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Telmisartan/Hydrochlorothiazide

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Active ingredients
  • Hydrochlorothiazide 12.5–25 mg
  • Telmisartan 40–80 mg
Other brand names
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
June 30, 2025
FDA Insert
Prescribing information, PDF file
Active ingredients
  • Hydrochlorothiazide 12.5–25 mg
  • Telmisartan 40–80 mg
Other brand names
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
June 30, 2025
Manufacturer
Solco Healthcare LLC
Registration number
ANDA209028
NDC roots
43547-441, 43547-442, 43547-443
FDA Insert
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Telmisartan and hydrochlorothiazide tablets are a combination medication used to treat high blood pressure (hypertension). This medication works by combining two active ingredients: telmisartan, which is an angiotensin II antagonist that helps relax blood vessels, and hydrochlorothiazide, a thiazide diuretic that helps your body get rid of excess salt and water. By lowering blood pressure, this medication can help reduce the risk of serious cardiovascular events, such as strokes and heart attacks.

These tablets are available in different strengths, allowing for flexibility in treatment. They are taken orally and are typically used when other treatments are not sufficient on their own. If you have high blood pressure, your healthcare provider may prescribe this combination to help manage your condition effectively.

Uses

Telmisartan and hydrochlorothiazide tablets are used to help manage high blood pressure (hypertension). By lowering your blood pressure, these tablets can significantly reduce the risk of serious health issues, such as strokes and heart attacks (myocardial infarctions).

It's important to note that these tablets are typically not recommended as the first treatment option for high blood pressure. Instead, they are often used in combination with other medications to achieve better control of your blood pressure levels.

Dosage and Administration

When you start taking this medication, the usual starting dose is 80 mg of the active ingredient combined with 12.5 mg of another component, taken once a day. Depending on how your body responds, your doctor may increase your dose to 160 mg of the active ingredient and 25 mg of the other component if necessary.

If you have a condition affecting your bile ducts (biliary obstructive disorders) or liver function (hepatic insufficiency), your doctor will begin your treatment at a lower dose of 40 mg of the active ingredient and 12.5 mg of the other component. Always follow your healthcare provider's instructions regarding dosage and adjustments to ensure safe and effective treatment.

What to Avoid

If you are hypersensitive (allergic) to telmisartan or any of its components, you should avoid using this medication. Additionally, if you have anuria (the inability to produce urine), it is important not to take telmisartan. You should also refrain from using telmisartan if you are taking aliskiren, especially if you have diabetes, as this combination can lead to serious health issues.

It's crucial to be aware that telmisartan is a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body relies on a substance to function normally). Always consult with your healthcare provider if you have any concerns or questions about using this medication.

Side Effects

You may experience some common side effects while taking this medication, including upper respiratory tract infections, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea. It's important to be aware of these reactions, as they occur in at least 2% of patients.

There are also significant warnings associated with this medication. If you become pregnant, you should stop taking it immediately, as it can harm the developing fetus. Additionally, be cautious of potential hypersensitivity reactions, and monitor for signs of fluid or electrolyte imbalances. In rare cases, overdosage can lead to low blood pressure, dizziness, and heart rate changes, as well as dehydration and electrolyte depletion. Always consult your healthcare provider if you have concerns about these side effects.

Warnings and Precautions

It's important to be aware of some serious warnings and precautions when using this medication. If you become pregnant, you should stop taking telmisartan and hydrochlorothiazide immediately, as these drugs can harm the developing fetus. Additionally, you should avoid exposing a fetus or newborn to this medication.

Before starting treatment, make sure to correct any issues with fluid or salt levels in your body, as this can help prevent low blood pressure (hypotension). Regular monitoring of kidney function and potassium levels is essential, especially if you are at risk. Be alert for signs of fluid or electrolyte imbalance, and watch for any allergic reactions. If you experience symptoms of anaphylaxis (a severe allergic reaction), seek emergency medical help right away.

If you notice any signs of fluid or electrolyte imbalance or experience a hypersensitivity reaction, stop taking the medication and contact your doctor for further guidance. Regular lab tests may be necessary to monitor your condition, including checking for increased CPK levels and assessing kidney function and potassium levels.

Overdose

If you suspect an overdose of telmisartan, it's important to be aware of the potential signs and symptoms. The most common effects may include low blood pressure (hypotension), dizziness, and a rapid heartbeat (tachycardia). In some cases, you might experience a slow heartbeat (bradycardia) due to stimulation of the vagus nerve. If you notice any of these symptoms, seek medical attention immediately.

