Losartan Potassium (Cozaar)

Trade Name : COZAAR

Merck Sharp & Dohme Corp.

TABLET, FILM COATED

Strength 25 mg/1

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

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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 (Cozaar) which is also known as COZAAR and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 25 mg/1 per ml. Read more

Losartan Potassium (Cozaar) 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

Packaging and Delivery

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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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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 COZAAR 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 COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()
  • COZAAR is 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. ()
  • 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. ()
  • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ()
  • Hypertension
  • Hypertensive Patients with Left Ventricular Hypertrophy
  • Nephropathy in Type 2 Diabetic Patients
  • Tablets: 25 mg; 50 mg; and 100 mg. ()
  • COZAAR is contraindicated:
  • Hypersensitivity to any component. ()
  • Coadministration with aliskiren in patients with diabetes. ()
  • No data
  • Hypotension: Correct volume or salt depletion prior to administration of COZAAR. ()
  • Monitor renal function and potassium in susceptible patients. (, )
  • Most common adverse reactions (incidence u22652% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ()n n n
  • No data
  • Agents increasing serum potassium: Risk of hyperkalemia. ()
  • Lithium: Risk of lithium toxicity. ()
  • 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. ()
  • No data
  • COZAAR 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 m. (, )
  • Hepatic Impairment: Recommended starting dose 25 mg once daily. (, , )
  • 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.
  • COZAAR (losartan potassium) is an angiotensin II receptor blocker acting on the AT receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[-(-1-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.
  • Its empirical formula is CHClKNO, and its structural formula is:
  • Losartan 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, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.
  • COZAAR 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 hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide.
  • COZAAR 25 mg, 50 mg and 100 mg tablets 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. COZAAR 25 mg, COZAAR 50 mg, and COZAAR 100 mg may also contain carnauba wax.
  • 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.
  • 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).
  • No data
  • COZAAR is a white film-coated tablet supplied as follows:
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • The trademarks depicted herein are owned by their respective companies.
  • Copyright u00a9 2015-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk0954-t-1911r011
  • Read the Patient Information that comes with COZAAR before you start taking it 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 COZAAR?
  • What is COZAAR?
  • COZAAR is a prescription medicine called an angiotensin receptor blocker (ARB). It is used:
  • COZAAR has 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 COZAAR?
  • What should I tell my doctor before taking COZAAR?
  • 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 COZAAR?
  • What are the possible side effects of COZAAR?
  • COZAAR may cause the following side effects that may be serious:
  • The most common side effects of COZAAR in people with high blood pressure are:
  • The most common side effects of COZAAR 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 won't go away.
  • This is a complete list of side effects. For a complete list, ask your doctor or pharmacist.
  • How do I store COZAAR?
  • General information about COZAAR
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use COZAAR for a condition for which it was not prescribed. Do not give COZAAR to other people, even if they have the same symptoms that you have. It may harm them.
  • This leaflet summarizes the most important information about COZAAR. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about COZAAR that is written for health professionals.
  • What are the ingredients in COZAAR?
  • Active ingredients:
  • Inactive ingredients:
  • microcrystalline cellulose, lactose hydrous, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. COZAAR 25 mg, COZAAR 50 mg, and COZAAR 100 mg may also contain carnauba wax.
  • Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2006-2018 Merck Sharp & Dohme Corp., a subsidiary of n
  • All rights reserved.
  • Revised: 10/2018
  • usppi-mk0954-t-1810r010
  • NDC 0006-0951-54
  • Cozaarn (Losartan PotassiumTablets)
  • 25 mg
  • Each tablet contains 25 mg of losartan potassium.Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C(59-86u00b0F) [see USP Controlled Room Temperature].Keep container tightly closed.Protect from light.
  • Rx only
  • 90 Tablets
  • NDC 0006-0952-31
  • Cozaarn (Losartan PotassiumTablets)
  • 50 mg
  • Each tablet contains 50 mg of losartan potassium.Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C(59-86u00b0F) [see USP Controlled Room Temperature].Keep container tightly closed.Protect from light.
  • Rx only
  • 30 Tablets
  • NDC 0006-0960-31
  • Cozaarn (Losartan PotassiumTablets)
  • 100 mg
  • Each tablet contains 100 mg of losartan potassium.Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C(59-86u00b0F) [see USP Controlled Room Temperature].Keep container tightly closed.Protect from light.
  • Rx only
  • 30 Tablets

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