Prednisolone - EvaPharma 5 mg 30 tablets

Prednisolone – EVAPHARMA 5 mg 30 oral disintegrating tablets

Composition:

Each oral disintegrating tablet contains:

Active ingredient:

Prednisolone sodium metasulfobenzoate 7.86 mg (equivalent to 5 mg prednisolone).

Inactive ingredients: mannitol, mannitol (Mannogem EZ), Pearlitol Flash, crospovidone (Kollidone CL), crospovidone (Polyplasdone XL-10), aspartame, hydrophobic colloidal anhydrous silica (Aerosil 972), ethyl acrylate and methylmethacrylate copolymer, vanilla flavor, anise flavor, magnesium stearate.

Description:

Prednisolone is a synthetic glucocorticoid with potent anti-inflammatory, immunosuppressive, and anti-allergic properties. It inhibits inflammatory mediators, reduces capillary permeability, and stabilizes cell membranes. It is indicated in a wide range of autoimmune and inflammatory disorders, including systemic connective tissue diseases, severe dermatological conditions, allergic reactions, gastrointestinal, respiratory, renal, neurological, and ocular diseases. It is also used in oncology protocols and in organ transplantation to prevent or manage graft rejection.

Indications for Use:

Indicated for the treatment of:

-Autoimmune diseases: systemic lupus erythematosus, vasculitis, polymyositis, sarcoidosis

-Severe dermatological conditions: pemphigus, bullous pemphigoid, lichen planus, acute urticaria

-Digestive tract diseases: ulcerative colitis, Crohn’s disease, autoimmune hepatitis, acute alcoholic hepatitis

-Endocrine: De Quervain’s thyroiditis, hypercalcemia

-Hematologic: immune thrombocytopenia, autoimmune hemolytic anemia, lymphoid malignancies

-Infectious: tuberculous pericarditis, severe pneumocystis pneumonia

-Neoplastic: antiemetic during chemotherapy, inflammatory flare-ups

-Renal: nephrotic syndrome, lupus nephritis stage III–IV, granulomatous sarcoidosis

-Neurologic: myasthenia gravis, cerebral edema, West syndrome, multiple sclerosis

-Ophthalmologic: uveitis, exophthalmos, optic neuropathies

-ENT: otitis media, polyposis, acute sinusitis, subglottic laryngitis

-Respiratory: asthma, COPD, sarcoidosis, interstitial pulmonary fibrosis

-Rheumatic: rheumatoid arthritis, Horton’s disease

-Transplantation: prevention and treatment of graft rejection, GVHD

Dosage and Method of Administration:

Adults:

Loading dose: 0.35–1.2 mg/kg/day (4–14 tablets for 60 kg adult).

Maintenance dose: 5–15 mg/day (1–3 tablets).

Children:

Loading dose: 0.5–2 mg/kg/day.

Maintenance dose: 0.25–0.5 mg/kg/day.

Alternate-day dosing may be considered to limit growth suppression.

Method of administration:

Place tablet in the mouth, allow to dissolve, swallow, and drink water. For children <6 years, dissolve in a small amount of water first. Do not chew the tablet.

Contraindications:

-Hypersensitivity to prednisolone or excipients

-Active infections except indicated ones

-Active viral infections (hepatitis, herpes, varicella, shingles)

-Uncontrolled psychoses

-Live vaccines

-Phenylketonuria (due to aspartame)

Precautions:

-Use with gastroprotection in ulcer history

-Increased infection risk and masking of symptoms

-Risk of disseminated strongyloidiasis — screen/treat endemic patients

-Gradual dose tapering after long-term use to avoid withdrawal syndrome

-Monitor adrenal suppression

-Caution in: elderly, ulcerative colitis, recent GI surgery, renal/hepatic failure, osteoporosis, myasthenia, children

-Risk of vision issues, tendon rupture (especially with fluoroquinolones)

Side Effects:

Withdrawal syndrome, adrenal insufficiency, immunosuppression, infections, GI upset, psychiatric symptoms, osteoporosis, hyperglycemia, hypertension, cataract, glaucoma, etc.

Pregnancy and Breastfeeding:

Use only when clearly needed. Avoid prolonged high-dose therapy. Monitor infant during breastfeeding.

Storage Conditions:

Store below 30°C, in original packaging, protected from moisture and light.

Packaging:

Carton box containing 3 blisters of 10 tablets and a package insert.