Consumer medicine information

Cafnea Injection and Cafnea Oral Solution

Caffeine citrate

BRAND INFORMATION

Brand name

Cafnea

Active ingredient

Caffeine citrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cafnea Injection and Cafnea Oral Solution.

What is in this leaflet

This leaflet answers some common questions about Cafnea Injection and Cafnea Oral Solution. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of your baby being given Cafnea Injection or Cafnea Oral Solution against the benefits this medicine is expected to have for your baby.

If you have any concerns about either medicine being given to your baby, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Cafnea Injection and Cafnea Oral Solution are used for

Cafnea Injection and Cafnea Oral Solution are used to help improve the breathing of premature infants suffering from apnoea of prematurity who have been born between 28 and less than 33 weeks gestation.

Apnoea of prematurity is a condition where a baby stops breathing for short periods of time.

Cafnea Injection and Cafnea Oral Solution work by stimulating breathing in premature babies.

Ask your doctor if you have any questions about why Cafnea Injection or Cafnea Oral Solution has been prescribed for your baby. Your doctor may have prescribed it for another reason.

Before Cafnea Injection or Cafnea Oral Solution is given

When they should not be given

Your baby should not be given Cafnea Injection or Cafnea Oral Solution if they have an allergy to:

  • caffeine or citrate
  • any other similar medicine.

Your baby should not be given Cafnea Injection or Cafnea Oral Solution if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present. The solutions are normally clear, and colourless.

Your baby should not be given either medicine if, when mixed with another solution it causes the solution, to become discoloured, cloudy, turbid, precipitate or form particles. The solutions are normally clear, and colourless.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

If you are not sure whether your baby should be given either medicine talk to your doctor.

Before either is given

Tell your doctor if your baby has allergies to any other medicines, foods, preservatives, or dyes.

Your doctor will check if your baby’s breathing problems are caused by other medical conditions. If the breathing problems are caused by another medical condition Cafnea Injection or Cafnea Oral Solution may not be used until the other condition is treated.

Your doctor will check if your baby has any of the following medical conditions:

  • seizure disorders
  • heart problems
  • kidney problems
  • liver problems.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist. Some medicines can be passed onto your baby through the placenta before birth or in breast milk.

Some medicines may interfere with Cafnea Injection and Cafnea Oral Solution. These include:

  • methylxanthines such as theophylline and aminophylline, medicines used to control asthma
  • antibiotics used to treat bacterial infections such as ciprofloxacin, enoxacin, norfloxacin
  • any medicine containing caffeine
  • medicines used to treat heart problems such as Mexiletine and Verapamil
  • Cimetidine a medicine used to treat reflux and ulcers
  • Fluvoxamine a medicine used to treat depression
  • Idrocilamide a medicine used to relax muscle
  • Methoxsalen a medicine used to treat skin problems
  • Tiabendazole used to treat certain worm infections
  • Artemisinin a medicine used to treat malaria
  • medicines used to treat fungal infections such as Fluconazole and Terbinafine
  • Phenytoin a medicine used to treat epilepsy
  • benzodiazapines a group of medicines used as a sedative or to treat anxiety
  • Clozapine a medicine used to treat schizophrenia.

These medicines may be affected by Cafnea Injection and Cafnea Oral Solution, or may affect how well they work. Your doctor and pharmacist have more information on medicines to be careful with or avoid while your baby is being given Cafnea Injection or Cafnea Oral Solution.

How Cafnea Injection and Cafnea Oral Solution are given

Cafnea Injection must only be given by a doctor or nurse.

How it is given

Cafnea Injection is usually infused into a vein slowly using a syringe infusion pump.

How much is given

Your doctor will decide what dose of Cafnea Injection your baby will receive and for how long they will receive it. This depends on their medical condition and other factors, such as weight.

It will also depend on what medicines and fluids the mother has consumed prior to delivery as these may have crossed the placenta and been passed onto the baby.

Cafnea Oral Solution must only be given by a doctor or nurse.

How it is given

Cafnea Oral Solution is usually given in a measured dose by mouth through a dropper or feeding tube.

How much is given

Your doctor will decide what dose of Cafnea Oral Solution your baby will receive and for how long they will receive it. This depends on their medical condition and other factors, such as weight.

