Predstad 5

Rx

Indications

For treatments:

• Rheumatoid arthritis, systemic lupus erythematosus, certain forms of vasculitis, temporal arteritis and polyarteritis nodosa, sarcoidosis, bronchial asthma, ulcerative colitis, hemolytic anemia, agranulocytosis, and severe allergic reactions including anaphylaxis.
• Acute leukemia, lymphoma, breast cancer and prostate cancer.

Dosage

Adults

• Initial (induction) therapy: 4–14 tablets/day for an adult weighing 60 kg.
• Severe inflammatory conditions: 9–14 tablets/day for an adult weighing 60 kg.
• Higher doses may be prescribed in special cases.
• Maintenance therapy: 1–3 tablets/day.

Children

• Initial (induction) therapy: 2–10 tablets/day for a child weighing 25 kg.
• Maintenance therapy: 1–2 tablets for a child weighing 25 kg.

An alternate-day corticosteroid regimen (no medication on one day, followed by double the prescribed daily dose the next day) is used in children to minimize the risk of growth retardation. This alternate-day regimen should only be considered after the inflammatory condition has been brought under control with high-dose corticosteroids and provided there has been no relapse during treatment.

Administration

• Predstad 5 is administered orally.
• Put the orodispersible tablet in the mouth, let it dissolve, swallow and drink a glass of water.
• In children under 6 years old, the tablet can be disintegrated beforehand in a little water, then swallowed.
• Do not chew the tablet.

• Hypersensitivity to prednisolone or to any of the ingredients.
• Any infectious state, excluding the specified indications.
• Certain evolving viruses (in particular hepatitis, herpes, chickenpox, shingles).
• Psychotic states not yet controlled by treatment.
• Administration of live virus vaccines.
• Phenylketonuria (due to the presence of aspartame).

Possible adverse reactions

• Hypokalaemia;
• Latrogenic Cushing’s syndrome;
• Menstrual irregularities;
• Gastroduodenal ulcers;
• Acne, purpura;
• Euphoria, insomnia, excitement;
• Blurred vision.

• Patients with osteoporosis, newly established anastomoses (intestine, blood vessel), psychosis, gastric ulcer, duodenal ulcer, diabetes, hypertension, cardiac insufficiency and growing individuals (children).
• Systemic corticosteroids should be used cautiously in the elderly.
• Acute adrenal insufficiency may occur with abrupt withdrawal after long-term therapy or with stress.
• At high doses, interference with vaccination can occur.

In case of long-term treatment with corticosteroids

• A diet low in fast-absorbing and high-protein sugars must be combined, due to the hyperglycemic effect and protein catabolism with negative nitrogen balance.
• Water and sodium retention is usual, partly responsible for a possible rise in blood pressure.
• The sodium intake will be reduced for daily dosages greater than 15 or 20 mg of prednisone equivalent and moderate in long-term treatments at low doses.
• Potassium supplementation is only justified for treatments at high doses, prescribed for a long time or in the event of a risk of arrhythmias or in association with hypokalaemia treatment.
• The patient must systematically have a calcium and vitamin D intake.
• When corticosteroid therapy is essential, diabetes and arterial hypertension are not contraindications but the treatment can lead to their imbalance. Their care should be reassessed.
• Patients should avoid contact with people with chickenpox or measles.
• Attention is drawn to athletes, this specialty containing an active ingredient that can induce a positive reaction of tests carried out during doping controls.
• Predstad 5 contains aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
• Chronic maternal administration of systemic corticosteroids has been associated with a mild decrease in birth weight in human beings. High systemic doses of glucocorticoids may cause small risk for neonatal adrenal hypoplasia.
• Caution should be exercised when prednisolone is given to a nursing mother.
• Patients should be aware of how they react to drug before driving or operating machinery.