Amlodipine-Valsartan 10-160mg Tabs

Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells. This leads to peripheral arterial vasodilation and reduction in peripheral vascular resistance, thereby lowering blood pressure. Valsartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced aldosterone secretion, and decreased sodium and water reabsorption, ultimately lowering blood pressure.

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 immediately or seek emergency medical attention:

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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Swelling in the arms or legs
Stiff muscles, shakiness, or abnormal muscle movements

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:

Dizziness
Nose or throat irritation
* Symptoms of a common cold

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 allergic reaction you experienced, including any symptoms that occurred.
If you have kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, particularly if you also have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you are breast-feeding, as you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

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

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, rise slowly from a seated or lying position and exercise caution when navigating stairs.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, adhere to the schedule for blood work and other laboratory tests as recommended by your doctor.

Be aware that this medication may rarely cause new or worsening chest pain, particularly when first initiated or when the dosage is increased. In some cases, it may also lead to a heart attack. This risk is potentially higher in individuals with severe heart blood vessel disease. It is crucial to discuss these risks with your doctor.

Before using any over-the-counter (OTC) products that may increase blood pressure, consult with your doctor. These products include cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. Similarly, if you are following a low-salt or salt-free diet, discuss this with your doctor to ensure safe management.

It may take several weeks to experience the full effects of this medication. Before consuming alcohol, consult with your doctor to understand any potential interactions.

In hot weather or during physical activity, be mindful of fluid loss and drink plenty of fluids to stay hydrated. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, notify your doctor, as these conditions may lead to low blood pressure.

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 (eGFR <60 mL/min/1.73 m2))

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Salt substitutes containing potassium
• NSAIDs (including selective COX-2 inhibitors) - increased risk of renal impairment and reduced antihypertensive effect
• Lithium (increased serum lithium concentrations and toxicity)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure
• Strong CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure

• Simvastatin (amlodipine increases simvastatin exposure; limit simvastatin dose to 20 mg daily)
• Other antihypertensive agents (additive hypotensive effect)
• Grapefruit juice (may increase amlodipine exposure)

• Not available

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Peripheral edema (swelling of ankles/feet)
• Fatigue
• Headache
• Flushing
• Palpitations
• Symptoms of hyperkalemia (muscle weakness, irregular heartbeat, fatigue)
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing)

Contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with valsartan. Discontinue as soon as pregnancy is detected.

Not recommended during breastfeeding. Both amlodipine and valsartan are excreted into breast milk in small amounts. Due to the potential for serious adverse effects in the infant (e.g., hypotension, hyperkalemia), 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.

No overall differences in effectiveness or safety were observed between elderly (≥65 years) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Initiate at the lower end of the dosing range and monitor renal function and electrolytes closely, especially in those with impaired renal function or concomitant conditions.

• This combination is typically used when monotherapy with either amlodipine or valsartan is insufficient to control blood pressure.
• Take the medication at approximately the same time each day to maintain consistent blood levels.
• Patients should be advised to report any swelling of the hands, ankles, or feet, as peripheral edema is a common side effect of amlodipine.
• Monitor for symptoms of hyperkalemia (e.g., muscle weakness, fatigue, irregular heartbeat) due to the valsartan component, especially in patients with renal impairment or those taking potassium-sparing diuretics or potassium supplements.
• Educate patients on the importance of avoiding potassium-containing salt substitutes without consulting their physician.
• Counsel women of childbearing potential about the risks of fetal exposure and the need to use effective contraception.

• Other Angiotensin Receptor Blockers (ARBs) (e.g., losartan, irbesartan, candesartan)
• Other Calcium Channel Blockers (CCBs) (e.g., nifedipine, felodipine, diltiazem, verapamil)
• ACE Inhibitors (e.g., lisinopril, enalapril, ramipril)
• Thiazide Diuretics (e.g., hydrochlorothiazide, chlorthalidone)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Alpha-blockers (e.g., prazosin, doxazosin)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more details. 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 information about the medication taken, the amount, and the time it happened.