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Valsartan is indicated:

• For hypertension
• To reduce hospitalizations in patients with congestive heart failure
• To reduce death in patients who developed congestive heart failure after myocardial infarction

Angiotensin-ll receptor blocker

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hypertension: The usual dose of Valsartan is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. 

Heart failure: The usual dose is 40 mg twice daily and may be increased to 80-160 mg twice daily. 

Post-Myocardial Infarction: The initial dose after myocardial infarction is 20 mg twice daily. The dose should be increased with a target of 160 mg daily if tolerated without side effects.

Administration of Valsartan with food decreases the absorption of Valsartan by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.

Valsartan is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur if patient have been taking diuretics along with Valsartan.

Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment.

Heart Failure and Myocardial Infarction: Caution should be exercised when initiating therapy in patients with heart failure and post-myocardial infarction patients.

No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide

As Valsartan is not metabolized to a significant extent, clinically relevant drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitrostudies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Furosemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co medication is considered necessary, caution is advisable

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some elderly persons cannot be ruled out.

Hepatic Impairment:

• Mild to moderate: Max: 80 mg once daily.
• Severe: Contraindicated.

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.

Store between 15-30° C. Protect from moisture and heat.

Valsartan is indicated:

• For hypertension
• To reduce hospitalizations in patients with congestive heart failure
• To reduce death in patients who developed congestive heart failure after myocardial infarction

Angiotensin-ll receptor blocker

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hypertension: The usual dose of Valsartan is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. 

Heart failure: The usual dose is 40 mg twice daily and may be increased to 80-160 mg twice daily. 

Post-Myocardial Infarction: The initial dose after myocardial infarction is 20 mg twice daily. The dose should be increased with a target of 160 mg daily if tolerated without side effects.

Administration of Valsartan with food decreases the absorption of Valsartan by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.

Valsartan is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur if patient have been taking diuretics along with Valsartan.

Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment.

Heart Failure and Myocardial Infarction: Caution should be exercised when initiating therapy in patients with heart failure and post-myocardial infarction patients.

No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide

As Valsartan is not metabolized to a significant extent, clinically relevant drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitrostudies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Furosemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co medication is considered necessary, caution is advisable

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some elderly persons cannot be ruled out.

Hepatic Impairment:

• Mild to moderate: Max: 80 mg once daily.
• Severe: Contraindicated.

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.

Store between 15-30° C. Protect from moisture and heat.

Valsartan is indicated:

• For hypertension
• To reduce hospitalizations in patients with congestive heart failure
• To reduce death in patients who developed congestive heart failure after myocardial infarction

Angiotensin-ll receptor blocker

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hypertension: The usual dose of Valsartan is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. 

Heart failure: The usual dose is 40 mg twice daily and may be increased to 80-160 mg twice daily. 

Post-Myocardial Infarction: The initial dose after myocardial infarction is 20 mg twice daily. The dose should be increased with a target of 160 mg daily if tolerated without side effects.

Administration of Valsartan with food decreases the absorption of Valsartan by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.

Valsartan is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur if patient have been taking diuretics along with Valsartan.

Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment.

Heart Failure and Myocardial Infarction: Caution should be exercised when initiating therapy in patients with heart failure and post-myocardial infarction patients.

No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide

As Valsartan is not metabolized to a significant extent, clinically relevant drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitrostudies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Furosemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co medication is considered necessary, caution is advisable

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some elderly persons cannot be ruled out.

Hepatic Impairment:

• Mild to moderate: Max: 80 mg once daily.
• Severe: Contraindicated.

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.

Store between 15-30° C. Protect from moisture and heat.

This combination is indicated for the treatment of hypertension.

Combined antihypertensive preparations

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of anangiotensin converting enzyme (ACE) inhibitor tends to reverse the potassium loss associated with these diuretics.

Hypertension: A patient whose blood pressure is not controlled with Valsartan and Hydrochlorothiazide monotherapy, should switch to Valsartan and Hydrochlorothiazide combination once daily. Highest allowed dose of Valsartan should not be greater than 320 mg in combination with hydrochlorothiazide 25 mg. 

