Active ingredients: Cortisone (cortisone acetate)
Cortone Acetate 25 mg tablets
Why is Cortone acetate used? What is it for?
Cortone Acetate contains the active substance cortisone acetate which belongs to a group of medicines called corticosteroids (or glucocorticoids). Corticosteroids can replace cortisol, a hormone produced naturally in our body by the adrenal glands, which contributes to regulating important processes for the general state of health.
Cortone Acetate is used:
- as an adjunct treatment for a short time in case of - acute and chronic joint diseases, such as rheumatoid arthritis - acute inflammation involving the tendons and the membranes surrounding them (acute tenosynovitis) - inflammation of the joints (bursitis acute and subacute) - acute inflammation of a joint due to gout
- after reappearance or as maintenance treatment in case of: - disease characterized by skin lesions and immune system disorders (systemic lupus erythematosus) - acute inflammation of the heart caused by rheumatic disease (acute rheumatic carditis)
- to treat bullous disease of the skin and mucous membranes (pemphigus)
- to control allergic conditions that cannot be treated traditionally, such as bronchial asthma and skin, contact or allergic inflammations (contact dermatitis, atopic dermatitis)
- in case of chronic and acute inflammations and allergies that involve the eye and connected appendages
- to relieve the symptoms and consequences of leukemia and lymphomas in adults and acute leukemia in childhood
- when hormone replacement treatment is required, including in diseases that cause insufficient hormone production, such as Addison's disease, acute adrenal insufficiency, Waterhouse-Friderichsen syndrome, adrenal insufficiency after surgery
- together with other medicines in the treatment of recurrent lesions of the colon (ulcerative colitis), a form of diarrhea (intractable sprue) and chronic inflammation of the intestine (regional enteritis).
Contraindications When Cortone acetate should not be used
Do not take Cortone Acetate
- if you are allergic to cortisone acetate or any of the other ingredients of this medicine (listed in section 6);
- if you have an infectious disease called tuberculosis;
- if you suffer from ulcer of the stomach and part of the intestine (gastro-duodenal ulcer);
- if you suffer from mental illness (psychosis);
- if you have fungal infections in your body;
- if you suffer from herpes simplex eye infection; - if you have recently undergone bowel surgery (intestinal anastomosis).
However, the use of cortisone acetate is justified for the treatment of diseases sensitive to this hormone, which are life-threatening or sight-threatening.
Precautions for use What you need to know before taking Cortone acetate
Talk to your doctor or pharmacist before taking Cortone Acetate.
Your doctor will have you checked to check the possible effects of cortisone acetate on the replacement of substances in the blood [electrolytes, calcium (calcium elimination increases during treatment with glucocorticoids), fluids, proteins and carbohydrates].
Take special care with Cortone Acetate
- if swelling appears (caused by fluid accumulation): use a low sodium diet (less than 1 g per day); if this does not lead to the swelling going away, your doctor may reduce the dosage of Cortone Acetate until your urine production normalizes or may give you a medicine that increases urine production. Only in rare cases does the swelling become so severe that it is necessary to suspend treatment with cortisone acetate;
- if you have or have had problems with emotional instability or a tendency to develop mental illness, as these can become worse during treatment. The following may also occur: euphoria, difficulty sleeping (insomnia), changes in mood or personality, severe depression or symptoms of real mental illness;
- if you have blood clotting problems (hypoprothrombinemia), ask your doctor before taking acetylsalicylic acid (aspirin);
- if you have or have had severe stress such as trauma or surgery, even if you have already stopped therapy for a few months: your doctor will decide whether to continue or re-administer the medicine, usually at higher doses;
- if you have an infection: glucocorticoids can hide some signs of infection and infections can occur during their use. In these cases your doctor will consider whether to give you an antibiotic;
- if you must be vaccinated: you must not be vaccinated against smallpox and you must not receive any other vaccinations either because problems with the nervous system may develop and the antibody action may be insufficient;
- if you have tuberculosis: you can use Cortone Acetate in cases of fulminant or generalized disease and together with an appropriate treatment to treat tuberculosis. If you have hidden tuberculosis or a positive response to tuberculin, your doctor will keep you under close surveillance as the disease may come back. In prolonged treatment with corticosteroids, your doctor may give you a chemotherapy drug to prevent the development of the disease (chemoprophylaxis); - if you are hyperthyroid (over-functioning of the thyroid gland);
- if you have liver disease (liver cirrhosis);
- if you have a form of chronic inflammation of the intestine with danger of bowel perforation (ulcerative colitis);
- if you have collections of pus (abscesses), infections that cause pus to form;
- if a disease caused by inflammation of part of the intestine (diverticulitis);
- if you have diabetes mellitus;
- if you have a type of heart disease (heart failure);
- if kidney function is impaired; - if you have high blood pressure;
- if you have a decrease in the mineral content in your bones (osteoporosis);
- if you suffer from severe muscle weakness (myasthenia gravis).
