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Overview

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This medicine contains an important and useful components, as it consists of
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Name

Valsartan + Hydrochlorothiazide

Precaution

Before using **Valsartan + Hydrochlorothiazide**, it is essential that patients consult their healthcare provider to ensure the medication is safe for their specific condition. Several precautions should be considered: - **Pregnancy and Breastfeeding**: This combination is **contraindicated** during **pregnancy**, particularly during the second and third trimesters, due to potential harm to the fetus. It should also be avoided during breastfeeding, as it may pass into breast milk. - **Kidney Function**: Both **Valsartan** (an **angiotensin II receptor blocker** or ARB) and **Hydrochlorothiazide** (a **thiazide diuretic**) affect kidney function. Patients with existing **renal impairment** or a history of **kidney disease** should be closely monitored. This combination may exacerbate **renal dysfunction**. - **Electrolyte Imbalances**: The use of **Hydrochlorothiazide** can lead to low levels of **potassium** (hypokalemia), sodium (hyponatremia), and magnesium, as well as elevated **calcium**. Regular monitoring of electrolytes is necessary. - **Liver Disease**: Patients with **severe hepatic impairment** should avoid this combination due to the potential for worsened liver function. Caution is required for those with moderate liver conditions. - **Dehydration and Hypotension**: **Hydrochlorothiazide** can lead to dehydration and low blood pressure (hypotension), particularly in patients who are salt-depleted or are on other antihypertensive therapies. This can increase the risk of **dizziness** and fainting. - **Allergic Reactions**: Some individuals may experience allergic reactions such as **rash**, **swelling**, or **difficulty breathing**. Patients should be informed of these signs and report them immediately.

Indication

**Valsartan + Hydrochlorothiazide** is a combination medication indicated primarily for the management of **hypertension** (high blood pressure). This combination therapy is effective in reducing blood pressure through the following mechanisms: - **Valsartan**, an **angiotensin II receptor blocker (ARB)**, helps lower blood pressure by blocking the action of **angiotensin II**, a substance that causes blood vessels to constrict. - **Hydrochlorothiazide**, a **thiazide diuretic**, promotes the excretion of excess sodium and water from the body, which helps reduce blood volume and lowers blood pressure. - It may also be used for patients who have not achieved adequate blood pressure control with **Valsartan** or **Hydrochlorothiazide** alone. - This combination is useful for patients with **primary hypertension** and is typically prescribed when monotherapy does not provide adequate blood pressure control.

Contra indication

**Valsartan + Hydrochlorothiazide** should not be used in the following situations: - **Pregnancy**: The use of this combination during pregnancy, particularly in the second and third trimesters, is contraindicated due to the risk of fetal harm, including kidney damage and low blood pressure in the baby. - **Severe Renal Impairment**: This medication is contraindicated in patients with **severe renal impairment** (creatinine clearance less than 30 mL/min), as it can worsen kidney function and electrolyte imbalances. - **Hypersensitivity**: Patients who are **allergic** to **valsartan**, **hydrochlorothiazide**, or any of the ingredients in the combination should avoid this medication. - **Severe Hepatic Impairment**: This combination is contraindicated in patients with **severe liver disease**, as it may exacerbate liver dysfunction. - **Anuria**: Patients who are unable to urinate (**anuria**) should not take this combination, as **Hydrochlorothiazide** may worsen kidney function.

Side Effect

Common and severe side effects of **Valsartan + Hydrochlorothiazide** include: - **Common Side Effects**: - **Dizziness**: This may occur, particularly when standing up quickly, due to blood pressure reduction (orthostatic hypotension). - **Headache**: Some patients experience headaches as a side effect, especially when starting the medication. - **Fatigue**: Tiredness or feeling weak is a common side effect. - **Cough**: Although less common than with ACE inhibitors, a mild dry cough may occur. - **Electrolyte Imbalances**: **Low potassium (hypokalemia)**, **low sodium (hyponatremia)**, and **low magnesium** levels can occur, leading to symptoms such as muscle cramps, weakness, or irregular heart rhythms. - **Severe Side Effects**: - **Severe Hypotension**: Especially after the first dose, low blood pressure may occur, causing dizziness, fainting, or a feeling of lightheadedness. - **Kidney Dysfunction**: This medication can lead to worsening kidney function, especially in patients with pre-existing kidney disease. - **Angioedema**: Rare, but some individuals may develop **swelling of the face, lips, tongue, or throat**, which could cause difficulty breathing. - **Hyperkalemia**: High potassium levels may lead to **heart arrhythmias**, which can be life-threatening if not treated promptly. - **Pancreatitis**: In rare cases, **inflammation of the pancreas** can occur, leading to severe abdominal pain, nausea, and vomiting.

