Amlodipine-Valsartan 5-320mg Tabs

Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. 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, including vascular smooth muscle and the adrenal gland. This inhibition prevents the vasoconstrictive 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

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness
Nose or throat irritation
* Signs of a common cold

Reporting Side Effects

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 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 currently taking a medication that contains aliskiren, particularly if you 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 in combination with your other medications and health conditions. Never 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 driving or performing tasks that require alertness, as it may affect you. To minimize the risk of dizziness or fainting, rise slowly from a sitting 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, which can increase the risk of a heart attack. This risk may be higher in individuals with severe heart blood vessel disease. Discuss these potential risks with your doctor.

Before using over-the-counter (OTC) 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, and certain natural products or aids, consult with your doctor.

If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

It may take several weeks to experience the full effects of this medication. Before consuming alcohol, talk to your doctor.

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, notify your doctor, as these symptoms 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)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Lithium
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - for amlodipine component
• NSAIDs (including COX-2 inhibitors) - risk of renal impairment and reduced antihypertensive effect

• CYP3A4 inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenobarbital, phenytoin) - for amlodipine component
• Grapefruit juice - for amlodipine component
• Other antihypertensives (additive hypotensive effect)
• Colesevelam (may reduce valsartan absorption)

• Not available

• Dizziness
• Lightheadedness
• Fainting (signs of hypotension)
• Swelling of face, lips, tongue, throat (angioedema)
• Difficulty breathing
• Chest pain
• Palpitations
• Peripheral edema (amlodipine-related)
• Unusual fatigue or weakness
• Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)

Contraindicated during pregnancy due to the risk of fetal injury and death associated with the valsartan component (ARB). Discontinue as soon as pregnancy is detected.

Use with caution. Amlodipine is present in human milk. It is unknown if valsartan is excreted in human milk, but it is present in rat milk. Due to the potential for 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. Not recommended for use in children.

No overall differences in efficacy or safety were observed between elderly (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Consider lower initial doses of the amlodipine component (e.g., 2.5 mg) if appropriate, and monitor closely for adverse effects, especially hypotension and peripheral edema.

• This combination is useful for patients whose blood pressure is not adequately controlled with either amlodipine or valsartan alone.
• Peripheral edema, a common side effect of amlodipine, may be less pronounced when combined with valsartan due to the vasodilatory effects of valsartan.
• Always check for pregnancy status in women of childbearing potential due to the Black Box Warning for fetal toxicity.
• Monitor potassium levels, especially in patients with renal impairment, diabetes, or those on potassium-sparing diuretics/supplements.
• Advise patients to report any signs of angioedema immediately, as this is a rare but serious side effect of ARBs.

• Other ARBs (e.g., losartan, irbesartan, candesartan)
• Other CCBs (e.g., nifedipine, diltiazem, verapamil)
• ACE inhibitors (e.g., lisinopril, enalapril)
• Thiazide diuretics (e.g., hydrochlorothiazide)
• Beta-blockers (e.g., metoprolol, carvedilol)

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. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.