Losartan/hctz 100/12.5mg Tablets

Losartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor, preventing vasoconstriction and aldosterone secretion. Hydrochlorothiazide is a thiazide diuretic that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium.

Serious Side Effects: Seek Medical Help Immediately

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 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 Skin Cancer Risk

People taking hydrochlorothiazide have a rare risk of developing certain types of skin cancer. To minimize this 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 immediately.

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Dizziness
Signs of a common cold
Back pain

This is not an exhaustive list of potential 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 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 is not an exhaustive list of potential interactions. To ensure safe use, 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 drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider, and have regular blood tests as advised by your doctor.

Interactions with Other Substances
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab 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. Additionally, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Over-the-Counter (OTC) Products and Other Substances
Before using 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 forms of cannabis, or prescription or OTC drugs that may cause drowsiness with your doctor.

Precautions in Hot Weather and with Physical Activity
Be cautious in hot weather or during physical activity, 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.

Interactions with Other Medications
If you are taking cholestyramine or colestipol, consult your pharmacist about how to take these medications with this drug. Be aware of the potential for gout attacks.

Potential Side Effects
This medication may cause increased cholesterol and triglyceride levels; discuss this with your doctor. If you have lupus, this medication may exacerbate your condition or trigger a flare-up; report any new or worsening symptoms to your doctor promptly.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Aliskiren (in patients with diabetes or renal impairment)

• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors - reduced antihypertensive effect, increased risk of renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements or salt substitutes containing potassium (increased risk of hyperkalemia)
• Other antihypertensive agents (additive hypotensive effects)
• Alcohol (additive hypotensive effects)
• Corticosteroids (intensified electrolyte depletion, particularly hypokalemia)
• Pressor amines (e.g., norepinephrine - possible decreased response to pressor amines)
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine - increased responsiveness to muscle relaxants)
• Cholestyramine and colestipol resins (impaired absorption of hydrochlorothiazide)

• Antidiabetic agents (oral agents and insulin - dosage adjustment may be required)
• Digitalis glycosides (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia)
• Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
• Calcium salts (increased serum calcium levels due to decreased excretion)
• Cyclosporine (increased risk of hyperuricemia and gout-type complications)
• Barbiturates, narcotics, or antidepressants (additive orthostatic hypotension)

• Not typically categorized as minor for this combination, but general caution with other medications affecting blood pressure or electrolytes.

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Excessive fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Irregular heartbeat (palpitations)
• Swelling of hands, ankles, or feet (edema)
• Difficulty breathing or unusual cough
• Signs of allergic reaction (rash, itching, swelling, severe dizziness)
• Signs of hyperkalemia (numbness/tingling, muscle weakness, slow/irregular heartbeat)
• Signs of hypokalemia (severe muscle cramps, severe weakness, irregular heartbeat)

Contraindicated. Use of drugs acting on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Discontinue as soon as pregnancy is detected.

Not recommended. Both Losartan and Hydrochlorothiazide are excreted in human milk. Due to the potential for adverse effects on the nursing infant, 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 efficacy have not been established in pediatric patients under 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2. Not recommended for routine use in children.

No overall differences in effectiveness or safety were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and monitor renal function and electrolytes closely due to increased susceptibility to adverse effects (e.g., dehydration, electrolyte imbalance, renal impairment).

• This combination is often used when monotherapy with an ARB or diuretic alone is insufficient to control blood pressure.
• Advise patients to take the medication at the same time each day, preferably in the morning, to avoid nocturia (frequent nighttime urination) due to the diuretic component.
• Educate patients about the risk of orthostatic hypotension (dizziness upon standing) and advise them to rise slowly from a sitting or lying position.
• Emphasize the importance of regular blood pressure monitoring and adherence to prescribed laboratory tests (electrolytes, renal function).
• Caution patients about the use of NSAIDs, as they can reduce the antihypertensive effect and increase the risk of renal dysfunction, especially in elderly or volume-depleted patients.
• Patients should be advised to avoid potassium-containing salt substitutes and potassium supplements unless specifically instructed by their physician.

• ACE Inhibitors (e.g., Lisinopril, Enalapril)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Calcium Channel Blockers (e.g., Amlodipine, Diltiazem)
• Other Diuretics (e.g., Loop diuretics like Furosemide, Potassium-sparing diuretics like Spironolactone)
• Direct Renin Inhibitors (e.g., Aliskiren - generally not first-line)
• Alpha-blockers (e.g., Doxazosin, Prazosin)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. 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 type and amount of medication taken, as well as the time it was taken.