Lotrel 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, which can be life-threatening, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellowing of the 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 only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness
* Cough

Reporting Side Effects

This is not an exhaustive list of possible 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
A history of angioedema, a severe and potentially life-threatening reaction characterized by 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 may 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 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.

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

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, rise slowly from a sitting or lying down position, and be careful when climbing stairs.

Allergies and Interactions

If you are allergic to tartrazine (FD&C Yellow No. 5), consult with your doctor before taking this medication, as some products may contain this ingredient. Additionally, if you are taking a salt substitute that contains potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. If you are on a low-salt or salt-free diet, also discuss this with your doctor.

Monitoring Your Condition

Regularly check your blood pressure as directed by your doctor, and undergo blood tests as scheduled. Your doctor may use these tests to monitor your condition and adjust your treatment plan as needed.

Rare but Serious Side Effects

Although rare, it is possible to experience new or worsening chest pain 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 with your doctor immediately.

Infection Risk

Low white blood cell counts have been reported in people taking captopril, a medication similar to this one. 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.

Interactions with Other Medications and Substances

Before taking over-the-counter (OTC) medications 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 with 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 may lead to fluid loss. Drink plenty of fluids to stay hydrated, and inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may cause low blood pressure.

Severe Allergic Reaction

A severe and potentially life-threatening reaction called angioedema has been reported in some individuals taking this medication. The risk of angioedema may be higher in Black patients.

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 with 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

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
• Potassium supplements - increased risk of hyperkalemia
• Lithium - increased serum lithium levels and toxicity
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - may reduce antihypertensive effect of ACE inhibitors and increase risk of renal impairment
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema (contraindicated with Sacubitril/Valsartan)

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, diltiazem, verapamil) - increased amlodipine exposure, leading to increased risk of hypotension and edema
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - decreased amlodipine exposure, potentially reducing efficacy
• Diuretics (thiazide or loop) - increased risk of symptomatic hypotension, especially with initial doses
• Other antihypertensive agents - additive hypotensive effects
• Gold (sodium aurothiomalate) - nitritoid reactions (flushing, nausea, vomiting, hypotension) reported rarely with concomitant ACE inhibitor use

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

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Swelling of face, lips, tongue, throat, or extremities (angioedema)
• Difficulty breathing or swallowing (angioedema)
• Persistent dry cough (common ACE inhibitor side effect)
• Unusual fatigue or weakness
• Muscle cramps or weakness (hyperkalemia)
• Chest pain or palpitations (though rare, could indicate adverse cardiac effects)
• Yellowing of skin or eyes, dark urine, severe abdominal pain (signs of hepatic dysfunction)

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. First trimester exposure may also carry risks.

Use with caution. Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk in small amounts. Monitor breastfed infants for hypotension, bradycardia, and hyperkalemia. Consider alternative agents, especially in preterm or neonatal 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, 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, which can improve adherence but limits individual dose titration of components. If dose adjustment is needed beyond available strengths, consider switching to individual components.
• The most common side effect of ACE inhibitors like benazepril is a persistent dry cough, which is not dose-related and resolves upon discontinuation.
• Angioedema is a rare but serious side effect of ACE inhibitors; patients should be educated on symptoms and to seek immediate medical attention.
• Amlodipine can cause peripheral edema (swelling in ankles/feet), which is dose-dependent. Combining with an ACE inhibitor like benazepril can help mitigate this side effect.
• Monitor potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements, due to the risk of hyperkalemia from benazepril.
• Avoid concomitant use with sacubitril/valsartan due to significantly increased risk of angioedema; a washout period of at least 36 hours is required between stopping an ACE inhibitor and starting sacubitril/valsartan.

• Other ACE inhibitors (e.g., lisinopril, enalapril)
• Other Calcium Channel Blockers (e.g., nifedipine, diltiazem)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
• 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 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.