It will also depend on what medicines and fluids the mother has consumed prior to delivery as these may have crossed the placenta and been passed onto the baby.

If too much is given (overdose)

Both Cafnea Injection and Cafnea Oral Solution must only be given by a doctor or nurse so an overdose is not likely to occur.

Contact your doctor or nurse immediately if you notice any symptoms of an overdose in your baby:

  • jitteriness
  • loss in weight
  • fever
  • irritability, sleeplessness
  • poor feeding
  • rapid shallow breathing, difficulty breathing
  • muscle spasms or contractions including tremors in the hands or feet and arching of the back
  • muscle spasm in which the head and the heels are bent backward and the body bowed forward
  • muscle stiffness causing poor control of movement
  • unusual jaw and lip movement
  • vomiting
  • passing large amounts of urine
  • excessive thirst, dry mouth and skin
  • seizures, fits or convulsions
  • increased heart rate
  • stomach bloating
  • pain or redness at the injection site.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While Cafnea Injection or Cafnea Oral Solution is being given

Your doctor may do tests on your baby from time to time to make sure the medicine is working and to prevent unwanted side effects.

Side effects

Tell your doctor or nurse as soon as possible if your baby does not appear well while receiving Cafnea Injection or Cafnea Oral Solution. Cafnea Injection and Cafnea Oral Solution may have unwanted side effects in a few babies. All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some side effects may require medical treatment.

Do not be alarmed by the following list of side effects. Your baby may not experience any of them.

Ask your doctor to answer any questions you may have.

If any of the following happen, tell your doctor or nurse immediately:

  • irritability, jitteriness, restlessness
  • fast heart beat
  • stomach upset or vomiting
  • reflux
  • passing large amounts of urine
  • excessive thirst, dry mouth and skin
  • sweating
  • weakness, dizziness, trembling
  • flushing or paleness
  • symptoms of necrotising enterocolitis a serious stomach condition. These include:
    - lack of energy (lethargy)
    - severe vomiting
    - stomach/abdominal bloating (distension)
    - bloody stools.

The above list includes very serious side effects. Your baby may need urgent medical attention.

Tell your doctor or nurse if you notice anything that is making your baby feel unwell.

Other side effects not listed above may also occur in some babies.

Some side effects can only be found when your doctor does tests from time to time to check your baby’s progress.

After Cafnea Injection or Cafnea Oral Solution is given

Storage

Cafnea Injection and Cafnea Oral Solution will be stored in the surgery, pharmacy or ward of a hospital in a cool dry place where the temperature stays below 30°C.

Cafnea Injection or Cafnea Oral Solution will be opened for use on your baby. It will be used only once and then it will be discarded. It will never be stored after it is opened or used for more than one baby.

Product description

What it looks like

Cafnea Injection and Cafnea Oral Solution are clear, colourless solutions in a clear glass vial with a grey rubber stopper, aluminium seal and a plastic top.

Cafnea Injection is available in a 2 mL vial.

Cafnea Oral Solution is available in a 7 mL vial.

Ingredients

Cafnea Injection contains 40 mg of caffeine citrate injection in 2 mL equivalent to 20 mg of caffeine base as the active ingredient.

It also contains:

  • citric acid monohydrate
  • sodium citrate dihydrate
  • water for injections.

Cafnea Oral Solution contains 25 mg of caffeine citrate in 5 mL equivalent to 12.5 mg of caffeine base as the active ingredient.

It also contains:

  • citric acid monohydrate
  • sodium citrate dihydrate
  • water for injections.

These medicines do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes, alcohol or preservatives.

Manufacturer

Cafnea Injection and Cafnea Oral Solution are made in Australia by:

Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Cafnea Injection
(caffeine citrate 40 mg in 2 mL)
2 ml vial,
AUST R 153873
Phebra product code INJ101

Cafnea Oral Solution
(caffeine citrate 25 mg in 5 mL)
5 mL of solution in a 7 mL vial.
AUST R 153874
Phebra product code SOL026

This leaflet was last updated on 05 May 2021.

Cafnea, Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS June 2021

BRAND INFORMATION

Brand name

Cafnea

Active ingredient

Caffeine citrate

Schedule

Unscheduled

 

1 Name of Medicine

Caffeine citrate.

