Drugplain

Fludrocortisone Acetate .1 mg/1

FLUDROCORTISONE ACETATE · TABLET · NCS HealthCare of KY, LLC dba Vangard Labs

1 Recall on Record
Plain English

Fludrocortisone acetate is a corticosteroid medication taken by mouth that helps your body retain salt and water, and is used to treat conditions involving low blood pressure or inadequate adrenal hormone production. Your doctor will determine the right dose for your condition.

Key Facts

Brand Name
Fludrocortisone Acetate
Generic Name
FLUDROCORTISONE ACETATE
NDC Code (Product)
0615-6562
Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Strength
.1 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040431
Marketing Start
03/18/2002

Recall History

1 Recall on Record
Class II06/28/2024

Teva Pharmaceuticals USA, Inc

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue150 reports
fall147 reports
dizziness139 reports
nausea131 reports
death129 reports
diarrhoea126 reports
headache109 reports
off label use105 reports
pneumonia100 reports
hypotension96 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Fludrocortisone acetate tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

Dosage & Administration

DOSAGE AND ADMINISTRATION Dosage depends on the severity of the disease and the response of the patient. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remission or exacerbations of the disease and stress (surgery, infection, trauma) (see WARNINGS and PRECAUTIONS, General ). Addison's Disease In Addison's disease, the combination of fludrocortisone acetate tablets with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects. The usual dose is 0.1 mg of fludrocortisone acetate tablets daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Fludrocortisone acetate tablets are preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses). Salt-Losing Adrenogenital Syndrome The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of fludrocor…

Warnings

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. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. However, since fludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, edema or weight gain. Periodic ch…

Contraindications

CONTRAINDICATIONS Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.

Drug Interactions

Drug Interactions When administered concurrently, the following drugs may interact with adrenal corticosteroids. Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide) – enhanced hypokalemia. Check serum potassium levels at frequent intervals; use potassium supplements if necessary (see WARNINGS ). Digitalis glycosides – enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Monitor serum potassium levels; use potassium supplements if necessary. Oral anticoagulants – decreased prothrombin time response. Monitor prothrombin levels and adjust anticoagulant dosage accordingly. Antidiabetic drugs (oral agents and insulin) – diminished antidiabetic effect. Monitor for symptoms of hyperglycemia; adjust dosage of antidiabetic drug upward if necessary. Aspirin – increased ulcerogenic effect; decreased pharmacologic effect of aspirin. Rarely salicylate toxicity may occur in patients who discontinue steroids after concurrent high-dose aspirin therapy. Monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered (see PRECAU…

Adverse Reactions

ADVERSE REACTIONS Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis. When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem; however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid. Musculoskeletal – muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures. Gastrointestinal – peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis. Dermatologic – impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hi…

Frequently Asked Questions

What is Fludrocortisone Acetate used for?

Fludrocortisone acetate is a corticosteroid medication taken by mouth that helps your body retain salt and water, and is used to treat conditions involving low blood pressure or inadequate adrenal hormone production. Your doctor will determine the right dose for your condition.

Is Fludrocortisone Acetate a controlled substance?

Fludrocortisone Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Fludrocortisone Acetate?

The generic name for Fludrocortisone Acetate is FLUDROCORTISONE ACETATE. There are 3 other brand versions of FLUDROCORTISONE ACETATE.

What is the NDC code for Fludrocortisone Acetate .1 mg/1?

The NDC (National Drug Code) for Fludrocortisone Acetate .1 mg/1 is 0615-6562, listed by NCS HealthCare of KY, LLC dba Vangard Labs.

Product NDC

0615-6562

Package NDC

0615-6562-39

Other Fludrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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