Exforge 10/160mg Tablets

Exforge combines two antihypertensive agents with complementary mechanisms to control blood pressure: 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, reduced aldosterone secretion, and decreased 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. 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
* Signs 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.
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 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. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

Important Information to Share with Your Healthcare Team

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Precautions to Ensure Your Safety

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.

Monitoring Your Health

Check your blood pressure as directed by your healthcare provider. Additionally, have your blood work and other laboratory tests performed as scheduled by your doctor.

Potential Cardiovascular Risks

Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose. In some cases, a heart attack may happen. This risk may be higher in individuals with severe heart blood vessel disease. Discuss these potential risks with your doctor.

Interactions with Other Medications and Products

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

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.

Additional Considerations

It may take several weeks to experience the full effects of this medication. Before consuming alcohol, consult with 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, inform your doctor, as these conditions may lead to low blood pressure.

Special Considerations for Older Adults

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)
• Sacubitril/valsartan (Entresto) - due to increased risk of angioedema

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Salt substitutes containing potassium
• NSAIDs (including COX-2 inhibitors)
• Lithium
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort)

• Other antihypertensives (additive effect)
• Grapefruit juice (for amlodipine)
• Simvastatin (amlodipine increases simvastatin exposure)
• Dantrolene (IV) (for amlodipine, risk of hyperkalemia and cardiovascular depression)

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Peripheral edema (swelling of ankles/feet)
• Headache
• Flushing
• Palpitations
• Shortness of breath
• Unusual weight gain
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing/swallowing)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with valsartan (an ARB). Discontinue as soon as pregnancy is detected. First trimester exposure data is limited but potential risks cannot be excluded.

Amlodipine is present in human milk. It is unknown if valsartan is present in human milk. Due to the potential for serious adverse reactions in breastfed infants, including hypotension and hyperkalemia, breastfeeding is not recommended during treatment with Exforge.

Safety and efficacy have not been established in pediatric patients (under 18 years of age). Not recommended for use in this population.

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

• Exforge is a fixed-dose combination and should not be used as initial therapy for hypertension unless the patient's blood pressure is adequately controlled on the individual components or if the patient requires the specific combination for optimal blood pressure control.
• Monitor for peripheral edema, a common side effect of amlodipine, which may be less pronounced with the combination due to valsartan's vasodilatory effects.
• Counsel patients on the importance of avoiding potassium supplements and salt substitutes containing potassium due to the risk of hyperkalemia with valsartan.
• Emphasize the critical importance of discontinuing the medication immediately if pregnancy is detected due to the black box warning for fetal toxicity.
• Patients with severe aortic stenosis may be at increased risk of hypotension with amlodipine due to its vasodilatory effects.

• 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)
• Direct Renin Inhibitors (e.g., aliskiren - with caution due to interactions)

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 information. If you have any questions or concerns about this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.