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Hydroxychloroquine Sulphate is indicated in-

• Acute and chronic rheumatoid arthritis
• Systemic Lupus Erythematosus (SLE)
• Malaria

Anti-malarial drugs, Disease-modifying antirheumatic drugs (DMARDs), Drugs used for Rheumatoid Arthritis

Hydroxychloroquine Sulphate synthetically produced version of quinine. It acts as an immunosuppressant by inhibiting production of rheumatoid and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. It also acts by disrupting cell walls of infected red blood cells and kills the developing parasites.

Hydroxychloroquine Sulphate tablets are for oral administration and are taken with food to avoid stomach upset.

Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.

Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.

Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.

• First dose: 10 mg base/kg (but not exceeding a single dose of 620 mg base).
• Second dose: 5 mg base/kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
• Third dose: 5 mg base/kg 18 hours after second dose.
• Fourth dose: 5 mg base/kg 24 hours after third dose.

Generally Hydroxychloroquine Sulphate is well tolerated. However, few side effects like nausea, vomiting, stomach upset, loss of appetite, diarrhea, tiredness, weakness or headache and visual problem may occur the first several days.

Children are especially sensitive to the 4-aminoquinoline compounds. Patients should be strongly warned to keep these drugs out of the reach of children. Opthalmologic examination requires in every 12 months.

During pregnancy, this drug should be used only if clearly needed. Since small amounts of this medication are found in breast milk consult your doctor before medication.

Symptoms of overdose consist of headache, drowsiness, visual disturbances, cardiovascular collapse, and convulsions, followed by sudden and early respiratory and cardiac arrest. Gastric lavage until the stomach is completely emptied.

Store below 30° C.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Rosuvastatin is indicated in-

• Heterozygous Hypercholesterolemia (Familial and Non familial)
• Homozygous Hypercholesterolemia (Familial)
• Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
• Primary prevention of cardiovascular disease

Other Anti-anginal & Anti-ischaemic drugs, Statins

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Rosuvastatin can be taken with or without food, at any time of day.

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

Rosuvastatin is contraindicated if-

• Known hypersensitivity to product components
• Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Pregnant women and women who may become pregnant
• Nursing mothers

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

Remarkable drug interactions of Rosuvastatin are-

• Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
• Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
• Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
• Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
• Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Use in children: The safety and effectiveness in pediatric patients have not been established.

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Specific mineral & vitamin combined preparations

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

This can be given to pregnant and lactating mothers as per recommendation of physician.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Glucocorticoids

Hydrocortisone inhibits prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Hydrocortisone reduces various vasoactive agents released during inflammation. It also controls the rate of protein synthesis.

Tablet: The initial dosage of Hydrocortisone Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy. 

It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Injection:

• Adult: By IM injection or slow IV injection or infusion. The initial dose of Hydrocortisone sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition. 
• Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.

Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.

Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.

Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.

Drugs that induce hepatic enzymes such as Phenobarbital, Phenytoin and Rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as Troleandomycin and Ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity.

This should be prescribed in pregnancy and lactation only if absolutely required.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
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.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
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.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
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.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Prednisolone eye drops is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Glucocorticoids

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.

Adult: Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue the therapy before completing the course. 

Paediatric: Safety and effectiveness in pediatric patients have not been established.

Elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.  Fungal and viral infections of the cornea are particularly may develop coincidentally with long-term applications of steroid.

Prednisolone Acetate is contraindicated in viral diseases of the cornea, conjunctiva and known hypersensitivity to any of the ingredients of this preparation or other corticosteroids.

Shake the bottle well before use. Prolonged use of corticosteroids may result in damage to the optic nerve and defects in vision. If this product is used for longer period of time, intraocular pressure should be routinely monitored.

No significant drug interactions have been reported.

Prednisolone Acetate is pregnancy category C. So, this drug should be used during pregnancy only if clearly needed. It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prednisolone Acetate is administered to a nursing woman.

A one-time accidental overdose of Prednisolone Ophthalmic Suspension generally will not cause acute problems. Long time overdose may show general side-effects. In accidental overdose sufficient water should be taken to dilute the medication.

Store in a cool, dry place and protect from light. Keep out of the reach of children. Protect from freezing.  Shake well before using.

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
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.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
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.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Glucocorticoids

Hydrocortisone inhibits prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Hydrocortisone reduces various vasoactive agents released during inflammation. It also controls the rate of protein synthesis.

Tablet: The initial dosage of Hydrocortisone Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy. 

It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Injection:

• Adult: By IM injection or slow IV injection or infusion. The initial dose of Hydrocortisone sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition. 
• Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.

Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.

Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.

Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.

Drugs that induce hepatic enzymes such as Phenobarbital, Phenytoin and Rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as Troleandomycin and Ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity.

This should be prescribed in pregnancy and lactation only if absolutely required.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Other Topical corticosteroids

Hydrocortisone binds to the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Specifically glucocorticoids induce lipocortin-1 (annexin-1) synthesis, which then binds to cell membranes preventing the phospholipase A2 from coming into contact with its substrate arachidonic acid. This leads to diminished eicosanoid production. The cyclooxygenase (both COX-1 and COX-2) expression is also suppressed, potentiating the effect. In other words, the two main products in inflammation Prostaglandins and Leukotrienes are inhibited by the action of Glucocorticoids. Glucocorticoids also stimulate the lipocortin-1 escaping to the extracellular space, where it binds to the leukocyte membrane receptors and inhibits various inflammatory events: epithelial adhesion, emigration, chemotaxis, phagocytosis, respiratory burst and the release of various inflammatory mediators (lysosomal enzymes, cytokines, tissue plasminogen activator, chemokines etc.) from neutrophils, macrophages and mastocytes. Additionally the immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Hydrocortisone Acetate should be applied in a small quantity to the affected area 2 or 3 times daily.

