Benazepril/hctz 5/6.25mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication at the same time every day to establish a routine.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to complete the full course of treatment as prescribed.
Note that this medication may increase your urine production. To minimize sleep disturbances, try to avoid taking your medication too close to bedtime. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, away from direct light and moisture. Avoid storing your medication in the bathroom, as the humidity and temperature fluctuations can affect its potency. Protect your medication from heat sources and keep it in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take this medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking this medication without talking to your doctor, even if you feel well.
- Limit your intake of sodium (salt) as directed by your doctor.
- Maintain a healthy diet rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol consumption.
- Monitor your blood pressure regularly at home if advised by your doctor.
- Avoid potassium supplements or salt substitutes containing potassium unless specifically instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 immediate medical attention:
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 or swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine or changes in urine output
+ Blood in the urine or significant weight gain
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Unusual thirst or hunger
+ Frequent urination or flushing
+ Rapid breathing or 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, seizures, or extreme fatigue
+ Decreased appetite 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 or yellowing of the skin and eyes
+ Fatigue, decreased appetite, or stomach pain
+ Nausea and vomiting or pale-colored stools
Changes in skin moles or the appearance of new or changing skin growths, which can be a sign of skin cancer
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, fatigue, or weakness
Cough
Headache
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden swelling of the face, lips, tongue, or throat (angioedema) - seek emergency medical help immediately.
- Difficulty breathing or swallowing.
- Severe dizziness or fainting.
- Signs of electrolyte imbalance: unusual tiredness, muscle weakness, muscle cramps, irregular heartbeat.
- Signs of kidney problems: decreased urination, swelling in feet or ankles.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, persistent nausea/vomiting.
- Persistent dry cough.
- Severe skin rash or blistering.
Before Using This Medicine
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.
Difficulty urinating or inability 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, especially 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 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.
Precautions & 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 understand 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.
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 can cause your condition to become active or worsen. Inform your doctor immediately if you experience any new or worsening symptoms.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss with your doctor. Low white blood cell counts have occurred with captopril, a similar medication, which may increase the risk of infection. This is more likely to occur in individuals with kidney problems, especially those with certain other health conditions. If you experience signs of infection, such as fever, chills, or sore throat, contact your doctor promptly.
Heat-Related Illness and Fluid Loss
In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent fluid loss. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as this may lead to low blood pressure.
Angioedema and Anaphylaxis
A severe and potentially life-threatening reaction called angioedema has been associated with this medication. 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.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Dizziness, lightheadedness, fainting
- Tachycardia (rapid heart rate)
- Bradycardia (slow heart rate)
- Electrolyte imbalances (e.g., hyperkalemia, hypokalemia, hyponatremia)
- Dehydration
- Renal failure
What to Do:
Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Seek emergency medical attention. Treatment is supportive and symptomatic, including intravenous fluids for hypotension and correction of electrolyte imbalances.
Drug Interactions
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
- Sacubitril/valsartan (within 36 hours of ACE inhibitor)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
- Potassium supplements
- Lithium
- NSAIDs (including COX-2 inhibitors)
- Other antihypertensives (additive hypotensive effects)
- Insulin and oral hypoglycemics (may enhance hypoglycemic effect)
- Corticosteroids (may antagonize diuretic effect)
- Cholestyramine and colestipol (may impair HCTZ absorption)
Moderate Interactions
- Allopurinol (increased risk of hypersensitivity reactions)
- Digoxin (increased risk of digitalis toxicity due to hypokalemia)
- Neuromuscular blocking agents (prolonged blockade)
- Pressor amines (e.g., norepinephrine, reduced response)
- Alcohol, barbiturates, or narcotics (additive orthostatic hypotension)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline and assess efficacy.
Timing: Before initiating therapy
Rationale: To detect pre-existing imbalances and monitor for drug-induced changes.
Timing: Before initiating therapy
Rationale: To assess kidney function and guide dosing, as both drugs are renally cleared.
Timing: Before initiating therapy
Rationale: Benazepril is a prodrug activated in the liver; HCTZ can rarely cause hepatic dysfunction.
Timing: Before initiating therapy
Rationale: Hydrochlorothiazide can increase uric acid levels.
Timing: Before initiating therapy
Rationale: Hydrochlorothiazide can affect glucose metabolism.
Timing: Before initiating therapy
Routine Monitoring
Frequency: Regularly, especially after dose adjustments
Target: <130/80 mmHg (or individualized target)
Action Threshold: Persistently elevated BP indicates need for dose adjustment or alternative therapy; symptomatic hypotension requires intervention.
Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated.
Target: Potassium: 3.5-5.0 mEq/L; Sodium: 135-145 mEq/L
Action Threshold: Potassium <3.5 or >5.5 mEq/L; Sodium <130 or >150 mEq/L requires investigation and intervention.
Frequency: Within 1-2 weeks of initiation or dose change, then periodically (e.g., every 3-6 months) or as clinically indicated.
Target: Stable or within acceptable limits for patient's age/condition
Action Threshold: Significant increase in creatinine (>30% from baseline) or decrease in eGFR requires investigation and potential dose adjustment/discontinuation.
Frequency: Periodically, especially in patients with history of gout.
Target: Within normal limits
Action Threshold: Symptomatic hyperuricemia or gout flare requires intervention.
Frequency: Periodically, especially in diabetic patients.
Target: Individualized glycemic targets
Action Threshold: Significant hyperglycemia requires intervention.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing)
- Persistent dry cough (ACE inhibitor effect)
- Swelling of face, lips, tongue, or throat (angioedema - medical emergency)
- Difficulty breathing or swallowing (angioedema)
- Muscle cramps or weakness (electrolyte imbalance)
- Unusual fatigue or lethargy
- Signs of dehydration (excessive thirst, dry mouth, decreased urination)
- Yellowing of skin or eyes (jaundice - rare, but indicates liver issues)
- Skin rash or itching
Special Patient Groups
Pregnancy
Contraindicated in the 2nd and 3rd trimesters due to risk of fetal injury and death. Use in the 1st trimester is generally discouraged due to potential risks.
Trimester-Specific Risks:
Lactation
Both benazepril and hydrochlorothiazide are excreted in human milk. Use during lactation is generally not recommended due to potential for adverse effects in the infant (e.g., hypotension, electrolyte disturbances) and potential to suppress lactation (HCTZ).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the hypotensive and electrolyte-altering effects. Start with lower doses and titrate slowly. Monitor renal function and electrolytes closely.
Clinical Information
Clinical Pearls
- This combination is often used when monotherapy with an ACE inhibitor or diuretic is insufficient to control blood pressure.
- Advise patients to report any signs of angioedema (swelling of face, lips, tongue, throat) immediately, as this is a life-threatening emergency.
- Counsel patients on the importance of avoiding potassium supplements or salt substitutes unless specifically advised by their physician, due to the risk of hyperkalemia with benazepril.
- Hydrochlorothiazide can increase uric acid levels and may precipitate gout attacks in susceptible individuals.
- Patients should be advised to stay well-hydrated, especially during exercise or hot weather, but avoid excessive fluid intake without medical advice.
- Orthostatic hypotension (dizziness upon standing) is a common side effect, especially at the start of therapy or with dose increases. Advise patients to rise slowly from a sitting or lying position.
Alternative Therapies
- Other classes of antihypertensives (e.g., ARBs, Calcium Channel Blockers, Beta-blockers, other diuretics)
- Lifestyle modifications (diet, exercise, weight management, stress reduction)