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Olixar
Olanzapine
Olixar
Olanzapine
Indications
Unipolar and bipolar depression
Indication detailsView
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is indicated for the treatment of acute manic or mixed episodes in bipolar disorder, with or without psychotic features and with or without a rapid cycling course
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.
DosageView
Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.
Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.
Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.
AdministrationView
Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.
Side effectsView
Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.
ContraindicationsView
Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.
PrecautionsView
Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.
InteractionsView
Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.
Pregnancy & lactationView
Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.
Pediatric usageView
Children: Olanzapine has not been studied in subjects under 18 years of age.
Elderly patients (age 65 and over): starting dose 5 mg/day
Patients with hepatic, renal impairment: starting dose 5 mg/day
Elderly patients (age 65 and over): starting dose 5 mg/day
Patients with hepatic, renal impairment: starting dose 5 mg/day
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Olixar
Olanzapine
Olixar
Olanzapine
Indications
Unipolar and bipolar depression
Indication detailsView
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine is indicated for the treatment of acute manic or mixed episodes in bipolar disorder, with or without psychotic features and with or without a rapid cycling course
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
Olanzapine is an antipsychotic agent and has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors. The mechanism of action of Olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is not mutagenic or clastogenic as well as not carcinogenic.
DosageView
Schizophrenia, combination therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 10 mg daily only after reassessment. Maximum dose is 20 mg daily.
Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.
Monotherapy for Mania: Initially 15 mg once daily. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20 mg daily. Dosage greater than 15 mg only after reassessment. Maximum dose is 20 mg daily.
AdministrationView
Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered while discontinuing Olanzapine.
Side effectsView
Very common undesirable effects are somnolence and weight gain. Besides increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects including constipation and dry mouth, asthenia, edema and photosensitivity reaction etc. may be observed.
ContraindicationsView
Olanzapine is contraindicated in those patients with a known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow-angle glaucoma.
PrecautionsView
Olanzapine should be used cautiously in patients who have a history of seizures or have conditions associated with seizures. Olanzapine should be used cautiously in patients with low leukocyte and/or neutrophil counts for any reason, drug induced bone marrow depression/toxicity caused by radiation therapy or chemotherapy, hypereosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines know to increase QT interval, especially in the elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.
InteractionsView
Olanzapine may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucoronyl transferase enzymes e.g, Omeprazole and Rifampicin, may increase Olanzapine clearance. Inhibitors of CYP1A2 may potentially inhibit Olanzapine elimination. Carbamazepine may increase the clearance of Olanzapine. Concomitant administration of activated charcoal reduces the oral bioavailability of Olanzapine by 50-60%. Caution should be taken when Olanzapine is administered with centrally acting drugs and alcohol.
Pregnancy & lactationView
Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the foetus. So, patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine. There is no report to show teratogenecity. Patients should not breast feed if they are taking Olanzapine.
Pediatric usageView
Children: Olanzapine has not been studied in subjects under 18 years of age.
Elderly patients (age 65 and over): starting dose 5 mg/day
Patients with hepatic, renal impairment: starting dose 5 mg/day
Elderly patients (age 65 and over): starting dose 5 mg/day
Patients with hepatic, renal impairment: starting dose 5 mg/day
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Olme
Olmesartan Medoxomil
Olme
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olme
Olmesartan Medoxomil
Olme
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olme
Olmesartan Medoxomil
Olme
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olme-AM
Amlodipine Besilate + Olmesartan Medoxomil
Olme-AM
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are 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 usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Olme-H
Olmesartan Medoxomil + Hydrochlorothiazide
Olme-H
Olmesartan Medoxomil + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.
Side effectsView
The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.
ContraindicationsView
The combination of Olmesartan 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.
PrecautionsView
- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
- Hyperuricemia may occur in certain patients receiving thiazide therapy.
- Impaired renal function.
InteractionsView
Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
- Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
- Antidiabetic drugs (oral agents and Insulin): Dosage adjustment of the antidiabetic drug may be required.
- Other antihypertensive drugs: Additive effect.
- Corticosteroids, ACTH.
- Lithium.
Pregnancy & lactationView
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
Pediatric usageView
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Overdose effectsView
Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.
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, hypokalemia may accentuate cardiac arrhythmias.
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, hypokalemia may accentuate cardiac arrhythmias.
StorageView
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
Olmeben
Olmesartan Medoxomil
Olmeben
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olmeben
Olmesartan Medoxomil
Olmeben
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olmeben Plus
Olmesartan Medoxomil + Hydrochlorothiazide
Olmeben Plus
Olmesartan Medoxomil + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.
