Solupred Uses, Dosage, Side Effects, Precautions & Warnings

What is Solupred?
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solupred medicine Generic drug of the therapeutic class: Anti-inflammatory
active ingredients: Prednisolone

What is Solupred?

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

what is solupred used for and indication ?

Conditions or diseases:
Collagenosis, connectivites:
  • 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 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 short-course in case of failure of inhaled treatment in 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.

Solupred Dosage

Oral way.

  1. Anti-inflammatory equivalence (equipotence) for 5 mg prednisone: 5 mg prednisolone.
  2. The tablets will be dissolved in a glass of water during the meal.
  3. If the calculated weight dose is less than 5 mg per day, a more appropriate dosage is available.

solupred dosage adulte

  1. The dosage varies according to the diagnosis, the severity of the condition, the prognosis, the patient’s response and the tolerance to the treatment.
  2. Attack treatment : 0.35 to 1.2 mg / kg / day. As an indication : 4 to 14 tablets in an adult of 60 kg.
  3. In severe inflammatory diseases , the dosage ranges from 0.75 to 1.2 mg / kg / day. As an indication: 9 to 14 tablets per day for an adult of 60 kg.
  4. The very exceptional situations may require higher doses.
  5. Maintenance treatment: 5 to 15 mg / day, or 1 to 3 tablets a day.

solupred dosage child

  1. The dosage should be appropriate to the condition and weight of the child.
  2. Attack treatment : 0.5 to 2 mg / kg / day. As an indication : 2 to 10 tablets for a child of 25 kg.
  3. Maintenance treatment : 0.25 to 0.5 mg / day. As an indication : 1 to 2 tablets for a child of 25 kg.
  4. The prescription of alternating day corticosteroid therapy (one day without corticosteroid and the second day with a double dosage of the daily dosage that would have been required) is used in children to try to limit stunting.
  5. This alternate day schedule can be considered only after control of inflammatory disease by high doses of corticosteroids, and when during decay no rebound is observed.

IN GENERAL

  1. Treatment at the “attack dose” should be continued until the disease is well controlled. In the case of long-term treatment, the decrease must be slow. Obtaining a weaning is the goal. Maintaining a maintenance dose (minimum effective dose) is a compromise that is sometimes necessary.
  2. 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.

Stop treatment

  1. The rate of withdrawal depends mainly on the duration of treatment, the starting dose and the disease.
  2. The treatment causes resting secretions of ACTH and cortisol with sometimes lasting adrenal insufficiency. When weaning, the stop must be done gradually, in stages, because of the risk of relapse: reduction of 10% every 8 to 15 days on average.
  3. For short courses of less than 10 days, stopping treatment does not require decay.
  4. When decreasing doses (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, alone, the possibility of occurrence of adrenal insufficiency during a stress.
  5. 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, excluding 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
  • Hypersensitivity to prednisolone or to any of the excipients
  • Phenylketonuria (due to the presence of aspartame).

How it works Solupred

Pharmacotherapeutic group: GLUCOCORTICOIDES, ATC code: H02AB06.

H: Non-sexual systemic 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.

Solupred Side Effects

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

This medicine, essential for your health, is most often well tolerated when you follow the recommendations and especially the diet low in salt, sugar and high protein (see also the paragraph “Warnings and precautions”).

It may nevertheless result, depending on the dose and the duration of the treatment, more or less troublesome effects.

The most common side effects are:

  1. · A modification of some results of your analyzes (salt, sugar, potassium) that may require a diet or a complementary treatment.
  2. · An appearance of bruises.
  3. · Elevated blood pressure, water retention and salt may lead to heart failure.
  4. · Mood disorders (excitement, euphoria), sleep disorders (insomnia).
  5. · A set of disorders called Cushing’s syndrome recognizable by weight gain, swelling and redness of the face, excessive growth of hair.
  6. · Bone fragility (osteoporosis, fractures, vertebral compression in particular).
  7. · Painful disorders of bone at the hip larticulation (osteonecrosis).

Other, much rarer effects have been observed:

  1. · Insufficient production of hormones by the gland located above the kidneys (adrenal gland).
  2. · Stunting in children
  3. · Rule disorders.
  4. · Muscle weakness, tendon rupture especially if SOLUPRED 5 mg, effervescent tablet is associated with certain antibiotics (fluoroquinolones).
  5. · Digestive disorders: digestive ulcer, bleeding and digestive perforations,
  6. · Inflammation of the pancreas especially among child.
  7. · A weakening of the skin, a delay of cicatrization, of lacné.
  8. · Disorientation in time and space (confusion), convulsion, depressive state at the end of treatment.
  9. · Vision problems that may lead to loss of vision: blurred vision, some forms of glaucoma (increased fluid pressure) and cataracts (opacification of the lens), chorioretinopathies (retinal disease).
  10. · Endocrine disorders (hormonal disorders): occurrence of seizures related to the presence of pheochromocytoma (tumor of the adrenal glands) and can put your life in danger.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information on the safety of the medicine.

