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Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Loop diuretics

Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.

Furosemide 40 mg Tablet-
Edema:

• Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
• Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
• Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
• Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:

• Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
• Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.

By continuous intravenous infusion:

• Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.

Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.

Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.

Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.

Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.

Protect from light. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Loop diuretics

Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.

Furosemide 40 mg Tablet-
Edema:

• Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
• Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
• Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
• Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:

• Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
• Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.

By continuous intravenous infusion:

• Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.

Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.

Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.

Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.

Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.

Protect from light. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Loop diuretics

Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.

Furosemide 40 mg Tablet-
Edema:

• Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
• Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
• Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
• Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:

• Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
• Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.

By continuous intravenous infusion:

• Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.

Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.

Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.

Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.

Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.

Protect from light. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Loop diuretics

Furosemide is a monosulphonyl diuretic. It is an effective diuretic that retains its activity even in low glomerular filtration rate (GFR). Furosemide has a distinctive action on renal tubular function. It affects a peak diuresis far greater than that observed with other agents. Other features are (I) prompt onset of action (II) inhibition of sodium and chloride transport in the ascending limb of the loop of Henle and (III) independence of their action from acid-base balance changes. Furosemide acts primarily to inhibit electrolyte reabsorption in the thick ascending limb of the loop of Henle. Furosemide is readily absorbed from the gastrointestinal tract and considerable proportions are bound to plasma proteins. It is rapidly excreted in the urine. With an hour after intravenous injection, its effect is evident in about 5 minutes and last for about 2 hours.

Furosemide 40 mg Tablet-
Edema:

• Adults: The initial adult dose is 40 mg daily, reduced to 20 mg daily or 40mg on alternate days. In some patients daily doses of 80mg or higher (given in divided doses) may be required. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). For resistant edema, 80-120 mg daily. In patients with clinically severe edematous states the dose of furosemide may be carefully titrated up to 600 mg/day. When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.
• Children: Neonate: 0.5-2 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-2 mg/kg 2-3 times daily (every 24 hours if postmenstrual age less than 31 weeks); higher doses may be required in resistant edema; max. 12 mg/kg daily, not to exceed 80 mg daily.
• Child 12-18 years:20-40 mg daily, increased in resistant edema to 80-120 mg daily.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: The usual initial dose of furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
• Children: The usual dose is 1 - 3 mg/kg body weight daily up to a maximum dose of 40mg/day.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Furosemide 250 mg Tablet: For selected patients with advanced chronic renal failure, diuretic therapy may be started with Furosemide orally. If conventional doses (80 to 160 mg orally) fail to produce an adequate diuresis, a single dose of 250 mg is given as a starting dose. If a satisfactory diuresis does not ensue within 4-6 hours, the initial dose may be doubled to 500 mg. The criterion of optimal dosage is a urinary output of at least 2.5 liters per day. A maximum daily dose of 1000 mg should not be exceeded.

Furosemide Syrup: Furosemide Liquid has an exceptionally wide therapeutic range, the effect being proportional to the dosage. Furosemide Liquid is best given as a single dose either daily or on alternate days. The usual initial daily dose is 40 mg. This may require adjustment until the effective dose is achieved as a maintenance dose. In mild cases, 20 mg daily or 40 mg on alternate days may be sufficient, whereas in cases of resistant edema, daily doses of 80 mg and above may be used as one or two daily, or intermittently. Severe cases may require gradual titration of the furosemide dosage up to 600 mg daily. The recommended maximum daily dose of furosemide administration is 1,500 mg.

Furosemide Injection-
Edema:

Adults: Doses of 20-50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg.

By slow intravenous injection:

• Neonate: 0.5-1 mg/kg every 12-24 hours (every 24 hours if postmenstrual age under 31 weeks).
• Child 1 month-12 years: 0.5-1 mg/kg repeated every 8 hours as necessary;maximum 2 mg/kg (max. 40 mg) every 8 hours.
• Child 12-18 years: 20-40 mg repeated every 8 hours as necessary; higher doses may be required in resistant cases.

By continuous intravenous infusion:

• Child 1 month-18 years: 0.1-2 mg/kg/hour (following cardiac surgery, initially 100 micrograms/kg/hour, doubled every 2 hours until urine output exceeds 1 mL/kg/hour).
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

Hypertension:

• Adults: Doses of 20 to 50 mg intramuscularly or intravenously may be given initially. If larger doses are required, they should be given increasing by 20 mg increments and not given more often than every two hours. If doses greater than 50 mg are required it is recommended that they should be given by slow intravenous infusion. The recommended maximum daily dose of furosemide administration is 1,500 mg. Children: Parenteral doses for children range from 0.5-1.5 mg/kg body weight daily up to a maximum total daily dose of 20 mg.
• Elderly: In the elderly furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved.