For Elderly: No initial dosage adjustment is necessary for elderly patients.

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

The combination of Valsartan and Hydrochlorothiazide is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur.

The combination of Valsartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder. 

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment because thiazides may precipitate azotemia. 

Heart Failure and Myocardial Infarction: Caution should be observed when initiating therapy in patients with heart failure and post-myocardial infarction patients.

Valsartan:

• Diuretics: Patient on diuretics may occasionally experience excessive reduction in blood pressure after initiation of therapy with Valsartan. No drug interaction of clinical significance has been identified with thiazide diuretics. 
• Agents increasing Serum Potassium: Since Valsartan decreases the production of aldosterone, potassium supplements or salt containing potassium substitutes may lead to hyperkalemia. 
• Lithium Salts: As with other drugs which eliminate sodium, lithium clearance may be reduced. Therefore, serum lithium levels should be monitored carefully if lithium salts are to be administered.
• Other drugs showing interaction are Warfarin, Digoxin.

Hydrochlorothiazide:

• When administered concurrently, the following drugs may interact with thiazide diuretics: alcohol, barbiturates, or narcotics may potentiate antihypertensive effect or orthostatic hypotension may occur.
• Antidiabetic drugs (oral agents and insulin): dosage adjustment of the antidiabetic drug may be required.
• Other antihypertensive drugs give additive effect.
• Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins.

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Hydrochlorothiazide is excreted in breast milk.

Use in Patients with Renal Impairment: The usual regimens of therapy with this combination may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.

Use in patients with Hepatic Impairment: Care should be taken in patient with hepatic impairment.

Valsartan: Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline. 

Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. if digitalis has also been administered with it, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.

Store between 15-30° C.

This combination is indicated for the treatment of hypertension.

Combined antihypertensive preparations

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of anangiotensin converting enzyme (ACE) inhibitor tends to reverse the potassium loss associated with these diuretics.

Hypertension: A patient whose blood pressure is not controlled with Valsartan and Hydrochlorothiazide monotherapy, should switch to Valsartan and Hydrochlorothiazide combination once daily. Highest allowed dose of Valsartan should not be greater than 320 mg in combination with hydrochlorothiazide 25 mg. 

For Elderly: No initial dosage adjustment is necessary for elderly patients.

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

The combination of Valsartan and Hydrochlorothiazide is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur.

The combination of Valsartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder. 

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment because thiazides may precipitate azotemia. 

Heart Failure and Myocardial Infarction: Caution should be observed when initiating therapy in patients with heart failure and post-myocardial infarction patients.

Valsartan:

• Diuretics: Patient on diuretics may occasionally experience excessive reduction in blood pressure after initiation of therapy with Valsartan. No drug interaction of clinical significance has been identified with thiazide diuretics. 
• Agents increasing Serum Potassium: Since Valsartan decreases the production of aldosterone, potassium supplements or salt containing potassium substitutes may lead to hyperkalemia. 
• Lithium Salts: As with other drugs which eliminate sodium, lithium clearance may be reduced. Therefore, serum lithium levels should be monitored carefully if lithium salts are to be administered.
• Other drugs showing interaction are Warfarin, Digoxin.

Hydrochlorothiazide:

• When administered concurrently, the following drugs may interact with thiazide diuretics: alcohol, barbiturates, or narcotics may potentiate antihypertensive effect or orthostatic hypotension may occur.
• Antidiabetic drugs (oral agents and insulin): dosage adjustment of the antidiabetic drug may be required.
• Other antihypertensive drugs give additive effect.
• Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins.

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Hydrochlorothiazide is excreted in breast milk.

Use in Patients with Renal Impairment: The usual regimens of therapy with this combination may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.

Use in patients with Hepatic Impairment: Care should be taken in patient with hepatic impairment.

Valsartan: Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline. 

Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration) resulting from excessive diuresis. if digitalis has also been administered with it, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.

