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Candesartan cilexetil/Hydrochlorothiazide
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- Active ingredients
- Candesartan Cilexetil 16–32 mg
- Hydrochlorothiazide 12.5–25 mg
- Other brand names
- Atacand Hct (by Ani Pharmaceuticals, Inc.)
- Candesartan Cilexetil and Hydrochlorothiazide (by Ani Pharmaceuticals, Inc.)
- Candesartan Cilexetil and Hydrochlorothiazide (by Macleods Pharmaceuticals Limited)
- Candesartan Cilexetil and Hydrochlorothiazide (by Mylan Pharmaceuticals Inc.)
- Candesartan Cilexetil and Hydrochlorothiazide (by Solco Healthcare Llc)
- View full label-group details →
- Drug classes
- Angiotensin 2 Receptor Blocker, Thiazide Diuretic
- Dosage form
- Tablet
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2018
- Label revision date
- November 11, 2024
- FDA Insert
- Prescribing information, PDF file
- Active ingredients
- Candesartan Cilexetil 16–32 mg
- Hydrochlorothiazide 12.5–25 mg
- Other brand names
- Atacand Hct (by Ani Pharmaceuticals, Inc.)
- Candesartan Cilexetil and Hydrochlorothiazide (by Ani Pharmaceuticals, Inc.)
- Candesartan Cilexetil and Hydrochlorothiazide (by Macleods Pharmaceuticals Limited)
- Candesartan Cilexetil and Hydrochlorothiazide (by Mylan Pharmaceuticals Inc.)
- Candesartan Cilexetil and Hydrochlorothiazide (by Solco Healthcare Llc)
- View full label-group details →
- Drug classes
- Angiotensin 2 Receptor Blocker, Thiazide Diuretic
- Dosage form
- Tablet
- Route
- Oral
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2018
- Label revision date
- November 11, 2024
- Manufacturer
- Zydus Lifesciences Limited
- Registration number
- ANDA203466
- NDC roots
- 70771-1325, 70771-1326, 70771-1327
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Candesartan Cilexetil and Hydrochlorothiazide Tablets are a combination medication used primarily to treat high blood pressure (hypertension). Candesartan cilexetil is an angiotensin II receptor blocker, which helps relax blood vessels, making it easier for your heart to pump blood. Hydrochlorothiazide is a diuretic (often referred to as a "water pill") that helps your body get rid of excess salt and water, further aiding in lowering blood pressure.
This medication is available in several formulations, including 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg, all packaged in bottles containing 1000 tablets. By combining these two active ingredients, Candesartan Cilexetil and Hydrochlorothiazide work together to effectively manage your blood pressure and improve overall heart health.
Uses
Candesartan Cilexetil and Hydrochlorothiazide Tablets are primarily used to help manage high blood pressure, also known as hypertension. By lowering your blood pressure, these tablets can help reduce the risk of serious health issues, such as heart attacks and strokes.
If you have any questions about how this medication works or its benefits, be sure to discuss them with your healthcare provider. They can provide you with more information tailored to your specific health needs.
Dosage and Administration
You will take Candesartan Cilexetil and Hydrochlorothiazide tablets by mouth (oral administration). These tablets come in different strengths: 16 mg of Candesartan Cilexetil with 12.5 mg of Hydrochlorothiazide, 32 mg of Candesartan Cilexetil with 12.5 mg of Hydrochlorothiazide, and 32 mg of Candesartan Cilexetil with 25 mg of Hydrochlorothiazide.
Make sure to follow your healthcare provider's instructions regarding the specific dosage and frequency that is right for you. Always take the medication as directed to ensure its effectiveness and your safety.
What to Avoid
You should avoid using Candesartan Cilexetil and Hydrochlorothiazide if you have a history of angioedema (swelling caused by fluid buildup) related to previous treatment with an ACE inhibitor or if the cause of your angioedema is unknown. Additionally, do not take this medication if you are allergic to any of its ingredients or if you have anuria, which means you are unable to produce urine.