- if you have an infestation with a parasite called Strongyloid
- if you are being treated with drugs that suppress the immune system: care should be taken for any onset of infections
- if you can come into contact with chickenpox: treatment with immunoglobulins may be indicated
- if it can come into contact with measles: immunoglobulin prophylaxis may be indicated
The maintenance dosage must always be the minimum capable of controlling symptoms: a reduction in dosage must always be done gradually. The medicine is not contraindicated for people intolerant to gluten (celiacs).
Children
The doctor will carefully monitor the growth and development of children undergoing prolonged treatment.
Interactions Which drugs or foods can modify the effect of Cortone acetate
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Interactions have been reported with some antiepileptics (phenobarbital and phenytoin), antifungals (ketoconazole), salicylate, anticoagulants taken by mouth and some antibiotics (rifampicin and troleandomycin).
Warnings It is important to know that:
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Since adequate studies on the effect of corticosteroids on human reproduction are not yet available, before using these medicines in pregnant women, nursing mothers or women of childbearing potential, the doctor will carefully evaluate the possible risks and benefits for the mother and for the fetus: Babies born to mothers who have taken high doses of corticosteroids during pregnancy will be carefully screened for signs of impaired adrenal gland activity.
Feeding time
Corticosteroids are found in breast milk and may prevent growth, interfere with the body's production of corticosteroids, or cause other side effects in the newborn. Women taking corticosteroids should not breastfeed. Tell your doctor if you are breastfeeding. or intend to breastfeed.
Driving and using machines
Cortone Acetate does not interfere with the ability to drive and use machines.
Cortone Acetate contains lactose
Cortone Acetate contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Cortone acetate: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose depends not so much on the specific diagnosis as on the medical judgment of the disease, the severity and foreseeable duration of the disease and the individual response.
The recommended dose given below, based on clinical experience, can serve as a guide to the doctor who will adapt it to your case.
The tablets should be taken 2-4 times a day as directed by the doctor.
- Simultaneous inflammation of multiple joints (primary chronic polyarthritis), asthma, eye diseases and other chronic, usually non-fatal forms. Attack dose: 80-100 mg per day until satisfactory response is obtained; usually for 1 to 2 weeks. Maintenance dose: Gradually reduce the attack dose by 5-15 mg every 4-5 days until the minimum suitable dose for daily maintenance is reached: usually 50-75 mg.
- Severe seasonal asthma, acute eye diseases and other forms that lead to a limited disease. First day: 200-300 mg; Second day: 100-200 mg; Third day: 100 mg. Then reduce a little at a time and finally suspend. In case of eye infections, combine treatment with antibiotics.
- Acute inflammation of the joints and other acute forms of disease which gradually increase in severity, or which lead to death or permanent damage to the body. Attack dose: first day up to 400 mg; then 200 mg per day until obtained satisfactory response Maintenance dose: reduce gradually to 100 mg (or less) per day until decrease in symptom severity seems likely, resume treatment if relapse occurs.
- Diseases characterized by skin lesions and immune system disorders (disseminated lupus erythematosus and pemphigus) and other diseases which are prolonged or usually lead to death. Attack dose: first day 400 mg or more; then 200 mg per day until satisfactory response is obtained. Maintenance dose: reduce gradually to 100 mg (or less) per day. Continue for a period to be defined or until the decrease in symptom severity seems likely. Then suspend a little at a time; however, resume treatment in case of relapses.
- Asthma, adrenal insufficiency often associated with meningitis (Waterhouse Friderichsen syndrome), swelling of the larynx, acute episodes of generalized lupus erythematosus, and other acute life-threatening conditions. In the first few days: 300-450 mg or more, then reduce to maintenance dosage or discontinue.
