Pedicort Forte 15 mg/5 ml oral solution 100 ml

Pedicort Forte 15 mg/5 ml oral solution 100 ml 

Composition:
Each 5 ml of oral solution contains:
Prednisolone (as sodium phosphate) - 15 mg (equivalent to 20.2 mg prednisolone sodium phosphate).
Excipients:
Sorbitol 70% Non crystalline, Glycerin, Sucrose, Sodium benzoate, Povidone (PVP K30), Ethanol (96%), Sodium Hydroxide, Raspberry 333 flavor, FD&C Red 40 (Allura), Purified water.
Description:
Pedicort Forte is a systemic corticosteroid containing synthetic prednisolone with potent anti-inflammatory and immunosuppressive properties.
It is used to reduce inflammatory responses, suppress excessive immune reactions, and manage acute or chronic allergic, rheumatic, dermatological and respiratory conditions.
Indications:
Pedicort Forte is indicated for:
- Bronchial asthma;
- Allergic and inflammatory disorders;
- Rheumatoid arthritis and other collagen diseases;
- Dermatitis and dermatoses (eczema, psoriasis, pemphigus, etc.).
Dosage and Administration:
Dosage varies depending on the disease severity and patient response.
General adult dose:
Approx. 1 mg prednisolone (0.35 ml) per kg/day, divided into 2 doses (every 12 hours).
Examples:
- Acute bronchial asthma: 40-50 mg/day (13.4-16.7 ml/day) for at least 5 days.
- Allergic & inflammatory conditions: 10-20 mg/day (3.5-6.7 ml/day).
- Maintenance dose: 2.5-15 mg/day (0.84-5.0 ml/day).
- Rheumatoid arthritis: 7.5-10 mg/day (2.5-3.4 ml/day).
Children:
- Asthma (1 month-11 years): 1-2 mg/kg/day (0.35-0.67 ml/kg/day), max 40 mg/day.
- Adolescents (12-17 years): same as adults.
- Allergic/inflammatory conditions: 0.1-2 mg/kg/day in 1-4 doses.
Oral administration only.
Withdrawal must be gradual.
Contraindications:
- Hypersensitivity to prednisolone, glucocorticoids or excipients;
- Gastric/duodenal ulcer;
- Bacterial, viral (herpes, varicella), or systemic fungal infections;
- Psychiatric disorders;
- Pre- or post-vaccination periods;
- Glaucoma;
- Herpetic keratitis;
- BCG lymphadenitis;
- Poliomyelitis.
Precautions:
Use with caution in:
- Gastrointestinal diseases;
- Active or latent infections;
- Hypothyroidism or liver cirrhosis;
- Stressful medical conditions;
- Exposure to measles or varicella;
- Diabetes, hypertension, heart failure;
- Scleroderma (risk of renal crisis ≥15 mg/day);
- Prolonged therapy (osteoporosis risk);
- Glaucoma risk;
- Children (growth suppression);
- Elderly.
- Contains 100 mg ethanol per 5 ml - caution in pregnancy, lactation, liver disease, epilepsy.
- Vaccination not recommended.
- Do not discontinue abruptly.
Side Effects:
Endocrine disorders:
- Common: lipodystrophy, hyperglycaemia.
- Uncommon: weight gain, diabetes, dyslipidaemia, menstrual irregularities, hirsutism.
- Rare: impotence, adrenal suppression, growth retardation, protein catabolism.
Cardiac/Vascular:
- Common: fluid retention, hypokalaemia, hypertension, vasculitis, intracranial hypertension.
 - Unknown: bradycardia.
Skin:
- Common: skin atrophy, striae, acne, bruising.
 - Rare: rash.
Renal:
- Unknown: scleroderma renal crisis.
Blood/Lymphatic:
- Common: delayed wound healing, leukocytosis, thrombocytosis.
Musculoskeletal:
- Common: osteoporosis, fracture risk.
- Rare: muscle weakness, myasthenic crisis.
- Very rare: osteonecrosis, tendon rupture.
Gastrointestinal:
- Rare: gastric/duodenal ulcer, pancreatitis, peritonitis.
Eye:
- Rare: glaucoma, cataract.
- Unknown: blurred vision.
Immune system:
- Uncommon: decreased immunity, activation of viral infections.
Nervous system:
- Rare: seizures, headache, dizziness, sleep disturbances.
Psychiatric:
- Rare: mood changes, euphoria, depression, psychosis.
Pregnancy and Breastfeeding:
Use only if clearly necessary.
Inform physician if pregnancy occurs.
Storage Conditions:
Store at ≤30°C, protected from light.
Keep out of reach of children.
Packaging:
A carton box containing a Bottle 100 ml and leaflet.