DANTROLENE injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DANTROLENE SODIUM

Composition:

DANTROLENE SODIUM 20 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Dantrolene Sodium for Injection 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). Dantrolene Sodium for Injection is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible. None.

Product summary:

Dantrolene Sodium for Injection, USP (NDC 0143-9297-01) is available in vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3,000 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). Store reconstituted solution at 20° to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. Protect from direct light. Store unreconstituted product at 20° to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. Avoid prolonged exposure to light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DANTROLENE- DANTROLENE INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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DANTROLENE SODIUM FOR INJECTION, USP
RX ONLY
DESCRIPTION
Dantrolene Sodium for Injection, USP is a sterile, non-pyrogenic,
lyophilized formulation.
Dantrolene Sodium for Injection, USP is supplied in 100 mL vials
containing 20 mg
dantrolene sodium, 3,000 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. Chemically,
dantrolene sodium is hydrated
1-[[[5-(4-nitrophenyl)-2furanyl]methylene]amino]-2,4-
imidazolidinedione sodium salt. The structural formula for the
hydrated salt is:
The hydrated salt contains approximately 15% water (3.5 moles) and has
a molecular
weight of 399. The anhydrous salt (dantrolene) has a molecular weight
of 336.
CLINICAL PHARMACOLOGY
In isolated nerve-muscle preparation, dantrolene sodium has been shown
to produce
relaxation by affecting the contractile response of the muscle at a
site beyond the
myoneural junction. In skeletal muscle, dantrolene sodium dissociates
the excitation-
contraction coupling, probably by interfering with the release of Ca++
from the
sarcoplasmic reticulum. The administration of intravenous dantrolene
sodium to human
volunteers is associated with loss of grip strength and weakness in
the legs, as well as
subjective CNS complaints (see also PRECAUTIONS, INFORMATION FOR
PATIENTS).
Information concerning the passage of dantrolene sodium across the
blood-brain
barrier is not available.
In the anesthetic-induced malignant hyperthermia syndrome, evidence
points to an
intrinsic abnormality of skeletal muscle tissue. In affected humans,
it has been
postulated that "triggering agents" (e.g., general anesthetics and
depolarizing
neuromuscular blocking agents) produce a change within the cell which
results in an
elevated myoplasmic calcium. This elevated myoplasmic calcium
activate