Consumer medicine information

Neo-synephrine 1% injection

Phenylephrine hydrochloride

BRAND INFORMATION

Brand name

Neo-Synephrine

Active ingredient

Phenylephrine hydrochloride

Schedule

What is in this leaflet

This leaflet answers some common questions about NEO-SYNEPHRINE™.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks associated with giving you NEO-SYNEPHRINE™ against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor, pharmacist or nurse.

Keep this leaflet while you are being given NEO-SYNEPHRINE™. You may need to read it again.

What NEO-SYNEPHRINE™ is used for

NEO-SYNEPHRINE™ is used to help increase your blood pressure and slow down your heart, for example, during surgery or in states of shock. It does this by causing constriction (narrowing) of your blood vessels.

It belongs to a group of medicines called vasoconstrictors.

Ask your doctor if you have any questions about why NEO-SYNEPHRINE™ has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is available only with a doctor’s prescription.

Before you are given NEO-SYNEPHRINE™

When you must not be given it

You must not be given NEO-SYNEPHRINE™ if you are allergic to:

phenylephrine
sodium metabisulfite
any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.

You must not be given NEO-SYNEPHRINE™ if you have:

very high blood pressure.
a very fast heart beat (palpitations)

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have, or have had, any medical conditions, especially the following:

thyroid disease
slow heart rate
other heart disease
severe arteriosclerosis (a disease of the arteries)

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of being given NEO-SYNEPHRINE™ during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed. Your doctor will discuss the risks and benefits of being given NEO-SYNEPHRINE™ when breast-feeding.

If you have not told your doctor or nurse about any of the above, tell them before you are given NEO-SYNEPHRINE™.

Taking other medicines

Tell your doctor if you are taking other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and NEO-SYNEPHRINE™ may interfere with each other. These include:

certain medicines to treat depression (such as monoamine oxidase inhibitors and tricyclic antidepressants.)
halothane anaesthetics (a type of medicine used as an anaesthetic)
certain medicines used to stimulate labour in pregnant women.

These medicines may be affected by NEO-SYNEPHRINE™ or affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid, while using NEO-SYNEPHRINE™.

How NEO-SYNEPHRINE™ is given

How it is given

NEO-SYNEPHRINE™ can be given to you in three ways:

as a slow injection or infusion (drip) into a vein,
as a deep injection into a muscle or
as an injection just under the skin.

Sometimes it is diluted before use and given with fluids into a vein. Your doctor will determine how you will be given this medicine. It may depend on why you need to use this drug.

NEO-SYNEPHRINE™ must only be given by a doctor or nurse.

How much is given

Your doctor will decide what dose and how long you will receive NEO-SYNEPHRINE™. The dose will be different, depending on how your doctor gives you NEO-SYNEPHRINE™ and why you are being given it.

If you take too much (overdose)

As NEO-SYNEPHRINE™ is given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive too much.

Immediately tell your doctor or nurse if you think that you or anyone else has taken or been given too much NEO-SYNEPHRINE™.

If you are not in a hospital, telephone your doctor or the Poisons Information Centre telephone 13 11 26 in Australia for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much NEO-SYNEPHRINE™. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of overdose include sensation of fullness in the head, tingling in the hands or feet and irregular or fast heart beat.

While you are being given NEO-SYNEPHRINE™

Things you must do

Your doctor will monitor your blood pressure closely while you are being given NEO-SYNEPHRINE™.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given NEO-SYNEPHRINE™.

Tell any other doctors, dentists, and pharmacists who treat you that you are being given this medicine.

Things to be careful of

Be careful driving or operating machinery until you know how NEO-SYNEPHRINE™ affects you. Make sure you know how you react to NEO-SYNEPHRINE™ before you drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given or after receiving NEO-SYNEPHRINE™.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

headache
restlessness
excitability.

These are mild side effects.

Tell your doctor immediately if you notice any of the following:

fast or irregular heart beats (also called palpitations).
very slow pulse
sensation of fullness in the head,
tingling in the hands or feet

These are very serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor if you notice any other effects. Other side effects not listed above may also occur in some patients.

After receiving NEO-SYNEPHRINE™

Storage

NEO-SYNEPHRINE™ should only be given to you in hospital. It will be stored in a cool dry place away from the light, where the temperature stays below 25°C.

