Prednisolone. 5 mg. 20 tablets

Prednisolone. 5 mg. 20 tablets
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Prednisolone is a corticosteroid drug product from the group of the so-called steroid (naturally occurring hormone produced in the body) to be applied for treatment of various diseases. 

Prednisolone. 5 mg. 20 tablets

 
 
WHAT prednisolone AND WHAT IT IS USED

Prednisolone is a corticosteroid drug product from the group of the so-called steroid ( naturally occurring hormone produced in the body) to be applied for treatment of various diseases. In addition, they alter the body's immune response to various stimuli . Prednisolone corticosteroid administered in the treatment of :

Allergic diseases - skin rash (urticaria ), allergic rhinitis, allergic conjunctivitis , bronchial asthma, severe life-threatening conditions ( angioneurotic edema) ;

Systemic connective tissue diseases - rheumatic diseases and diseases of the coupling system ( polymyalgia rheumatica , polyarteritis iodoza , systemic lupus , polymyositis, dermatomyositis, scleroderma , vasculitis ) ;

Inflammatory joint diseases - diseases of the locomotory system ( rheumatism, reactive arthritis , rheumatoid arthritis , psoriatic arthritis , chronic juvenile arthritis ) ;

Gastrointestinal disorders - some diseases of the gastro -intestinal tract (Crohn's disease , ulcerative colitis , chronic active hepatitis in a non-viral origin ) ;

Respiratory diseases (pulmonary aspergillosis , pulmonary fibrosis , pulmonary alveolitis , foreign body aspiration and gastric contents , pulmonary sarcoidosis, elastic croup ) ;

Kidney diseases - mainly autoimmune ( lupus nephritis , acute interstitial nephritis, changes in glomerulonephritis ) in renal transplantation;

Neurological diseases - subacute demyelinating polyneuropathy, cranial trauma , myasthenia gravis , multiple sclerosis ;

Cardiovascular disease - a condition after a heart attack , inflammation of the heart sac ( pericarditis ) ;

Blood diseases - anemia (haemolytic autoimmune ), some blood cancers ( leukemia - acute and chronic lymphocytic lymphoma , multiple myeloma ) , idiopathic thrombocytopenic purpura ;

Endocrine disease - primary and secondary adrenal insufficiency , congenital adrenal increase , adreno - genital syndrome , inflammation of the thyroid ( thyroidites ) ;

Skin diseases - severe skin disease ( pemphigus vulgaris, bullous pemphigoid, pyoderma ganrenozum ) .

Eye diseases - inflammation of the sclera ( scleritis ) inflammation of the uvea (front and rear uveitis ) , vascular inflammation of the retina ( vasculitis) , orbital pseudotumor , malignant ocular Graves' disease ;


2 . WHAT YOU NEED TO KNOW BEFORE treatment with prednisolone

Prednisolone does not apply to :

* Hypersensitivity to the drug or any of the excipients

* Systemic fungal diseases.

 In this medicinal product, please note the following : The product is used with caution in patients with the following diseases :

- Hypertension ;

- Congestive heart failure ;

And liver failure;

Adrenal insufficiency;

- Diabetes or family obremeneiost to diabetes ;

- Osteoporosis - especially in postmenopausal women ;

Patients with a history of severe mental illness , especially in history for those caused by steroidyai hormones Existing emotional instability may be exacerbated by corticosteroid therapy , epilepsy and / or seizure conditions , ulcers of the stomach and duodenum ;

Spend muscle weakness following treatment with steroid hormones ( steroid myopathy ) Patients with myasthenia gravis who are anticholinesterase therapy, in patients with bleeding disorders because of the risk of increased blood clotting and development of thrombosis, thrombophlebitis and thromboembolic events .

Adverse effects of the product can be minimized by using the lowest effective dose for the minimum period or periodic administration of a single morning dose . The patient should be monitored regularly.

adrenal insufficiency

Corticosteroids used for a long period may lead to suppression of certain structures in the brain and adrenal ( hypothalamic- pituitary suppression of adrenaline ) - secondary adrenal insufficiency. Its extent and duration varies and depends on the dose , frequency of administration and duration of glucocorticoid treatment. Acute adrenal insufficiency leading to fatal outcome may occur if therapy with glucocorticoids break sharply. Drug-induced adrenal insufficiency can be avoided by gradually reducing the dose . This condition may persist for months after discontinuation , although stress conditions during this period must be recovered at the reception. Since their minerayakortikoidna secretion may be impaired have salt intake and / or mineralocorticoid . During long-term treatment with the product any disease , trauma or surgery requires a temporary increase in the dose , and if treatment is discontinued product needs to be restored again .

