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Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide)

Trade Name : Losartan Potassium and Hydrochlorothiazide

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 5012.5 mg/1mg/1

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide) which is also known as Losartan Potassium and Hydrochlorothiazide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 50; 12.5 mg/1; mg/1 per ml. Read more

Losartan Potassium And Hydrochlorothiazide (Losartan Potassium And Hydrochlorothiazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 n
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • 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. ()
  • 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 cardiovascular events, primarily strokes and myocardial infarctions. ()
  • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ()
  • Hypertension
  • Hypertensive Patients with Left Ventricular Hypertrophy
  • Tablets (losartan potassium/hydrochlorothiazide content): 50/12.5 mg; 100/12.5 mg; and 100/25 mg. ()
  • Losartan potassium and hydrochlorothiazide tablets are contraindicated:
  • Hypersensitivity to any component of losartan potassium and hydrochlorothiazide tablets. ()
  • Anuria. ()
  • Coadministration with aliskiren in patients with diabetes. ()
  • No data
  • Hypotension: Correct volume or salt depletion prior to administration of losartan potassium and hydrochlorothiazide tablets. ()
  • Monitor renal function and potassium in susceptible patients. ()
  • Observe for clinical signs of fluid or electrolyte imbalance. ()
  • Acute angle-closure glaucoma. ()
  • Exacerbation of systemic lupus erythematosus. ()
  • Most common adverse reactions (incidence u2265 2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain. ()
  • No data
  • Agents increasing serum potassium: Risk of hyperkalemia. ()
  • Lithium: Risk of lithium toxicity. ()
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ()
  • Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ()
  • Antidiabetic drugs: dosage adjustment of antidiabetic may be required. ()
  • Cholestyramine and colestipol: Reduced absorption of thiazides. ()
  • No data
  • Hepatic Impairment: Losartan potassium and hydrochlorothiazide tablets are not recommended for initial therapy, because the recommended starting dose is not available. ()
  • Losartan Potassium
  • Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m basis.
  • 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
  • The oral LD of hydrochlorothiazide is greater than 10 g/kg in both mice and rats. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.
  • Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg, and Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT receptor subtype and a diuretic, hydrochlorothiazide, USP.
  • Losartan potassium, USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[-(-1-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its structural formula is:
  • CHClKNO M.W. 461.01
  • Losartan potassium, USP is a white to off-white free-flowing crystalline powder. 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, USP is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is:
  • CHClNOS M.W. 297.74
  • Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
  • Losartan Potassium and Hydrochlorothiazide Tablets USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide, USP. Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, pregelatinized corn starch, talc, and titanium dioxide. Additionally 50 mg/12.5 mg tablets contain D&C Yellow #10 (Aluminum Lake) and FD&C Blue #1 (Aluminum Lake). 100 mg/25 mg tablets contain D&C Yellow #10 (Aluminum Lake).
  • Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
  • No data
  • Losartan Potassium-Hydrochlorothiazide
  • No carcinogenicity studies have been conducted with the losartan potassium-hydrochlorothiazide combination.
  • Losartan potassium-hydrochlorothiazide when tested at a weight ratio of 4:1, was negative in the Ames microbial mutagenesis assay and the V-79 Chinese hamster lung cell mutagenesis assay. In addition, there was no evidence of direct genotoxicity in the alkaline elution assay in rat hepatocytes and chromosomal aberration assay in Chinese hamster ovary cells at noncytotoxic concentrations.
