celestene 2 mg medicine Uses, Dosage, Side Effects &Warnings

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Celestene 2 mg Generic medicine of the therapeutic class: Anti-inflammatory
active ingredients: Betamethasone

Important to know about Celestene ?

• This medication is a corticosteroid.
• It is indicated in certain diseases, where it is used for its anti-inflammatory effect.

celestene 2mg what is it used for and indication ?

Conditions or diseases:

Collagenosis and connectivitis:

• Evolutionary thrusts of systemic diseases, including: systemic lupus erythematosus, vasculitis, polymyositis, visceral sarcoidosis.

Dermatological:

• Severe autoimmune bullous dermatoses, especially pemphigus and bullous pemphigoid.
• Serious forms of angiomas of the infant.
• Some forms of lichen plan.
• Some acute urticaria.
• Severe forms of neutrophilic dermatoses.

Digestives:

• Evolutionary thrusts of ulcerative colitis and Crohn’s disease.
• Chronic active autoimmune hepatitis (with or without cirrhosis).
• Severe acute alcoholic hepatitis, histologically proven.

Endocrine:

• Subacute Thyroiditis of severe De Quervain.
• Some hypercalcemia.

Hematologic:

• Severe immunological thrombocytopenic purpura.
• Autoimmune haemolytic anemias.
• In combination with various chemotherapies in the treatment of lymphoid malignant hemopathies.
• Chronic erythroblastopenia, acquired or congenital.

Infectious:

• Tuberculous pericarditis and severe forms of life-threatening tuberculosis.
• Pneumocystis carinii pneumonia with severe hypoxia.

Neoplasms:

• Antiemetic treatment during antineoplastic chemotherapy.
• Oedematous and inflammatory thrust associated with antineoplastic treatments (radio and chemotherapy).

Nephrological:

• Nephrotic syndrome with minimal glomerular lesions.
• Nephrotic syndrome of primitive segmental and focal hyalinoses.
• Stages III and IV of lupus nephropathy.
• Intrarenal granulomatous sarcoidosis.
• Vasculitis with renal involvement.
• Primitive extracapillary glomerulonephritis

Neurological:

• Gravis.
• Cerebral edema of tumoral cause.
• Chronic polyradiculoneuropathy, idiopathic, inflammatory.
• Infant spasm (West syndrome), Lennox-Gastaut syndrome.
• Multiple sclerosis in relapse, in relays of an intravenous corticotherapy.

Ophthalmological:

• Uveitis anterior and posterior severe.
• Exophthalmos oedematous.
• Some optic neuropathies, in reliance on intravenous corticosteroids (in this indication, oral first-line is not recommended).

ENT:

• Some serous otitis.
• Nasosinus polypsis.
• Some acute or chronic sinusitis.
• Seasonal allergic rhinitis in short cure.
• Stridulous acute laryngitis (subglottic laryngitis) in children.

Respiratory:

• Persistent asthma, preferably in short course, in case of failure of inhaled treatment at high doses.
• Exacerbations of asthma, especially severe acute asthma.
• Chronic obstructive pulmonary disease in assessing the reversibility of obstructive syndrome.
• Sarcoidosis progressive.
• Diffuse interstitial pulmonary fibrosis.

Rheumatologic:

• Rheumatoid arthritis and some polyarthritis.
• Rhizomelic pseudopolyarthritis and Horton’s disease.
• Acute articular rhumatism.
• Severe and rebellious cervicobrachial neuralgia.

Organ Transplantation and Hematopoietic Allogeneic Stem Cells:

• Prophylaxis or treatment of transplant rejection.
• Prophylaxis or treatment of graft-versus-host disease.

Celestene Dosage

Oral way.

• · Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 0.75 mg betamethasone.
• The tablets can be swallowed as is with a little water or dissolved in a little water, preferably during meals.

RESERVED FOR ADULTS

• Celestene 2 mg is particularly suitable for the treatment of attack or short-term treatments requiring medium or high doses in adults.
• In maintenance treatment, there are more appropriate dosages.
• In children, there are more appropriate dosages and pharmaceutical forms.
• · The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient’s response and the tolerance to the treatment.
• Attack treatment : 0.05 mg to 0.2 mg / kg / day (0.35 mg to 1.2 mg / kg / day prednisone equivalent). As an indication : 1.5 to 6 tablets in an adult of 60 kg.
• In severe inflammatory diseases , the dosage varies from 0.1 to 0.2 mg / kg / day of betamethasone (0.75 mg / kg / day to 1.2 mg / kg / day equivalent prednisone). As an indication : 3 to 6 tablets per day for an adult of 60 kg.
• The very exceptional situations may require higher doses.

