Amlodipine-Benaz 2.5/10mg Capsules

Manufacturer DR.REDDY'S LABORATORIES, INC. Active Ingredient Amlodipine and Benazepril(am LOE di peen & ben AY ze pril) Pronunciation am LOE di peen & ben AY ze pril
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive
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Pharmacologic Class
Calcium Channel Blocker (dihydropyridine) / Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Category D
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FDA Approved
Aug 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a combination of two drugs, amlodipine and benazepril, used to treat high blood pressure. Amlodipine helps relax blood vessels, making it easier for blood to flow. Benazepril also relaxes blood vessels and helps your body get rid of extra water and salt. Together, they help lower your blood pressure, which can reduce your risk of heart attack and stroke.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

To keep your medication safe and effective, store it at room temperature in a dry place, away from the bathroom. Keep all medications out of the reach of children and pets, and store them in a secure location. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's been 12 hours or more since the missed dose, skip it and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking the medication without consulting your doctor, even if you feel well.
  • Limit alcohol intake as it can further lower blood pressure.
  • Follow a low-sodium diet as recommended by your doctor.
  • Engage in regular physical activity.
  • Maintain a healthy weight.
  • Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
  • Inform your doctor or dentist that you are taking this medication before any surgery or dental procedures.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg amlodipine/10 mg benazepril once daily
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

initialTherapy: Start with 2.5 mg amlodipine/10 mg benazepril or 5 mg amlodipine/20 mg benazepril once daily.
titration: Dosage may be increased after 2 weeks, up to a maximum of 10 mg amlodipine/40 mg benazepril once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No initial dosage adjustment typically needed for CrCl > 30 mL/min.
Moderate: For CrCl ≤ 30 mL/min, consider starting with a lower dose (e.g., 2.5 mg amlodipine/10 mg benazepril) and titrate carefully. Monitor renal function closely.
Severe: For CrCl ≤ 30 mL/min, consider starting with a lower dose (e.g., 2.5 mg amlodipine/10 mg benazepril) and titrate carefully. Monitor renal function closely.
Dialysis: Benazeprilat is dialyzable to some extent. Amlodipine is not dialyzable. Administer dose after dialysis on dialysis days. Monitor blood pressure and renal function.

Hepatic Impairment:

Mild: No specific adjustment for benazepril. For amlodipine, consider starting with 2.5 mg daily in severe hepatic impairment.
Moderate: No specific adjustment for benazepril. For amlodipine, consider starting with 2.5 mg daily in severe hepatic impairment.
Severe: Consider starting with 2.5 mg amlodipine/10 mg benazepril once daily. Titrate slowly and monitor closely due to prolonged amlodipine half-life.

Pharmacology

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Mechanism of Action

Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. This leads to peripheral arterial vasodilation and reduction in peripheral vascular resistance, lowering blood pressure. Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor and stimulator of aldosterone secretion. This results in decreased vasoconstriction, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), and inhibition of bradykinin degradation, all contributing to blood pressure reduction.
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Pharmacokinetics

Absorption:

Bioavailability: Amlodipine: 64-90%; Benazepril: ~37% (of benazeprilat)
Tmax: Amlodipine: 6-12 hours; Benazepril: 0.5-1 hour (benazepril), 1-2 hours (benazeprilat)
FoodEffect: Amlodipine: Not significantly affected; Benazepril: Reduced absorption but not clinically significant.

Distribution:

Vd: Amlodipine: ~21 L/kg; Benazeprilat: ~8.7 L
ProteinBinding: Amlodipine: ~97.5%; Benazepril: ~96.7%; Benazeprilat: ~95.3%
CnssPenetration: Limited

Elimination:

HalfLife: Amlodipine: 30-50 hours; Benazeprilat: Effective half-life 10-11 hours, terminal 22-24 hours
Clearance: Not available (specific values for combination)
ExcretionRoute: Amlodipine: Urine (60% as metabolites), feces (20-25%); Benazeprilat: Urine (primarily)
Unchanged: Amlodipine: ~10% in urine; Benazepril: <1% in urine
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Pharmacodynamics

OnsetOfAction: Amlodipine: Gradual; Benazepril: ~1 hour
PeakEffect: Amlodipine: 6-12 hours; Benazepril: 2-4 hours
DurationOfAction: Amlodipine: 24 hours; Benazepril: 24 hours

Safety & Warnings

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BLACK BOX WARNING

FETAL TOXICITY: When pregnancy is detected, discontinue Amlodipine and Benazepril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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Side Effects

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 immediate medical attention:

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 potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
New or worsening chest pain
Swelling in the arms or legs
Severe stomach pain
Severe nausea or vomiting
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)

Note: Liver problems have been reported with similar medications, and in some cases, have been fatal. If you experience any signs of liver problems, seek medical attention immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Dizziness
* Cough

This is not an exhaustive list of possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Difficulty breathing or swallowing - seek immediate medical attention.
  • Severe dizziness or fainting.
  • Persistent dry cough.
  • Yellowing of the skin or eyes (jaundice).
  • Unusual tiredness or weakness.
  • Signs of infection (fever, sore throat).
  • New or worsening swelling in the ankles or feet.
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Before Using This Medicine

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

It is essential to inform your doctor about the following conditions 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 you experienced, including the symptoms that occurred.
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.
Kidney disease, as this condition may affect how your body processes the medication.
Dehydration or electrolyte imbalances, as these conditions can impact the safety and efficacy of the treatment.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
Recent use (within the last 36 hours) of a medication containing sacubitril, as this may interact with the current treatment.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor to avoid potential interactions and ensure your safety.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

When to Expect Results and Precautions

You may need to wait a few weeks to experience the full effects of this medication. In the meantime, be cautious when driving or engaging in activities that require your full attention, as this medication may affect your alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be careful when climbing stairs.

