Pedicort Forte 15 mg/5 ml oral solution 100 ml
Al Esraa Pharmaceuticals
Al Esraa Pharmaceuticals
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.