For hydrochlorothiazide, an overdose can lead to issues related to electrolyte depletion, such as low potassium (hypokalemia), low chloride (hypochloremia), and low sodium (hyponatremia), as well as dehydration from excessive urination. If you have taken digitalis (a heart medication) along with hydrochlorothiazide, low potassium levels can worsen heart rhythm problems. If you experience any concerning symptoms, it’s crucial to contact a healthcare professional right away. Remember, supportive treatment may be necessary, and telmisartan cannot be removed from the body through hemofiltration or dialysis.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety and effectiveness of telmisartan and hydrochlorothiazide, a combination medication, have not been established for individuals with severe kidney impairment (when kidney function is significantly reduced). Therefore, if you have severe renal impairment (with a creatinine clearance of 30 mL/min or less), this medication is not recommended for you.

For those with mild to moderate kidney impairment (creatinine clearance between 30 to 90 mL/min), no dose adjustment is necessary. However, always consult your healthcare provider before starting or continuing any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available about the effects of this medication on nursing mothers or their infants. This means that if you are breastfeeding or planning to breastfeed, it’s important to consult with your healthcare provider for personalized advice. They can help you weigh the benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best outcomes for you and your baby.

Pediatric Use

The safety and effectiveness of telmisartan and hydrochlorothiazide, a combination medication, have not been established for children. This means that if you are considering this treatment for your child, it is important to consult with a healthcare professional first, as there may be unknown risks.

For newborns who were exposed to this medication before birth, special care is needed. If your baby shows signs of low urine output (oliguria) or low blood pressure (hypotension), it is crucial to seek immediate medical attention. In such cases, doctors may need to provide support for blood pressure and kidney function, which could include procedures like exchange transfusions or dialysis. Always prioritize your child's health by discussing any concerns with their doctor.

Geriatric Use

In clinical studies, about 20% of patients taking telmisartan/hydrochlorothiazide were aged 65 and older, with 5% being 75 and older. While the medication has shown similar effectiveness and safety for older adults compared to younger individuals, it’s important to note that some older patients may be more sensitive to its effects.

If you or a loved one is an older adult considering this medication, doctors typically recommend starting at a lower dose. This cautious approach is due to the higher likelihood of having conditions that affect the liver, kidneys, or heart, as well as the possibility of taking other medications. Always consult with a healthcare provider to ensure the best and safest treatment plan.

Renal Impairment

If you have kidney problems, it's important to keep a close eye on your renal function and potassium levels. Regular monitoring can help ensure that your treatment is safe and effective. This is especially crucial for those who are more susceptible to changes in kidney function. Always discuss any concerns with your healthcare provider, who can guide you on the best practices for managing your health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware of potential interactions between your medications and any treatments you may be receiving. For instance, if you are taking lithium, there is a risk of lithium toxicity, which can be serious. Non-steroidal anti-inflammatory drugs (NSAIDs), commonly used for pain relief, can reduce the effectiveness of certain medications that help manage blood pressure and may increase the risk of kidney problems.

Additionally, if you are on antidiabetic medications, your doctor may need to adjust your dosage. Combining certain drugs, like digoxin, with telmisartan (a medication for high blood pressure) can lead to increased levels of digoxin in your blood, which requires careful monitoring. Always discuss any medications or lab tests with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place at a temperature between 20°C to 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), but try to keep it within the recommended limits. Always keep the bottle tightly closed to protect the contents from moisture and contamination.

When it comes to handling the tablets, do not remove them from the bottle until you are ready to use them. This helps maintain their effectiveness and safety. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

There are some important health considerations to be aware of regarding this medication. Postmarketing experience (observations made after the drug has been on the market) has reported various side effects, including eosinophilia (an increase in a type of white blood cell), tachycardia (rapid heartbeat), and vertigo (dizziness). Other potential effects include abnormal liver function, anaphylactic reactions (severe allergic reactions), and renal issues such as acute renal failure.

Additionally, there is an increased risk of non-melanoma skin cancer, particularly squamous cell carcinoma (SCC), especially in white patients who have taken high cumulative doses of hydrochlorothiazide. For the general population, the risk is about 1 additional case of SCC for every 16,000 patients per year, while for those taking 50,000 mg or more, the risk increases to about 1 additional case for every 6,700 patients per year. If you experience any unusual symptoms or have concerns, it's important to consult your healthcare provider.

FAQ

What is Telmisartan and hydrochlorothiazide used for?

Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, either alone or with other antihypertensive agents, to lower blood pressure and reduce the risk of cardiovascular events.

