Index
Tablets of this drug are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease.
They are also indicated for the treatment of adrenogenital syndrome with salt loss.
Active ingredient: fludrocortisone acetate.
Dosage
Newborn and during the first year: from 50 to 200 micrograms per day, and from 200 to 300 micrograms per day.
Adults and children over two years: 50 to 200 micrograms per day.
The fludrocortisone dose should be adjusted according to blood pressure, serum potassium, serum sodium, and plasma renin activity, which should be within the upper limit of normal.
Dosage should be reassessed periodically during treatment.
Administration mode
Orally
In children under six years of age, the tablets will be crushed and dissolved, preferably in fruit juice or room temperature water, then immediately mixed and administered.
How does it work?
Fludrocortisone has significant mineralocorticoid activity and glucocorticoid activity, superior to cortisol.
However, the glucocorticoid effects of fludrocortisone are not sufficient at therapeutic doses to be administered alone in adrenocortical insufficiency. A glucocorticoid must always be associated.
At therapeutic doses, fludrocortisone causes sodium retention and increases urinary excretion of potassium and hydrogen ions, causing an increase in blood pressure and weight gain.
At supratherapeutic doses, fludrocortisone inhibits adrenocortical gland secretions, pituitary corticotropin excretion, and thymic activity.
It causes an accumulation of liver glycogen and negatively affects the nitrogen balance.
Contraindications
Hypersensitivity to fludrocortisone or any of the excipients.
Usage precautions
In cases of secondary adrenocortical insufficiency, mineralocorticoid substitution is not systematic, but its usefulness is appreciated in clinical and biological data.
With the recommended replacement doses for fludrocortisone, warnings and precautions for corticosteroids are not warranted.
Due to the mineralocorticoid effect of fludrocortisone, salt intake should be dose-dependent.
In children, sodium supplementation (1 to 2 g per day) is associated with taking fludrocortisone during the first years of life.
The presence of hypertension and edema, tachycardia, and a significant decrease in plasma renin activity are all signs that may indicate a fludrocortisone overdose leading to a reduction in dose.
Fludrocortisone should be used with caution in patients with severe unbalanced hypertension and heart failure.
In cases of hypovolaemia (increased diarrhea, excessive sweating due to intense physical exertion, etc.), it may be necessary to increase the dose of fludrocortisone.
Replacement therapy with fludrocortisone should not be interrupted.
Fludrocortisone should be used cautiously when drug therapy with enzyme-inducing anticonvulsants or rifampin is administered concomitantly.
athletes
Attention will be drawn to the fact that this specialty contains an active ingredient that can induce a positive reaction from tests carried out during doping controls.
Interactions
Associations are subject to precautions for use.
Enzyme-inducing anticonvulsants
Decrease in plasma concentrations and the efficacy of corticosteroids by increasing their hepatic metabolism by the inducer: the consequences are significant in addicts treated with hydrocortisone and in the case of transplantation.
Clinical and biological surveillance; corticosteroid dose adjustment during inducer treatment and discontinuation.
Rifampicin
Decrease in plasma concentrations and the efficacy of corticosteroids by increasing their hepatic metabolism with rifampicin: the consequences are particularly important in addicts treated with hydrocortisone and in transplantation.
Clinical and biological surveillance; corticosteroid dose adjustment during rifampicin treatment and after discontinuation.
Overdose
In case of massive overdose, symptomatic treatment should be instituted, in particular, to correct fluid and electrolyte disorders: administration of water and potassium, salt restriction; It is recommended to monitor the plasma ionogram and blood pressure for at least 48 hours.
Pregnancy
There are currently no data of sufficient relevance in clinical studies to evaluate the possible malformation or foetotoxic effect of fludrocortisone when administered during pregnancy.
Animal studies have shown reproductive toxicity.
However, given the indication, fludrocortisone may be prescribed during pregnancy if necessary.
Maternal adrenocortical insufficiency should be treated during pregnancy, adjusting the dose of fludrocortisone if necessary. Treatment with fludrocortisone should be discontinued in case of toxemia during pregnancy.
There should be a period of clinical (weight, diuresis) and biological (plasma ionogram) monitoring of the newborn.
Feeding
In the absence of data on the passage of milk, it is better to avoid breastfeeding; if you are breastfeeding, you should begin regular check-ups of the newborn baby.
Side effects of fludrocortisone
Along with its necessary effects, fludrocortisone can cause some unwanted effects. Although not all of these side effects can occur, if they do occur, they may need medical attention.
Check with your doctor right away if you experience any of the following side effects while taking fludrocortisone:
Less common or rare:
- Abdominal pain.
- Agitation.
- Anxiety.
- Back pain or rib pain.
- Blindness.
- Swelling.
- Bloody or black sticky stools.
- Blurry vision.
- Burning in the stomach.
- Changes in skin color
- Chest pain or stiffness
- A cold.
- Confusion.
- Constipation.
