CAFFEINE CITRATE injection CAFFEINE CITRATE solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)

Boleh didapati daripada:

Sun Pharmaceutical Industries, Inc.

INN (Nama Antarabangsa):

CAFFEINE CITRATE

Komposisi:

CAFFEINE CITRATE 20 mg in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. Caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Ringkasan produk:

Both caffeine citrate injection and caffeine citrate oral solution are available as clear, color‑less, sterile, non-pyrogenic, preservative-free, aqueous solutions in 5 mL colorless glass vials. The vials of caffeine citrate injection are sealed with gray rubber stopper and white flip off aluminum seal printed with “FOR INTRAVENOUS USE ONLY” in red. The vials of caffeine citrate oral solution are sealed with gray rubber stopper and a dark blue matte finish, flip off tear off aluminum seal printed with “FOR ORAL USE ONLY – FLIP UP & TEAR” in white. Both the injection and oral solution vials contain 3 mL solution at a concentra‑tion of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial). Caffeine citrate injection, USP NDC 47335-289-27:                           3 mL vial, individually packaged in a carton. Caffeine citrate oral solution, USP NDC 47335-290-27:                           3 mL vial (NOT CHILD-RESISTANT), 10 vials per white polypropylene child-resistant container. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Preservative free. For single use only. Discard unused portion. ATTENTION PHARMACIST: Detach “Instructions for Use” from the package insert and dispense with caffeine citrate oral solution prescription. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. NOVAPLUS® NOVAPLUS is a registered trademark of Novation, LLC. ISS. 12/2013 PJPI0464

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION
CAFFEINE CITRATE - CAFFEINE CITRATE SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
CAFFEINE CITRATE INJECTION, USP
CAFFEINE CITRATE ORAL SOLUTION, USP
DESCRIPTION
Both caffeine citrate injection for intravenous administration and
caffeine citrate oral solution are clear,
colorless, sterile, non-pyrogenic, preservative-free, aqueous
solutions adjusted to pH 4.7. Each mL
contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base)
prepared in solution by the
addition of 10 mg caffeine anhydrous, USP to 5 mg citric acid
monohydrate, USP, 8.3 mg sodium citrate
dihydrate, USP and Water for Injection, USP.
Caffeine, a central nervous system stimulant, is an odorless white
crystalline powder or granule, with a
bitter taste. It is sparingly soluble in water and ethanol at room
temperature. The chemical name of
caffeine is 3,7-dihydro-1,3,7-trimethyl-1_H_-purine-2,6-dione. In the
presence of citric acid it forms
caffeine citrate salt in solution. The structural formula and
molecular weight of caffeine citrate
follows.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Caffeine is structurally related to other methylxanthines,
theophylline, and theo bromine. It is a
bronchial smooth muscle relaxant, a CNS stimulant, a cardiac muscle
stimulant, and a diuretic.
Although the mechanism of action of caffeine in apnea of prematurity
is not known, several mechanisms
have been hypothesized. These include: (1) stimu lation of the
respiratory center, (2) increased minute
ventilation, (3) decreased threshold to hypercapnia, (4) increased
response to hypercapnia, (5) increased
skeletal muscle tone, (6) decreased diaphragmatic fatigue, (7)
increased meta bolic rate, and (8)
increased oxygen consumption.
Most of these effects have been attributed to antagonism of adenosine
recep tors, both A and A
subtypes, by caffeine, which has been demonstrated in receptor binding
assays and observed at
concentrations approximating those achieved therapeutically.
PHARMACOKINETICS
1
2
_Absorption