- Diseases that cause insufficient hormone production (Addison's disease) or removal of the adrenal glands. 10-20 mg, or sometimes more, per day along with 4-6 g of sodium chloride or 1-3 mg of a drug called deoxycorticosterone acetate.
- In the event of a crisis, surgery or other severe states of stress. 100-300 mg or more per day until the unusual stress is overcome and normal nutrition is resumed.
Use in children
Children undergoing prolonged treatment should be carefully monitored from the point of view of growth and development.
Overdose What to do if you have taken too much Cortone acetate
If you take more Cortone Acetate than you should
There are no data on overdose in humans. Ask your doctor or pharmacist for more information on using the medicine.
If you forget to take Cortone Acetate
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Cortone Acetate
Treatment should be discontinued little by little (except when it has started a few days ago, or possibly when it needs to be stopped to correct a serious side effect) and the patient must then be carefully monitored for the possibility of a sudden relapse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Cortone acetate
Like all medicines, this medicine can cause side effects, although only some people get them. The frequency of the side effects listed below is not known
Undesirable effects at the level of water and salt content in the blood
- sodium retention
- fluid retention
- loss of potassium resulting in an excessive concentration of bicarbonates in the blood associated with low potassium levels
- high blood pressure with heart failure characterized by fluid accumulation.
Undesirable effects on the muscles and bones
- muscle disease caused by steroids (class of drugs to which Cortone Acetate belongs) - decrease in muscle volume
- reduced mineral content in the bones (osteoporosis) with possible fractures of the long bones.
- tendon ruptures
- necrosis of the femoral head and humerus
Gastrointestinal side effects
- inflammation of the esophagus with ulcerative lesions
- inflammation of the pancreas
- peptic ulcer of the stomach and / or duodenum with possible perforation
- perforation of the small and large intestine in patients who already present inflammatory bowel disease
- nausea
- abdominal distension
- Alterations in the liver with increase in some specific liver tests: transaminase and alkaline phosphatase
Undesirable effects on the skin
- difficult healing
- skin changes due to thinning
- blood effusions of varying sizes in the skin.
- changes in responses to any skin tests
- urticaria
- allergic dermatitis
- increased sweating
Neurological side effects
- euphoria
- trouble sleeping
- mood swings
- severe depression
- convulsions
- dizziness
- headache.
Hormonal side effects
- disease characterized by weight gain, fluid retention, skin striae and abnormal hair growth due to excess cortisone (Cushing's syndrome)
- changes in growth and development in children
- slowing of the activity of the adrenal glands and pituitary gland
- Diabetes or prediabetes states, decreased tolerance to carbohydrates (sugars) with the need in known diabetics to increase the doses of insulin or anti-diabetic drugs by mouth
- menstrual irregularities.
Ocular side effects
- a particular type of cataract (posterior subcapsular)
- increased pressure inside the eye - bulging eyes.
Undesirable effects on the metabolism
- reduction in muscle mass due to excessive protein metabolism (negative nitrogen balance)
- weight gain
- increased appetite.
Immune side effects
- manifestations of hypersensitivity
Vascular side effects
- thromboembolism
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Cortone Acetate contains
- The active ingredient is cortisone acetate. Each tablet contains 25 mg of cortisone acetate.
- The other ingredients are: lactose, corn starch, magnesium stearate.
Description of Cortone Acetate's appearance and contents of the pack
20 tablets of 25 mg.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CORTONE ACETATE - "25 MG TABLETS" 20 TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active principle: cortisone acetate 25 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Affections of rheumatological interest as adjunctive therapy for short-term administration (to help the patient overcome an acute episode or exacerbation) in rheumatoid arthritis (special cases may require low-dose maintenance therapy), acute nonspecific tenosynovitis, acute and subacute bursitis, arthritis acute gouty.
Collagen diseases: during an exacerbation or as maintenance therapy in particular cases of systemic lupus erythematosus, acute rheumatic carditis.
Dermatological affections: pemphigus.
Allergic forms: (to control severe or debilitating allergic conditions that cannot be treated conventionally): bronchial asthma, contact dermatitis, atopic dermatitis.
Ophthalmic diseases: chronic and acute severe inflammatory and allergic processes involving the eye and its appendages.
Neoplasms (for palliative purposes only): leukemia and lymphomas in adults, acute leukemia in childhood.
