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Losartan Potassium (Losartan Potassium)

Trade Name : Losartan Potassium

REMEDYREPACK INC.

TABLET, FILM COATED

Strength 25 mg/1

Storage and handling for Losartan Potassium

LOSARTAN POTASSIUM Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Losartan Potassium (Losartan Potassium) which is also known as Losartan Potassium and Manufactured by REMEDYREPACK INC.. It is available in strength of 25 mg/1 per ml. Read more

Losartan Potassium (Losartan Potassium) 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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Packaging and Delivery

Validated Cold Chain Shipment

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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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
  • Warnings and Precautions
  • u00a0u00a0u00a0u00a0u00a0 Hyperkalemia (n n n )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2018n nn
  • u00a0
  • When pregnancy is detected, discontinue losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus n n n n
  • When pregnancy is detected, discontinue losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (n n n )n n n
  • Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for:
  • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (n n n )n n n
  • 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. (n n n )n n n
  • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (n n n )n n n
  • Hypertension
  • u2022u00a0 Usual adult dose: 50 mg once daily. (n n n ) n nn
  • u2022u00a0 Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). (n n n ) n nn
  • Hypertensive Patients with Left Ventricular Hypertrophy
  • u2022u00a0 Usual starting dose: 50 mg once daily. (n n n ) n nn
  • u2022u00a0 Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium tablets to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. (n n n , n n n ) n nn
  • Nephropathy in Type 2 Diabetic Patients
  • u2022u00a0 Usual dose: 50 mg once daily. (n n n ) n nn
  • u2022u00a0 Increase dose to 100 mg once daily if further blood pressure response is needed. (n n n ) n nn
  • Tablets: 25 mg; 50 mg; and 100 mg. (n n n )n nn
  • Losartan potassium tablets are contraindicated:
  • Hypersensitivity to any component. (n n n ) n n n
  • Coadministration with aliskiren in patients with diabetes. (n n n ) n n n
  • No data
  • Hypotension: Correct volume or salt depletion prior to administration of losartan potassium. (n n n ) n n n
  • Monitor renal function and potassium in susceptible patients. (n n n , n n n ) n n n
  • Most common adverse reactions (incidence u22652% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. (n n n ) n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Agents increasing serum potassium: Risk of hyperkalemia. (n n n ) n n n
  • Lithium: Risk of lithium toxicity. (n n n ) n n n
  • NSAIDs: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. (n n n ) n n n
  • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. (n n n ) n n n
  • No data
  • Losartan potassium is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 mn n n . (n n n , n n n ) n n n
  • Hepatic Impairment: Recommended starting dose 25 mg once daily. (n n n , n n n , n n n ) n n n
  • 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/mn n n basis. n nn
  • 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.
  • Losartan potassium tablets are an angiotensin II receptor blocker acting on the ATn n n receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[n n n -(n n n -1n n n tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. n nn
  • Its molecularu00a0formula is Cn n n Hn n n ClKNn n n O, and its structural formula is:n nn
  • Losartan potassium USP is a white to off-white 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.
  • Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), low substituted hydroxypropyl cellulose, magnesium stearate, hydroxypropyl cellulose, hypromellose 6 cP, titanium dioxide, FD&C blue #2/indigo carmine aluminum lake, D&C yellow #10 aluminum lake, and purified water.
  • Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.
  • No data
  • 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.n n n n Losartan potassium was negative in the microbial mutagenesis and V-79 mammalian cell mutagenesis assays and in the n n n alkaline elution and n n n and n n n chromosomal aberration assays. In addition, the active metabolite showed no evidence of genotoxicity in the microbial mutagenesis, n n n alkaline elution, and n n n chromosomal aberration assays.n n n n 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).n nn
  • No data
  • Losartan potassium tablets USP are supplied as follows:
  • Losartan Potassium Tablets USP, 25 mg are green colored, oval shaped, biconvex film-coated tablets debossed with u2018Eu2019 on one side and u201845u2019 on other side.
  • NDC: 70518-2132-00
  • NDC: 70518-2132-01
  • NDC: 70518-2132-02
  • PACKAGING: 30 in 1 BLISTER PACK
  • PACKAGING: 90 in 1 BOTTLE PLASTIC
  • PACKAGING: 90 in 1 BOTTLE PLASTIC
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
  • Repackaged and Distributed By:
  • Remedy Repack, Inc.
  • 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Pregnancy
  • Advise female patients of childbearing age about the consequences of exposure to losartan potassium during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible n n
  • Potassium Supplements
  • Advise patients receiving losartan potassium not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider n .n
  • Patient Information
  • Losartan Potassium Tablets USP
  • (loe sar' tan poe tas' ee um)
  • 25 mg, 50 mg, 100 mg
  • Rx only
  • Read the Patient Information that comes with losartan potassium 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 tablets?
  • What are losartan potassium tablets?
  • Losartan potassium tablets is a prescription medicine called an angiotensin receptor blocker (ARB). It is used:
  • Losartan potassium tablets have not been studied in children less than 6 years old or in children with certain kidney problems.
  • High Blood Pressure (hypertension).
  • Left Ventricular Hypertrophy (LVH)
  • Type 2 Diabetes with Nephropathy.
  • Who should not take losartan potassium tablets?
  • What should I tell my doctor before taking losartan potassium tablets?
  • Tell your doctor about all of your medical conditions including if you:
  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • How should I take losartan potassium tablets?
  • What are the possible side effects of losartan potassium tablets?
  • The most common side effects of losartan potassium tablets in people with high blood pressure are:
  • The most common side effects of losartan potassium tablets in people with type 2 diabetes with diabetic kidney disease are:
  • Tell your doctor if you get any side effect that bothers you or that wonu2019t go away.
  • This is n a complete list of side effects. For a complete list, ask your doctor or pharmacist.n
  • How do I store losartan potassium tablets?
  • General information about losartan potassium tablets
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use losartan potassium tablets for a condition for which it was not prescribed. Do not give losartan potassium 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 tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about losartan potassium tablets that is written for health professionals.
  • What are the ingredients in losartan potassium tablets? n- Active ingredient:
  • Inactive ingredients:
  • Ora-Plusu2122 and Ora-Sweet SFu2122 are the trademarks of Paddock Laboratories, Inc.
  • Repackaged By / Distributed By: RemedyRepack Inc.
  • 625 Kolter Drive, Indiana, PA 15701
  • (724) 465-8762
  • DRUG: Losartan Potassium
  • GENERIC: Losartan Potassium
  • DOSAGE: TABLET, FILM COATED
  • ADMINSTRATION: ORAL
  • NDC: 70518-2132-0
  • NDC: 70518-2132-1
  • NDC: 70518-2132-2
  • COLOR: green
  • SHAPE: OVAL
  • SCORE: No score
  • SIZE: 8 mm
  • IMPRINT: E;45
  • PACKAGING: 30 in 1 BLISTER PACK
  • PACKAGING: 90 in 1 BOTTLE PLASTIC
  • PACKAGING: 90 in 1 BOTTLE PLASTIC
  • ACTIVE INGREDIENT(S):
  • INACTIVE INGREDIENT(S):

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