Caffeine citrate

What is Caffeine citrate?

• Caffeine citrate (Cafcit) is a central nervous system stimulant, used to treat a lack of breathing in premature babies.

Caffeine citrate

Caffeine citrate

What are the uses of this medicine?

• 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 does this medicine work?

• Caffeine is structurally related to other methylxanthines, theophylline, and theobromine.
• It is a bronchial smooth muscle relaxant, a CNS stimulant, a cardiac muscle stimulant, and a diuretic.
• Although the mechanism of action of caffeine in apnea of prematurity is not known, several mechanisms have been hypothesized.
• These include:

(1) stimulation of the respiratory center, (2) increased minute ventilation, (3) decreased threshold to hypercapnia, (4) increased response to hypercapnia, (5) increased skeletal muscle tone, (6) decreased diaphragmatic fatigue, (7) increased metabolic rate, and (8) increased oxygen consumption.

• Most of these effects have been attributed to antagonism of adenosine receptors, both A1 and A2 subtypes, by caffeine.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to any of its components.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• cimetidine
• ketoconazole
• phenobarbital
• phenytoin
• ketoprofen
• theophylline

Is this medicine FDA approved?

• Caffeine was discovered in 1819.
• It is on the World Health Organization's List of Essential Medicines.
• The intravenous form may also be taken by mouth.
• It was approved for use in the European Union in August 2020.

How should this medicine be used?

• 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.

Recommended dosage:

• The recommended loading dose and maintenance doses of caffeine citrate as follow:

	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

Administration:

• 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.
• 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 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.
• It is given by mouth or slow injection into a vein.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Both Caffeine Citrate Injection, USP for intravenous administration and Caffeine Citrate Oral Solution

This medicine is available in fallowing brand namesː

• Cafcit

What side effects can this medication cause?

The most common side effects of this medicine include:

• restlessness, jitteriness or shakiness
• faster heart beat
• increased urination (increased diaper wetting)

Caffeine Citrate may cause some serious side effects which may include:

• bloated abdomen (stomach area)
• vomiting
• bloody stools (bloody bowel movements)
• loss of energy, lethargy (acting sluggish)

What special precautions should I follow?

• Patients being treated with caffeine citrate should be carefully monitored for the development of necrotizing enterocolitis.
• Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of caffeine citrate.
• Caffeine is a central nervous system stimulant and in cases of caffeine overdose, seizures have been reported. Caffeine citrate should be used with caution in infants with seizure disorders.
• Caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies. Therefore, caffeine citrate should be used with caution in infants with cardiovascular disease.
• Caffeine citrate should be administered with caution in infants with impaired renal or hepatic function.
• Caffeine citrate does not contain any preservatives and each vial is for single use only. Any unused portion of the medication should be discarded.
• It is important that the dose of caffeine citrate be measured accurately, i.e., with a 1cc or other appropriate syringe.
• Consult your physician if the baby continues to have apnea events; do not increase the dose of caffeine citrate without medical consultation.
• Consult your physician if the baby begins to demonstrate signs of gastrointestinal intolerance, such as abdominal distention, vomiting, or bloody stools, or seems lethargic.
• Caffeine citrate should be inspected visually for particulate matter and discoloration prior to its administration. Vials containing discolored solution or visible particulate matter should be discarded.

What to do in case of emergency/overdose?

Symptoms of overdose may 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.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Caffeine citrate have been established in pediatric patients.
• Caffeine citrate is intended to treat apnea of prematurity.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• caffeine citrate

Inactive ingredients:

• citric acid monohydrate
• trisodium citrate dihydrate
• water

Who manufactures and distributes this medicine?

Mfd. for:

• SAGENT Pharmaceuticals
• Schaumburg, IL (USA)
• Made in Canada
• Sagent Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).

• Dailymed label info on Caffeine citrate
• FDA Caffeine citrate

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