 

Protivovazpalntelen / immunosuppressive effect and infections

Suppression of the inflammatory response and immune function increases susceptibility to infections such as septicemia ( severe infection of the blood) and tuberculosis may be masked and reach an advanced stage before being recognized. The immunosuppressive effects of glgokokortikoidite can lead to reactivation of latent infection , or exacerbation of an existing infection . varicella
It has been shown that the background of chickenpox immunity suppressive therapy can be fatal . Patients (parents and children) of such treatment should avoid contact with chickenpox or herpes zoster and if available to seek medical .

In patients receiving systemic corticosteroids , or those treated with them in the last three months needed immunization with varicella - zoster immune globulin . It must be given within 10 days of exposure to chickenpox . Proven disease at the dose of corticosteroids should be increased . The effect of corticosteroids can be increased in patients with hypothyroidism ( underactive thyroid gland ), and those with chronic liver damage with affected liver function .

measles

 Patients should avoid exposure to measles and, if so, to seek medical advice . Use of a live vaccine

Not recommended for live vaccines in patients receiving high doses of corticosteroids . Vaccination should be postponed for at least 3 months after discontinuation of treatment.
ocular effects
Prolonged treatment with corticosteroids may produce posterior subcapsular and nuclear cataracts (particularly in children) , ekzoftalm ( protrusion of the eyeball ) or increased intraocular pressure leading to glaucoma with possible damage to the optic nerves. There is a risk of development of secondary fungi or viral infection of the eye .

Corticosteroids are used with caution in patients with ocular herpes simplex because of the risk of perforation .

Disease Kaishng

 kortikostereroidite can cause or intensify Cushing's syndrome , they should be avoided in patients with this disease. Corticosteroids have a strong effect in reduced thyroid function and cirrhosis. Upon treatment with corticosteroids may occur psychiatric disorders such as euphoria , insomnia , mood , personality changes , severe depression .


Use in children

Corticosteroids can cause irreversible growth retardation in childhood and in adult life , which is why their application should be avoided . If necessary, a continuous treatment, it should be limited to a minimum inhibition of their own production of hormones. The growth and development of children should be supervised . Treatment where possible should be performed with single doses or during certain periods.

Use in elderly patients
Treatment of elderly patients , especially long , must comply with the changes in this age - osteoporosis, diabetes , hypertension, hipokadiemnya , sensitivity to infection and thinning of the skin. A patient monitoring .


Application of Prednisolone and intake of food and beverages

No evidence of a need for a special diet or restrictions on certain types of food and beverages during treatment with this product.


pregnancy

Before intake of any medicines consult your doctor or pharmacist
Corticosteroids should be prescribed only when the benefit outweighs the risk of their use.

breastfeeding
 Before intake of any medicines consult your doctor or pharmacist Corticosteroids are excreted in breast milk in small amounts. Adopted it, they may suppress growth and prevent their glucocorticoid production in newborns. If treatment with prednisolone, to breast-feeding should be stopped.


Driving and using machines

Prednisolone does not affect driving or operating machinery. Taking other medicines . Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines soon , even if they have not been prescribed by your doctor !
The following are possible interactions:

Drugs that induce a particular group of liver enzymes ( cytochrome P-450 ) as phenobarbital , phenytoin , rifampicin, rnfabutin , carbamazepine , primidone and aminoglutethimide can reduce the therapeutic effect of corticosteroids by enhancing metabolism . May be a lack of expected response to the dose be increased

Drugs that suppress the designated group of liver enzymes ( cytochrome P-450 ) as ketoconazole and troleandomycin , erythromycin , cimetidine may reduce the secretion of glucocorticoids from the body. The doses of corticosteroids , when used in combination with them , to be reduced in order to avoid potential side effects .

Glucocorticoids may increase blood glucose levels . Diabetic patients receiving concomitant insulin and / or oral hypoglycemic agents require compliance therapy. Simultaneous administration of drugs such as indomethacin, which can lead to ulcers in the gastrointestinal tract, increasing the risk of formation of such . Acetylsalicylic acid ( acetysal ) should be used with caution in combination with glucocorticoids in patients with hypoprothrombinemia .

 Blood concentrations of salitsidatite may fall when administered concomitantly with corticosteroids. Renal excretion of salicylates is increased by corticosteroids and stopping them can lead to poisoning by salicylates . This requires concomitant use be undertaken with caution. Rifamycin increase metabolism of corticosteroids , and this can reduce the effect thereof . Eritromitsii suppresses metabolism of methylprednisolone and possibly other ???????????????.?????????? of anticoagulants can be reduced or , less commonly , increased corticosteroid . It is imperative to monitor the prothrombin time and bleeding time in order to avoid spontaneous bleeding . Carbamazepine, phenobarbital, phenytoin and primidone increase metabolism of corticosteroids and may reduce their effect.

