Losartan/hctz 100/25mg Tablets

Manufacturer AUROBINDO Active Ingredient Losartan and Hydrochlorothiazide(loe SAR tan & hye droe klor oh THYE a zide) Pronunciation loe SAR tan & hye droe klor oh THYE a zide
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It is used to lower the chance of stroke in people with high blood pressure and a heart problem called left ventricular hypertrophy. This drug may not help lower the chance of stroke in Black patients with these health problems.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB) / Thiazide Diuretic
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Pregnancy Category
Category D
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FDA Approved
Apr 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a combination of two drugs: Losartan, which helps relax blood vessels, and Hydrochlorothiazide, a 'water pill' that helps your body get rid of extra salt and water. Together, they work to lower your blood pressure.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, as advised by your doctor or healthcare provider.

Be aware that this medication may increase your urine production. To minimize sleep disturbances, try to avoid taking it close to bedtime. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the container tightly closed and store all medications in a safe location, out of reach of children and pets.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily with or without food.
  • Do not stop taking this medication without talking to your doctor, even if you feel well.
  • Continue to follow a low-sodium diet as recommended by your doctor.
  • Limit alcohol intake as it can further lower blood pressure.
  • Stay hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake unless advised by your doctor.
  • Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
  • Regularly monitor your blood pressure at home if advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg Losartan / 25 mg Hydrochlorothiazide orally once daily
Dose Range: 50 - 100 mg

Condition-Specific Dosing:

initial_therapy: Not recommended for initial therapy unless blood pressure is severely elevated and the benefit of prompt blood pressure control outweighs the risk of initiating combination therapy.
dose_titration: Dosage may be increased after 2-4 weeks if blood pressure is not adequately controlled with lower strengths.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment needed (CrCl > 30 mL/min)
Moderate: No dose adjustment needed (CrCl > 30 mL/min)
Severe: Contraindicated (CrCl ≤ 30 mL/min) due to ineffectiveness of HCTZ and potential for Losartan accumulation.
Dialysis: Contraindicated. Losartan is not dialyzable. HCTZ is minimally dialyzable.

Hepatic Impairment:

Mild: Use with caution. Consider starting with lower Losartan dose (e.g., 25 mg Losartan monotherapy) before initiating combination.
Moderate: Use with caution. Consider starting with lower Losartan dose (e.g., 25 mg Losartan monotherapy) before initiating combination.
Severe: Not recommended due to significant hepatic metabolism of Losartan.

Pharmacology

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Mechanism of Action

Losartan: Selectively blocks the binding of angiotensin II to the AT1 receptor, thereby inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide: 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.
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Pharmacokinetics

Absorption:

Bioavailability: Losartan: ~33% (due to first-pass metabolism); Hydrochlorothiazide: 65-75%
Tmax: Losartan: 1 hour (Losartan), 3-4 hours (active metabolite E-3174); Hydrochlorothiazide: 1-2.5 hours
FoodEffect: Losartan: Food slightly decreases Cmax but does not significantly affect AUC; Hydrochlorothiazide: Food increases absorption.

Distribution:

Vd: Losartan: ~34 L (Losartan), ~12 L (E-3174); Hydrochlorothiazide: ~0.8 L/kg
ProteinBinding: Losartan: >98%; Hydrochlorothiazide: 40-68%
CnssPenetration: Losartan: Limited; Hydrochlorothiazide: No

Elimination:

HalfLife: Losartan: ~2 hours; E-3174: ~6-9 hours; Hydrochlorothiazide: 5.6-14.8 hours
Clearance: Not available
ExcretionRoute: Losartan: Biliary/Fecal (~60%), Renal (~35%); Hydrochlorothiazide: Renal (>95% unchanged)
Unchanged: Losartan: ~4% (urine); Hydrochlorothiazide: >95% (urine)
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Pharmacodynamics

OnsetOfAction: Losartan: Within 6 hours; Hydrochlorothiazide: Within 2 hours
PeakEffect: Losartan: 3-6 weeks for full BP reduction; Hydrochlorothiazide: 4 hours
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Losartan/HCTZ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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Side Effects

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 immediate medical attention:

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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of fluid and electrolyte imbalances, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Fatigue or weakness
+ Decreased appetite
+ Urination changes
+ Dry mouth
+ Dry eyes
+ Severe nausea or vomiting
Signs of pancreatitis (pancreas problems), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Severe dizziness or fainting
Swelling in the arms or legs
Yellowing of the skin or eyes
Erectile dysfunction

Eye Problems:

This medication can cause certain eye problems, which may lead to permanent vision loss if left untreated. If you experience any of the following symptoms, contact your doctor immediately:

Changes in vision
Eye pain

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

Skin Cancer Risk:

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 recommendations for skin checks
Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth

Other Side Effects:

Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they persist, contact your doctor:

Dizziness
Signs of a common cold
* Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (especially when standing up)
  • Unusual tiredness or weakness
  • Muscle cramps or pain
  • Irregular heartbeat
  • Signs of dehydration (e.g., extreme thirst, dry mouth, decreased urination)
  • Yellowing of skin or eyes (jaundice)
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Difficulty breathing
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Before Using This Medicine

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. Describe the allergic reaction you experienced, including any symptoms.
A known sulfa allergy.
Current or planned use of dofetilide.
Difficulty urinating or inability to pass urine.
Dehydration; if you are dehydrated, discuss this with your doctor before taking the medication.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking.
Any natural products or vitamins you are using.
* Existing health problems.