  • Losartan potassium, coadministered with hydrochlorothiazide, had no effect on the fertility or mating behavior of male rats at dosages up to 135 mg/kg/day of losartan and 33.75 mg/kg/day of hydrochlorothiazide. These dosages have been shown to provide respective systemic exposures (AUCs) for losartan, its active metabolite and hydrochlorothiazide that are approximately 60, 60 and 30 times greater than those achieved in humans with 100 mg of losartan potassium in combination with 25 mg of hydrochlorothiazide. In female rats, however, the coadministration of doses as low as 10 mg/kg/day of losartan and 2.5 mg/kg/day of hydrochlorothiazide was associated with slight but statistically significant decreases in fecundity and fertility indices. AUC values for losartan, its active metabolite and hydrochlorothiazide, extrapolated from data obtained with losartan administered to rats at a dose of 50 mg/kg/day in combination with 12.5 mg/kg/day of hydrochlorothiazide, were approximately 6, 2, and 2 times greater than those achieved in humans with 100 mg of losartan in combination with 25 mg of hydrochlorothiazide.
  • Losartan Potassium
  • Losartan potassium was not carcinogenic when administered at maximally tolerated dosages to rats and mice for 105 and 92 weeks, respectively. Female rats given the highest dose (270 mg/kg/day) had a slightly higher incidence of pancreatic acinar adenoma. The maximally tolerated dosages (270 mg/kg/day in rats, 200 mg/kg/day in mice) provided systemic exposures for losartan and its pharmacologically active metabolite that were approximately 160 and 90 times (rats) and 30 and 15 times (mice) the exposure of a 50 kg human given 100 mg per day.
  • Losartan potassium was negative in the microbial mutagenesis and V-79 mammalian cell mutagenesis assays and in the alkaline elution and and chromosomal aberration assays. In addition, the active metabolite showed no evidence of genotoxicity in the microbial mutagenesis, alkaline elution, and chromosomal aberration assays.
  • Fertility and reproductive performance were not affected in studies with male rats given oral doses of losartan potassium up to approximately 150 mg/kg/day. The administration of toxic dosage levels in females (300/200 mg/kg/day) was associated with a significant (p < 0.05) decrease in the number of corpora lutea/female, implants/female, and live fetuses/female at C-section. At 100 mg/kg/day only a decrease in the number of corpora lutea/female was observed. The relationship of these findings to drug-treatment is uncertain since there was no effect at these dosage levels on implants/pregnant female, percent post-implantation loss, or live animals/litter at parturition. In nonpregnant rats dosed at 135 mg/kg/day for 7 days, systemic exposure (AUCs) for losartan and its active metabolite were approximately 66 and 26 times the exposure achieved in man at the maximum recommended human daily dosage (100 mg).
  • Hydrochlorothiazide
  • Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.
  • Hydrochlorothiazide was not genotoxic in the Ames mutagenicity assay of strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the sex-linked recessive lethal trait gene. Positive test results were obtained only in the CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 mcg/mL, and in the non-disjunction assay at an unspecified concentration.
  • Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to mating and throughout gestation.
  • No data
  • Losartan Potassium and Hydrochlorothiazide Tablets USP are supplied as a film-coated tablet.
  • 50 mg/12.5 mg are yellow, film-coated, oval-shaped, unscored tablets, debossed with u201c93u201d on one side and u201c7367u201d on the other in bottles of 30 (NDC 0093-7367-56), 90 (NDC 0093-7367-98), and 1000 (NDC 0093-7367-10).
  • 100 mg/12.5 mg are white to off-white, film-coated, oval-shaped, unscored tablets, debossed with u201c93u201d on one side and u201c7369u201d on the other in bottles of 30 (NDC 0093-7369-56), 90 (NDC 0093-7369-98), and 1000 (NDC 0093-7369-10).
  • 100 mg/25 mg are light yellow, film-coated, oval-shaped, unscored tablets, debossed with u201c93u201d on one side and u201c7368u201d on the other in bottles of 30 (NDC 0093-7368-56), 90 (NDC 0093-7368-98), and 1000 (NDC 0093-7368-10).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Pregnancy:n- [see Warnings and Precautions () and Use in Specific Populations ()].
