July 25, 2016
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Cafcit

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Cafcit




Indications
Dosage
How Supplied

INDICATIONS

Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and < 33 weeks gestational age.

DOSAGE AND ADMINISTRATION

Prior to initiation of caffeine citrate, baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who consumed caffeine prior to delivery, since caffeine readily crosses the placenta.

The recommended loading dose and maintenance doses of caffeine citrate follow.

  Dose of Caffeine Citrate Volume Dose of Caffeine Citrate mg/kg Route Frequency
Loading Dose 1 mUkg 20 mg/kg Intravenous* (over30 minutes) One Time
Maintenance Dose 0.25 mL/kg 5 mg/kg Intravenous* (over 10 minutes) orOrally Every24 hours**
*using a syringe infusion pump
** beginning 24 hours after the loading dose

NOTE THAT THE DOSE OF CAFFEINE BASE IS ONE-HALF THE DOSE WHEN EXPRESSED AS CAFFEINE CITRATE (e.g., 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base).

Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L. Caffeine citrate should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded.

Drug Compatibility

To test for drug compatibility with common intravenous solutions or medications, 20 mL of caffeine citrate injection w ere combined with 20 mL of a solution or medication, with the exception of an Intralipid® admixture, which was combined as 80 mL/80 mL. The physical appearance of the combined solutions was evaluated for precipitation. The admixtures were mixed for 10 minutes and then assayed for caffeine. The admixtures were then continually mixed for 24 hours, with further sampling for caffeine assays at 2,4 ,8 , and 24 hours. Based on this testing, caffeine citrate injection, 60 mg/3 mL is chemically stable for 24 hours at room temperature when combined with the following test products.

  • Dextrose Injection, USP5%
  • 50% Dextrose Injection USP

HOW SUPPLIED

Caffeine Citrate Injection, USP is supplied as follows:

NDC Caffeine Citrate Injection, USP (20 mg per mL) Package Factor
25021-601-03 60 mg per 3 mL Single-Dose Vial 1 vial per carton

Caffeine Citrate Oral Solution, USP is supplied as follows:

NDC Caffeine Citrate Oral Solution, USP (20 mg permL) Package Factor
25021-602-03 60 mg per 3 mL Single-Dose Vial {NOT CHILD RESISTANT) 10 vials per child resistant carton

Both Caffeine Citrate Injection, USP and Caffeine Citrate Oral Solution, USP are available as clear, colorless, aqueous solutions.

Both the injection and oral solution vials contain 3 mL solution at a concentration of 20 mg per mL caffeine citrate (60 mg per vial) equivalent to 10 mg per mL caffeine base (30 mg per vial).

Storage Conditions

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

For Single Use Only. Discard unused portion.

ATTENTION PHARMACIST: Detach “Instructions for Use” from the package insert and dispense with Caffeine Citrate Oral Solution, USP prescription.

Sterile, Nonpyrogenic, Preservative-free. The container closure Is not made with natural rubber latex.

SAGENT™ : Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA). Revised: July 2012

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/1/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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