Solupred 4 mg (Tablet)

Indications

• Endocrine Disorders
• Rheumatic Disorders
• Collagen Diseases
• Dermatologic Diseases
• Allergy
• Ophthalmic Diseases
• Respiratory Diseases
• Hematological Disorders
• Neoplastic Diseases
• Edematous States
• Gastrointestinal Disease
• CNS Disease

Potency

Greater anti-inflammatory potency than Prednisolone

Sodium and Water Retention

Less tendency to induce sodium and water retention

Relative Potency

At least four to one compared to Hydrocortisone

Drug Form

Tablet

Pharmacodynamic Properties

Potent anti-inflammatory agent

Pharmacokinetic Properties

High oral bioavailability, rapid absorption

Maximum Plasma Concentration

Achieved around 1.5 to 2.3 hours after oral administration

Tissue Distribution

Widely distributed into tissues, crosses blood-brain barrier and placental barrier

Metabolism

Metabolized in the liver to inactive metabolites

Bioavailability

82% to 89% following oral administration

Plasma Protein Binding

Approximately 77%

Dosage Range

2-48 mg daily in divided doses

Initial Dosage

4-48 mg per day depending on specific disease entity

Maintenance Dosage

Determined by decreasing initial drug dosage in small decrements

Treatment of Acute Exacerbations of Multiple Sclerosis

Daily doses of 160 mg for a week followed by 64 mg every other day for 1 month

Alternate-Day Therapy (ADT)

A corticosteroid dosing regimen

Interaction with Erythromycin, Clarithromycin, Phenobarbital, Phenytoin, Rifampin, and Ketoconazole

Inhibits the metabolism of Solupred

Interaction with Estrogens, including Birth Control Pills

Can increase the effect of corticosteroids by 50%

Interaction with Cyclosporin

Reduces the metabolism of Solupred

Interaction with Blood Thinners (e.g. Warfarin)

May increase or decrease the effect

Contraindications

Systemic fungal infections, known hypersensitivity to components

Side Effects

• Fluid retention
• Weight gain
• High blood pressure
• Potassium loss
• Headache
• Muscle weakness
• Hair growth on the face
• Glaucoma
• Cataracts
• Growth retardation in children
• Convulsions
• Psychic disturbances including depression and insomnia

Pregnancy Category

Category C

Precautions & Warnings

• Adrenocortical insufficiency may persist for months after discontinuation of therapy
• Enhanced effect on patients with hypothyroidism and in those with cirrhosis
• Use cautiously in patients with ocular herpes simplex and hypoprothrombinemia

Overdose Effects

Rare reports of acute toxicity and/or death following an overdose

Therapeutic Class

Glucocorticoids

Storage Conditions

Cool, dry place, away from light, keep out of reach of children