Synacthen 250 micrograms/ml solution for injection

Main information

  • Trade name:
  • Synacthen 250 micrograms/ml solution for injection
  • Dosage:
  • 250 mcg/ml microgram(s)/millilitre
  • Pharmaceutical form:
  • Solution for injection
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Synacthen 250 micrograms/ml solution for injection
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • ACTH; tetracosactide

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA2206/002/001
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 21-02-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PACKAGE LEAFLET: INFORMATION FOR THE USER

Synacthen 250 micrograms/ml, solution for injection

(Tetracosactide)

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 or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if

their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist . See section 4.

What is in this leaflet

What Synacthen 250 micrograms/ml is and what it is used for

What you need to know before you use Synacthen 250 micrograms/ml

How to use Synacthen 250 micrograms/ml

Possible side effects

How to store Synacthen 250 micrograms/ml

Contents of the pack and other information

1.

WHAT SYNACTHEN 250 MICROGRAMS/ML IS AND WHAT IT IS USED FOR

Synacthen ampoules contains tetracosactide. This is a substance which stimulates the adrenal glands

to produce certain hormones.

Synacthen (tetracosactide) is used as a test to find out the cause of certain hormonal problems e.g.,

low levels of the hormone cortisol as in Addison’s disease. Two blood samples will be taken, one

before the injection of Synacthen and the other 30 minutes after injection. These blood samples will

show whether your adrenal glands are functioning as well as they should by measuring the hormone

levels.

2

WHAT YOU NEED TO KNOW BEFORE YOU USE SYNACTHEN 250

MICROGRAMS/ML

Do not take Synacthen:

if you have:

Known

hypersensitivity

(are

allergic)

tetracosactide

and/or

ACTH

(Adrenocorticotropic

hormone) or any of the other ingredients of this medicine (listed in section 6).

Acute psychosis (loss of sense of reality).

An Infectious disease.

Peptic ulcer (sore in mucosa of the stomach and/or intestinal tract).

Refractory heart failure (severe cardiac condition).

Cushing’s syndrome (hormonal disorder).

Primary adrenocortical insufficiency (adrenal gland does not produce enough steroid hormone).

Adrenogenital syndrome (overproduction of a hormone resulting in increased testosterone given

to the baby).

Allergic disorders (e.g. asthma).

Pregnancy and breast-feeding.

Warnings and precautions

Talk to your doctor or nurse before using Synacthen if you have previously experienced adverse

reactions to ACTH, Synacthen or other drugs.

Take special care with Synacthen 250 micrograms/ml

Synacthen may interact with routine drug testing in athletes.

Other medicines and Synacthen

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,

including medicines obtained without a prescription.

Synacthen brings about an increase in adrenocortical production of glucocorticoids (a steroid

hormone) and mineralocorticoids, drug interactions of the type seen with these corticosteroids

(steroid hormone) may occur.

Patients receiving medication for diabetes mellitus or for moderate to severe hypertension (high

blood pressure) must have their dosage adjusted if treatment with Synacthen is started.

Synacthen 250 micrograms/ml with food and drink

No information available.

Pregnancy and breast-feeding

Pregnancy

Synacthen must not be used during pregnancy.

Lactation

Synacthen must not be used while breast-feeding.

Driving and using machines

Since Synacthen may have an effect on the central nervous system, patients should be very cautious

when driving vehicles or using machines.

Synacthen 250 micrograms/ml contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially “sodium-

free”.

3

HOW TO USE SYNACTHEN 250 MICROGRAMS/ML

Always use Synacthen 250 micrograms/ml exactly as your doctor has told you. You should check

with your doctor or pharmacist if you are not sure.

Adults

This preparation of Synacthen is intended for administration for diagnostic purposes only. It may be

administered as a single dose into a vein or muscle.

The 30-minute Synacthen diagnostic test is based on measurement of the concentration of cortisol in

the plasma (the liquid in your blood excluding the blood cells) immediately before and exactly 30

minutes after a dose of 1 ml (250 micrograms) Synacthen has been administered into a vein or

muscle. Adrenocortical function can be regarded as normal if the concentration of cortisol in the

plasma after dose injection (administration with Synacthen) amounts to at least 200 nmol/litre (70

micrograms/litre).

Use in the elderly

There is no evidence to suggest that dosage should be different in the elderly.

Use in children

The dosage will be administered into a vein. The concentration is decided by the physician and will be

around 1 ml (250 micrograms) per 1.73 m

body surface area. For children aged 5-7 years,

approximately half the adult dose will be adequate.

