CAFCIT® (caffeine citrate) is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.

Prior to initiation of CAFCIT® (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 CAFCIT® follow. NOTE THAT THE DOSE EXPRESSED AS CAFFEINE B.S. 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.

CAFCIT® should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Vials containing discolored solution or visible particulate matter should be discarded.

Drug Compatibility

To test for drug compatibility with common intravenous solutions or medications, twenty (20) mL of CAFCIT® (caffeine citrate) Injection were 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, CAFCIT® (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, USP 5%
• 50% Dextrose Injection USP
• Intralipid ® 20% IV Fat Emulsion
• Aminosyn ® 8.5% Crystalline Amino Acid Solution
• Dopamine HCl Injection, USP 40 mg/mL diluted to 0.6 mg/mL with Dextrose Injection, USP 5%
• Calcium Gluconate Injection, USP 10% (0.465 mEq/Ca⁺² /mL)
• Heparin Sodium Injection, USP 1000 units/mL diluted to 1 unit/mL with Dextrose Injection, USP 5%
• Fentanyl Citrate Injection, USP 50 µg/mL diluted to 10 µg/mL with Dextrose Injection, USP 5%

Both CAFCIT Injection and CAFCIT Oral Solution are available as clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions in 3 mL colorless glass vials. The vials are sealed with a teflon-faced gray rubber stopper and an aluminum over-seal with white flip-off polypropylene disk inset. The vials of CAFCIT Oral Solution are sealed with a teflon-faced gray rubber stopper and a peel-off aluminum overseal with a blue flip-off polypropylene disk inset.

Both the injection and oral solution 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).

CAFCIT® (caffeine citrate) Injection
NDC 0054-8118-01: 3 mL single-dose vial, individually packaged in a carton.

CAFCIT® (caffeine citrate) Oral Solution
NDC 0087-6111-42: 3 mL vial (NOT CHILD-RESISTANT), 10 vials per white polypropylene child resistant container.

Store at 15°-30°C (59°-86°F).

Preservative Free. For single use only. Discard unused portion.

Manufactured by:
Ben Venue Laboratories, Inc., Bedford, Ohio 44146.

Distributed by:
Mead Johnson & Company, Evansville, IN 47721 U.S.A.
Mead Johnson^TM Nutritionals
©2003 Mead Johnson & Company Revised (2) May 2003
LB1976P

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