  • Symptomatic Hypotension:n- [see Warnings and Precautions ()].
  • Potassium Supplements:n- [see Drug Interactions ()].
  • Arrayn- [see Warnings and Precautions ()].
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. M 11/2019
  • Losartan Potassium (loe saru2019 tan poe tasu2019 ee um) and Hydrochlorothiazide (hye droe klor oh thye' a zide) Tablets
  • 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg
  • Rx only
  • Read the Patient Information that comes with losartan potassium and hydrochlorothiazide tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment.
  • What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets?
  • What are losartan potassium and hydrochlorothiazide tablets?
  • Losartan potassium and hydrochlorothiazide tablets contain 2 prescription medicines, an angiotensin receptor blocker (ARB) and a diuretic (water pill). It is used to:
  • Losartan potassium and hydrochlorothiazide tablets have not been studied in children less than 18 years old.
  • High Blood Pressure (hypertension).
  • Left Ventricular Hypertrophy (LVH)
  • Who should not take losartan potassium and hydrochlorothiazide tablets?
  • Do not take losartan potassium and hydrochlorothiazide tablets if you:
  • What should I tell my doctor before taking losartan potassium and hydrochlorothiazide tablets?
  • Tell your doctor about all your medical conditions including if you:
  • Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Losartan potassium and hydrochlorothiazide tablets and certain other medicines may interact with each other. Especially tell your doctor if you are taking:
  • Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
  • How should I take losartan potassium and hydrochlorothiazide tablets?
  • What are the possible side effects of losartan potassium and hydrochlorothiazide tablets?
  • Losartan potassium and hydrochlorothiazide tablets may cause the following side effects that may be serious:
  • The most common side effects of losartan potassium and hydrochlorothiazide tablets in people with high blood pressure are:
  • Tell your doctor if you get any side effect that bothers you or that won't go away. This is not a complete list of side effects. For a complete list, ask your doctor or pharmacist.
  • How should I store losartan potassium and hydrochlorothiazide tablets?
  • General information about losartan potassium and hydrochlorothiazide tablets
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use losartan potassium and hydrochlorothiazide tablets for a condition for which they were not prescribed. Do not give losartan potassium and hydrochlorothiazide tablets to other people, even if they have the same symptoms that you have. They may harm them.
  • This leaflet summarizes the most important information about losartan potassium and hydrochlorothiazide tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for health professionals.
  • What are the ingredients in losartan potassium and hydrochlorothiazide tablets?
  • Active ingredients:
  • Inactive ingredients:
  • lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, pregelatinized corn starch, talc, and titanium dioxide. Additionally 50 mg/12.5 mg tablets contain D&C Yellow # 10 (Aluminum Lake) and FD&C Blue # 1 (Aluminum Lake). 100 mg/25 mg tablets contain D&C Yellow # 10 (Aluminum Lake).
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. G 10/2018
  • NDCn- 7367
  • LOSARTAN POTASSIUM and
  • HYDROCHLOROTHIAZIDE
  • Tablets USP
  • 50 mg/12.5 mg
  • PHARMACIST: PLEASE DISPENSE WITH
  • ATTACHED PATIENT INFORMATION LEAFLET
  • Rx only
  • 30 TABLETS
  • TEVA
  • Arrayn- Array
  • NDCn- 7369
  • LOSARTAN POTASSIUM and
  • HYDROCHLOROTHIAZIDE
  • Tablets USP
  • 100 mg/12.5 mg
  • PHARMACIST: PLEASE DISPENSE WITH
  • ATTACHED PATIENT INFORMATION LEAFLET
  • Rx only
  • 30 TABLETS
  • TEVA
  • NDCn- 7368
  • LOSARTAN POTASSIUM and
  • HYDROCHLOROTHIAZIDE
  • Tablets USP
  • 100 mg/25 mg
  • PHARMACIST: PLEASE DISPENSE WITH
  • ATTACHED PATIENT INFORMATION LEAFLET
  • Rx only
  • 30 TABLETS
  • TEVAn
  • Arrayn- Array

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