Amlodipine-Benaz 5/40mg Capsules

Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial cells, leading to peripheral arterial vasodilation and reduction in peripheral vascular resistance. Benazepril is an angiotensin-converting enzyme (ACE) inhibitor that prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This inhibition leads to decreased angiotensin II levels, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), and reduced sympathetic nervous system activity. The combination provides additive blood pressure lowering effects.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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. 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 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.

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 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 them assess potential interactions and ensure safe treatment. Never start, stop, or modify 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 the effectiveness of your treatment.

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 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 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, contact your doctor immediately.

Infection Risk

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

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, consult your doctor. Additionally, discuss your alcohol consumption with your doctor, as it may interact with this medication.

Precautions in Hot Weather and 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 contact your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these can cause low blood pressure.

Rare but Serious Allergic Reaction

A severe and potentially life-threatening reaction called angioedema can occur, especially 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 mellitus or renal impairment (GFR < 60 mL/min/1.73 m²))
• Sacubitril/valsartan (Entresto) - concomitant use with ACE inhibitors is contraindicated due to increased risk of angioedema. Do not administer within 36 hours of switching from or to an ACE inhibitor.

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including COX-2 inhibitors (may reduce antihypertensive effect of ACE inhibitors and increase risk of renal impairment, especially in elderly or volume-depleted patients)
• Lithium (increased serum lithium levels and lithium toxicity)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) have been reported rarely in patients on concomitant gold therapy and ACE inhibitors.

• 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.
• Other antihypertensive agents (e.g., diuretics, beta-blockers, other vasodilators) - additive hypotensive effects.
• Tricyclic antidepressants, antipsychotics, anesthetics (may enhance hypotensive effect).
• Sympathomimetics (e.g., decongestants, appetite suppressants) - may reduce antihypertensive effect.

• Grapefruit juice (may increase amlodipine exposure, but generally not clinically significant for most patients)
• Antacids (may decrease benazepril absorption, separate administration by 1-2 hours)

• Angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
• Persistent dry cough (common ACE inhibitor side effect)
• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Fatigue
• Peripheral edema (swelling of ankles/feet, more common with amlodipine)
• Chest pain or palpitations
• Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
• Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death from the benazepril component. Discontinue as soon as pregnancy is detected. Exposure during the first trimester is generally not associated with major malformations, but discontinuation is still recommended.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk. Use with caution. Monitor breastfed infants for hypotension, bradycardia, and hyperkalemia. Consider alternative agents, especially in preterm or newborn infants.

Safety and efficacy have not been established in pediatric patients. Not recommended for use in this population.

Start with lower doses and titrate slowly, especially for the amlodipine component, due to potentially reduced clearance and increased sensitivity to hypotensive effects. Monitor renal function and electrolytes closely. Elderly patients may be more susceptible to adverse effects like hypotension and hyperkalemia.

• This combination is useful for patients whose blood pressure is not adequately controlled with either amlodipine or benazepril alone, or for whom combination therapy is appropriate.
• Always check for a history of angioedema with any ACE inhibitor, as it is a life-threatening adverse effect.
• Counsel patients on the importance of avoiding potassium supplements and salt substitutes unless specifically advised by their physician.
• Monitor renal function and serum potassium regularly, especially in patients with pre-existing renal impairment, heart failure, or those on concomitant diuretics.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate switching to an ARB if intolerable.
• Peripheral edema is a common side effect of amlodipine; the ACE inhibitor component may help mitigate this in some patients.

• 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, chlorthalidone)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Alpha-blockers (e.g., prazosin, doxazosin)

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.