Olmesartan/amlod/hctz 40-5-25mg T

Manufacturer SUN PHARMACEUTICALS Active Ingredient Olmesartan, Amlodipine, and Hydrochlorothiazide(ole me SAR tan, am LOE di peen, & hye droe klor oh THYE a zide) Pronunciation ole me SAR tan, am LOE di peen, & 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.
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Drug Class
Antihypertensive
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Pharmacologic Class
Angiotensin II Receptor Blocker (ARB), Dihydropyridine Calcium Channel Blocker (CCB), Thiazide Diuretic Combination
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Pregnancy Category
Category D
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FDA Approved
Jan 2010
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a combination of three drugs used to treat high blood pressure (hypertension). Olmesartan helps relax blood vessels, Amlodipine relaxes blood vessels and improves blood flow, and Hydrochlorothiazide is a 'water pill' that helps your body get rid of extra salt and water. Together, they help lower your blood pressure.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well. To establish a routine, take the medication at the same time every day.

Note that this medication may increase the frequency of urination. To minimize sleep disturbances, try to avoid taking the medication too close to bedtime. Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of medications, consult your pharmacist, who may be aware of drug take-back programs in your area.

What to Do If You Miss 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 to make up for the missed one.
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Lifestyle & Tips

  • Take medication consistently, at the same time each day.
  • Do not stop taking the medication without consulting your doctor.
  • Limit sodium intake in your diet.
  • Engage in regular physical activity.
  • Maintain a healthy weight.
  • Limit alcohol consumption.
  • Avoid grapefruit and grapefruit juice.
  • Stay hydrated, especially in hot weather or during exercise, but avoid excessive fluid intake if advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet (Olmesartan 40 mg / Amlodipine 5 mg / HCTZ 25 mg) orally once daily

Condition-Specific Dosing:

hypertension: Initial therapy or as substitution for individual components
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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 dosage adjustment needed (CrCl > 30 mL/min)
Moderate: Use with caution; monitor renal function and electrolytes closely. Not recommended for CrCl < 30 mL/min.
Severe: Contraindicated (CrCl < 30 mL/min) due to HCTZ component.
Dialysis: Not recommended; Olmesartan is not dialyzable, Amlodipine is poorly dialyzable, HCTZ is dialyzable but not recommended for severe impairment.

Hepatic Impairment:

Mild: No dosage adjustment needed for Olmesartan or HCTZ. Amlodipine dose adjustment may be considered (start with lower amlodipine dose if initiating individual components).
Moderate: Use with caution; monitor closely. Amlodipine dose reduction may be necessary. Not studied in severe hepatic impairment.
Severe: Not recommended due to lack of data and potential for increased amlodipine exposure.

Pharmacology

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Mechanism of Action

Olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues. Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to peripheral arterial vasodilation and reduction in blood pressure. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.
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Pharmacokinetics

Absorption:

Bioavailability: Olmesartan: ~26%; Amlodipine: 64-90%; HCTZ: 50-80%
Tmax: Olmesartan: 1-2 hours; Amlodipine: 6-12 hours; HCTZ: 1-2.5 hours
FoodEffect: Olmesartan: No significant effect; Amlodipine: No significant effect; HCTZ: No significant effect

Distribution:

Vd: Olmesartan: 17 L; Amlodipine: 21 L/kg; HCTZ: 0.8-1.7 L/kg
ProteinBinding: Olmesartan: >99%; Amlodipine: ~97.5%; HCTZ: 40-68%
CnssPenetration: Limited

Elimination:

HalfLife: Olmesartan: 13 hours; Amlodipine: 30-50 hours; HCTZ: 5.6-14.8 hours
Clearance: Not available
ExcretionRoute: Olmesartan: Biliary (50-65%), Renal (30-35%); Amlodipine: Renal (60% as metabolites); HCTZ: Renal (95% unchanged)
Unchanged: Olmesartan: ~35% (renal); Amlodipine: ~10% (renal); HCTZ: ~95% (renal)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (HCTZ, Olmesartan); 24-48 hours (Amlodipine)
PeakEffect: Olmesartan: 2 weeks; Amlodipine: 7-14 days; HCTZ: 4 hours
DurationOfAction: 24 hours (all components contribute to once-daily dosing)

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Olmesartan/Amlodipine/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 immediately or seek emergency medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, irregular heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Painful urination.
Joint pain or swelling.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
New or worsening chest pain.
Significant weight loss.
Muscle spasms.
Restlessness.

Eye Problems:

This medication can cause certain eye problems, which may lead to permanent vision loss if left untreated. If you experience any eye problems, symptoms such as changes in vision or eye pain usually occur within hours to weeks of starting this medication. Contact your doctor immediately if you notice any of these symptoms.

Skin Cancer Risk:

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize this risk, protect your skin from the sun and follow your doctor's recommendations 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:

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 discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Dizziness, fatigue, or weakness.
Headache.
Nose or throat irritation.
Common cold symptoms.
Upset stomach.
* Diarrhea.

Reporting 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Swelling of the face, lips, tongue, or throat (signs of angioedema)
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Unusual tiredness or weakness
  • Muscle cramps or weakness
  • Irregular heartbeat
  • Decreased urination
  • Persistent dry cough
  • Signs of high potassium (numbness, tingling, muscle weakness, slow/irregular heartbeat)
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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 conditions to ensure safe treatment:

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 the symptoms that occurred.
A known sulfa allergy.
Current use of dofetilide.
Inability to urinate.
Presence of kidney disease.
Use of another medication with similar properties. If you are unsure, consult your doctor or pharmacist for clarification.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Breastfeeding status. Note that you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine the safety of taking this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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. This will help ensure they are aware of any potential interactions or effects.

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and be careful when navigating stairs.

If you have diabetes, this medication may cause an increase in blood sugar levels. Consult your doctor about strategies to maintain control over your blood sugar levels. Additionally, monitor your blood pressure as directed and undergo regular blood work and lab tests as advised by your doctor.

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

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. Similarly, if you are on a low-salt or salt-free diet, consult your doctor for guidance.

Although rare, it is possible to experience new or worsening chest pain after starting or increasing the dose of this medication, which may increase the risk of a heart attack. This risk may be higher in individuals with severe heart blood vessel disease. 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.

Exercise caution when using alcohol, marijuana, or other forms of cannabis, as well as prescription or OTC medications that may cause drowsiness. Discuss these interactions with your doctor.

In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, vomiting, diarrhea, or loose stools, inform your doctor, as these symptoms may lead to low blood pressure.

If you are taking colesevelam, colestipol, or cholestyramine, consult your pharmacist about the best way to take these medications in conjunction with this drug. Additionally, be aware of the potential for gout attacks.

Individuals with lupus should be aware that this medication may exacerbate or reactivate the condition. If you experience new or worsening symptoms, inform your doctor promptly.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including IV fluids for hypotension, vasopressors if needed, and correction of electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Do not co-administer with ACE inhibitors or ARBs in patients with diabetic nephropathy
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Major Interactions

  • Lithium (increased lithium toxicity)
  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) or potassium supplements (risk of hyperkalemia with Olmesartan)
  • NSAIDs (reduced antihypertensive effect, risk of renal impairment)
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (increased amlodipine exposure)
  • CYP3A4 inducers (e.g., rifampin, St. John's Wort) (decreased amlodipine exposure)
  • Digoxin (increased digoxin levels with amlodipine)
  • Colestipol/Cholestyramine (reduced HCTZ absorption)
  • Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
  • Non-depolarizing skeletal muscle relaxants (increased responsiveness to the muscle relaxant)
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Moderate Interactions

  • Alcohol (additive hypotensive effect)
  • Barbiturates, narcotics, or antidepressants (additive orthostatic hypotension)
  • Antidiabetic drugs (oral agents and insulin) (HCTZ may decrease glucose tolerance)
  • Pressor amines (e.g., norepinephrine) (HCTZ may decrease arterial responsiveness)
  • Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
  • Amantadine (increased risk of adverse effects with HCTZ)
  • Cytotoxic agents (e.g., cyclophosphamide, methotrexate) (HCTZ may reduce renal excretion)
  • Calcium salts (increased serum calcium levels with HCTZ)
  • Grapefruit juice (increased amlodipine exposure)
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Minor Interactions

  • Bile acid sequestrants (may reduce HCTZ absorption, administer HCTZ 4 hours before or after)
  • Other antihypertensives (additive hypotensive effects)

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, Chloride, Magnesium, Calcium)

Rationale: HCTZ can cause electrolyte imbalances (hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia)

Timing: Prior to initiation

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess kidney function, especially important with ARBs and HCTZ; identify contraindications

Timing: Prior to initiation

Liver Function Tests (ALT, AST, Bilirubin)

Rationale: To assess hepatic function, especially for amlodipine metabolism

Timing: Prior to initiation

Uric Acid

Rationale: HCTZ can increase uric acid levels

Timing: Prior to initiation

Blood Glucose

Rationale: HCTZ can affect glucose metabolism

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, as clinically indicated (e.g., weekly initially, then monthly)

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

Action Threshold: Persistently elevated BP despite therapy; symptomatic hypotension

Serum Electrolytes (Potassium, Sodium)

Frequency: Within 1-2 weeks of initiation/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: Hypokalemia (<3.5 mEq/L), Hyponatremia (<130 mEq/L), or significant shifts

Renal Function (BUN, Serum Creatinine, eGFR)

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

Target: Stable within patient's baseline

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

Uric Acid

Frequency: Periodically (e.g., annually or as clinically indicated)

Target: Within normal limits

Action Threshold: Symptomatic hyperuricemia or gout flares

Blood Glucose

Frequency: Periodically (e.g., annually or as clinically indicated), more frequently in diabetics

Target: Within normal limits or individualized diabetic targets

Action Threshold: Significant hyperglycemia

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Peripheral edema
  • Muscle cramps or weakness (signs of electrolyte imbalance)
  • Persistent dry cough (less common with ARBs than ACEIs)
  • Signs of allergic reaction (rash, itching, swelling)
  • Signs of liver problems (yellowing skin/eyes, dark urine, severe stomach pain)
  • Signs of kidney problems (decreased urination, swelling in feet/ankles)

Special Patient Groups

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Pregnancy

CONTRAINDICATED. Olmesartan, an ARB, can cause fetal harm or death when administered to pregnant women, especially during the second and third trimesters. Discontinue as soon as pregnancy is detected.

Trimester-Specific Risks:

First Trimester: While risks are primarily in 2nd/3rd trimesters, exposure during the first trimester should be avoided due to potential for fetal malformations and the risk of continued exposure into later trimesters.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
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Lactation

Not recommended. It is not known if Olmesartan or Amlodipine are excreted in human milk. HCTZ is excreted in human milk and can suppress lactation. Due to the potential for serious adverse effects on the breastfed 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.

Infant Risk: Risk of hypotension, hyperkalemia (Olmesartan), electrolyte disturbances, and potential for decreased milk supply (HCTZ).
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

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Geriatric Use

No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses of individual components if titrating. Monitor renal function and electrolytes closely due to increased risk of renal impairment and electrolyte imbalances in the elderly.

Clinical Information

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Clinical Pearls

  • This combination is often used when monotherapy or dual therapy is insufficient to control blood pressure.
  • Patients should be advised to avoid sudden changes in position to minimize orthostatic hypotension, especially when starting therapy or increasing dose.
  • Monitor for signs of angioedema, though less common with ARBs than ACEIs.
  • Educate patients on the importance of regular blood pressure monitoring at home.
  • Emphasize the critical importance of avoiding this medication during pregnancy due to the black box warning.
  • Patients should report any unusual swelling, muscle weakness, or irregular heartbeats immediately.
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Alternative Therapies

  • Other ARB/CCB/diuretic combinations
  • Separate administration of an ARB, a CCB, and a thiazide diuretic
  • Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers, direct vasodilators) depending on patient profile and comorbidities.
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Cost & Coverage

Average Cost: $100 - $300 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2)
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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 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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.