Patient Medication Information: uses, side effects, how to take - Caffeine Citrate Oral Solution USP
What is Caffeine Citrate Oral Solution USP used for?
- Caffeine Citrate Oral Solution USP is used for the treatment of interrupted breathing (apnea) in premature babies.
How does Caffeine Citrate Oral Solution USP work?
Apnea in premature babies occurs when the baby’s breathing centres in the brain are not fully developed. Caffeine Citrate Oral Solution USP contains caffeine citrate. It belongs to a group of medicines called methylxanthines. Caffeine acts as a central nervous system stimulant. It stimulates the breathing center in your baby’s brain to help them to breathe.
What are the ingredients in Caffeine Citrate Oral Solution USP:
Medicinal ingredients: caffeine citrate
Non-medicinal ingredients: citric acid monohydrate, sodium citrate, and water for injection
Caffeine Citrate Oral Solution USP comes in the following dosage forms:
Solution: 20 mg / mL
Do not use Caffeine Citrate Oral Solution USP if you are:
- allergic to caffeine citrate or to any of the other ingredients in Caffeine Citrate Oral Solution USP (see What are the ingredients in Caffeine Citrate Oral Solution USP)
Serious Warnings and Precautions
Caffeine citrate:
- increases how much blood is pumped by the heart
- increases metabolism which may result in higher energy and nutrition requirements during treatment
- belongs to a group of drugs known as methylxanthines. Methylxanthines have been linked to the development of necrotizing enterocolitis – a serious disease that affects the intestine of premature babies
- is a central nervous system stimulant and may cause seizures
- If your baby has kidney problems, there is an increased potential for caffeine to accumulate in your baby’s body
To help avoid side effects and ensure proper use, talk to your baby’s healthcare professional before your baby is given Caffeine Citrate Oral Solution USP. Talk about any health conditions or problems your baby may have, including if:
- your newborn has previously been treated with theophylline
- your newborn suffers from seizures
- you (the mother) consumed large amounts of caffeine prior to delivery
- you have a premature infant who suffers from heart disease or you had unusual rhythm disturbances before the baby was born
- your newborn has kidney or liver problems
- your newborn has frequent regurgitation (bringing swallowed food up again to the mouth)
- your newborn produces more urine than usual
- your newborn has a reduced weight gain or food intake
Other warnings you should know about:
Breast-feeding: If you are breast-feeding while your infant is being treated with Caffeine Citrate Oral Solution USP, you should not drink coffee or take any other high caffeine products. Caffeine passes into breast milk.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Caffeine Citrate Oral Solution USP:
- Theophylline (used to treat breathing problems). This medicine may increase the risk for a serious disease that affects the intestine of premature babies (called necrotising enterocolitis) when it is given with medicines used to treat gastric disease (such as antihistamine H2 receptor blockers or proton-pump inhibitors that reduces gastric acid secretion). Tell your baby’s doctor if your newborn has been previously treated with theophylline.
Drugs that decrease the amount of caffeine removed by the body such as:
- cimetidine (used to treat gastric disease)
- ketoconazole (used to treat fungal infections)
Drugs that increase the amount of caffeine removed by the body such as:
- phenobarbital (used to treat epilepsy)
- phenytoin (used to treat epilepsy)
These medicines are not to be given to your baby while your baby is receiving treatment with Caffeine Citrate Oral Solution USP. If your baby is taking any of these medicines, the doctor may need to adjust the dose or change one of the medicines to something else.
How Caffeine Citrate Oral Solution USP is given:
Caffeine Citrate Oral Solution USP should only:
- Be given when other causes of apnea had been ruled out or be properly treated by your baby’s doctor before your baby starts treatment
- Be given under the supervision of a doctor experienced in neonatal intensive care
- Be used in a neonatal intensive care unit (NICU) where adequate facilities / equipment are available to monitor your baby
Usual dose:
Your baby’s doctor will decide:
- How much Caffeine Citrate Oral Solution USP to give your baby. The dose will depend on your baby’s body weight
- For how long it will be given. Your baby’s doctor should stop treatment with Caffeine Citrate Oral Solution USP when your baby has 5 to 7 days without apnea attacks
The usual starting dose is 20 mg per kilogram of body weight (equal to 1 mL per kilogram of body weight) given once.
- The starting dose will be given as an infusion into their vein (intravenous infusion). It is given using a syringe infusion pump or other metered infusion device. This method is also known as “a drip.”
The usual maintenance dose is 5 mg per kilogram of body weight (equal to 0.25 mL per kilogram of body weight) given every 24 hours.
- After their first dose, their maintenance doses may be given by intravenous infusion or by mouth.
Your baby’s doctor may need to do blood tests during treatment with Caffeine Citrate Oral Solution USP to check the levels of caffeine in your baby’s blood. This is to make sure the right amount of Caffeine Citrate Oral Solution USP is being given.
Overdose:
If your baby receives more Caffeine Citrate Oral Solution USP than they should, they may experience:
- high blood levels of sugar (hyperglycemia)
- low blood levels of potassium (hypokalaemia)
- tremors of the hands and feet
If you think your baby has been given too much Caffeine Citrate Oral Solution USP, contact your child’s healthcare professional immediately.
- feeling restless
- muscle tension and muscle spasms
- stiffening and contraction of muscles followed by uncontrolled twitching (tonic-clonic movements)
- uncontrolled jaw and lip movement
- rapid breathing (tachypnea)
- rapid heart rate (tachycardia)
- vomiting
- gastric problems
- fever
- feeling jittery
- high blood levels of certain chemicals (urea)
- higher number of certain cells (leukocyte) in blood
- seizures
Tell your baby’s doctor right away if you notice any of these symptoms.
What are possible side effects from using Caffeine Citrate Oral Solution USP:
These are not all the possible side effects your baby may feel when taking Caffeine Citrate Oral Solution USP. If your baby experiences any side effects not listed here, contact their healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Hyperglycemia: (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue | X | ||
Infusion site phlebitis, infusion site inflammation (swelling of a vein): pain, tenderness, redness or swelling | X | ||
Tachycardia (abnormally fast heartbeat) | X | ||
| UNCOMMON | |||
Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat | X | ||
Convulsion: seizure, spasms, shaking or fits | X | ||
| NOT KNOWN | |||
| Deafness | X | ||
Hypoglycaemia (low blood sugar), failure to thrive, feeding intolerance | X | ||
| Increased left ventricular output and increased stroke volume (an increase in the amount of blood pumped by the left ventricle of the heart in one contraction) | X | ||
| Irritability, feeling jittery, restlessness, brain injury | X | ||
Regurgitation (bringing swallowed food up again to the mouth), increased gastric Aspirate | X | ||
Necrotising enterocolitis (serious disease that affects the intestines): swelling or bloating in the abdomen, discolouration of the abdomen, bloody stool, diarrhea, vomiting | X | ||
| Sepsis (infection of the blood): fever or dizziness, chills, high or very low body temperature, little or no urine, low blood pressure, palpitations, rapid breathing, rapid heartbeat. | X | ||
Urine output increased, urine sodium and calcium increased, haemoglobin decreased, thyroxine decreased (abnormal thyroid lab results) | X | ||
If your baby has a troublesome symptom or side effect that is not listed here, talk to your healthcare professional.
Storage:
Caffeine Citrate Oral Solution USP will be stored by the doctor. It will be stored at 15-30°C.
If you want more information about Caffeine Citrate Oral Solution USP:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) ; the sponsor Omega Laboratories Limited by calling 1-800-363-0584
Last Revised: Apr-20-2022.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect- canada/adverse-reaction-reporting.html )
- for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.