Conditions requiring hormone replacement therapy, including Addison's disease, acute adrenal insufficiency, Waterhouse-Friderichsen syndrome, postoperative adrenal insufficiency.
Gastrointestinal diseases: as an adjuvant in the treatment of ulcerative colitis, intractable sprue, regional enteritis.
04.2 Posology and method of administration
The posology depends not so much on the specific diagnosis as on the severity, prognosis, foreseeable duration of the disease and the individual response. The following posologies, based on clinical experience, can serve as guidance to the physician and be appropriate to the individual case in the opinion of the physician.
The tablets should be administered in 2-4 divided doses per day.
Primary chronic polyarthritis, chronic asthma, chronic diseases and other chronic forms that are usually non-lethal.
Attack dose: 80-100 mg per day until satisfactory response is obtained; usually for 1 to 2 weeks.
Maintenance dose: Gradually reduce the starting dose by 5-15 mg every 4-5 days until the minimum suitable daily maintenance dose is reached: usually 50-75 mg.
Severe seasonal asthma, acute circumscribed ocular diseases and other circumscribed morbid forms.
First day: 200-300 mg; second day: 100-200 mg; third day: 100 mg.
Then gradually reduce and finally suspend. In the infectious processes of the eye associate antibiotic therapy.
Acute articular rheumatism and other acute morbid forms that are progressing or with a fatal evolution or leading to permanent organic damage.
Attack dose: first day, up to 400 mg; thereafter 200 mg per day until satisfactory response is obtained.
Maintenance dose: gradually reduce to 100 mg or less per day until remission seems likely; resume treatment if relapse occurs.
Disseminated lupus erythematosus, pemphigus and other prolonged or usually fatal diseases.
Attack dose: first day 400 mg or more; then 200 mg or more per day until satisfactory response is obtained.
Maintenance dose: Gradually reduce to 100 mg or less per day. Continue indefinitely or until remission seems likely. Then gradually suspend; however, resume treatment in case of relapses.
Asthmatic status, Waterhouse-Friederichsen syndrome, laryngeal edema, acute episodes of disseminated lupus erythematosus and other acute life-threatening conditions.
In the first few days: 300-450 mg or more, then reduce to maintenance dosage or discontinue.
Addison's disease or adrenalectomy.
10-20 mg or sometimes more, per day combining 4-6 g of sodium chloride or 1-3 mg of deoxycorticosterone acetate.
In the event of a crisis, surgery or other major stressful states.
100-300 mg or more per day until the unusual stress is overcome and normal nutrition is resumed.
04.3 Contraindications
Tuberculosis, gastro-duodenal ulcer, psychosis, systemic mycotic infections, ocular herpes simplex, recent intestinal anastomosis.
Although tuberculosis, recent intestinal anastomoses and herpes simplex of the eye are almost absolute contraindications, the use of cortisone acetate is justified if it is a life threatening disease, or vision, which is susceptible to therapy with this hormone. .
Hypersensitivity to this drug.
04.4 Special warnings and appropriate precautions for use
It is advisable to use the minimum posology necessary for the control of the disease, implementing a gradual dose reduction as soon as this is possible. Medium or high doses of hydrocortisone or cortisone can cause increased blood pressure, water and salt retention, or excessive potassium depletion. These effects are less likely to occur with synthetic derivatives, unless these are used at high doses. A low-salt diet and additional potassium intake may be required. All corticosteroids increase calcium excretion. During prolonged therapy, an antiulcer regimen including an antacid may be appropriate as a precaution.
In patients under corticosteroid therapy exposed to considerable stress, an increase in the dosage of fast-acting corticosteroids is indicated, before, during and after the stressful situation.
Drug-induced secondary adrenocortical insufficiency can be minimized by gradually reducing the dosage.
However, this type of relative insufficiency may persist for a few months after discontinuation of therapy; in any stressful situation that occurs during this period, it is therefore advisable to return hormone therapy.
If the patient is already on steroid treatment, an increase in dosage may be necessary. Since the secretion of mineralocorticoids may be inadequate, the simultaneous administration of a mineralocorticoid or both is advisable.
After long-term therapy, discontinuation of corticosteroids could result in a syndrome including fever, myalgia, arthralgia, and malaise. This can also happen in patients with no evidence of adrenal insufficiency.
Patients should not be vaccinated against smallpox during corticosteroid therapy. Other immune procedures should not be implemented in patients treated with corticosteroids, especially at high doses, given the danger of a lack of antibody response.
