June 30, 2016
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"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.




How Supplied


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) (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 (caffeine citrate) follow.

  Dose of CAFCIT Volume Dose of CAFCIT mg/kg Route Frequency
Loading Dose 1 mL/kg 20 mg/kg Intravenous*
(over 30 minutes)
One Time
Maintenance Dose 0.25 mL/kg 5 mg/kg Intravenous*
(over 10 minutes) or Orally
Every 24 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.

CAFCIT (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

T o test for drug compatibility with common intravenous solutions or medications, 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 HCI 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 g/mL diluted to 10 g/mL with Dextrose Injection, USP 5%


Both CAFCIT (caffeine citrate) Injection and CAFCIT (caffeine citrate) Oral Solution are available as clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions in 3 mL colorless glass vials. The vials of CAFCIT (caffeine citrate) Injection are sealed with a teflonfaced gray rubber stopper and an aluminum overseal with a white flip-off polypropylene disk inset. The vials of CAFCIT (caffeine citrate) 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 0087-6011-42: 3 mL 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.

ATTENTION PHARMACIST: Detach “Instructions for Use” from the package insert and dispense with CAFCIT (caffeine citrate) Oral Solution prescription.

Each bottle (vial) of CAFCIT contains a total of 60 mg of caffeine citrate in 3 mL (20 mg/mL).

Manufactured by: Ben Venue Laboratories, Inc., Bedford, Ohio 44146. Distributed by: Mead Johnson & Company, Evansville, IN 47721 U.S.A. Revised May 2003

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

Last reviewed on RxList: 5/4/2009

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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