Caffeine Citrate: Package Insert and Label Information (Page 2 of 2)
OVERDOSAGE
Following overdose, serum caffeine levels have ranged from approximately 24 mg/L (a post marketing 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) 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 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.
| *Using a syringe infusion pump | ||||
| **Beginning 24 hours after the loading dose | ||||
| Dose of Caffeine Citrate Volume | Dose of 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** |
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 were combined with 20 mL of a solution or medication. 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 per 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
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 per mL) | Package Factor |
| 25021-602-03 | 60 mg per 3 mL Single-Dose Vial | 10 vials per child |
| (NOT CHILD RESISTANT) | 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); excursions permitted between 15° and 30°C (59° and 86°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)
Made in Canada
©2020 Sagent Pharmaceuticals, Inc.
March 2020
SAGENT Pharmaceuticals®
Caffeine Citrate Oral Solution, USP
SAGENT ®
Rx only
Each bottle (vial) of caffeine citrate contains a total of 60 mg of caffeine citrate in 3 mL (20 mg per mL).
Information and Instructions for Use
This leaflet tells you about caffeine citrate and how to give it to your baby. Read the following information before giving this medicine to your baby. Completely discuss caffeine citrate with your baby’s doctor. Continue to discuss any questions you have about this medicine at your baby’s checkups.
After you remove your baby’s dose, throw away the open bottle (vial) and all medicine left in it. Use each vial of caffeine citrate for only one dose. There will be extra medicine left in the vial after one dose is removed. Leftover medicine should not be used because caffeine citrate does not contain preservatives. Once the vial is open, any medicine that is not used right away must be discarded.
What is caffeine citrate?
The main ingredient of caffeine citrate is caffeine citrate. Caffeine citrate is a clear, colorless, medicine to treat apnea of prematurity — short periods when premature babies stop breathing. Apnea of prematurity is due to the baby’s breathing centers not being fully developed.
How do I give caffeine citrate to my baby?
Give caffeine citrate to your baby once a day, at about the same time each day. Your baby’s doctor will prescribe the right amount of caffeine citrate based on your baby’s weight and age. Carefully follow the doctor’s dosing instructions.
Measure the dose of caffeine citrate carefully. Your baby’s doctor, nurse, or pharmacist will give you a suitable syringe or supply of syringes to measure small but accurate doses of caffeine citrate.
Never change (increase or decrease) your baby’s dose without speaking to your baby’s doctor.
If your baby continues to have periods of apnea, call your baby’s doctor right away.
Caffeine citrate can be swallowed by mouth or given through a feeding tube. Based on your baby’s own situation, your baby’s doctor or other healthcare professional should teach you how to give caffeine citrate correctly.
Caffeine citrate should be clear and colorless. Before giving caffeine citrate , look for small particles, cloudiness, or discoloration in the medicine. Do not use vials that contain cloudy or discolored medicine, or any visible particles.
Caffeine citrate does NOT contain any preservatives. Do not open the vial until it is time for your baby to receive the dose of medicine. Use each vial only once. After you remove your baby’s dose, throw away the vial and all medicine left in the opened vial.
Ten (10) vials of caffeine citrate are packaged in a child-resistant container. Caffeine citrate vials are NOT CHILD-RESISTANT. Always store vials of caffeine citrate in the child-resistant container. Follow the instructions below to open the child-resistant container, to open a vial of caffeine citrate, and to remove a dose of medicine from the vial.
To open the child-resistant container that holds the vials of caffeine citrate:
(Instructions with pictures are also printed on the top of the container)
- Hold the bottom-half of the child-resistant container with one hand and push the lower semicircular section on the front of the container with your thumb.
- With your other hand, pull the cover up until you hear it click.
- While holding the ends of the bottom-half of the container with both hands, place both index fingers on the two semicircular locking tabs on the sides of the container.
- Press the two tabs and raise the cover up.
To open a vial of caffeine citrate:
- Hold the plastic top between the thumb and index finger. Use your thumb to flip the plastic top completely off the vial.
- Carefully lift up the metal ring.
- Pull the metal ring away from the vial and then pull it down towards the bottom of the vial without twisting the ring.
- After you pull the ring down and the metal band around the top of the vial is completely broken through, carefully remove the rest of the metal band by pulling it out and away from the vial.
- Being careful not to spill any medicine, remove the rubber stopper from the top of the vial.
To remove the prescribed dose from the vial:
You will need a small syringe to measure the exact amount of medicine that your baby’s doctor prescribed. Your baby’s doctor, nurse or pharmacist will give you this small syringe. Note that a milliliter (mL) is the same as a cubic centimeter (cc).
- Insert the tip of the syringe in the medicine and pull up on the plunger to draw the medicine into the syringe. Remove slightly more of the medicine than the exact amount to be given to your baby.
- Turn the syringe tip up so that any air in it rises to the top. Remove the air by gently pushing up on the syringe plunger. Continue to push the syringe plunger up to remove any extra medicine in the syringe, until only the exact number of milliliters (or cubic centimeters) that your baby’s doctor prescribed remains in the syringe.
- Give the caffeine citrate to your baby as your baby’s doctor instructed.
- Throw away the sharp metal pieces, the rubber stopper, the open vial, and
any medicine that remains in it after your baby receives the dose.
What are possible side effects of caffeine citrate?
Your baby may or may not develop side effects from taking caffeine citrate. Each baby is different. If your baby develops one or more of the following symptoms, speak with your baby’s doctor right away:
- restlessness, jitteriness or shakiness
- faster heart beat
- increased urination (increased diaper wetting)
The following symptoms may be caused by serious bowel or stomach problems. Call your baby’s doctor right away if your baby develops:
- bloated abdomen (stomach area)
- vomiting
- bloody stools (bloody bowel movements)
- loss of energy, lethargy (acting sluggish)
This is not a complete list of side effects reported with caffeine citrate. If you have a concern about your baby, speak with your baby’s doctor. If you want more information about caffeine citrate, speak with your baby’s doctor or pharmacist.
To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
SAGENT®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Canada©2020 Sagent Pharmaceuticals, Inc.
March 2020
SAGENT Pharmaceuticals®
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 25021-601-03
Rx only
Caffeine Citrate Injection, USP
60 mg per 3 mL
(20 mg per mL)
3 mL Single-Dose Vial
Discard unused portion
For Intravenous Use Only
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 25021-602-03
Rx only
Caffeine Citrate Oral Solution, USP
60 mg per 3 mL
(20 mg per mL)
3 mL Single-Dose Vial
For Oral Use Only
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| Labeler — Sagent Pharmaceuticals (796852890) |
Revised: 07/2020 Sagent Pharmaceuticals
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