Exforge HCT 10-320-25mg Tablets

Exforge HCT combines three antihypertensive agents with complementary mechanisms of action to control blood pressure.
* **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.
* **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.
* **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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Confusion or feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or breath that smells like fruit
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Changes in urine output or dry mouth
+ Dry eyes or severe nausea and vomiting
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or stomach pain
+ Upset stomach or vomiting
+ Light-colored stools or yellow skin and 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 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 recommendations 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. While many people experience no side effects or only mild 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, tiredness, or weakness
Headache
Upset stomach
* Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, 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 affect certain laboratory tests, so inform all your healthcare providers and lab personnel that you are taking this drug.

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

Potential Side Effects
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 your doctor. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness with your doctor.

Heat and Fluid Loss
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 your pharmacist about how to take these medications with this drug. Be aware of the potential for gout attacks.

Special Considerations
If you have lupus, this medication may exacerbate your condition. Inform your doctor immediately if you experience new or worsening symptoms. Liver problems have been associated with this medication, and in some cases, hospitalization has been required. Discuss this risk with your doctor.

Age-Related Considerations
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 moderate to severe renal impairment (CrCl < 60 mL/min/1.73 m2) due to increased risk of hypotension, hyperkalemia, and renal impairment.
• Concomitant use with sacubitril/valsartan (Entresto) due to increased risk of angioedema (do not administer within 36 hours of switching from or to an ACE inhibitor).

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium: Increased risk of hyperkalemia due to valsartan.
• Lithium: Increased serum lithium concentrations and toxicity due to HCTZ and valsartan (reduced renal clearance).
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including COX-2 inhibitors: May attenuate the antihypertensive effect of valsartan and HCTZ, and increase the risk of renal function deterioration, including possible acute renal failure, especially in elderly, volume-depleted, or renally impaired patients.
• 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.
• Dofetilide: Increased risk of dofetilide-induced arrhythmias due to HCTZ-induced hypokalemia.

• Antidiabetic agents (oral agents and insulin): HCTZ may decrease the hypoglycemic effect; dosage adjustment of antidiabetic agent may be required.
• Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, due to HCTZ.
• Cholestyramine and colestipol resins: May impair absorption of HCTZ.
• Digoxin: HCTZ-induced hypokalemia or hypomagnesemia may predispose to digitalis toxicity.
• Muscle relaxants, non-depolarizing (e.g., tubocurarine): HCTZ may potentiate their effect.
• Pressor amines (e.g., norepinephrine): Possible decreased response to pressor amines due to HCTZ.
• Allopurinol: Increased risk of hypersensitivity reactions to allopurinol with HCTZ.
• Calcium salts: Increased serum calcium levels due to HCTZ (decreased excretion).

• Alcohol, barbiturates, or narcotics: May potentiate orthostatic hypotension.
• Other antihypertensive agents: Additive hypotensive effect.

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Swelling in ankles, feet, or hands (edema, common with amlodipine)
• Unusual fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance, especially hypokalemia)
• Excessive thirst or dry mouth (signs of dehydration or electrolyte imbalance)
• Shortness of breath or chest pain (rare, but serious cardiovascular symptoms)
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing or swallowing - rare but serious with ARBs)
• Symptoms of hyperkalemia (e.g., palpitations, muscle weakness, fatigue)
• Symptoms of gout (joint pain, swelling, redness)

Contraindicated during pregnancy. Exforge HCT can cause fetal harm when administered to a pregnant woman. Drugs that act directly on the renin-angiotensin system (like valsartan) can cause injury and death to the developing fetus. If pregnancy is detected, discontinue Exforge HCT as soon as possible.

Use with caution. It is not known if amlodipine or valsartan are excreted in human milk. Hydrochlorothiazide is excreted in human milk and can suppress lactation. Due to the potential for serious adverse reactions in breastfed infants, including hypotension and electrolyte disturbances, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.

No overall differences in effectiveness or safety were observed between elderly patients (65 years and older) and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to the hypotensive effects of amlodipine and the electrolyte imbalances (especially hypokalemia) and renal effects of HCTZ. Renal function should be monitored closely.

• Exforge HCT 10-320-25mg is a high-dose triple combination therapy, typically reserved for patients whose blood pressure is not adequately controlled on dual therapy or lower doses of the components.
• Due to the valsartan component, it carries a black box warning for fetal toxicity and is contraindicated in pregnancy.
• Careful monitoring of serum electrolytes (especially potassium, sodium) and renal function (BUN, creatinine) is crucial, particularly at initiation and with dose changes, due to the combined effects of valsartan (hyperkalemia risk) and HCTZ (hypokalemia, hyponatremia, renal impairment risk).
• Amlodipine commonly causes peripheral edema, which may be less pronounced in combination with a diuretic like HCTZ, but patients should still be monitored for this side effect.
• Patients should be advised to avoid potassium supplements or salt substitutes unless directed by a physician.
• Orthostatic hypotension can occur, especially at the start of therapy or with dose increases; advise patients to rise slowly from a sitting or lying position.

• Other classes of antihypertensives (e.g., ACE inhibitors, beta-blockers, other diuretics, other calcium channel blockers)
• Dual combination therapies (e.g., ARB + CCB, ARB + diuretic, CCB + diuretic)
• Individual monotherapy agents (amlodipine, valsartan, hydrochlorothiazide) titrated separately.

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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.