Exforge 5/160mg Tablets

Exforge is a combination of two antihypertensive agents: Amlodipine, a dihydropyridine calcium channel blocker (CCB), and Valsartan, an angiotensin II receptor blocker (ARB). Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells, leading to peripheral arterial vasodilation and reduction in peripheral vascular resistance, thereby lowering blood pressure. Valsartan 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, 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 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 a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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. Be sure to describe the allergic reaction and its symptoms.
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 breastfeeding, 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 you determine whether 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.

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, get up slowly from a sitting or lying position, and be careful when climbing stairs.

Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work and other laboratory tests done as scheduled 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 this 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. Also, if you are on a low-salt or salt-free diet, consult 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 avoid dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform 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 [GFR <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)
• Lithium
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - may increase amlodipine exposure
• Simvastatin - amlodipine increases simvastatin exposure (limit simvastatin dose to 20 mg/day)

• CYP3A4 inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenobarbital, phenytoin) - may decrease amlodipine exposure
• Other antihypertensive agents (additive hypotensive effect)
• Grapefruit juice (may increase amlodipine exposure)

• Not typically listed as clinically significant for this combination

• Dizziness
• Lightheadedness
• Fainting (syncope)
• Swelling of ankles, feet, or hands (peripheral edema)
• Unusual fatigue or weakness
• Shortness of breath
• Chest pain
• Rapid or irregular heartbeat
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing or swallowing)

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

Caution is advised. Both amlodipine and valsartan are excreted in breast milk. Monitor breastfed infants for adverse effects (e.g., hypotension, lethargy). Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Exforge and any potential adverse effects on the breastfed infant.

Safety and effectiveness 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 younger patients, but 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 levels closely due to increased likelihood of decreased renal function in the elderly.

• Exforge is a fixed-dose combination and should not be used for initial therapy in patients with uncomplicated hypertension.
• It is typically used when blood pressure is not adequately controlled with either amlodipine or valsartan monotherapy.
• Peripheral edema is a common side effect of amlodipine; the valsartan component may help mitigate this effect in some patients.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but serious side effect of ARBs.
• Monitor for hyperkalemia, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements.
• Avoid concomitant use with aliskiren in patients with diabetes or moderate to severe renal impairment.

• ACE Inhibitors (e.g., Lisinopril, Enalapril)
• Other Angiotensin Receptor Blockers (e.g., Losartan, Irbesartan)
• Other Calcium Channel Blockers (e.g., Nifedipine, Diltiazem)
• Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Alpha-blockers (e.g., Doxazosin, Terazosin)

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 facilitate prompt and effective treatment.