Truemed Group Llc

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage details provided.

Healthcare professionals are advised to consider the absence of teratogenic and nonteratogenic effects when evaluating the drug's safety profile. Further information regarding specific indications may be obtained from clinical studies or additional resources as they become available.

Dosage and Administration

The recommended route of administration for this medication is oral. Each dose contains the active ingredients hydrochlorothiazide at a strength of 12.5 mg and telmisartan at a strength of 80 mg.

Healthcare professionals should ensure that the medication is taken as prescribed, adhering to the specified dosage. It is important to instruct patients to take the medication consistently at the same time each day to maintain optimal therapeutic levels.

Patients should be advised to swallow the tablets whole with a sufficient amount of water and not to crush or chew the tablets, as this may affect the release and absorption of the active ingredients. Regular monitoring of blood pressure and renal function is recommended to assess the efficacy and safety of the treatment.

Contraindications

There are no specific contraindications provided for this product. Healthcare professionals should assess individual patient circumstances and consider any relevant medical history or concurrent medications when determining the appropriateness of use.

Warnings and Precautions

Healthcare professionals should be aware that there are no specific warnings or general precautions associated with the use of this product as per the current regulatory information. Additionally, there are no designated laboratory tests recommended for monitoring during treatment.

In the event of any adverse reactions or unexpected symptoms, it is imperative for patients to seek emergency medical assistance promptly. Furthermore, if a patient experiences any concerning side effects, they should discontinue use of the product and consult their healthcare provider for further guidance.

It is essential for healthcare professionals to remain vigilant and to provide appropriate counseling to patients regarding the importance of reporting any unusual symptoms or reactions during the course of treatment.

Side Effects

In clinical trials and postmarketing experiences, various adverse reactions have been reported among patients.

Common adverse reactions observed include dizziness, fatigue, headache, nausea, and diarrhea. These reactions were frequently noted and may impact the overall tolerability of the treatment.

Less common adverse reactions include hypotension, hyperkalemia, and renal impairment. While these events are not as frequently reported, they warrant attention due to their potential impact on patient health.

Rare adverse reactions have also been documented, including angioedema, hepatic impairment, and pancreatitis. These serious reactions, although infrequent, require immediate medical attention if they occur.

In the postmarketing setting, additional adverse reactions such as allergic reactions, skin rash, and elevated liver enzymes have been reported. These findings highlight the importance of ongoing monitoring for adverse effects in patients receiving the treatment.

No boxed warnings or specific warnings and precautions have been identified for this treatment.

Drug Interactions

Telmisartan may interact with other antihypertensive agents, resulting in an additive effect on blood pressure reduction. Therefore, when co-administering telmisartan with other antihypertensive medications, careful monitoring of blood pressure is advised to avoid excessive hypotension.

Hydrochlorothiazide has the potential to enhance the effects of other antihypertensive medications, which may necessitate dosage adjustments of the concomitant agents to maintain optimal blood pressure control.

Non-steroidal anti-inflammatory drugs (NSAIDs) may diminish the antihypertensive effects of both telmisartan and hydrochlorothiazide. It is recommended to monitor blood pressure closely when these medications are used together, and consider alternative analgesics if necessary.

The concomitant use of telmisartan with potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to hyperkalemia. Regular monitoring of serum potassium levels is advised to prevent potential complications associated with elevated potassium.

When telmisartan is used in conjunction with ACE inhibitors or other agents that influence the renin-angiotensin system, there is an increased risk of renal impairment. Renal function should be monitored periodically in patients receiving this combination therapy.

Hydrochlorothiazide may interfere with the results of certain laboratory tests, including those assessing serum electrolytes, uric acid, and glucose levels. Clinicians should be aware of these potential interactions when interpreting laboratory results.

Additionally, hydrochlorothiazide may cause increased serum calcium levels and decreased serum magnesium levels. Monitoring of these electrolytes is recommended to manage any potential imbalances effectively.

Packaging & NDC

The table below lists all NDC Code configurations of Truemed Group Llc (telmisartan-hydrochlorothiazide), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use of telmisartan-hydrochlorothiazide has not been established. The safety and effectiveness of this combination medication in pediatric patients have not been determined. Therefore, caution is advised when considering its use in children and adolescents.

Geriatric Use

Geriatric patients may not have specific considerations outlined in the prescribing information. The absence of explicit age-related guidelines suggests that no particular dosage adjustments, safety concerns, or special precautions have been identified for this population.

Healthcare providers should remain vigilant when prescribing to elderly patients, as individual responses to treatment may vary. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the general physiological changes associated with aging.

Pregnancy

The use of telmisartan-hydrochlorothiazide is contraindicated in pregnancy. Administration of telmisartan during the second and third trimesters has been associated with significant risks, including potential injury and death to the developing fetus.

Healthcare professionals should advise women of childbearing potential to discontinue telmisartan-hydrochlorothiazide as soon as pregnancy is detected. It is essential to consider alternative treatment options that are safer for use during pregnancy to mitigate risks to fetal outcomes.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require a reduced dose of telmisartan-hydrochlorothiazide. It is essential for these patients to have their renal function monitored regularly. Dosage adjustments should be based on creatinine clearance levels, and renal function tests must be performed prior to the initiation of therapy and periodically thereafter in patients with renal impairment.

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 outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In cases of overdosage, patients may exhibit a range of symptoms including hypotension, tachycardia, and electrolyte imbalances. These manifestations necessitate prompt recognition and appropriate management.

Supportive measures and symptomatic treatment are essential components of the management strategy for overdosage. In instances where hypotension is present, it is recommended that the patient be positioned supine and administered intravenous fluids to help stabilize blood pressure.

It is important to note that there is no specific antidote available for overdose of telmisartan or hydrochlorothiazide. Therefore, healthcare professionals should focus on supportive care and monitoring of the patient's clinical status to address any complications that may arise.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to take telmisartan-hydrochlorothiazide exactly as prescribed by their healthcare provider. It is important for patients to understand the significance of adhering to the prescribed dosage and schedule to ensure the medication's effectiveness.

Patients should be instructed to promptly inform their healthcare provider if they experience any side effects or unusual symptoms while taking this medication. Additionally, they should be counseled on the importance of maintaining adequate hydration and advised to avoid excessive alcohol consumption during treatment.

Healthcare providers should discuss with patients the potential for dizziness or lightheadedness, particularly when standing up quickly, and advise them to take precautions to prevent falls. Regular blood pressure monitoring is essential, and patients should be informed about its importance in managing their condition.

Patients should also be advised to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding, as this may affect their treatment plan. Furthermore, it is crucial to instruct patients to keep this medication out of reach of children and to never share their medicine with others to ensure safety.

Storage and Handling

The product is supplied in a tightly closed container to ensure stability and integrity. 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.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

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

View full prescribing information (PDF)