SOLU-CORTEF FOR INJECTION 100 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HYDROCORTISONE SODIUM SUCCINATE

Available from:

PFIZER PRIVATE LIMITED

ATC code:

H02AB09

Dosage:

100 mg/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

HYDROCORTISONE SODIUM SUCCINATE 100 mg/vial

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

PFIZER MANUFACTURING BELGIUM NV

Authorization status:

ACTIVE

Authorization date:

1990-06-26

Patient Information leaflet

SOLU-CORTEF
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page
1
of
17
1. NAME OF THE MEDICINAL PRODUCT
SOLU-CORTEF™ For Injection 100 mg/vial.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone sodium succinate equivalent to hydrocortisone 100 mg.
3. PHARMACEUTICAL FORM
White, lyophilized powder for solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the drug of
choice; synthetic analogues may be used in conjunction with
mineralocorticoids where
applicable; in infancy mineralocorticoid supplementation is of
particular importance)
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the
drug of choice;
mineralocorticoid supplementation may be necessary, particularly when
synthetic analogues
are used)
Pre-operatively, and in the event of serious trauma or illness, in
patients with known adrenal
insufficiency or when adrenocortical reserve is doubtful
Shock unresponsive to conventional therapy if adrenocortical
insufficiency exists or is
suspected
Congenital adrenal hyperplasia
Non-suppurative thyroiditis
Hypercalcemia associated with cancer
2. NON-ENDOCRINE DISORDERS
Rheumatic Disorders - As adjunctive therapy for short-term
administration (to tide the patient
over an acute episode or exacerbation) in:
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-
dose maintenance therapy)
Epicondylitis
Acute non-specific tenosynovitis
Acute gouty arthritis
Psoriatic arthritis
Ankylosing spondylitis
Acute and subacute bursitis
Page
2
of
17
Collagen Diseases - During an exacerbation or as maintenance therapy
in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
Dermatologic Diseases
Pemphigus
Bullous dermatiti

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
SOLU-CORTEF™ For Injection 100 mg/vial.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone sodium succinate equivalent to hydrocortisone 100 mg.
3. PHARMACEUTICAL FORM
White, lyophilized powder for solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. ENDOCRINE DISORDERS
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the drug of
choice; synthetic analogues may be used in conjunction with
mineralocorticoids where
applicable; in infancy mineralocorticoid supplementation is of
particular importance)
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the
drug of choice;
mineralocorticoid supplementation may be necessary, particularly when
synthetic analogues
are used)
Pre-operatively, and in the event of serious trauma or illness, in
patients with known adrenal
insufficiency or when adrenocortical reserve is doubtful
Shock unresponsive to conventional therapy if adrenocortical
insufficiency exists or is
suspected
Congenital adrenal hyperplasia
Non-suppurative thyroiditis
Hypercalcemia associated with cancer
2. NON-ENDOCRINE DISORDERS
Rheumatic Disorders - As adjunctive therapy for short-term
administration (to tide the patient
over an acute episode or exacerbation) in:
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis
(selected cases may require low-
dose maintenance therapy)
Epicondylitis
Acute non-specific tenosynovitis
Acute gouty arthritis
Psoriatic arthritis
Ankylosing spondylitis
Acute and subacute bursitis
Collagen Diseases - During an exacerbation or as maintenance therapy
in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
Allergic States - Control of severe