Caffeine Citrate 10mg/ml Oral Solution

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: myHealthbox

Thành phần hoạt chất:

Caffeine citrate

Sẵn có từ:

Viridian Pharma Ltd

Mã ATC:

N06BC01

INN (Tên quốc tế):

Caffeine citrate

Liều dùng:

10mg/ml

Dạng dược phẩm:

Oral Solution

Tuyến hành chính:

Oral use

Các đơn vị trong gói:

Vials

Loại thuốc theo toa:

POM - Prescription Only Medicine

Sản xuất bởi:

Martindale Pharmaceuticals

Nhóm trị liệu:

Psychostimulants, agents used for ADHD and nootropics, Xanthine derivatives, Caffeine

Chỉ dẫn điều trị:

It is indicated in neonates for the treatment of apnoea of prematurity.

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2011-09-01

Tờ rơi thông tin

IN THIS LEAFLET:
1.  What Caffeine Citrate 10mg/ml Oral
  Solution is and what is it used for
2.  Before your baby is given Caffeine Citrate  
  10mg/ml Oral Solution 
3.  How Caffeine Citrate 10mg/ml Oral  

  Solution is used
4.  Possible side effects
5.   Storing Caffeine Citrate 10mg/ml Oral    
 Solution 
6.   Further information
1. WHAT CAFFEINE CITRATE 10MG/ML 
ORAL SOLUTION IS AND WHAT IT IS 
USED FOR
• Caffeine belongs to a group of medicines 
known as methylxanthines
• It stimulates breathing, and is used to 
treat apnoea of prematurity (breathing 
difficulties as a result of being born 
prematurely).
2. BEFORE YOUR BABY TAKES 
CAFFEINE CITRATE 10MG/ML ORAL 
SOLUTION 
YOUR BABY SHOULD NOT BE GIVEN CAFFEINE 
CITRATE 10MG/ML ORAL SOLUTION if there is 
known hypersensitivity (allergy) to any of the 
ingredients listed in paragraph 6 overleaf.
SPECIAL CARE IS NEEDED WITH CAFFEINE 
CITRATE 10MG/ML ORAL SOLUTION WHEN YOUR 
BABY: 
• has liver or kidney disease
• has had any unusual heart rhythms 
detected.
Please tell the doctor looking after your baby 
of any of such problems.
As with most medicines, Caffeine Citrate 
10mg/ml Oral Solution may interact with 
other medicines given at the same time. A 
premature baby may need many medicines, 
and any problems with caffeine are likely 
to be minor, but tell the doctor about any 
other medication they may not know about, 
particularly any other medicine (for example 
theophylline) given to your baby to help it 
breathe.  
If you, as the mother, drank a lot of coffee, 
or took any other high caffeine-containing 
product just before your baby was born, 
some caffeine may still be present in your 
baby’s circulation. Tell the doctor about this.
Medications containing phenobarbitone or 
phenytoin, taken by the mother herself to 
treat epilepsy, may also have an effect on the 
way the baby reacts to caffeine therapy.  If 
you have been taking treatment for epilepsy 
during pregnancy, plea

Đặc tính sản phẩm

Caffeine Citrate 10mg/ml Oral Solution
Summary of Product Characteristics Updated 30­Jun­2015 | Martindale Pharmaceuticals Ltd
1. Name of the medicinal product
Caffeine Citrate 10 mg/ml Oral Solution
2. Qualitative and quantitative composition
Caffeine Citrate 10 mg/ml
Each 1ml of solution contains 10 mg Caffeine citrate, equivalent to 5 mg of Caffeine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
Appearance: clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Caffeine citrate 10 mg/ml Oral Solution is indicated in neonates for the treatment of apnoea of prematurity.
4.2 Posology and method of administration
Posology
Neonates
The recommended doses of Caffeine Citrate 10 mg/ml Oral Solution are expressed below. Please note:
(a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base.
(b) caffeine is clinically effective within 4 hours. If the patient fails to respond within this time, a second loading dose
may be given. If there is no clinical response to the second loading dose, caffeine blood levels should be measured
(see 'special warnings and precautions for use' section 4.4 below)
(c) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on
cessation of treatment.
(d) Infants must be of sufficient respiratory maturity not to require positive pressure ventilation.

Dose of Caffeine
Citrate 10mg/ml
Oral Solution
Dose Expressed
as Caffeine
Citrate
Dose Expressed
as Caffeine Base
Route
Frequency
Loading Dose
See (b) above
2ml/kg
20mg/kg
10 mg/kg
Oral
Once
Maintenance
Dose
0.5­1ml/kg*
5­10mg/kg*
2.5­5.0mg/kg*
Oral
Every 24 hours**
* In some cases maintenance doses higher than 10 mg/kg/day (expressed as caffeine citrate) may be req