Candesartan HCT 16-12.5mg Tablets

Candesartan is an angiotensin II receptor blocker (ARB). It selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced sodium and water reabsorption. Hydrochlorothiazide is a thiazide diuretic. It acts on the distal convoluted tubule of the kidney to inhibit the reabsorption of sodium and chloride ions. This increases the excretion of sodium, chloride, and water, leading to a reduction in plasma volume and blood pressure. It also increases potassium and magnesium excretion and decreases calcium excretion.

Urgent Side Effects: Seek Medical Attention 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 help 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 lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Eye problems, which can lead to permanent vision loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:
+ Change in vision
+ Eye pain
+ These symptoms usually occur within hours to weeks of starting this medication
Rarely, certain types of skin cancer have been reported in people taking hydrochlorothiazide. To minimize your risk:
+ Protect your skin from the sun
+ Have your skin checked regularly as advised by your doctor
+ Contact your doctor immediately if you notice any changes in the color or size of a mole, or any new or changing skin lump or growth

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms or any other side effects that bother you or do not go away, contact your doctor or seek medical help:

Signs of a common cold
Back pain
Flu-like symptoms
* Dizziness

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 conditions to ensure safe treatment:

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 treatment with dofetilide.
Inability to urinate.
Kidney disease.
Elevated calcium levels.
* Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.

Additionally, if you are breast-feeding or plan to breast-feed, discuss this with your doctor.

This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health conditions. 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, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Managing Diabetes and Blood Pressure
If you have diabetes, this medication may increase your blood sugar levels. Consult your doctor about maintaining control over your blood sugar. Additionally, monitor your blood pressure as directed by your doctor, and undergo regular blood tests and other laboratory tests as advised.

Potential Side Effects
This medication may cause elevated cholesterol and triglyceride levels. Discuss this with your doctor. It may also affect certain laboratory test results, so inform all your healthcare providers and laboratory personnel that you are taking this medication.

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

Precautions with Other Medications and Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or OTC medications that may slow your reactions, consult your doctor.

Staying Hydrated
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 are taking cholestyramine or colestipol, consult your pharmacist about how to take these medications with this drug. Be aware of the potential for gout attacks.

Lupus Considerations
If you have lupus, this medication may reactivate or worsen the condition. Inform your doctor immediately if you experience any new or worsening symptoms.

Timeline for Full Effect
It may take approximately one month to experience the full effects of this medication.

• Aliskiren (in patients with diabetes or renal impairment)
• ACE inhibitors (increased risk of hyperkalemia, hypotension, renal impairment)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Lithium (reduced renal clearance of lithium, leading to increased lithium levels and toxicity)
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib) (attenuation of antihypertensive effect, increased risk of renal impairment, especially in dehydrated or elderly patients)
• Barbiturates, narcotics, alcohol (additive orthostatic hypotension)
• Corticosteroids, ACTH (intensified electrolyte depletion, particularly hypokalemia)
• Digitalis glycosides (hypokalemia/hypomagnesemia may predispose to digitalis toxicity)
• Non-depolarizing skeletal muscle relaxants (e.g., tubocurarine) (potentiated effect)

• Antidiabetic agents (insulin, oral hypoglycemics) (thiazides may decrease glucose tolerance, requiring dose adjustment)
• Cholestyramine, colestipol (may impair absorption of hydrochlorothiazide)
• Pressor amines (e.g., norepinephrine) (possible decreased response to pressor amines)
• Allopurinol (increased risk of hypersensitivity reactions to allopurinol)
• Calcium salts (increased serum calcium levels due to decreased excretion)
• Cyclosporine (increased risk of hyperuricemia and gouty complications)
• Diazoxide (enhanced hyperglycemic and antihypertensive effects)
• Methyldopa (isolated reports of hemolytic anemia)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Irregular heartbeat (palpitations)
• Swelling in ankles, feet, or hands (edema)
• Persistent dry cough (less common with ARBs than ACEIs, but still monitor)
• Signs of allergic reaction (rash, itching, swelling of face/lips/tongue, difficulty breathing)
• Signs of dehydration (excessive thirst, dry mouth, decreased urination)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death. Discontinue as soon as pregnancy is detected. First trimester exposure should be avoided if possible, though risks are less clear.

Not recommended during breastfeeding. Both candesartan and hydrochlorothiazide are excreted in breast milk. Hydrochlorothiazide can reduce milk production. Potential for serious adverse effects in the infant.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

No overall differences in efficacy or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and monitor renal function and electrolytes closely due to increased susceptibility to volume depletion and electrolyte imbalances.

• Candesartan HCT is a fixed-dose combination and should not be used for initial therapy unless the patient has already been stabilized on the individual components.
• Monitor blood pressure regularly, especially after initiation or dose changes, to ensure adequate control and avoid hypotension.
• Electrolyte monitoring (especially potassium and sodium) is crucial due to the diuretic component, which can cause hypokalemia, and the ARB component, which can cause hyperkalemia. The combination may balance these effects, but imbalances can still occur.
• Advise patients to report any signs of dizziness, fainting, or muscle weakness, which could indicate hypotension or electrolyte disturbances.
• Avoid concomitant use with potassium supplements or potassium-sparing diuretics unless serum potassium is closely monitored.
• Patients with severe renal impairment (CrCl < 30 mL/min) should not use this combination due to the hydrochlorothiazide component.
• Educate female patients of childbearing potential about the severe fetal toxicity risk and the need to discontinue the drug immediately if pregnancy is detected.

• ACE inhibitors (e.g., Lisinopril, Enalapril)
• Calcium Channel Blockers (e.g., Amlodipine, Nifedipine)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Other diuretics (e.g., Loop diuretics like Furosemide, Potassium-sparing diuretics like Spironolactone)
• 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 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.