CAFFEINE CITRATE- caffeine citrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Micro Labs Limited

INN (International Name):

CAFFEINE CITRATE

Composition:

CAFFEINE CITRATE 60 mg in 3 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Caffeine citrate injection USP is indicated for the treatment of apnea of prematurity. Caffeine citrate injection USP is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Product summary:

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 a clear USP Type I 5 mL glass vial with grey chlorobutyl rubber stoppers with white colored, flip off aluminum seals. The injection 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 60 mg/3 mL is a clear, colorless aqueous solution, individually packaged in a carton and is available as follows. 3 mL fill in 5 mL glass vial                                       NDC 42571-244-69 Mono Carton of 5 mL glass vial                             NDC 42571-244-69 3 mL Single Dose Vial packaged in a carton of 10 NDC 42571-244-98 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative free. For single use only. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-855-839-8195. Manufactured by: Micro Labs Limited Bangalore-560 099, INDIA. Manufactured for: Micro Labs USA Inc. Basking Ridge, NJ 07920 Revised: March 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION, SOLUTION
MICRO LABS LIMITED
----------
CAFFEINE CITRATE INJECTION, USP
RX ONLY
DESCRIPTION
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 trisodium citrate
dihydrate and Water for Injection.
Caffeine USP, a central nervous system stimulant, is an odorless white
crystalline substance or granule,
with a bitter taste. It is freely soluble in chloroform, sparingly
soluble in water and in alcohol, slightly
soluble in ether. 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
1
2
_Absorption_
After oral administration of 10 mg caffeine base/kg to preterm
neonates, the peak pla