Amlodipine-Benaz 10/40mg 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 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 vasoconstriction, reduced aldosterone-mediated sodium and water retention, and decreased bradykinin degradation, leading to vasodilation and reduced blood pressure.

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
Liver problems, which can be indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)

Other Possible Side Effects

Most people experience either no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Dizziness
* Cough

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 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 increase the risk of adverse effects.
Concurrent use of a medication containing aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of complications.
Recent use (within the last 36 hours) of a medication containing sacubitril, as this may interact with the current medication.

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 health problems you are experiencing. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dose 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 performing tasks that require alertness, as this medication may affect you. 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 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 instructed by your doctor, and have blood work done as recommended. This will help your doctor monitor your condition and adjust your treatment plan as needed.

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, consult your doctor immediately.

Infection Risk

Low white blood cell counts have been reported with captopril, a similar medication. This may increase your risk of infection, especially if you have kidney problems or other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor right away.

Over-the-Counter Medications and Interactions

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, consult your doctor. These products may interact with your medication or increase your blood pressure.

Alcohol and Fluid Intake

Discuss your alcohol consumption with your doctor before drinking. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

Severe Allergic Reactions

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. If you experience any symptoms of angioedema, such as swelling of the face, lips, tongue, or throat, seek medical attention immediately.

Special Considerations

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 (GFR < 60 mL/min/1.73 m²))
• 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, salt substitutes containing potassium (increased risk of hyperkalemia)
• Lithium (increased serum lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors) (may reduce antihypertensive effect of ACE inhibitors and increase risk of renal impairment, especially in dehydrated or elderly patients)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) (increased risk of angioedema)
• Gold (injectable) (nitritoid reactions, including facial flushing, nausea, vomiting, and hypotension, rarely reported in patients on ACE inhibitors receiving injectable gold)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) (may increase amlodipine exposure, leading to increased hypotensive effects)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) (may decrease amlodipine exposure, leading to reduced efficacy)

• Other antihypertensive agents (additive hypotensive effects)
• Diuretics (increased risk of symptomatic hypotension, especially with initial doses)
• Tacrolimus (increased tacrolimus blood levels with amlodipine co-administration)
• Simvastatin (amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg daily)
• Dantrolene (intravenous) (risk of hyperkalemia and cardiovascular collapse with amlodipine)

• Grapefruit juice (may increase amlodipine exposure, but generally not clinically significant for most patients)

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Swelling of face, lips, tongue, throat, or extremities (angioedema, a serious side effect of ACE inhibitors)
• Persistent dry cough (common side effect of ACE inhibitors)
• Fatigue or weakness
• Shortness of breath
• Chest pain (rare, but can occur with amlodipine in some patients)
• Yellowing of skin or eyes, dark urine, severe abdominal pain (signs of hepatic dysfunction)

Contraindicated during pregnancy, especially during the second and third trimesters, due to the risk of fetal injury and death associated with ACE inhibitors. If pregnancy is detected, discontinue as soon as possible.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk. Due to the potential for serious adverse effects in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. 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 of individual components if needed, and titrate slowly. Monitor renal function and electrolytes closely due to increased risk of adverse effects in this population.

• This combination is useful for patients who require both a CCB and an ACE inhibitor for blood pressure control, or for those whose blood pressure is not adequately controlled on monotherapy.
• Angioedema is a rare but potentially life-threatening side effect of ACE inhibitors. Patients should be educated on the signs and symptoms and advised to seek immediate medical attention if it occurs.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate switching to an ARB if intolerable.
• Monitor renal function and serum potassium levels, especially in patients with pre-existing renal impairment, heart failure, or those taking potassium-sparing diuretics or supplements.
• Patients should be advised to avoid sudden discontinuation of the medication, as this can lead to rebound hypertension.
• Take consistently at the same time each day for optimal blood pressure control.

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

If your symptoms or health issues persist or worsen, it is 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 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.