CAFCIT (Page 3 of 3)

OVERDOSAGE

Following overdose, serum caffeine levels have ranged from approximately 24 mg/L (a postmarketing spontaneous case report in which an infant exhibited irritability, poor feeding, and insomnia) to 350 mg/L. Serious toxicity has been associated with serum levels greater than 50 mg/L (see PRECAUTIONS, Laboratory Tests and DOSAGE AND ADMINISTRATION). Signs and symptoms reported in the literature after caffeine overdose in preterm infants include fever, tachypnea, jitteriness, insomnia, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycemia, elevated blood urea nitrogen, and elevated total leukocyte concentration. Seizures have also been reported in cases of overdose. One case of caffeine overdose complicated by development of intraventricular hemorrhage and long-term neurological sequelae has been reported. Another case of caffeine citrate overdose (from New Zealand; not CAFCIT) of an estimated 600 mg caffeine citrate (approximately 322 mg/kg) administered over 40 minutes was complicated by tachycardia, ST depression, respiratory distress, heart failure, gastric distention, acidosis, and a severe extravasation burn with tissue necrosis at the peripheral intravenous injection site. No deaths associated with caffeine overdose have been reported in preterm infants.

Treatment of caffeine overdose is primarily symptomatic and supportive. 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.

DOSAGE AND ADMINISTRATION

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.

Dose of CAFCIT (caffeine citrate) Volume

Dose of CAFCIT (caffeine citrate) 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 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 CAFCIT 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 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 mcg/mL diluted to 10 mcg/mL with Dextrose Injection, USP 5%

HOW SUPPLIED

CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced gray rubber stopper and an aluminum overseal with a white flip-off printed with “FOR INTRAVENOUS USE ONLY” in red.

The 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® Injection (caffeine citrate injection, USP) is supplied as:

NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10

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

Not made with natural rubber latex.

Preservative free. For single dose only. Discard unused portion.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

Manufactured by:

Hikma Pharmaceuticals USA Inc.

Eatontown, NJ 07724 USA

Revised December 2019

462-708-01

PRINCIPAL DISPLAY PANELS

CAFCIT®
INJECTION
(caffeine citrate
injection, USP)
60 mg/3 mL
(20 mg/mL)
For Intravenous Use Only 3 mL Single Dose Vial

Cafcit Injection container label 462-709-00
(click image for full-size original)

NDC 0641-6164-10 Rx only
CAFCIT®
INJECTION
(caffeine citrate
injection, USP)
60 mg/3 mL
(20 mg/mL)
For Intravenous Use Only 10 x 3 mL Single Dose Vials

Cafcit Injection shelfpack label 462-710-00
(click image for full-size original)

SERIALIZATION IMAGE

Layout 1Layout 1
CAFCIT caffeine citrate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6164
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE CITRATE (CAFFEINE) CAFFEINE CITRATE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 5 mg in 1 mL
SODIUM CITRATE 8.3 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6164-10 10 VIAL in 1 BOX contains a VIAL (0641-6164-01)
1 NDC:0641-6164-01 3 mL in 1 VIAL This package is contained within the BOX (0641-6164-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020793 11/04/2008
Labeler — Hikma Pharmaceuticals USA Inc. (946499746)

Revised: 01/2020 Hikma Pharmaceuticals USA Inc.

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