Phenylephrine 10mg/1ml solution for injection ampoules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Phenylephrine hydrochloride

Inapatikana kutoka:

Advanz Pharma

INN (Jina la Kimataifa):

Phenylephrine hydrochloride

Kipimo:

10mg/1ml

Dawa fomu:

Solution for injection

Njia ya uendeshaji:

Intramuscular; Subcutaneous; Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: ; GTIN: 5060337260039

Taarifa za kipeperushi

FOR THE INFORMATION OF THE MEDICAL PROFESSION.
PHENYLEPHRINE 10 MG/ML INJECTION
Phenylephrine hydrochloride
Phenylephrine Injection is a sterile solution of Phenylephrine
Hydrochloride in purified
water.
Phenylephrine is a sympathomimetic agent with mainly direct effects on
adrenergic
receptors. It has predominantly alpha-adrenergic activity and is
without significant
stimulating effects on the central nervous system at usual doses.
After injection, it
produces peripheral vasoconstriction and an increase in arterial
pressure. It also produces
reflex bradycardia.
INDICATIONS
Phenylephrine Injection is indicated in adults and children to treat
hypotensive states, for
example circulatory failure during spinal anaesthesia, or drug induced
hypotension.
CONTRAINDICATIONS, WARNINGS, ETC.
Phenylephrine Injection is contraindicated in the presence of severe
hypertension and
hyperthyroidism. It should not be given to patients being treated with
monoamine oxidase
inhibitors, nor within two weeks of stopping such treatment. Extreme
caution is required
in patients with pre-existing cardiovascular disease, such as
ischaemic heart disease,
arrhythmias and occlusive vascular disease. Anginal pain may be
precipitated in patients
with angina pectoris. Care is also required in patients with diabetes
mellitus or closed
angle glaucoma.
INTERACTIONS
Phenylephrine
may
interact
with
cyclopropane,
halothane
and
other
halogenated
inhalational anaesthetics to induce ventricular fibrillation. There
may be an increased risk
of arrhythmias with concomitant use of cardiac glycosides, quinidine
and tricyclic
antidepressants. Phenylephrine, by increasing the blood pressure, may
reverse the effect
of
many
antihypertensives.
Interactions
of
phenylephrine
with
alpha
receptor
agonists/antagonists and beta receptor blocking drugs may be complex.
Caution should
be
applied
when
administering
atomoxetine
concurrently,
as
there
is
potential
for
synergistic pharmacological effects. Severe hypertension may occur
following the use of
phenylephrine and atrop

Tabia za bidhaa

OBJECT 1
PHENYLEPHRINE INJECTION BP 10 MG/ML
Summary of Product Characteristics Updated 19-Sep-2016 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Phenylephrine 10 mg/ml Injection
2. Qualitative and quantitative composition
Each 1 ml ampoule contains 10 mg of the active ingredient
phenylephrine hydrochloride.
Excipients with known effect:
Sodium hydroxide solution (q.s.- quantity per ml)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
A clear, colourless sterile solution
4. Clinical particulars
4.1 Therapeutic indications
Phenylephrine Injection is indicated in adults and children for the
treatment of hypotensive states e.g.
circulatory failure, during spinal anaesthesia or drug induced
hypotension.
4.2 Posology and method of administration
Posology
_Adults_
Phenylephrine Injection may be administered subcutaneously or
intramuscularly in a dosage of 2 to 5 mg
with further doses of 1 to 10 mg if necessary according to response,
or in a dose of 100 to 500
micrograms by slow intravenous injection as a 0.1% solution, repeated
as necessary after at least 15
minutes.
Alternatively, 10 mg in 500 ml of glucose 5% injection or sodium
chloride 0.9% injection may be infused
intravenously, initially at a rate of up to 180 micrograms per minute,
reduced according to response to 30-
60 micrograms per minute.
_Paediatric population_
100 mcg/kg body weight subcutaneously or intramuscularly.
_Elderly _
There is no need for dosage reduction in the elderly.
Method of administration
For subcutaneous, intramuscular, slow intravenous injection or
intravenous infusion.
4.3 Contraindications
Hypersensitivity to phenylephrine or to any of the excipients listed
in section 6.1.
Patients taking monoamine oxidase inhibitors, or within 14 days of
ceasing such treatment.
Severe hypertension and hyperthyroidism.
4.4 Special warnings and precautions for use
Great care should be exercised in administering Phenylephrine
Injection to patients with pre-existing
cardiovascular disease such as ischa