Store between 15-30° C.

Valsartan is indicated:

• For hypertension
• To reduce hospitalizations in patients with congestive heart failure
• To reduce death in patients who developed congestive heart failure after myocardial infarction

Angiotensin-ll receptor blocker

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hypertension: The usual dose of Valsartan is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. 

Heart failure: The usual dose is 40 mg twice daily and may be increased to 80-160 mg twice daily. 

Post-Myocardial Infarction: The initial dose after myocardial infarction is 20 mg twice daily. The dose should be increased with a target of 160 mg daily if tolerated without side effects.

Administration of Valsartan with food decreases the absorption of Valsartan by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.

Valsartan is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur if patient have been taking diuretics along with Valsartan.

Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment.

Heart Failure and Myocardial Infarction: Caution should be exercised when initiating therapy in patients with heart failure and post-myocardial infarction patients.

No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide

As Valsartan is not metabolized to a significant extent, clinically relevant drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitrostudies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Furosemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co medication is considered necessary, caution is advisable

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some elderly persons cannot be ruled out.

Hepatic Impairment:

• Mild to moderate: Max: 80 mg once daily.
• Severe: Contraindicated.

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.

Store between 15-30° C. Protect from moisture and heat.

Valsartan is indicated:

• For hypertension
• To reduce hospitalizations in patients with congestive heart failure
• To reduce death in patients who developed congestive heart failure after myocardial infarction

Angiotensin-ll receptor blocker

Valsartan is an oral medication that belongs to a class of drugs called angiotensin receptor blockers (ARBs). It is orally active and specific angiotensin II antagonist acting on the AT1 subtype. Angiotensin's attachment to the receptors cause the blood vessels to narrow (vasoconstrict) which leads to an increase in blood pressure (hypertension). Valsartan blocks the angiotensin II receptor. By blocking the action of angiotensin, Valsartan dilates blood vessels and reduces blood pressure without affecting pulse rate. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. It does not bind or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hypertension: The usual dose of Valsartan is 80 to 160 mg once daily. The maximum dose is 320 mg daily. Maximum blood pressure reduction occurs within 4 weeks. 

Heart failure: The usual dose is 40 mg twice daily and may be increased to 80-160 mg twice daily. 

Post-Myocardial Infarction: The initial dose after myocardial infarction is 20 mg twice daily. The dose should be increased with a target of 160 mg daily if tolerated without side effects.

Administration of Valsartan with food decreases the absorption of Valsartan by about 40%, so it should be taken on an empty stomach. No initial dosage adjustment is required for elderly patients with mild to moderate renal and hepatic insufficiency.

Valsartan is generally well tolerated and side effects are rare. The most common side effects include headache, dizziness, fatigue, abdominal pain, cough, diarrhea and nausea. Patient may also experience hyperkalemia, impotency, reduced renal function, allergic reactions, dyspnea, constipation, back pain, muscle cramps, rash, anxiety, insomnia and vertigo. Hypotension may also occur if patient have been taking diuretics along with Valsartan.

Valsartan is contraindicated in patients who are hypersensitive to any component of this product.

Impaired Hepatic Function: As the majority of Valsartan is eliminated in the bile, care should be exercised in patients with mild to moderate hepatic impairment including biliary obstructive disorder.

Impaired Renal Function: Dosage reduction or discontinuation may be required with patients having pre-existing renal impairment.

Heart Failure and Myocardial Infarction: Caution should be exercised when initiating therapy in patients with heart failure and post-myocardial infarction patients.

No drug interactions of clinical significance have been found. Compounds which have been studied in clinical trials include Cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, Hydrochlorothiazide, Amlodipine and Glibenclamide

As Valsartan is not metabolized to a significant extent, clinically relevant drug-drug interactions in the form of metabolic induction or inhibition of the cytochrome P450 system are not expected with Valsartan. Although valsartan is highly bound to plasma proteins, in vitrostudies have not shown any interaction at this level with a range of molecules which are also highly protein bound, such as Diclofenac, Furosemide, and Warfarin. Concomitant use of potassium sparing diuretics (e.g., Spironolactone, Triamterene, Amiloride) potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. If co medication is considered necessary, caution is advisable

Pregnancy: Valsartan should not be used in pregnancy, as in 2nd and 3rd trimester it can cause injury and even death to fetus. When pregnancy is detected, Valsartan should be stopped as soon as possible.

