Fludrocortisone tablets

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking fludrocortisone it is important that your doctor or pharmacist knows:

• If you are pregnant or breast-feeding.
• If you have high blood pressure.
• If you have had a heart attack or have any other heart problems.
• If you have liver or kidney problems.
• If you (or anyone in your family) have diabetes or increased eye pressure (glaucoma).
• If you have weakened bones (osteoporosis).
• If you have an underactive thyroid.
• If you have ever had a mental health problem - for example, depression.
• If you have epilepsy.
• If you have had a stomach ulcer or an inflammatory bowel disorder.
• If you have any kind of infection, or if you have ever had tuberculosis (TB).
• If you (or anyone you are in close contact with) have recently had chickenpox, measles or shingles.
• If you have ever had a blood clot in an artery or vein.
• If you have a condition known as myasthenia gravis, which causes muscle weakness, or if you have ever developed muscle pain after taking a steroid medicine.
• If you are taking other medicines, including those available to buy without a prescription, as well as herbal and complementary medicines.
• If you have ever had an allergic reaction to a medicine.

• Before starting this treatment, read the manufacturer's printed information leaflet from inside the pack and be careful to follow any printed instructions you have also been given. The leaflet will give you more information about fludrocortisone and a full list of side-effects which you may experience from taking it.
• Your doctor or pharmacist will tell you how many tablets to take. This information will also be on the label of the packet of tablets to remind you. It is important that you take fludrocortisone exactly as your doctor has told you. It is usual to take fludrocortisone once daily, just after breakfast.
• Try to take your dose at the same time each day, as this will help you to remember to take it. If you do forget to take a dose, take it as soon as you remember. If you do not remember until the following day, skip the missed dose. Do not take two doses together to make up for a forgotten dose.
• Continue to take fludrocortisone tablets regularly each day - it is vital for your well-being. Fludrocortisone replacement treatment is almost always lifelong.

Fludrocortisone acetate tablets 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.

Fludrocortisone acetate tablets USP are available as:

0.1 mg: Yellow, oval, flat-faced, beveled-edge tablet, scored on one side. Debossed with a “stylized b” on one side and 997|1/10 on the scored side.

Available in bottles of 100 (NDC 0555-0997-02)

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Avoid Excessive Heat

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

TEVA PHARMACEUTICALS USA, INC.. North Wales, PA 19454. Revised: May 2016

The physician should advise the patient to report any medical history of heart disease, high blood pressure, or kidney or liver disease and to report current use of any medicines to determine if these medicines might interact adversely with fludrocortisone acetate (see DRUG INTERACTIONS).

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice.

The patient's understanding of his steroid-dependent status and increased dosage requirement under widely variable conditions of stress is vital. Advise the patient to carry medical identification indicating his dependence on steroid medication and, if necessary, instruct him to carry an adequate supply of medication for use in emergencies.

Stress to the patient the importance of regular follow-up visits to check his progress and the need to promptly notify the physician of dizziness, severe or continuing headaches, swelling of feet or lower legs, or unusual weight gain.

Advise the patient to use the medicine only as directed, to take a missed dose as soon as possible, unless it is almost time for the next dose, and not to double the next dose.

Inform the patient to keep this medication and all drugs out of the reach of children.

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, hirsutism, acneiform eruptions, and hives; reactions to skin tests may be suppressed.

Neurological

Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances.

Endocrine

Menstrual irregularities, development of the cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic

Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic

Hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism.

Allergic Reactions

Allergic skin rash, maculopapular rash, and urticaria.

Other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions.

Read the entire FDA prescribing information for Fludrocortisone (Fludrocortisone)