Cafcit

DRUG DESCRIPTION

Both CAFCIT® (caffeine citrate) Injection for intravenous administration and CAFCIT® (caffeine citrate) Oral Solution are clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions adjusted to pH 4.7. Each mL contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base) prepared in solution by the addition of 10 mg caffeine anhydrous to 5.0 mg citric acid monohydrate, 8.3 mg sodium citrate dihydrate and Water for Injection.

Caffeine, a central nervous system stimulant, is an odorless white crystalline powder or granule, with a bitter taste. It is sparingly soluble in water and ethanol at room temperature. The chemical name of caffeine is 3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione. In the presence of citric acid it forms caffeine citrate salt in solution. The structural formula and molecular weight of caffeine citrate follows.

CAFCIT®
  (caffeine citrate) Structural Formula Illustration

What are the possible side effects of caffeine citrate (Cafcit)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using caffeine citrate and call your doctor at once if your child has any of these serious side effects:

  • stomach pain, tenderness, bloating,
  • constipation or diarrhea;
  • green-colored vomit;
  • blood in the stools;
  • unusual weakness;
  • seizure (convulsions);
  • twitching or uncontrolled muscle...

Read All Potential Side Effects and See Pictures of Cafcit »

What are the precautions when taking caffeine citrate (Cafcit)?

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).

This medication should be used only when clearly needed during pregnancy....

Read All Potential Precautions of Cafcit »


Cafcit Consumer (continued)

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 immediately 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 immediately 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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).

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.


Cafcit Patient Information Including Side Effects

Brand Names: Cafcit

Generic Name: caffeine citrate (oral) (Pronunciation: KAF een SIT rate)

  • What is caffeine citrate (Cafcit)?
  • What are the possible side effects of caffeine citrate (Cafcit)?
  • What is the most important information I should know about caffeine citrate (Cafcit)?
  • What should I discuss with my health care provider before taking caffeine citrate (Cafcit)?
  • How should I take caffeine citrate (Cafcit)?
  • What happens if I miss a dose (Cafcit)?
  • What happens if I overdose (Cafcit)?
  • What should I avoid while taking caffeine citrate (Cafcit)?
  • What other drugs will affect caffeine citrate (Cafcit)?
  • Where can I get more information?

What is caffeine citrate (Cafcit)?

Caffeine citrate is a central nervous system stimulant. It also has effects on the lungs and metabolism.

Caffeine citrate is used to treat breathing problems in premature infants.

Caffeine citrate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of caffeine citrate (Cafcit)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using caffeine citrate and call your doctor at once if your child has any of these serious side effects:

  • stomach pain, tenderness, bloating,
  • constipation or diarrhea;
  • green-colored vomit;
  • blood in the stools;
  • unusual weakness;
  • seizure (convulsions);
  • twitching or uncontrolled muscle movements; or
  • fever, fast or slow heart rate.

Less serious side effects may include sleep problems, loss of appetite, fussiness, or excessive crying.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about caffeine citrate (Cafcit)?

Caffeine citrate should not be given to a child who has had an allergic reaction to it in the past.

Before using caffeine citrate, tell the doctor if your child is allergic to any drugs, or has a seizure disorder, heart disease, kidney disease, liver disease, or high or low blood sugar.

Do not use the medication for longer than 12 days without the advice of your child's doctor.

Each bottle of caffeine citrate is for one use only, even if your child does not use the entire bottle for a single dose. Throw away any medication left over in the bottle after measuring your child's dose.

Call your doctor if the child's breathing symptoms do not improve after using caffeine citrate.

To be sure caffeine citrate is helping your child's condition, the child's blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

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