Nursing mothers: It is not known whether Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in paediatric patients have not been established.

Geriatric use: No overall difference in the efficacy or safety of Valsartan was observed in this patient population, but greater sensitivity of some elderly persons cannot be ruled out.

Hepatic Impairment:

• Mild to moderate: Max: 80 mg once daily.
• Severe: Contraindicated.

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia, bradycardia could occur from parasympathetic (vagal) stimulation. If excessive hypotension occurs, the patient should be placed in the supine position and if necessary, has to be given an intravenous infusion of normal saline.

Store between 15-30° C. Protect from moisture and heat.

Other antibiotic

Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.

Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.

Patients with Normal Renal Function:

• Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
• Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
• Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.

Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function.  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-

• CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
• CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
• CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
• CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
• CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
• CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
• CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
• CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
• CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
• CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h

The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.

Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.

Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin

Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.

Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.

Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.

It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.

Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract

Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit

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

Other antibiotic

Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.

Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.

Patients with Normal Renal Function:

• Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
• Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
• Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.

Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function.  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-

• CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
• CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
• CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
• CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
• CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
• CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
• CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
• CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
• CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
• CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h

The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.

Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.

Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin

Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.

Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.

Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.

It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.

Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract

Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit

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

Other antibiotic

Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.

Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.

Patients with Normal Renal Function:

• Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
• Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
• Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.

Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function.  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-

• CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
• CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
• CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
• CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
• CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
• CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
• CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
• CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
• CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
• CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h

The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.

Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.

Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin

Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.

Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.

Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.

It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.

Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract

Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit

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

Other antibiotic

Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.

Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.

Patients with Normal Renal Function:

• Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
• Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
• Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.

Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function.  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-

• CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
• CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
• CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
• CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
• CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
• CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
• CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
• CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
• CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
• CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h

The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.

Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.

Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin

Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.

Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.

Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.

It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.

Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract

Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit

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

Eflornithine Hydrochloride cream, 13.9% is indicated for the reduction of unwanted facial hair in women. Eflornithine Hydrochloride has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.

Hair Growth Inhibitor

Eflornithine prevents hair growth by inhibiting the anagen phase of hair production. This occurs by eflornithine irreversibly binding (also called suicide inhibition) to ornithine decarboxylase (ODC) and physically preventing the natural substrate ornithine from accessing the active site.

Adults: Apply a thin layer of Eflornithine cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with Eflornithine (Wonica should be applied at least 5 minutes after hair removal). Cosmetics or sunscreens may be applied over treated areas after cream has dried. 

Elderly: No apparent differences in safety were observed between older patients and younger patients. 

Children: The safety and effectiveness of this product have not been established in pediatric patients less than 12 years of age.

Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Eflornithine. Side effects can include acne, barbae, pseudofolliculitis, stinging skin, headache, burning skin, dry skin, erythema (redness), pruritus (itching), tingling skin, dyspepsia, skin irritation, rash, alopecia, dizziness, folliculitis, hair ingrown, facial edema, anorexia, nausea, asthenia, vertigo

Eflornithine is contraindicated in patients with a history of sensitivity to any components of the preparation.

For external use only. Transient stinging or burning may occur when applied to abraded or broken skin.

It is not known whether Eflornithine has any interaction with other topically applied drug products.

Pregnancy Category C. It is not known whether or not Eflornithine Hydrochloride is excreted in human milk. Caution should be exercised when Eflornithine is administered to a nursing woman.

Overdosage information with Eflornithine is unavailable. However, if very high topical doses (e.g., multiple tubes per day) or oral ingestion has been encountered (a 30 gm tube contains 4.2 gm of Eflornithine Hydrochloride), the patient should be monitored, and appropriate supportive measures should be administered as necessary.

