Neocafen Injection
Caffeine Citrate
20 mg/ml
Incepta Pharmaceuticals Ltd.
| Pack size | 3 ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 150.00 AED |
Indications
Neocafen Injection is used for:
Apnea of prematurity
Adult Dose
Child Dose
Intravenous
Indicated for the short-term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
Neonates
Loading Dose-Dose of Caffeine Citrate-20 mg (1 ml) /kg-Route-Intravenous infusion (over 30 minutes) by using a syringe infusion pump-Frequency - One Time
Maintenance Dose-Dose of Caffeine Citrate-5 mg (0.25 ml) /kg-Route-Intravenous infusion (over 10 minutes) by using a syringe infusion pump-Frequency - Every 24 hours (beginning 24 hours after the loading dose)
The duration of treatment of apnea of prematurity in clinical trials was limited to 10 to 12 days.
The safety and efficacy of caffeine citrate for longer periods of treatment have not been established.
Renal Dose
Administration
For intravenous infusion by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device only.
Caffeine citrate can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50mg/ml (5%), or sodium chloride 9mg/ml (0.9%) or calcium gluconate 100mg/ml (10%) immediately after withdrawal from the ampoule.
Contra Indications
Caffeine Citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components.
Precautions
Caffeine Citrate should be used with caution in infants with seizure disorders, cardiovascular disease and impaired renal or hepatic function. Serum concentrations of caffeine should be monitored and dose administration of Caffeine Citrate should be adjusted to avoid toxicity in this population.
Overdose:
Serious toxicity has been associated with serum levels greater than 50 mg/L. Signs and symptoms
reported after caffeine overdose in preterm infants include fever, tachypnea, insomnia, tremor, hypertonia, seizures, vomiting, hyperglycemia, elevated blood urea nitrogen and elevated total leukocyte concentration. Caffeine levels have been shown to decrease after exchange transfusions. Convulsions may be treated with intravenous administration of diazepam or a barbiturate such as pentobarbital sodium.
Pregnancy-Lactation
Pregnancy Category: C (crosses placenta, can remain in fetus/neonate 64-300 hr)
Lactation: enters breast milk; use with caution
Breastfeeding mothers of neonates treated with caffeine citrate should not ingest caffeine-containing foods and beverages or medicinal products containing caffeine, since caffeine is excreted into breastmilk.
Interactions
Cytochrome P450 1A2 (CYP1A2) is known to be the major enzyme involved in the metabolism of caffeine. Therefore, caffeine has the potential to interact with drugs that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.
Few data exist on drug interactions with caffeine in preterm neonates. Based on adult data, lower doses of caffeine may be needed following coadministration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin).
Caffeine administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers. The clinical significance of this interaction in preterm neonates is not known.
Interconversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.
Contraindicated (7)
fezolinetant
isocarboxazid
linezolid
phenelzine
procarbazine
selegiline transdermal
tranylcypromine
Adverse Effects
Side effects of Caffeine Citrate :
Few cases of sepsis, hemorrhage, necrotizing enterocolitis, gastritis, gastrointestinal hemorrhage, acidosis, cerebral hemorrhage, dyspnea, lung edema, dry skin, rash, skin breakdown, kidney failure were reported.
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 A1 and A2 subtypes, by caffeine.
Note
Neocafen 20 mg/ml Injection manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Caffeine Citrate. Neocafen is availble in Bangladesh.
Farmaco BD drug index information on Neocafen Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.