Pregnancy Category ID

3

Mode of Action

**Valsartan + Hydrochlorothiazide** works in two different ways to lower blood pressure: - **Valsartan** is an **angiotensin II receptor blocker (ARB)**. It blocks the action of **angiotensin II**, a hormone that causes blood vessels to constrict. By blocking this action, **Valsartan** helps blood vessels relax and dilate, reducing blood pressure. - **Hydrochlorothiazide** is a **thiazide diuretic**, which works by increasing the amount of sodium and water excreted by the kidneys. This reduces the volume of fluid in the blood vessels, helping to lower blood pressure. Together, these two drugs act synergistically to reduce blood pressure, with **Valsartan** primarily focusing on the vasculature and **Hydrochlorothiazide** acting through the kidneys.

Interaction

**Valsartan + Hydrochlorothiazide** may interact with several other medications, which can affect their efficacy or lead to adverse effects: - **Other Antihypertensive Medications**: The combination of **Valsartan + Hydrochlorothiazide** with other antihypertensive drugs (such as **ACE inhibitors**, **beta-blockers**, or **calcium channel blockers**) may enhance the blood pressure-lowering effects, potentially causing **hypotension**. - **Lithium**: The use of **Valsartan + Hydrochlorothiazide** with **lithium** can increase lithium levels, leading to **lithium toxicity**. Regular monitoring of lithium levels is essential. - **NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)**: **NSAIDs** (such as **ibuprofen**, **naproxen**) can reduce the effectiveness of both **Valsartan** and **Hydrochlorothiazide** in lowering blood pressure and may increase the risk of **kidney damage**. - **Potassium-Sparing Diuretics**: Combining this medication with **potassium-sparing diuretics** (such as **spironolactone**) may increase the risk of **hyperkalemia** (high potassium levels). - **Angiotensin-Converting Enzyme (ACE) Inhibitors**: Concurrent use with **ACE inhibitors** (like **lisinopril**) may significantly increase the risk of **hyperkalemia**, **hypotension**, and **kidney dysfunction**. - **Corticosteroids**: **Hydrochlorothiazide** can enhance the effects of **corticosteroids**, which may increase the risk of **electrolyte imbalances**, especially **hypokalemia**.

Pregnancy Category Note

Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, D

Adult Dose

The typical dosing of **Valsartan + Hydrochlorothiazide** in adults depends on the severity of hypertension: - **Initial Dose**: The usual starting dose for most patients is **80 mg of Valsartan** and **12.5 mg of Hydrochlorothiazide** once daily. - **Maintenance Dose**: Depending on the patient's response, the dose may be increased up to **160 mg of Valsartan** and **25 mg of Hydrochlorothiazide** daily. - **Maximum Dose**: The maximum dose is typically **320 mg of Valsartan** and **25 mg of Hydrochlorothiazide** per day. - Doses should be adjusted based on the patient's **blood pressure response** and tolerance.

Child Dose

**Valsartan + Hydrochlorothiazide** is not typically recommended for children under 18 years of age, as its safety and efficacy have not been established in pediatric populations. In cases where pediatric dosing is required, it should be managed by a healthcare provider with expertise in pediatric care. Before initiating treatment with **Valsartan + Hydrochlorothiazide**, patients should always consult with their healthcare provider to determine if it is the right choice based on their individual health conditions and needs. Regular follow-up appointments are necessary to monitor the efficacy of treatment and detect any potential side effects or complications.

Renal Dose

For patients with **renal impairment**, adjustments to the dose of **Valsartan + Hydrochlorothiazide** are necessary: - **Mild to Moderate Renal Impairment (Creatinine Clearance ≥30 mL/min)**: No significant dose adjustments are needed, but kidney function should be monitored regularly. - **Severe Renal Impairment (Creatinine Clearance <30 mL/min)**: Use of this combination is not recommended due to the risk of worsening kidney function.

Administration

Information not available