Predsol 5 mg/5 ml 125 ml

Predsol 5 mg/5 ml 125 ml

Composition:
Active ingredient:
Prednisolone sodium phosphate - 6.7 mg (equivalent to 5 mg prednisolone) per 5 ml.
Inactive ingredients:
Potassium dihydrogen phosphate anhydrous, dipotassium hydrogen phosphate, disodium edetate, methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitol, neohesperidin dihydrochalcone, Ponceau 4R, strawberry flavor, purified water.
Description:
Preusol contains prednisolone sodium phosphate, a synthetic glucocorticoid with potent anti-inflammatory, antiallergic, and immunosuppressive properties.
The soluble form minimizes gastric irritation and is suitable for high-dose therapy.
Indications for Use:
Rheumatologic and connective tissue disorders:
- Rheumatoid arthritis
- Systemic lupus erythematosus (non-organ-threatening)
- Juvenile dermatomyositis
Severe or chronic allergic conditions unresponsive to conventional therapy:
- Bronchial asthma (children and adults)
- Sarcoidosis
- Autoimmune hemolytic anemia.
Dosage and Method of Administration:
The lowest effective dose should be used.
Adults:
- Short-term therapy: 20-30 mg daily, then taper by 2.5-5 mg every 2-5 days.
- Rheumatoid arthritis: 7.5-10 mg daily for maintenance.
- Other conditions: 10-30 mg daily for 1-3 weeks, then reduce to minimal effective dose.
Children:
- Under 2 years: up to 10 mg daily.
- 2-5 years: up to 20 mg daily.
- Over 5 years: up to 30 mg daily or as prescribed.
- Take after meals.
Discontinue gradually after long-term use.
Contraindications:
- Hypersensitivity to prednisolone or excipients.
- Active tuberculosis, psychosis, peptic ulcer disease.
- Herpes simplex, systemic fungal or parasitic infections without specific treatment.
- Use of live vaccines.
Precautions:
- Adrenal suppression may occur during prolonged therapy - withdraw gradually.
- Increases susceptibility to infections and may mask their symptoms.
- May cause growth retardation in children; use minimal dose for shortest duration.
- In systemic sclerosis, may cause renal crisis.
- Psychiatric reactions and visual disturbances (cataract, glaucoma, CSCR) possible.
- Caution in patients with diabetes, hypertension, osteoporosis, renal or hepatic impairment.
- Avoid live vaccines during treatment.
Side Effects:
Depend on dose and treatment duration.
Possible reactions:
- Metabolic: sodium and fluid retention, hypokalemia, weight gain.
- Gastrointestinal: nausea, ulcers, bleeding.
- Cardiovascular: hypertension, arrhythmia.
- Endocrine: Cushingoid features, adrenal suppression.
- Musculoskeletal: myopathy, osteoporosis.
- Psychiatric: euphoria, irritability, insomnia, depression, psychosis.
- Dermatologic: acne, rash, urticaria, delayed wound healing, Stevens-Johnson syndrome.
Pregnancy and Breastfeeding:
Use only if benefits outweigh potential risks.
May cause fetal adrenal suppression if used in late pregnancy.
Glucocorticoids pass into breast milk; avoid breastfeeding for 4 hours after high doses.
Storage Conditions:
Store below 30°C in the original package.
Protect from light.
Keep out of reach of children.
Packaging:
Carton box containing bottle 125 ml with tamper-evident cap, measuring cup, and leaflet.