Mylan-Losartan HCTZ Uses

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What is Mylan-Losartan HCTZ?

Mylan-Losartan HCTZ contains a combination of Mylan-Losartan HCTZ. Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Losartan (Mylan-Losartan HCTZ) is an angiotensin II receptor antagonist. Losartan (Mylan-Losartan HCTZ) keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Mylan-Losartan HCTZ is used to treat high blood pressure (hypertension). It is also used to lower the risk of stroke in certain people with heart disease.

Mylan-Losartan HCTZ may also be used for purposes not listed in this medication guide.

Mylan-Losartan HCTZ indications

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Hypertension

Mylan-Losartan HCTZ® 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 (Mylan-Losartan HCTZ) and Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ).

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.

Mylan-Losartan HCTZ may be administered with other antihypertensive agents.

Hypertensive Patients With Left Ventricular Hypertrophy

Mylan-Losartan HCTZ is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients.

How should I use Mylan-Losartan HCTZ?

Use Mylan-Losartan HCTZ as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Mylan-Losartan HCTZ.

Uses of Mylan-Losartan HCTZ in details

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Use: Labeled Indications

Hypertension: Management of hypertension.

Hypertension with left ventricular hypertrophy: To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH). Evidence suggests that this benefit does not apply to black patients.

Mylan-Losartan HCTZ description

Each tablet contains Losartan (Mylan-Losartan HCTZ) potassium 50 or 100 mg and Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) 12.5 mg.

Losartan (Mylan-Losartan HCTZ) Potassium: Losartan (Mylan-Losartan HCTZ) potassium, a nonpeptide molecule, is chemically described as 2-butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol monopotassium salt.

Its empirical formula is C22H22ClKN6O.

Losartan (Mylan-Losartan HCTZ) potassium 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 eg, acetonitrile and methyl ethyl ketone.

Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of Losartan (Mylan-Losartan HCTZ).

Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ): Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Its empirical formula is C7H8ClN3O4S2.

It 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.

Mylan-Losartan HCTZ dosage

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Hypertension

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

Initiate a patient whose blood pressure is not adequately controlled with Losartan (Mylan-Losartan HCTZ) 50 mg monotherapy with Mylan-Losartan HCTZ 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 Mylan-Losartan HCTZ 50/12.5 once daily or one tablet of Mylan-Losartan HCTZ 100/25 once daily.

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

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

Hypertensive Patients with Left Ventricular Hypertrophy

In patients whose blood pressure is not adequately controlled on 50 mg Losartan (Mylan-Losartan HCTZ) potassium, initiate treatment with Mylan-Losartan HCTZ 50/12.5. If additional blood pressure reduction is needed, increase the dose to Mylan-Losartan HCTZ 100/12.5, followed by Mylan-Losartan HCTZ 100/25. For further blood pressure reduction add other antihypertensives.

Mylan-Losartan HCTZ interactions

See also:
What other drugs will affect Mylan-Losartan HCTZ?

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Agents Increasing Serum Potassium

Coadministration of Losartan (Mylan-Losartan HCTZ) with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients.

Lithium

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics. Monitor lithium levels in patients receiving Mylan-Losartan HCTZ and lithium.

Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors

Losartan (Mylan-Losartan HCTZ) Potassium

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including Losartan (Mylan-Losartan HCTZ)) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Losartan (Mylan-Losartan HCTZ) and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Losartan (Mylan-Losartan HCTZ), may be attenuated by NSAIDs, including selective COX-2 inhibitors.

Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ)

The administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Mylan-Losartan HCTZ and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.

In patients receiving diuretic therapy, coadministration of NSAIDs with angiotensin receptor blockers, including Losartan (Mylan-Losartan HCTZ), may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ), Losartan (Mylan-Losartan HCTZ), and NSAID therapy.

Dual Blockade Of The Renin-Angiotensin System (RAS)

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of Losartan (Mylan-Losartan HCTZ) therapy and followed them for a median of 2.2 years. Patients receiving the combination of Losartan (Mylan-Losartan HCTZ) and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end-stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.

Closely monitor blood pressure, renal function, and electrolytes in patients on Mylan-Losartan HCTZ and other agents that affect the RAS.

Do not coadminister aliskiren with Mylan-Losartan HCTZ in patients with diabetes. Avoid use of aliskiren with Mylan-Losartan HCTZ in patients with renal impairment (GFR < 60 mL/min).

The Use Of Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) With Other Drugs

When administered concurrently, the following drugs may interact with thiazide diuretics :

Antidiabetic drugs (oral agents and insulin) — dosage adjustment of the antidiabetic drug may be required.

Cholestyramine and colestipol resins — Absorption of Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Stagger the dosage of Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) and the resin such that Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

Mylan-Losartan HCTZ side effects

See also:
What are the possible side effects of Mylan-Losartan HCTZ?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Losartan (Mylan-Losartan HCTZ) potassium-Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively.

In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% of subjects treated with Losartan (Mylan-Losartan HCTZ)-Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) and at a greater rate than placebo were: back pain (2.1% vs 0.6%), dizziness (5.7% vs 2.9%), and upper respiratory infection (6.1% vs 4.6%).

The following additional adverse reactions have been reported in clinical trials with Mylan-Losartan HCTZ and/or the individual components:

Blood and the lymphatic system disorders: Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.

Metabolism and nutrition disorders: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia.

Psychiatric disorders: Insomnia, restlessness.

Nervous system disorders: Dysgeusia, headache, migraine, paraesthesias.

Eye disorders: Xanthopsia, transient blurred vision.

Cardiac disorders: Palpitation, tachycardia.

Vascular disorders: Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders: Nasal congestion, pharyngitis, sinus disorder, respiratory distress (including pneumonitis and pulmonary edema).

Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, diarrhea, constipation, nausea, vomiting, pancreatitis, sialoadenitis.

Hepato-biliary disorders: Jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus.

Musculoskeletal and connective tissue disorders: Muscle cramps, muscle spasm, myalgia, arthralgia.

Renal and urinary disorders: Glycosuria, renal dysfunction, interstitial nephritis, renal failure.

Reproductive system and breast disorders: Erectile dysfunction/impotence.

General disorders and administration site conditions: Chest pain, edema/swelling, malaise, fever, weakness.

Investigations: Liver function abnormalities.

Cough

Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of Losartan (Mylan-Losartan HCTZ) on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to Losartan (Mylan-Losartan HCTZ) 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.

Table 1:
*
Demographics = (89% Caucasian, 64% female)
Demographics = (90% Caucasian, 51% female)
Study 1* HCTZ Losartan (Mylan-Losartan HCTZ) Lisinopril
Cough 25% 17% 69%
Study 2† Placebo Losartan (Mylan-Losartan HCTZ) Lisinopril
Cough 35% 29% 62%

These studies demonstrate that the incidence of cough associated with Losartan (Mylan-Losartan HCTZ) therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ) or placebo therapy.

Cases of cough, including positive re-challenges, have been reported with the use of Losartan (Mylan-Losartan HCTZ) in postmarketing experience.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Mylan-Losartan HCTZ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Digestive: Hepatitis has been reported rarely in patients treated with Losartan (Mylan-Losartan HCTZ).

Hematologic: Thrombocytopenia.

Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with Losartan (Mylan-Losartan HCTZ); some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with Losartan (Mylan-Losartan HCTZ). Anaphylactic reactions have been reported.

Musculoskeletal: rhabdomyolysis

Skin: Erythroderma

Mylan-Losartan HCTZ contraindications

See also:
What is the most important information I should know about Mylan-Losartan HCTZ?

Hypersensitivity to Losartan (Mylan-Losartan HCTZ), sulphonamide-derived substances (as Hydrochlorothiazide (Mylan-Losartan (Mylan-Losartan HCTZ) HCTZ)) or to any of the excipients of Mylan-Losartan HCTZ.

Therapy resistant hypokalemia or hypercalcemia; severe hepatic impairment; cholestasis and biliary obstructive disorders; refractory hyponatremia; symptomatic hyperuricemia/gout; 2nd and 3rd trimester of pregnancy; lactation; severe renal impairment (ie, creatinine clearance <30 mL/min); anuria.

Excipient: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Mylan-Losartan HCTZ.

Use in lactation: It is not known whether Losartan (Mylan-Losartan HCTZ) is excreted in human milk. However, Losartan (Mylan-Losartan HCTZ) is excreted in the milk of lactating rats. Because no information is available regarding the use of Losartan (Mylan-Losartan HCTZ) during breastfeeding, Losartan (Mylan-Losartan HCTZ) is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.

Thiazides pass into human milk and may inhibit lactation. Because of the potential for adverse effects on the nursing infant, Losartan (Mylan-Losartan HCTZ)/HCTZ is contraindicated during breastfeeding.



Active ingredient matches for Mylan-Losartan HCTZ:

Hydrochlorothiazide/Losartan in Canada.


List of Mylan-Losartan HCTZ substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet, Film-Coated; Oral; Moxonidine 0.3 mg (Icn)
Tablet, Film-Coated; Oral; Clopamide 5 mg; Dihydroergocristine Mesylate 0.5 mg; Reserpine 0.1 mg (Icn)
Normatens - 20 Dragee (Icn)$ 10.00
Tablet; Oral; Hydrochlorothiazide 25 mg; Labetalol Hydrochloride 100 mg (Schering)
Tablet; Oral; Hydrochlorothiazide 25 mg; Labetalol Hydrochloride 200 mg (Schering)
Tablet; Oral; Hydrochlorothiazide 25 mg; Labetalol Hydrochloride 300 mg (Schering)
Tablet; Oral; Hydrochlorothiazide 25 mg; Labetalol Hydrochloride 400 mg (Schering)
Nusar -H Hydrochlorothiazide 12.5mg, Losartan K 25mg TAB / 10$ 0.54
NUSAR -H 50 MG/12.5 MG TABLET 1 strip / 10 tablets each (Emcure Pharmaceuticals Ltd)$ 1.50
Nusar H 25+12.5 Tablet (Emcure Pharmaceuticals Ltd.)$ 0.09
Nusar-H Capsule/ Tablet / 12.5mg-50mg / 10 units (Emcure)$ 0.71
10's (Emcure)$ 0.54
Nusar-H Hydrochlorothiazide 12.5mg, Losartan K 25mg TAB / 10 (Emcure)$ 0.54
NUSAR-H tab 10's (Emcure)$ 0.54
Tablet; Oral; Losartan Potassium 100 mg (Msd)
Tablet; Oral; Losartan Potassium 12.5 mg (Msd)
Tablet; Oral; Losartan Potassium 50 mg (Msd)
Tablet; Oral; Hydrochlorothiazide 12.5 mg; Losartan Potassium 50 mg (Msd)
Osart -H Losartan K 50mg, Hydrochlorothiazide 12.5mg TAB / 10$ 0.63
10's (Invision)$ 0.63
Osart-H Losartan K 50mg, Hydrochlorothiazide 12.5mg TAB / 10 (Invision)$ 0.63
OSART-H tab 10's (Invision)$ 0.63
Osart-H Losartan K 50mg, Hydrochlorothiazide 12.5mg TAB / 10 (Invision)$ 0.63

References

  1. DailyMed. "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "LOSARTAN POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "losartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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