dantrium- dantrolene sodium injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

dantrolene sodium (UNII: 287M0347EV) (dantrolene - UNII:F64QU97QCR)

Boleh didapati daripada:

Procter and Gamble Pharmaceuticals

INN (Nama Antarabangsa):

dantrolene sodium

Borang farmaseutikal:

INJECTION

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Dantrium Intravenous 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. Dantrium Intravenous 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). Dantrium Intravenous 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.

Ringkasan produk:

Dantrium Intravenous (NDC 0149-0734-02) is available in vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3000 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 unreconstituted product at controlled room temperature (59°F to 86°F or 15°C to 30°C) and avoid prolonged exposure to light. Address medical inquiries to Procter & Gamble Pharmaceuticals, Medical Communications Department, PO Box 8006, Mason, Ohio 45040-8006. To place an order, call Procter & Gamble Pharmaceuticals Customer Service 800-448-4878. Mfg. by: Ben Venue Laboratories Bedford, OH 44146 Dist. By: Procter & Gamble Pharmaceuticals, TM Owner, Cincinnati, Ohio 45202

Ciri produk

DANTRIUM- DANTROLENE SODIUM INJECTION
PROCTER AND GAMBLE PHARMACEUTICALS
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DANTRIUM® INTRAVENOUS
(DANTROLENE SODIUM FOR INJECTION)
DESCRIPTION
DANTRIUM INTRAVENOUS is a sterile, non-pyrogenic, lyophilized
formulation of dantrolene sodium for
injection. DANTRIUM INTRAVENOUS is supplied in 70 mL vials containing
20 mg dantrolene sodium, 3000
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).
DANTRIUM is classified as a direct-acting skeletal muscle relaxant.
Chemically, DANTRIUM is hydrated 1-
[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione
sodium salt. The structural
formula for the hydrated salt is:
The hydrated salt contains approximately 15% water (3-1/2 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, DANTRIUM has been shown to
produce relaxation by affecting the
contractile response of the muscle at a site beyond the myoneural
junction. In skeletal muscle, DANTRIUM
dissociates the excitation-contraction coupling, probably by
interfering with the release of Ca++ from
the sarcoplasmic reticulum. The administration of intravenous DANTRIUM
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 DANTRIUM
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 activates acute
cellular catabolic processes that cascad