Benazepril/hctz 10/12.5mg Tablets

Benazepril is a prodrug that is hydrolyzed to benazeprilat, an angiotensin-converting enzyme (ACE) inhibitor. It prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor, thereby reducing peripheral vascular resistance and aldosterone secretion. This leads to decreased sodium and water retention. Hydrochlorothiazide is a thiazide diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule, increasing the excretion of sodium, chloride, and water, as well as potassium and magnesium. This reduces plasma volume and peripheral vascular resistance.

Urgent 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty 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 or drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing or rapid breathing
+ Fruity-smelling breath
Signs of fluid and electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Changes in urine output or inability to pass urine
+ Dry mouth, dry eyes, or severe nausea and 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
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellowing of the skin or eyes

Additional Important Safety Information

This medication can increase the risk of certain types of skin cancer. To minimize this risk, 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.

Other Possible Side Effects

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

Dizziness, tiredness, or weakness
Cough
* Headache

If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, you can contact your doctor or report them to the FDA at 1-800-332-1088 or 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.
Elevated calcium levels.
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, particularly 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 disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health conditions. 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 activities that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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.

Interactions with Lab Tests and Other Medications
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication. 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 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 and Substances
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 and Risks
Be aware of the risk of gout attacks. If you have lupus, this medication may activate or worsen your condition. Report any new or worsening symptoms to your doctor promptly.

Cholesterol and Triglyceride Levels
This medication may cause increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss with your doctor.

Infection Risk
Low white blood cell counts have been associated with captopril, a similar medication. This may increase the risk of infection, particularly in people with kidney problems and other underlying health conditions. Seek medical attention immediately if you experience symptoms of infection, such as fever, chills, or sore throat.

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

Angioedema Risk
A severe and potentially life-threatening reaction called angioedema has been reported. The risk of angioedema 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 (concurrent use or within 36 hours of switching)
• Neprilysin inhibitors (e.g., sacubitril)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• NSAIDs (e.g., ibuprofen, naproxen, celecoxib) (may reduce antihypertensive effect and increase risk of renal impairment)
• Lithium (increased serum lithium levels and toxicity)
• Other antihypertensive agents (additive hypotensive effects)
• Drugs that increase serum potassium (e.g., trimethoprim, cyclosporine, heparin)
• Corticosteroids (may antagonize diuretic effect of HCTZ)
• Digoxin (thiazide-induced hypokalemia may potentiate digoxin toxicity)
• Antidiabetic agents (insulin, oral hypoglycemics) (thiazides may decrease glucose tolerance, requiring dose adjustment)

• Allopurinol (increased risk of hypersensitivity reactions with HCTZ)
• Cholestyramine and colestipol resins (may reduce absorption of HCTZ)
• Skeletal muscle relaxants, non-depolarizing (e.g., tubocurarine) (thiazides may potentiate their effect)
• Pressor amines (e.g., norepinephrine) (thiazides may decrease arterial responsiveness)
• Alcohol, barbiturates, or narcotics (may potentiate orthostatic hypotension)

• Not available

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Persistent dry cough (common ACEI side effect)
• Swelling of face, lips, tongue, or throat (signs of angioedema, requires immediate medical attention)
• Muscle cramps or weakness (signs of electrolyte imbalance, especially hypokalemia)
• Unusual fatigue or lethargy
• Signs of dehydration (dry mouth, thirst)
• Yellowing of skin or eyes, dark urine (signs of liver problems, rare)
• Sudden decrease in vision or eye pain (signs of acute angle-closure glaucoma, rare but serious with HCTZ)

Contraindicated in the second and third trimesters of pregnancy due to risk of fetal injury and death (renal dysfunction, oligohydramnios, skeletal malformations, lung hypoplasia). Use in the first trimester is generally discouraged, and alternative antihypertensive therapies should be considered if pregnancy is planned or detected.

Both benazepril and hydrochlorothiazide are excreted in breast milk. Use with caution. Monitor breastfed infants for signs of hypotension, dehydration, and electrolyte imbalances. Lower doses or alternative agents may be preferred, especially in preterm infants or those with renal impairment.

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 (e.g., hypokalemia, hyponatremia) and may have age-related decline in renal function. Initiate at the lower end of the dosing range and titrate slowly with close monitoring of blood pressure, renal function, and electrolytes.

• This combination is often used when monotherapy with an ACE inhibitor or a thiazide diuretic is insufficient to control blood pressure.
• The diuretic component (HCTZ) helps to counteract the sodium and water retention that can sometimes occur with ACE inhibitors, and the ACE inhibitor (benazepril) helps to mitigate the potassium loss associated with thiazide diuretics.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a serious and potentially life-threatening side effect of ACE inhibitors.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate switching to an ARB/diuretic combination if intolerable.
• Monitor for orthostatic hypotension, especially at the start of therapy, with dose increases, or in volume-depleted patients.
• Patients with a history of gout or diabetes should be monitored closely for exacerbation of these conditions due to the HCTZ component.

• Other classes of antihypertensives (e.g., Calcium Channel Blockers, Beta-blockers, Alpha-blockers, direct vasodilators)
• Monotherapy with an ACE inhibitor (e.g., Benazepril)
• Monotherapy with a thiazide diuretic (e.g., Hydrochlorothiazide, Chlorthalidone)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it's a good idea to consult with your pharmacist. 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.