Lotrel 5/40mg 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-mediated sodium and water retention, and inhibition of bradykinin degradation, all contributing to blood pressure reduction.

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)

Liver problems can be serious and potentially life-threatening. If you experience any of these symptoms, contact your doctor immediately.

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

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 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 determine whether it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage 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 prevent any potential interactions with other treatments.

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 alertness, as this medication may affect you. 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 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 inform 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 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, consult 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 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 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 Reactions

A severe and potentially life-threatening reaction called angioedema has been reported in some individuals taking this medication. The risk 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 your doctor to discuss any potential risks to your baby.

• Aliskiren (in patients with diabetes or renal impairment due to increased risk of hypotension, hyperkalemia, and renal impairment)
• Sacubitril/Valsartan (Entresto) (concurrent 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 (may reduce antihypertensive effect of ACE inhibitors and increase risk of renal impairment and hyperkalemia)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) (increased risk of angioedema)
• Gold (injectable) (nitritoid reactions including facial flushing, nausea, vomiting, and hypotension have been reported rarely in patients on ACE inhibitors receiving injectable gold)

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, diltiazem, grapefruit juice) (may increase amlodipine exposure, leading to increased hypotensive effects)
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) (may decrease amlodipine exposure, leading to reduced efficacy)
• Other antihypertensive agents (additive hypotensive effects)
• Diuretics (increased risk of symptomatic hypotension, especially with initial doses)
• Antidiabetic agents (e.g., insulin, oral hypoglycemics) (ACE inhibitors may enhance the blood glucose-lowering effect, increasing risk of hypoglycemia)
• Tricyclic antidepressants, antipsychotics, anesthetics (may enhance hypotensive effect)

• Not typically listed as specific minor interactions for this combination, but general caution with other medications that affect blood pressure.

• Angioedema (swelling of face, lips, tongue, throat, extremities)
• Persistent dry cough
• Dizziness or lightheadedness (especially upon standing)
• Fatigue
• Peripheral edema (swelling of ankles/feet)
• Shortness of breath
• Chest pain
• Yellowing of skin or eyes (jaundice)
• Unusual bruising or bleeding
• Signs of infection (fever, sore throat)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with ACE inhibitors. Use in the first trimester is generally not recommended due to potential risks.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk. Caution should be exercised when Lotrel is administered to a nursing mother. Consider the benefits of breastfeeding versus the potential risks to the infant and the mother's clinical need for the drug.

Safety and effectiveness in pediatric patients have not been established. 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 closely for adverse effects, especially hypotension and changes in renal function.

• Lotrel combines an ACE inhibitor and a calcium channel blocker, offering dual mechanisms for blood pressure control and potentially improving adherence compared to taking two separate pills.
• The most common side effects are cough (due to benazepril) and peripheral edema (due to amlodipine).
• Patients should be educated on the signs of angioedema and instructed to seek immediate medical attention if it occurs.
• Monitor renal function and serum potassium levels, especially in patients with pre-existing renal impairment, heart failure, or those on potassium-sparing diuretics or potassium supplements.
• Avoid concomitant use with aliskiren in diabetic patients or those with renal impairment.
• Avoid concomitant use with sacubitril/valsartan due to increased risk of angioedema.
• Grapefruit juice can increase amlodipine levels; advise patients to avoid or limit intake.
• This combination is often used when monotherapy with either an ACE inhibitor or a CCB is insufficient to control blood pressure.

• Other ACE inhibitors (e.g., lisinopril, enalapril, ramipril)
• Other Calcium Channel Blockers (e.g., nifedipine, felodipine, diltiazem, verapamil)
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, 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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 overdose, including the medication taken, the amount, and the time it occurred.