ORAPRED ODT- prednisolone sodium phosphate tablet, orally disintegrating

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

PREDNISOLONE SODIUM PHOSPHATE (UNII: IV021NXA9J) (PREDNISOLONE - UNII:9PHQ9Y1OLM)

Saatavilla:

Concordia Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

PREDNISOLONE SODIUM PHOSPHATE

Koostumus:

PREDNISOLONE 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: - Atopic dermatitis - Drug hypersensitivity reactions - Seasonal or perennial allergic rhinitis - Serum sickness - Bullous dermatitis herpetiformis - Contact dermatitis - Exfoliative erythroderma - Mycosis fungoides - Pemphigus - Severe erythema multiforme (Stevens-Johnson syndrome) - Congenital adrenal hyperplasia - Hypercalcemia of malignancy - Nonsuppurative thyroiditis - Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable. During acute episodes in: - Crohn's Disease - Ulcerative colitis - Acquired (autoimmune) hemolytic anemia - Diamond-Blackfan anemia - Idiopathic thrombocytopenic

Tuoteyhteenveto:

Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 13.4 mg prednisolone sodium phosphate (equivalent to 10 mg prednisolone base) is a white, flat faced, beveled tablet, debossed with ORA on one side and 10 on the other. Supplied as: Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) 20.2 mg prednisolone sodium phosphate (equivalent to 15 mg prednisolone base) is a white, flat faced, beveled tablet, debossed with ORA on one side and 15 on the other. Supplied as: Orapred ODT: (prednisolone sodium phosphate orally disintegrating tablets) 40.3 mg prednisolone sodium phosphate (equivalent to 30 mg prednisolone base) is a white, flat faced, beveled tablet, debossed with ORA on one side and 30 on the other. Supplied as: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled Room Temperature]. Protect from moisture. Do not break or use partial Orapred ODT tablets. Keep out of the reach of children.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

ORAPRED ODT- PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY
DISINTEGRATING
CONCORDIA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORAPRED ODT SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORAPRED ODT .
ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE ORALLY DISINTEGRATING
TABLETS)
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
Orapred ODT is a corticosteroid indicated
as an anti-inflammatory or immunosuppressive agent for certain
allergic, dermatologic,
gastrointestinal, hematologic, ophthalmologic, nervous system, renal,
respiratory, rheumatologic,
specific infectious diseases or conditions and organ transplantation
(1)
for the treatment of certain endocrine conditions (1)
for palliation of certain neoplastic conditions (1)
DOSAGE AND ADMINISTRATION
Individualize dosing based on disease severity and patient response:
Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of
prednisolone sodium
phosphate) (2)
Maintenance Dose: Use lowest dosage that will maintain an adequate
clinical response (2)
Discontinuation: Withdraw gradually if discontinuing long-term or
high-dose therapy (2)
Take with food to avoid gastrointestinal (GI) irritation (2)
DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE
FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING
ORAPRED ODT. (2)
DOSAGE FORMS AND STRENGTHS
Orally Disintegrating Tablets:
10 mg Tablets (as 13.4 mg prednisolone sodium phosphate) (3)
15 mg Tablets (as 20.2 mg prednisolone sodium phosphate) (3)
30 mg Tablets (as 40.3 mg prednisolone sodium phosphate) (3)
CONTRAINDICATIONS
Hypersensitivity to prednisolone or any components of this product.
(4)
WARNINGS AND PRECAUTIONS
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's
syndrome and hyperglycemia:
Monitor patients for these conditions with chronic use. Taper doses
gradually for withdrawal after
chronic use. (5.1)
Infections: Increased susceptibility to new infect