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Luai Al Bakour
El Temamy Pharmacy
Akoni Hijyen Teknolojileri Sanayi ve Dış Ticaret LTD. ŞTİ
Britton Chance Center for Biomedical Photonics
Arabian Trade Center - ATC
Medical Facility (32206):
Legality International. (Pvt.) Ltd.
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Allergic conditions; collagen diseases (eg, systemic lupus erythematous, acute rheumatic carditis); dermatologic diseases; edematous states; endocrine conditions; GI diseases; hematologic diseases; neoplastic conditions; neoplastic diseases; nervous system conditions (eg, acute exacerbations of multiple sclerosis); ophthalmic conditions; conditions related to organ transplantation; pulmonary disease (eg, asthma); renal condition (eg, nephrotic syndrome); rheumatologic conditions; specific infectious diseases including trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concomitantly with appropriate antituberculous chemotherapy; tuberculosis with pleural or pericardial effusion. Treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Treatment of corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).
Oral Hypersensitivity to corticosteroids or any component of the product; systemic fungal infections; administration of live, or live, attenuated vaccines in patients receiving immunosuppressive doses. Ophthalmic Most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infection of the eye and fungal diseases of the ocular structure; acute untreated purulent ocular infections; hypersensitivity to other corticosteroids or any component of the product.
Cardiovascular Bradycardia; cardiac arrest; cardiac arrhythmias; cardiac enlargement; CHF; circulatory collapse; elevated BP; fat embolism; hypertension; hypertrophic cardiomyopathy in premature infants; myocardial rupture following recent MI; pulmonary edema; syncope; tachycardia; thromboembolism; thrombophlebitis; vasculitis. CNS Arachnoiditis; behavioral and mood changes; convulsions; depression; emotional instability; euphoria; headache; increased appetite; increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of therapy; insomnia; malaise; meningitis; mood swings; neuritis; neuropathy; paraparesis/paraplegia; paresthesia; personality changes; sensory disturbances; vertigo. Dermatologic Acne; allergic dermatitis; cutaneous and subcutaneous atrophy; dry scalp; edema; facial erythema; hyper- or hypopigmentation; impaired wound healing; increased sweating; petechiae and ecchymosis; rash; sterile abscess; striae; suppressed reactions to skin tests; thin fragile skin; thinning scalp hair; urticaria. EENT Exophthalmos; glaucoma; increased IOP; posterior subcapsular cataracts. Ophthalmic use Acute anterior uveitis; conjunctival hyperemia; conjunctivitis; corneal ulcers; delayed wound healing; glaucoma; increased IOP; keratitis; loss of accommodation; mydriasis; optic nerve damage; perforation of the globe; posterior subcapsular cataract formation; ptosis; secondary ocular infection (eg, bacterial, viral). GI Abdominal distention; elevation in serum liver enzymes levels; hepatomegaly; hiccups; nausea; pancreatitis; peptic ulcer with possible perforation and hemorrhage; ulcerative esophagitis. Endocrine Abnormal fat deposits; decreased carbohydrate tolerance; development of Cushingoid state; hirsutism; manifestations of latent diabetes mellitus and increased requirement for insulin and oral hypoglycemic agents in diabetes; menstrual irregularities; moon facies; secondary adrenocortical and pituitary unresponsiveness (particularly during stress, as in trauma, surgery, or illness); suppression of growth in children. Genitourinary Alteration in motility and number of spermatozoa. Hypersensitivity Anaphylactoid reaction; anaphylaxis; angioedema. Metabolic-Nutritional Alterations in blood glucose; fluid retention; hypokalemic alkalosis; negative nitrogen balance due to catabolism; potassium loss; sodium retention; weight gain. Musculoskeletal Aseptic necrosis of femoral and humeral heads; charcot-like arthropathy; loss of muscle mass; muscle weakness; osteoporosis; pathologic fracture of long bones; steroid myopathy; tendon rupture; vertebral compression fractures.
