Valsartan/Hydrochlorothiazide

Description

Valsartan and Hydrochlorothiazide Tablets USP are available in multiple strengths: 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. Each strength is supplied in bottles containing 1000 tablets. The National Drug Code (NDC) for the 80/12.5 mg formulation is 70771-1485-0, for the 160/12.5 mg formulation is 70771-1486-0, for the 160/25 mg formulation is 70771-1487-0, for the 320/12.5 mg formulation is 70771-1488-0, and for the 320/25 mg formulation is 70771-1489-0. These tablets are available by prescription only.

Uses and Indications

Valsartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension.

Limitations of Use: The insert does not provide specific statements regarding teratogenic or nonteratogenic effects. Therefore, healthcare professionals should exercise caution and consider individual patient circumstances when prescribing this medication.

Dosage and Administration

Valsartan and Hydrochlorothiazide are administered orally. The following dosage forms are available:

Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg: Each tablet contains 80 mg of Valsartan and 12.5 mg of Hydrochlorothiazide.

Valsartan and Hydrochlorothiazide Tablets USP, 160/12.5 mg: Each tablet contains 160 mg of Valsartan and 12.5 mg of Hydrochlorothiazide.

Valsartan and Hydrochlorothiazide Tablets USP, 160/25 mg: Each tablet contains 160 mg of Valsartan and 25 mg of Hydrochlorothiazide.

Valsartan and Hydrochlorothiazide Tablets USP, 320/12.5 mg: Each tablet contains 320 mg of Valsartan and 12.5 mg of Hydrochlorothiazide.

Valsartan and Hydrochlorothiazide Tablets USP, 320/25 mg: Each tablet contains 320 mg of Valsartan and 25 mg of Hydrochlorothiazide.

Healthcare professionals should determine the appropriate dosage based on the individual patient's needs and response to therapy. It is essential to follow established guidelines for titration and to monitor the patient's blood pressure and renal function during treatment.

Contraindications

Use of this medication is contraindicated in the following situations:

Patients with a history of angioedema related to previous treatment with an ACE inhibitor or angiotensin receptor blocker should not use this medication due to the risk of exacerbating angioedema.

Hypersensitivity to valsartan, hydrochlorothiazide, or any component of the formulation is a contraindication, as it may lead to severe allergic reactions.

Anuria is a contraindication, as the medication may not be effectively eliminated in these patients.

Severe renal impairment, defined as a glomerular filtration rate (GFR) of less than 30 mL/min, contraindicates use due to the potential for worsening renal function.

Patients with hepatic impairment or biliary cirrhosis should not use this medication, as it may exacerbate liver-related complications.

Pregnancy or planning to become pregnant is a contraindication due to potential harm to the fetus.

Additionally, this medication should not be used in combination with aliskiren in patients with diabetes, as this may increase the risk of adverse effects.

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, including whether to continue treatment or consult with a specialist.

Side Effects

Patients receiving Valsartan and Hydrochlorothiazide may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Boxed Warning: Valsartan and Hydrochlorothiazide are associated with fetal toxicity. When pregnancy is detected, it is imperative to discontinue the medication, as it can cause injury or death to the fetus.

Common Adverse Reactions: The most frequently reported adverse reactions include dizziness, fatigue, headache, hypotension, and hyperkalemia. These reactions are generally mild to moderate in severity.

Serious Adverse Reactions: Serious adverse reactions have been observed, including angioedema, renal impairment, hepatic impairment, severe hypotension, and electrolyte imbalances such as hypokalemia and hyperkalemia. These conditions require immediate medical attention.

Additional Adverse Reactions: Other adverse reactions reported include:

• Cardiovascular: Orthostatic hypotension

• Gastrointestinal: Nausea, vomiting, diarrhea

• Hematologic: Anemia, thrombocytopenia

• Musculoskeletal: Muscle cramps

• Neurological: Dizziness, headache

• Dermatologic: Rash, pruritus

• Respiratory: Cough

• Renal: Increased blood urea nitrogen (BUN) and creatinine levels

Postmarketing Experience: In the postmarketing setting, there have been reports of liver function test abnormalities, pancreatitis, and hypersensitivity reactions. These experiences highlight the importance of monitoring patients for any signs of adverse effects during treatment.

Drug Interactions

Valsartan and hydrochlorothiazide exhibit several clinically significant drug interactions that may necessitate careful monitoring and dosage adjustments.

Antihypertensive Agents Valsartan may interact with other antihypertensive agents, resulting in an additive effect on blood pressure. This interaction may enhance the risk of hypotension, particularly when hydrochlorothiazide is also administered, as it can further amplify the effects of other antihypertensive medications. Clinicians should monitor blood pressure closely and consider dosage adjustments as necessary.

Diuretics Hydrochlorothiazide may interact with other diuretics, increasing the risk of electrolyte imbalances. This necessitates regular monitoring of electrolyte levels, particularly potassium, to prevent complications. Additionally, the use of hydrochlorothiazide may lead to an increase in serum uric acid levels, which could precipitate gout in susceptible individuals.