Side effectsView
The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.
ContraindicationsView
The combination of Olmesartan 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.
PrecautionsView
- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
- Hyperuricemia may occur in certain patients receiving thiazide therapy.
- Impaired renal function.
InteractionsView
Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
- Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
- Antidiabetic drugs (oral agents and Insulin): Dosage adjustment of the antidiabetic drug may be required.
- Other antihypertensive drugs: Additive effect.
- Corticosteroids, ACTH.
- Lithium.
Pregnancy & lactationView
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
Pediatric usageView
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Overdose effectsView
Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.
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, hypokalemia may accentuate cardiac arrhythmias.
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, hypokalemia may accentuate cardiac arrhythmias.
StorageView
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
Olmecar
Olmesartan Medoxomil
Olmecar
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olmecar
Olmesartan Medoxomil
Olmecar
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olmecar
Olmesartan Medoxomil
Olmecar
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.
Olmecar Plus
Olmesartan Medoxomil + Hydrochlorothiazide
Olmecar Plus
Olmesartan Medoxomil + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.
Side effectsView
The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.
ContraindicationsView
The combination of Olmesartan 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.
PrecautionsView
- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
- Hyperuricemia may occur in certain patients receiving thiazide therapy.
- Impaired renal function.
InteractionsView
Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
- Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
- Antidiabetic drugs (oral agents and Insulin): Dosage adjustment of the antidiabetic drug may be required.
- Other antihypertensive drugs: Additive effect.
- Corticosteroids, ACTH.
- Lithium.
Pregnancy & lactationView
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
Pediatric usageView
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Overdose effectsView
Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.
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, hypokalemia may accentuate cardiac arrhythmias.
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, hypokalemia may accentuate cardiac arrhythmias.
StorageView
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
Olmedip
Amlodipine Besilate + Olmesartan Medoxomil
Olmedip
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are 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 usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Olmedip
Amlodipine Besilate + Olmesartan Medoxomil
Olmedip
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are 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 usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Olmefast H
Olmesartan Medoxomil + Hydrochlorothiazide
Olmefast H
Olmesartan Medoxomil + Hydrochlorothiazide
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil & Hydrochlorothiazide combination is indicated for the treatment of hypertension.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing the 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 Aldosterone secretion & urinary Potassium loss and decreases serum Potassium. The renin-aldosterone link is mediated by angiotensin-II. So, co-administration of an angiotensin-II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
DosageView
Hypertension: The usual starting dose is 20/12.5 mg one tablet once daily. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets 40/25 once daily.
Side effectsView
The common side-effects are nausea, headache, dizziness, hyperuricemia, upper respiratory tract infection and urinary tract infection. Other adverse effects are chest pain, back pain, peripheral edema, abdominal pain, dyspepsia, gastroenteritis, diarrhea.
ContraindicationsView
The combination of Olmesartan 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.
PrecautionsView
- Periodic determination of serum electrolytes should be performed at appropriate intervals to detect possible electrolyte imbalance like hypokalemia, hyponatremia and hypochloremic alkalosis.
- Hyperuricemia may occur in certain patients receiving thiazide therapy.
- Impaired renal function.
InteractionsView
Olmesartan: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics:
- Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
- Antidiabetic drugs (oral agents and Insulin): Dosage adjustment of the antidiabetic drug may be required.
- Other antihypertensive drugs: Additive effect.
- Corticosteroids, ACTH.
- Lithium.
Pregnancy & lactationView
Safety and effectiveness in nursing mother & pregnancy have not been established. The drug should be discontinued during these conditions.
Pediatric usageView
Renal Impairment Patients: The usual regimens of therapy with this may be followed provided the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. So, this preparation is not recommended.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Hepatic Impairment Patients: No dosage adjustment is necessary with hepatic impairment.
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Geriatric use: Clinical studies of Olmesartan and Hydrochlorothiazide combination did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
Overdose effectsView
Olmesartan: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia. Supportive treatment should be instituted.
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, hypokalemia may accentuate cardiac arrhythmias.
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, hypokalemia may accentuate cardiac arrhythmias.
StorageView
Store in a cool and dry place, protect from light and moisture. Keep out of the reach of children.