Store at 25°C, excursions permitted to 15°C-30°C. Do not freeze.

Herbal and Nutraceuticals, Vitamin-E Preparations

Vitamin E acts as an antioxidant in the body. Vitamin E protects polyunsaturated fatty acids (which are components of cellular membrane) and other oxygen-sensitive substances such as vitamin A & vitamin C from oxidation. In premature neonates irritability, edema, thrombosis and hemolytic anemia may be caused due to vitamin E deficiency. Creatinuria, ceroid deposition, muscle weakness, decreased erythrocyte survival or increased in vitro hemolysis by oxidizing agents have been identified in adults and children with low serum tocopherol concentrations.

Betterment of cardiovascular health: 400 IU-800 IU per day
Deficiency syndrome in adults: 200 IU-400 IU per day
Deficiency syndrome in children: 200 IU per day
Thalassemia: 800 IU per day
Sickle-cell anemia: 400 IU per day
Betterment of skin & hair: 200 IU-400 IU per day (Topical use is also established for beautification)
Chronic cold in adults: 200 IU per day

Overdosage (>1 gm) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy.

No known contraindications found.

It may increase the risk of thrombosis in some patients, such as those taking estrogens.

Vitamin E may impair the absorption of Vitamin A & function of Vitamin K and potentiates the effect of Warfarin.

Vitamin E is safe in pregnancy and lactation, when used as recommended doses. Higher doses are not established.

Vitamin E is safe for children.

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

Other antibiotic

Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.

Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.

Patients with Normal Renal Function:

• Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
• Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
• Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.

Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function.  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-

• CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
• CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
• CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
• CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
• CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
• CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
• CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
• CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
• CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
• CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h

The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.

Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.

Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin

Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.

Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.

Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.

It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.

Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract

Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit

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

Other antibiotic

Vancomycin binds tightly to D-alanyl-D-alanine portion cell wall precursor causing blockage of glycopeptide polymerisation which produces immediate inhibition of cell wall synthesis and secondary damage to the cytoplasmic membrane.

Concentrations of no more than 5 mg/ml and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used.

Patients with Normal Renal Function:

• Adults: Usual daily dose is 2 gm (in 4 or 2 divided doses).
• Children: Total daily dose is 40 mg/Kg (in 4 divided doses).
• Infants and Neonates: An initial dose of 15 mg/Kg is suggested followed by 10 mg/Kg every 12 hours in the first week, then every 8 hours up to 1 month.

Patients with Impaired Renal Function and Elderly Patients: Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, dosage reduction may be necessary to a greater extent than expected because of decreasing renal function.  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following chart-

• CrCl 100 ml/min: Vancomycin Dose 1545 mg/24 h
• CrCl 90 ml/min: Vancomycin Dose 1390 mg/24 h
• CrCl 80 ml/min: Vancomycin Dose 1235 mg/24 h
• CrCl 70 ml/min: Vancomycin Dose 1080 mg/24 h
• CrCl 60 ml/min: Vancomycin Dose 925 mg/24 h
• CrCl 50 ml/min: Vancomycin Dose 770 mg/24 h
• CrCl 40 ml/min: Vancomycin Dose 620 mg/24 h
• CrCl 30 ml/min: Vancomycin Dose 465 mg/24 h
• CrCl 20 ml/min: Vancomycin Dose 310 mg/24 h
• CrCl 10 ml/min: Vancomycin Dose 155 mg/24 h

The initial dose should be not less than 15 mg/kg even in patients with mild to moderate renal insufficiency. Above chart is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. Since individual maintenance doses of 250-1,000 mg are convenient, 1 dose may be given every several days rather than on a daily basis in patients with marked renal impairment. In anuria, a dose of 1000 mg every 7-10 days has been recommended. Intermittent infusion is the recommended method of administration. Intraperitoneal administration is not recommended.

Vancomycin is well tolerated. However during or soon after rapid infusion of Vancomycin, patients may develop anaphylactic reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper body ("red neck") or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if Vancomycin is given by a slow infusion over 60 minutes.