2 Qualitative and Quantitative Composition

Cafnea Injection contains 20 mg/mL caffeine citrate (equivalent to 10 mg/mL of caffeine base).
Cafnea Oral Solution contains 5 mg/mL caffeine citrate (equivalent to 2.5 mg/mL of caffeine base).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Both Cafnea Injection (caffeine citrate injection 40 mg/2 mL) and Cafnea Oral Solution (caffeine citrate oral solution 25 mg/5 mL) are clear, colourless, preservative free sterile solutions adjusted to a pH of 4.2 - 5.2.

4 Clinical Particulars

4.1 Therapeutic Indications

Cafnea Injection and Cafnea Oral Solution are indicated for the short-term treatment of apnoea of prematurity (AOP) in infants of gestational age 28 to less than 33 weeks.

4.2 Dose and Method of Administration

Cafnea Injection and Cafnea Oral Solution are intended to be used in neonatal specialist units. The product is for single use in one patient only. Discard any residue.

Note.

A prior check should be made to ensure that no other methylxanthine (e.g. theophylline and aminophylline) is being administered.
Baseline serum levels of caffeine should be measured if mothers have consumed caffeine containing fluids prior to delivery, since caffeine readily crosses the placenta.
The dose expressed as caffeine base is half the dose when expressed as caffeine citrate (e.g. 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base).

Loading dose.

Caffeine citrate 20 mg/kg bodyweight intravenously using a syringe infusion pump over 30 minutes.

Maintenance dose.

Caffeine citrate 5 mg/kg once a day until apnoea ceases or until treatment is considered to be no longer required. The maintenance dose can be increased to a maximum of 10 mg/kg caffeine citrate once a day if apnoea persists. The maintenance dose should be adjusted weekly for changes in bodyweight. If symptoms suggestive of caffeine induced toxicity are observed such as tachycardia, tachypnoea, jitteriness, tremors and unexplained seizures and vomiting, the dose of caffeine citrate can be reduced or withheld. The dose of caffeine citrate can be withheld or reduced for other clinical reasons.
Maintenance dose can be administered either intravenously (over 10 minutes) using Cafnea Injection or orally using Cafnea Oral Solution once the infant is tolerating full enteral feeds. Maintenance dose begins 24 hours after loading dose.

Compatibility.

Cafnea Injection and Cafnea Oral Solution are compatible with 0.9% sodium chloride solution.

4.3 Contraindications

Cafnea Injection and Cafnea Oral Solution are contraindicated in patients who have demonstrated hypersensitivity to caffeine or citrate.

4.4 Special Warnings and Precautions for Use

Prior to treatment it is essential that other causes of apnoea (e.g. CNS disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea) be ruled out or treated prior to initiation of caffeine citrate therapy.
Caffeine is a CNS stimulant and in cases of caffeine overdose, seizures have been reported. Cafnea Injection and Cafnea Oral Solution should be used with caution in infants with seizure disorders.
Clinical trials have indicated that necrotising enterocolitis may develop in neonates under treatment. Patients should be carefully monitored for the development of necrotising enterocolitis.

Cardiovascular effects.

Cafnea Injection and Cafnea Oral Solution should be used with caution in infants with cardiovascular disease since caffeine has been shown to increase heart rate, left ventricular output, and stroke volume.

Gastro-oesophageal disease.

Cafnea Injection and Cafnea Oral Solution may relax the lower oesophageal sphincter and increase the gastric acid excretion leading to increased episodes of gastro-oesophageal reflux in neonates.

Use in hepatic impairment.

Cafnea Injection and Cafnea Oral Solution should be administered with caution in infants with impaired hepatic function. In such cases, serum caffeine should be monitored and dose administration should be adjusted to avoid potential toxicity.

Use in renal impairment.

Cafnea Injection and Cafnea Oral Solution should be administered with caution in infants with impaired renal function. In such cases, serum caffeine should be monitored and dose administration should be adjusted to avoid potential toxicity.

Use in the elderly.

Cafnea is not applicable to this indication. See Section 4.1 Therapeutic Indications.

Paediatric use.