The ampoules should not be taken out of the box until just before they are to be used. This is because the medicine is affected by light.

This is not all the information available on NEO-SYNEPHRINE™. If you have any more questions or are not sure about anything, ask your doctor of pharmacist.

Product Description

What it looks like

NEO-SYNEPHRINE™ is a clear, colourless, aqueous solution in glass ampoules presented in amber clamshells each containing 5 ampoules. Five packs of 5 ampoules are shrink-wrapped to form packs of 25 ampoules.

Ingredients

Each 1 mL of NEO-SYNEPHRINE™ contains 10 mg of phenylephrine hydrochloride as the active ingredient.

It also contains:

sodium metabisulfite
sodium chloride
sodium citrate dihydrate
citric acid
water for injections

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Australian Sponsor:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Australian Registration Number:

10mg/mL ampoule AUST R 15472

This leaflet was prepared in June 2019.

Published by MIMS August 2019

BRAND INFORMATION

Brand name

Neo-Synephrine

Active ingredient

Phenylephrine hydrochloride

Schedule

1 Name of Medicine

Phenylephrine hydrochloride.

2 Qualitative and Quantitative Composition

Each ampoule contains 10 mg of phenylephrine hydrochloride per one mL (1% solution) as well as 3.5 mg of sodium chloride for isotonicity, 4 mg of sodium citrate dihydrate and 1 mg of citric acid as buffering agents, 2 mg of sodium metabisulfite as an antioxidant and water for injections. It is for use in one patient on one occasion only. Discard any residue.

Excipient with known effect.

Sodium metabisulfite.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Neo-Synephrine, brand of phenylephrine hydrochloride injection, is a vasoconstrictor and pressor drug chemically related to adrenaline and ephedrine. Phenylephrine hydrochloride is a synthetic sympathomimetic agent. It is a white or almost white, crystalline powder, freely soluble in water and alcohol.
Neo-Synephrine is a clear, colorless, aqueous solution, free from visible particulates, in sterile form for parenteral injection.
Solution for injection.
It has a pH of between 4.5 and 6.5.
Neo-Synephrine contains no antimicrobial preservative.

4 Clinical Particulars

4.1 Therapeutic Indications

Phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock, shock-like states, and drug induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anaesthesia, and as a vasoconstrictor in regional analgesia.

4.2 Dose and Method of Administration

Dosage.

Mild or moderate hypotension.

Subcutaneously or intramuscularly.

Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose should not exceed 5 mg.

Intravenously.

Usual dose, 0.2 mg. Range, from 0.1 mg to 0.5 mg. Initial dose should not exceed 0.5 mg.
Injections should not be repeated more often than every 10 to 15 minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5 mg intravenous dose should elevate the pressure for about 15 minutes.
Severe hypotension and shock (including medicine related hypotension). Blood volume depletion should always be corrected as fully as possible before any vasopressor is administered. When, as an emergency measure, intra-aortic pressures must be maintained to prevent cerebral or coronary artery ischemia, phenylephrine hydrochloride can be administered before and concurrently with blood volume replacement.
Hypotension and occasionally severe shock may result from overdosage or idiosyncrasy following the administration of certain drugs, especially adrenergic and ganglion blocking agents, rauwolfia and veratrum alkaloids, and phenothiazine tranquilizers. Patients who receive a phenothiazine derivative as preoperative medication are especially susceptible to these reactions. As an adjunct in the management of such episodes, phenylephrine hydrochloride is a suitable agent for restoring blood pressure.
Higher initial and maintenance doses of phenylephrine hydrochloride are required in patients with persistent or untreated severe hypotension or shock. Hypotension produced by powerful peripheral adrenergic blocking agents, chlorpromazine or phaeochromocytomectomy may also require more intensive therapy.

Continuous infusion.