If you use more Synacthen 250 micrograms/ml than you should

Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic

purposes.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Synacthen can cause side effects, although not everybody gets them.

Undesirable effects related to Synacthen

Hypersensitivity reactions:

Synacthencan provoke hypersensitivity reactions, which tend to be more

severe (anaphylactic shock) in patients susceptible to allergies (especially asthma). Hypersensitivity

reactions may include skin reactions at the injection site, dizziness, nausea, vomiting, hives, itching,

flushing, general feeling of being unwell, , shortness of breath and/or a rapid swelling of the skin and

mucous membranes (angioneurotic oedema or Quincke's oedema). If you experiencing any of these

reactions you should tell a doctor

immediately

Infections and infestations

Increased susceptibility to infection, abscess

Blood and the lymphatic system

disorders

An increase in white blood cells (leukocytosis)

Endocrine disorders

Irregular menstruation, Cushing’s syndrome (a hormone

disorder caused by high levels of cortisol in the blood) and a

state when the pituitary does not produces enough hormone

which may lead to a secondary adrenocortical insufficiency

(when the adrenal glands are not working properly).

Particularly in times of stress, e.g. after trauma, surgery or

illness there may be a decreased carbohydrate tolerance,

high blood sugars, manifestations of latent (dormant)

diabetes mellitus andexcessive hair growth.

Metabolism and nutrition disorders

Increased appetite, low blood potassium, calcium

deficiency, retention of sodium and fluid in the body

Psychiatric disorders

Mental disorder

Nervous system disorders

Headache, vertigo, convulsions

Optic disc swelling as a result of an increased preassure

within the skull, usually after treatment

Eye disorders

Cataracts, increased pressure within the eyeball, glaucoma,

bulging of the eye ball (exophthalmose)

Cardiac disorders

Congestive heart failure (heart failure in which the heart is

unable to adequately pump out the blood), increased blood

pressure

Thickening of the heart muscle may occur in single cases in

infants and small children treated over a prolonged period

with high doses. This symptom will return to normal after

end of treatment.

Vascular disorders

Blood clot (thromboembolism), inflammation of the blood

vessel walls (necrotising vasculitis)

Gastrointestinal disorders

Peptic ulcer with possible perforation and bleeding,

inflammation of the pancrease, abdominal distension,

inflammation of the lining of the gullet

Skin and subcutaneous tissue

disorders

Skin atrophy (cells of the skin wither away), red spots under

the skin and brusing , erythema, increased perspiration,

acne and skin hyper pigmentation

Musculoskeletal, connective tissue and

bone disorders

Osteoporosis, muscular weakness, loss of muscle mass,

compression fractures of the bones in the spine, bone death

in the femoral and humeral heads (specific bones in the

body), pathological fracture of long bones, tendon rupture

General disorders and administration

site conditions

Hypersensitivity reactions

increased

weight, impaired

healing, retarded growth

Investigations

Negative nitrogen balance due to protein degradation,

suppression of skin test reactions

Isolated cases of adrenal haemorrhage (an internal bleeding from part of the suprarenal glands) have

been reported with Synacthen.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor or pharmacist.

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 HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine

5

HOW TO STORE SYNACTHEN 250 MICROGRAMS/ML

Your medicine should be stored in the fridge (2–8°C). Keep ampoules in the outer carton to protect

from light. Any solution remaining after injection should be discarded.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the label and box.

The product should be used immediately after opening.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Synacthen 250 micrograms/ml contains

The active substance is 250 micrograms of tetracosactide. Each ampoule contains tetracosactide

250 micrograms, as tetracosactide acetate.

The ampoules also contain glacial acetic acid, sodium acetate, sodium chloride and water for

injections.

What Synacthen 250 micrograms/ml looks like and contents of the pack

The product is a clear, colourless aqueous solution in a type 1 (Ph. Eur.) clear glass 1 ml ampoule.

The product is presented as a pack of 5 ampoules of 1 ml.

Marketing Authorisation Holder and Manufacturer

Manufactured by:

Alfasigma S.p.A.

Via Pontina Km 30.400

00071- Pomezia (Rome)

Italy

Doppel Farmaceutici srl

Via Volturno, 48

20089 Rozzano (Milan)

Italy

Product licence/authorisation holder:

Alfasigma S.p.A. –

Via Ragazzi del ’99, n.5,

40133 Bologna (BO)

Italy

Local representative:

CD Pharma S.r.l.

Viale Cassiodoro, 16

20145 Milan

Italy

Tel. +39 02-43980539

info@cdpharmagroup.one

This leaflet was last revised 03/2019