Solone Oral Solution contains Prednisolone Sodium Phosphate USP equivalent to Prednisolone 5 mg per 5 ml. It is manufactured by ACI Limited in Bangladesh.

Indications:

Solone Oral Solution is a corticosteroid, a type of steroid medication, which works by suppressing the immune system and reducing inflammation in the body. It is used to treat a wide variety of medical conditions, including:

• Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis. 
• Endocrine Disorders:Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia,non-suppurative thyroiditis, hypercalcemia associated with cancer. 
• Dermatologic Diseases:Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis. 
• Allergic States: Severe or incapacitating allergic conditions unresponsive to conventional treatment, such as seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness,drug hypersensitivity reactions. 
• Respiratory Diseases:Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis (with appropriate chemotherapy), aspiration pneumonitis. 
• Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia(RBC anemia), congenital (erythroid) hypoplastic anemia. 
• Edematous States:To induce diuresis or remission of proteinuria in nephrotic syndrome (of the idiopathic type or due to lupus erythematosus).
• Gastrointestinal Diseases: To tide the patient over a critical period in ulcerative colitis, regional enteritis (Crohn's disease).
• Neoplastic Diseases: For palliative management of acute leukemia and lymphomas in adults and children.
• Nervous System: Acute exacerbations of multiple sclerosis.
• Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa.

Pharmacology:

Prednisolone is a synthetic adrenocortical steroid with predominantly glucocorticoid properties. It directly inhibits the action of the Phospholipase A2 enzyme, which is responsible for producing various inflammatory mediators like Leukotrienes, SRS-A, and Prostaglandins. It suppresses the immune system by reducing the activity and production of lymphocytes and eosinophils, and inhibiting leukocyte infiltration at inflammation sites.

Dosage and Administration:

Solone Oral Solution is administered orally. The dosage varies widely depending on the specific disorder being treated, its severity, and the patient's response. It is often given in divided daily doses. It is recommended to take it with food to minimize gastric upset.

Typical Dosage Examples (for adults, dosage for children varies by weight and age and must be prescribed by a physician):

• Anti-inflammatory conditions: 5 to 60 mg per day in divided doses (1 to 4 times a day).
• Acute Asthma: 40-60 mg/day orally, either as a single daily dose or divided every 12 hours for 3-10 days.
• Allergic Conditions (tapering dose):
  • Day 1: 10 mg before breakfast, 5 mg after lunch and dinner, and 10 mg at bedtime.
  • Day 2: 5 mg before breakfast, after lunch, and after dinner and 10 mg at bedtime.
  • Day 3: 5 mg before breakfast, after lunch, after dinner, and at bedtime.
  • Day 4: 5 mg before breakfast, after lunch, and at bedtime.
  • Day 5: 5 mg before breakfast and at bedtime.
  • Day 6: 5 mg before breakfast.
• Nephrotic Syndrome:Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein-free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks. Maintenance dose: 0.5 to 1 mg/kg/dose given every other day for 3 to 6 months. 

Important: Doses should be gradually reduced and not stopped abruptly, especially after prolonged therapy, to avoid withdrawal symptoms or adrenal insufficiency.

Side Effects:

The incidence and severity of side effects are generally dose-dependent and related to the duration of treatment.

Common side effects (especially with long-term use):

• Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, hypertension. 
• Musculoskeletal:Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis (thinning of bones), vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones. 
• Gastrointestinal:Peptic ulcer with possibleperforation and hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis. 
• Dermatologic:Impaired wound healing, thin fragile skin, petechiae and ecchymoses (bruising), facial erythema (redness), increased sweating, acne, hirsutism (excessive hair growth), striae (stretch marks).
• Neurological: Convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache. 
• Endocrine: Development of Cushingoid state (moon face, buffalo hump), suppression of growth in children, secondary adrenocortical and pituitary unresponsiveness, decreased carbohydrate tolerance, manifestationof latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities. 
• Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos. 
• Metabolic:Negative nitrogen balance due to protein catabolism, weight gain, increased appetite.
• Psychiatric: Euphoria, insomnia, mood swings, personality changes, severe depression, psychosis.
• Increased susceptibility to infection: Steroids can mask signs of infection and increase susceptibility to new infections.

Contraindications:

• Known hypersensitivity to Prednisolone or any component of the oral solution.
• Systemic fungal infections (unless appropriate anti-fungal therapy is employed).
• Live or live-attenuated vaccines should generally not be given to individuals receiving immunosuppressive doses of corticosteroids.
• Ocular herpes simplex due to the possibility of corneal perforation.

Precautions and Warnings:

• Adrenal Suppression: Long-term therapy can lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Abrupt withdrawal can cause adrenal insufficiency.
• Infections: Corticosteroids can mask signs of infection and decrease resistance. Monitor for new infections.
• Existing Medical Conditions: Use with extreme caution and close monitoring in patients with:
  • Tuberculosis (active or latent)
  • Hypertension (high blood pressure)
  • Congestive heart failure
  • Liver failure, renal insufficiency
  • Diabetes mellitus or family history of diabetes
  • Osteoporosis
  • Peptic ulcer disease, diverticulitis, ulcerative colitis
  • Thyroid dysfunction
  • History of severe affective disorders or psychosis
  • Epilepsy
  • Glaucoma or cataracts
• Growth in Children: Long-term administration in children can cause growth retardation.
• Chickenpox and Measles: Patients on corticosteroids are more susceptible to severe or fatal chickenpox or measles. Avoid exposure; if exposed, seek immediate medical attention.

Pregnancy and Lactation:

• Pregnancy (US FDA Pregnancy Category C): There is evidence of harmful effects of corticosteroids on pregnancy in animals. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Lactation: Prednisolone is excreted in small amounts in breast milk. If maternal doses exceed 40 mg/day, the infant should be monitored for adrenal suppression. A decision should be made whether to discontinue nursing or the drug.

Drug Interactions:

• Enzyme Inducers (e.g., Phenobarbital, Phenytoin, Rifampicin, Carbamazepine, Aminoglutethimide): May reduce the efficacy of prednisolone by increasing its metabolism, potentially requiring increased prednisolone doses.
• Enzyme Inhibitors (e.g., Ketoconazole, Troleandomycin): May decrease prednisolone metabolism, increasing its effects and potential toxicity.
• Non-Steroidal Anti-inflammatory Drugs (NSAIDs): Increased risk of gastrointestinal ulceration and bleeding.
• Diuretics (especially potassium-depleting): Increased risk of hypokalemia.
• Anticoagulants (e.g., Warfarin): May alter anticoagulant effects; close monitoring of INR is needed.
• Antidiabetic Agents: Prednisolone can increase blood glucose levels, requiring adjustment of antidiabetic medication dosage.
• Anticholinesterases: Concurrent use may produce severe weakness in patients with myasthenia gravis.
• Cardiac Glycosides (e.g., Digoxin): Increased risk of digitalis toxicity due to hypokalemia.
• Live Vaccines: Contraindicated with immunosuppressive doses of corticosteroids.
• Cyclosporine: Increased plasma levels of both drugs, with potential for increased adverse effects (e.g., convulsions).

Storage Conditions:

Store below 30°C in a cool, dry place, protected from light. Keep out of reach of children.

Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.