However, immunization of patients who are taking corticosteroids as replacement therapy, for example for Addison's disease, can be done.
In the presence of hypoprothrombinemia, acetylsalicylic acid should be used with caution during corticosteroid therapy.
The use of CORTONE ACETATE tablets in current tuberculosis should be limited to cases of fulminant or disseminated tuberculosis in which the corticosteroid is used for the treatment of the disease in combination with an appropriate antituberculous regimen. When corticosteroids are indicated in patients with latent tuberculosis. or with a positive response to tuberculin, rigorous monitoring is required as disease reactivation may occur. During prolonged corticosteroid therapy, these patients should undergo chemoprophylaxis. Steroids should be used with caution in the presence of: colitis nonspecific ulcerative with possibility of perforation, abscesses or other pyogenic infections; diverticulitis; recent intestinal anastomosis; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; myasthenia gravis. Cases of systemic emboli of adipose tissue have been described as possible co multiplications from overdosing of cortisone.
Corticosteroids should be used with caution in patients with ophthalmic herpes simplex, given the possible risk of corneal perforation. In hyperthyroid and cirrhotic patients the effects of corticosteroids are more marked. In some patients, steroids can increase or decrease sperm motility and sperm count.
Diphenildantoin, ephedrine, phenobarbital, rifampicin, can induce an increase in the metabolism and clearance of corticosteroids; consequently it may be necessary to increase the dosage of the steroid. Corticorteroids can mask some symptoms of infection and overlapping infections may occur during their use. In the course of corticosteroid therapy, reduced resistance to infections and the tendency of infectious processes not to localize can be observed.
Psychic alterations may occur during treatment with corticosteroids which can range from symptoms of euphoria, insomnia, mood changes, personality changes, severe depression, to true and proper psychotic manifestations. When present, psychic instability and psychotic tendencies can be aggravated by corticosteroids. Prolonged use of corticosteroids can cause posterior subcapsular cataract, glaucoma with possible damage to the optic nerves and can favor the onset of secondary ocular infections due to fungi or viruses. Children and adolescents undergoing prolonged corticosteroid therapy should be closely monitored for growth and development. Prothrombin time should be monitored frequently in patients receiving coumarin corticosteroids and coumarin anticoagulants at the same time, as corticosteroids have been shown in some cases to impair the response to anticoagulants. Some studies have shown that the effect produced by adding corticosteroids is the inhibition of the response to coumarin compounds. When corticosteroids are co-administered with potassium-depleting diuretics, it should be strictly monitored for hypokalaemia in patients.
For those who practice sports: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests. Patients treated with drugs that depress the immune system are more prone to infections than healthy individuals. Varicella and measles, for example, they can have a more severe or even fatal course in non-immune children or adults treated with corticosteroids. Particular attention should be paid to avoid exposure of children or adults who have not contracted these diseases. It is not known how the dose, route of administration and duration of administration of corticosteroids affect the risk of developing a "disseminated infection. The contribution to the risk by the underlying disease, and / or by a previous one is also unknown. Treatment with corticosteroids. If exposed to chickenpox, prophylaxis with immunoglobulin varicella zoster (VZIG) may be indicated. If exposed to measles, prophylaxis with a pool of intramuscular immunoglobulin (IG) may be indicated. for complete prescribing information for VZIG and IG.) If you contract chickenpox, treatment with antiviral drugs may be considered. Similarly, corticosteroids should be used with extreme caution in patients with known or suspected Strongyloid (worm) infestation. vite) In such patients, corticosteroids that induce immunosuppression can lead to Strongiloi hyperinfestation de and the spread of larvae, often accompanied by severe and potentially fatal gram-negative septicemia.
04.5 Interactions with other medicinal products and other forms of interaction
Drugs that induce liver enzymes such as phenobarbital, phenytoin and rifampicin may increase the elimination of corticosteroids, in which case the dose of corticosteroids may need to be increased to achieve the desired effect. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and therefore reduce their elimination.Therefore, the dose of corticosteroids should be titrated to avoid steroid toxicity.
Corticosteroids can increase the elimination of salicylate when taken chronically in high doses.
