Amlod/val/hctz 5/160/12.5mg Tablets

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 blood pressure. 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, 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 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, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or fruity-smelling breath
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, 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, tiredness, decreased appetite, stomach pain or nausea, light-colored 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 lead to permanent vision loss if left untreated (these symptoms usually occur within hours to weeks of starting the medication)
Rarely, skin cancer has been reported in people taking hydrochlorothiazide; protect your skin from the sun and have regular skin checks as advised by your doctor; contact your doctor immediately if you notice any changes in mole color or size, or new or changing skin lumps or growths

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have 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, 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:

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 or past use of dofetilide.
Presence of 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 conditions with your doctor and pharmacist. They will help determine the safety of taking this medication with your other drugs and health problems. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

It is crucial that you inform all of 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 activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position. Be cautious when climbing stairs.

Monitoring Your Condition

If you have diabetes, closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as recommended by your doctor, and discuss the results with them.

Interactions with Other Substances

This medication may affect certain laboratory tests. Inform all of 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, consult with your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Potential Side Effects

It may take several 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. In some cases, this can lead to a heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk with your doctor.

Over-the-Counter Products and Substances

Before using over-the-counter 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 with your doctor. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription or over-the-counter medications that may cause drowsiness with your doctor.

Precautions in Hot Weather and with Physical Activity

Be cautious in hot weather or when engaging in physical activity, as this can lead to fluid loss. Drink plenty of fluids to stay hydrated. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms can lead to low blood pressure.

Interactions with Other Medications

If you take cholestyramine or colestipol, consult with 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 can cause your condition to become active or worsen. Inform your doctor immediately if you experience any new or worsening symptoms. Liver problems have been associated with this medication, and in some cases, hospitalization has been required. Discuss this risk with your doctor.

Use in Older Adults

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 impairment)
• Anuria (due to HCTZ component)

• Lithium (increased serum lithium levels and toxicity)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) or potassium supplements (increased risk of hyperkalemia due to valsartan)
• NSAIDs (including COX-2 inhibitors) (attenuation of antihypertensive effect, increased risk of renal impairment and hyperkalemia)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (increased amlodipine exposure)
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) (decreased amlodipine exposure)
• Other antihypertensive agents (additive hypotensive effects)
• Digoxin (increased digoxin levels due to HCTZ)

• Simvastatin (increased simvastatin exposure due to amlodipine; limit simvastatin dose to 20 mg daily)
• Colestipol/Cholestyramine (reduced absorption of HCTZ)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Non-depolarizing skeletal muscle relaxants (increased responsiveness to the muscle relaxant due to HCTZ)
• Antidiabetic agents (oral agents and insulin) (HCTZ may decrease glucose tolerance, requiring dose adjustment)
• Alcohol, barbiturates, or narcotics (potentiation of orthostatic hypotension)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines due to HCTZ)

• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels with HCTZ)
• Diazoxide (enhanced hyperglycemic and hypotensive effects with HCTZ)

• 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
• Increased urination
• Irregular heartbeat
• Signs of allergic reaction (rash, itching, swelling)
• Symptoms of hyperkalemia (e.g., paresthesias, muscle weakness, fatigue, bradycardia)
• Symptoms of hypokalemia (e.g., muscle weakness, cramps, constipation, palpitations)

Contraindicated. Drugs acting directly on the renin-angiotensin system (valsartan) can cause fetal injury and death. Hydrochlorothiazide can also cause fetal harm (e.g., jaundice, thrombocytopenia).

Not recommended. Hydrochlorothiazide is excreted in human milk and may suppress lactation. Valsartan and amlodipine are also excreted in milk in animal studies, and potential for adverse effects on the infant is unknown but possible.

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

Use with caution. Start with lower doses and titrate slowly, especially for amlodipine. Monitor renal function and electrolytes more frequently due to increased susceptibility to adverse effects and potential for age-related decline in renal function. Elderly patients may be more sensitive to the hypotensive effects.

• This fixed-dose combination is indicated for patients whose blood pressure is not adequately controlled on dual therapy or for initial therapy in patients likely to need multiple drugs.
• The combination simplifies dosing and may improve adherence compared to taking individual components.
• Monitor for signs of hyperkalemia (due to valsartan) and hypokalemia (due to HCTZ), as these can occur despite the opposing effects.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although rare with ARBs.
• Caution is advised when co-administering with other drugs that affect potassium levels or renal function (e.g., NSAIDs).
• Patients with severe aortic stenosis may be at increased risk of hypotension with amlodipine.

• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, other diuretics, other calcium channel blockers)
• Dual therapy with two different classes of antihypertensives
• Monotherapy with a single antihypertensive agent (if appropriate for BP control)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.