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Florinef

Generic name: fludrocortisone acetate
Brand Name: Florinef

Indications

Florinef is 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 and Administration

Florinef is available for oral administration as 0.1 mg/tablet.

Normal Dosage:

Addison's Disease: In Addison's disease, the combination of Florinef Acetate (Fludrocortisone Acetate Tablets USP) 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 Florinef Acetate 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. Florinef Acetate is 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 Florinef Acetate daily.

Overdose: Symptoms of an overdose include swelling or fluid retention, high blood pressure (headache, blurred vision), weight gain, and low levels of potassium in the blood.
Drug Description
Florinef Acetate (Fludrocortisone Acetate Tablets USP) contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11β,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate; its graphic formula is:


Florinef Acetate (Fludrocortisone Acetate) structural formula illustration

Side effects
The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Sodium and water retention.
  • Swelling due to fluid retention (oedema).
  • High blood pressure (hypertension).
  • Headache.
  • Low blood potassium level (hypokalaemia).
  • Muscle weakness.
  • Fatigue.
  • Increased susceptibility to infection.
  • Impaired wound healing.
  • Increased sweating.
  • Increased hair growth (hirsutism).
  • Thinning of skin and stretch marks.
  • Disturbances of the gut such as indigestion (dyspepsia), distention of the abdomen and ulceration (peptic ulcer).
  • Decreased bone density and increased risk of fractures of the bones.
  • Difficulty in sleeping (insomnia).
  • Depression.
  • Weight gain.
  • Raised blood sugar level.
  • Changes to your menstrual cycle.
  • Partial loss of vision due to opacity in the lens of the eye (cataracts).
  • Raised pressure in the eye (glaucoma).
  • Increased pressure in the skull (intracranial pressure).

Precautions

Before taking this drug inform your doctor if you are using medicines for the following conditions:

  • if you are taking any prescription or nonprescription medicine, or dietary supplement
  • if you have allergies to medicines, food, or other substances
  • if you are scheduled for a vaccination with a live virus vaccine (eg, smallpox)
  • if you have a history of an underactive thyroid, liver or kidney problems, heart problems or heart attack, bleeding problems, diabetes, high blood pressure, inflammation of the esophagus, stomach problems (eg, ulcers),and depression.
  • if you have measles, chickenpox, herpes infection of the eye, or any other type of bacterial, fungal, parasitic, or viral infection
  • if you have recently had tuberculosis (TB) or have had a positive skin test for TB

Before taking this drug consult your doctor if:

  • you are allergic to any ingredient in Florinef
  • you have a systemic fungal infection
  • you are scheduled to have a smallpox vaccination
  • Contact your doctor or health care provider right away if any of these apply to you.

Drug Interactions

  • Anabolic steroids (eg, oxymetholone) or aprepitant because they may increase the risk of Florinef 's side effects
  • Barbiturates (eg, phenobarbital), carbamazepine, estrogens, hydantoins (eg, phenytoin), or rifampin because they may reduce the effectiveness of the drug.
  • Amphotericin B, azole antifungals (eg, ketoconazole), clarithromycin, digoxin, loop diuretics (eg, furosemide), steroidal contraceptives (eg, desogestrel), thiazide diuretics (eg, hydrochlorothiazide), or troleandomycin because side effects, such as weakness, confusion, muscle aches, irregular heartbeat, joint pain, or low blood sugar.
 

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