CAFFEINE CITRATE- caffeine citrate solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Micro Labs Limited

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 remo

Sommarju tal-prodott:

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                                                                NDC 42571-346-69 10 vials per white polypropylene child-resistant container.               NDC 42571-346-69 Store at 20° to 25°C (68° to 77°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. Manufactured by: Micro Labs Limited Bangalore-560099, INDIA. Manufactured for: Micro Labs USA Inc. Basking Ridge, NJ 07920 Revised: February 2019

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CAFFEINE CITRATE - CAFFEINE CITRATE SOLUTION
MICRO LABS LIMITED
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CAFFEINE CITRATE ORAL SOLUTION, USP 60 MG/3 ML
RX ONLY.
DESCRIPTION
Caffeine Citrate Oral Solution is 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 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-1H-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 fr