What is the usual starting dose for Telmisartan and hydrochlorothiazide?

The usual starting dose is 80 mg/12.5 mg once daily, which can be titrated up to 160 mg/25 mg as needed.

Are there any contraindications for taking Telmisartan and hydrochlorothiazide?

Yes, contraindications include hypersensitivity to telmisartan or any component, anuria, and co-administration with aliskiren in patients with diabetes.

What are some common side effects of Telmisartan and hydrochlorothiazide?

Common side effects include upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea.

What should I do if I become pregnant while taking Telmisartan and hydrochlorothiazide?

If pregnancy is detected, you should discontinue Telmisartan and hydrochlorothiazide as soon as possible, as it can cause injury and death to the developing fetus.

What precautions should I take while using Telmisartan and hydrochlorothiazide?

You should monitor renal function and potassium levels, correct any volume or salt depletion before starting therapy, and observe for signs of hypotension or electrolyte imbalance.

Is Telmisartan and hydrochlorothiazide safe for elderly patients?

While no overall differences in effectiveness and safety were observed, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range.

What should I do in case of an overdose?

In case of overdose, you may experience hypotension, dizziness, or tachycardia. Seek medical attention immediately.

How should I store Telmisartan and hydrochlorothiazide?

Store the tablets at 20°C to 25°C (68°F to 77°F) and keep the bottle tightly closed. Do not remove tablets from the bottle until immediately before administration.

Packaging Info

The table below lists all NDC Code configurations of Telmisartan and Hydrochlorothiazide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Telmisartan and Hydrochlorothiazide.
Details

FDA Insert (PDF)

This is the full prescribing document for Telmisartan 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.

View FDA-approved insert (PDF)

Description

Telmisartan and hydrochlorothiazide tablets are a combination formulation containing telmisartan, an orally active angiotensin II antagonist that selectively targets the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic. Telmisartan is a non-peptide molecule with the chemical designation 4'-[(1,4'-dimethyl-2'-propyl2,6'-bi-1H-benzimidazol-1'-yl)methyl]-1,1'-biphenyl-2-carboxylic acid, exhibiting an empirical formula of C33H30N4O2 and a molecular weight of 514.63. It appears as a white to slightly yellowish solid, is practically insoluble in water across a pH range of 3 to 9, sparingly soluble in strong acids (except hydrochloric acid), and soluble in strong bases.

Hydrochlorothiazide is characterized as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, with an empirical formula of C7H8ClN3O4S2 and a molecular weight of 297.74. This compound is presented as a white or practically white, odorless crystalline powder, slightly soluble in water, and freely soluble in sodium hydroxide solution.

The tablets are formulated for oral administration in three dosage combinations: 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg of telmisartan and hydrochlorothiazide, respectively. Inactive ingredients include crospovidone (Type B), hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, povidone, sodium hydroxide, sodium starch glycolate, and sodium stearyl fumarate. The 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red as a coloring agent, while the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and must be protected from moisture.

Uses and Indications

Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, either as monotherapy or in combination with other antihypertensive agents, to effectively lower blood pressure. The reduction of blood pressure is associated with a decreased risk of both fatal and nonfatal cardiovascular events, including strokes and myocardial infarctions.

Limitations of Use: Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy in the management of hypertension.

Dosage and Administration

The usual starting dose for the medication is 80 mg/12.5 mg administered once daily. Based on the patient's response and tolerability, the dose may be titrated up to a maximum of 160 mg/25 mg as needed.

For patients with biliary obstructive disorders or hepatic insufficiency, it is recommended to initiate treatment at a lower dose of 40 mg/12.5 mg once daily. Careful monitoring of these patients is advised to assess efficacy and tolerability, with adjustments made as clinically indicated.

Contraindications

Use of this product is contraindicated in patients with hypersensitivity to telmisartan or any of its components, as this may lead to severe allergic reactions. Additionally, the product should not be used in patients with anuria, due to the risk of renal complications. Co-administration with aliskiren is contraindicated in patients with diabetes, as this combination may increase the risk of adverse effects.

Warnings and Precautions

Fetal toxicity is a significant concern associated with the use of telmisartan and hydrochlorothiazide. It is imperative that these medications be discontinued immediately upon detection of pregnancy, as they can cause serious injury or death to the developing fetus due to their action on the renin-angiotensin system.