IN GENERAL

• Treatment at the “attack dose” should be continued until the disease is well controlled. Decay must be slow. Obtaining a weaning is the goal. Maintaining a maintenance dose (minimum effective dose) is a compromise that is sometimes necessary.
• For prolonged treatment at high doses, the first doses can be divided into two daily doses. Thereafter, the daily dose may be administered as a single dose preferably in the morning during the meal.

· Discontinuation of treatment

• The rate of withdrawal depends mainly on the duration of treatment, the starting dose and the disease.
• The treatment causes resting secretions of ACTH and cortisol with sometimes lasting adrenal insufficiency. When weaning, stopping should be done gradually, in stages because of the risk of relapse: reduction of 10% every 8 to 15 days on average.
• For short courses of less than 10 days, stopping treatment does not require decay.

When decreasing doses from celestene (prolonged cure):

at the dosage of 5 to 7 mg of prednisone equivalent, when the causal disease no longer requires corticosteroid treatment, it is desirable to replace the synthetic corticoid with 20 mg / day of hydrocortisone until recovery of corticotropic function. If corticosteroid therapy is to be maintained at less than 5 mg prednisone equivalent per day, a small dose of hydrocortisone can be added to achieve a hydrocortisone equivalent of 20 to 30 mg per day. When the patient is only under hydrocortisone, it is possible to test the corticotropic axis by endocrine tests. These tests do not eliminate the possibility of adrenal insufficiency during a stress.

Under hydrocortisone or even at a distance from arrest, the patient should be advised of the need to increase the usual dosage or to resume replacement therapy (eg 100 mg hydrocortisone intramuscularly every 6 to 8 hours) in case stress: surgery, trauma, infection.

Contraindications

This medication is generally contraindicated in the following situations (there is, however, no absolute contraindication for a life-saving corticosteroid therapy):

• Any infectious condition other than the specified indications ( see section Therapeutic indications ),
• Certain evolving viroses (in particular hepatitis, herpes, chickenpox, shingles),
• Psychotic states not yet controlled by treatment,

Live vaccines

• · Hyper-sensitivity to one of the compounds,
• Phenylketonuria (linked to the presence of aspartame).
• This drug is generally not recommended in combination with non-antiarrhythmic drugs, giving torsades de pointes ( see section Interactions with other drugs and other forms of interactions ).

How it works Celestene

Pharmacotherapeutic group: GLUCOCORTICOID – SYSTEMIC USE

( H. Non-sexual hormones )

• Physiological glucocorticoids (cortisone and hydrocortisone) are essential metabolic hormones. Synthetic corticosteroids, including this specialty, are used primarily for their anti-inflammatory effect. In high doses, they reduce the immune response.
• Their metabolic and sodium retention effect is less than that of hydrocortisone.

Celestene 2 mg Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This drug, essential, is most often well tolerated when one follows the recommendations and especially the diet (see Warnings and precautions). It may nevertheless result, according to the dose and the duration of the treatment, more or less troublesome effects.

The most frequently encountered are:

1. · Swelling and redness of the face, weight gain
2. · Appearance of blue
3. · Elevation of blood pressure
4. · Excitement and sleep disorders
5. · Bone fragility
6. · Modification of certain biological parameters (salt, sugar, potassium), which may require a diet or additional treatment.

Other, much rarer effects have been observed:

1. · Risk of insufficiency of secretion of the adrenal gland
2. · Growth disorder in children
3. · Rule disorders
4. · Muscle weakness
5. · Hiccups, ulcers and other digestive disorders
6. · Skin disorders
7. · Some forms of glaucoma (increased pressure inside the eye) and cataracts (opacification of the lens).

Celestene Interactions

Associations advised against

Drugs giving torsades de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)

Use substances that do not have the disadvantage of causing torsades de pointes in case of hypokalemia.

Associations subject to precautions for use

Acetylsalicylic acid by general route and by extrapolation other salicylates

Decrease of salicylemia during corticosteroid treatment and risk of salicylate overdose after discontinuation, by increased elimination of salicylates by corticosteroids.

Adjust salicylate doses during combination and after discontinuation of corticosteroid treatment.

Antiarrhythmics giving torsades de pointes (amiodarone, bretylium, disopyramide, quinidine, sotalol).

Hypokalemia is a contributing factor as well as bradycardia and a preexisting long QT space.

Prevent hypokalemia, correct it if necessary; monitor the QT space. In case of torsade, do not administer antiarrhythmic (electrosystolic drive).