It's important to note that this medication is not classified as a controlled substance, and there are no specific concerns regarding abuse, misuse, or dependence associated with it. Always consult your healthcare provider if you have any questions or concerns about your treatment.
Side Effects
You may experience some common side effects, including dizziness, fatigue, headache, low blood pressure (hypotension), and high potassium levels (hyperkalemia). More serious reactions can occur, such as swelling of the face or throat (angioedema), kidney or liver problems, severe low blood pressure, and imbalances in electrolytes.
Allergic reactions like rash, itching (pruritus), and hives (urticaria) are also possible. Other side effects may include heart palpitations, rapid heartbeat (tachycardia), nausea, vomiting, diarrhea, and skin sensitivity to sunlight (photosensitivity). In rare cases, there have been reports of acute kidney failure, liver function abnormalities, and pancreatitis. If you notice any concerning symptoms, it's important to consult your healthcare provider.
Warnings and Precautions
While there are no specific warnings or precautions associated with this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or have concerns while using this medication, it's a good idea to consult your doctor for guidance.
Since there are no required lab tests or emergency instructions provided, you can feel reassured that this medication is straightforward in its use. However, if you ever feel uncertain or if your condition changes, don’t hesitate to reach out to your healthcare provider for advice. Your health and safety are paramount.
Overdose
If you suspect an overdose of candesartan cilexetil or hydrochlorothiazide, it's important to be aware of potential symptoms, which may include low blood pressure (hypotension), rapid heart rate (tachycardia), and imbalances in electrolytes (minerals in your body that help regulate various functions).
In the case of hypotension, you should lie down flat (in a supine position) and receive intravenous fluids to help stabilize your condition. There is no specific antidote for an overdose of these medications, so treatment will focus on supportive care and addressing any symptoms that arise. If you notice any signs of overdose or feel unwell, seek immediate medical attention to ensure your safety.
Pregnancy Use
If you are pregnant or planning to become pregnant, it is important to know that Candesartan Cilexetil and Hydrochlorothiazide should not be used during pregnancy. Taking this medication can potentially harm your baby, leading to serious injury or even death. The risks are particularly high if the medication is used during the second and third trimesters, which are the later stages of pregnancy.
To ensure the safety of your pregnancy, it is strongly advised to stop using Candesartan Cilexetil and Hydrochlorothiazide as soon as you find out you are pregnant. Always consult your healthcare provider for guidance on managing your health during this important time.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to know that there are no specific warnings or recommendations regarding the use of Candesartan Cilexetil and Hydrochlorothiazide for nursing mothers. This means that, based on the available information, these medications do not have known risks associated with breastfeeding. However, always consult with your healthcare provider before starting any new medication to ensure it is safe for you and your baby.
Pediatric Use
Candesartan Cilexetil and Hydrochlorothiazide have not been tested for safety and effectiveness in children, meaning that their use in pediatric patients (children and adolescents) has not been established. Because of this lack of information, it is not recommended to use these medications in children. If you are considering treatment options for your child, it's important to discuss alternatives with your healthcare provider.
Geriatric Use
As you age, your body may respond differently to medications like Candesartan Cilexetil and Hydrochlorothiazide. Older adults often have increased sensitivity to these drugs, which means you might experience stronger effects or side effects than younger individuals. Because kidney function can decline with age, your doctor may need to adjust your dosage to ensure it's safe and effective for you.
It's important for you or your caregivers to keep a close eye on how you respond to the medication. Regular check-ups can help your healthcare provider monitor for any adverse effects and determine if any changes to your dosage are necessary. Always communicate openly with your healthcare team about any concerns or symptoms you may experience.
Renal Impairment
If you have kidney problems, it's important to use candesartan cilexetil and hydrochlorothiazide with caution. Your doctor may need to adjust your dosage based on your kidney function, so regular monitoring of your renal health is essential while you are on this medication.
If your creatinine clearance (a measure of how well your kidneys are filtering waste) is less than 30 mL/min, you should not take this combination of medications. Always consult your healthcare provider for guidance tailored to your specific situation.