Solupred Interactions

Hypokalaemic drugs

  • Hypokalemia is a factor favoring the development of cardiac arrhythmias (torsades de pointes, in particular) and increasing the toxicity of certain drugs, for example digoxin. As a result, medications that can lead to hypokalemia are involved in a large number of interactions.
  • These are hypokalaemic diuretics, alone or in combination, stimulant laxatives, glucocorticoids, tetracosactide and amphotericin B (route IV).

Associations advised against

(See section Warnings and precautions for use )

Attenuated live vaccines

  • Risk of widespread, life-threatening vaccine disease.

Acetylsalicylic acid

  • Increased hemorrhagic risk.
  • Combination not recommended with anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose and / or ≥ 3 g daily).

Associations subject to precautions for use

Oral anticoagulants

  • Possible impact of corticosteroid therapy on the metabolism of the oral anticoagulant and that of the coagulation factors. Hemorrhagic risk specific to corticosteroids (digestive mucosa, vascular fragility) in high doses or in prolonged treatment greater 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 drugs (diuretics with or without hypokalemia, stimulant laxatives, IV amphotericin B, tetracosactide)

  • Increased risk of hypokalemia. Monitoring of serum potassium with, if necessary, correction.

Enzymatic inducing anticonvulsants: carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone

  • Decreased plasma concentrations and corticosteroid efficacy by increased hepatic metabolism by the inducer; the consequences are particularly important for addisoners treated with hydrocortisone and for transplantation. Clinical and biological surveillance; adjustment of corticosteroid dosage during treatment with the inducer and after discontinuation.

Digital

  • Hypokalemia favoring the toxic effects of digitalis. Correct any hypokalemia beforehand and perform clinical, electrolytic and electrocardiographic monitoring.

Insulin, metformin, sulphonylureas

  • Increased blood glucose with sometimes ketoacidosis by decreasing glucocorticoid tolerance due to corticosteroids. Prevent the patient and strengthen the self-monitoring glycemic and urinary, 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 concentrations of isoniazid. Invoked mechanism: increased hepatic metabolism of isoniazid and decreased glucocorticoid. Clinical and biological surveillance.

Drugs that may give torsades de pointes: class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide) and class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide), certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, cyamemazine, sulpiride, sultopride) , amisulpride, tiapride, pimozide, haloperidol, droperidol, veralipride), bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, lumefantrine, methadone, mizolastine, moxifloxacin, pentamidine, spiramycin IV, vincamine IV)

Drug with same Active ingredient
  • Higher risk of ventricular arrhythmias, especially torsades de pointes. Correct all hypokalemia before administering the product and perform clinical, electrolytic and electrocardiographic monitoring.

Rifampicin

  • Decreased plasma concentrations and efficacy of corticosteroids by increasing their hepatic metabolism with rifampicin; the consequences are particularly important for addisoners treated with hydrocortisone and for transplantation. Clinical and biological surveillance; Adjustment of corticosteroid dosage during rifampicin treatment and after discontinuation.

Gastrointestinal Topicals, Antacids and Charcoal (described for prednisolone, dexamethasone)

  • Decreased digestive absorption of glucocorticoids. Take topical gastrointestinal and antacid drugs away from glucocorticoids (more than 2 hours if possible).

Associations to consider

Antihypertensives

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

Fluoroquinolones

  • Possible increase in the risk of tendonopathy or even tendon rupture (exceptional), particularly in patients receiving prolonged corticosteroid therapy.

Acetylsalicylic acid

  • Increased hemorrhagic risk.
  • To be taken into account with analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day).

Nonsteroidal anti-inflammatory drugs

  • Increased risk of ulceration and gastrointestinal bleeding.

Ciclosporin

  • Increased effects of prednisolone: ​​Cushingoid appearance, reduced carbohydrate tolerance (decreased clearance of prednisolone).

Warnings and Precautions

Special warnings

  1. In case of peptic ulcer, corticosteroid therapy is not contraindicated if anti-ulcer treatment is associated.
  2. In the case of an 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 in particular to bacteria, yeasts and parasites. The occurrence of a malignant yellowing is a significant risk. All subjects from an endemic area (tropical, subtropical, southern Europe) should have parasitological examination of the stool and systematic eradication before corticosteroid therapy.
  4. Evidence of an infection may be masked by corticosteroid therapy.
  5. It is important, before the start of treatment, to rule out any possibility of visceral foci, especially tuberculosis, and to monitor, during treatment, the appearance of infectious pathologies.
  6. In case of old tuberculosis, prophylactic anti-tuberculosis treatment is necessary, if there are significant radiological sequelae and if one can not ensure that a good 6-month rifampicin treatment has been given.
  7. 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.
  8. Oral or injectable corticosteroids can promote the appearance of tendonopathy, or even tendon rupture (exceptional). This risk is increased when co-prescribed with fluoroquinolones and in dialysis patients with secondary hyperparathyroidism or renal transplantation.
  9. This medicinal product is not recommended in combination with a live attenuated vaccine or with anti-inflammatory doses of acetylsalicylic acid.
  10. This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