- Seizures
- Coughing up blood
- Dark urine.
- Height decrease.
- Decreased range of motion.
- Decreased urine output
- Decreased vision
- Depression.
- Difficulty to swallow.
- Dry mouth.
- Expression of fear of imminent death.
- Eye pain.
- The eyeballs protrude from the eye sockets.
- Fainting or lightheadedness when getting up from a lying or sitting position.
- Fast or slow heartbeat
- Fever.
- Reddened dry skin
- Arm or leg fractures without any injury.
- Neck or back fractures.
- Hallucinations
- Headache.
- Acidity.
- Urticaria.
- Increase in fat deposits on the face, neck, and trunk.
- Increased hunger
- Increased thirst.
- Increased urination
- Indigestion.
- Irregular breathing or shortness of breath.
- Irregular heartbeat
- Joint pain
- Lack or slowdown of expected growth in children.
- Walk lamely.
- Loss of appetite
- Loss of consciousness.
- Muscle cramps or pain
- Nausea or vomiting
- Nervousness.
- Pain, tenderness, or swelling of the feet or legs.
- Pains in the stomach or side, possibly radiating to the back.
- Bumps in the ears.
- Problems with wound healing.
- Redness and itching of the skin.
- Redness of the eyes.
- Redness of the face.
- Severe or continuous dizziness.
- Extreme weakness of the arms and legs.
- Acne.
- Perspiration.
- Swelling of the face, fingers, feet, or lower legs.
- Swelling of the nostrils, face, or eyelids.
- Swollen neck veins.
- Tear of eyes
- Unexplained weight loss
- Unusual tiredness or weakness
- Vision changes
- Weight gain.
- Wheezing
- Yellow eyes or skin.
Some side effects of fludrocortisone can occur and generally do not require medical attention.
These side effects may go away during treatment as your body adjusts to the medicine.
Also, your healthcare professional can educate you on ways to prevent or reduce some of these side effects.
Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rare:
- Acne, pimples.
- Bruises, large, flat, blue, or purplish patches on the skin.
- Change in skin or nail color.
- Increased sweating
- Loss of muscle mass.
- Menstrual changes
- Muscular weakness.
- Reddish purple lines on arms, face, legs, trunk, or groin.
- Insomnia, difficulty sleeping, unable to sleep.
- Small, red, or purple spots on the skin.
- Swelling of the abdominal or stomach area, feeling of bloating or bloating in the stomach.
- Thin and fragile skin.
- Unusual increase in hair growth.
Most adverse reactions are caused by the mineralocorticoid activity of this drug, including:
- Sodium and water retention, hypertension.
- Edema.
- Cardiac enlargement.
- Congestive heart failure
- Loss of potassium.
- Hypokalemic alkalosis.
Cardiovascular
Frequency not reported:
- Hypertension.
- Cardiac enlargement.
- Congestive heart failure
- Thrombophlebitis.
- Syncope.
- Cardiomegaly.
Gastrointestinal
Frequency not reported:
- Peptic ulcer.
- Drilling.
- Hemorrhage.
- Pancreatitis.
- Abdominal distension.
- Ulcerative esophagitis.
- Diarrhea.
Endocrine
Frequency not reported:
- Cushingoid state developed.
- Growth suppression in children.
- Lack of secondary adrenocortical and pituitary response.
- Decreased tolerance to carbohydrates.
- Manifestation of latent diabetes mellitus.
- Increased insulin requirements.
- Requirements for oral hypoglycemic agents increased.
Metabolic
Frequency not reported:
- Hyperglycemia
- Negative nitrogen balance.
- Loss of potassium.
- Hypokalemic alkalosis.
- Sodium retention.
- Fluid retention.
- Decreased appetite.
Immunological
Frequency not reported:
- Angiitis necrosante.
- Anaphylactoid reaction.
Musculoskeletal
Frequency not reported:
- Muscular weakness.
- Asteroidea myopathy.
- Loss of muscle mass.
- Osteoporosis.
- Vertebral compression fractures.
- Aseptic necrosis of the femoral and humeral heads.
- Pathological long bone fracture.
- Spontaneous fractures.
Ocular
Frequency not reported:
- Catarata subcapsular posterior.
- Increased intraocular pressure.
- Glaucoma.
- Exophthalmos.
Psychiatric
Frequency not reported:
- Metal disorder
- Insomnia.
Dermatological
Frequency not reported:
- Wound healing.
- Fragile skin
- Bruises
- Petechiae.
- Equimosis.
- Facial erythema.
- Increased sweating
- Subcutaneous fat atrophy.
- Stretch marks.
- Hyperpigmentation of the skin.
- Hyperpigmentation of the nails.
Nervous system
Frequency not reported:
- Convulsion.
- Increased intracranial pressure.
- Papilledema.
- Vertigo.
- Headache.
- Seizures
- Epilepsy.
Other
Frequency not reported: Edema.
- Aggravated infection
- Masking the infection.
