These highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1995 · Bryant Ranch Prepack

Dosage Form

Manufacturer

Bryant Ranch Prepack

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

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Losartan Potassium and Hydrochlorothiazide Tablets

(loe sar' tan poe tas' ee um and hye'' droe klor'' oh thye' a zide)

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 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 and hydrochlorothiazide tablets?

Losartan potassium and hydrochlorothiazide tablets can cause harm or death to an unborn baby.
Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
If you get pregnant while taking losartan potassium and hydrochlorothiazide tablets tell your doctor right away.

What are losartan potassium and hydrochlorothiazide tablets?

Losartan potassium and hydrochlorothiazide tablets contains 2 prescription medicines, an angiotensin receptor blocker (ARB) and a diuretic (water pill). It is used to:

lower high blood pressure (hypertension). Losartan potassium and hydrochlorothiazide tablets are not usually the first medicine used to treat high blood pressure.
lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy (LVH). Losartan potassium and hydrochlorothiazide tablets may not help Black patients with this problem.

Losartan potassium and hydrochlorothiazide tablets has not been studied in children less than 18 years old.

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. The losartan ingredient in losartan potassium and hydrochlorothiazide tablets can help your blood vessels relax so your blood pressure is lower. The hydrochlorothiazide ingredient in losartan potassium and hydrochlorothiazide tablets works by making your kidneys pass more water and salt.

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.

Who should not take losartan potassium and hydrochlorothiazide tablets?

Do not take losartan potassium and hydrochlorothiazide tablets if you:

are allergic to any ingredients in losartan potassium and hydrochlorothiazide tablets. See a complete list of ingredients in losartan potassium and hydrochlorothiazide tablets at the end of this leaflet.
are not passing urine.
have diabetes and are taking a medicine called aliskiren to reduce blood pressure.

What should I tell my doctor before taking losartan potassium and hydrochlorothiazide tablets?

Tell your doctor about all your medical conditions including if you:

are pregnant or planning to become pregnant. See"What are the most important information I should know about losartan potassium and hydrochlorothiazide tablets?"
are breastfeeding or plan to breastfeed. Losartan potassium and hydrochlorothiazide can pass into your milk and may harm your baby. You and your doctor should decide if you will take losartan potassium and hydrochlorothiazide tablets or breastfeed. You should not do both.
have been vomiting (throwing up), having diarrhea, sweating a lot, or not drinking enough fluids. These could cause you to have low blood pressure.
have liver problems
have kidney problems
have systemic lupus erythematosus (Lupus; SLE)
have diabetes
have gout
have any allergies
have had skin cancer or if you develop a new skin lesion during the treatment. Treatment with hydrochlorothiazide may increase the risk of some types of skin cancer (non-melanoma skin cancer). Discuss with your doctor how to protect your skin from sun exposure and how often you should undergo skin cancer screening.

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:

potassium supplements
salt substitutes containing potassium
other medicines that may increase serum potassium
water pills (diuretics)
lithium (a medicine used to treat a certain kind of depression)
medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
other medicines to reduce blood pressure.

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?

Take losartan potassium and hydrochlorothiazide tablets exactly as prescribed by your doctor. Your doctor may change your dose if needed.
Losartan potassium and hydrochlorothiazide tablets can be taken with or without food.
If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
If you take too much losartan potassium and hydrochlorothiazide tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
Your doctor may do blood tests from time to time while you are taking 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:

Injury or death of unborn babies.See "What are the most important information I should know about losartan potassium and hydrochlorothiazide tablets?"
Allergic reaction.Symptoms of an allergic reaction are swelling of the face, lips, throat, or tongue and may include severe shortness of breath and/or difficulty breathing. Get emergency medical help right away and stop taking losartan potassium and hydrochlorothiazide tablets.
Low blood pressure (hypotension).Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. Call your doctor right away.
If you have kidney problems, you may see a worsening in how well your kidneys work.Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain.
A new or worsening condition called systemic lupus erythematosus (Lupus; SLE)
Eye problems.One of the medicines in losartan potassium and hydrochlorothiazide tablets can cause eye problems that, if left untreated, may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting losartan potassium and hydrochlorothiazide tablets. Tell your doctor right away if you have:

○ decrease in vision

○ eye pain

● Sensitivity of the skin to the sun and risk of skin cancer.

