnolence
5 (17)
4 (13)
Dysphonia
4 (13)
1 (3)
Dysphagia
3 (10)
4 (13)
Nausea
3 (10)
3 (10)
Feeling abnormal
3 (10)
3 (10)
Headache
1 (3)
4 (13)
Vomiting
1 (3)
2 (6)
Vision blurred
1 (3)
1 (3)
Pain in extremity
1 (3)
1 (3)
Muscular Weakness/Asthenia
1 (3)
1 (3)
Atrioventricular block
1 (3)
0
Tachycardia
1 (3)
0
Infusion site pain
1 (3)
0
Dizziness
1 (3)
0
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of another formulation of Ryanodex sodium for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Pulmonary Edema
There have been reports of pulmonary edema developing during the treatment of malignant hyperthermia crises with another Ryanodex sodium dosage form. The contributory effect of the diluent volume and mannitol in these cases is not known.
Thrombophlebitis and Tissue Necrosis
There have been reports of thrombophlebitis following administration of intravenous Ryanodex. Tissue necrosis secondary to extravasation has been reported.
Hypersensitivity/Anaphylactic Reactions
There have been reports of urticaria and erythema possibly associated with the administration of Ryanodex sodium for injection. Anaphylaxis has been reported.
Injection Site Reactions
Injection site reactions including pain, erythema, and swelling, commonly due to extravasation, have been reported.
Dantrium (Australia, Belgium, Canada, Chile, France, Greece, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, South Africa, United Kingdom, United States)
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DailyMed. "DANTROLENE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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