LOSARTAN POTASSIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium tablets are 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. (See PRECAUTIONS, Race and CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.) Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end

Product summary:

Losartan potassium tablets, USP 25 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "25" on one side and "113" on the other side. Losartan potassium tablets, USP 50 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "114" on one side and breakline on the other side. Losartan potassium tablets, USP 100 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "100" on one side and "115" on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009. This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States Losartan  Potassium  Tablets , USP 25mg , 50mg , 100mg Rx  only Read the Patient Information that comes with losartan potassium tablets 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  losartan  potassium  tablets?   Do  not  take  losartan  potassium  tablets  if  you  are  pregnant  or  plan  to  become  pregnant.  Losartan  potassium  tablets  can  harm  your  unborn  baby  causing  injury  and  even  death.  Stop  taking  losartan  potassium  tablets  if  you  become  pregnant  and  call  your  doctor  right  away. If you plan to become pregnant, talk to your doctor about other treatment options before taking losartan potassium tablets. What  are  losartan  potassium  tablets?   Losartan potassium tablets are 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). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Losartan potassium tablets can help your blood vessels relax so your blood pressure is lower. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart’s main pumping chamber). LVH can happen from several things. High blood pressure is the most common cause of LVH. Type 2 Diabetes with Nephropathy . Type 2 diabetes is a type of diabetes that happens mainly in adults. If you have diabetic nephropathy it means that your kidneys do not work properly because of damage from the diabetes. 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. Losartan potassium tablets and certain other medicines may interact with each other. Especially tell your doctor if you are taking: How should I take losartan potassium tablets? What are the possible side effects of losartan potassium tablets? Losartan potassium tablets may cause the following side effects that may be serious: 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 won’t go away. This is not a complete list of side effects. For a complete list, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 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. It 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? Active ingredients: losartan potassium, USP Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Manufactured  by: TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009. This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM - LOSARTAN POTASSIUM TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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LOSARTAN POTASSIUM TABLETS, USP USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT DIRECTLY ON
THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When
pregnancy is detected, losartan potassium tablets should be
discontinued as soon as possible. See
WARNINGS, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
Losartan potassium is an angiotensin II receptor (type AT )
antagonist. Losartan potassium, a non-
peptide molecule, is chemically described as
2-butyl-4-chloro-1-[_p_-(_o_-_1H_-tetrazol-5-
ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.
Its empirical formula is C
H ClKN O, and its structural formula is:
Losartan potassium, USP 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.
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:
colloidal silicon dioxide,
hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium
stearate, microcrystalline
cellulose, pregelatinized starch, talc and titanium dioxide.
Losartan potassium 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.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II [formed from angiotensin I in a reaction catalyzed by
angiotensin converting enzyme
(ACE, kininase II)], is a potent vasoconstrictor, the primary
vasoactive hormone of the renin-angiotensin
system and an important component in the pathophysiology of
hypertension. It also stimulates
aldosteron