Add 10 mg of the drug (1 mL of 1% solution) to 500 mL of dextrose 5% injection or sodium chloride 0.9% injection (providing a 1:50,000 solution equivalent to 20 microgram per mL). To raise the blood pressure rapidly, start the infusion at about 100 microgram to 180 microgram per minute (based on 20 drops per mL this would be 100 to 180 drops per minute). When the blood pressure is stabilized (at a low normal level for the individual), a maintenance rate of 40 microgram to 60 microgram per minute usually suffices (based on 20 drops per mL this would be 40 to 60 drops per minute). If the drop size of the infusion system varies from the 20 drops per mL, the dose must be adjusted accordingly.
If a prompt initial pressor response is not obtained, additional increments of phenylephrine hydrochloride (10 mg or more) are added to the infusion bottle. The rate of flow is then adjusted until the desired blood pressure level is obtained. (In some cases, a more potent vasopressor, such as norepinephrine bitartrate, may be required.) Hypertension should be avoided. The blood pressure should be checked frequently. Headache and/or bradycardia may indicate hypertension. Arrhythmias are rare.
Spinal anaesthesia (hypotension). Routine parenteral use of phenylephrine hydrochloride has been recommended for the prophylaxis and treatment of hypotension during spinal anaesthesia. It is best administered subcutaneously or intramuscularly three or four minutes before injection of the spinal anaesthetic. The total requirement for high anaesthetic levels is usually 3 mg and, for lower levels, 2 mg. For hypotensive emergencies during spinal anaesthesia, phenylephrine hydrochloride may be injected intravenously, using an initial dose of 0.2 mg. Any subsequent dose should not exceed the previous dose by more than 0.1 mg to 0.2 mg and no more than 0.5 mg should be administered in a single dose. To combat hypotension during spinal anaesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds (approx 11 kg) body weight, administered subcutaneously or intramuscularly, is recommended.
Prolongation of spinal anaesthesia. The addition of 2 mg to 5 mg of phenylephrine hydrochloride to the anaesthetic solution increases the duration of motor block by as much as approximately 50 percent without any increase in the incidence of complications such as nausea, vomiting, or blood pressure disturbances.
Vasoconstrictor for regional analgesia. Concentrations about ten times those employed when adrenaline is used as a vasoconstrictor are recommended. The optimum strength is 1:20,000 (equivalent to 50 microgram per mL) made by adding 1 mg of phenylephrine hydrochloride to every 20 mL of local anaesthetic solution. Some pressor responses can be expected when 2 mg or more are injected.
Paroxysmal supraventricular tachycardia. Rapid intravenous injection (within 20 to 30 seconds) is recommended; the initial dose should not exceed 0.5 mg, and subsequent doses, which are determined by the initial blood pressure response, should not exceed the preceding dose by more than 0.1 mg to 0.2 mg, and should never exceed 1 mg.

Paediatric use.

To combat hypotension during spinal anaesthesia in children, a dose of 0.5 mg to 1 mg per 25 pounds (approx. 11 kg) body weight, administered subcutaneously or intramuscularly, is recommended.

Method of administration.

Phenylephrine hydrochloride is generally injected subcutaneously, intramuscularly, slowly intravenously, or in dilute solution as a continuous intravenous infusion. In patients with paroxysmal supraventricular tachycardia and, if indicated, in case of emergency, phenylephrine hydrochloride is administered directly intravenously. The dose should be adjusted according to the pressor response. (See Table 1.)

For convenience in intermittent intravenous administration, dilute 1 mL of Neo-Synephrine 1% with 9 mL of sterile water for injection to yield 0.1% phenylephrine hydrochloride. (See Table 2.)

4.3 Contraindications

Phenylephrine hydrochloride should not be used in patients with severe hypertension, ventricular tachycardia, or in patients who are hypersensitive to it.

4.4 Special Warnings and Precautions for Use

If used in conjunction with oxytocic medicines, the pressor effect of sympathomimetic pressor amines is potentiated (see Section 4.6 Fertility, Pregnancy and Lactation). The obstetrician should be warned that some oxytocic drugs may cause severe persistent hypertension and that even a rupture of a cerebral blood vessel may occur during the postpartum period.
Contains sodium metabisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

General.

Phenylephrine hydrochloride should be employed only with extreme caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart block, myocardial disease, or severe arteriosclerosis.

Use in hepatic impairment.

No data available.

Use in renal impairment.

No data available.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Vasopressors, particularly metaraminol, may cause serious cardiac arrhythmias during halothane anaesthesia and therefore should be used only with great caution or not at all.

