Benazepril/hctz 20/25mg Tablets

Benazepril is an ACE inhibitor. It prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, leading to decreased systemic vascular resistance, reduced aldosterone secretion (which decreases sodium and water reabsorption), and increased bradykinin levels (contributing to vasodilation). Hydrochlorothiazide is a thiazide diuretic. It inhibits sodium reabsorption in the distal convoluted tubules, leading to increased excretion of sodium, chloride, and water. It also increases potassium and bicarbonate excretion and decreases calcium excretion.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Kidney problems: Inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
High blood sugar: Confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Fluid and electrolyte imbalances: Mood changes, confusion, muscle pain or weakness, irregular heartbeat, severe dizziness or fainting, increased thirst, seizures, fatigue, weakness, decreased appetite, changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Persistent cough: A cough that does not go away.
Stomach pain: Severe or persistent stomach pain.
Eye problems: Changes in vision or eye pain, which can occur within hours to weeks of starting this medication. If left untreated, these problems can lead to permanent vision loss.
Liver problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes. In rare cases, liver problems can be fatal.

Other Potential Side Effects

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following:

Common side effects: Dizziness, tiredness, weakness, cough, or headache. If these symptoms bother you or persist, contact your doctor or seek medical attention.
Skin cancer: Rarely, people taking hydrochlorothiazide may develop certain types of skin cancer. Protect your skin from the sun and follow your doctor's recommendations for skin checks. If you notice any changes in the color or size of a mole, or any new or changing skin lump or growth, contact your doctor immediately.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A known sulfa allergy.
A history of angioedema, a severe and potentially life-threatening reaction characterized by symptoms such as swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
High calcium levels in your blood.
Inability to urinate.
Current or planned use of the following medications:
+ Azilsartan
+ Candesartan
+ Eprosartan
+ Fimasartan
+ Irbesartan
+ Losartan
+ Olmesartan
+ Telmisartan
+ Valsartan
Use of a medication containing aliskiren, especially if you have diabetes or kidney problems.
Use of dofetilide.
Recent use (within the last 36 hours) of a medication containing sacubitril.
Breastfeeding or plans to breastfeed.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to verify the safety of taking this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
If you have diabetes (high blood sugar), closely monitor your blood sugar levels. Check your blood pressure as directed by your healthcare provider. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor.

Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

Dietary Considerations
If you are on a low-salt or salt-free diet, consult with your doctor. Also, if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor.

Over-the-Counter (OTC) Products and Interactions
Before using OTC products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult with your doctor.

Interactions with Other Medications
If you take cholestyramine or colestipol, consult with your pharmacist about how to take these medications with this drug. Before using alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may cause drowsiness, discuss this with your doctor.

Potential Side Effects
Be aware of the following potential side effects:

Gout attacks: Monitor for symptoms
Lupus: This medication can activate or worsen lupus. Report any new or worsening symptoms to your doctor immediately
High cholesterol and triglyceride levels: If you have a history of high cholesterol or triglycerides, discuss this with your doctor
Low white blood cell counts: This can increase the risk of infection, particularly in people with kidney problems. Seek medical attention if you experience symptoms like fever, chills, or sore throat
Dehydration: In hot weather or during physical activity, drink plenty of fluids to prevent fluid loss. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as this can lead to low blood pressure
Angioedema: A severe and potentially life-threatening reaction that may be more common in Black patients
* Age-related precautions: If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

• Aliskiren (in patients with diabetes or moderate to severe renal impairment)
• Sacubitril/valsartan (within 36 hours of ACE inhibitor dose)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Lithium (increased serum lithium levels and toxicity)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors (attenuation of antihypertensive effect, increased risk of renal impairment, especially in dehydrated or elderly patients)
• Other antihypertensives (additive hypotensive effects)
• Dual blockade of the Renin-Angiotensin System (RAS) with ARBs or aliskiren (increased risk of hypotension, hyperkalemia, and renal impairment)
• Corticosteroids (may antagonize diuretic effect of HCTZ)
• Digitalis glycosides (increased risk of digitalis toxicity due to hypokalemia/hypomagnesemia from HCTZ)
• Insulin and oral antidiabetic agents (HCTZ may decrease glucose tolerance, requiring dose adjustment of antidiabetic agents)

• Cholestyramine and colestipol resins (may impair absorption of HCTZ)
• Muscle relaxants, non-depolarizing (prolonged effect due to HCTZ)
• Pressor amines (e.g., norepinephrine) (decreased response to pressor amines due to HCTZ)
• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Tetracyclines (increased risk of uremia with HCTZ)
• Barbiturates, narcotics, or alcohol (additive orthostatic hypotension)

• Not specifically listed as minor, but general caution with other medications that affect blood pressure or electrolytes.

• Dizziness or lightheadedness (especially upon standing)
• Persistent dry cough (ACE inhibitor effect)
• Swelling of face, lips, tongue, or throat (angioedema - rare but serious)
• Unusual fatigue or weakness
• Muscle cramps or weakness (electrolyte imbalance)
• Nausea, vomiting, or excessive thirst (dehydration, electrolyte imbalance)
• Signs of gout (joint pain, swelling)
• Signs of liver problems (yellowing skin/eyes, dark urine, severe stomach pain)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death (renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and death). Discontinue as soon as pregnancy is detected.

Both benazeprilat and hydrochlorothiazide are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., hypotension, hyperkalemia, and effects on renal function from benazeprilat; and potential for hypokalemia, and interference with bilirubin metabolism from HCTZ), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

Use with caution. Elderly patients may be more sensitive to the hypotensive and electrolyte-altering effects. Start with lower doses and monitor renal function and electrolytes closely. HCTZ may be less effective in elderly patients with reduced renal function.

• This combination is typically used when monotherapy with either an ACE inhibitor or a thiazide diuretic is insufficient to control blood pressure.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, or throat) immediately, as this is a life-threatening emergency.
• Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in volume-depleted patients.
• Counsel patients on the importance of avoiding potassium supplements or salt substitutes unless specifically advised by their physician due to the ACE inhibitor component.
• Thiazide diuretics can increase serum uric acid and glucose levels; monitor patients with a history of gout or diabetes closely.
• Patients should be advised to inform their healthcare provider if they become pregnant or plan to become pregnant due to the severe fetal toxicity risk.

• Other classes of antihypertensives (e.g., ARBs, Calcium Channel Blockers, Beta-blockers, other diuretics)
• Monotherapy with an ACE inhibitor (e.g., Benazepril)
• Monotherapy with a thiazide diuretic (e.g., Hydrochlorothiazide)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, the amount consumed, and the time it occurred.