Exforge HCT 10-160-25mg Tablets

Exforge HCT combines three antihypertensive agents with complementary mechanisms to control blood pressure:
1. Amlodipine: 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 a reduction in peripheral vascular resistance, thereby lowering blood pressure.
2. Valsartan: 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 inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced aldosterone secretion, and decreased sodium and water reabsorption, thus lowering blood pressure.
3. Hydrochlorothiazide (HCTZ): A thiazide diuretic that inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water. This reduces plasma volume and peripheral vascular resistance, contributing to its antihypertensive effect.

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 medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe nausea or vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, pale stools, vomiting, or yellowing of the skin or eyes.
Muscle spasms.
New or worsening chest pain.
Restlessness.
Swelling in the arms or legs.
Stiff muscles, shakiness, or abnormal muscle movements.
Eye problems, such as changes in vision or eye pain, which can occur within hours to weeks of starting this medication and may lead to permanent vision loss if left untreated.

Important Skin Cancer Warning

Rarely, people taking hydrochlorothiazide have developed certain types of skin cancer. To minimize your risk, protect your skin from the sun and follow your doctor's instructions for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people experience none or only mild symptoms. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Dizziness, fatigue, or weakness.
Headache.
Upset stomach.
* Back pain.

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. Describe the allergic reaction you experienced, including the symptoms that occurred.
A known sulfa allergy.
Current use of dofetilide.
Presence of kidney disease or liver disease.
Inability to urinate.
Use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
* Breastfeeding status, 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 determine the safety of taking this medication with your other drugs and health problems. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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

Precautions and Warnings

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 position and exercise caution when climbing stairs.
If you have diabetes, closely monitor your blood sugar levels as directed by your healthcare provider.
Regularly check your blood pressure as instructed by your healthcare provider.
Have blood work done as directed by your doctor and discuss the results with them.
Be aware that this medication may affect certain laboratory tests. Inform all healthcare providers and laboratory personnel that you are taking this medication.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor.
If you are on a low-salt or salt-free diet, discuss this with your doctor.

Potential Side Effects and Interactions

It may take several weeks to experience the full effects of this medication.
Although rare, new or worsening chest pain can occur after starting or increasing the dose of this medication, which may increase the risk of heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk 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.
Discuss the use of alcohol, marijuana or other forms of cannabis, and prescription or OTC medications that may cause drowsiness with your doctor.
Exercise caution in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.
Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these symptoms may lead to low blood pressure.

Special Considerations

If you take cholestyramine or colestipol, consult with your pharmacist about how to take these medications with this drug, and be aware of the potential for gout attacks.
If you have lupus, this medication may cause your condition to become active or worsen. Inform your doctor immediately if you experience any new or worsening symptoms.
Liver problems have been associated with this medication, and in some cases, hospitalization has been necessary. Discuss this risk with your doctor.
If you are 65 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) due to increased risk of hyperkalemia, hypotension, and renal impairment (Valsartan component).
• Anuria (Hydrochlorothiazide component).

• Lithium (increased serum lithium levels and toxicity due to HCTZ and Valsartan).
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium (increased risk of hyperkalemia with Valsartan).
• NSAIDs, including selective COX-2 inhibitors (may reduce antihypertensive effect of Valsartan and HCTZ, and increase risk of renal impairment).
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (may increase amlodipine exposure, leading to increased risk of hypotension and edema).
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) (may decrease amlodipine exposure, leading to reduced efficacy).
• Other antihypertensive agents (additive hypotensive effects).

• Corticosteroids, ACTH (may intensify electrolyte depletion, particularly hypokalemia, with HCTZ).
• Cholestyramine and colestipol resins (may impair absorption of HCTZ).
• Antidiabetic drugs (oral agents and insulin) (HCTZ may decrease glucose tolerance, requiring dosage adjustment of antidiabetic drugs).
• Digitalis glycosides (hypokalemia/hypomagnesemia from HCTZ may predispose to digitalis toxicity).
• Muscle relaxants, non-depolarizing (e.g., tubocurarine) (HCTZ may potentiate their effect).
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ).

• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension with HCTZ).

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Peripheral edema (swelling of ankles/feet)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Unusual thirst or dry mouth (signs of dehydration/electrolyte imbalance)
• Signs of hyperkalemia (e.g., palpitations, muscle weakness)
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing/swallowing) - rare but serious.

CONTRAINDICATED. Exforge HCT can cause injury and death to the developing fetus when administered to pregnant women. If pregnancy is detected, discontinue Exforge HCT as soon as possible. There are no adequate and well-controlled studies of Exforge HCT in pregnant women.

Not recommended. Hydrochlorothiazide is excreted in human milk. It is not known whether valsartan or amlodipine are excreted in human milk. Due to the potential for adverse effects on the nursing 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 in pediatric patients have not been established. Use is not recommended.

No overall differences in effectiveness or safety were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses of individual components if appropriate, and monitor renal function and electrolytes closely due to increased susceptibility to adverse effects and comorbidities.

• Exforge HCT is a triple combination therapy, typically reserved for patients whose blood pressure is not adequately controlled with dual therapy or who are already on the individual components.
• Due to the valsartan component, it carries a Black Box Warning for fetal toxicity; it must be discontinued immediately if pregnancy is detected.
• Monitor serum electrolytes (especially potassium and sodium) and renal function (creatinine, eGFR) regularly, particularly after initiation or dose changes, due to the effects of both valsartan and hydrochlorothiazide.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, although this is rare with ARBs compared to ACE inhibitors.
• Amlodipine can cause peripheral edema, which is a common side effect. This may be less pronounced in combination with a diuretic like HCTZ.
• Advise patients to avoid potassium supplements or salt substitutes unless directed by a healthcare professional, due to the risk of hyperkalemia with valsartan.

• Single-agent antihypertensives from different classes (e.g., ACE inhibitors, beta-blockers, other diuretics, other CCBs)
• Dual-therapy combinations (e.g., ACEI/diuretic, ARB/diuretic, CCB/ACEI, CCB/ARB)
• Lifestyle modifications (diet, exercise, weight management, stress reduction).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 for more information. If you have any questions or concerns about this 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.