Lotrel 10/20mg Capsules

Lotrel is a combination of two antihypertensive agents: Amlodipine and Benazepril. 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 increased bradykinin levels, all contributing to blood pressure reduction.

Serious Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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 do not experience significant side effects, but some may occur. 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 is not an exhaustive list of potential 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, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have 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 the medication's safety and efficacy.
Dehydration or electrolyte imbalances, as these conditions may impact the medication's effects.
If you are taking a medication containing aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you have taken a medication containing sacubitril within the last 36 hours, as this may interact with the current medication.

It is crucial to note that this list is not exhaustive, and you should inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will enable your healthcare team to assess the safety of taking this medication in conjunction with your other treatments and health conditions. Never start, stop, or modify the dose of any medication without first consulting your doctor to ensure your safety.

Important Information About Your Medication

It is crucial that you inform all 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 performing tasks 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 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 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. This will help your doctor monitor your condition and adjust your treatment plan as needed.

Rare but Serious Side Effects

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 associated 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.

Interactions with Other Medications and Substances

Before taking over-the-counter (OTC) medications that may increase blood pressure, such as cough or cold remedies, 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 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 associated 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)
• 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 lithium levels and toxicity)
• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect and increase risk of renal impairment, especially in elderly or volume-depleted patients
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure
• Simvastatin (increased simvastatin exposure, limit simvastatin dose to 20 mg/day)

• Diuretics (increased risk of symptomatic hypotension, especially with initial doses)
• Tricyclic antidepressants, antipsychotics, anesthetics (increased risk of orthostatic hypotension)
• Gold (nitritoid reactions with injectable gold in patients on ACE inhibitors)
• Grapefruit juice (may increase amlodipine exposure, though generally considered minor for amlodipine)

• Not available

• Dizziness
• Lightheadedness
• Fatigue
• Peripheral edema (swelling of ankles/feet)
• Cough (dry, persistent)
• Headache
• Flushing
• Palpitations
• Shortness of breath
• Swelling of face, lips, tongue, throat (angioedema)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with the benazepril component (ACE inhibitor). Discontinue as soon as pregnancy is detected. Use in the first trimester is also generally not recommended.

Both amlodipine and benazepril (benazeprilat) are excreted in breast milk in small amounts. The American Academy of Pediatrics considers amlodipine compatible with breastfeeding. Benazepril is generally considered compatible with breastfeeding, especially in full-term infants. However, caution is advised, and the infant should be monitored for adverse effects (e.g., hypotension). Consider alternatives, especially for preterm or sick infants.

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

Use with caution. Elderly patients may have reduced renal or hepatic function, which can affect drug clearance. Start with lower doses and titrate slowly. Monitor renal function and electrolytes closely. Amlodipine clearance may be reduced in the elderly, leading to higher systemic exposure.

• Lotrel combines two effective antihypertensive mechanisms, often allowing for better blood pressure control with fewer pills.
• The most common side effects are peripheral edema (amlodipine) and dry cough (benazepril).
• Angioedema is a rare but serious side effect of ACE inhibitors; educate patients on symptoms and to seek immediate medical attention.
• Monitor renal function and serum potassium, especially in patients with pre-existing renal impairment, diabetes, or those on potassium-sparing diuretics.
• First-dose hypotension can occur, especially in volume-depleted patients; consider starting with a lower dose and monitoring closely.
• Avoid concomitant use with aliskiren in diabetic patients or those with renal impairment due to increased risk of adverse events.
• Avoid concomitant use with sacubitril/valsartan due to significantly increased risk of angioedema.

• Other ACE inhibitors (e.g., lisinopril, enalapril, ramipril)
• Other Calcium Channel Blockers (e.g., nifedipine, felodipine, diltiazem, verapamil)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan, candesartan)
• Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Alpha-blockers (e.g., prazosin, doxazosin)
• Direct vasodilators (e.g., hydralazine, minoxidil)

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 ensure you receive the best possible care.