The most common side effects of losartan potassium and hydrochlorothiazide tablets in people with high blood pressure are:

"colds" (upper respiratory infection)
dizziness
stuffy nose
back pain

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?

Store losartan potassium and hydrochlorothiazide tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Keep losartan potassium and hydrochlorothiazide tablets in a tightly closed container, and keep losartan potassium and hydrochlorothiazide tablets out of the light.
Keep losartan potassium and hydrochlorothiazide tablets and all medicines out of the reach of children.

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 it was not prescribed. Do not give losartan potassium and hydrochlorothiazide 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 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: losartan potassium, hydrochlorothiazide

Inactive ingredients:

microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, pregelatinized starch, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and D&C yellow No. 10 aluminum lake.

Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Ind. Area, Meerut Road, Ghaziabad – 201 003, India

Manufactured for:

[image: MM3]

East Brunswick, NJ 08816

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What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

71335-2662-1
71335-2662-2
71335-2662-3
71335-2662-4

Full prescribing information (for healthcare professionals)

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WARNING: FETAL TOXICITY

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 [see Warnings and Precautions (5.1)].

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Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 are yellow colored, oval shaped, biconvex, film-coated tablets with "U" debossed on one side and plain on other side.
Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 are yellow colored, oval shaped, biconvex, film-coated tablets with "191" debossed on one side and "U" debossed on other side.
Losartan potassium and hydrochlorothiazide tablets, USP 100/25 are yellow colored, oval shaped, biconvex, film-coated tablets with "192" debossed on one side and "U" debossed on other side.

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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

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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/m² 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 LD₅₀ 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.

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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 AT₁ receptor subtype and a diuretic, hydrochlorothiazide USP.

Losartan potassium USP, 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 molecular formula is C₂₂H₂₂ClKN₆O, and its structural formula is:

[image: MM1]

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.

Hydrochlorothiazide USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C₇H₈ClN₃O₄S₂ and its structural formula is:

[image: MM2]

Hydrochlorothiazide USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Losartan potassium and hydrochlorothiazide tablets are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50 mg/12.5 mg contains 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets, USP 100 mg/12.5 mg contains 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets, USP 100 mg/25 mg contains 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and D&C yellow No. 10 aluminum lake.

Losartan potassium and hydrochlorothiazide tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets, USP 100 mg/12.5 mg contains 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.

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

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Advise the patient to read the FDA-approved patient labeling (Patient Information).

Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616.

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to losartan potassium and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. If syncope occurs, advise patients to contact their healthcare provider [see Warnings and Precautions (5.2)].

Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1)].

Acute Myopia and Secondary Angle-closure Glaucoma: Advise patients to discontinue losartan potassium and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.6)].

Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

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13014563

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Important Safety Information

Serious warning (boxed)Boxed warningThe FDA's most prominent safety warning.

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Available doses and forms

Do not use if…Contraindications.

Drug interactions

Important warnings and precautions

Possible side effects

Use in specific groups

If you take too much (overdose)

Patient information

Medication GuideLosartan Potassium and Hydrochlorothiazide Tablets (loe sar' tan poe tas' ee um and hye'' droe klor'' oh thye' a zide) 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg Rx only Read the Patient Information that comes with losa…

What's in this medicine

Package labelLosartan Potassium/Hctz 100/12.5mg Tab

How it's supplied100 mg/12.5 mg Tablets: Losartan potassium and hydrochlorothiazide tablets, USP are supplied as: Yellow colored, oval shaped, biconvex, film-coated tablets with "191" debossed on one side and "U" debossed on other side.…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

SPL UNCLASSIFIED SECTION

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