REGITINE®

10mg/1mL Injection

Phentolamine Mesylate

What is in this leaflet

This leaflet answers some common questions about Regitine.

It does not contain all 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 of
you being given Regitine against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor or
pharmacist.

Keep this leaflet. You may need to read it again.

What Regitine is used for

Regitine is an injection that can be used during the surgical removal of a
phaechromocytoma, a rare tumour of the adrenal gland. Often during the surgery,
the tumour produces chemicals that cause a sudden rise in blood pressure.
Regitine can help to prevent or reverse this rise in blood pressure.

Regitine can also be used as a diagnostic test to find out if you have an
adrenal tumour, when other tests are not available.

Ask your doctor if you have any questions about why Regitine has been
prescribed for you.

Your doctor may have prescribed it for another purpose.

Regitine is only available with a doctor's prescription. It is not
habit-forming.

Before you are given Regitine

When you must not be given it

You must not be given Regitine if you have ever had an allergic reaction
to:

  • phentolamine, the active ingredient in Regitine
  • sodium metabisulphite, an ingredient in Regitine, or any other sulphites
    in medicines or foods
  • any of the other ingredients listed at the end of this leaflet

Some of the 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 Regitine if you have any of the following medical
conditions:

  • a heart attack now or at any time in the past
  • angina or other heart problems
  • kidney problems

If you are not sure whether any of the above conditions apply to you, your
doctor can advise you.

Before you are given it

Tell your doctor if you have any of the following medical conditions:

  • an inflammation of the stomach (gastritis) or a stomach ulcer
  • asthma

Your doctor may want to take special precautions if you have any of the above
conditions.

Tell your doctor if you are pregnant or breast-feeding.

There is not enough information to recommend the use of Regitine during
pregnancy or while breast-feeding. Your doctor can advise you about the risks
and benefits involved.

Tell your doctor if you are allergic to any other medicines, foods, dyes
or preservatives.


Your doctor will want to know if you are prone to allergies.

If you have not told your doctor about any of these things, tell him/her
before you are given Regitine.

Taking other medicines

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


Some medicines and Regitine may interfere with each other. These include:

  • other medicines used to treat high blood pressure
  • antipsychotic medicines used to treat some mental disorders
  • medicines to help you sleep or calm you down
  • pain relievers
  • dopamine, a medicine used to treat shock

These medicines may be affected by Regitine or they may affect how well it
works. Your doctor and pharmacist have more information.

How Regitine is given

Use during surgery: for an adult, 2 to 5 mg of Regitine is injected
intravenously (into a vein) and repeated if necessary, depending on the blood
pressure response. For a child, the lowest effective dose is given.

Use as a diagnostic test:

  • other medicines you may be taking, including medicines for treating high
    blood pressure, are usually ceased for at least 24 hours before the test is
    done. This allows your blood pressure to return to its usual level.
  • during the test you will lie down, preferably in a quiet, darkened room,
    until your blood pressure is constant
  • a single injection of 5 mg of Regitine will be given intravenously (into a
    vein) or intramuscularly (into a muscle). The dose for a child is 1 mg into a
    vein or 3 mg into a muscle.
  • you will remain lying flat while your blood pressure is taken every few
    minutes for at least 30 minutes.
  • a fall in blood pressure of more than a certain amount indicates that
    there is an adrenal tumour.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well
while you are being given Regitine.


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 the following list of possible side effects. You may
not experience any of them.

Tell your doctor or nurse as soon as possible if you notice any of the
following:

  • signs of allergy such as rash, itching or hives on the skin; swelling of
    the face, lips, tongue or other parts of the body; shortness of breath,
    wheezing or troubled breathing
  • feeling of fast or irregular heart beat (pounding, racing, skipping beats)
  • chest pain
  • dizziness or light headedness, especially when standing up suddenly
  • weakness
  • headache
  • nausea (feeling sick) or vomiting
  • diarrhoea
  • pain in the stomach or abdomen
  • flushing of the face
  • congested (blocked) nose

The above side effects may require medical attention.

If you are driving, operating machinery or doing jobs that require you to
be alert shortly after having the Regitine test, be careful until you know how
this medicine has affected you.


This medicine may cause dizziness or light headedness in some people.

Tell your doctor if you notice anything else that is making you feel
unwell.

Other side effects not listed above may happen in some people.

Product description

What it looks like

Regitine is available in a glass ampoule containing a colourless to faintly
yellowish clear liquid; in packs of 5 ampoules.

Ingredients

Each ampoule of Regitine contains 10 mg of phentolamine (as mesylate). The
ampoule also contains:

  • sodium metabisulphite
  • glucose-anhydrous
  • water for injections.

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