QUINIDINE GLUCONATE INJECTION, USP THIS PRODUCT IS TO BE USED BY THE PHYSICIAN OR UNDER HIS/HER DIRECTION.

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Quinidine gluconate (UNII: R6875N380F) (Quinidine - UNII:ITX08688JL)

Mevcut itibaren:

Eli Lilly and Company

INN (International Adı):

Quinidine gluconate

Kompozisyon:

Quinidine gluconate 80 mg in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Treatment of malaria — Quinidine gluconate injection is indicated for the treatment of life–threatening Plasmodium falciparum malaria. Conversion of atrial fibrillation/flutter — Quinidine gluconate injection is also indicated (when rapid therapeutic effect is required, or when oral therapy is not feasible) as a means of restoring normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time, then its use should be discontinued. Treatment of ventricular arrhythmias — Quinidine gluconate injection is also indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgement of the physician are life–threatening. Because of the proarrhythmic effects of quinidine, its use with ventricular arrhythmias of lesser severity is generally not recomme

Ürün özeti:

The 80 mg/mL, 10 mL Multiple–Dose Vial is available as:             1 NDC 0002–1407–01 (VL530) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature].

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

QUINIDINE GLUCONATE- QUINIDINE GLUCONATE SOLUTION
ELI LILLY AND COMPANY
----------
QUINIDINE GLUCONATE INJECTION, USP
THIS PRODUCT IS TO BE USED BY THE PHYSICIAN OR UNDER HIS/HER
DIRECTION.
DESCRIPTION
Quinidine is an antimalarial schizonticide and an antiarrhythmic agent
with class 1a activity; it is the d–
isomer of quinine and its molecular weight is 324.43. Quinidine
gluconate is the gluconate salt of
quinidine; its chemical name is cinchonan–9–ol, 6'–methoxy–,
(9_S_)–, mono–D–gluconate; its structural
formula is
its empirical formula is C
H N O •C H O , and its molecular weight is 520.58, of which 62.3% is
quinidine base.
Each vial of Quinidine Gluconate Injection contains 800 mg (1.5 mmol)
of quinidine gluconate (500 mg
of quinidine) in 10 mL of Sterile Water for Injection, 0.005% of
edetate disodium, 0.25% phenol, and
(as needed) D–gluconic acid δ–lactone to adjust the pH.
CLINICAL PHARMACOLOGY
_Pharmacokinetics and Metabolism —_ After intramuscular injection of
quinidine gluconate, peak serum
levels of quinidine are achieved in a little less than two hours. This
time to peak levels is identical to
the time measured when quinidine salts are administered orally.
The volume of distribution of quinidine is typically 2–3 L/kg in
healthy young adults, but this may be
reduced to as little as 0.5 L/kg in patients with congestive heart
failure, or increased to 3–5 L/kg in
patients with cirrhosis of the liver. At concentrations of 2–5 mg/L
(6.5–16.2 μmol/L), the fraction of
quinidine bound to plasma proteins (mainly to α –acid glycoprotein
and to albumin) is 80–88% in adults
and older children, but it is lower in pregnant women, and in infants
and neonates it may be as low as 50–
70%. Because α –acid glycoprotein levels are increased in response
to stress, serum levels of total
quinidine may be greatly increased in settings such as acute
myocardial infarction, even though the
serum content of unbound (active) drug may remain normal. Protein
binding is also increased in ch