
PREDNISOLONE - LIQUISONE
15 mg/5mL SYRUP
FORMULATION:
Each 5 mL (1 teaspoonful) contains:
Prednisolone (as Sodium Phosphate)..........15mg
DESCRIPTION:
Prednisolone is a synthetic adrenal corticosteroid (glucocorticoid) which is a derivative of the natural steroid, cortisol, which is produced by the adrenal glands and is readily absorbed from the gastrointestinal tract. It is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. It is designated chemically as pregna- 1, 4 diene-3,20dione,11,17,21-trihydroxy-,(11β).
ACTION AND PHARMACOKINETICS:
Prednisolone decreases inflammation by inhibition of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and production of the lymphocytes and eosinophils. Peak plasma concentrations of prednisolone are obtained 1 to 2 hours after administration by mouth and it has a usual plasma half-life of 2 to 4 hours. Its initial absorption, but not its overall bioavailability, is affected by food. Prednisolone is excreted in the urine as free and conjugated metabolites, together with an appreciable proportion of unchanged prednisolone. Prednisolone crosses the placenta and small amounts are excreted in breast milk.
INDICATION:
It is used to achieve prompt suppression of inflammation in many inflammatory and allergic condition such as: rheumatoid arthritis, systemic lupus, acute gouty arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease. Severe allergic conditions that fail conventional treatment may also respond to prednisolone like bronchial asthma, allergic rhinitis, drug-induced dermatitis, contact and atopic dermatitis. Chronic skin conditions such as: dermatitis, herpetiformis, pemphigus, severe psoriasis, severe seborrheic dermatitis, chronic allergy and inflammatory conditions of the uvea, iris, conjunctiva and optic nerves of the eyes are also treated with prednisolone. Prednisolone may be used in the treatment of blood cell cancers (leukemias), and lymph gland cancers (lymphomas). Blood diseases involving destruction of platelets by the body’s own immune cells (idiopathic thrombocytopenia purpura), and destruction of red blood cells by immune cells (autoimmune hemolytic anemia) can also be treated with prednisolone. Prednisolone is also used in physiological doses for replacement therapy in adrenal insufficiency. Other miscellaneous conditions treated with prednisolone include thyroiditis and sarcoidosis.
DOSAGE AND ADMINISTRATION:
The usual starting dose range for adults is 5 mg to 60 mg daily and for pediatric patients is 0.14 to 2 mg/kg/day in three divided doses depending on the disease being treated or as prescribed by the physician. Prednisolone should be taken with food to avoid stomach irritation.
SIDE EFFECTS:
Large doses of corticosteroids, or of corticotropin, may produce Cushingoid symptoms typical of hyperactivity of the adrenal cortex, with moon-face, sometimes with hirsutism, buffalo hump, flushing, increased bruising, ecchymoses, striae, and acne, sometimes leading to a fully developed Cushing’s syndrome. If administration is discontinued these symptoms are usually reversed, but sudden cessation is dangerous.Others side effects include amenorrhea, hypedrosis, skin thinning, ocular changes including development of cataract, mental and neurological disturbances, intracranial hypertension, acute pancreatitis, and aseptic necrosis of bone. An increase in coagulability of the blood may lead to thrombo-embolic complications. Peptic ulceration has been reported. There are also side effects arising from reducing the dose; these include tiredness, headaches, muscle and joint aches and depression.
PREGNANCY
FDA pregnancy category C. This medication may be harmful to an unborn baby. Prednisolone can pass into breast milk and may harm a nursing baby.
PRECAUTION
Patients with hypothyroidism, cirrhosis, ulcerative colitis, CHF, convulsive disorders, thrombophloebitis, peptic ulcer, elderly, DM, hypertension, psychological disturbances, osteoporosis, pregnancy, lactation, adrenal suppression and infection. May cause irreversible growth retardation, glaucoma and corneal perforation.
CONTRAINDICATIONS
Hypersensitivity, live vaccines, herpes simplex keratitis, systemic infections, and fungal infections.
CAUTIONS
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
STORAGE CONDITION
Store at temperatures not exceeding 30ºC.
AVAILABILITY
Amber Bottle x 30 mL/Box
Manufactured for:
Remed Pharmaceuticals, Inc. 1113 11F AIC Burgundy Empire Tower ADB Ave. corner Sapphire & Garnet Sts., Ortigas Center, Pasig City 1605
By:
Lloyd Laboratories, Inc.
#10 Lloyd Avenue, First Bulacan Industrial City
City of Malolos, Bulacan