Olmesartan/amlod/hctz 20-5-12.5mg 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, decreased aldosterone secretion, and reduced sodium and water reabsorption. 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 and chloride reabsorption in the distal convoluted tubule, leading to increased 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 very tired or weak
+ Decreased appetite or inability to urinate
+ Dry mouth, dry eyes, or severe stomach upset
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 right away:

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
Signs of a common cold
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.
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 conditions with your doctor and pharmacist. This will help determine the safety of taking this medication in conjunction with your other treatments and health issues. 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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

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

It is also important to 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 cautious and drink plenty of fluids to avoid 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. Be aware of the potential for gout attacks.

Individuals with lupus should be aware that this medication may reactivate or worsen 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)
• Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium (in patients with severe renal impairment due to increased risk of hyperkalemia)

• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors, may reduce antihypertensive effect and increase risk of renal impairment, especially in elderly or volume-depleted patients)
• Other antihypertensives (additive hypotensive effects)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem, verapamil, grapefruit juice - may increase amlodipine exposure and risk of hypotension)
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital - may decrease amlodipine exposure and efficacy)
• Colestipol and Cholestyramine (may reduce absorption of HCTZ)
• Corticosteroids, ACTH (may intensify electrolyte depletion, particularly hypokalemia)
• Digitalis glycosides (hypokalemia/hypomagnesemia induced by HCTZ may increase digitalis toxicity)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine - HCTZ may potentiate their effect)
• Pressor amines (e.g., norepinephrine - HCTZ may decrease arterial responsiveness)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Antidiabetic agents (oral agents and insulin - HCTZ may decrease their effectiveness, requiring dosage adjustment)
• Calcium salts (increased serum calcium levels with HCTZ)
• Cyclosporine (increased risk of hyperuricemia and gouty complications with HCTZ)
• Tacrolimus (increased risk of tacrolimus toxicity with amlodipine)
• Simvastatin (amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg/day)

• Alcohol (additive hypotensive effect)
• Barbiturates, narcotics (additive hypotensive effect)
• Diazoxide (enhanced hyperglycemic and hypotensive effects with HCTZ)
• Metformin (risk of lactic acidosis with HCTZ in renal impairment)
• Anticholinergic agents (e.g., atropine, biperiden - may increase HCTZ bioavailability by decreasing GI motility)
• Amantadine (increased risk of adverse effects with HCTZ)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate - HCTZ may reduce renal excretion, increasing myelosuppressive effects)
• Carbamazepine (risk of symptomatic hyponatremia with HCTZ)
• Dofetilide (increased risk of Torsades de Pointes with HCTZ-induced hypokalemia)

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

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Swelling in ankles, feet, or hands (edema)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Unusual thirst or dry mouth
• Nausea or vomiting
• Irregular heartbeat
• Signs of hyperkalemia (e.g., paresthesias, muscle weakness, fatigue, bradycardia)
• Signs of hyponatremia (e.g., headache, confusion, seizures)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death from the olmesartan component (ARB). Discontinue as soon as pregnancy is detected. Limited data on first trimester exposure, but potential risks cannot be excluded.

Use is generally not recommended. Olmesartan is excreted in rat milk; unknown if excreted in human milk. Amlodipine is present in human milk in low amounts, but effects on the breastfed infant are unknown. HCTZ is excreted in human milk and can suppress lactation. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant.

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

Use with caution, especially in patients >75 years old. Amlodipine clearance is decreased in the elderly, leading to increased exposure. HCTZ may cause greater electrolyte disturbances and volume depletion in the elderly. Consider lower starting doses and careful titration, and monitor renal function and electrolytes closely.

• This is a fixed-dose combination, so individual component doses cannot be adjusted independently. If dose adjustments are needed, consider switching to individual components or a different combination.
• Patients should be advised to report any signs of swelling (angioedema), especially of the face, lips, or tongue, immediately.
• Monitor for orthostatic hypotension, especially at initiation or with dose increases, and advise patients to rise slowly.
• Educate patients about the importance of regular blood pressure monitoring and adherence to therapy, even if asymptomatic.
• Due to the HCTZ component, advise patients to stay well-hydrated, especially in hot weather or during exercise, to prevent dehydration and electrolyte imbalances.
• Counsel women of childbearing potential about the severe fetal risks associated with ARBs and the need for effective contraception or discontinuation if pregnancy is planned or detected.

• 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 (e.g., Olmesartan, Amlodipine, HCTZ)
• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers, direct vasodilators)

If your symptoms or health issues persist or worsen, it is 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 for more information. If you have any questions or concerns about your 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 medication taken, the amount, and the time it happened.