Losartan/hctz 50/12.5mg Tablets

Losartan: An angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues (e.g., vascular smooth muscle, adrenal gland). This prevents the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased aldosterone secretion, and reduced sodium and water reabsorption. Hydrochlorothiazide: A thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule of the nephron. This increases the excretion of sodium, chloride, and water, leading to a reduction in plasma volume and blood pressure. It also increases potassium and magnesium excretion and decreases calcium excretion.

Urgent Side Effects: Seek Medical Help Right Away

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

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
Follow your doctor's instructions for skin checks
Contact your doctor immediately if you notice:
+ Changes in the color or size of a mole
+ New or changing skin lumps or growths

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, some may be bothered by:
Dizziness
Signs of a common cold
Back pain

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, you can:
Contact your doctor
Call the FDA at 1-800-332-1088
Report side effects 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 symptoms you experienced.
A known sulfa allergy.
Current or planned use of dofetilide.
Difficulty urinating.
Dehydration; if you are dehydrated, discuss this with your doctor.
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 (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, 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, get up slowly from a sitting or lying position and exercise caution when climbing stairs.

If you have diabetes, closely monitor your blood sugar levels. Additionally, check your blood pressure as directed by your healthcare provider and undergo blood tests as scheduled. Be aware that this medication may interfere with certain laboratory tests, so 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. Similarly, if you are on a low-sodium or sodium-free diet, discuss this with your doctor.

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. Also, discuss the use of alcohol, marijuana or other cannabis products, or prescription and OTC drugs that may cause drowsiness with your doctor.

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, which may lead to low blood pressure, inform your doctor promptly.

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

This medication may cause elevated cholesterol and triglyceride levels; discuss this with your doctor. If you have lupus, this medication can exacerbate the condition; immediately report any new or worsening symptoms to your doctor.

If you are 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 potential risks to your baby.

• Aliskiren (in patients with diabetes or renal impairment)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors - may reduce diuretic, natriuretic, and antihypertensive effects; may worsen renal function)
• ACE inhibitors (increased risk of hyperkalemia, hypotension, renal impairment with dual blockade)
• Other antihypertensive agents (additive hypotensive effect)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Cholestyramine, Colestipol resins (impaired absorption of hydrochlorothiazide)

• Alcohol, barbiturates, narcotics (orthostatic hypotension)
• Antidiabetic drugs (oral agents and insulin - may require dosage adjustment due to HCTZ effect on glucose)
• Digitalis glycosides (hypokalemia/hypomagnesemia may predispose to digitalis toxicity)
• Muscle relaxants, non-depolarizing (enhanced effect)
• Pressor amines (e.g., norepinephrine - decreased arterial responsiveness)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels with HCTZ)
• Cyclosporine (increased risk of hyperuricemia and gout with HCTZ)
• Diazoxide (hyperglycemic and hypotensive effects)

• Not available (interactions are generally categorized as major or moderate due to clinical significance)

• Dizziness
• Lightheadedness
• Fainting (especially upon standing)
• Fatigue
• Muscle cramps or weakness
• Nausea
• Vomiting
• Excessive thirst
• Dry mouth
• Swelling in ankles or feet (rare, but monitor for fluid retention if BP not controlled)
• Signs of hyperkalemia (e.g., irregular heartbeat, muscle weakness)
• Signs of hypokalemia (e.g., muscle cramps, weakness, irregular heartbeat)

Contraindicated in the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Avoid use in the first trimester as well.

Not recommended during breastfeeding. Both losartan and hydrochlorothiazide are excreted in breast milk. Losartan has no human data, but animal data show excretion. Hydrochlorothiazide can decrease milk supply, especially in early postpartum.

Safety and effectiveness have not been established in pediatric patients under 18 years of age. Not recommended for routine use.

No specific dosage adjustment is generally required based on age alone. However, elderly patients may be more sensitive to the effects of the drug, particularly volume depletion and renal impairment. Monitor renal function and electrolytes closely.

• Losartan/HCTZ is a first-line option for hypertension, especially when a single agent is insufficient or when a diuretic is indicated.
• The combination product simplifies dosing and may improve adherence compared to taking two separate pills.
• Monitor for orthostatic hypotension, especially at initiation or dose escalation, and advise patients to rise slowly.
• Educate patients about the importance of avoiding potassium supplements or salt substitutes unless specifically instructed by their physician.
• Regular monitoring of renal function and electrolytes (especially potassium and sodium) is crucial, particularly in patients with pre-existing renal impairment, heart failure, or those on concomitant medications that affect electrolytes.
• Due to the black box warning, ensure female patients of childbearing potential are aware of the fetal toxicity risk and use effective contraception. Discontinue immediately if pregnancy is detected.

• ACE inhibitors (e.g., Lisinopril, Enalapril)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Other diuretics (e.g., Chlorthalidone, Indapamide, Furosemide)
• Direct Renin Inhibitors (e.g., Aliskiren - generally not recommended with ARBs)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about this 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 details about the overdose, including the medication taken, the amount, and the time it occurred.