Amlod/val/hctz 10/320/25mg 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 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, increasing the excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.

Serious Side Effects: Seek Medical Help 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 attention 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 fluid and electrolyte problems, such as:
+ 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 throwing up
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Throwing up
+ Yellow skin or eyes
Muscle spasm
Chest pain that is new or worsening
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. If you experience any eye problems, contact your doctor immediately.

Rare but Serious Skin Cancer Risk

People taking hydrochlorothiazide have a rare risk of developing certain types of skin cancer. To minimize this 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 Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Feeling dizzy, tired, or weak
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. Be sure to describe the symptoms you experienced.
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 if it is safe to take this medication with your other drugs and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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.

Caution When Performing 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, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition

If you have diabetes, closely monitor your blood sugar levels. Additionally, check your blood pressure as directed by your healthcare provider. Regular blood tests will also be necessary, as ordered by your doctor. Be sure to discuss any concerns or questions with your doctor.

Interactions with Other Substances

This medication may affect certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking it. 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 and Risks

It may take a few weeks to experience the full effects of this medication. Although rare, new or worsening chest pain can occur, especially in individuals with severe heart blood vessel disease. In some cases, this can lead to a heart attack. Your doctor will monitor you for these potential risks.

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 substances that may slow your reactions with your doctor.

Precautions in Hot Weather and Physical Activity

Be cautious in hot weather or during physical activity, as this medication can increase the risk of 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 your current prescription. Additionally, 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 may be necessary. 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 (GFR <60 mL/min/1.73 m²))
• Potassium supplements or potassium-sparing diuretics (in patients with hyperkalemia)

• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (increased amlodipine exposure)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) (decreased amlodipine exposure)
• Other antihypertensive agents (additive hypotensive effects)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) (increased risk of hyperkalemia with valsartan)
• Potassium supplements (increased risk of hyperkalemia with valsartan)
• Colestipol and Cholestyramine resins (reduced absorption of hydrochlorothiazide)

• Alcohol (additive hypotensive effect)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Digitalis glycosides (increased risk of digitalis toxicity with hypokalemia/hypomagnesemia)
• Insulin and oral antidiabetic agents (may require dosage adjustment of antidiabetic agents)
• Muscle relaxants, non-depolarizing (potentiated effect)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
• Amantadine (increased risk of adverse effects of amantadine)
• Cytotoxic agents (e.g., cyclophosphamide, methotrexate) (potentiated myelosuppressive effects)
• Calcium salts (increased serum calcium levels)

• Not available

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Peripheral edema (swelling of ankles/feet)
• Fatigue
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Irregular heartbeat (palpitations)
• Persistent cough (less common with ARBs than ACEIs)
• Signs of allergic reaction (rash, itching, swelling)

Contraindicated during the second and third trimesters of pregnancy due to the valsartan component (an ARB), which can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected. Use during the first trimester is generally not recommended due to potential risks.

Not recommended during breastfeeding. Amlodipine is present in human milk. Valsartan is excreted in the milk of lactating rats, and it is unknown if it is excreted in human milk. Hydrochlorothiazide is excreted in human milk and can suppress lactation. Due to the potential for serious adverse effects on 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 (under 18 years of age). Therefore, use in this population is not recommended.

No overall differences in effectiveness or safety were observed between elderly (65 years and older) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses of individual components if initiating separately. Monitor renal function and electrolytes closely, as elderly patients are more likely to have age-related decreases in renal function and may be more sensitive to the hypotensive and electrolyte effects.

• This combination medication is typically reserved for patients whose blood pressure is not adequately controlled on dual therapy or who require multiple agents to achieve target blood pressure.
• The 10/320/25mg strength represents the maximum recommended doses for amlodipine and hydrochlorothiazide, and the maximum dose for valsartan. It should only be used in patients who have tolerated and require these high doses.
• Patients should be advised to report any signs of swelling (edema), dizziness, or muscle cramps, as these can indicate side effects or electrolyte imbalances.
• Due to the hydrochlorothiazide component, patients should be advised about potential photosensitivity and to use sun protection.
• Monitor for hyperkalemia due to valsartan and hypokalemia due to hydrochlorothiazide; these opposing effects can sometimes balance out, but close monitoring is still essential.
• Avoid concomitant use with NSAIDs, especially in elderly or volume-depleted patients, due to increased risk of renal impairment and reduced antihypertensive effect.

• Dual therapy with an ARB + CCB (e.g., amlodipine/valsartan - Exforge)
• Dual therapy with an ARB + diuretic (e.g., valsartan/HCTZ - Diovan HCT)
• Dual therapy with a CCB + diuretic (e.g., amlodipine + HCTZ)
• Monotherapy with any of the three classes if appropriate for BP control
• 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 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.