Healthcare professionals should take general precautions to avoid fetal or neonatal exposure. Prior to initiating therapy, it is essential to correct any volume or salt depletion and to monitor patients for signs and symptoms of hypotension. Regular monitoring of renal function and potassium levels is recommended, particularly in patients who may be susceptible to imbalances. Clinicians should remain vigilant for clinical signs of fluid or electrolyte imbalance, as well as potential hypersensitivity reactions.

Additionally, patients should be informed about the risk of acute myopia and secondary angle-closure glaucoma, which may occur during treatment.

Laboratory tests should include monitoring for increased creatine phosphokinase (CPK) levels, as well as ongoing assessment of renal function and potassium levels in susceptible individuals.

In the event of an anaphylactic reaction, immediate emergency medical assistance should be sought. Patients should also be advised to discontinue the medication and contact their healthcare provider if they observe any clinical signs of fluid or electrolyte imbalance or experience a hypersensitivity reaction.

Side Effects

Patients receiving telmisartan and hydrochlorothiazide may experience a range of adverse reactions. Common adverse reactions, occurring in 2% or more of patients, include upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea.

Serious warnings associated with this medication include fetal toxicity. It is imperative to discontinue telmisartan and hydrochlorothiazide as soon as pregnancy is detected, as drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. To avoid fetal or neonatal exposure, it is essential to correct any volume or salt depletion before initiating therapy. Clinicians should monitor for signs and symptoms of hypotension, renal function, and potassium levels in susceptible patients, as well as observe for clinical signs of fluid or electrolyte imbalance.

Additional adverse reactions may include hypersensitivity to telmisartan or any of its components, anuria, and complications arising from co-administration with aliskiren in patients with diabetes.

In cases of overdosage, the most likely manifestations include hypotension, dizziness, and tachycardia, with bradycardia potentially occurring due to parasympathetic (vagal) stimulation. For hydrochlorothiazide overdose, the most common signs and symptoms are those resulting from electrolyte depletion, such as hypokalemia, hypochloremia, and hyponatremia, along with dehydration due to excessive diuresis.

Drug Interactions

Co-administration of certain medications with telmisartan and hydrochlorothiazide may lead to significant drug interactions, necessitating careful monitoring and potential dosage adjustments.

Lithium: The use of telmisartan and hydrochlorothiazide may increase the risk of lithium toxicity. Patients receiving both therapies should be monitored for signs of lithium accumulation and toxicity.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Concurrent use of NSAIDs may diminish the diuretic, natriuretic, and antihypertensive effects of telmisartan and hydrochlorothiazide. Additionally, there is an increased risk of renal impairment. It is advisable to monitor renal function in patients receiving this combination.

Dual Blockade of the Renin-Angiotensin System: The combination of telmisartan with other agents that block the renin-angiotensin system may elevate the risk of renal impairment, hypotension, and hyperkalemia. Close monitoring of renal function and serum potassium levels is recommended.

Antidiabetic Drugs: When telmisartan and hydrochlorothiazide are used in conjunction with antidiabetic medications, dosage adjustments may be necessary to maintain glycemic control. Regular monitoring of blood glucose levels is advised.

Cholestyramine and Colestipol: The absorption of thiazides may be reduced when administered with cholestyramine or colestipol. It is recommended to separate the dosing of these agents to minimize the impact on thiazide absorption.

Digoxin: Co-administration of telmisartan and hydrochlorothiazide with digoxin has been associated with significant increases in digoxin plasma concentrations, specifically a median increase of 49% in peak levels and 20% in trough levels. Monitoring of digoxin levels is essential in patients receiving this combination to avoid potential toxicity.

Packaging & NDC

The table below lists all NDC Code configurations of Telmisartan and Hydrochlorothiazide, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Telmisartan and Hydrochlorothiazide.
Details

Pediatric Use

Safety and effectiveness of telmisartan and hydrochlorothiazide in pediatric patients have not been established. In neonates with a history of in utero exposure to these medications, if oliguria or hypotension occurs, it is essential to support blood pressure and renal perfusion. In such cases, exchange transfusions or dialysis may be required to reverse hypotension and/or substitute for disordered renal function.

Geriatric Use

In controlled clinical trials, approximately 20% of patients treated with telmisartan/hydrochlorothiazide were aged 65 years or older, with 5% being 75 years of age or older. Overall, no significant differences in effectiveness and safety were observed between elderly patients and younger patients. However, it is important to note that greater sensitivity to the medication may be present in some older individuals.

When prescribing telmisartan/hydrochlorothiazide to geriatric patients, dose selection should be approached with caution. It is generally recommended to initiate treatment at the lower end of the dosing range. This recommendation is based on the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies in this population. Careful monitoring of these patients is advised to ensure safety and efficacy.