Coadministration of amphotericin corticosteroids may develop hilokaliemiya (low potassium levels in the blood) , so this combination should be avoided when possible. Ketoconazole inhibits the metabolism of methylprednisolone and possibly other corticosteroids. Ritonavir increases blood concentrations of prednisolone and other corticosteroids. May result in increased toxicity and hypokalemia when given with corticosteroids. Increased risk of toxicities on hematopoiesis in combination with methotrexate. Live vaccines should be administered to individuals with reduced immune response. Response to other vaccines may be of insufficient Estrogens may enhance the effects of glucocorticoids and that dose adjustment if estrogens are added or excluded from treatment course . Prednisolone can suppress the growth effects of somatropin . Increased risk of hypokalemia (low potassium ), using the high doses of corticosteroids at high doses of bambuterol , fenoterol, formoterol, ritodrine, salbutamol, terbutaline and ealmeterol . The desired effect of drugs that lower blood sugar ( including insulin) , antihypertensive ( blood pressure lowering ) and diuretic (increasing urine flow ) decreased by corticosteroids and hypokalaemic effects of acetazolamide , loop and thiazide diuretics, and theophylline carbenoxolone increases.


3 . HOW TO USE prednisolone

Always take Prednisolone as instructed by the doctor! The choice of product , route of administration and dose are highly individual and medical indication , fractionation Annex shall be taken 2 to 4 times daily at high doses. At a lower maintenance dose (5 to 10 mg), taken once in the morning .

 Llterniragtsa therapy

 This type of therapy is used in the need for long-term maintenance therapy - dose in 48 hours is taken once in a day. In such a reception largely avoid the phenomena of hypocorticism decreased suppression of pituitary - adrenal a systematic achieves the desired effect.

pulse therapy

Apply 1 g methylprednisolone i.v. in 200-250 ml serum for 20 min on three consecutive days. This way of dosing is used in severe systemic connective tissue disease , CNS active processes , heavy trombotsitopeiiya . Necessarily be followed by oral therapy. The initial treatment with the product starts with a higher dose (40-60 mg per day ) , the dose is gradually reduced to the minimum effective dose . A reduction to 30 mg per day may be from 1-2 tablets of 7-10 days , then the maintenance dose of 5 to 7,5 mg is reduced by ½ to 1 tablet every 10-15 days. Initially evening dose was removed , and then a lunch . Intercurrent illness at the dose should be increased. Dose of 5 mg daily does not inhibit pituitary- nadbabrechiata system.


Use in children

The dose will typically be determined based on clinical response as in adults. Alternating therapy is recommended if possible. In adreno - cortical insufficiency oral dose of 140 mg / kg body weight per day , divided four . For other indications , the daily dose is body weight 500 mg / kg per day, divided into 3-4 doses.

Use in elderly patients

Treatment of such patients must comply with the most side effects in this age. If you have the impression that the effect of Prednisolone is strong or too weak, talk to your doctor or pharmacist !

If you take a large amount of the drug

When taking a higher dose than prescribed immediately contact a doctor ! Rare are the cases of overdosage of glucocorticoids . There is no specific antidote , treatment is symptomatic and supportive. Monitoring of electrolyte levels.

If you forget to use Prednisolone :

If you forget to take the next dose then take the missed as soon as possible , but do not take the same time to the next .


4 . POSSIBLE SIDE EFFECTS

Like any other medicine, Prednisolone can cause side effects .

The incidence of adverse effects is related to dose , time of administration and duration of treatment.

General - leukocytosis (increased white blood cell count ) , hypersensitivity, incl. Anaphylaxis (severe life-threatening reaction) , thromboembolism (formation of blood clots and blockage of blood vessels) , fatigue , malaise ;

Cardiovascular - Congestive heart failure , hypertension ;

Gastrointestinal - heartburn , nausea , vomiting, peptic ulcers with perforations and bleeding , abdominal pain, increased appetite, weight gain , diarrhea , ulcers of the esophagus, oesophageal candidiasis , acute pancreatitis ; Muskulosksletni - proximal myopathy , osteoporosis, vertebral fractures and long bone, avascular osteonecrosis , tendon rupture , myalgia ;

Metabolic / nutritional, - sodium and water retention hipokaliemichia alkalosis , potassium loss , negative calcium balance and carbon ;

Skin - delayed healing processes , hair, skin thinning , striae , telangiectasia ( vascular extensions of the skin) , acne, increased sweating, pruritus (itching in the genitals) , rash, urticaria ;

Endocrine - suppression of hypothalamic- pituitary adrenal system, especially under stress , as in trauma surgery or disease, stunted growth in childhood and adulthood , menstrual disorders and cessation of menstruation , increased weight, impaired carbohydrate tolerance with the need for antidiabetic therapy event hidden diabetes , increased appetite ;

Central and peripheral nervous system - euphoria, psychological dependence , depression, insomnia , confusion, headache, dizziness ;

Increased intracranial pressure with papilloedema in children , usually following discontinuation of treatment , increased symptoms of schizophrenia and epilepsy;


If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 .

Do not use after the expiry date stated on the package !


 
 
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