Olmesartan/amlod/hctz 40-5-12.5mg T

Olmesartan medoxomil is a prodrug that is hydrolyzed to olmesartan, a selective AT1 subtype angiotensin II receptor antagonist. It blocks 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 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 signs.

Skin Cancer Risk:

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. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

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

Reporting Side Effects:

If you have questions about side effects or want to report any, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 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.
Concomitant use of a drug 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.

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 any potential interactions with other treatments.

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 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. Regularly monitor your blood pressure as advised by your doctor, and undergo blood tests and other laboratory examinations as scheduled.

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 following 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 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 cannabis products, or prescription and OTC medications that may cause drowsiness with your doctor.

In hot weather or during physical activity, be cautious and drink plenty of fluids 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. 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 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 hypotension, hyperkalemia, and renal dysfunction with olmesartan)

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs (including selective COX-2 inhibitors; may reduce antihypertensive effect and increase risk of renal impairment with olmesartan and HCTZ)
• Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other agents that increase serum potassium (increased risk of hyperkalemia with olmesartan)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin; may significantly increase amlodipine exposure)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort; may significantly decrease amlodipine exposure)

• Bile acid sequestrants (e.g., cholestyramine, colestipol; may impair absorption of HCTZ)
• Corticosteroids (may enhance electrolyte depletion, particularly hypokalemia, with HCTZ)
• Alcohol (may potentiate orthostatic hypotension)
• Other antihypertensive agents (additive hypotensive effects)
• Digitalis glycosides (increased risk of digitalis toxicity with HCTZ-induced hypokalemia)
• Non-depolarizing skeletal muscle relaxants (prolonged effect with HCTZ)
• Antidiabetic agents (HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic medication)

• Not typically listed as minor for this combination, but general caution with drugs affecting blood pressure or electrolytes.

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Swelling of ankles/feet (edema)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Unusual fatigue or lethargy
• Persistent dry cough (less common with ARBs than ACEIs)
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing/swallowing)
• Signs of severe skin reactions (rash, blistering, peeling)
• Changes in vision (acute myopia, secondary angle-closure glaucoma with HCTZ)

Contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death from the olmesartan component. Discontinue as soon as pregnancy is detected. Use in the first trimester is also generally not recommended due to potential risks.

Not recommended during breastfeeding. Olmesartan is unknown if excreted in human milk. Amlodipine and HCTZ are excreted in human milk. Potential for adverse effects on the breastfed infant (e.g., hypotension, electrolyte imbalance, diuresis).

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

Use with caution, especially in patients with impaired renal or hepatic function. Start with lower doses if appropriate and monitor blood pressure, renal function, and electrolytes closely. Elderly patients may be more sensitive to the hypotensive and diuretic effects.

• This is a triple combination therapy, typically reserved for patients whose blood pressure is not adequately controlled with dual therapy or who are already on the individual components.
• Due to the HCTZ component, it is contraindicated in patients with anuria or severe renal impairment (CrCl < 30 mL/min).
• The Black Box Warning for fetal toxicity (due to olmesartan) is critical; ensure female patients of childbearing potential are aware and use effective contraception.
• Monitor electrolytes (especially potassium, sodium) and renal function regularly, particularly after dose adjustments or in patients with comorbidities.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although rare with ARBs.
• Amlodipine can cause peripheral edema, which may be dose-dependent. This side effect might be mitigated by the diuretic effect of HCTZ, but patients should still be monitored for swelling.

• Individual components (Olmesartan, Amlodipine, Hydrochlorothiazide) taken separately.
• Dual combination therapies (e.g., Olmesartan/Amlodipine, Olmesartan/HCTZ, Amlodipine/HCTZ).
• Other classes of antihypertensives (e.g., ACE inhibitors, Beta-blockers, Alpha-blockers, other diuretics, other calcium channel blockers).

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 be sure 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 overdose, including the medication taken, the amount, and the time it occurred.