Cafnea is indicated for use in pre-term infants of gestational age 28 to less than 33 weeks. See Section 4.1 Therapeutic Indications; Section 5.1, Clinical trials.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There is little data on drug interactions with caffeine in preterm neonates. However, CYP1A2 is the major enzyme responsible for caffeine metabolism and there is potential for interactions between caffeine and drugs that are substrates for this enzyme, or inhibit or reduce it. Studies in adults show that co-administration of mexiletine, cimetidine, fluvoxamine, oral idrocilamide, oral methoxsalen and 5-methoxypsoralen, enoxacin, tiabendazole, artemisinin, fluconazole and terbinafine, verapamil may decrease caffeine elimination. Co-administration of phenytoin may increase caffeine elimination. Caffeine antagonises the effects of benzodiazepines. Caffeine increases the levels of both endogenous and orally administered melatonin as well as clozapine. Caffeine may cause a reduction in the bioavailability of fluvoxamine.
Caffeine elimination half-life has been reported to be increased and clearance decreased by concomitant administration of antibacterials such as ciprofloxacin, enoxacin and pipemidic acid, lomefloxacin, norfloxacin and ofloxacin.
Other methylxanthines (theophylline, aminophylline) should not be used concomitantly.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies in animals are limited but suggest that neonatal exposure to caffeine does not pose a hazard to later fertility.
Not applicable.
 Not applicable. If mothers are drinking caffeine containing fluids, this should be taken into consideration when determining the dose for the neonate.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Necrotising enterocolitis is a common event in preterm infants and must be investigated whether or not the infant is receiving caffeine. See Table 1.
In noncontrolled studies the following effects have been reported.
CNS stimulation: i.e. irritability, restlessness, jitteriness.
Cardiovascular effects: tachycardia, increased left ventricular output and increased stroke volume.
Gastrointestinal effects: i.e. increased gastric aspirate, gastrointestinal intolerance.
Alterations in serum glucose: hypoglycaemia and hyperglycaemia.
Renal effects: increased urine flow rate, increased creatinine clearance and increased sodium and calcium excretion.
Adverse effects observed in the Schmidt et al2,3 controlled clinical trials have included tachycardia, tachypnoea, jitteriness, tremors, unexplained seizures and vomiting. Caffeine reduced weight gain temporarily.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Up to three times the usual dose has been given without noticeable side effects except an increase in jitteriness and a loss in weight which returns to normal following cessation of therapy. Higher doses may result in fever, irritability, poor feeding, insomnia, tachypnoea, jitteriness, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycaemia, elevated blood urea nitrogen, and elevated total leukocyte concentration, seizures, neurological sequelae, tachycardia, respiratory distress, heart failure, gastric distention and acidosis.

Treatment of overdose.

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.

Treatment of withdrawal.

Caffeine withdrawal.

No withdrawal symptoms have been reported following short-term therapy (less than three weeks).
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

Note.

The pharmacology, dosage regimens and clinical descriptions apply only to preterm infants with apnoea.
Caffeine is a methylxanthine and is structurally related to other methylxanthines such as theophylline.

5.1 Pharmacodynamic Properties

Mechanism of action.

Caffeine is a centrally acting respiratory stimulant. It increases respiratory rate (breaths/minute) significantly in premature infants and significantly reduces the number of short and prolonged attacks of apnoea. There is evidence that caffeine has a direct effect on the myocardium. In ventilator dependent preterm infants, caffeine has been shown to reduce pulmonary resistance and increase lung compliance with a concomitant reduction in the requirement for inspired oxygen.
The following pharmacodynamic effects of caffeine were found in preterm infants with apnoea.
Caffeine increases heart rate.
Caffeine increased respiratory rate in some studies but not others.
Mean arterial blood pressure, TcPO2, TcPCO2 are unchanged.
Blood flow volumes in the coeliac artery and superior mesenteric artery, LVO, PCO2, do not change significantly.
Caffeine increases cerebral blood flow in some studies but not in others.

Clinical trials.

Efficacy study.