This could lead to a decrease in serum salicylate levels or increase the risk of salicylate toxicity when the corticosteroid is stopped. Salicylate in combination with corticosteroids should be used with caution in patients with hypo prothrombinaemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of increased as well as decreased effects of anticoagulants when administered concomitantly with corticosteroids. Therefore, clotting indices must be monitored to maintain the desired anticoagulant effect.
04.6 Pregnancy and lactation
Pregnancy
As adequate studies on corticosteroids in relation to human reproduction are not yet available, the use of these drugs in pregnant women, in nursing mothers or in women of childbearing age requires that the possible risks and benefits derived from the drug for the mother and fetus.Babies born to mothers who have been treated with substantial doses of corticosteroids during pregnancy should be subjected to careful checks to ascertain any signs of hypoadrenalism.
Feeding time
Corticosteroids are found in breast milk and may impede growth, interfere with the production of endogenous corticosteroids, or cause other side effects. Women taking pharmacological doses of corticosteroids should not breastfeed.
04.7 Effects on ability to drive and use machines
It does not interfere with the ability to drive and use of machines.
04.8 Undesirable effects
Diagnostic tests: sodium retention, fluid retention, congestive heart failure in predisposed patients, loss of K with consequent hypokalaemic alkalosis. Hypertension with congestive heart failure.
Musculoskeletal and connective system disorders: steroid myopathy, hypotrophy of muscle masses, osteoporosis with possible pathological fractures of the long bones, tendon ruptures, aseptic necrosis of the femoral head and humerus.
Gastrointestinal disorders: ulcerative esophagitis, pancreatitis, peptic ulcer with possible perforation and haemorrhage, perforation of the small and large intestine, particularly in patients with inflammatory bowel disease, abdominal distension, nausea.
Hepatobiliary disorders: increased alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase.
Skin and subcutaneous tissue disorders: difficult healing, skin dystrophies, petechiae and ecchymosis, erythema, skin reactions and tests, other skin reactions, such as allergic dermatitis, urticaria, angioneurotic edema, increased sweating can be suppressed.
Nervous system disorders: convulsions, increased intracranial pressure with papilledema (pseudotumor of the brain) usually after treatment, dizziness, headache.
Endocrine pathologies: menstrual irregularities. Development of cushingoid syndrome.
Growth arrest in children.
Lack of adrenocortical and pituitary response particularly under stress, such as trauma, surgery and morbid conditions.
Reduced tolerance to carbohydrates. Manifestations of latent diabetes mellitus.
Need to increase insulin or oral hypoglycemic dosages in diabetics.
Ocular pathologies: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.
Metabolic disorders of metabolism and nutrition: negative nitrogen balance due to protein catabolism. Weight gain. Increased appetite.
Disorders of the immune system: hypersensitivity.
Vascular pathologies: thromboembolism.
04.9 Overdose
There are no data on overdose in humans.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: CORTONE ACETATE is an adrenal corticosteroid with glucocorticoid activity and some mineralocorticoid properties. Glucocorticoids are adrenocortical steroids, which can be found both naturally and synthetic; they also have the property of retaining salt and are used as replacement therapy in states of adrenocortical deficiency.
They are also used for their potent anti-inflammatory action which allows their use in a wide range of clinical applications. Glucocorticoids cause profound and varied metabolic effects.
They also modify the body's immune responses to various stimuli.
ATC code: H02AB10.
05.2 "Pharmacokinetic properties
CORTONE ACETATE (Cortisone acetate) is easily absorbed from the gastrointestinal tract and is rapidly converted in the liver to the active metabolite
hydrocortisone (Cortisol). The biological half-life of Cortisone is only about 30 minutes.
05.3 Preclinical safety data
Cortone Acetate is not expected to have genotoxic or carcinogenic effects of any kind
although no specific studies have been conducted to prove this.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Each tablet of CORTONE ACETATE contains:
Excipients:
lactose, corn starch, magnesium stearate.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
5 years a
06.4 Special precautions for storage
There are no special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
The tablets are contained in PVC and aluminum blisters.
20 tablets of 25 mg
06.6 Instructions for use and handling
No special instructions.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Salimbene Valley (PV)
08.0 MARKETING AUTHORIZATION NUMBER
CORTONE ACETATE "25 mg tablets" - 20 tablets: A.I.C. n ° 004561015
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
CORTONE ACETATE "25 mg tablets" - 20 tablets
Date of first authorization: April 1959
Date of last renewal: 31.05.2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 27 February 2015
