Exforge HCT 5-160-12.5mg Tablets

Exforge HCT combines three antihypertensive agents with complementary mechanisms to lower blood pressure: Amlodipine (a dihydropyridine calcium channel blocker) inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing peripheral arterial vasodilation and reduction in peripheral vascular resistance. Valsartan (an angiotensin II receptor blocker) selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland, inhibiting the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide (a thiazide diuretic) inhibits sodium reabsorption in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, and to a lesser extent, potassium and magnesium.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or throwing up
Signs of kidney problems, including:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Significant weight gain
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Throwing up
+ Yellow skin or eyes
Muscle spasm
Chest pain that is new or worsening
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 lead to permanent vision loss if left untreated. If you experience any eye problems, contact your doctor right away.

Rare but Serious Side Effects

Rarely, people taking hydrochlorothiazide may develop 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 Side Effects

Most people do not experience serious side effects, and many have only minor or no side effects at all. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling dizzy, tired, or weak
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. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Current or planned 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 issues with your doctor and pharmacist. They will help determine the safety of taking this medication with your other drugs and health conditions. Never start, stop, or adjust the dose 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.

Caution with Daily Activities

Until you understand how this medication affects you, avoid driving and other tasks that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Monitoring Your Condition

If you have diabetes, closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider, and undergo blood tests as scheduled. Be aware that this medication may interfere with certain laboratory tests, so inform all healthcare providers and lab personnel that you are taking this medication.

Interactions with Other Substances

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

Potential Side Effects and Risks

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.

Over-the-Counter Products and Substances

Before using over-the-counter 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, or certain natural products, consult with your doctor. Also, discuss the use of alcohol, marijuana or other cannabis products, or prescription and over-the-counter medications that may cause drowsiness with your doctor.

Precautions in Hot Weather and with Physical Activity

Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to low blood pressure.

Interactions with Other Medications

If you take cholestyramine or colestipol, consult with your pharmacist about how to take these medications with your current medication. Be aware of the potential for gout attacks.

Special Considerations

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.

Use in Older Adults

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)
• Potassium supplements or potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) in combination with valsartan
• Lithium (due to increased lithium toxicity with HCTZ and valsartan)

• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment with valsartan and HCTZ
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) - may increase amlodipine exposure
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - may decrease amlodipine exposure
• Other antihypertensive agents - additive hypotensive effects
• Digoxin - increased risk of digitalis toxicity with HCTZ (due to hypokalemia)
• Corticosteroids - enhanced electrolyte depletion, particularly hypokalemia with HCTZ
• Cholestyramine and colestipol resins - may impair absorption of HCTZ

• Alcohol - additive hypotensive effects
• Barbiturates, narcotics - additive hypotensive effects
• Insulin and oral antidiabetic agents - HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents
• Non-depolarizing skeletal muscle relaxants - HCTZ may potentiate their effect
• Pressor amines (e.g., norepinephrine) - HCTZ may decrease arterial responsiveness
• Allopurinol - increased risk of hypersensitivity reactions with HCTZ
• Calcium salts - increased serum calcium levels with HCTZ
• Cyclosporine - increased risk of hyperuricemia and gout with HCTZ
• Grapefruit juice - may increase amlodipine exposure

• Antacids - may decrease absorption of HCTZ (separate administration)
• Food - generally not clinically significant, but valsartan absorption is reduced

• Dizziness or lightheadedness (especially upon standing)
• Swelling of ankles, feet, or hands (peripheral edema)
• Unusual fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Excessive thirst or dry mouth
• Nausea or vomiting
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing)
• Changes in urination (frequency, volume)
• Chest pain or palpitations

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

Not recommended. Amlodipine, valsartan, and hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., hypotension, hyperkalemia, electrolyte disturbances), 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 this population.

No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully, monitoring renal function and electrolytes closely due to increased susceptibility to adverse effects and potential for polypharmacy.

• Exforge HCT is a fixed-dose combination and should not be used for initial therapy of hypertension. It is intended for patients whose blood pressure is not adequately controlled on dual therapy or for whom triple therapy is appropriate.
• Monitor for signs of angioedema, especially in patients with a history of angioedema with ACE inhibitors or ARBs.
• Patients should be advised to report any symptoms of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat).
• Due to the hydrochlorothiazide component, monitor for hyperuricemia and hyperglycemia, especially in patients with a history of gout or diabetes.
• Peripheral edema is a common side effect of amlodipine; it may be less pronounced in combination with an ARB like valsartan.
• Counsel patients on the importance of adherence and lifestyle modifications (diet, exercise) for optimal blood pressure control.

• Individual components (Amlodipine, Valsartan, Hydrochlorothiazide) taken separately
• Other classes of antihypertensives (e.g., ACE inhibitors, Beta-blockers, Alpha-blockers, direct vasodilators)
• Dual therapy combinations (e.g., ARB + CCB, ARB + Diuretic, ACEI + Diuretic)

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 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.