 Oral anticoagulants

• Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and that of the coagulation factors.
• Haemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) at high doses or prolonged treatment for more than 10 days.
• When the association is justified, strengthen supervision: biological control 8 ^th day and every 15 days during and after corticosteroid discontinuation.
• Other hypokalaemic agents (alone or associated hypokalaemic diuretics, stimulant laxatives, amphotericin B (IV route)).
• Increased risk of hypokalemia by additive effect.
• Monitor the serum potassium, correct if necessary especially in case of digitalis therapy.

Digitalis

• Hypokalemia favoring the toxic effects of digitalis.
• Monitor the serum potassium, correct if necessary and possibly ECG.

Parenteral heparins

• Aggravation by heparin of the hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or prolonged treatment longer than 10 days.
• The association must be justified, strengthen surveillance.
• Enzyme inducers: carbamazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin.
• Decreased plasma levels and efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important for addisonians and transplant patients.
• Clinical and biological surveillance, adjustment of the dosage of corticosteroids during the association and after discontinuation of the enzyme inducer.

 Insulin, metformin, sulphonylureas

• Elevation of blood glucose with sometimes ketosis (decreased tolerance to carbohydrates by corticosteroids).
• Prevent the patient and strengthen blood and urinary self-monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of the antidiabetic during treatment with corticosteroids and after discontinuation.

Isoniazid (described for prednisolone)

• Decreased plasma levels of isoniazid. Invoked mechanism: increased hepatic metabolism of isoniazid and decreased glucocorticoid.
• Clinical and biological surveillance.
• Gastrointestinal topical: salts, oxides and hydroxides of magnesium, aluminum and calcium (described for prednisolone, dexamethasone).
• Decreased digestive absorption of glucocorticoids.
• Take the gastrointestinal topical glucocorticoid away (more than 2 hours if possible).

Associations to consider

Antihypertensive

• Decreased antihypertensive effect (water-soluble retention of corticosteroids).

 Alpha interferon

• Risk of inhibition of the action of interferon.

 Attenuated live vaccines

• Risk of generalized illness, possibly fatal. This risk is increased in subjects already immunocompromised by the underlying disease.
• Use inactivated vaccine when present (poliomyelitis).

Warnings and Precautions

Special warnings:

1. · In cases of peptic ulcer disease, corticosteroids are not contraindicated if anti-ulcer therapy is combined.
2. In case of ulcerative history, corticosteroid therapy may be prescribed, with clinical monitoring and if necessary after fibroscopy.
3. · Corticosteroid therapy can promote the occurrence of various infectious complications due to bacteria, yeasts and parasites. The occurrence of malignant yellows is a significant risk.
4. All subjects from an endemic area (tropical, subtropical, southern Europe) should have parasitological examination of stool and systematic eradication before corticosteroid therapy.
5. Evidence of an infection may be masked by corticosteroid therapy.
6. It is important, before the start of treatment, to remove any possibility of visceral foci, particularly tuberculosis, and to monitor, during treatment, the appearance of infectious pathologies.
7. In case of old tuberculosis, prophylactic anti-tuberculosis treatment is necessary, if there are important radiological sequelae and if it can not be ensured that a well-conducted treatment of 6 months with rifampicin has been given.
8. · The use of corticosteroids requires particularly appropriate monitoring, especially in elderly patients and in cases of ulcerative colitis (risk of perforation), recent intestinal anastomoses, renal failure, hepatic insufficiency, osteoporosis, myasthenia gravis.
9. · This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use

· In case of long-term corticosteroid treatment :

1. o A diet low in fast and hyperprotid absorption sugars must be associated, because of the hyperglycemic effect and the protein catabolism with negativization of the nitrogen balance.
2. o Hydrosoduced retention is usual, partly responsible for a possible rise in blood pressure. Sodium lapport will be reduced for daily dosages greater than 15 or 20 mg prednisone equivalent and moderate in long-term low dose treatments.
3. o Potassium supplementation is justified only for high-dose treatments, prescribed for a long time or in case of risk of rhythm disorders or association with hypokalaemic treatment.
4. o The patient must always have a calcium and vitamin D intake.
5. o When corticosteroid therapy is essential, diabetes and high blood pressure are not contraindications, but treatment can lead to imbalance. Their management should be re-evaluated.
6. o Patients should avoid contact with individuals with chickenpox or measles.

· Attention is drawn to athletes , this specialty containing an active ingredient that can induce a positive reaction of the tests performed during anti-doping controls.

