Solu-Cortef 100mg powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone sodium succinate

Available from:

Pfizer Ltd

ATC code:

H02AB09

INN (International Name):

Hydrocortisone sodium succinate

Dosage:

100mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200; GTIN: 5012882006051

Patient Information leaflet

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLU-CORTEF
® 100 MG
hydrocortisone sodium succinate
PFIZER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 please ask your doctor, nurse or
pharmacist.

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 SOLU-CORTEF IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SOLU-CORTEF
3.
HOW SOLU-CORTEF IS GIVEN TO YOU
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SOLU-CORTEF
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SOLU-CORTEF IS AND WHAT IT IS USED FOR
Solu-Cortef contains hydrocortisone sodium succinate.
Hydrocortisone belongs to a group of medicines called corticosteroids
or steroids.
Corticosteroids are produced naturally in your body and are important
for many body
functions.
Boosting your body with extra corticosteroid such as Solu-Cortef can
help when injected by a
doctor or nurse if your body cannot produce enough corticosteroid due
to problems with your
ADRENAL GLANDS (e.g. adrenal insufficiency).
Corticosteroids can also help treat SHOCK following surgery, injuries,
hypersensitivity
(ANAPHYLACTIC) reactions or other stressful conditions. These include
inflammatory or allergic
conditions affecting the:

BOWEL and GUT e.g. Crohn’s disease (inflammation of the gut) or
ulcerative colitis
(inflammation of the lower bowel)

LUNGS e.g. bronchial asthma or inflammation caused by breathing in
(aspirating)
vomit or stomach contents

SKIN e.g. Stevens-Johnson syndrome (an autoimmune disorder in which an
immune
system causes the skin to blister and peel), or systemic lupus
erythematosus (lupus)
Solu-Cortef may be prescribed to treat conditions other than those
listed above, such as
adrenal insufficiency and other medical

Summary of Product characteristics

OBJECT 1
SOLU-CORTEF
Summary of Product Characteristics Updated 08-May-2018 | Pfizer
Limited
1. Name of the medicinal product
Solu-Cortef 100 mg
2. Qualitative and quantitative composition
Each vial contains hydrocortisone sodium succinate 133.7 mg equivalent
to hydrocortisone 100 mg.
Excipient with known effect:
Each vial contains 10.14 mg of sodium
For the full list of excipients, see section 6.1
3. Pharmaceutical form
White, freeze dried powder for parenteral use.
4. Clinical particulars
4.1 Therapeutic indications
Anti-inflammatory agent.
Solu-Cortef is indicated for any condition in which rapid and intense
corticosteroid effect is required such
as:
1. Endocrine disorders
Primary or secondary adrenocortical insufficiency
2. Collagen diseases
Systemic lupus erythematosus
3. Dermatological diseases
Severe erythema multiforme (Stevens-Johnson syndrome)
4. Allergic states
Bronchial asthma, anaphylactic reactions
5. Gastro-intestinal diseases
Ulcerative colitis, Crohn's disease
6. Respiratory diseases
Aspiration of gastric contents
7. Medical emergencies
Solu-Cortef is indicated in the treatment of shock secondary to
adrenocortical insufficiency or shock
unresponsive to conventional therapy when adrenocortical insufficiency
may be present.
4.2 Posology and method of administration
Solu-Cortef may be administered by intravenous injection, by
intravenous infusion, or by intramuscular
injection, the preferred method for initial emergency use being
intravenous injection. Following the initial
emergency period, consideration should be given to employing a
longer-acting injectable preparation or
an oral preparation.
Dosage usually ranges from 100 mg to 500 mg depending on the severity
of the condition, administered
by intravenous injection over a period of one to ten minutes. This
dose may be repeated at intervals of 2,
4 or 6 hours as indicated by the patient's response and clinical
condition.
In general high-dose corticosteroid therapy should be continued only
until the patient's condition has
stabilised - usually not