Phenylephrine 1mg/10ml solution for injection ampoules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Phenylephrine hydrochloride

Tilgjengelig fra:

Martindale Pharmaceuticals Ltd

INN (International Name):

Phenylephrine hydrochloride

Dosering :

100microgram/1ml

Legemiddelform:

Solution for injection

Administreringsrute:

Intravenous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: ; GTIN: 5026468761425

Informasjon til brukeren

WHAT IS IN THIS LEAFLET
1.
What Phenylephrine is and what it is used for
2.
What you need to know before you use Phenylephrine
3.
How to use Phenylephrine
4.
Possible side effects
5.
How to store Phenylephrine
6.
Contents of the pack and other information
1. WHAT PHENYLEPHRINE IS AND WHAT IT IS USED
FOR
This drug belongs to a group called adrenergic or
dopaminergic agents. Phenylephrine is used to treat low
blood pressure that can occur during different types of
anesthesia.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PHENYLEPHRINE
DO NOT USE PHENYLEPHRINE IF:
• you are allergic (hypersensitive) to phenylephrine or any
of the other ingredients of this medicine (listed in section
6).
• you suffer from hypertension (increased blood pressure)
• you are suffering from a peripheral vascular disease (poor
blood circulation)
• you take a non•selective monoamine oxidase inhibitor
(MAO) (or within 2 weeks of their withdrawal) for
treatment of depression (iproniazide, nialamide).
• you suffer from a severe overactive thyroid gland
(hyperthyroidism)
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using
Phenylephrine :
• if you are elderly
• if you have an overactive thyroid gland
• if you suffer from heart problems as a slow pulse,
heart block (partial), heart muscle disease, poor blood
circulation in the heart, severe peripher vascular
insufficiency, heart rhythm disorders, tachycardia (high
heart rate), bradycardia (low heart rate), angina pectoris
• if you have poor blood circulation in the brain
• if you have atherosclerosis (hardening and thickening of
the blood vessel walls)
• if you have diabetes mellitus
• if you are treated with oxytocin as the effect on the blood
vessels can be enhanced and cause very high blood
pressure and stroke in the period immediately after
childbirth
• if you suffer from arterial hypertension
• if you suffer from a closed angle glaucoma
In patients with serious heart failure phenylephrine may
worsen the heart failure as a consequence of bloo

Preparatomtale

OBJECT 1
PHENYLEPHRINE 0.1 MG/ML, SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 06-Apr-2016 | Martindale
Pharma
1. Name of the medicinal product
Phenylephrine 0.1 mg/ml, solution for injection
2. Qualitative and quantitative composition
One ml of Phenylephrine 0.1 mg/ml, solution for injection, contains
phenylephrine hydrochloride
equivalent to 0.1 mg of phenylephrine.
- Each 5 ml ampoule of Phenylephrine 0.1 mg/ml contains phenylephrine
hydrochloride equivalent to 0.5
mg phenylephrine.
- Each 10 ml ampoule of Phenylephrine 0.1 mg/ml contains phenylephrine
hydrochloride equivalent to
1.0 mg phenylephrine.
Excipient with known effect:
Each 10 ml ampoule contains 1,6 mmol (36,8 mg) sodium.
Each 5 ml ampoule contains 0,8 mmol (18,4 mg) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, colourless solution with an osmolality of 270-300 mOsm/kg.
pH: 4,5-6,5.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of hypotension during spinal, epidural and general
anaesthesia.
4.2 Posology and method of administration
Posology
_Adults_
_Intravenous bolus injection:_
Normal dose is 50 to 100 micrograms, which can be repeated until the
desired effect is attained. One
bolus dose should not exceed 100 micrograms.
_Continuous infusion:_
Initial dose is 25 to 50 micrograms/min. The doses may be increased or
decreased to maintain the systolic
blood pressure close to the normal value. Doses between 25 and 100
micrograms/min have been assessed
to be effective.
_Renal impairment:_
Lower doses of phenylephrine may be needed in patients with impaired
renal function.
_Hepatic impairment:_
Higher doses of phenylephrine may be needed in patients with cirrhosis
of the liver.
_Older people:_
Treatment of the elderly should be carried out with care.
_Paediatric population:_
The safety and efficacy of phenylephrine in children have not been
established. No data are available.
Method of administration
:
Parenteral administration. Intravenous bolus injec