Atacand HCT 16-12.5mg Tablets

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 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 that inhibits the reabsorption of sodium and chloride ions in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water, as well as potassium and magnesium. This reduces plasma volume and peripheral vascular resistance.

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
+ 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 occurs within hours to weeks of starting this medication)
Rarely, certain types of skin cancer have occurred 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:
- A change in color or size of a mole
- Any new or changing skin lump or growth

Other Side Effects

Most people do not experience serious side effects, and some may only have minor side effects. However, 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 attention:

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 symptoms you experienced.
A known sulfa allergy.
Current treatment with dofetilide.
Inability to urinate.
Pre-existing kidney disease.
Elevated calcium levels.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Breast-feeding or plans to breast-feed.

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 if it is safe to take 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, rise slowly from a sitting or lying position. 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. Monitor your blood pressure as directed by your doctor. Additionally, follow your doctor's instructions for regular blood work and lab tests.

Potential Effects on Cholesterol and Triglycerides
This medication may cause elevated cholesterol and triglyceride levels. Discuss this with your doctor.

Lab Tests and Interactions
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication. If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.

Dietary Considerations
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.

Interactions with Other Substances
Before using alcohol, marijuana, or other forms of cannabis, or prescription or OTC medications that may slow your actions, consult your doctor.

Precautions in Hot Weather
Be cautious in hot weather or during physical activity. 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.

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

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

• Aliskiren (in patients with diabetes or moderate to severe renal impairment)

• Lithium (increased serum lithium concentrations and toxicity)
• NSAIDs (including selective COX-2 inhibitors - may reduce antihypertensive effect and increase risk of renal impairment)
• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Other antihypertensive agents (additive hypotensive effect)
• Digoxin (increased risk of digitalis toxicity with hypokalemia/hypomagnesemia from HCTZ)

• Corticosteroids (may antagonize the diuretic and antihypertensive effects of HCTZ)
• Pressor amines (e.g., norepinephrine - HCTZ may decrease arterial responsiveness)
• Antidiabetic agents (oral agents and insulin - HCTZ may increase blood glucose levels, requiring dose adjustment)
• Cholestyramine and colestipol resins (may impair absorption of HCTZ)
• Muscle relaxants, non-depolarizing (e.g., tubocurarine - HCTZ may potentiate their effect)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Calcium salts (increased serum calcium levels due to decreased excretion by HCTZ)

• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)

• Dizziness or lightheadedness (especially upon standing)
• Fatigue or weakness
• Muscle cramps or weakness (signs of electrolyte imbalance)
• Excessive thirst or dry mouth (signs of dehydration)
• Swelling of face, lips, tongue, or throat (signs of angioedema - rare but serious)
• Persistent cough (less common with ARBs than ACEIs, but possible)
• Unusual bleeding or bruising (rare, but HCTZ can affect platelets)
• Yellowing of skin or eyes (jaundice, rare liver issue)

Contraindicated. Atacand HCT can cause injury and death to the developing fetus when administered to pregnant women. If pregnancy is detected, discontinue Atacand HCT as soon as possible.

Not recommended. Both candesartan and hydrochlorothiazide are excreted in breast milk. Due to the potential for adverse effects on the nursing infant (e.g., hypotension, hyperkalemia, and potential for decreased milk production with HCTZ), 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. 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 titrate carefully, monitoring renal function and electrolytes closely, as elderly patients are more likely to have impaired renal function.

• Atacand 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 for signs of angioedema (swelling of face, lips, tongue, throat), though less common with ARBs than ACE inhibitors.
• Patients should be advised to report any symptoms of dizziness or lightheadedness, especially during the first few days of therapy or with dose increases.
• Hydrochlorothiazide can cause photosensitivity reactions; advise patients to use sunscreen and protective clothing.
• Thiazide diuretics can exacerbate or activate systemic lupus erythematosus.
• Patients with a history of gout should be monitored closely due to the hyperuricemic effect of HCTZ.

• Other classes of antihypertensives (e.g., ACE inhibitors, Beta-blockers, Calcium Channel Blockers, other diuretics)
• Monotherapy with Candesartan (Atacand) or Hydrochlorothiazide

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it is a good idea to check with your pharmacist. If you have any questions or concerns about this 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.