Olmefast-AM
Amlodipine Besilate + Olmesartan Medoxomil
Olmefast-AM
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are 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 usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Olmefast-AM
Amlodipine Besilate + Olmesartan Medoxomil
Olmefast-AM
Amlodipine Besilate + Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Indicated for the treatment of hypertension alone or with other antihypertensive agents, to lower blood pressure. This combination drug is indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals. The decision to use a combination as initial therapy should be individualized and shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the Renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex.
Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that Olmesartan Medoxomil is a reversible, competitive inhibitor of the AT1 receptor. Olmesartan Medoxomil does not inhibit ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin).
DosageView
Substitute individually titrated components for patients on Amlodipine and Olmesartan Medoxomil. This combination may also be given with increased amounts of Amlodipine, Olmesartan Medoxomil, or both, as needed.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Initial therapy: Initiate with 5/20 mg once daily for 1 to 2 weeks and titrate as needed up to a maximum of 10/40 mg once daily. Due to decreased clearance of Amlodipine among elderly patients the recommended starting dose of Amlodipine is 2.5 mg in patients 75 years. The lowest dose of the combination is 5/20 mg; therefore, initial therapy with this combination drug is not recommended in patients >75 years old.
Side effectsView
The most common side effects include peripheral edema, headache, flushing, and dizziness. It can also cause Intestinal problems known a sprue-like enteropathy.
ContraindicationsView
Cannot be co-administered with Aliskiren in patients with diabetes.
PrecautionsView
Amlodipine and Olmesartan Medoxomil combination should be used with caution because there is a risk for-
- Hypotension in volume- or salt depleted patients.
- Vasodilation in patients with severe aortic stenosis.
- Increased frequency, duration or severity of angina or acute Ml in patients with severe obstructive coronary artery disease.
InteractionsView
The antihypertensive effect of angiotensin II receptor antagonists, including Olmesartan Medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Blood pressure, renal function and electrolytes should be closely monitored in patients on combination therapy and other agents that affect the RAS.
Pregnancy & lactationView
Pregnancy Category D. Amlodipine and Olmesartan Medoxomil combination should not be used in 2nd and 3rd trimester because it can cause fetal death. When pregnancy is detected this combination should be discontinued as soon as possible. It is not known whether Olmesartan and Amlodipine are 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 usageView
Pediatric use: The safety and effectiveness have not been established in pediatric patients.
Geriatric use: No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.
Renal impairment: There are no studies in patients with renal impairment.
Hepatic impairment: Initial therapy is not recommended in hepatically impaired patients.
Overdose effectsView
There is no information on over dosage in humans.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Olmenor
Olmesartan Medoxomil
Olmenor
Olmesartan Medoxomil
Indications
Hypertension
Indication detailsView
Olmesartan Medoxomil is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Angiotensin-II formed from angiotensin-I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin-II by selectively blocking the binding of angiotensin-II to the AT 1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland). In-vitro-binding studies indicate that Olmesartan is a reversible & competitive inhibitor of AT 1 receptor. Olmesartan does not inhibit ACE (kinase-I, the enzyme that converts angiotensin-I to angiotensin-II and degrades bradykinin).
DosageView
Dosage must be individualized. The usual recommended starting dose of Olmesartan is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan may be increased to 40 mg. Doses above 40 mg do not appear to have a greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) or with moderate to marked hepatic dysfunction. For patients with possible depletion of intravascular volume (e.g. patients treated with diuretics, particularly those with impaired renal function), Olmesartan should be initiated under close medical supervision and consideration should be given to use of a lower starting dose. Olmesartan may be administered with or without food.
Side effectsView
Common: The most common side effects include Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis, and sinusitis.
Rare: Chest pain, peripheral edema, arthritis.
Rare: Chest pain, peripheral edema, arthritis.
ContraindicationsView
Olmesartan is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil. In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil.
InteractionsView
With medicine: No significant drug interactions were reported in which Olmesartan was co-administered.
With food & others: Food does not affect the bioavailability of Olmesartan.
With food & others: Food does not affect the bioavailability of Olmesartan.
Pregnancy & lactationView
Pregnancy: When pregnancy is detected, discontinue this product as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. 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 usageView
Paediatric use: Safety and effectiveness in paediatric patients have not been established.
Overdose effectsView
Symptoms: There is no experience of overdose with Olmesartan. The most likely effects of olmesartan medoxomil overdosage are hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurred.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
Treatment: If intake is recent, gastric lavage or induction of emesis may be considered. Clinically significant hypotension due to an overdose of Olmesartan requires the active support of the cardiovascular system, including close monitoring of heart and lung function, the elevation of the extremities, and attention to circulating fluid volume and urine output.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of the reach of children.