Hepatic Impairment
If you have liver problems, it's important to know that candesartan cilexetil is mainly processed by your liver. Because of this, you may need a lower dose of this medication to ensure it's safe and effective for you. Your healthcare provider will likely monitor your liver function through specific tests to keep an eye on how well your liver is working while you take this medication.
Please be aware that candesartan cilexetil is not recommended for individuals with severe liver impairment, as it could pose significant risks. Always discuss your liver health with your doctor to determine the best treatment plan for you.
Drug Interactions
It's important to talk to your healthcare provider about all the medications you are taking, including candesartan cilexetil. This medication can interact with other blood pressure medications, potentially leading to a stronger effect on lowering your blood pressure. If you are using non-steroidal anti-inflammatory drugs (NSAIDs), they might lessen the effectiveness of candesartan cilexetil. Additionally, combining this medication with potassium-sparing diuretics, potassium supplements, or other drugs that raise potassium levels can increase the risk of high potassium (hyperkalemia), which can be dangerous.
Candesartan cilexetil can also influence the results of certain lab tests, such as those that check your potassium levels, kidney function, and blood pressure. Always keep your healthcare provider informed about your medications and any lab tests you may need, as this will help ensure your safety and the effectiveness of your treatment.
Storage and Handling
To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F). Make sure to keep the product protected from light and always store it in a tightly closed container to maintain its integrity.
After opening, remember to discard any unused portion to avoid contamination and ensure safety. Following these guidelines will help you use the product effectively and safely.
Additional Information
No further information is available.
FAQ
What is Candesartan Cilexetil and Hydrochlorothiazide used for?
Candesartan Cilexetil and Hydrochlorothiazide Tablets are used for the treatment of hypertension (high blood pressure).
What are the available formulations of this medication?
The available formulations are 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg, each in bottles containing 1000 tablets.
How should I take Candesartan Cilexetil and Hydrochlorothiazide?
This medication is for oral use, and the recommended dosage should be determined by your healthcare professional based on your condition.
Are there any contraindications for this medication?
Yes, it is contraindicated in patients with a history of angioedema related to ACE inhibitors, hypersensitivity to any component, or anuria (inability to produce urine).
What are some common side effects of Candesartan Cilexetil and Hydrochlorothiazide?
Common side effects include dizziness, fatigue, headache, hypotension (low blood pressure), and hyperkalemia (high potassium levels).
Can I take this medication during pregnancy?
No, Candesartan Cilexetil and Hydrochlorothiazide is contraindicated in pregnancy as it may cause injury or death to the fetus.
Is this medication safe for pediatric patients?
The safety and effectiveness of Candesartan Cilexetil and Hydrochlorothiazide in pediatric patients have not been established, and it is not recommended for children.
What should I do if I experience serious side effects?
If you experience serious side effects such as angioedema, renal impairment, or severe hypotension, seek medical attention immediately.
Are there any drug interactions I should be aware of?
Candesartan cilexetil may interact with other antihypertensive agents, NSAIDs, and potassium-sparing diuretics, potentially increasing the risk of side effects.
How should I store Candesartan Cilexetil and Hydrochlorothiazide?
Store the medication at 20°C to 25°C (68°F to 77°F), protect it from light, and keep it in a tightly closed container.
Packaging Info
The table below lists all NDC Code configurations of Candesartan Cilexetil and Hydrochlorothiazide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
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FDA Insert (PDF)
This is the full prescribing document for Candesartan Cilexetil and Hydrochlorothiazide, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Candesartan Cilexetil and Hydrochlorothiazide Tablets USP are available in three formulations: 16 mg/12.5 mg, 32 mg/12.5 mg, and 32 mg/25 mg. Each formulation is supplied in bottles containing 1000 tablets. The product is identified by the following National Drug Codes (NDC): 70771-1325-0 for the 16 mg/12.5 mg formulation, 70771-1326-0 for the 32 mg/12.5 mg formulation, and 70771-1327-0 for the 32 mg/25 mg formulation. The tablets are designed for oral administration and are characterized by their specific dosage strengths.
