Caffeine citrate 10mg/1ml solution for infusion ampoules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Caffeine citrate

Commercializzato da:

Martindale Pharmaceuticals Ltd

Codice ATC:

N06BC01

INN (Nome Internazionale):

Caffeine citrate

Dosaggio:

10mg/1ml

Forma farmaceutica:

Solution for infusion

Via di somministrazione:

Oral; Intravenous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04040000; GTIN: 5014124170858

Foglio illustrativo

COMPOSITION
1.
Each 1ml contains 10mg of caffeine citrate,
equivalent to 5mg of caffeine.
Each 2ml contains 20mg of caffeine citrate,
equivalent to 10mg of caffeine.
It also contains Water for Injections, Sodium
Hydroxide, Dilute Hydrochloric Acid, Sodium
Chloride and Citric Acid
CLINICAL PARTICULARS
2.1. THERAPEUTIC INDICATIONS
Treatment of apnoea of prematurity.
2.2. POSOLOGY AND METHOD OF ADMINISTRATION
The recommended doses of Caffeine Citrate
10mg/ml Solution for Injection are expressed
below.
Please note:
(a) the dose expressed as caffeine citrate is twice
the dose expressed as caffeine base.
(b) given orally or intravenously, 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 2.4 below)
(c) Caffeine Citrate 10mg/ml Solution for
Injection is also effective when administered
orally, and this route may be used
alternatively without adjusting the dose.
(d) because of the slow elimination of caffeine
in this patient population, there is no
requirement for dose tapering on cessation
of treatment.
(e) Infants must be of sufficient respiratory
maturity not to require positive pressure
ventilation.
_Continued next column_
_2.2 Posology and Method of Administration (Continued) _
Treatment should be continued until the child has
reached a gestational age of 37 weeks, by which time
apnoea of prematurity usually resolves spontaneously.
This limit may however be revised according to
clinical judgement in individual cases depending on
response to treatment, the continuing presence of
apnoeic episodes despite treatment, or other clinical
considerations.
Caffeine Citrate 10mg/ml Solution for Injection should
not be given intramuscularly; being acidic, i.m. injection
is likely to be painful. When given intravenously, it
should be given as a slow infusion rather than a bolus
injectio

Scheda tecnica

OBJECT 1
CAFFEINE CITRATE 10MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 14-Jul-2017 | Martindale
Pharma
1. Name of the medicinal product
Caffeine Citrate 10mg/ml Solution for Injection
2. Qualitative and quantitative composition
Caffeine Citrate 10mg/ml
Each 1ml of solution contains, 10mg Caffeine Citrate, equivalent to
5mg of Caffeine.
Each 2ml of solution contains, 20mg Caffeine Citrate, equivalent to
10mg of Caffeine.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
Appearance: clear and colourless.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of apnoea of prematurity.
4.2 Posology and method of administration
The recommended doses of Caffeine Citrate 10mg/ml Solution for
Injection are expressed below. Please
note:
(a) the dose expressed as caffeine citrate is twice the dose expressed
as caffeine base.
(b) given orally or intravenously, 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) Caffeine Citrate 10mg/ml Solution for Injection is also effective
when administered orally, and this
route may be used alternatively without adjusting the dose.
(d) because of the slow elimination of caffeine in this patient
population, there is no requirement for dose
tapering on cessation of treatment.
(e) Infants must be of sufficient respiratory maturity not to require
positive pressure ventilation.
DOSE OF CAFFEINE
CITRATE 10MG/ML
SOLUTION FOR
DOSE EXPRESSED
AS CAFFEINE
CITRATE
DOSE EXPRESSED
AS CAFFEINE BASE
ROUTE
FREQUENCY
INJECTION
LOADING DOSE
SEE (B) ABOVE
2ML/KG
20 MG/KG
10MG/KG
INTRAVENOUS**
(OVER 30 MIN) OR
ORAL
ONCE
MAINTENANCE
DOSE
0.5-1ML/KG*
5-10MG/KG*
2.5-5.0MG/KG*
INTRAVENOUS**
(OVER 10 MIN) OR
ORAL
EVERY 24
HOURS***
* In some cases maintenance doses higher than 10mg/k