Potassium-Sparing Diuretics and Supplements The concomitant use of valsartan with potassium-sparing diuretics or potassium supplements may elevate the risk of hyperkalemia. Monitoring of serum potassium levels is advised to mitigate this risk.

Antidiabetic Medications Hydrochlorothiazide may reduce the effectiveness of certain antidiabetic medications, potentially leading to increased blood glucose levels. Patients should be monitored for changes in glycemic control, and adjustments to antidiabetic therapy may be required.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The administration of NSAIDs may diminish the antihypertensive effects of both valsartan and hydrochlorothiazide. Clinicians should be aware of this interaction and consider alternative pain management strategies or increased monitoring of blood pressure.

Lithium Valsartan may interact with lithium, resulting in increased lithium levels and a risk of toxicity. Regular monitoring of lithium levels is recommended to ensure patient safety.

In summary, careful consideration of these interactions is essential for optimizing therapeutic outcomes and minimizing adverse effects in patients receiving valsartan and hydrochlorothiazide.

Packaging & NDC

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

Pediatric Use

Pediatric use of valsartan and hydrochlorothiazide has not been established, and safety and effectiveness in pediatric patients remain undetermined. Therefore, the use of valsartan and hydrochlorothiazide is not recommended in children under 18 years of age.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of valsartan 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 essential to monitor renal function in geriatric patients, as they are at a higher risk for adverse effects associated with these medications. Caution is particularly advised when administering valsartan and hydrochlorothiazide to elderly patients who have pre-existing renal impairment, as this may further complicate their clinical management. Regular assessment and careful consideration of individual patient factors are recommended to optimize treatment outcomes in this demographic.

Pregnancy

The use of Valsartan and Hydrochlorothiazide is contraindicated in pregnancy due to the potential for serious adverse effects on the developing fetus. Administration of Valsartan during pregnancy may lead to injury or death of the fetus. Therefore, if pregnancy is detected while a patient is being treated with Valsartan and Hydrochlorothiazide, it is imperative to discontinue the medication as soon as possible to mitigate risks to fetal outcomes. Healthcare professionals should counsel women of childbearing potential regarding the risks associated with the use of this medication during pregnancy and ensure appropriate contraceptive measures are in place.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation mentioned in the provided drug insert for Valsartan 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 information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

Renal impairment may affect the pharmacokinetics of valsartan and hydrochlorothiazide. Dosage adjustments may be necessary for patients with renal impairment, and renal function should be monitored regularly. It is important to consider the patient's creatinine clearance when determining the appropriate dosage. Patients with severe renal impairment, defined as a creatinine clearance of less than 30 mL/min, should not use valsartan and hydrochlorothiazide.

Hepatic Impairment

Patients with hepatic impairment may experience increased exposure to valsartan due to its primary elimination via hepatic metabolism. For individuals with mild to moderate hepatic impairment, no dosage adjustment is necessary; however, caution should be exercised when prescribing valsartan to this population.

In contrast, valsartan is not recommended for use in patients with severe hepatic impairment. Additionally, it is advised that liver function tests be monitored periodically in patients with any degree of hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for guiding treatment decisions and ensuring patient safety.

Nonclinical Toxicology

In animal studies, no teratogenic effects were observed with the administration of valsartan and hydrochlorothiazide. However, adverse developmental outcomes were noted at doses that resulted in maternal toxicity. Additionally, these studies did not indicate any increase in fetal malformations associated with the compounds.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include angioedema, hyperkalemia, renal impairment, hepatic impairment, hypotension, dizziness, fatigue, cough, rash, nausea, diarrhea, abdominal pain, back pain, muscle cramps, palpitations, syncope, anemia, and thrombocytopenia. Additionally, elevated liver enzymes, pancreatitis, acute kidney injury, and a drug interaction with NSAIDs leading to renal impairment have also been noted.

It is important to recognize that these adverse reactions were reported during postmarketing surveillance and may not be directly related to the use of valsartan and hydrochlorothiazide.

Patient Counseling

Patients should be advised to take Valsartan and Hydrochlorothiazide tablets exactly as prescribed by their healthcare provider. It is important for patients to understand that they may experience dizziness or lightheadedness, particularly when standing up quickly; therefore, they should be instructed to rise slowly from sitting or lying positions to minimize these effects.

Patients should be informed about the signs of allergic reactions, such as rash, itching, or swelling, and should be encouraged to report any such symptoms to their healthcare provider promptly. Additionally, patients should 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.

Counseling should also include the importance of regular blood pressure monitoring and the necessity of attending follow-up appointments to ensure the effectiveness of the treatment. Patients should be made aware of the potential for electrolyte imbalances and the need for periodic blood tests to monitor potassium levels.

It is essential to advise patients to maintain adequate hydration and to avoid excessive alcohol consumption while taking this medication, as these factors can influence their health outcomes. Lastly, patients should be instructed to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and supplements, to prevent potential drug interactions.

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 degradation.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Valsartan and Hydrochlorothiazide as submitted by Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)