Before starting, stopping, or modifying the dose of any medication, including this one, consult with your doctor to ensure your safety. Verify that it is safe to take this medication in combination with your other medications and health conditions.
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Precautions & Cautions

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 be cautious when climbing stairs.

If you have diabetes, 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. Similarly, 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.

Exercise caution when consuming alcohol, marijuana, or other forms of cannabis, and avoid using prescription or OTC drugs that may cause drowsiness. Consult your doctor before using these substances.

In hot weather or during physical activity, 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 best way to take 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 recommended.

If you have lupus, be aware that this medication can exacerbate the condition. Inform your doctor immediately if you experience any new or worsening symptoms.

Older adults (65 years and older) should use this medication with caution, as they 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.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate)
  • Electrolyte imbalances (e.g., severe hypokalemia, hyponatremia)
  • Dehydration

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US). Management is supportive, including intravenous fluids for hypotension and correction of electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Concomitant use with ACE inhibitors or other ARBs
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Major Interactions

  • 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
  • Other antihypertensive agents (additive hypotensive effect)
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Moderate Interactions

  • Corticosteroids (increased risk of hypokalemia)
  • Antidiabetic agents (oral agents and insulin - HCTZ may decrease glucose tolerance, requiring dose adjustment)
  • Cholestyramine and colestipol resins (decreased absorption of HCTZ)
  • Digoxin (hypokalemia/hypomagnesemia from HCTZ can increase digoxin toxicity)
  • Muscle relaxants, non-depolarizing (enhanced effect)
  • Pressor amines (e.g., norepinephrine - diminished response)
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Minor Interactions

  • Alcohol, barbiturates, or narcotics (additive orthostatic hypotension)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide therapy

Timing: Prior to initiation

Serum Electrolytes (Potassium, Sodium, Magnesium, Calcium)

Rationale: To assess baseline electrolyte status and identify pre-existing imbalances; HCTZ can cause hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia; Losartan can cause hyperkalemia.

Timing: Prior to initiation

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function; Losartan can affect renal function, and HCTZ is ineffective in severe renal impairment.

Timing: Prior to initiation

Uric Acid

Rationale: HCTZ can increase serum uric acid levels.

Timing: Prior to initiation

Fasting Glucose

Rationale: HCTZ can affect glucose metabolism.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Daily (home monitoring), periodically in clinic (e.g., every 2-4 weeks until controlled, then every 3-6 months)

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent elevation above target, or symptomatic hypotension

Serum Electrolytes (Potassium, Sodium)

Frequency: 1-2 weeks after initiation or dose change, then periodically (e.g., every 3-6 months or as clinically indicated)

Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L

Action Threshold: Potassium <3.0 or >5.5 mEq/L; Sodium <130 mEq/L or symptomatic hyponatremia

Renal Function (BUN, Serum Creatinine, eGFR)

Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)

Target: Stable within normal limits or acceptable range for patient

Action Threshold: Significant increase in creatinine (>30% from baseline) or decrease in eGFR

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Muscle cramps or weakness
  • Excessive thirst
  • Dry mouth
  • Nausea
  • Vomiting
  • Swelling in ankles or feet (rare, but can indicate fluid retention or other issues)

Special Patient Groups

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Pregnancy

Contraindicated in the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Avoid use in the first trimester if possible. If pregnancy is detected, discontinue as soon as possible.

Trimester-Specific Risks:

First Trimester: Limited data, but potential risk cannot be excluded. Generally avoided.
Second Trimester: High risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: High risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
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Lactation

Not recommended during breastfeeding. Both Losartan and Hydrochlorothiazide are excreted in human milk. Potential for adverse effects on the breastfed infant (e.g., hypotension, electrolyte disturbances).

Infant Risk: Moderate to High (L3)
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Pediatric Use

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

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Geriatric Use

No specific dose adjustment is required based on age alone. However, geriatric patients may be more susceptible to the hypotensive and electrolyte-disturbing effects. Monitor renal function and electrolytes closely.

Clinical Information

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Clinical Pearls

  • This combination is often used when monotherapy with an ARB or a thiazide diuretic is insufficient to control blood pressure.
  • Not for initial therapy in most patients, unless the need for rapid and significant blood pressure reduction outweighs the risks of combination therapy.
  • Patients should be advised to report any symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat).
  • Caution is advised in patients with severe aortic or mitral stenosis, or hypertrophic cardiomyopathy, as ARBs can worsen outflow obstruction.
  • Avoid in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy.
  • Hydrochlorothiazide can exacerbate gout due to increased uric acid levels.
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Alternative Therapies

  • ACE inhibitors (e.g., Lisinopril, Enalapril)
  • Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Other diuretics (e.g., Loop diuretics like Furosemide, Potassium-sparing diuretics like Spironolactone)
  • Direct Renin Inhibitors (e.g., Aliskiren - generally not recommended in combination with ARBs/ACEIs)
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

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 discuss them with 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 medication taken, the amount, and the time it occurred.