SODIUM NITRITE injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Sodium Nitrite (UNII: M0KG633D4F) (Nitrite Ion - UNII:J39976L608)

Dostupné z:

Hope Pharmaceuticals

INN (Medzinárodný Name):

Sodium Nitrite

Zloženie:

Sodium Nitrite 30 mg in 1 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Sodium Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. None Risk Summary Life-sustaining therapy should not be withheld. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated (see Clinical Considerations). Therefore, if a pregnant woman has known or suspected cyanide poisoning, Sodium Nitrite Injection for sequential use with Sodium Thiosulfate Injection is recommended [see Indications and Usage (1)]. There are no available data on Sodium Nitrite Injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal

Prehľad produktov:

Each Sodium Nitrite carton (NDC 60267-311-10) consists of the following: Storage Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze. (Note: Sodium Thiosulfate must be obtained separately.)

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

SODIUM NITRITE- SODIUM NITRITE INJECTION, SOLUTION
HOPE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM NITRITE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM
NITRITE INJECTION.
SODIUM NITRITE INJECTION, USP
INITIAL U.S. APPROVAL: 2011
WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
SODIUM NITRITE CAN CAUSE SERIOUS ADVERSE REACTIONS AND DEATH FROM:
HYPOTENSION (5.1)
METHEMOGLOBIN FORMATION (5.2)
PATIENTS SHOULD BE CLOSELY MONITORED TO ENSURE ADEQUATE PERFUSION AND
OXYGENATION
DURING TREATMENT WITH SODIUM NITRITE.
INDICATIONS AND USAGE
Sodium Nitrite Injection, an antidote, is indicated for sequential use
with sodium thiosulfate for treatment
of acute cyanide poisoning that is judged to be serious or
life-threatening. (1)
Use with caution if the diagnosis of cyanide poisoning is uncertain.
(1)
DOSAGE AND ADMINISTRATION
If clinical suspicion of cyanide poisoning is high, administer Sodium
Nitrite Injection without delay and in
conjunction with appropriate airway, ventilatory, and circulatory
support. (2.1)
The expert advice of a regional poison control center may be obtained
by calling 1-800-222-1222. (2.1)
Dosing:
AGE
INTRAVENOUS DOSE OF SODIUM NITRITE AND SODIUM THIOSULFATE
ADULTS
1.)
2.)
CHILDREN
1.)
2.)
_Redosing_: If signs of cyanide poisoning reappear, repeat treatment
using one-half the original dose of
both sodium nitrite and sodium thiosulfate. (2.2)
_Monitoring_: Blood pressure must be monitored during treatment. (2.2)
Sodium nitrite is chemically incompatible with hydroxocobalamin and
should not be administered via
the same intravenous line. (2.4)
DOSAGE FORMS AND STRENGTHS
Sodium Nitrite Injection consists of:
one vial of sodium nitrite injection, USP 300 mg/10 mL (30 mg/mL) (3)
CONTRAINDICATIONS
None. (4)
SODIUM NITRITE -10 mL of sodium nitrite at the rate of 2.5 to 5
mL/minute
SODIUM THIOSULFATE - 50 mL