Bisoprolol fumarate/Hydrochlorothiazide

Description

Bisoprolol Fumarate and Hydrochlorothiazide Tablets are available in three strengths: 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg. Each strength is formulated as a tablet for oral administration. The product is supplied in a unit-of-use package containing 30 tablets. This medication is available by prescription only.

Uses and Indications

Bisoprolol Fumarate and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension.

There are no specific teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

The medication is administered orally. It is available in the following dosage forms: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg.

Healthcare professionals should determine the appropriate dosage based on the individual patient's needs and response to treatment. The dosing regimen may vary, and it is essential to monitor the patient's condition regularly to adjust the dosage as necessary.

Patients should be instructed to take the tablets with or without food, as directed by their healthcare provider. It is important to ensure that the tablets are swallowed whole and not crushed or chewed to maintain the integrity of the medication.

Contraindications

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

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment. Regular laboratory tests may be necessary to assess the patient's response to therapy and to ensure safety. Specific monitoring parameters should be established based on the individual patient's health status and the medication's profile.

In the event of severe side effects or unexpected reactions, immediate medical attention should be sought. Healthcare providers should instruct patients to discontinue use and contact their physician if they experience any concerning symptoms.

Overall, a thorough understanding of the potential risks and the implementation of appropriate monitoring strategies are vital for the safe administration of this medication.

Side Effects

Patients receiving treatment may experience a range of adverse reactions. Common adverse reactions reported include fatigue, dizziness, headache, nausea, diarrhea, and abdominal pain. These effects are generally mild to moderate in severity.

Serious side effects have also been observed, including bradycardia, hypotension, heart failure, severe allergic reactions such as anaphylaxis, and liver dysfunction characterized by elevated liver enzymes. It is important for healthcare providers to monitor patients for these serious reactions, particularly in those with pre-existing conditions.

Additional adverse reactions noted in clinical trials and postmarketing experiences include respiratory effects, such as bronchospasm in patients with a history of asthma, electrolyte imbalances like hypokalemia, skin reactions including rash and pruritus, as well as psychological effects such as depression and sleep disturbances. Sexual dysfunction has also been reported.

Postmarketing experience has revealed rare but serious cases of severe skin reactions, including Stevens-Johnson syndrome, as well as instances of pancreatitis, thrombocytopenia, and hepatitis.

A boxed warning advises caution when administering this treatment to patients with a history of severe allergic reactions or asthma, highlighting the need for careful patient selection and monitoring.

Drug Interactions

Bisoprolol may interact with other antihypertensive agents, resulting in additive effects on blood pressure. Caution is advised when combining bisoprolol with other beta-blockers, as this combination is not recommended due to the potential for enhanced hypotensive effects.

Hydrochlorothiazide can interact with other diuretics, increasing the risk of electrolyte imbalances. When bisoprolol is used in conjunction with hydrochlorothiazide, there is a potential for an enhanced hypotensive effect when combined with other antihypertensive medications.

In terms of laboratory test interactions, hydrochlorothiazide may influence the results of certain tests, particularly those assessing serum electrolytes, uric acid, and glucose levels. Additionally, bisoprolol may interfere with the interpretation of laboratory tests related to cardiac function. Monitoring of these parameters is recommended to ensure accurate assessment and management.

Packaging & NDC

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

Pediatric Use

Safety and effectiveness of bisoprolol fumarate and hydrochlorothiazide in pediatric patients have not been established. Consequently, there is no recommended dosage for this population.

Geriatric Use

Elderly patients may not require specific dosage adjustments; however, caution is advised due to the potential for increased sensitivity to side effects. It is important to recognize that geriatric patients may exhibit reduced kidney function, which can influence the pharmacokinetics of bisoprolol and hydrochlorothiazide.

Close monitoring of elderly patients is essential, particularly for signs of hypotension, bradycardia, and electrolyte imbalances, with a specific focus on hypokalemia. To minimize the risk of adverse effects, consideration should be given to initiating treatment at the lower end of the dosing range for this population.

Pregnancy

Bisoprolol Fumarate and Hydrochlorothiazide is contraindicated in pregnancy due to the potential risks to the fetus. The use of this medication during pregnancy may lead to adverse fetal outcomes. Healthcare professionals should advise pregnant patients to avoid this medication and consider alternative treatments that are safer for use during pregnancy. Women of childbearing potential should be informed of these risks and the importance of effective contraception while on this medication.

Lactation

There is no information available regarding the use of Bisoprolol Fumarate and Hydrochlorothiazide in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when prescribing this medication to nursing mothers.

Renal Impairment

Patients with renal impairment may require dosage adjustments for bisoprolol fumarate and hydrochlorothiazide. Regular monitoring of renal function is essential for these patients. Dosage adjustments should be based on creatinine clearance levels. It is important to assess renal function prior to initiating treatment and to continue periodic assessments throughout the course of therapy.

Hepatic Impairment

Patients with hepatic impairment do not require specific dosage adjustments or precautions when receiving this medication. However, it is advisable to monitor liver function periodically to ensure the continued safety and efficacy of treatment in this population. Regular assessment of liver enzymes and overall liver health may be warranted, particularly in patients with moderate to severe hepatic impairment.

Overdosage

In cases of overdosage with bisoprolol fumarate and hydrochlorothiazide, healthcare professionals should be aware that severe bradycardia, hypotension, and acute heart failure may occur. Patients may present with symptoms such as dizziness, fatigue, and fainting, which necessitate prompt medical attention.

Supportive treatment should be initiated immediately upon recognition of an overdose. It is important to note that there is no specific antidote available for bisoprolol or hydrochlorothiazide overdose. Furthermore, hemodialysis is not expected to significantly enhance the elimination of either drug from the body.

Healthcare providers should closely monitor the patient's vital signs and provide appropriate interventions to manage the symptoms and stabilize the patient.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, fatigue, headache, and hypotension. These events were documented in the context of routine pharmacovigilance activities.

Patient Counseling

Patients should be advised to take Bisoprolol Fumarate and Hydrochlorothiazide exactly as prescribed by their healthcare provider. It is important to inform patients that they should not discontinue the medication without consulting their healthcare provider, as abrupt withdrawal may worsen their condition.

Patients should be instructed to report any signs of worsening heart failure, such as increased shortness of breath, weight gain, or swelling of the ankles or feet. Additionally, they should be advised to monitor their blood pressure regularly and report any significant changes to their healthcare provider.

Healthcare providers should counsel patients about the potential for dizziness or lightheadedness, particularly when standing up quickly. Patients should be encouraged to rise slowly from sitting or lying positions to minimize these effects. They should also be informed to notify their healthcare provider if they experience any symptoms of low blood pressure, such as fainting or severe dizziness.

Patients should be advised to maintain adequate fluid intake and to avoid excessive alcohol consumption while taking this medication. Furthermore, it is essential to inform patients that they should notify their healthcare provider if they become pregnant or plan to become pregnant while taking this medication.

Lastly, patients should be encouraged to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements, to avoid potential drug interactions.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain 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 prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Bisoprolol Fumarate 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)