CAFFEINE CITRATE ORAL SOLUTION- caffeine citrate solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Armas Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. Caffeine citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components. Caffeine Citrate Oral Solution Each bottle (vial) of caffeine citrate oral solution contains a total of 60 mg of caffeine citrate in 3 mL (20 mg/mL). Information and Instructions for Use This leaflet tells you about caffeine citrate oral solution (KAF-een SIT-rate) and how to give it to your baby.  Read the following information before giving this medicine to your baby.  Completely discuss caffeine citrate oral solution with your baby’s doctor.  Continue to discuss any questions you have about this medicine at your baby’s checkups. After you remove your baby’s dose, throw away the open bottle (vial) and all medicine left in it .  Use each vial of caffeine citrate oral solution for only one dose.  There will be extra medicine left in the vial after one dose is remov

Produkt oppsummering:

Caffeine citrate Oral Solution, USP is available as clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions in 5 mL colorless glass vials.  The vials of Caffeine citrate Oral Solution, USP are sealed with a gray rubber stopper and a peel-off aluminum overseal with a blue flip-off polypropylene disk inset. Caffeine citrate Oral Solution, USP 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 Oral Solution, USP Caffeine citrate oral solution, USP 60 mg/3 mL is a clear, colorless aqueous solution, 10 vials per white polypropylene child-resistant container and is available as follows. 3 mL fill in 5 mL glass vial                                                                10 vials per white polypropylene child-resistant container.                   NDC 72485-110-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative Free. For single dose only. Discard unused portion. ATTENTION PHARMACIST: Detach “Instructions for Use” from the package insert and dispense with Caffeine Citrate Oral Solution prescription. Manufactured by: Micro Labs Limited Bangalore-560099, INDIA. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 (USA) Rev. 10/2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CAFFEINE CITRATE ORAL SOLUTION- CAFFEINE CITRATE SOLUTION
ARMAS PHARMACEUTICALS INC.
----------
CAFFEINE CITRATE ORAL SOLUTION
RX ONLY.
DESCRIPTION
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 to 5 mg citric acid monohydrate, 8.3 mg trisodium
citrate dihydrate
and Water for Injection.
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: _After oral administration of 10 mg caffeine base/kg to
preterm neonates,
the peak plasma level (C
) for caffeine ranged from 6 to 10 mg/L and the mean time
to