Hydrocortisone Acetate 1% cream is usually well-tolerated, but if signs of hypersensitivity appear, application should be stopped.

In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur. As with all corticosteroids, prolonged application to the face is undesirable.

There is inadequate evidence for safety in human pregnancy. It is recommended that topical corticosteroids should not be used extensively during pregnancy. It is highly unlikely that sufficiently high blood levels of Hydrocortisone are achieved during topical therapy to reach breast milk.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued.

Store in a cool and dry place, away from light. Keep out of reach of children.

Glucocorticoids

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
• Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
• Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

The following clinical conditions require special caution and frequent patient monitoring is necessary-

• Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
• Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
• Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
• Emotional instability or psychotic tendency, epilepsy.
• Previous corticosteroid-induced myopathy.
• Liver failure.
• Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
• Ocular herpes simplex because of possible corneal perforation.

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Glucocorticoids

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
• Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
• Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

The following clinical conditions require special caution and frequent patient monitoring is necessary-

• Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
• Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
• Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
• Emotional instability or psychotic tendency, epilepsy.
• Previous corticosteroid-induced myopathy.
• Liver failure.
• Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
• Ocular herpes simplex because of possible corneal perforation.

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Glucocorticoids

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
• Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
• Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

The following clinical conditions require special caution and frequent patient monitoring is necessary-

• Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
• Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
• Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
• Emotional instability or psychotic tendency, epilepsy.
• Previous corticosteroid-induced myopathy.
• Liver failure.
• Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
• Ocular herpes simplex because of possible corneal perforation.

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Glucocorticoids

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
• Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
• Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

The following clinical conditions require special caution and frequent patient monitoring is necessary-

• Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
• Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
• Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
• Emotional instability or psychotic tendency, epilepsy.
• Previous corticosteroid-induced myopathy.
• Liver failure.
• Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
• Ocular herpes simplex because of possible corneal perforation.

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Glucocorticoids

Deflazacort provides anti-inflammatory action by inhibiting Phospholipase A2 enzyme which is responsible for prostaglandin synthesis. Besides Deflazacort decreases the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals Deflazacort provides immunosuppressive action.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 3-18 mg/day. The smallest effective dose should be used and increased if necessary.
• Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.
• Other conditions: The dose of Deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.
• Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25-1.0 mg/kg on alternate days.

Deflazacort withdrawal: In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent Ml, thromboembolism.

Hypersensitivity to or any of the ingredients. Patients receiving live virus immunization.

The following clinical conditions require special caution and frequent patient monitoring is necessary-

• Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Glucocorticoids can cause salt and water retention and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary.
• Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is the probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
• Diabetes mellitus or family history, osteoporosis, myasthenia gravis, renal insufficiency.
• Emotional instability or psychotic tendency, epilepsy.
• Previous corticosteroid-induced myopathy.
• Liver failure.
• Hypothyroidism and cirrhosis, which may increase the glucocorticoid effect.
• Ocular herpes simplex because of possible corneal perforation.

Deflazacort is metabolized in the liver. It is recommended to increase the maintenance dose of Deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, (e.g. ketoconazole) it may be possible to reduce the maintenance dose of Deflazacort.

Pregnancy: Deflazacort does cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of up to 50 mg daily of Deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breastfeeding are likely to outweigh any theoretical risk.

Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Deflazacort should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment: In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly: In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

Store in a cool (below 25°C) and dry place, protected from light & moisture. Keep out of the reach of children.

Other Topical corticosteroids

Hydrocortisone binds to the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Specifically glucocorticoids induce lipocortin-1 (annexin-1) synthesis, which then binds to cell membranes preventing the phospholipase A2 from coming into contact with its substrate arachidonic acid. This leads to diminished eicosanoid production. The cyclooxygenase (both COX-1 and COX-2) expression is also suppressed, potentiating the effect. In other words, the two main products in inflammation Prostaglandins and Leukotrienes are inhibited by the action of Glucocorticoids. Glucocorticoids also stimulate the lipocortin-1 escaping to the extracellular space, where it binds to the leukocyte membrane receptors and inhibits various inflammatory events: epithelial adhesion, emigration, chemotaxis, phagocytosis, respiratory burst and the release of various inflammatory mediators (lysosomal enzymes, cytokines, tissue plasminogen activator, chemokines etc.) from neutrophils, macrophages and mastocytes. Additionally the immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Hydrocortisone Acetate should be applied in a small quantity to the affected area 2 or 3 times daily.

Hydrocortisone Acetate 1% cream is usually well-tolerated, but if signs of hypersensitivity appear, application should be stopped.

In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur. As with all corticosteroids, prolonged application to the face is undesirable.

There is inadequate evidence for safety in human pregnancy. It is recommended that topical corticosteroids should not be used extensively during pregnancy. It is highly unlikely that sufficiently high blood levels of Hydrocortisone are achieved during topical therapy to reach breast milk.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued.

Store in a cool and dry place, away from light. Keep out of reach of children.