Amlod/val/hctz 5/160/25mg Tablets

Amlodipine is a dihydropyridine calcium channel blocker 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. Valsartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland, inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. 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.

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 or seek medical attention immediately:

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, trouble 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 fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, pale stools, vomiting, or yellowing of the skin and eyes.
Muscle spasms.
New or worsening chest pain.
Restlessness.
Swelling in the arms or legs.
Stiff muscles, shakiness, or abnormal muscle movements.
Eye problems, such as changes in vision or eye pain, which can occur within hours to weeks of starting this medication and may lead to permanent vision loss if left untreated.

Important Skin Cancer Warning

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 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 immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people experience none or only mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Dizziness, tiredness, or weakness.
Headache.
Upset stomach.
* Back pain.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
A known sulfa allergy.
Current or planned use of dofetilide.
Pre-existing medical conditions, including kidney disease or liver disease.
Inability to urinate.
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 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.

Important Warnings and Precautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider, and have regular blood tests as advised by your doctor.

Interactions with Other Substances
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug. If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Additionally, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Potential Side Effects
It may take a few weeks to experience the full effects of this medication. Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose, which may increase the risk of heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk with your doctor.

Over-the-Counter (OTC) Products and Other Substances
Before using 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.

Heat and Fluid Loss
Be cautious in hot weather or during physical activity, 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.

Interactions with Other Medications
If you take cholestyramine or colestipol, consult your pharmacist about how to take these medications with this drug. Be aware of the potential for gout attacks.

Special Considerations
If you have lupus, this medication may activate or worsen your condition. Inform your doctor immediately if you experience new or worsening symptoms. Liver problems have been reported with this medication, and in some cases, hospitalization has been necessary. Discuss this risk with your doctor.

Age-Related Precautions
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)
• Potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium (due to valsartan component, increased risk of hyperkalemia)
• Lithium (due to hydrochlorothiazide component, increased lithium levels and toxicity)

• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect of valsartan and hydrochlorothiazide, and increase risk of renal impairment
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - may increase amlodipine exposure, leading to increased risk of hypotension and edema
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - may decrease amlodipine exposure, leading to reduced efficacy
• Other antihypertensive agents - additive hypotensive effects
• Digoxin (due to hydrochlorothiazide, may increase digoxin toxicity if hypokalemia occurs)
• Corticosteroids (due to hydrochlorothiazide, may enhance electrolyte depletion, particularly hypokalemia)
• Antidiabetic agents (insulin, oral hypoglycemics) - hydrochlorothiazide may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents

• Cholestyramine and colestipol (may impair absorption of hydrochlorothiazide)
• Muscle relaxants, non-depolarizing (due to hydrochlorothiazide, may enhance effect)
• Allopurinol (due to hydrochlorothiazide, increased risk of hypersensitivity reactions)
• Calcium salts (due to hydrochlorothiazide, increased serum calcium levels)
• Cyclosporine (due to valsartan, increased risk of hyperkalemia; due to hydrochlorothiazide, increased risk of hyperuricemia and gout)

• Alcohol (may potentiate orthostatic hypotension)
• Barbiturates, narcotics (may potentiate orthostatic hypotension)

• Dizziness
• Lightheadedness
• Fatigue
• Swelling (ankles, feet)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Unusual thirst or dry mouth
• Irregular heartbeat
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing)
• Persistent cough (less common with ARBs than ACEIs)

Contraindicated during pregnancy, especially during the second and third trimesters, due to the valsartan component. Drugs acting directly on the renin-angiotensin system can cause fetal injury and death. If pregnancy is detected, discontinue as soon as possible.

Not recommended during breastfeeding. Hydrochlorothiazide is excreted in human milk and can suppress lactation. Valsartan is excreted in animal milk, and it is unknown if it is in human milk. Amlodipine is excreted in human milk. Due to the 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 children.

Use with caution. Elderly patients may be more sensitive to the effects of amlodipine (e.g., peripheral edema) and may be at increased risk for volume depletion and electrolyte imbalances with hydrochlorothiazide. Consider lower starting doses and careful titration, especially in those with impaired renal or hepatic function. Monitor renal function and electrolytes closely.

• This is a triple combination therapy, often used when monotherapy or dual therapy is insufficient to control blood pressure.
• Due to the valsartan component, it carries a Black Box Warning for fetal toxicity; absolutely contraindicated in pregnancy.
• Monitor electrolytes (especially potassium) and renal function closely, particularly at initiation and with dose changes, due to the valsartan and hydrochlorothiazide components.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately.
• Orthostatic hypotension can occur, especially at the start of therapy or with dose increases; advise patients to rise slowly from a sitting or lying position.
• The amlodipine component can cause peripheral edema, which is dose-dependent.

• Individual components (Amlodipine, Valsartan, Hydrochlorothiazide) used separately or in dual combinations
• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, other diuretics, other calcium channel blockers)
• Lifestyle modifications (diet, exercise, weight management, stress reduction)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 this 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.