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Losartan Potassium And Hydrochlorothiazide is a brand name for Losartan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Losartan potassium and hydrochlorothiazide tablets are a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal…
Verbatim from this product's FDA label. Tap a section to expand.
5 mg once daily. 1 ) Titrate as needed to a maximum dose of 100 mg/25 mg. 5 mg. Titrate as needed to a maximum of 100 mg/25 mg. 5 mg) once daily. 2 )]. 5 once daily. 5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily.
5 mg) once daily. 5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily. 5 once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response.
5 once daily or one tablet of losartan potassium and hydrochlorothiazide tablets 100/25 once daily. 5. 5, followed by losartan potassium and hydrochlorothiazide tablets 100/25. For further blood pressure reduction add other antihypertensives [see Clinical Studies ( 14 )] .
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. gov/medwatch. 1 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 potassium-hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3,889 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.
3% of patients treated with the combination and placebo, respectively. 6%). The following additional adverse reactions have been reported in clinical trials with losartan potassium and hydrochlorothiazide tablets 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.
5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. 2 ) Monitor renal function and potassium in susceptible patients. 3 ) Observe for clinical signs of fluid or electrolyte imbalance.
5 ) Acute angle-closure glaucoma. 6 ) Exacerbation of systemic lupus erythematosus. 1 Fetal Toxicity Losartan potassium and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. 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 tablets as soon as possible.
Thiazides cross the placental barrier and appear in cord blood. 1 )]. , those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium and hydrochlorothiazide tablets.
Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. Do not use losartan potassium and hydrochlorothiazide tablets as initial therapy in patients with intravascular volume depletion.
3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. , patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium and hydrochlorothiazide tablets.
4 CONTRAINDICATIONS Losartan potassium and hydrochlorothiazide tablets are contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of losartan potassium and hydrochlorothiazide tablets.
( 4 ) Anuria. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Losartan in United States of America.
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Vascular disorders:
Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).
Respiratory, thoracic and mediastinal disorders:
Nasal congestion.
Gastrointestinal disorders:
Dyspepsia, abdominal pain, gastric irritation, cramping, 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.
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, malaise, 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 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 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135).
The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.
Table 1:
Study 1 * HCTZ Losartan Lisinopril Cough 25% 17% 69% Study 2 † Placebo Losartan Lisinopril Cough 35% 29% 62% * Demographics = (89% Caucasian, 64% female) † Demographics = (90% Caucasian, 51% female) These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy.
Cases of cough, including positive re-challenges, have been reported with the use of losartan in postmarketing experience. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of losartan potassium and hydrochlorothiazide tablets.
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.
Hematologic:
Thrombocytopenia.
Hypersensitivity:
Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, tongue, and/or swelling of the intestine. Vasculitis, including Henoch-Schönlein purpura; anaphylactic reactions which can present as respiratory distress (including pneumonitis and pulmonary edema).
Musculoskeletal:
Rhabdomyolysis.
Skin:
Erythroderma.
Non-melanoma Skin Cancer:
Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses.
The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥ 50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.
Monitor renal function periodically in these patients. 8 )] . 2 )] . 4% versus 0% for placebo. Losartan potassium and hydrochlorothiazide tablets contain hydrochlorothiazide which can cause hypokalemia, hyponatremia and hypomagnesemia.
Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Losartan potassium and hydrochlorothiazide tablets also contain losartan which can cause hyperkalemia. 1 )] . 1 )] . Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy. Because losartan decreases uric acid, losartan in combination with hydrochlorothiazide attenuates the diuretic-induced hyperuricemia. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium.
Monitor calcium levels. 6 Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. 7 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.