AURO-HYDROCORTISONE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

HYDROCORTISONE

Pieejams no:

AURO PHARMA INC

ATĶ kods:

H02AB09

SNN (starptautisko nepatentēto nosaukumu):

HYDROCORTISONE

Deva:

20MG

Zāļu forma:

TABLET

Kompozīcija:

HYDROCORTISONE 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

Active ingredient group (AIG) number: 0106344013; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2022-01-17

Produkta apraksts

Page 1 of 26
PRESCRIBING INFORMATION
PR
AURO-HYDROCORTISONE
Hydrocortisone Tablets USP
10 mg, 20 mg
Corticosteroid
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
Canada
Date of Preparation:
January 17, 2022
Submission
Control No.: 252124
Page 2 of 26
PRESCRIBING INFORMATION
PR
AURO-HYDROCORTISONE
Hydrocortisone Tablets USP
10 mg, 20 mg
PHARMACOLOGICAL CLASSIFICATION
Corticosteroid
INDICATIONS AND CLINICAL USE
ENDOCRINE DISORDERS: Primary or secondary adrenocortical insufficiency
(hydrocortisone or
cortisone is the first choice; synthetic analogs may be used in
conjunction
with
mineralocorticoids where applicable; in infancy, mineralocorticoid
supplementation is of
particular importance); congenital adrenal hyperplasia; nonsuppurative
thyroiditis;
hypercalcemia associated with cancer.
RHEUMATIC DISORDERS: As adjunctive therapy for short-term
administration
(to tide the patient
over an acute episode or exacerbation) in: psoriatic arthritis,
rheumatoid arthritis, including
juvenile rheumatoid arthritis (selected cases may require low dose
maintenance therapy),
ankylosing
spondylitis,
acute and subacute bursitis, acute non-specific tenosynovitis, acute
gouty
arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis,
epicondylitis.
COLLAGEN DISEASES: During an exacerbation or as maintenance therapy in
selected cases of:
systemic lupus erythematosus, acute rheumatic carditis, systemic
dermatomyositis
(polymyositis).
DERMATOLOGIC DISEASES: pemphigus, bullous dermatitis herpetiformis,
severe erythema
multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis
fungoides, severe
psoriasis and severe seborrheic dermatitis.
ALLERGIC STATES: Control of severe or incapacitating allergic
conditions
intractable to adequate
trials of conventional treatment: seasonal or perennial allergic
rhinitis,
bronchial asthma, contact
dermatitis, atopic dermatitis, serum sickness and drug
hypersensitivity
reactions.
OPHTHALMIC DISEASES: Severe acute and chronic allergic and
inflamma