Lotrel 2.5/10mg 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 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. This results in decreased vasoconstriction, reduced aldosterone secretion (leading to decreased sodium and water retention), and inhibition of 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 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

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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. 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 increase the risk of adverse reactions.
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 modify the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. You may not experience the full effects of this drug for a few weeks.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

If you have an allergy to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient. Monitor your blood pressure and undergo blood tests as directed by your doctor.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor. Additionally, if you are on a low-salt or salt-free diet, consult your doctor for guidance.

Although rare, it is possible to experience new or worsening chest pain after starting this medication or increasing the dose, which may increase the risk of a heart attack. This risk may be higher in individuals with severe heart blood vessel disease. Consult your doctor if you have concerns.

Captopril, a similar medication, has been associated with low white blood cell counts, which can increase the risk of infection. This is more common in individuals with kidney problems, especially those with other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.

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, or certain natural products, consult your doctor. Also, discuss your alcohol consumption with your doctor.

In hot weather or during physical activity, be cautious 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.

A severe and potentially life-threatening reaction called angioedema has been reported, with a higher risk in Black patients. 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) - concomitant use or within 36 hours of switching due to increased risk of angioedema

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Lithium (increased serum lithium levels and toxicity)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors (reduced antihypertensive effect, increased risk of renal impairment)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• Gold (injectable) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely with concomitant ACE inhibitor use

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure, leading to increased hypotensive effect
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure, potentially reducing efficacy
• Diuretics (thiazide or loop) - additive hypotensive effect, especially with initial doses
• Other antihypertensive agents - additive hypotensive effect
• Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia (rare, but monitor blood glucose)

• Grapefruit juice - may increase amlodipine exposure, but generally not clinically significant for most patients
• Antacids - may slightly decrease benazepril absorption, but generally not clinically significant

• Dizziness or lightheadedness (especially upon standing)
• Persistent dry cough (common with ACE inhibitors)
• Swelling of face, lips, tongue, or throat (angioedema - requires immediate medical attention)
• Shortness of breath
• Chest pain (rare, but report new or worsening angina)
• Fatigue or weakness
• Palpitations
• Yellowing of skin or eyes (jaundice - rare, but indicates liver issues)

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.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk. Use with caution. Monitor breastfed infant for hypotension, bradycardia, and hyperkalemia.

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

No overall differences in effectiveness or safety were 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.

• Lotrel is a fixed-dose combination and should not be used for initial therapy in patients who require individualized dose titration of either component.
• The most common side effect of ACE inhibitors is a persistent dry cough, which usually resolves upon discontinuation.
• Angioedema (swelling of face, lips, tongue, throat) is a rare but serious side effect of ACE inhibitors and requires immediate medical attention. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk.
• Amlodipine can cause peripheral edema (swelling of ankles/feet), which is dose-dependent. Combining with an ACE inhibitor like benazepril can help mitigate this side effect.
• Monitor renal function and serum potassium levels regularly, especially in patients with pre-existing renal impairment, diabetes, or those on potassium-sparing diuretics or supplements.
• Advise patients to avoid salt substitutes containing potassium unless directed by a healthcare professional.

• Other ACE inhibitors (e.g., Lisinopril, Ramipril)
• Other Calcium Channel Blockers (e.g., Nifedipine, Diltiazem)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
• Thiazide Diuretics (e.g., Hydrochlorothiazide)
• Beta-blockers (e.g., Metoprolol, Carvedilol)

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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.