Amlodipine-Benaz 5/20mg 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 secretion (leading to decreased sodium and water reabsorption), and potentiation of bradykinin (a vasodilator), 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 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.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

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. Be sure to describe the allergic reaction you experienced, including any 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 them assess potential interactions and ensure safe treatment. Never start, stop, or modify the dosage of any medication without consulting your doctor.

Important Information About Your Medication

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. It may take several weeks to experience the full effects of this drug.

Caution and Safety Precautions

Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when climbing stairs.

Allergies and Interactions

If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products 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 and Follow-up

Regularly check your blood pressure as directed by your doctor, and undergo blood tests as scheduled. Consult your doctor if you have any concerns or questions.

Rare but Serious Side Effects

Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose, which may increase the risk of heart attack. This risk may be higher in individuals 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. Seek medical attention immediately if you experience signs of infection, such as fever, chills, or sore throat.

Interactions with Other Medications and Substances

Before using over-the-counter 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, and certain natural products or aids, consult your doctor. Also, discuss the use of alcohol with your doctor and exercise caution in hot weather or during physical activity to avoid fluid loss. Drink plenty of fluids to stay hydrated.

Special Precautions

If you experience excessive sweating, fluid loss, vomiting, or diarrhea, which may lead to low blood pressure, inform your doctor. A severe and potentially life-threatening reaction called angioedema has been reported, with a higher risk in Black patients.

Age and Breastfeeding 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, discuss the potential risks to your baby with your doctor.

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

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Lithium
• NSAIDs (including COX-2 inhibitors)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus)
• Other antihypertensives (additive hypotensive effects)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - for amlodipine
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - for amlodipine

• Tricyclic antidepressants
• Antipsychotics
• Alpha-blockers
• Grapefruit juice (for amlodipine - avoid large amounts)
• Immunosuppressants (e.g., cyclosporine, tacrolimus) - for amlodipine

• Peripheral edema (swelling of ankles/feet) - common with amlodipine
• Persistent dry cough - common with benazepril
• Dizziness or lightheadedness (especially upon standing) - orthostatic hypotension
• Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing/swallowing) - rare but serious with benazepril
• Signs of hyperkalemia (muscle weakness, fatigue, irregular heartbeat)
• Signs of liver dysfunction (yellowing of skin/eyes, dark urine, severe abdominal pain)

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

Both amlodipine and benazepril are excreted in human milk. Caution should be exercised when administered to a nursing mother. Monitor the infant for adverse effects (e.g., hypotension, poor feeding). Consider alternative agents, especially for preterm or newborn infants.

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, especially considering potential for reduced renal or hepatic function and polypharmacy. Monitor renal function and blood pressure closely.

• The combination of an ACE inhibitor and a calcium channel blocker can provide synergistic blood pressure lowering and may reduce the incidence of peripheral edema associated with CCBs alone.
• Patients should be educated about the risk of angioedema, a rare but potentially life-threatening side effect of ACE inhibitors. Any swelling of the face, lips, tongue, or throat requires immediate medical attention.
• A persistent dry cough is a common side effect of ACE inhibitors (benazepril) and may necessitate a switch to an ARB if intolerable.
• Monitor serum potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements.
• Amlodipine has a long half-life, contributing to its once-daily dosing and sustained blood pressure control.

• Other ACE inhibitors (e.g., lisinopril, enalapril)
• Other Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
• Other Calcium Channel Blockers (e.g., nifedipine, diltiazem)
• 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's essential to contact your doctor promptly. 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 this 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 happened.