Olmesartan/amlod/hctz 40-10-25mg T

Olmesartan medoxomil is a prodrug that is hydrolyzed to olmesartan, a selective AT1 subtype angiotensin II receptor antagonist, blocking the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to peripheral arterial vasodilation and reduction in peripheral vascular resistance. Hydrochlorothiazide 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 Attention 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 help 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
Pain when passing urine
Joint pain or swelling
Shortness of breath, significant weight gain, or swelling in the arms or legs
Chest pain that is new or worsening
Significant weight loss
Muscle spasm
Restlessness

Eye Problems:

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

Skin Cancer:

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your 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 right away.

Other Side Effects:

Like all medications, this drug can cause side effects. While many people do not experience side effects or only have mild ones, it is essential to contact your doctor or seek medical help if you experience any of the following:

Feeling dizzy, tired, or weak
Headache
Nose or throat irritation
Signs of a common cold
Upset stomach
* Diarrhea

If you have questions about side effects or are concerned about any symptoms, 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 issues with your doctor and pharmacist. They will help determine the safety of taking this medication in combination with your other treatments and health conditions. 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 that you receive the best possible care.

To minimize the risk of accidents, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to reduce the likelihood of dizziness or fainting. Be cautious when climbing stairs to avoid falls.

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. Monitor your blood pressure as directed by your healthcare provider, and undergo regular blood tests and other laboratory tests as recommended.

This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory 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-sodium or sodium-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 taking any 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 medications 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, and monitor your condition accordingly.

Individuals with lupus should be aware that this medication may exacerbate their condition. If you experience any new or worsening symptoms, inform your doctor promptly. If you are 65 years 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 impairment)

• Lithium (increased lithium levels and toxicity)
• NSAIDs (reduced antihypertensive effect, increased risk of renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (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)

• Digoxin (HCTZ can increase digoxin toxicity due to hypokalemia)
• Corticosteroids (increased risk of electrolyte depletion, particularly hypokalemia)
• Bile acid sequestrants (e.g., cholestyramine, colestipol) (reduced HCTZ absorption)
• Alcohol (additive hypotensive effect)
• Other antihypertensives (additive hypotensive effect)

• Not available

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Fatigue
• Muscle cramps or weakness
• Unusual thirst
• Confusion
• Nausea or vomiting
• Swelling in ankles, feet, or hands (edema)
• Irregular heartbeat

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with the olmesartan component. Discontinue as soon as pregnancy is detected. Limited data on first trimester exposure, but risk cannot be excluded.

Not recommended during breastfeeding. Olmesartan is excreted in the milk of lactating rats, and it is unknown if it is excreted in human milk. Amlodipine and HCTZ are excreted in human milk. Potential for serious adverse effects in the breastfed infant (e.g., hypotension, electrolyte disturbances).

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

Use with caution in elderly patients (≥65 years) due to increased sensitivity to the effects of antihypertensives and potential for age-related decline in renal and hepatic function. Start at the lowest effective dose if components are titrated individually, and monitor renal function and electrolytes closely. Amlodipine clearance may be reduced in the elderly.

• This fixed-dose combination is intended for patients whose blood pressure is not adequately controlled on dual therapy or who are already on the individual components.
• Monitor for orthostatic hypotension, especially at initiation or dose escalation, and advise patients to rise slowly from a sitting or lying position.
• Educate patients on the signs and symptoms of electrolyte imbalance (e.g., hypokalemia, hyponatremia) and to report them promptly.
• Avoid concomitant use of potassium supplements or salt substitutes containing potassium unless specifically directed and monitored by a healthcare provider.
• Patients should be advised to inform their healthcare provider if they become pregnant or plan to become pregnant, as this medication must be discontinued immediately.
• The amlodipine component can cause peripheral edema, which is typically dose-dependent.

• Other Angiotensin Receptor Blockers (ARBs)
• Angiotensin-Converting Enzyme (ACE) Inhibitors
• Other Calcium Channel Blockers (CCBs)
• Other Diuretics (e.g., loop diuretics, potassium-sparing diuretics)
• Beta-blockers
• Alpha-blockers
• Direct Renin Inhibitors (e.g., aliskiren)

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.