Uses and Indications
Candesartan Cilexetil and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension.
Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with this medication as per the available data.
Dosage and Administration
Candesartan Cilexetil and Hydrochlorothiazide Tablets USP are administered orally. The available formulations and their respective dosages are as follows:
Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 16 mg/12.5 mg, should be taken as directed by the healthcare professional.
Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/12.5 mg, are also to be taken orally, following the prescribed dosage.
Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, 32 mg/25 mg, are indicated for oral administration as well.
Healthcare professionals should ensure that patients are informed about the appropriate dosing regimen and any specific instructions related to the timing and method of administration.
Contraindications
Candesartan Cilexetil and Hydrochlorothiazide is contraindicated in patients with a history of angioedema related to previous treatment with an ACE inhibitor or of unknown origin. Use is also contraindicated in individuals who are hypersensitive to any component of this product. Additionally, this medication should not be administered to patients with anuria, as it may exacerbate renal impairment.
Warnings and Precautions
There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests are required or suggested for safe use. Healthcare professionals should remain vigilant and monitor patients as necessary, although no specific monitoring parameters have been outlined.
In the event of any adverse reactions or concerns, it is advisable for healthcare providers to assess the situation and determine the appropriate course of action, as no explicit instructions for emergency medical help or discontinuation of the medication have been provided.
Side Effects
Patients may experience a range of adverse reactions while receiving treatment. Common adverse reactions include dizziness, fatigue, headache, hypotension, and hyperkalemia.
Serious side effects that have been reported include angioedema, renal impairment, hepatic impairment, severe hypotension, and electrolyte imbalances. Additionally, allergic reactions such as rash, pruritus, and urticaria have been observed.
Cardiovascular effects may manifest as palpitations and tachycardia. Neurological adverse reactions include dizziness and syncope. Gastrointestinal disturbances may present as nausea, vomiting, and diarrhea. Dermatologic reactions can include rash and photosensitivity.
Postmarketing experience has revealed additional serious concerns, including acute renal failure, liver function test abnormalities, and pancreatitis. Other adverse reactions that may occur include cough, fatigue, muscle cramps, back pain, insomnia, depression, anemia, thrombocytopenia, and elevated blood urea nitrogen (BUN) and creatinine levels.
Healthcare professionals should monitor patients for these adverse reactions and manage them appropriately.
Drug Interactions
Candesartan cilexetil has several notable drug interactions that may impact its efficacy and safety profile.
Antihypertensive Agents Candesartan cilexetil may interact with other antihypertensive medications, resulting in an additive effect on blood pressure reduction. Clinicians should monitor blood pressure closely when initiating or adjusting doses of concomitant antihypertensive therapy.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of NSAIDs may diminish the antihypertensive effect of candesartan cilexetil. It is advisable to monitor blood pressure and consider dose adjustments of candesartan cilexetil if NSAIDs are prescribed.
Potassium-Sparing Diuretics and Potassium Supplements Candesartan cilexetil may increase the risk of hyperkalemia when used in conjunction with potassium-sparing diuretics, potassium supplements, or other medications that elevate potassium levels. Regular monitoring of serum potassium levels is recommended, and dosage adjustments may be necessary based on the patient's potassium status.
Laboratory Test Interactions Candesartan cilexetil may influence the results of certain laboratory tests, including those assessing serum potassium levels, renal function, and blood pressure measurements. Healthcare providers should be aware of these potential interactions when interpreting laboratory results.
Packaging & NDC
The table below lists all NDC Code configurations of Candesartan Cilexetil and Hydrochlorothiazide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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| Tablet |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
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Pediatric Use
Pediatric use of Candesartan Cilexetil and Hydrochlorothiazide has not been established, and safety and effectiveness in pediatric patients have not been determined. Therefore, the use of Candesartan Cilexetil and Hydrochlorothiazide is not recommended in children.
Geriatric Use
Elderly patients may exhibit increased sensitivity to the effects of Candesartan Cilexetil and Hydrochlorothiazide. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy.
