Benazepril/hctz 20/12.5mg Tablets

Benazepril is an angiotensin-converting enzyme (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 (leading to vasodilation). Hydrochlorothiazide is a thiazide diuretic. It inhibits sodium reabsorption in the distal convoluted tubule, leading to increased excretion of sodium, chloride, and water. It also increases potassium and magnesium excretion and decreases calcium excretion. The combination provides additive antihypertensive effects and helps mitigate some of the electrolyte imbalances (e.g., hypokalemia) that can occur with diuretic monotherapy.

Serious Side Effects: Seek Medical Help Right Away

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 immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Fatigue or weakness
+ Decreased appetite
+ Changes in urine output
+ Dry mouth
+ Dry eyes
+ Severe nausea or vomiting
Persistent cough
Stomach pain
Eye problems, such as changes in vision or eye pain, which can lead to permanent vision loss if left untreated. These symptoms usually occur within hours to weeks of starting the medication.
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Important Warnings

This medication can increase the risk of certain types of skin cancer. Protect your skin from the sun and follow your doctor's instructions 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.
Liver problems have been reported with similar medications, and in some cases, have been fatal.

Common Side Effects

Not everyone experiences side effects, and many people have only minor symptoms. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness
Fatigue
Weakness
Cough
* Headache

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.
Urinary retention, which means you are unable to pass urine.
Current or planned use of the following medications:
+ Azilsartan
+ Candesartan
+ Eprosartan
+ Fimasartan
+ Irbesartan
+ Losartan
+ Olmesartan
+ Telmisartan
+ Valsartan
Use of a medication containing aliskiren, particularly if you have diabetes or kidney problems.
Use of dofetilide.
Recent use (within the last 36 hours) of a medication containing sacubitril.
Breast-feeding or plans to breast-feed.

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. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dose 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, discuss with your doctor if you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product.

Over-the-Counter (OTC) Products
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, and certain natural products or aids, consult with your doctor.

Interactions with Other Medications
If you take cholestyramine or colestipol, consult with your pharmacist about how to take them with this medication. Before using alcohol, marijuana or other forms of cannabis, or prescription or OTC medications that may slow your actions, discuss 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 high cholesterol or triglycerides, discuss 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

Heat and Fluid Loss
In hot weather or during physical activity, drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these can lead to low blood pressure.

Angioedema
A severe and potentially life-threatening reaction called angioedema can occur. The risk may be higher in Black patients.

Special Considerations for Older Adults
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 renal impairment)
• Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of switching
• Angiotensin Receptor Blockers (ARBs) - in patients with diabetes or renal impairment (dual blockade)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
• Potassium supplements - increased risk of hyperkalemia
• Lithium - increased serum lithium levels and toxicity
• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect, increase risk of renal impairment (especially in elderly, volume-depleted, or renally impaired patients)
• Other antihypertensives - additive hypotensive effects
• Insulin and oral antidiabetic agents - HCTZ may decrease glucose tolerance, requiring adjustment of antidiabetic medication
• Corticosteroids, ACTH - intensified electrolyte depletion, particularly hypokalemia
• Digoxin - hypokalemia/hypomagnesemia induced by HCTZ can increase digoxin toxicity
• Allopurinol - increased risk of hypersensitivity reactions to allopurinol
• Colestyramine and colestipol resins - impaired absorption of HCTZ

• Barbiturates, narcotics, alcohol - may potentiate orthostatic hypotension
• Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant
• Calcium salts - increased serum calcium levels due to decreased excretion by HCTZ
• Immunosuppressants (e.g., cyclosporine) - increased risk of hyperuricemia and gout-type complications with HCTZ
• Trimethoprim - increased risk of hyperkalemia

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Dry cough (persistent, non-productive)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing
• Muscle cramps or weakness (electrolyte imbalance)
• Unusual thirst
• Nausea/vomiting
• Signs of infection (fever, sore throat - rare, but possible neutropenia)

CONTRAINDICATED. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Discontinue as soon as pregnancy is detected.

Both benazepril and hydrochlorothiazide are excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., hypotension, hyperkalemia, and effects on renal function from benazepril; and potential for hypokalemia, jaundice, and growth inhibition from HCTZ), breastfeeding is generally not recommended during treatment.

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 effects (e.g., hypokalemia, hyponatremia) and may have age-related decline in renal function, requiring careful dose titration and monitoring. Start with lower doses and monitor closely.

• This combination is effective for patients whose blood pressure is not adequately controlled with monotherapy or who experience diuretic-induced hypokalemia with HCTZ alone.
• The dry cough is a common side effect of ACE inhibitors and is not dose-dependent. If bothersome, switching to an ARB/diuretic combination may be considered.
• Angioedema is a rare but life-threatening side effect of ACE inhibitors. Patients should be educated on its symptoms and instructed to seek immediate medical attention if it occurs.
• Monitor for orthostatic hypotension, especially at initiation, with dose increases, or in volume-depleted patients.
• Advise patients to avoid sudden changes in position to minimize dizziness.
• Patients should be advised to report any signs of infection (e.g., fever, sore throat) due to the rare risk of neutropenia with ACE inhibitors.
• Thiazide diuretics can worsen gout and diabetes control; monitor uric acid and blood glucose levels accordingly.

• Other classes of antihypertensives (e.g., Calcium Channel Blockers, Beta-blockers, Alpha-blockers, direct vasodilators)
• ACE inhibitor monotherapy (e.g., Benazepril)
• Thiazide diuretic monotherapy (e.g., Hydrochlorothiazide)
• Angiotensin Receptor Blocker (ARB) monotherapy
• Other diuretic classes (e.g., loop diuretics, potassium-sparing diuretics)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.