Fludrocortisone Acetate description, usages, side effects, indications, overdosage, supplying and lots more!

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Fludrocortisone Acetate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

FLUDROCORTISONE ACETATE DESCRIPTION


Fludrocortisone Acetate




CLINICAL PHARMACOLOGY






INDICATIONS & USAGE



FLUDROCORTISONE ACETATE CONTRAINDICATIONS



WARNINGS

BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION, THE USE OF FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER THAN THOSE INDICATED HEREIN IS NOT ADVISED.







PRECAUTIONS

General:









INFORMATION FOR PATIENTS








LABORATORY TESTS



DRUG INTERACTIONS












DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Pregnancy Category C:


Pregnancy: Nonteratogenic Effects:



NURSING MOTHERS



PEDIATRIC USE




FLUDROCORTISONE ACETATE ADVERSE REACTIONS




Musculoskeletal:


Gastrointestinal:


Dermatologic:


Neurological:


Endocrine:


Ophthalmic:


Metabolic:


Allergic Reactions:



OVERDOSAGE



DOSAGE & ADMINISTRATION



Addison's Disease:



Salt-Losing Adrenogenital Syndrome:


HOW SUPPLIED






STORAGE AND HANDLING





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Fludrocortisone Acetate

Fludrocortisone Acetate

Fludrocortisone Acetate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-556(NDC:0555-0997)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FLUDROCORTISONE ACETATE FLUDROCORTISONE 0.1 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
STARCH, CORN
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
D&C YELLOW NO. 10
ALUMINUM OXIDE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc

Product Characteristics

Color Size Imprint Code Shape
yellow 9 mm b;997;1;10 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-556-20 100 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040425 2011-10-03


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Be sure to consult your doctor before taking any medication!
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