Associations advised against

Drugs giving torsades de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine, vincamine)

• Use substances which do not have the disadvantage of causing torsades de pointes in case of hypokalemia.

Associations subject to precautions of use

Acetylsalicylic acid by general route and by extrapolation other salicylates

• Decrease of salicylemia during corticosteroid treatment and risk of salicylate overdose after discontinuation, by increased salicylate elimination by corticosteroids.
• Adjust salicylate doses during combination and after stopping corticosteroid treatment.

Antiarrhythmics giving torsades de pointes (amiodarone, bretylium, disopyramide, quinidine, sotalol).

• Hypokalemia is a contributing factor as well as bradycardia and a preexisting long QT space.
• Prevent hypokalemia, correct if necessary; monitor the QT space. In case of torsade, do not administer anantiarrhythmic (electrosystolic drive).

Oral anticoagulants

• Possible impact of corticosteroid therapy on the metabolism of oral lanticoagulant and coagulation factors.
• Haemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) at high doses or prolonged treatment for more than 10 days.
• When the association is justified, reinforce the monitoring: biological control on the 8th day, then every 15 days during the corticotherapy and after its stop.

Other hypokalaemic agents (alone or associated hypokalaemic diuretics, stimulant laxatives, amphotericin B (IV route)).

• Hypokalemia favoring the toxic effects of digitalis.
• Monitor the serum potassium, correct if necessary and possibly ECG.

Parenteral heparins

• Heparin aggravation of hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or prolonged treatment greater than 10 days.
• Association must be justified, strengthen monitoring.

Enzyme inducers: carbamazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin.

• Decreased plasma levels and the efficacy of corticosteroids by increasing their hepatic metabolism. The consequences are particularly important for addisonians and transplant patients.
• Clinical and biological surveillance, adaptation of the dosage of corticosteroids during the association and after the end of the enzymatic inducer.

 Insulin, metformin, sulphonylureas

• Elevation of blood glucose with sometimes ketosis (decreased tolerance to carbohydrates by corticosteroids).
• Prevent the patient and strengthen blood and urinary monitoring, especially at the beginning of treatment. If necessary, adjust the dosage of antidiabetic during treatment with corticosteroids and after stopping.

 Isoniazid (described for prednisolone)

• Decreased plasma levels of lisoniazide. Invoked mechanism: increased lisoniazide hepatic metabolism and decreased glucocorticoid metabolism.
• Clinical and biological surveillance.

Gastrointestinal topical: salts, oxides and hydroxides of magnesium, aluminum and calcium (described for prednisolone, dexamethasone).

• Decreased digestive absorption of glucocorticoids.
• Take the gastrointestinal topical glucocorticoid away (more than 2 hours if possible).

Associations to consider

Antihypertensives

• Decreased antihypertensive effect (water-soluble retention of corticosteroids).

Alpha interferon

• Risk of inhibition of the action of interferon.

 Attenuated live vaccines

• Risk of generalized illness, possibly fatal. This risk is increased in subjects already immunocompromised by the underlying disease.
• Use inactivated vaccine when present (poliomyelitis).

Drive and use machines:

Not applicable.

PREGNANCY / BREAST FEEDING / FERTILITY

celestone during pregnancy

• In animals, the experiment shows a teratogenic effect that varies according to the species.In humans, there is a placental transfer. However, epidemiological studies have not detected any risk of malformation related to taking corticosteroids during

• ^st  quarter. In chronic diseases, requiring treatment throughout pregnancy, a slight intrauterine growth retardation is possible. Neonatal adrenal insufficiency has been observed exceptionally after high dose corticosteroid therapy. It is justified to observe a period of clinical surveillance (weight, diuresis) and biological monitoring of the newborn.
• As a result, corticosteroids may be prescribed during pregnancy, if needed.

Breastfeeding

In case of treatment at large doses and chronically, breastfeeding is not recommended.

To be effective, this medicine should be used regularly. However, if you miss a dose, continue the treatment normally.

What happens if I overdose from Celestene ?

Call your doctor or pharmacist if you have used CELESTENE 2 mg dispersible tablet breakable in greater or greater amounts than prescribed

What is  Forms and Composition?

FORMS and PRESENTATIONS

• Dispersible 2 mg tablet (white):   Bottle of 20.

COMPOSITION

	p cp
betamethasone	2 mg

• Excipients: granulated lactose monohydrate and cellulose powder 75/25 (Cellactose), crospovidone (Polyplasdone XL 10), aspartame, magnesium stearate.
• Excipients with known effect: aspartame (E951), lactose.

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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