SODIUM NITROPRUSSIDE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Sodium Nitroprusside (UNII: EAO03PE1TC) (Nitroprusside - UNII:169D1260KM)

Saatavilla:

Dr.Reddy's Laboratories Inc.,

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside injection can be minimized.   Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.   Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure. Sodium nitroprusside should not be used in the treatment of compensatory hypertension, where the primary hemodynamic lesion is aortic coarctation or arteriovenous shunting.   Sodium nitroprusside should not be used to produce hypotension during surgery in patients with known inadequate cerebral circulation, or in moribund patients (A.S.A. Class 5E) coming to emergency surgery.   Patients with congenital (Leber’s) optic atrophy or with tobacco amblyopia have unusually high cyanide/thiocyanate ratios

Tuoteyhteenveto:

Sodium nitroprusside injection is supplied in amber-colored, single-dose 50 mg/2 mL Vials (NDC 43598-587-23).   Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]   To protect sodium nitroprusside injection from light, it should be stored in its carton until it is used.   Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in INDIA Issued: 0419 To report SUSPECTED ADVERSE REACTIONS, contact Dr. REDDY'S LABORATORIES Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088or www.fda.gov/medwatch.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SODIUM NITROPRUSSIDE- SODIUM NITROPRUSSIDE INJECTION, SOLUTION
DR.REDDY'S LABORATORIES INC.,
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SODIUM NITROPRUSSIDE INJECTION
BOXED WARNING
SODIUM NITROPRUSSIDE INJECTION IS NOT SUITABLE FOR DIRECT INJECTION.
THE SOLUTION MUST BE
FURTHER DILUTED IN STERILE 5% DEXTROSE INJECTION BEFORE INFUSION.
SODIUM NITROPRUSSIDE CAN CAUSE PRECIPITOUS DECREASES IN BLOOD PRESSURE
(SEE DOSAGE
AND ADMINISTRATION). IN PATIENTS NOT PROPERLY MONITORED, THESE
DECREASES CAN LEAD
TO IRREVERSIBLE ISCHEMIC INJURIES OR DEATH. SODIUM NITROPRUSSIDE
SHOULD BE USED ONLY WHEN
AVAILABLE EQUIPMENT AND PERSONNEL ALLOW BLOOD PRESSURE TO BE
CONTINUOUSLY
MONITORED.EXCEPT WHEN USED BRIEFLY OR AT LOW (<2 MCG/KG/MIN) INFUSION
RATES, SODIUM
NITROPRUSSIDE GIVES RISE TO IMPORTANT QUANTITIES OF CYANIDE ION, WHICH
CAN REACH TOXIC,
POTENTIALLY LETHAL LEVELS (SEE WARNINGS).
THE USUAL DOSE RATE IS 0.5 TO10 MCG/KG/MIN, BUT INFUSION AT THE
MAXIMUM DOSE RATE SHOULD
NEVER LAST MORE THAN 10 MINUTES. IF BLOOD PRESSURE HAS NOT BEEN
ADEQUATELY CONTROLLED AFTER
10 MINUTES OF INFUSION AT THE MAXIMUM RATE, ADMINISTRATION OF SODIUM
NITROPRUSSIDE SHOULD
BE TERMINATED IMMEDIATELY.
ALTHOUGH ACID-BASE BALANCE AND VENOUS OXYGEN CONCENTRATION SHOULD BE
MONITORED AND
MAY INDICATE CYANIDE TOXICITY, THESE LABORATORY TESTS PROVIDE
IMPERFECT GUIDANCE.
DESCRIPTION
Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-)
dihydrate, a hypotensive agent whose
structural formula is
Sodium Nitroprusside
whose molecular formula is Na [Fe(CN) NO] • 2H O, and whose
molecular weight is 297.95. Dry
sodium nitroprusside is a reddish-brown powder, soluble in water. In
an aqueous solution infused
intravenously, sodium nitroprusside is a rapid-acting vasodilator,
active on both arteries and veins.
Sodium nitroprusside solution is rapidly degraded by trace
contaminants, often with resulting color
changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also
sensitive to certain
wavelengths of light, and it must be protected from light in clinical
use.
Sodium Nitroprusside I