The randomised double blinded placebo controlled trial by Erenberg et al1 evaluated the efficacy and safety of caffeine citrate for the treatment of AOP. The study included a total of 87 preterm infants of 28-32 weeks post-conceptional age. Infants randomised to caffeine received a loading dose of 20 mg/kg caffeine citrate IV. A daily maintenance dose of caffeine citrate 5 mg/kg was administered by IV or orally for 10 days.
The primary efficacy end point was at least a 50% reduction in apnoeic episodes from baseline events and elimination of apnoea. Caffeine citrate was significantly more effective than placebo in reducing apnoeic episodes by at least 50% in 6 days (p < 0.05). The percentage of patients with 50% reduction in apnoeic episodes was 68.9% active treatment vs 43.2% placebo (p = 0.02). Caffeine citrate was also significantly better at eliminating apnoea in 5 days (p < 0.05). The percentage of patients with elimination of apnoeic episodes was 24.4% active treatment vs 0% placebo (p = 0.005).

Safety study.

The long term safety study by Schmidt et al2,3 was a large multinational study involving 2006 randomised preterm infants with birth weights of 500 to 1250 g in which caffeine was compared to placebo for the short and long term safety of caffeine treatment for apnoea of prematurity (AOP), the prevention of AOP or to facilitate extubation. Treated infants received an intravenous loading dose of 20 mg/kg of caffeine citrate followed by a daily maintenance dose of 5 mg/kg IV or orally. If apnoea persisted, the daily maintenance dose could be increased to a maximum of 10 mg/kg. Maintenance dose was adjusted weekly for changes in body weight. See Table 2.

5.2 Pharmacokinetic Properties

Absorption.

Following an oral dose of caffeine citrate solution, the time to reach peak concentration ranges from 30 minutes to 2 hours. Absorption following oral administration is complete. Feeding does not affect the rate or extent of oral caffeine absorption in premature infants. Following an intravenous (IV) loading dose of 20 mg/kg of caffeine citrate, the mean peak plasma level for caffeine is 12 mg/L. Following a single 10 mg/kg IV infusion of caffeine citrate, the mean ± SD serum concentration of caffeine was 14.5 ± 1.4 micrograms/mL at 10 minutes, 11.3 ± 0.1 micrograms/mL at 24 hours and 6.1 micrograms/mL at 72 hours. After a loading dose of 10 mg/kg of caffeine citrate and maintenance dose of either 5 mg/kg/day orally or 10 mg/kg/day orally, serum concentrations reached steady state at about 5 days with higher concentrations being observed with the 5 mg/kg maintenance regimen4 (see Figure 1). Following maintenance doses of caffeine citrate 5 mg/kg, caffeine plasma levels range from 5 to 15 mg/L.

Distribution.

Caffeine is distributed rapidly in infants with a volume of distribution, V = 0.8 to 0.9 L/kg.

Metabolism.

Caffeine is poorly metabolised in preterm infants. The primary metabolites of caffeine are paraxanthines (main metabolite), theobromine, and theophylline. Interconversion between caffeine and theophylline has been observed in premature infants and approximately 3% to 8% of administered caffeine is expected to be converted to theophylline.
Caffeine is metabolised in the liver by cytochrome P450 enzymes, primarily by CYP1A2. This enzyme catalyses N1, N3, and N7-demethylation of caffeine. In addition, CYP2E1 also catalyses N1 and N7-demethylation, while CYP3A catalyses 8-hydroxylation. The N3 and N7 metabolic pathways are not mature until a postnatal age of about 4 months and explain the long half-life and low clearance in infants younger than this age.

Excretion.

More than 85% of caffeine is excreted unchanged in the urine. Preterm infants from 28 to 32 gestational weeks excrete 85% to 97% of caffeine unchanged. The terminal half-life in infants decreases from birth until it reaches adult values at approximately 60 weeks. Premature neonates have a significantly longer caffeine half-life than neonates born at term. The mean terminal life in neonates ranges from 65 to 102 hours. Excretion of caffeine in preterm infants is slow with a half-life of 80 to 120 hours. Following cessation of treatment serum concentrations of caffeine are likely to remain elevated due to the long elimination half-life of the drug (see Figure 1).

Special groups.

Neonates of Asian background tolerated an IV loading dose of 20 mg/kg caffeine citrate with a maintenance dose of 5 mg/kg/day caffeine citrate IV. A higher maintenance dose resulted in an increase of hyperglycaemia and tachycardia6.
Other studies have found no effect of gender or race on volume of distribution of caffeine. Hepatic impairment as measured by serum creatinine or serum urea levels did not influence volume of distribution.

