Drug Details
Drug Name(s) CAFCIT
FDA Application No (NDA) 020793
Active Ingredient(s) CAFFEINE CITRATE
Company EUROHLTH INTL SARL
Original Approval or September 21, 1999
Tentative Approval Date
Chemical Type2 New active ingredient
Review Classification
Priority review drug O Orphan drug
Uses
This medication is used for the short-term treatment of a breathing problem (apnea) in premature infants. Caffeine blocks certain proteins (adenosine receptors) which lead to improved breathing in these infants.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by yourhealth care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication is also a stimulant that may be used to keep you awake and alert.
How to use CafcitThis medication is usually given once daily by mouth or through a feeding tube; with or without formula. The dosage is based on your infant's weight, medical conditions, and response to therapy. Carefully measure each dose with the provided dosing syringe.
Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.
Because this product does not contain preservatives, discard any unused medicine after preparing the dose for your infant.
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.
If your infant's condition persists or worsens, contact your doctor or pharmacist.
This medication is used for the short-term treatment of a breathing problem (apnea) in premature infants. Caffeine blocks certain proteins (adenosine receptors) which lead to improved breathing in these infants.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by yourhealth care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication is also a stimulant that may be used to keep you awake and alert.
How to use CafcitThis medication is usually given once daily by mouth or through a feeding tube; with or without formula. The dosage is based on your infant's weight, medical conditions, and response to therapy. Carefully measure each dose with the provided dosing syringe.
Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.
Because this product does not contain preservatives, discard any unused medicine after preparing the dose for your infant.
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.
If your infant's condition persists or worsens, contact your doctor or pharmacist.
Side Effects
Nausea, vomiting, stomach upset, headache, trouble sleeping, restlessness, poor feeding, rash or dry skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur:trouble breathing, vision changes, change in the amount of urine.
In rare (sometimes, fatal) cases, this medication has been associated with a serious stomach condition (necrotizing enterocolitis). Tell your doctor right away if your infant experiences the following: lack of energy (lethargy), severe vomiting, stomach/abdominal bloating (distension), bloody stool.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Nausea, vomiting, stomach upset, headache, trouble sleeping, restlessness, poor feeding, rash or dry skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur:trouble breathing, vision changes, change in the amount of urine.
In rare (sometimes, fatal) cases, this medication has been associated with a serious stomach condition (necrotizing enterocolitis). Tell your doctor right away if your infant experiences the following: lack of energy (lethargy), severe vomiting, stomach/abdominal bloating (distension), bloody stool.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Precautions
Before taking caffeine citrate, tell your doctor or pharmacist if your infant is allergic to it; or if your infant has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your infant's medical history, especially of: heart disease, kidney disease, liver disease, stomach problems (e.g., peptic ulcers, necrotizing enterocolitis), seizures.
Caution is advised when using this drug in infants because they may be more sensitive to its effects, especially the stimulant effects (e.g., trouble sleeping, restlessness, nervousness).
Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Before taking caffeine citrate, tell your doctor or pharmacist if your infant is allergic to it; or if your infant has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your infant's medical history, especially of: heart disease, kidney disease, liver disease, stomach problems (e.g., peptic ulcers, necrotizing enterocolitis), seizures.
Caution is advised when using this drug in infants because they may be more sensitive to its effects, especially the stimulant effects (e.g., trouble sleeping, restlessness, nervousness).
Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.