CAFFEINE CITRATE injection CAFFEINE CITRATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

CAFFEINE CITRATE

Composition:

CAFFEINE CITRATE 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Both caffeine citrate injection and caffeine citrate oral solution are available as clear, color­less, 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 TOP & TEAR" in white. Both the injection and oral solution 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). Caffeine citrate injection, USP NDC 47335-289-40:                           3 mL vial, individually packaged in a carton. Caffeine citrate oral solution, USP NDC 47335-290-44:                           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: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. PJPI0274B ISS. 12/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION
CAFFEINE CITRATE - CAFFEINE CITRATE SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 theobromine.
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)
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: _Afte