Lotrel 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, 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. This leads to decreased vasoconstriction, reduced aldosterone secretion (which decreases sodium and water retention), and potentiation of bradykinin (a vasodilator), resulting in a reduction in blood pressure.

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 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. 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 may affect how your body processes the medication.
Dehydration or electrolyte imbalances, as these conditions can impact the safety and effectiveness 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. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. 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 your full attention, as this medication may affect your alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, 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 consult your doctor.

Monitoring Your Condition

Regularly check your blood pressure as directed by your doctor, and have blood tests done 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, contact your doctor immediately.

Infection Risk

Low white blood cell counts have been reported with captopril, a similar medication. This can 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) 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 can lead to fluid loss. Drink plenty of fluids to stay hydrated, and contact your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these can cause low blood pressure.

Severe Allergic Reaction

A severe and potentially life-threatening reaction called angioedema has been reported with this medication. The risk may be higher in Black patients. If you experience any symptoms of angioedema, 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 ACE inhibitor discontinuation
• Angiotensin Receptor Blockers (ARBs) in combination with ACE inhibitors (dual blockade) in patients with diabetes or renal impairment

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
• Potassium supplements - increased risk of hyperkalemia
• NSAIDs (including COX-2 inhibitors) - may reduce antihypertensive effect of ACE inhibitors and increase risk of renal impairment
• Lithium - increased serum lithium levels and toxicity
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• Cyclosporine - increased risk of angioedema
• Tacrolimus - increased risk of angioedema
• Dantrolene (IV) - risk of hyperkalemia and cardiovascular collapse with amlodipine
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased amlodipine exposure
• Strong CYP3A4 inducers (e.g., rifampin, St. John's Wort) - decreased amlodipine exposure

• Diuretics (thiazide or loop) - enhanced hypotensive effect, especially with initial doses
• Other antihypertensives - additive hypotensive effect
• Tricyclic antidepressants, antipsychotics - enhanced hypotensive effect
• Alpha-blockers - enhanced hypotensive effect
• Grapefruit juice - may increase amlodipine exposure (avoid large quantities)
• Simvastatin - amlodipine may increase simvastatin exposure (limit simvastatin dose to 20 mg/day)

• Not available

• Dizziness or lightheadedness (especially upon standing)
• Swelling of face, lips, tongue, throat (angioedema)
• Difficulty breathing or swallowing
• Persistent dry cough
• Fatigue or weakness
• Muscle cramps or weakness (signs of hyperkalemia)
• Yellowing of skin or eyes (jaundice)
• Dark urine or pale stools

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death from the benazepril component. Discontinue as soon as pregnancy is detected. Exposure during the first trimester should be avoided if possible, though risks are less clear.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk in small amounts. The risk to a breastfed infant appears to be low, but caution is advised, especially with preterm infants or those with underlying medical conditions. Monitor infant for hypotension.

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 carefully, monitoring renal function and blood pressure closely due to increased risk of adverse effects (e.g., hypotension, renal impairment).

• Lotrel is a fixed-dose combination; individual titration of amlodipine and benazepril may be necessary before switching to the combination product, especially in patients with renal or hepatic impairment.
• Angioedema is a rare but potentially life-threatening side effect of ACE inhibitors; educate patients on symptoms and to seek immediate medical attention.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate discontinuation if bothersome.
• Monitor serum potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
• Avoid concomitant use with aliskiren in patients with diabetes or renal impairment due to increased risk of hyperkalemia, hypotension, and renal impairment.
• Avoid concomitant use with sacubitril/valsartan (Entresto) due to increased risk of angioedema; a washout period of 36 hours is required between discontinuing an ACE inhibitor and starting Entresto.

• Other ACE inhibitors (e.g., lisinopril, enalapril)
• 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)
• 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 your 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.