Lotrel 10/40mg 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. This leads to decreased vasoconstriction, reduced aldosterone secretion (which decreases sodium and water retention), and potentiation of bradykinin (a vasodilator), all contributing to blood pressure reduction.

Urgent Side Effects: Seek Medical Help Immediately

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 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
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

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 or seek medical attention:

Dizziness
* Cough

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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 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 discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust 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 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 navigating 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 healthcare provider. You should also have blood work done as recommended by your doctor to monitor your condition.

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 any over-the-counter (OTC) products, including cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, consult with your doctor to ensure they will not interact with your medication. You should also discuss your alcohol consumption with your doctor.

Staying Hydrated and Managing Side Effects

Be cautious in hot weather or when engaging in physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms may lead to 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 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; do not administer within 36 hours of switching from or to an ACE inhibitor)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Lithium (increased serum lithium levels and toxicity)
• 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)
• Simvastatin (amlodipine can increase simvastatin exposure; limit simvastatin dose to 20 mg daily)

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, 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)
• Gold (parenteral) (nitritoid reactions reported rarely with concomitant ACE inhibitor use)

• Antacids (may decrease benazepril absorption, separate administration by 1-2 hours)

• Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or swallowing (angioedema)
• Persistent dry cough (common ACE inhibitor side effect)
• Fatigue or weakness
• Palpitations or chest pain
• Muscle cramps or weakness (may indicate hyperkalemia)
• Yellowing of skin or eyes, dark urine, severe abdominal pain (signs of liver dysfunction, rare)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with ACE inhibitors. If pregnancy is detected, discontinue Lotrel as soon as possible. Limited data on first trimester exposure, but potential risks cannot be excluded.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk in small amounts. The clinical significance of this is unknown. Use with caution in nursing mothers. Monitor breastfed infants for hypotension, bradycardia, and hyperkalemia.

Safety and effectiveness in pediatric patients have not been established. 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 electrolytes closely, as elderly patients may have reduced renal function and be more sensitive to hypotensive effects.

• Lotrel is a fixed-dose combination and should not be used for initial therapy of hypertension. Patients should be titrated on individual components first, or if appropriate, started on a lower strength of Lotrel.
• Counsel patients on the risk of angioedema, especially with the first few doses. Instruct them to seek immediate medical attention if swelling of the face, lips, tongue, or throat occurs.
• Monitor renal function and serum potassium levels regularly, especially in patients with pre-existing renal impairment, diabetes, or those on concomitant medications that affect potassium.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate discontinuation if bothersome.
• Amlodipine has a long half-life, so full antihypertensive effect may not be seen for several days after initiation or dose adjustment.
• Avoid concomitant use with aliskiren in diabetic patients or those with renal impairment due to increased risk of adverse events.

• Other ACE inhibitors (e.g., lisinopril, enalapril, ramipril)
• Other Calcium Channel Blockers (e.g., nifedipine, felodipine, verapamil, diltiazem)
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, irbesartan)
• Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Direct Renin Inhibitors (e.g., aliskiren)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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.