As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis of prolonged therapy. Prolonged use can produce alkalosis. It may also cause uric acid retention and may rarely produce acute gout. Furosemide may provoke hyperglycemia and glycosuria.

Furosemide is contraindicated in anuria, electrolyte deficiency and pre-comatose states associated with liver cirrhosis. Hypersensitivity to furosemide or sulphonamides.

Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention. A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such furosemide.

Driving a vehicle or performing other hazardous tasks: Some adverse effects (e.g. an undesirably pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and, therefore, constitute a risk in situations where these abilities are of special importance (e.g. operating a vehicle or machinery).

A marked fall in blood pressure may be seen when ACE inhibitors are added to furosemide therapy. Serum lithium levels may be increased when lithium is given concomitantly with furosemide. The toxic effects of nephrotoxic antibiotics may be increased by concomitant administration of potent diuretics such as furosemide.

Pregnancy category C. Furosemide should be cautiously used in cardiogenic shock complicated by pulmonary oedema and in the first trimester of pregnancy. Blood pressure and pulse during rapid diuresis should be monitored. Caution should be observed in patients liable to electrolyte deficiency. In case of nursing mother, furosemide may inhibit lactation or may pass into breast milk. In that case it should be used with caution.

Protect from light. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

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

This cream is indicated for the treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection is confirmed or suspected.

Betamethasone & Combined preparations

Betamethasone is a topical fluorinated corticosteroid that has an anti-inflammatory and antipruritic effect. Fusidic acid is a potent topical antibacterial agent which is effective against Staphylococcus aureus, Streptococci, Corynebacteria, Neiserria and certain Clostridia and Bacteroides.

Apply this cream or ointment to the affected area twice daily. Max duration is 2 weeks.

Hypersensitivity, contact dermatitis, eczema (aggravated condition), skin burning sensation, pruritus, dry skin, application site pain or irritation. Rarely, erythema, urticaria (including rash erythematous and generalised rash), application site swelling or vesicles.

Skin lesions of viral, fungal or bacterial origin (e.g. herpes or varicella), skin manifestations in relation to TB or syphilis, perioral dermatitis and rosacea, ulcerative condition.

May increase risk of developing antibiotic resistance. Stasis dermatitis and other skin disease w/ impaired circulation. Not to be used for >7 days if there is no clinical improvement. Avoid prolonged continuous treatment esp in infants and children. Pregnancy and lactation.

Fucidic Acid: Synergistic action with antistaphylococcal penicillin. Antagonism with ciprofloxacin.

Betamethasone: Increased hyperglycaemia and hypokalaemia with thiazide diuretics. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents.

Potentially Fatal: Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Enhanced effect in women taking oestrogens or oral contraceptives.

Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established; however, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods

Do not store above 25º C. Store in original container.

Treatment of infections caused by susceptible organisms especially Staph eg, osteomyelitis, septicaemia, endocarditis, superinfected cystic fibrosis, pneumonia, skin & soft tissue infections, surgical & traumatic wound infections.

Other antibiotic

Fusidic acid inhibits bacterial protein synthesis by interfering with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes.

Adult: 250-500 mg every 8 hourly
Skin & soft tissue infection: 250 mg twice daily.

GI disturbances eg, dyspepsia, nausea, vomiting, epigastric pain, anorexia; jaundice & change of liver function.

Hypersensitivity

Hepatic impairment, biliary obstruction or disease. Monitor hepatic function periodically in patients on high or prolonged oral doses. Avoid during 3rd trimester of pregnancy. Lactation. Premature, jaundiced, acidotic or seriously ill neonates.

Drugs metabolized by CYP450 isoenzymes.

No data found

Sodium Fusidate Ointment is indicated for treatment of skin infections caused by Staphylococci, Streptococci, Corynebacterium minutissimum and other Fusidate sensitive organisms. The most important indications being: impetigo, boils, abscess, varicose ulcers, skin grafts, hidradenitis, infected wounds, sycosis barbae, paronychia, folliculitis, carbuncles and erythrasma.

Topical Antibiotic preparations

Sodium Fusidate, an antibiotic derived from Fusidium coccineum, exerts powerful activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin or other antibiotics, are particularly susceptible to Sodium Fusidate. The therapeutic efficacy of topically applied Sodium Fusidate is due partly to the pronounced antibacterial activity of Sodium Fusidate against the organisms responsible for skin infection and partly to the unique ability of this antibiotic to penetrate intact skin.

Fusidic Acid is an anti-microbial agent that acts as an inhibitor of protein synthesis in the microorganism. It interferes with the translocation step by stabilizing the ribosome-guanosine dephosphate elongation factor G-complex. This prevents binding of aminoacyl t-RNA to the ribosome and thereafter stops transfer of additional amino acids to the growing polypeptide.