Oxytocic medicines.

The pressor effect of sympathomimetic pressor amines is potentiated (see Section 4.4 Special Warnings and Precautions for Use).

MAO inhibitors.

The pressor effect of sympathomimetic pressor amines is markedly potentiated in patients receiving monoamine oxidase inhibitors (MAOI). Therefore, when initiating pressor therapy in these patients, the initial dose should be small and used with due caution. The pressor response of adrenergic agents may also be potentiated by tricyclic antidepressants.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Animal reproduction studies have not been conducted with phenylephrine hydrochloride. It is also not known whether phenylephrine hydrochloride can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
It is not known whether this medicine is excreted in human milk. Because many are excreted in human milk, caution should be exercised when phenylephrine hydrochloride is administered to a nursing woman.

Use in labour and delivery.

If vasopressor drugs are either used to correct hypotension or added to the local anaesthetic solution, the obstetrician should be cautioned that some oxytocic drugs may cause severe persistent hypertension and that even a rupture of a cerebral blood vessel may occur during the postpartum period (see Section 4.4 Special Warnings and Precautions for Use).

4.7 Effects on Ability to Drive and Use Machines

No data available.

4.8 Adverse Effects (Undesirable Effects)

Headache, reflex bradycardia, excitability, restlessness and, rarely, arrhythmias.

Reported suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdosage may induce ventricular extrasystoles and short paroxysms of ventricular tachycardia, a sensation of fullness in the head and tingling of the extremities. Should an excessive elevation of blood pressure occur, it may be immediately relieved by an α-adrenergic blocking agent, e.g. phentolamine.
The oral LD₅₀ in the rat is 350 mg/kg, in the mouse 120 mg/kg.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Phenylephrine hydrochloride produces vasoconstriction that lasts longer than that of adrenaline and ephedrine. Responses are more sustained than those to adrenaline, lasting 20 minutes after intravenous and as long as 50 minutes after subcutaneous injection. Its action on the heart contrasts sharply with that of adrenaline and ephedrine, in that it slows the heart rate and increases the stroke output, producing no disturbance in the rhythm of the pulse.
Phenylephrine hydrochloride is a powerful postsynaptic alpha-receptor stimulant with little effect on the beta-receptors of the heart. In therapeutic doses, it produces little if any stimulation of either the spinal cord or cerebrum. A singular advantage of this drug is the fact that repeated injections produce comparable effects.
The predominant actions of phenylephrine hydrochloride are on the cardiovascular system. Parenteral administration causes a rise in systolic and diastolic pressures in man and other species. Accompanying the pressor response to phenylephrine hydrochloride is a marked reflex bradycardia that can be blocked by atropine; after atropine, large doses of phenylephrine hydrochloride increase the heart rate only slightly. In man, cardiac output is slightly decreased and peripheral resistance is considerably increased. Circulation time is slightly prolonged, and venous pressure is slightly increased; venous constriction is not marked. Most vascular beds are constricted; renal, splanchnic, cutaneous, and limb blood flows are reduced but coronary blood flow is increased. Pulmonary vessels are constricted and pulmonary arterial pressure is raised.
The drug is a powerful vasoconstrictor, with properties very similar to those of norepinephrine but almost completely lacking the chronotropic and inotropic actions on the heart. Cardiac irregularities are seen only very rarely even with large doses.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

No data available.

Metabolism.

No data available.

Excretion.

No data available.

5.3 Preclinical Safety Data

No long-term animal studies have been done to evaluate the potential of phenylephrine hydrochloride in these areas.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, sodium metabisulfite, sodium citrate dihydrate, citric acid, water for injections, nitrogen.

6.2 Incompatibilities

No data available.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Protect from light if removed from the packaging.

6.5 Nature and Contents of Container

Neo-Synephrine is presented in glass ampoules. The air in all ampoules has been displaced by nitrogen gas. The product is presented in amber clamshells each containing 5 ampoules. Five packs of five (5) ampoules are shrink-wrapped to form packs of 25 ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical name: (-)-m-hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride.
Molecular formula: C₉H₁₃NO₂.HCl.
Molecular weight: 203.7.

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Neo-synephrine 1% injection

Phenylephrine hydrochloride

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