What is Losarplus AL?
Losarplus AL contains a combination of Losarplus AL. Hydrochlorothiazide (Losarplus AL) is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention. Losartan (Losarplus AL) is an angiotensin II receptor antagonist. Losartan (Losarplus AL) keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.
Losarplus AL is used to treat high blood pressure (hypertension). It is also used to lower the risk of stroke in certain people with heart disease.
Losarplus AL may also be used for purposes not listed in this medication guide.
Losarplus AL indications
Hypertension
Losarplus AL® 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 (Losarplus AL) and Hydrochlorothiazide (Losarplus AL).
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.
Losarplus AL may be administered with other antihypertensive agents.
Hypertensive Patients With Left Ventricular Hypertrophy
Losarplus AL 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 Losarplus AL?
Use Losarplus AL as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Losarplus AL. Talk to your pharmacist if you have questions about this information.
- Take Losarplus AL by mouth with or without food.
- Drinking extra fluids while you are taking Losarplus AL is recommended. Check with your doctor for instructions.
- Losarplus AL may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
- If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Losarplus AL.
- Continue to take Losarplus AL even if you feel well. Do not miss any doses.
- If you miss a dose of Losarplus AL, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Losarplus AL.
Uses of Losarplus AL in details
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.
Losarplus AL description
Each tablet contains Losartan (Losarplus AL) potassium 50 or 100 mg and Hydrochlorothiazide (Losarplus AL) 12.5 mg.
Losartan (Losarplus AL) Potassium: Losartan (Losarplus AL) 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 (Losarplus AL) 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 (Losarplus AL).
Hydrochlorothiazide (Losarplus AL): Hydrochlorothiazide (Losarplus AL) 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.
Losarplus AL dosage
Hypertension
The usual starting dose of Losarplus AL is 50/12.5 (Losartan (Losarplus AL) 50 mg/Hydrochlorothiazide (Losarplus AL) 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (Losartan (Losarplus AL) 100 mg/Hydrochlorothiazide (Losarplus AL) 25 mg) once daily as needed to control blood pressure.
Initiate a patient whose blood pressure is not adequately controlled with Losartan (Losarplus AL) 50 mg monotherapy with Losarplus AL 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 Losarplus AL 50/12.5 once daily or one tablet of Losarplus AL 100/25 once daily.
Initiate a patient whose blood pressure is not adequately controlled with Losartan (Losarplus AL) 100 mg monotherapy with Losarplus AL 100/12.5 (Losartan (Losarplus AL) 100 mg/Hydrochlorothiazide (Losarplus AL) 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of Losarplus AL 50/12.5 once daily or one tablet of Losarplus AL 100/25 once daily.
Initiate a patient whose blood pressure is inadequately controlled with Hydrochlorothiazide (Losarplus AL) 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen, on Losarplus AL 50/12.5 once daily, reducing the dose of Hydrochlorothiazide (Losarplus AL) without reducing the overall expected antihypertensive response. Evaluate the clinical response to Losarplus AL 50/12.5 and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of Losarplus AL 50/12.5 once daily or one tablet of Losarplus AL 100/25 once daily.
Hypertensive Patients with Left Ventricular Hypertrophy
In patients whose blood pressure is not adequately controlled on 50 mg Losartan (Losarplus AL) potassium, initiate treatment with Losarplus AL 50/12.5. If additional blood pressure reduction is needed, increase the dose to Losarplus AL 100/12.5, followed by Losarplus AL 100/25. For further blood pressure reduction add other antihypertensives.
Losarplus AL interactions
See also:
What other drugs will affect Losarplus AL?
Agents Increasing Serum Potassium
Coadministration of Losartan (Losarplus AL) 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 Losarplus AL and lithium.
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors
Losartan (Losarplus AL) 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 (Losarplus AL)) 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 (Losarplus AL) and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Losartan (Losarplus AL), may be attenuated by NSAIDs, including selective COX-2 inhibitors.
Hydrochlorothiazide (Losarplus AL)
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 Losarplus AL 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 (Losarplus AL), 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 (Losarplus AL), Losartan (Losarplus AL), 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 (Losarplus AL) therapy and followed them for a median of 2.2 years. Patients receiving the combination of Losartan (Losarplus AL) 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 Losarplus AL and other agents that affect the RAS.
Do not coadminister aliskiren with Losarplus AL in patients with diabetes. Avoid use of aliskiren with Losarplus AL in patients with renal impairment (GFR < 60 mL/min).
The Use Of Hydrochlorothiazide (Losarplus AL) 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 (Losarplus AL) is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the Hydrochlorothiazide (Losarplus AL) and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Stagger the dosage of Hydrochlorothiazide (Losarplus AL) and the resin such that Hydrochlorothiazide (Losarplus AL) is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.
Losarplus AL side effects
See also:
What are the possible side effects of Losarplus AL?
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 (Losarplus AL) potassium-Hydrochlorothiazide (Losarplus AL) 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 (Losarplus AL)-Hydrochlorothiazide (Losarplus AL) 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 Losarplus AL 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 (Losarplus AL) 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 (Losarplus AL) 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg Hydrochlorothiazide (Losarplus AL) (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.
| |||
| Study 1* | HCTZ | Losartan (Losarplus AL) | Lisinopril |
| Cough | 25% | 17% | 69% |
| Study 2† | Placebo | Losartan (Losarplus AL) | Lisinopril |
| Cough | 35% | 29% | 62% |
These studies demonstrate that the incidence of cough associated with Losartan (Losarplus AL) therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with Hydrochlorothiazide (Losarplus AL) or placebo therapy.
Cases of cough, including positive re-challenges, have been reported with the use of Losartan (Losarplus AL) in postmarketing experience.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Losarplus AL. 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 (Losarplus AL).
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 (Losarplus AL); some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with Losartan (Losarplus AL). Anaphylactic reactions have been reported.
Musculoskeletal: rhabdomyolysis
Skin: Erythroderma
Losarplus AL contraindications
See also:
What is the most important information I should know about Losarplus AL?
Hypersensitivity to Losartan (Losarplus AL), sulphonamide-derived substances (as Hydrochlorothiazide (Losarplus AL)) or to any of the excipients of Losarplus AL.
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 Losarplus AL.
Use in lactation: It is not known whether Losartan (Losarplus AL) is excreted in human milk. However, Losartan (Losarplus AL) is excreted in the milk of lactating rats. Because no information is available regarding the use of Losartan (Losarplus AL) during breastfeeding, Losartan (Losarplus AL) 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 (Losarplus AL)/HCTZ is contraindicated during breastfeeding.
Active ingredient matches for Losarplus AL:
Hydrochlorothiazide/Losartan in Germany.
References
- 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).
- 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).
- PubChem. "losartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Losarplus AL are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Losarplus AL. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