It is recommended that healthcare providers closely monitor geriatric patients for any adverse effects that may arise during treatment. This monitoring will help determine the need for dosage modifications, ensuring that the therapeutic regimen remains appropriate for the individual patient's needs.
Pregnancy
The use of Candesartan Cilexetil and Hydrochlorothiazide is contraindicated in pregnancy due to the potential for serious adverse effects on fetal outcomes. Administration of this medication during pregnancy may result in injury or death to the fetus, particularly if used during the second and third trimesters.
Healthcare professionals are advised to discontinue the use of Candesartan Cilexetil and Hydrochlorothiazide as soon as pregnancy is detected to mitigate the risk of fetal harm. Women of childbearing potential should be informed of these risks and consider alternative treatment options prior to conception.
Lactation
There are no specific warnings or recommendations regarding nursing mothers or lactation mentioned in the provided drug insert for Candesartan Cilexetil and Hydrochlorothiazide. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific risks have been identified in the available information.
Renal Impairment
Candesartan cilexetil and hydrochlorothiazide should be used with caution in patients with renal impairment. Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function is recommended for patients receiving this medication. Additionally, patients with a creatinine clearance of less than 30 mL/min should not receive the combination of candesartan cilexetil and hydrochlorothiazide.
Hepatic Impairment
Candesartan cilexetil is primarily metabolized in the liver, and therefore, patients with hepatic impairment may require a reduced dose to ensure safety and efficacy. It is essential to monitor liver function tests in these patients to assess their hepatic status and adjust the dosage accordingly.
Candesartan cilexetil is contraindicated in patients with severe hepatic impairment, and its use in this population should be avoided to prevent potential adverse effects related to impaired drug metabolism.
Overdosage
In the event of overdosage, patients may experience a range of symptoms, including hypotension, tachycardia, and electrolyte imbalances. These manifestations necessitate prompt recognition and appropriate management.
Management of Overdosage
The treatment of overdosage should focus on supportive measures and symptomatic treatment. In cases where hypotension is present, it is recommended that the patient be placed in a supine position to facilitate hemodynamic stability. Additionally, the administration of intravenous fluids may be necessary to address fluid deficits and support blood pressure.
It is important to note that there is no specific antidote available for overdose of candesartan cilexetil or hydrochlorothiazide. Therefore, management should be primarily supportive, with careful monitoring of the patient's vital signs and electrolyte levels to guide further interventions.
Nonclinical Toxicology
No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted, and there was no increase in fetal malformations in the evaluated animal models. These findings suggest a favorable profile regarding developmental toxicity in the context of nonclinical studies.
Postmarketing Experience
Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports include hypotension, renal impairment, and hyperkalemia. Additionally, cases of angioedema have been documented. Instances of liver function abnormalities, characterized by elevated liver enzymes, have also been reported. Furthermore, postmarketing surveillance has noted occurrences of dizziness and fatigue.
Patient Counseling
Patients should be advised to take Candesartan Cilexetil and Hydrochlorothiazide tablets exactly as prescribed by their healthcare provider. It is important for patients to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding, as this may affect their treatment plan.
Patients should be instructed to report any signs of allergic reactions, such as rash, itching, or swelling, to their healthcare provider immediately. Additionally, they should monitor their blood pressure regularly and report any significant changes to their healthcare provider.
Patients should be informed about the potential for dizziness or lightheadedness, particularly when standing up quickly, and should be counseled to rise slowly from sitting or lying positions to minimize these effects. Maintaining adequate hydration is essential, and patients should be advised to avoid excessive alcohol consumption while taking this medication.
It is crucial for patients to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and supplements, to avoid potential drug interactions. Furthermore, patients should be instructed to keep this medication out of reach of children and to never share their medication with others.
Storage and Handling
The product is supplied in a tightly closed container to ensure integrity and stability. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its efficacy. Any unused portion should be discarded after opening to prevent contamination and ensure safety.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Candesartan Cilexetil and Hydrochlorothiazide as submitted by Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.