Amlodipine-Benaz 5/10mg Capsules

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 a reduction in peripheral vascular resistance, thereby 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 systemic vascular resistance, reduced aldosterone secretion (leading to decreased sodium and water retention), and reduced bradykinin degradation, all contributing to blood pressure reduction.

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 immediately or seek emergency 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, which can be life-threatening, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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.

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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This information will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or modify the dosage of any medication without consulting your doctor.

Important Information About Your Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

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, stand up slowly after sitting or lying down, 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 with 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 inform your doctor.

Monitoring Your Condition

Regularly check your blood pressure as directed by your doctor, and undergo blood tests as scheduled. This will help your doctor monitor your condition and adjust your treatment plan if necessary.

Rare but Serious Risks

Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose. In some cases, this may lead to a heart attack, particularly in individuals with severe heart blood vessel disease. If you experience any chest pain or discomfort, seek medical attention immediately.

Infection Risk

This medication can cause a decrease in white blood cell count, which may increase your risk of infection. This is more likely to occur in people with kidney problems, especially those with other underlying health conditions. If you develop symptoms of an infection, such as fever, chills, or sore throat, contact your doctor right away.

Interactions with Other Medications and Substances

Before taking any over-the-counter (OTC) products, including 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. These substances may interact with your medication and increase your blood pressure. Also, discuss your alcohol consumption with your doctor, as it may affect your treatment.

Staying Safe in Hot Weather and During Physical Activity

Be cautious in hot weather or when engaging in physical activity, as this can lead to fluid loss. Drink plenty of fluids to stay hydrated, and inform your doctor if you experience excessive sweating, vomiting, diarrhea, or loose stools, as these can cause low blood pressure.

Rare but Serious Allergic Reaction

In rare cases, a severe and potentially life-threatening allergic reaction called angioedema can occur. This risk may be higher in Black patients. If you experience any symptoms of an allergic reaction, seek medical attention immediately.

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.

• Aliskiren (in patients with diabetes or renal impairment due to increased risk of hypotension, hyperkalemia, and renal impairment)
• Sacubitril/Valsartan (Entresto) (due to increased risk of angioedema with ACE inhibitors; do not administer within 36 hours of switching from or to an ACE inhibitor)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes (increased risk of hyperkalemia)
• NSAIDs (including COX-2 inhibitors) (may reduce antihypertensive effect of benazepril and increase risk of renal impairment, especially in elderly or volume-depleted patients)
• Lithium (increased serum lithium levels and toxicity)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) (increased risk of angioedema)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (may increase amlodipine exposure, leading to increased hypotensive effects)
• Dantrolene (intravenous) (risk of hyperkalemia and cardiovascular collapse with amlodipine)

• Other antihypertensive agents (additive hypotensive effects)
• Diuretics (enhanced hypotensive effect, especially initial doses)
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) (may decrease amlodipine exposure, reducing efficacy)
• Simvastatin (amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg daily)
• Cyclosporine, Tacrolimus (amlodipine may increase levels of these immunosuppressants; monitor levels)
• Gold (injectable) (nitritoid reactions, including facial flushing, nausea, vomiting, and hypotension, reported rarely with concomitant ACE inhibitor therapy)

• Grapefruit juice (may increase amlodipine exposure, but generally not clinically significant with typical consumption)
• Antacids (may slightly decrease benazepril absorption, but generally not clinically significant)

• Dizziness or lightheadedness (especially upon standing)
• Swelling of face, lips, tongue, or throat (angioedema)
• Persistent dry cough
• Fatigue or weakness
• Peripheral edema (swelling of ankles/feet)
• Chest pain or palpitations (rare, but report new or worsening symptoms)

Contraindicated in the 2nd and 3rd trimesters of pregnancy due to the risk of fetal injury and death from the ACE inhibitor component. Discontinue as soon as pregnancy is detected. Exposure during the first trimester is also associated with potential risks.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted into human milk. Use with caution during breastfeeding. Monitor the infant for adverse effects, particularly hypotension.

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

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate slowly, monitoring renal function and blood pressure closely, due to potential for decreased renal function and increased sensitivity to hypotensive effects.

• This combination is particularly useful for patients who have not achieved adequate blood pressure control with monotherapy or who experience peripheral edema with amlodipine alone (ACEIs can help mitigate CCB-induced edema).
• The benazepril component can cause a persistent dry cough in some patients. If bothersome, discuss with a healthcare provider as an alternative ACEI or a different class of antihypertensive may be considered.
• Patients should be advised to report any signs of angioedema (swelling of face, lips, tongue, or throat) immediately, as this is a serious, potentially life-threatening side effect of ACE inhibitors.
• Avoid potassium supplements or salt substitutes containing potassium unless specifically advised by a healthcare provider, due to the risk of hyperkalemia with benazepril.
• Take consistently at the same time each day, with or without food.

• Other ACE inhibitors (e.g., lisinopril, enalapril, ramipril)
• Other Calcium Channel Blockers (e.g., nifedipine, felodipine, diltiazem, verapamil)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan, candesartan)
• Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Direct Renin Inhibitors (e.g., aliskiren)

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's a good idea 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.