Caffeine citrate 50mg/5ml oral solution

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Caffeine citrate

Beszerezhető a:

Martindale Pharmaceuticals Ltd

ATC-kód:

N06BC01

INN (nemzetközi neve):

Caffeine citrate

Adagolás:

10mg/1ml

Gyógyszerészeti forma:

Oral solution

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04040000; GTIN: 5014124172852

Betegtájékoztató

WHAT IS IN THIS LEAFLET:
1. What Caffeine Citrate 10mg/ml Oral
Solution is and what is it used for
2.
What you need to know 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.
How to store Caffeine Citrate 10mg/ml
Oral Solution
6. Contents of the pack and other 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 is used in the treatment of interrupted
breathing in premature babies (primary
apnoea of premature newborns).
These short periods when premature
babies stop breathing are due to the
baby’s breathing centres not being fully
developed. This medicine has been
shown to reduce the number of episodes
of interrupted breathing in premature
newborns.
2. WHAT YOU NEED TO KNOW BEFORE
YOUR BABY IS GIVEN CAFFEINE
CITRATE 10MG/ML ORAL SOLUTION
YOUR BABY SHOULD NOT BE GIVEN CAFFEINE
CITRATE 10MG/ML ORAL SOLUTION
• if allergic to caffeine citrate or to any of
the other ingredients of this medicine
listed in section 6.
WARNINGS AND PRECAUTIONS
Talk to your baby’s doctor before your
newborn is given Caffeine Citrate 10mg/ml
Oral Solution if your baby:
• has liver or kidney disease
• has had any unusual heart rhythms
detected or heart disease.
• suffers from seizures
• has frequent regurgitation
• produces more urine than usual
• has a reduced weight gain or food intake
• If you (the mother) consumed caffeine
prior to delivery
OTHER MEDICINES AND CAFFEINE CITRATE
10MG/ML ORAL SOLUTION
Tell your baby’s doctor if your newborn is
taking, have recently taken or might take
any other medicines.
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
medi

Termékjellemzők

OBJECT 1
CAFFEINE CITRATE 10MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 30-Oct-2017 | Martindale
Pharma
1. Name of the medicinal product
Caffeine Citrate 10mg/ml Oral Solution
2. Qualitative and quantitative composition
Caffeine Citrate 10mg/ml
Each 1ml of solution contains, 10mg Caffeine citrate, equivalent to
5mg of Caffeine.
Excipients with known effect:
Also, contains 3.02 mg of sodium per ml
For the 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
Treatment with caffeine citrate should be initiated under the
supervision of a physician experienced in
neonatal intensive care. Treatment should be administered only in a
neonatal intensive care unit in which
adequate facilities are available for patient surveillance and
monitoring.
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
0.5-1ML/KG*
5-10MG/KG*
2.5-5.0MG/KG*
ORAL
E