RYANODEX DANTROLENE SODIUM- dantrolene sodium injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DANTROLENE SODIUM (UNII: 287M0347EV) (DANTROLENE - UNII:F64QU97QCR)

Available from:

Eagle Pharmaceuticals, Inc.

INN (International Name):

dantrolene sodium

Composition:

dantrolene sodium 250 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None 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 backgroun

Product summary:

RYANODEX® (NDC 42367-540-32) is available in 20 mL vials containing a sterile lyophilized mixture of 250 mg dantrolene sodium for reconstitution with 5 mL sterile water for injection USP (without a bacteriostatic agent) to yield an orange colored injectable suspension. Store unreconstituted product at 20 °C to 25 °C (68 ºF to 77 ºF) [see USP Controlled Room Temperature], with excursions permitted to 15 ºC to 30 ºC (59 ºF to 86 ºF) and avoid prolonged exposure to light.

Authorization status:

New Drug Application

Summary of Product characteristics

RYANODEX DANTROLENE SODIUM- DANTROLENE SODIUM INJECTION, SUSPENSION
EAGLE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RYANODEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RYANODEX.
RYANODEX (DANTROLENE SODIUM) FOR INJECTABLE SUSPENSION, FOR
INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
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 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
surge ry.
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)
DOSAGE FORMS AND STRENGTHS
For injectable suspension: 250 mg of lyophilized powder in a
single-dose vial for reconstitution (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Skeletal Muscle Weakness: Ambulate patients with assistance until they
have normal strength and balance (5.1)
Dyspnea, Respiratory Muscle Weakness, and Decreased Inspiratory
Capacity: Monitor patients for the adequacy of
ventilation (5.1)
Dysphagia: Assess patients for difficulty swallowing and choking (5.1)
Somnolence and Dizziness: Can occur follow