CAFFEINE CITRATE injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Hikma Pharmaceuticals USA Inc.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

CAFCIT (caffeine citrate) is indicated for the treatment of apnea of prematurity. CAFCIT (caffeine citrate) is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Descriptif du produit:

CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced gray rubber stopper and an aluminum overseal with a white flip-off printed with “FOR INTRAVENOUS USE ONLY” in red. The vials contain 3 mL solution at a concentration of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial). CAFCIT® Injection (caffeine citrate injection, USP) is supplied as:    NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Preservative free. For single dose only. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Eatontown, NJ 07724 USA Revised December 2019 462-708-01

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

CAFFEINE CITRATE- CAFFEINE CITRATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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CAFFEINE CITRATE INJECTION, USP
RX ONLY
DESCRIPTION
CAFCIT® Injection (caffeine citrate injection, USP) for intravenous
administration is a
clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous
solution 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 to 5
mg citric acid
monohydrate, 8.3 mg sodium citrate dihydrate 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.
Caffeine citrate
C
H
N O MW 386.31
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Caffeine is structurally related to other methylxanthines,
theophylline, and theobromine.
It is a bronchial smooth muscle relaxant, a CNS stimulant, a cardiac
muscle stimulant,
14
18
4
9
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)
stimulation 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 metabolic rate, and
(8) increased
oxygen consumption.
Most of these effects have been attributed to antagonism of adenosine
receptors, both
A and A subtypes, by caffeine, which has been demonstrated in receptor
binding
assays and observed at concentrations approximating those achieved
therapeutically.
PHARMACOKINETICS
_Absorption_
After oral administration of 10 mg caffeine base/kg to preterm
neona