Allergies and Interactions

If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor before taking this medication, as some products may contain this ingredient. Additionally, if you are taking a salt substitute that contains potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. If you are on a low-salt or salt-free diet, also consult your doctor.

Monitoring Your Condition

Regularly check your blood pressure as directed by your doctor, and have blood work done as scheduled. This will help your doctor monitor your condition and adjust your treatment plan as needed.

Rare but Serious Risks

In rare cases, this medication may cause new or worsening chest pain, which can increase the risk of heart attack. This risk may be higher in people with severe heart blood vessel disease. Low white blood cell counts have also been reported with similar medications, particularly in people with kidney problems and other underlying health conditions. If you experience signs of infection, such as fever, chills, or sore throat, contact your doctor immediately.

Interactions with Other Medications and Substances

Before taking over-the-counter (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 or aids, consult your doctor. Also, discuss your alcohol consumption with your doctor, as it may interact with this medication.

Precautions in Hot Weather and Other Situations

Be cautious in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, contact your doctor, as these conditions may lead to low blood pressure.

Rare but Serious Allergic Reaction

A severe and potentially life-threatening reaction called angioedema has been reported with this medication. The risk of angioedema may be higher in Black patients.

Special Considerations for Older Adults and Breastfeeding Mothers

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Bradycardia (slow heart rate)
  • Tachycardia (fast heart rate)
  • Dizziness
  • Lightheadedness
  • Fainting
  • Shock
  • Electrolyte imbalances (e.g., hyperkalemia)
  • Renal failure

What to Do:

Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Supportive care, including intravenous fluids, vasopressors, and atropine for bradycardia, may be necessary. Gastric lavage or activated charcoal may be considered if ingestion is recent. Hemodialysis is not effective for amlodipine, but may help remove benazeprilat.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Sacubitril/Valsartan (Entresto) - concurrent use or within 36 hours of last dose of ACE inhibitor
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • Lithium
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus)
  • Gold therapy (injectable)
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Moderate Interactions

  • Other antihypertensive agents (additive hypotensive effect)
  • Diuretics (enhanced hypotensive effect)
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem, verapamil) - increased amlodipine exposure
  • CYP3A4 inducers (e.g., rifampin, St. John's Wort, carbamazepine, phenobarbital, phenytoin) - decreased amlodipine exposure
  • Simvastatin (increased simvastatin exposure)
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Minor Interactions

  • Not typically listed for this level of detail

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline.

Timing: Prior to initiation

Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)

Rationale: To assess baseline renal function, especially important for benazepril.

Timing: Prior to initiation

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as ACE inhibitors can cause hyperkalemia.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially important for amlodipine.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose changes, then periodically (e.g., monthly to every 3-6 months) once stable.

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent readings above target or symptomatic hypotension.

Serum Creatinine (SCr) and Blood Urea Nitrogen (BUN)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 6-12 months) or as clinically indicated.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant increase (>30% from baseline) or signs of acute kidney injury.

Serum Potassium (K+)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 6-12 months) or as clinically indicated, especially with concomitant medications affecting potassium.

Target: 3.5-5.0 mEq/L

Action Threshold: Hyperkalemia (>5.5 mEq/L) or hypokalemia.

Peripheral Edema

Frequency: At each visit.

Target: Absence of significant edema.

Action Threshold: New or worsening ankle/leg swelling.

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Persistent dry cough
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing
  • Chest pain
  • Palpitations
  • Unusual fatigue or weakness
  • Yellowing of skin or eyes (jaundice)
  • Dark urine

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential for major congenital malformations. Generally avoided.
Second Trimester: Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and death.
Third Trimester: Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and death.
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Lactation

Both amlodipine and benazepril are excreted in human milk. Use with caution. Monitor breastfed infants for hypotension, bradycardia, and hyperkalemia.

Infant Risk: Low to moderate risk. Potential for hypotension, bradycardia, and hyperkalemia in the infant. Consider alternative agents, especially for preterm or newborn infants.
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Pediatric Use

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

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Geriatric Use

Start at the lower end of the dosing range due to potential for increased sensitivity, reduced renal function, and increased risk of adverse effects (e.g., hypotension, peripheral edema). Monitor renal function and electrolytes closely.

Clinical Information

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Clinical Pearls

  • This combination offers the benefits of both a CCB and an ACEI, which can provide synergistic blood pressure lowering and may be beneficial for patients who do not achieve target BP with monotherapy.
  • The most common side effects are peripheral edema (from amlodipine) and cough (from benazepril).
  • Patients should be educated on the signs and symptoms of angioedema and instructed to seek immediate medical attention if they occur.
  • Regular monitoring of renal function and serum potassium is crucial, especially in patients with pre-existing renal impairment or those on concomitant medications that affect potassium levels.
  • Avoid concomitant use with potassium supplements or salt substitutes containing potassium unless specifically advised by a physician and with close monitoring.
  • Due to the risk of fetal toxicity, this medication is contraindicated in pregnancy and should be discontinued immediately if pregnancy is detected.
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Alternative Therapies

  • Other ACE inhibitors (e.g., lisinopril, enalapril)
  • Other Calcium Channel Blockers (e.g., nifedipine, felodipine)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Direct Renin Inhibitors (e.g., aliskiren - with caution)
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Cost & Coverage

Average Cost: Varies widely, typically $15-$100+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.