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Indications/Uses
Treatment of mild to moderate hypertension. Treatment of patients with hypertension not responding to monotherapy with calcium antagonist or angiotensin II receptor antagonists.
Dosage/Direction for Use
The usual initial dosage is one tablet daily. If blood pressure control is inadequate after a week or two, the dose may be increased to two tablets daily. The dosage, however, should be individualized.
Overdosage
The most likely manifestation of overdosage could be hypotension and tachycardia; bradycardia could occur from parasympathetic stimulation. If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous calcium gluconate may help to reverse the effects if calcium entry blockade. The combination cannot be removed by dialysis.
Administration
May be taken with or without food.
Contraindications
The combination is contraindicated in patients who are hypersensitive to any component of this product.
Special Precautions
Congestive Heart Failure: In general, calcium channel blockers should be used with caution in patients with heart failure.
Electrolyte Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Lithium: Losartan reduces lithium excretion; hence, serum lithium levels should be monitored carefully if lithium salts are to be co-administered with LOSARTAN potassium + AMLODIPINE besilate tablets.
Hypotension: Excessive fall of blood pressure can occur with amlodipine in some patients, especially the elderly. In patients who are intravascularly volume-depleted, symptomatic.
Renal Impairment: The combination should be used with caution in patients with severe renal disease. As a consequence of inhibiting the renin-angiotensin-aldosterone-system (RAAS), changes in renal function have been reported in susceptible individuals treated with losartan; in some patients, these changes in renal function were reversible upon discontinuation of therapy.
Hepatic Impairment: Caution should be exercised when administering the combination to patients with impaired hepatic function due to increase in the plasma concentration of the combination.
Use in Pregnancy: Drugs that act directly on the RAAS can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, LOSARTAN potassium + AMLODIPINE besilate tablet should be discontinued as soon as possible. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function.
Use in Lactation: It is not known whether losartan or amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing may be discontinued while the combination is administered.
Electrolyte Imbalance: Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.
Lithium: Losartan reduces lithium excretion; hence, serum lithium levels should be monitored carefully if lithium salts are to be co-administered with LOSARTAN potassium + AMLODIPINE besilate tablets.
Hypotension: Excessive fall of blood pressure can occur with amlodipine in some patients, especially the elderly. In patients who are intravascularly volume-depleted, symptomatic.
Renal Impairment: The combination should be used with caution in patients with severe renal disease. As a consequence of inhibiting the renin-angiotensin-aldosterone-system (RAAS), changes in renal function have been reported in susceptible individuals treated with losartan; in some patients, these changes in renal function were reversible upon discontinuation of therapy.
Hepatic Impairment: Caution should be exercised when administering the combination to patients with impaired hepatic function due to increase in the plasma concentration of the combination.
Use in Pregnancy: Drugs that act directly on the RAAS can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, LOSARTAN potassium + AMLODIPINE besilate tablet should be discontinued as soon as possible. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function.
Use in Lactation: It is not known whether losartan or amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing may be discontinued while the combination is administered.
Adverse Reactions
The combination of amlodipine and losartan is well tolerated. Side effects include nausea, headache, dizziness, abdominal pain, fatigue, flushing, palpitation and asthenia.
Drug Interactions
Rifampin: Rifampin, an inducer of drug metabolism, decreased the contraindications of losartan and its active metabolite.
Fluconazole: Fluconazole, an inhibitor of P450 2C9, decreased active metabolite concentration and increased losartan concentration.
Agents that Increase Serum Potassium: As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium.
NSAIDs including Selective Cyclooxygenase-2 Inhibitors: In some patients with compromised renal function who are being treated with NSAIDs, including those that selectively inhibit cyclooxygenase-2 inhibitors (COX-2 inhibitors), the co-administration of losartan may result in further deterioration of renal function. These effects are usually reversible.
Fluconazole: Fluconazole, an inhibitor of P450 2C9, decreased active metabolite concentration and increased losartan concentration.
Agents that Increase Serum Potassium: As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium.
NSAIDs including Selective Cyclooxygenase-2 Inhibitors: In some patients with compromised renal function who are being treated with NSAIDs, including those that selectively inhibit cyclooxygenase-2 inhibitors (COX-2 inhibitors), the co-administration of losartan may result in further deterioration of renal function. These effects are usually reversible.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Amlodipine: Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The contractile process of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. 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.
Losartan: Losartan and its principal active metabolite block 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.
Pharmacokinetics: Amlodipine: After oral administration of therapeutic doses of amlodipine, absorption produces peak plasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to be between 64% and 90%. The bioavailability of amlodipine is not altered by the presence of food.
Losartan: Losartan is an orally active agent that undergoes substantial first-pass metabolism by cytochrome P450 enzymes. It is converted, in part, to an active carboxylic acid metabolite that is responsible for most of the angiotensin II receptor antagonism that follows losartan treatment. The terminal half-life of losartan is about 2 hours and of the metabolite is about 6-9 hours.
Losartan: Losartan and its principal active metabolite block 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.
Pharmacokinetics: Amlodipine: After oral administration of therapeutic doses of amlodipine, absorption produces peak plasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to be between 64% and 90%. The bioavailability of amlodipine is not altered by the presence of food.
Losartan: Losartan is an orally active agent that undergoes substantial first-pass metabolism by cytochrome P450 enzymes. It is converted, in part, to an active carboxylic acid metabolite that is responsible for most of the angiotensin II receptor antagonism that follows losartan treatment. The terminal half-life of losartan is about 2 hours and of the metabolite is about 6-9 hours.
MedsGo Class
Angiotensin II Antagonists / Calcium Antagonists
Features
Brand
Xartan Duo
Full Details
Dosage Strength
50 mg / 5 mg
Drug Ingredients
- Amlodipine
- Losartan Potassium
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Amlodipine Besilate / Losartan Potassium
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY44023
Drug Classification
Prescription Drug (RX)