Candesartan HCT 32-25mg Tablets

Candesartan cilexetil is a prodrug that is rapidly converted to candesartan during absorption from the gastrointestinal tract. Candesartan is an angiotensin II receptor blocker (ARB) that selectively blocks the binding of angiotensin II to the AT1 receptor in many tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased peripheral resistance, and reduced blood pressure. Hydrochlorothiazide is a thiazide diuretic that 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. The combination provides additive antihypertensive effects.

Serious 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 immediately or seek medical attention:

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
+ A big weight gain
Signs of lupus, such as:
+ A rash on the cheeks or other body parts
+ Sunburn easy
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Eye problems, which can lead to lasting eyesight loss if left untreated. If you experience any of the following symptoms, contact your doctor right away:
+ Change in eyesight
+ Eye pain (usually occurring 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 as directed 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 Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

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. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Current treatment with dofetilide.
Inability to urinate.
Kidney disease or kidney problems.
High calcium levels in your blood.
* Use of a medication containing aliskiren, especially if you have diabetes or kidney problems.

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

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues, to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose 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 down 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 recommended.

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 Safe in Hot Weather
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 reactivate or worsen your condition. Inform your doctor immediately if you experience any new or worsening symptoms. It may take up to 1 month to feel the full effects of this medication.

• Aliskiren (in patients with diabetes or moderate-to-severe renal impairment)
• Concomitant use with ACE inhibitors or other ARBs (in patients with diabetic nephropathy)

• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors) (reduced antihypertensive effect, increased risk of renal impairment, hyperkalemia)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) (increased risk of hyperkalemia)
• Potassium supplements (increased risk of hyperkalemia)
• Other antihypertensive agents (additive hypotensive effects)
• Drugs that cause hyperkalemia (e.g., trimethoprim, cyclosporine, heparin)
• Digitalis glycosides (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia from HCTZ)
• Corticosteroids, ACTH (enhanced electrolyte depletion, particularly hypokalemia)
• Antidiabetic agents (oral agents and insulin) (HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents)

• Cholestyramine, Colestipol (reduced absorption of HCTZ)
• Pressor amines (e.g., norepinephrine) (HCTZ may decrease arterial responsiveness to pressor amines)
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) (HCTZ may potentiate their effect)
• Barbiturates, Narcotics, Alcohol (may potentiate orthostatic hypotension)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels due to decreased excretion by HCTZ)
• Cyclosporine (increased risk of hyperuricemia and gouty complications with HCTZ)

• None specifically categorized as minor with significant clinical impact for this combination beyond general caution.

• Dizziness or lightheadedness (especially upon standing)
• Excessive fatigue or weakness
• Muscle cramps or weakness
• Nausea or vomiting
• Dry mouth, increased thirst
• Swelling of face, lips, tongue, or throat (signs of angioedema)
• Difficulty breathing or swallowing
• Signs of dehydration (e.g., decreased urination, severe dry mouth)
• Symptoms of gout (joint pain, swelling)

Contraindicated during pregnancy. Candesartan, an ARB, can cause fetal injury and death when administered to pregnant women. Hydrochlorothiazide can cross the placental barrier and may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions.

Not recommended during breastfeeding. Candesartan is excreted in the milk of lactating rats, and it is unknown if it is 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, 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. Use is generally not recommended.

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to volume depletion and electrolyte imbalances (especially hypokalemia) with hydrochlorothiazide. Renal function should be monitored closely, and lower initial doses may be considered.

• This combination is particularly useful for patients whose blood pressure is not adequately controlled with monotherapy (either an ARB or a thiazide diuretic alone).
• Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a rare but serious side effect.
• Educate patients on the importance of regular blood pressure monitoring and adherence to medication, even if asymptomatic.
• Caution patients about orthostatic hypotension, especially at the start of therapy, with dose increases, or when standing up quickly.
• Remind patients that this medication is not a cure for high blood pressure but helps manage it. Lifestyle modifications remain crucial.
• Monitor for signs of electrolyte imbalance, particularly hypokalemia (muscle cramps, weakness) and hyperkalemia (fatigue, weakness, irregular heartbeat), and hyponatremia (nausea, headache, confusion).

• Other classes of antihypertensives (e.g., ACE inhibitors, Calcium Channel Blockers, Beta-blockers, other diuretics)
• Monotherapy with Candesartan or Hydrochlorothiazide if blood pressure is adequately controlled.

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take medication prescribed to someone else. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 detailed information, including the name of the medication taken, the amount, and the time it occurred.