Pregnancy

Pregnant patients should be aware that the safety and effectiveness of telmisartan and hydrochlorothiazide have not been established in individuals with severe renal impairment (creatinine clearance CrCl ≤30 mL/min). Therefore, the use of telmisartan and hydrochlorothiazide tablets is not recommended in this population.

For patients with mild (CrCl 60 to 90 mL/min) or moderate (CrCl 30 to 60 mL/min) renal impairment, no dose adjustment is necessary. However, healthcare providers should carefully consider the potential risks and benefits of treatment in pregnant patients, particularly those with renal impairment, and monitor fetal outcomes accordingly.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not established. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

Renal Impairment

Patients with renal impairment should have their renal function and potassium levels monitored closely, as they may be at increased risk for complications. Dosing adjustments may be necessary based on the degree of reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be considered as part of standard clinical practice.

Overdosage

Limited data are available regarding the overdosage of telmisartan in humans. The most likely manifestations of telmisartan overdosage include hypotension, dizziness, and tachycardia. Additionally, bradycardia may occur due to parasympathetic (vagal) stimulation. In the event of symptomatic hypotension, it is recommended that supportive treatment be initiated.

It is important to note that telmisartan is not removed by hemofiltration and is not dialyzable, which should be considered when managing an overdose.

In cases of hydrochlorothiazide overdose, the predominant signs and symptoms are typically those associated with electrolyte depletion, including hypokalemia, hypochloremia, and hyponatremia, as well as dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may exacerbate the risk of cardiac arrhythmias. The extent to which hydrochlorothiazide is removed by hemodialysis has not been established, and the oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

Healthcare professionals should remain vigilant for these symptoms and manage the patient accordingly, ensuring that appropriate supportive care is provided.

Nonclinical Toxicology

No teratogenic effects were observed in the studies conducted. The reproductive performance of male and female rats was unaffected at the highest administered dose of 100 mg/kg/day, which is approximately 13 times the maximum recommended human dose (MRHD) of telmisartan on a mg/m² basis. Additionally, hydrochlorothiazide did not demonstrate any adverse effects on the fertility of mice and rats of either sex when exposed to dietary doses of up to 100 mg/kg and 4 mg/kg, respectively, prior to mating and throughout gestation.

No studies have been conducted to evaluate the carcinogenicity, mutagenicity, or fertility effects of the combination of telmisartan and hydrochlorothiazide. However, telmisartan did not show evidence of carcinogenicity when administered in the diet to mice and rats for up to two years. Genotoxicity assays indicated no telmisartan-related effects at either the gene or chromosome level. In two-year feeding studies conducted by the National Toxicology Program (NTP), no evidence of carcinogenic potential was found for hydrochlorothiazide in female mice or in male and female rats, although equivocal evidence for hepatocarcinogenicity was noted in male mice. Hydrochlorothiazide was also not genotoxic in vitro, as demonstrated by the Ames mutagenicity assay and the Chinese Hamster Ovary (CHO) test for chromosomal aberrations.

In terms of animal pharmacology and toxicology, the highest doses administered to mice (1,000 mg/kg/day) and rats (100 mg/kg/day) correspond to approximately 59 and 13 times, respectively, the MRHD of telmisartan on a mg/m² basis. These doses resulted in average systemic exposures to telmisartan that were over 100 times and over 25 times, respectively, the systemic exposure observed in humans receiving the MRHD of telmisartan (80 mg/day). In rats, the dose of 100 mg/kg/day led to an average systemic exposure (telmisartan AUC as determined on day 6 of pregnancy) that was at least 50 times greater than the average systemic exposure in humans at the MRHD.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to read the FDA-approved patient labeling (Patient Information) thoroughly. This document contains essential information regarding the medication, including its indications, usage, potential side effects, and important safety information.

Providers should encourage patients to ask questions if they have any uncertainties about the information presented in the labeling. It is crucial for patients to understand how to use the medication properly and to be aware of any warnings or precautions associated with its use.

Additionally, healthcare providers should remind patients to report any adverse effects or unusual symptoms they may experience while taking the medication, as this can help ensure their safety and the effectiveness of their treatment.

Storage and Handling

The product is supplied in a tightly sealed bottle 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 keep the bottle tightly closed at all times. Tablets should not be removed from the bottle until immediately prior to administration to maintain their efficacy and safety.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Telmisartan and Hydrochlorothiazide as submitted by Solco Healthcare LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Telmisartan and Hydrochlorothiazide, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA209028) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.