Exforge 10/320mg Tablets

Exforge is a combination of two antihypertensive agents with complementary mechanisms to control blood pressure in patients with essential hypertension: Amlodipine, a dihydropyridine calcium channel blocker (CCB), 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, an angiotensin II receptor blocker (ARB), selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased aldosterone secretion, and reduced sodium and water reabsorption.

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 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 may not experience any side effects or may only have 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. Be sure to describe the allergic reaction and its symptoms.
If you have kidney disease, as this may affect the medication's safety and efficacy.
If you are taking a medication that contains aliskiren and 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 (prescription, over-the-counter, natural products, and vitamins) and health problems 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. Never start, stop, or change the dose of any medication without consulting your doctor first.

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, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, follow your doctor's instructions for having your blood work and other laboratory tests checked.

Although rare, it is possible to experience new or worsening chest pain after initiating this medication or increasing the dose, which may increase the risk of a heart attack. This risk may be more significant 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, discuss this with your doctor. Similarly, if you are following a low-salt or salt-free diet, consult with your doctor to ensure safe use of this medication.

It may take several weeks to experience the full effects of this medication. Before consuming alcohol, talk to 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, inform 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 [GFR < 60 mL/min/1.73 m²])

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements or salt substitutes containing potassium
• NSAIDs (including selective COX-2 inhibitors)
• Lithium
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin)
• CYP3A4 inducers (e.g., rifampin, St. John's wort)
• Simvastatin (max simvastatin dose 20 mg/day with amlodipine)

• Other antihypertensive agents (additive hypotensive effect)
• Grapefruit juice (may increase amlodipine exposure)
• Dantrolene (IV) (risk of hyperkalemia and cardiovascular collapse with amlodipine)

• Not available

• Dizziness
• Lightheadedness
• Peripheral edema (swelling of ankles/feet)
• Headache
• Flushing
• Fatigue
• Palpitations
• Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
• Signs of angioedema (e.g., swelling of face, lips, tongue, throat)

CONTRAINDICATED. Exforge can cause fetal harm or death when administered to a pregnant woman. Discontinue as soon as pregnancy is detected.

Not recommended. It is not known if amlodipine or valsartan are excreted in human 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 of Exforge in pediatric patients have not been established. Use is not recommended.

No overall differences in effectiveness or safety were observed between elderly (65 years and older) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Monitor renal function and blood pressure closely.

• Exforge is a fixed-dose combination and should not be used for initial therapy in patients with uncomplicated hypertension.
• The 10/320mg strength is typically reserved for patients who have not achieved adequate blood pressure control on lower doses of the combination or on the individual components.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this can be life-threatening.
• Monitor for peripheral edema, a common side effect of amlodipine, which may be less pronounced with the combination due to valsartan's vasodilatory effects.
• Caution is advised when co-administering with other agents that increase potassium levels or affect renal function (e.g., NSAIDs, potassium-sparing diuretics).

• Other Angiotensin Receptor Blockers (ARBs) (e.g., losartan, candesartan, irbesartan)
• Other Calcium Channel Blockers (CCBs) (e.g., nifedipine, diltiazem, verapamil)
• ACE Inhibitors (e.g., lisinopril, enalapril)
• Thiazide Diuretics (e.g., hydrochlorothiazide)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Other classes of antihypertensives based on patient comorbidities and guidelines.

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 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.