API

Prednisolone (5mg/5ml)

Drug classification

Glucocorticoid; corticosteroid (systemic).

Dosage form

Oral solution containing prednisolone 5 mg per 5 ml.

API strength per dosage

Dose

Omnacortil Oral Solution (prednisolone 5mg/5ml) dosing is individualized based on disease severity and patient response. Typical initial doses range from 5–60 mg daily in divided doses. Pediatric dosing is weight-based. Use lowest effective dose. Taper gradually after long-term use. Adjust cautiously in hepatic impairment; monitor closely. No specific renal adjustment, but use with caution.

Mechanism of action

Prednisolone binds to cytosolic glucocorticoid receptors, modulating gene transcription. This suppresses pro-inflammatory cytokines and mediators, inhibits leukocyte infiltration, and reduces capillary permeability. The result is decreased inflammation and immune response, providing anti-inflammatory and immunosuppressive effects throughout the body.

Indications

Treatment of Inflammatory conditionsTreatment of Autoimmune conditionsTreatment of Severe allergic reactionsTreatment of Allergic conditionsTreatment of Rheumatic disorderTreatment of Skin disordersTreatment of Eye disordersTreatment of Nephrotic syndrome

Side effects

Irritability Easy bruise Growth retardation Upper respiratory tract infection Cough Frequent urge to urinate Abnormal hair growth Obesity Reduction in bone density Upset stomach Behavioral changes Mood changes Weight gain

Pregnancy category

Prednisolone may be used in pregnancy if benefits outweigh risks; potential fetal risks exist, especially with prolonged use or high doses. Use lowest effective dose.

Precautions

Monitor for hyperglycemia, hypertension, infection risk, gastrointestinal bleeding, osteoporosis, adrenal suppression, mood changes, growth retardation in children, electrolyte imbalance, ocular effects (cataracts, glaucoma), taper dose gradually after long-term use, use caution in patients with diabetes, peptic ulcer, psychiatric disorders, or tuberculosis.

Contraindications

Systemic fungal infections, hypersensitivity to prednisolone or any component of the formulation, administration of live or attenuated vaccines in patients receiving immunosuppressive doses.