Losartan Potassium and Hydrochlorothiazide

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Overview

What is Losartan Potassium and Hydrochlorothiazide?

Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT receptor subtype and a diuretic, hydrochlorothiazide.

Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[(-1-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is CHClKNO, and its structural formula is:

Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone.

Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is CHClNOS and its structural formula is:

Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Losartan potassium and Hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and Hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and Hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and Hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and Hydrochlorothiazide 50/12.5 and Losartan potassium and Hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake.

Losartan potassium and Hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, Losartan potassium and Hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and Losartan potassium and Hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium.

What does Losartan Potassium and Hydrochlorothiazide look like?

What are the available doses of Losartan Potassium and Hydrochlorothiazide?

Tablets (losartan potassium/hydrochlorothiazide content): 50/12.5 mg; 100/12.5 mg; and 100/25 mg. ()

What should I talk to my health care provider before I take Losartan Potassium and Hydrochlorothiazide?

How should I use Losartan Potassium and Hydrochlorothiazide?

Losartan potassium and Hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients

Losartan potassium and Hydrochlorothiazide may be administered with other antihypertensive agents.

The usual starting dose of Losartan potassium and Hydrochlorothiazide is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure

Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with Losartan potassium and Hydrochlorothiazide 50/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of Losartan potassium and Hydrochlorothiazide 50/12.5 once daily or one tablet of Losartan potassium and Hydrochlorothiazide 100/25 once daily.

Initiate a patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy with Losartan potassium and Hydrochlorothiazide 100/12.5 (losartan 100 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of Losartan potassium and Hydrochlorothiazide 50/12.5 once daily or one tablet of Losartan potassium and Hydrochlorothiazide 100/25 once daily.

Initiate a patient whose blood pressure is inadequately controlled with hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen, on Losartan potassium and Hydrochlorothiazide 50/12.5 once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. Evaluate the clinical response to Losartan potassium and Hydrochlorothiazide 50/12.5 and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of Losartan potassium and Hydrochlorothiazide 50/12.5 once daily or one tablet of Losartan potassium and Hydrochlorothiazide 100/25 once daily.

What interacts with Losartan Potassium and Hydrochlorothiazide?

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What are the warnings of Losartan Potassium and Hydrochlorothiazide?

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What are the precautions of Losartan Potassium and Hydrochlorothiazide?

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What are the side effects of Losartan Potassium and Hydrochlorothiazide?

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What should I look out for while using Losartan Potassium and Hydrochlorothiazide?

Losartan potassium and Hydrochlorothiazide is contraindicated:

When pregnancy is detected, discontinue Losartan potassium and Hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

What might happen if I take too much Losartan Potassium and Hydrochlorothiazide?

Losartan

Potassium

Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.

Neither losartan nor its active metabolite can be removed by hemodialysis.

Hydrochlorothiazide

How should I store and handle Losartan Potassium and Hydrochlorothiazide?

Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5 mg Bottles of 30 tablets with Child Resistant Closure, NDC 59746-337-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-337-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-337-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-337-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-338-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-338-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-338-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-338-10.Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mgBottles of 30 tablets with Child Resistant Closure, NDC 59746-339-30. Bottles of 90 tablets with Child Resistant Closure, NDC 59746-339-90.Bottles of 100 tablets with Child Resistant Closure, NDC 59746-339-01. Bottles of 1000 tablets with Plain Closure, NDC 59746-339-10.Storage Keep this and all medicines out of the reach of children.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Losartan

Potassium

In vitro

Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin), nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hydrochlorothiazide

Non-Clinical Toxicology

Losartan potassium and Hydrochlorothiazide is contraindicated:

When pregnancy is detected, discontinue Losartan potassium and Hydrochlorothiazide tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

See Table 1 for clinically significant drug interactions with naproxen.

Table 1: Clinically Significant Drug Interactions with naproxen

Drug/Laboratory Test Interactions

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Losartan potassium and Hydrochlorothiazide as soon as possible.

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice, thrombocytopenia

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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