5.3 Preclinical Safety Data

Genotoxicity.

Assays for bacterial and mammalian mutagenicity in vitro, and for clastogenicity in vitro and in vivo generally show negative results for caffeine. Positive responses have been observed in some tests, but these studies use extreme concentrations, lethal doses or nonvalidated methods. Cafnea is not considered to pose a genotoxic hazard to patients.

Carcinogenicity.

In a small number of animal studies, caffeine did not show carcinogenicity or tumorigenicity. In a two year carcinogenicity study conducted in rats, caffeine (administered as base) did not increase tumour incidence at oral doses up to 102 mg/kg/day in males and 170 mg/kg/day in females. Systemic exposure in animals at these doses is estimated to be 2-6 times higher than that in neonates at the recommended maintenance dose of 5 mg/kg/day caffeine citrate.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cafnea Injection contains the excipients citric acid monohydrate and sodium citrate dihydrate in water for injections. The injection contains no preservatives.
Cafnea Oral Solution contains the excipients citric acid monohydrate and sodium citrate dihydrate in water for injections. The solution contains no preservatives.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG*). The expiry date can be found on the packaging.
*AUST R 153873 (injection); AUST R 153874 (oral solution).

6.4 Special Precautions for Storage

The product is for single use in one patient only. Discard any residue. Store below 30°C.

6.5 Nature and Contents of Container

Cafnea Injection: 40 mg caffeine citrate (equivalent to 20 mg caffeine) per 2 mL injection presented in a 2 mL clear vial available as a pack of 10 vials.
Phebra product code - INJ101.
Cafnea Oral Solution: 25 mg caffeine citrate (equivalent to 12.5 mg caffeine) per 5 mL of sterile solution presented in a 7 mL clear vial available as a pack of 10 vials.
Phebra product code - SOL026.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Caffeine citrate.

The molecular weight of the compound is 386.3.
The molecular formula is C8H10N4O2,C6H8O7.

Chemical structure.

Chemical structure of caffeine citrate:

Caffeine.

Caffeine in the presence of citric acid forms caffeine citrate in solution.
The molecular weight of caffeine is 194.2.
The chemical name for caffeine is 1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione.
The molecular formula is C8H10N4O2.

Chemical structure.

Chemical structure of caffeine:

CAS number.

69-22-7 (caffeine citrate); 58-08-2 (caffeine).

References

1 A. Erenberg, R. D. Leff, D. G. Haack, K. W. Mosdell, G. M. Hicks, and B. A. Wynne. Caffeine citrate for the treatment of apnoea of prematurity: a double-blind, placebo-controlled study. Pharmacotherapy 20 (6):644-652, 2000.
2 B. Schmidt, R. S. Roberts, P. Davis, L. W. Doyle, K. J. Barrington, A. Ohlsson, A. Solimano, and W. Tin. Caffeine therapy for apnoea of prematurity. N.Engl.J.Med. 354 (20):2112-2121, 2006.
3 B. Schmidt, R. S Roberts, P. Davis, L. W Doyle, K. J Barrington, A. Ohlsson, A. Solimano, W. Tin. Long-term effects of caffeine therapy for apnoea of prematurity. N Engl J Med. 357 (19):1893-902, 2007.
4 M. P. De Carolis, C. Romagnoli, U. Muzii, G. Tortorolo, M. Chiarotti, Giovanni N. De, and A. Carnevale. Pharmacokinetic aspects of caffeine in premature infants. Dev. Pharmacol.Ther. 16 (3):117-122, 1991.
5 C. Romagnoli, M. P. De Carolis, U. Muzii, E. Zecca, G. Tortorolo, M. Chiarotti, Giovanni N. De, and A. Carnevale. Effectiveness and side effects of two different doses of caffeine in preventing apnoea in premature infants. Ther.Drug Monit. 14 (1):14-19, 1992.
6 H. S. Lee, Y. M. Khoo, Y. Chirino-Barcelo, K. L. Tan, and D. Ong. Caffeine in apnoeic Asian neonates: a sparse data analysis. Br.J.Clin.Pharmacol. 54 (1):31-37, 2002.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes