Olmesartan/amlo/hctz 40-10-12.5mg T

Olmesartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, leading to vasodilation and reduced aldosterone secretion. Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, resulting in peripheral arterial vasodilation and reduction in peripheral vascular resistance. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.

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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination or flushing
+ Fast breathing or breath that smells like fruit
Signs of kidney problems, such as:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of fluid and electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst, seizures, or feeling extremely tired or weak
+ Decreased appetite or changes in urine output
+ Dry mouth, dry eyes, or severe stomach upset or vomiting
Pain while urinating
Joint pain or swelling
Shortness of breath, significant 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 of the following symptoms, contact your doctor immediately:

Changes in vision or eye pain (usually occurring 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 experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, tiredness, 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.

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 treatment with dofetilide.
Difficulty urinating or inability to pass urine.
Pre-existing 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, as 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 conditions with your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health issues. 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. This will help ensure your safety and prevent potential interactions with other treatments.

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. 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 recommended by your doctor.

Please note 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 this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk 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 forms of cannabis, or prescription or OTC drugs that may cause drowsiness with your doctor.

In hot weather or during physical activity, be mindful of your fluid intake to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, 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 with this drug. Additionally, be aware of the potential for gout attacks.

Individuals with lupus should be cautious, as this medication may exacerbate 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.

• Aliskiren (in patients with diabetes or renal impairment due to increased risk of hyperkalemia, hypotension, and renal failure)

• Lithium (increased lithium levels and toxicity)
• NSAIDs (reduced antihypertensive effect, increased risk of renal impairment, especially in dehydrated or elderly patients)
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium (increased risk of hyperkalemia)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure
• Cholestyramine, Colestipol (reduced absorption of HCTZ)

• Other antihypertensives (additive hypotensive effects)
• Alcohol (additive hypotensive effects)
• Antidiabetic agents (HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetics)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia with HCTZ)
• Digoxin (HCTZ-induced hypokalemia or hypomagnesemia can increase digoxin toxicity)
• Muscle relaxants, non-depolarizing (HCTZ may potentiate effect)
• Pressor amines (e.g., norepinephrine) - HCTZ may reduce arterial responsiveness
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels with HCTZ)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Swelling of ankles, feet, or hands (edema)
• Shortness of breath
• Unusual weight gain or loss
• Muscle cramps or weakness
• Irregular heartbeat
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing)
• Signs of electrolyte imbalance (e.g., excessive thirst, dry mouth, nausea, vomiting, confusion)

Contraindicated. Use of drugs acting on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal injury and death. Discontinue as soon as pregnancy is detected.

Not recommended. Olmesartan is unknown if excreted in human milk. Amlodipine is present in human milk at low levels. Hydrochlorothiazide is excreted in human milk and can suppress lactation. Due to potential for serious adverse effects in 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.

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

Use with caution. Elderly patients may be more sensitive to the hypotensive effects and electrolyte imbalances. Consider lower starting doses if individual components were not previously tolerated. Monitor renal function and electrolytes more frequently.

• This is a fixed-dose combination, not suitable for initial therapy. It's intended for patients whose blood pressure is not adequately controlled on dual therapy or who are already on the individual components.
• Due to the HCTZ component, monitor for electrolyte imbalances (especially hypokalemia, hyponatremia) and hyperuricemia.
• The amlodipine component can cause peripheral edema, which is generally dose-dependent.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics unless serum potassium is closely monitored.
• Educate patients on the importance of adherence and lifestyle modifications for optimal blood pressure control.

• Other ARB/CCB combinations (e.g., Olmesartan/Amlodipine, Valsartan/Amlodipine)
• Other ARB/Diuretic combinations (e.g., Olmesartan/HCTZ, Valsartan/HCTZ)
• Other CCB/Diuretic combinations
• Individual monotherapy agents from different classes (e.g., ACE inhibitors, Beta-blockers, other diuretics)
• Lifestyle modifications alone (for very mild hypertension)

If your symptoms or health issues persist or worsen, it's 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 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 information about the medication taken, the amount, and the time it happened.