Aminoglutethimide May lead to loss of prednisolone-induced adrenal suppression. Amphotericin B Coadministration may be followed by cardiac enlargement and CHF. Anticholinesterase agents Coadministration may produce severe weakness in patients with myasthenia gravis. If possible, withdraw anticholinesterase agent 24 h prior to starting prednisolone. Antidiabetic agents Because prednisolone may increase blood glucose concentrations, dose adjustments of antidiabetic agents may be required. Aspirin and other salicylates, NSAIDs Risk of GI bleeding may be increased. Salicylate clearance may be increased. CYP3A4 inducers (eg, barbiturates, carbamazepine, phenytoin, rifampin) Prednisolone metabolism may be increased, reducing prednisolone plasma levels and necessitating an increase in dosage. CYP3A4 inhibitors (eg, estrogens [eg, hormonal contraceptives], ketoconazole, macrolide antibiotics [eg, erythromycin]) Prednisolone metabolism may be decreased, increasing prednisolone plasma levels and increasing the risk of adverse reactions. Cholestyramine Prednisolone clearance may be increased, reducing plasma levels and decreasing the efficacy. Cyclosporine Increased activity of cyclosporine and prednisolone may occur. Convulsions have been reported with coadministration of corticosteroids and cyclosporine. Digitalis glycosides Because of possible hypokalemia, the risk of arrhythmias may be increased. Isoniazid Isoniazid serum levels may be reduced, decreasing the efficacy. Potassium-depleting agents (eg, amphotericin B, diuretics) Risk of hypokalemia may be increased. Toxoids and live or inactivated vaccines Because of inhibition of antibody response, patients on prolonged prednisolone therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Replication of some organisms contained in live attenuated vaccines may be potentiated. Warfarin Because data are conflicting, monitor coagulation indices frequently.
Monitor Body weight, BP, routine laboratory studies, including 2-hour postprandial blood glucose and serum potassium, and a chest x-ray, should be obtained at regular intervals during prolonged therapy. Monitor linear growth of infants and children on prolonged therapy. Upper GI x-rays are desirable in patients with known or suspected peptic ulcer disease. If ophthalmic product is used for more than 10 days or oral product more than 6 wk, routinely monitor IOP. Pregnancy Category C . Flo-Pred Category D . Lactation Excreted in breast milk. Children Safety and efficacy not established (ophthalmic). Elderly Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy. Hypersensitivity Reactions may occur, including anaphylaxis. Renal Function Use drug with caution. Adrenal suppression Prolonged therapy may lead to hypothalamic-pituitary-adrenal suppression. Bone density Bone formation may be decreased and bone resorption may be increased. Long-term use in children can have negative effects on growth and development. Cardiovascular effects Use drug with great caution in patient who has suffered recent MI. Cardiovascular/renal function Prednisolone may cause elevation of BP, salt and water retention, and increased excretion of calcium and potassium. Cerebral malaria Do not use. Fetal effects Can cause fetal harm when administered to pregnant women. Use during the first trimester of pregnancy has been associated with an increased risk of orofacial clefts, intrauterine growth restriction, and decreased birth weight. GI disorders Risk of GI perforation in patients with certain GI disorders may be increased (eg, active or latent peptic ulcers). Infections Signs of infection may be masked. Host-defense mechanisms may be decreased, allowing dissemination of infection. Risk of reactivation or exacerbation of latent infection may be increased. Kaposis sarcoma Has been reported in patients receiving corticosteroid therapy, usually for chronic conditions. Long-term ophthalmic local use Fungal infections of the cornea are particularly prone to develop with chronic use of corticosteroids, and fungal infections should be suspected in any persistent corneal ulceration. Mood and behavior disturbances Use may be associated with CNS effects ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may be aggravated. Ocular effects Use systemic drug with caution in ocular herpes simplex because of possible corneal perforation. Ophthalmic effects Prolonged use may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerve, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Use with caution in patients with glaucoma. Do not use in the treatment of optic neuritis. Stress Increased dosage of rapidly acting corticosteroid may be needed before, during, and after stressful situations. Surgery Use after cataract surgery may delay healing and increase the incidence of bleb formation. Threadworm infestation Use with great care. Thyroid status Changes in thyroid status may necessitate adjustments in prednisolone dosage. Tuberculosis Restrict use to those cases of fulminating or disseminated tuberculosis in which prednisolone is used for management of the disease in conjunction with an appropriate antituberculous regimen. Withdrawal Abrupt discontinuation may result in adrenal insufficiency.
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Yaser Habrawi , F.R.C.S.Ed
Dr. Samer Al-Jneidy
Samir Moussa M.D.
Dr . Dirar Abboud
Dr. Talal Sabouni
Dr. Hani Najjar
Dr. Faisal Dibsi
Dr. Tahsin Martini