Exforge HCT 5-160-25mg Tablets

Exforge HCT combines three antihypertensive agents with complementary mechanisms of action to control blood pressure: Amlodipine, a dihydropyridine calcium channel blocker (CCB); Valsartan, an angiotensin II receptor blocker (ARB); and Hydrochlorothiazide (HCTZ), a thiazide diuretic.
- Amlodipine: Inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells. This leads to peripheral arterial vasodilation and a 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 inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, reduced aldosterone secretion, and decreased sodium and water reabsorption.
- Hydrochlorothiazide: A thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule of the nephron. This increases the excretion of sodium, chloride, and water, leading to a reduction in plasma volume and, consequently, blood pressure.

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
+ 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 vomiting
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
+ Vomiting
+ Yellow 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 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. Be sure to describe the allergic reaction you experienced.
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 if it is safe to take this medication with your other drugs and health issues. 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 (high blood sugar), closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider, and undergo blood tests as scheduled. Discuss your test results with your doctor.

Interactions with Other Substances
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. If you are using 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 Cardiovascular Risks
Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose. In some cases, heart attack may also occur, particularly in individuals with severe heart blood vessel disease. Discuss these risks with your doctor.

Over-the-Counter (OTC) Products and Other Substances
Before using 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, or certain natural products, consult your doctor. Also, discuss the use of alcohol, marijuana or other forms of cannabis, or prescription or OTC 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 conditions may lead to low blood pressure.

Interactions with Other Medications
If you take cholestyramine or colestipol, consult your pharmacist about the proper administration of 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 may be necessary. Discuss these risks with your doctor.

Age-Related Precautions
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 due to increased risk of hyperkalemia, hypotension, and renal impairment)
• Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium (increased risk of hyperkalemia with valsartan)
• Lithium (increased serum lithium concentrations and toxicity with HCTZ and valsartan)

• NSAIDs (including COX-2 inhibitors): May reduce the diuretic, natriuretic, and antihypertensive effects of HCTZ and ARBs. May worsen renal function, especially in elderly, volume-depleted, or renally impaired patients.
• Other antihypertensive agents: Additive hypotensive effects.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase amlodipine exposure, leading to increased risk of hypotension.
• CYP3A4 inducers (e.g., rifampin, St. John's Wort): May decrease amlodipine exposure, leading to reduced efficacy.
• Angiotensin-converting enzyme (ACE) inhibitors: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) with ARBs is not recommended due to increased risk of hypotension, hyperkalemia, and renal impairment.

• Antidiabetic agents (oral agents and insulin): HCTZ may decrease the hypoglycemic effect of these agents; dosage adjustment may be required.
• Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, with HCTZ.
• Cholestyramine and colestipol resins: May impair the absorption of HCTZ.
• Digitalis glycosides: Hypokalemia or hypomagnesemia induced by HCTZ may predispose to digitalis toxicity.
• Muscle relaxants, non-depolarizing (e.g., tubocurarine): HCTZ may potentiate the effect of these agents.
• Allopurinol: Increased risk of hypersensitivity reactions to allopurinol with HCTZ.
• Amantadine: Increased risk of adverse effects of amantadine with HCTZ.
• Pressor amines (e.g., norepinephrine): Decreased arterial responsiveness to pressor amines with HCTZ.

• Alcohol, barbiturates, or narcotics: May potentiate orthostatic hypotension with HCTZ.
• Calcium salts: Increased serum calcium levels due to decreased excretion by HCTZ.

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Swelling in ankles, feet, or hands (edema)
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Excessive thirst or dry mouth (signs of dehydration/electrolyte imbalance)
• Unusual weight gain or swelling (fluid retention)
• Shortness of breath
• Chest pain
• Signs of allergic reaction (rash, itching, swelling of face/lips/tongue/throat)
• Signs of liver problems (yellowing of skin/eyes, dark urine, persistent nausea/vomiting)

Contraindicated during the second and third trimesters of pregnancy due to the valsartan component, which can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected. First trimester exposure risk is less clear but still generally advised against.

Not recommended during breastfeeding. Amlodipine is present in human milk, and hydrochlorothiazide is excreted in human milk and can suppress lactation. Valsartan is likely excreted in human milk. Due to the potential for serious adverse reactions in the breastfed 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. Not recommended for use in children.

No overall differences in safety or effectiveness were observed between elderly patients (65 years and older) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully, monitoring for hypotension and renal function.

• Exforge HCT is a fixed-dose combination and should not be used for initial therapy in patients who are not already on the individual components or who require significant dose titration of one component.
• Monitor for signs of angioedema (swelling of face, lips, tongue, throat) which, though rare with ARBs, can be life-threatening.
• Advise patients to avoid grapefruit and grapefruit juice due to interaction with amlodipine.
• Educate patients on the importance of regular blood pressure monitoring and adherence to therapy.
• Be mindful of potential electrolyte imbalances (hypokalemia, hyponatremia, hypercalcemia, hypomagnesemia) due to the hydrochlorothiazide component, especially in patients with pre-existing conditions or on interacting medications.
• Caution in patients with severe aortic stenosis (amlodipine) or bilateral renal artery stenosis (valsartan) due to risk of hypotension or worsening renal function, respectively.
• Patients should be advised to report any signs of skin cancer, as hydrochlorothiazide has been associated with an increased risk of non-melanoma skin cancer (NMSC).

• ACE inhibitors (e.g., Lisinopril)
• Beta-blockers (e.g., Metoprolol)
• Other Calcium Channel Blockers (e.g., Nifedipine, Diltiazem)
• Other Diuretics (e.g., Furosemide, Chlorthalidone)
• Alpha-blockers (e.g., Doxazosin)
• Direct Renin Inhibitors (e.g., Aliskiren)

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 details. 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 information about the medication taken, the amount, and the time it occurred.