Hyzaar 100/25 Tablets

Losartan is an angiotensin II receptor blocker (ARB). It selectively blocks the binding of angiotensin II to the AT1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland), leading to vasodilation, reduced aldosterone secretion, and decreased sodium and water reabsorption. Hydrochlorothiazide is a thiazide diuretic. It inhibits sodium and chloride reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium. This results in reduced plasma volume and peripheral vascular resistance.

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Signs of a pancreas problem (pancreatitis), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Severe dizziness or passing out
Swelling in the arms or legs
Yellow skin or eyes
Difficulty getting or maintaining an erection

This medication can also cause eye problems, which may lead to permanent vision loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:
Changes in vision
Eye pain

These symptoms usually occur within hours to weeks of starting the medication.

Rare but Serious Side Effects

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your risk, protect your skin from the sun and follow your doctor's instructions for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor right away.

Other Side Effects

Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Dizziness
Signs of a common cold
Back pain

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Current or planned use of dofetilide.
Any difficulties with urination.
Dehydration, as this may require a discussion with your doctor to determine the best course of action.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues, to your doctor and pharmacist. This will enable them to assess potential interactions and ensure safe use of this medication. Never initiate, discontinue, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

If you have diabetes (high blood sugar), closely monitor your blood sugar levels as directed by your healthcare provider. Regularly check your blood pressure as advised, and undergo blood tests as recommended by your doctor to ensure your safety while taking this medication.

Be aware that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor to discuss potential interactions. Additionally, if you are on a low-salt or salt-free diet, consult your doctor for guidance.

Before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor.

It is also crucial to discuss the use of alcohol, marijuana or other cannabis products, and prescription or OTC drugs that may cause drowsiness with your doctor before consumption.

In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

If you are taking cholestyramine or colestipol, consult your pharmacist about the proper administration of these medications with this drug, and be aware of the potential for gout attacks.

This medication may cause elevated cholesterol and triglyceride levels. Discuss this risk with your doctor and monitor your levels as advised.

If you have lupus, be aware that this medication can activate or worsen the condition. Immediately report any new or worsening symptoms to your doctor.

For individuals 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are breastfeeding, consult your doctor to discuss the potential risks to your baby and determine the best course of action.

• Aliskiren (in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m²))

• Lithium (increased serum lithium levels and toxicity)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• NSAIDs (including COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment, especially in elderly or volume-depleted patients)
• Other antihypertensive agents (additive hypotensive effects)
• Digoxin (thiazides may increase risk of digoxin toxicity due to hypokalemia)

• Alcohol, barbiturates, or narcotics (orthostatic hypotension may be potentiated)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine) (possible increased responsiveness to the muscle relaxant)
• Antidiabetic drugs (oral agents and insulin) (thiazides may decrease glucose tolerance, dosage adjustment of antidiabetic drug may be required)
• Cholestyramine and colestipol resins (impaired absorption of hydrochlorothiazide)
• CYP2C9 inhibitors (e.g., fluconazole) (may increase Losartan exposure)
• CYP2C9 inducers (e.g., rifampin) (may decrease Losartan exposure)

• Allopurinol (increased risk of hypersensitivity reactions with hydrochlorothiazide)
• Amantadine (increased risk of adverse effects with amantadine)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate) (increased myelosuppression with hydrochlorothiazide)

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Fatigue or weakness
• Muscle cramps or weakness (suggestive of electrolyte imbalance, e.g., hypokalemia)
• Swelling of face, lips, tongue, and/or throat (angioedema, rare but serious)
• Persistent dry cough (less common with ARBs than ACEIs, but possible)
• Signs of dehydration (dry mouth, decreased urination)
• Symptoms of gout (joint pain, swelling, redness)

Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. First trimester exposure risk is less clear but still generally avoided.

Not recommended. Both Losartan and Hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse effects in the breastfed infant (e.g., hypotension, electrolyte disturbances), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Monitor renal function and electrolytes more closely in elderly patients due to increased likelihood of age-related renal impairment and polypharmacy.

• Hyzaar is a fixed-dose combination and should not be used for initial therapy in patients with severe volume depletion or electrolyte abnormalities, as individual titration of components is not possible.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although it is rare with ARBs.
• Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in volume-depleted patients.
• Caution is advised in patients with a history of gout due to the hydrochlorothiazide component's potential to increase uric acid levels.
• This combination is particularly useful for patients whose blood pressure is not adequately controlled with either Losartan or Hydrochlorothiazide alone.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics unless serum potassium is closely monitored due to the risk of hyperkalemia from Losartan.

• Other classes of antihypertensives (e.g., ACE inhibitors, Calcium Channel Blockers, Beta-blockers, other diuretics)
• Losartan monotherapy
• Hydrochlorothiazide monotherapy

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.