Amlo/val/hctz 10/160/12.5mg 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 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.

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
+ 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 and follow your doctor's instructions for skin checks. If you notice any changes in your skin, such as:

A change in color or size of a mole
Any new or changing skin lump or growth

contact your doctor right away.

Other Side Effects:

Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling dizzy, tired, or weak
Headache
Upset stomach
Back pain

This is not a comprehensive list of all 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 allergic reaction you experienced.
A known sulfa allergy.
Current or planned 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 in conjunction with your other treatments 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 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 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 (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 of your healthcare providers and lab 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. Additionally, 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 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 Other 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 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 conditions 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 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 necessary. Discuss this risk with your doctor.

Age-Related Considerations

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)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (due to valsartan component, increased risk of hyperkalemia)
• Lithium (due to valsartan and HCTZ components, increased lithium levels and toxicity)

• NSAIDs (including COX-2 inhibitors): May reduce antihypertensive effect of valsartan and HCTZ, and increase risk of renal impairment and hyperkalemia.
• Other antihypertensives: Additive hypotensive effects.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase amlodipine exposure, leading to increased hypotensive effects.
• CYP3A4 inducers (e.g., rifampin, St. John's Wort): May decrease amlodipine exposure, leading to reduced efficacy.
• Digoxin: Increased risk of digoxin toxicity with HCTZ (due to hypokalemia/hypomagnesemia).
• Corticosteroids: May antagonize the diuretic and antihypertensive effects of HCTZ.
• Cholestyramine and colestipol resins: May impair absorption of HCTZ.

• Antidiabetic agents (oral agents and insulin): HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic dosage.
• Muscle relaxants, non-depolarizing: HCTZ may potentiate their effect.
• Alcohol, barbiturates, or narcotics: May potentiate orthostatic hypotension with HCTZ.
• Calcium supplements: HCTZ may increase serum calcium levels.

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Peripheral edema (ankles, feet)
• Muscle cramps or weakness (due to electrolyte imbalance)
• Unusual thirst or dry mouth
• Increased urination
• Signs of hyperkalemia (e.g., palpitations, muscle weakness)
• Signs of hypokalemia (e.g., muscle cramps, weakness, irregular heartbeat)
• Signs of angioedema (swelling of face, lips, tongue, throat)

Contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death from the valsartan (ARB) and hydrochlorothiazide components. Discontinue as soon as pregnancy is detected.

Not recommended during breastfeeding. Hydrochlorothiazide is excreted in breast milk and can suppress lactation. Valsartan and amlodipine are also likely excreted in breast milk. Potential for serious adverse effects in the infant.

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

Use with caution. Elderly patients may be more sensitive to the hypotensive effects and may have age-related decreases in renal function. Consider lower starting doses of individual components if initiating therapy, and monitor closely for adverse effects, especially hypotension and electrolyte imbalances.

• This fixed-dose combination is generally reserved for patients whose blood pressure is not adequately controlled on dual therapy with an ARB and a CCB, or an ARB and a diuretic, or for those who require three agents.
• Always check renal function and electrolytes before initiating and periodically during therapy, especially in patients with pre-existing renal impairment or those on concomitant medications that affect potassium levels.
• Educate patients about the signs of angioedema and the importance of seeking immediate medical attention if it occurs.
• Advise patients to report any symptoms of dizziness or fainting, especially when standing up, as this may indicate orthostatic hypotension.
• Due to the long half-life of amlodipine, the full antihypertensive effect may not be seen for several days to weeks after initiation or dose adjustment.

• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, alpha-blockers, direct vasodilators)
• Individual components taken separately (Amlodipine, Valsartan, Hydrochlorothiazide)
• Lifestyle modifications (diet, exercise, weight management, stress reduction)

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 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 medication taken, the amount, and the time it happened.