Vancomycin is contraindicated in Patients with known hypersensitivity to Vancomycin

Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of Vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.

Vancomycin is very irritating to tissue and causes injection site necrosis when injected intramuscularly. It must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving Vancomycin and are occasionally severe.

Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile, developing in patients who received intravenous Vancomycin.

It is not known whether it causes foetal harm or not. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity.

Vancomycin Hydrochloride is excreted in human milk. Caution should be exercised when Vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of Vancomycin from its gastro-intestinal tract

Supportive care is advised with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit

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

Third generation Cephalosporins

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

Adults and Adolescents (13 years and older)

• Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
• Community acquired pneumonia: 200 mg 12 hourly, 14 days
• Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
• Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
• Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
• Uncomplicated gonorrhea: single dose of 200 mg
• Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

• Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
• Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

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

Third generation Cephalosporins

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

Adults and Adolescents (13 years and older)

• Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
• Community acquired pneumonia: 200 mg 12 hourly, 14 days
• Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
• Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
• Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
• Uncomplicated gonorrhea: single dose of 200 mg
• Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

• Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
• Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

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

Third generation Cephalosporins

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

Adults and Adolescents (13 years and older)

• Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
• Community acquired pneumonia: 200 mg 12 hourly, 14 days
• Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
• Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
• Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
• Uncomplicated gonorrhea: single dose of 200 mg
• Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)

• Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
• Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
• Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Cefpodoxime has very few side effects. Possible side effects include gastrointestinal disorders (such as- diarrhea, nausea, vomiting and abdominal pain), rash, urticaria and itching.

Cefpodoxime is contraindicated in patients with known allergy to cephalosporins.

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of non-susceptible organisms.

Cefpodoxime concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers reduces peak plasma levels and the extent of absorption respectively. Renal excretion of Cefpodoxime is inhibit by probenecid.

US FDA pregnancy category of Cefpodoxime is B. There is, however, no adequate and well-controlled study 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Patients with severe renal impairment (creatinin clearance <30 ml/min) the dosing intervals should be increased to 24 hourly. The dosage adjustment is not require in cases of hepatic impairment.

Step 1: Shake the bottle well to loosen the powder.
Step 2: Add boiled and cooled water in the bottle.
Step 3: Shake until powder is completely mixed with water.

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

Stiffness, Congestion, Muscle aches, Sprains, Strains, Back pain, Joint pain, Cold, Flu, Catarrh, Headache

Topical Analgesics, Topical anti-inflammatory preparations

Camphor acts as a cough suppressant & topical analgesic. Eucalyptus Oil acts as a cough suppressant. Menthol acts as a acts as cough suppressant & topical analgesic

Topical: Rub gently 3-4 mintues on the chest and back 2-3 times daily. Cover the rubbed area with warm clothes.

Inhalation: 1 tsf of ointment to be dissolved in boiled water and inhale the steam by mouth or nose as required.

Redness, irritation, rash or pruritis may occur with sensitive skin.

Children under 3 years. History of convulsion.

Avoid contact with eyes. Should not be applied to wounds or damaged skin. Wash hand thoroughly after applying.

There are no known drug interactions and none well documented.

Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Tolvaptan is indicated in-

• Hypervolemic or euvolemic hyponatremia.
• Autosomal dominant polycystic kidney disease.

Selective vasopressin V2-receptor antagonist

Tolvaptan is a selective vasopressin V2-receptor antagonist. Tolvaptan affinity for the V2-receptor is 29 times greater than for the V1a-receptor. When taken orally, 15 to 60 mg doses of Tolvaptan antagonize the effect of vasopressin and cause an increase in urine water excretion that results in an increase in free water clearance (aquaresis), a decrease in urine osmolality, and a resulting increase in serum sodium concentrations. Urinary excretion of sodium and potassium and plasma potassium concentrations are not significantly changed.

Hypervolemic or euvolemic hyponatremia: The usual starting dose for Tolvaptan is 15 mg administered once daily without regard to meals. Increase the dose to 30 mg once daily, after at least 24 hours, to a maximum of 60 mg once daily, as needed to achieve the desired level of serum sodium. Do not use for more than 30 days due to the risk of hepatotoxicity.