Precautions for use

In case of long-term corticosteroid treatment:

  1. A diet low in fast-absorbing and high-protein sugars must be associated, because of the hyperglycemic effect and the protein catabolism with negativization of the nitrogen balance.
  2. Hydrosoduced retention is usual, partly responsible for a possible rise in blood pressure. This medicine contains sodium. This medicine contains 1.05 mmol (or 24 mg) of sodium per tablet. To be taken into account in patients on a strict sodium diet.
  3. Sodium intake will be reduced for daily dosages above 15 or 20 mg prednisone equivalent and moderate in long-term low-dose treatments.
  4. Potassium supplementation is warranted only for high-dose, long-term treatment or when there is a risk of rhythm disturbance or combination with hypokalaemic treatment.
  5. The patient must always have a calcium and vitamin D intake.
  6. When corticosteroid therapy is essential, diabetes and high blood pressure are not contraindications, but treatment can lead to imbalance. Their management needs to be re-evaluated.
  7. Patients should avoid contact with individuals with chickenpox or measles.
  8. Attention is drawn to athletes, this specialty containing an active ingredient that can induce a positive reaction tests conducted during anti-doping controls.

Drive and use machines

Not applicable.

 PREGNANCY / BREAST FEEDING / FERTILITY

solupred and pregnancy

  • This medication will only be used during pregnancy if necessary. If you discover that you are pregnant during treatment, consult your doctor because only he can judge the need to continue this treatment.

feeding

  • Breastfeeding should be avoided during treatment because of passage into breast milk.
  • Ask your doctor or pharmacist for advice before taking any medicine.

What happens if I overdose from Solupred ?

Not applicable.

What is  Forms and Composition ?

FORMS and PRESENTATIONS

Effervescent tablet 5 mg:   Bottle of 30. Effervescent tablet 20 mg:   Bottle of 20. Orodispersible 5 mg tablet:   Box of 30, in blister packs. Hospital model: Box of 50, in blister packs. 20 mg Orodispersible Tablet:  Box of 20, in blister packs. Hospital model: Box of 50, in blister packs. Oral solution 1 mg / ml:   50 ml bottle with child safety cap and dosing syringe (4 graduations: 0.5 ml, 1 ml, 1.5 ml, 2 ml).

COMPOSITION
Effervescent tablet : p cp
prednisolone 5 mg
or 20 mg
(as metasulfobenzoate sodium: 7.86 mg / cd at 5 mg, 32.416 mg / cp at 20 mg)

Excipients:

  • 5 mg Cp: tartaric acid, citric acid anhydrous, sodium bicarbonate, lithium benzoate, sucrose.
  • Cp 20 mg: tartaric acid, citric acid anhydrous, sodium bicarbonate, lithium benzoate, lemon natural flavor (maltodextrin, vegetable gum, sorbitol, lemon essential oil, citral, citronellal), sodium saccharin, silicone antifoam emulsion .

Excipients with known effect :

  • Cp at 5 mg: sodium (24 mg / cp), sucrose.
  • Cp at 20 mg: sodium (50.8 mg / cp), sorbitol.
Orodispersible tablet: p cp
prednisolone 5 mg
or 20 mg
(as metasulfobenzoate sodium: 7.86 mg / cp at 5 mg, 31.44 mg / cp at 20 mg)
  • Excipients (common): dispersion of 30% polyacrylate (Eudragit NE 30 D), hydrophobic colloidal silica (Aerosil R972), mannitol (granule), mannitol (powder), crospovidone, aspartame, magnesium stearate.
  • Excipient with known effect: aspartame.
Drinkable solution : p ml
prednisolone 1 mg
(as metasulfobenzoate sodium: 1.57 mg / ml)
  • Excipients: sodium cyclamate, glycerol, sorbic acid, sodium saccharinate, sorbitol (E420), sucrose, ethanol, purified water. Aroma: apricot (ethyl alcohol, vanillin, benzoic aldehyde, isoamyl acetate, diacetyl, ionone, allyl caproate, gamma undelactone, gamma nonalactone, levisticum tincture, essential oils of lemon, orange, bergamot, coriander , neroli, chamomile, cinnamon, nutmeg).
  • Excipients with known effect: sucrose, sorbitol (E420), ethanol.

1 ml of solution contains 30 mg of alcohol, 200 mg of sucrose and 150 mg of sorbitol (E420).

Alcoholic title: 4% (v / v).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

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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