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PHENYLEPHRINE UNIMEDIC 10 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): PHENYLEPHRINE HYDROCHLORIDE / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Phenylephrine 10 mg/ml, concentrate for solution for injection/infusion
phenylephrine

Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

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, non-severe peripheral 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
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- 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 blood
vessel constriction.
The blood pressure in your arteries will be monitored during treatment. If you have heart disease, additional
monitoring of vital functions will be performed.
Children
The medicine is not recommended for use in children due to insufficient data on efficacy, safety and dosage
recommendations.
Other medicines and Phenylephrine
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines.
Do not use Phenylephrine with:
- iproniazide, nialamide (for depression)
The following medicines may affect or be affected by concomitant use:
- dihydroergotamine, ergotamine, methylergometrine, methysergide (for migraine)
- linezolid (an antibiotic)
- bromocriptine, cabergoline, lisuride, pergolide (for Parkinson's disease)
- desipramine, imipramine, nortriptyline, moclobemide, toloxatone, minalcipram, venlafaxine (for
depression)
- anaesthetics that are inhaled (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane
- medicine used to treat high blood pressure (guanethidine)
- medicines used to treat heart failure and certain irregular heartbeats (cardiac glycosides)
- medicine used to treat abnormal heart rhythm (quinidine)
- medicine used during labour (oxytocin)
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor, pharmacist or nurse for advice before taking this medicine.
Pregnancy
This medication should not be used during pregnancy unless absolutely necessary.
Breast-feeding
This medication should not be used during breast-feeding unless it is absolutely necessary. However, in the
event of a single administration during childbirth, breast-feeding is possible.
Driving and using machines
Not relevant.
Phenylephrine contains sodium
- Each 2 ml ampoule (containing
1 ml solution) contains 0,2 mmol (3,7 mg) per ampoule. This means that it contains less than 1 mmol
sodium (23 mg) per ampoule, which means that it is almost free from sodium.

3.

How to take Phenylephrine

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The administration will be performed by a health-care professional with appropriate training and relevant
experience.
Use in Adults
Your doctor or nurse will give you Phenylephrine into a vein (intravenously). Your doctor will decide the
right dose for you and when and how it should be injected.
Use in patients with impaired renal function
Lower doses of phenylephrine may be needed in patients with impaired renal function.
Use in patients with impaired liver function
Higher doses of phenylephrine may be needed in patients with cirrhosis of the liver.
Use in older people
Treatment in older people should be carried out with care.
Use in children
It is not recommended for use in children due to insufficient data on efficacy, safety and dosage
recommendations.

If you use more Phenylephrine than you should
Signs that indicates that you have received too much Phenylephrine is a faster and irregular heart beat,
headache, nausea, vomiting, paranoid psychosis, hallucinations and hypertension (headache, shortness of
breath, tiredness).
It is unlikely that this will happen because you will get this medicine at a hospital.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions, with the frequencies not known, have been reported:
Some side effects may be serious.
Tell your doctor straight away if you get any of the following:
chest pain or pain due to the angina
irregular heartbeat
feeling the heart pumping in the chest
bleeding in the brain (speech disorder, dizziness, paralysis of one side of the body)
psychosis (loosing contact with reality)
Other side effects may include (frequencies are not known):
reaction of hypersensitivity (allergy)
excessive dilation of the pupils
increased pressure in the eye (aggravation of glaucoma)
excitability (excessive sensitivity of an organ or body part)
agitation (restlessness)
anxiety
confusion
headache
nervousness,
insomnia (difficulty falling or staying asleep)
shaking (tremor)
burning of the skin
prickling of the skin
itching or tingling skin sensation (paraesthesia)
slow or high heart rate
high blood pressure (headache, shortness of breath, tiredness)
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-

difficulty in breathing
fluids in the lung
nausea
vomiting
sweating
pallor or skin blanching (pale colour of the skin)
goose flesh
tissue damage at the site of the injection
muscle weakness
difficulty in passing urine or urine retention

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in
Appendix V*. By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How to store Phenylephrine

Keep the ampoules in the outer carton in order to protect from light.
Storage condition after dilution
Chemical and physical in-use stability has been demonstrated for 7 days at room temperature (20-25°C).
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic
conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Phenylephrine contains
The active substance is phenylephrine. Phenylephrine contains phenylephrine
hydrochloride
equivalent to 10 mg/ml phenylephrine.
The other ingredients are sodium chloride, sodium citrate, citric acid, water for injection and
hydrochloric acid and sodium hydroxid for pH adjustment
What Phenylephrine looks like and contents of the pack
Clear and colourless solution.
Phenylephrine 10 mg/ml, concentrate for solution for injection/infusion is available in glass ampoules of 2
ml (containing 1 ml solution).
The ampoules are packaged in trays of plastic and then in cartons of 5, 10, 20, 50 and 100 ampoules.

4

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AB
Storjordenvägen 2
SE-864 31 Matfors
Sweden
This leaflet was last revised in
2017-07-05
----------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Solution with a high concentration and that must be diluted before the administration.
Reconstitution/dilution:
Phenylephrine 10 mg/ml will be administered as an injection or infusion after dilution in sodium chloride 9
mg/ml (or glucose 50 mg/ml).
- Dilution to a concentration of 100 micrograms/ml: 1 ml of the 10 mg/ml solution is diluted in 100 ml
sodium chloride 9 mg/ml (or glucose 50 mg/ml).
- Dilution to a concentration of 50 micrograms/ml: 1 ml of the 10 mg/ml solution is diluted in 200 ml
sodium chloride 9 mg/ml or glucose 50 mg/ml.
Other concentrations may also occur.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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