Autosomal dominant polycystic kidney disease (ADPKD):

• Initially: 60 mg/day in divided doses (given as 45 mg upon wakening and 15 mg 8 hours later);
• Titrate per response and tolerability at intervals of at least 7 days between titrations to 90 mg/day in divided doses (given as 60 mg upon wakening and 30 mg 8 hours later) followed by 120 mg/day in divided doses (given as 90 mg upon wakening and 30 mg 8 hours later).
• Maintain urine osmolality of <300 mOsm/kg if possible; if the maximum dose is not tolerated, administration of a lower dose with the goal of achieving urine osmolality of 250 to 300 mOsm/kg is reasonable.

The most common side effects of Tolvaptan are: thirst, dry mouth, weakness, constipation, making large amounts of urine and urinating often & increased blood sugar levels.

Hypersensitivity to the active substance or to any of the excipients, anuria, volume depletion, hypovolemic hyponatremia, hypernatremia, Patients who cannot perceive thirst, pregnancy, breast-feeding.

Too rapid correction of serum sodium can cause serious neurologic sequelae.

Other Drugs Affecting Exposure to Tolvaptan:

• CYP 3A Inhibitors: Tolvaptan is a substrate of CYP 3A. CYP 3A inhibitors can lead to a marked increase in Tolvaptan concentrations. Do not use Tolvaptan with strong inhibitors of CYP 3A and avoid concomitant use with moderate CYP 3A inhibitors.
• CYP 3A Inducers: Avoid co-administration of CYP 3A inducers (e.g., Rifampin, Rifabutin, Rifapentin, Barbiturates, Phenytoin, Carbamazepine) with Tolvaptan, as this can lead to a reduction in the plasma concentration of Tolvaptan and decreased effectiveness of Tolvaptan treatment. If co-administered with CYP 3A inducers, the dose of Tolvaptan may need to be increased.
• P-gp Inhibitors: The dose of Tolvaptan may have to be reduced when Tolvaptan is co-administered with P-gp inhibitors, e.g., Cyclosporine.

There are no or limited amount of data from the use of Tolvaptan in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Tolvaptan is contraindicated during pregnancy. Women of childbearing potential have to use effective contraception during Tolvaptan treatment. It is unknown whether Tolvaptan is excreted in human milk.

Pediatric Use: Safety and effectiveness of Tolvaptan in pediatric patients have not been established.

Geriatric Use: Of the total number of hyponatremic subjects treated with Tolvaptan in clinical studies, 42% were 65 and over, while 19% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increasing age has no effect on Tolvaptan plasma concentrations.

Use in Patients with Hepatic Impairment: Moderate and severe hepatic impairment do not affect exposure to Tolvaptan to a clinically relevant extent. Avoid use of Tolvaptan in patients with underlying liver disease.

Use in Patients with Renal Impairment: No dose adjustment is necessary based on renal function. There are no clinical trial data in patients with CrCl<10 ml/min, and, because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in patients with a CrCl<10 ml/min is not recommended. No benefit can be expected in patients who are anuric.

Use in Patients with Congestive Heart Failure: The exposure to Tolvaptan in patients with congestive heart failure is not clinically relevantly increased. No dose adjustment is necessary.

Single doses up to 480 mg and multiple doses up to 300 mg per day for 5 days have been well tolerated in clinical trials in healthy volunteers. There is no specific antidote for Tolvaptan intoxication. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/ hypovolemia (profuse and prolonged aquaresis). In patients with suspected Tolvaptan overdose, assessment of vital signs, electrolyte concentrations, ECG and fluid status is recommended. Appropriate replacement of water and/or electrolytes must continue until aquaresis abates. Dialysis may not be effective in removing Tolvaptan because of its high binding affinity for human plasma protein (>98%).

Store at below 25°C in a dry place, protected from light. Keep out of reach of children.