Sodium Fusidate Ointment or cream is applied to the affected areas 2 to 3 times daily, generally for a period of 7 days. It can be used with or without a covering dressing. Caution should be observed when applying Sodium Fusidate Ointment near the eye region as this preparation may cause irritation if it gets into the eye. No special dosage modifications or special precautions are required for children.

Sodium Fusidate Ointment is remarkably well tolerated, and there is an extremely low frequency of hypersensitivity reactions.

Known hypersensitivity to Sodium Fusidate, severe hepatic failure.

Caution should be observed when applying Sodium Fusidate ointment in the eye region as this preparation may cause irritation upon contact with the eye.

Data no found

Sodium Fusidate Ointment is indicated for treatment of skin infections caused by Staphylococci, Streptococci, Corynebacterium minutissimum and other Fusidate sensitive organisms. The most important indications being: impetigo, boils, abscess, varicose ulcers, skin grafts, hidradenitis, infected wounds, sycosis barbae, paronychia, folliculitis, carbuncles and erythrasma.

Topical Antibiotic preparations

Sodium Fusidate, an antibiotic derived from Fusidium coccineum, exerts powerful activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin or other antibiotics, are particularly susceptible to Sodium Fusidate. The therapeutic efficacy of topically applied Sodium Fusidate is due partly to the pronounced antibacterial activity of Sodium Fusidate against the organisms responsible for skin infection and partly to the unique ability of this antibiotic to penetrate intact skin.

Fusidic Acid is an anti-microbial agent that acts as an inhibitor of protein synthesis in the microorganism. It interferes with the translocation step by stabilizing the ribosome-guanosine dephosphate elongation factor G-complex. This prevents binding of aminoacyl t-RNA to the ribosome and thereafter stops transfer of additional amino acids to the growing polypeptide.

Sodium Fusidate Ointment or cream is applied to the affected areas 2 to 3 times daily, generally for a period of 7 days. It can be used with or without a covering dressing. Caution should be observed when applying Sodium Fusidate Ointment near the eye region as this preparation may cause irritation if it gets into the eye. No special dosage modifications or special precautions are required for children.

Sodium Fusidate Ointment is remarkably well tolerated, and there is an extremely low frequency of hypersensitivity reactions.

Known hypersensitivity to Sodium Fusidate, severe hepatic failure.

Caution should be observed when applying Sodium Fusidate ointment in the eye region as this preparation may cause irritation upon contact with the eye.

Data no found

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Penicillinase-resistant penicillins

Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

Oral doses should be administered 1 hour before meal.

There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.

Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Treatment of infections caused by susceptible organisms especially Staph eg, osteomyelitis, septicaemia, endocarditis, superinfected cystic fibrosis, pneumonia, skin & soft tissue infections, surgical & traumatic wound infections.

Other antibiotic

Fusidic acid inhibits bacterial protein synthesis by interfering with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes.

Adult: 250-500 mg every 8 hourly
Skin & soft tissue infection: 250 mg twice daily.

GI disturbances eg, dyspepsia, nausea, vomiting, epigastric pain, anorexia; jaundice & change of liver function.

Hypersensitivity

Hepatic impairment, biliary obstruction or disease. Monitor hepatic function periodically in patients on high or prolonged oral doses. Avoid during 3rd trimester of pregnancy. Lactation. Premature, jaundiced, acidotic or seriously ill neonates.

Drugs metabolized by CYP450 isoenzymes.

No data found

Fusidic Acid is indicated for the topical treatment of superficial bacterial infections of the eye and its adnexa. These may include - bacterial conjunctivitis, blepharoconjunctivitis, blepharitis, sty and keratitis. It may also be used for the management of corneal and conjunctival abrasions and foreign body injuries.

Macrolides

Fusidic acid is an antimicrobial agent that inhibits bacterial protein synthesis. Fusidic acid interferes with amino acid transfer from aminoacyl-tRNA to protein on the ribosomes. Fusidic acid is active against a wide range of gram-positive organisms. The sustained release formulation ensures prolonged contact with the conjunctival sac. Fusidic acid penetrates well into the aqueous humor.

Adults and children (≥ 2 years): Instill one drop in the affected eye(s) twice daily for 7 days. Treatment should be continued for at least 48 hours after the eye returns to normal.

Fusidic acid is generally associated with very few adverse effects. The most frequently reported treatment-related side-effect is slight stinging or irritation.

Fusidic acid viscous eye drops is contraindicated in patients who are hypersensitive to any component of this preparation.

Synergistic action with antistaphylococcal penicillin. Antagonism with ciprofloxacin.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Fusidic acid should be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not clear if enough medication from the eye drop would pass into breast milk. Caution should be exercised while giving this eye drops to a nursing mother

Use in children: Safety & effectiveness in children below the age of 2 years have not been established.

Store between 2-25°C. Discard 1 mth after opening.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.