Amlod/val/hctz 10/160/25mg Tablets

Amlodipine is a dihydropyridine calcium channel blocker (CCB) 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 (HCTZ) 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. The combination provides additive antihypertensive effects by targeting different mechanisms involved in blood pressure regulation.

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 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
+ A big 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 worse
Restlessness
Swelling in the arms or legs
Stiff muscles, shakiness, or muscle movements that are not normal

Eye Problems:

This medication can cause certain eye problems, which can lead to lasting eyesight loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:

Change in eyesight
Eye pain (usually occurring within hours to weeks of starting this medication)

Skin Cancer Risk:

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize this risk:

Protect your skin from the sun
Have your skin checked as recommended by your doctor
Contact your doctor immediately if you notice:
+ A change in color or size of a mole
+ Any new or changing skin lump or growth

Other Side Effects:

Most people do not experience severe side effects, and many have no side effects or only minor 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
Upset stomach
Back pain

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
* Visit https://www.fda.gov/medwatch to report side effects online

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.
Existing health 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 medications and health conditions. 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 understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and 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, and undergo blood tests as scheduled. Discuss your test results with your doctor.

Interactions with Other Substances

This medication may interfere with 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. Additionally, if you are on a low-sodium or sodium-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 or increasing the dose of this medication, 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 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

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.

Interactions with Other Medications

If you take cholestyramine or colestipol, consult with your pharmacist about how to take these medications with your current medication. Be aware of the potential for gout attacks.

Special Considerations

If you have lupus, this medication may exacerbate your condition. 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 necessary. 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 (GFR <60 mL/min/1.73 m²))
• Potassium supplements or potassium-sparing diuretics (in patients with hyperkalemia or severe renal impairment)

• Lithium (increased lithium toxicity)
• NSAIDs (including selective COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) (increased amlodipine exposure)
• Strong CYP3A4 inducers (e.g., rifampin, St. John's Wort) (decreased amlodipine exposure)
• Other antihypertensives (additive hypotensive effects)
• Digoxin (HCTZ may increase digoxin toxicity due to electrolyte disturbances)
• Corticosteroids (increased electrolyte depletion, particularly hypokalemia, with HCTZ)
• Cholestyramine and colestipol resins (reduced absorption of HCTZ)

• Antidiabetic agents (insulin, oral hypoglycemics) (HCTZ may decrease glucose tolerance, requiring dose adjustment)
• Muscle relaxants, non-depolarizing (HCTZ may potentiate their effect)
• Pressor amines (e.g., norepinephrine) (HCTZ may decrease arterial responsiveness)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased risk of hypercalcemia with HCTZ)
• Cyclosporine (increased risk of hyperuricemia and gout with HCTZ)
• Grapefruit juice (may increase amlodipine exposure, though generally not considered clinically significant for most patients)

• Alcohol (additive hypotensive effect)
• Barbiturates, narcotics (additive hypotensive effect)

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Swelling in ankles or feet (peripheral edema, common with amlodipine)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Unusual thirst or dry mouth (dehydration)
• Irregular heartbeat (arrhythmias due to electrolyte imbalance)
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing or swallowing)
• Symptoms of hyperkalemia (e.g., paresthesias, muscle weakness, fatigue, bradycardia)
• Symptoms of hypokalemia (e.g., muscle weakness, cramps, constipation, palpitations)

Contraindicated in the 2nd and 3rd trimesters of pregnancy due to the risk of fetal injury and death associated with valsartan (ARB). Use in the 1st trimester is generally not recommended due to potential risks, though less severe than later trimesters. If pregnancy is detected, discontinue as soon as possible.

Not recommended during breastfeeding. Amlodipine is present in human milk in low amounts, generally considered compatible. Valsartan is unknown but has low oral bioavailability. Hydrochlorothiazide is excreted in breast milk and can suppress lactation. Due to the potential for serious adverse effects in the 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 this population.

No overall differences in safety or effectiveness have been observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses of individual components if needed, and monitor renal function and electrolytes closely due to increased susceptibility to adverse effects (e.g., hypotension, electrolyte imbalances, renal impairment).

• This combination product is not indicated for initial therapy of hypertension. It is intended for patients whose blood pressure is not adequately controlled on dual therapy or who are on stable doses of the individual components.
• Monitor for peripheral edema, a common side effect of amlodipine, which may be dose-dependent.
• Be vigilant for electrolyte imbalances (hypokalemia, hyponatremia, hypercalcemia, hypomagnesemia) due to the hydrochlorothiazide component, and hyperkalemia due to the valsartan component.
• Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although rare with ARBs.
• Caution should be exercised in patients with a history of gout or hyperuricemia, as HCTZ can increase uric acid levels.
• Patients with severe aortic stenosis or hypertrophic cardiomyopathy may be at increased risk of hypotension with vasodilators like amlodipine.

• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers, direct vasodilators)
• Individual components (Amlodipine, Valsartan, Hydrochlorothiazide) used separately or in dual combinations
• 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 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 medication taken, the amount, and the time it happened.