Amlodipine-Benaz 10/20mg 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. This inhibition leads to decreased vasoconstriction, reduced aldosterone secretion (leading to decreased sodium and water retention), and decreased sympathetic nervous system activity, resulting in 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)

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 experience any of the following side effects, or if they bother you or do not go away, contact your doctor:

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 condition may affect how your body processes the medication.
Dehydration or electrolyte imbalances, as these conditions can impact the safety and effectiveness of the treatment.
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 new medication.

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 dose 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 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 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, inform your doctor to discuss potential interactions.

Dietary Considerations and Monitoring

If you are on a low-salt or salt-free diet, consult your doctor to ensure this medication is safe for you. It is also crucial to monitor your blood pressure and have regular blood tests as directed by your doctor.

Rare but Serious Side Effects

Although rare, this medication may cause new or worsening chest pain, which can increase the risk of a heart attack. This risk may be higher in individuals with severe heart blood vessel disease. If you experience any chest pain or discomfort, seek medical attention immediately.

Infection Risk and White Blood Cell Count

In some cases, this medication may cause a decrease in white blood cell count, which can increase the risk of infection. This is more common in individuals with kidney problems, especially those with other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor promptly.

Over-the-Counter Medications and Interactions

Before taking any over-the-counter (OTC) medications, including cough or cold remedies, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult your doctor to avoid potential interactions that may increase your blood pressure.

Alcohol Consumption and Fluid Loss

Discuss your alcohol consumption with your doctor, and be cautious when drinking in hot weather or engaging in strenuous activities. It is essential to stay hydrated and drink plenty of fluids to prevent fluid loss. If you experience excessive sweating, vomiting, diarrhea, or loose stools, inform your doctor, as these symptoms can lead to low blood pressure.

Severe Allergic Reaction and Age-Related Considerations

A severe and potentially life-threatening allergic reaction called angioedema has been reported in some individuals taking this medication. The risk may be higher in Black patients. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding and Pregnancy

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.

• Aliskiren (in patients with diabetes or moderate to severe renal impairment due to increased risk of hypotension, hyperkalemia, and renal impairment)
• 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)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (may reduce antihypertensive effect of ACE inhibitors and increase risk of renal impairment, especially in elderly or volume-depleted patients)
• Lithium (increased serum lithium levels and toxicity)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) (increased risk of angioedema)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, 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)
• Dantrolene (IV) (risk of hyperkalemia and cardiovascular collapse with amlodipine)

• Other antihypertensives (additive hypotensive effects)
• Tricyclic antidepressants, antipsychotics (additive hypotensive effects)
• Gold (nitritoid reactions with injectable gold and ACE inhibitors)
• Cyclosporine, Tacrolimus (amlodipine may increase blood levels of these immunosuppressants)
• Simvastatin (amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg daily)

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

• Dizziness or lightheadedness (especially upon standing)
• Persistent dry cough (common with ACE inhibitors)
• Swelling of the face, lips, tongue, or throat (angioedema - rare but serious)
• Difficulty breathing or swallowing
• Chest pain or palpitations
• Unusual fatigue or weakness
• Yellowing of skin or eyes (jaundice)
• Dark urine or pale stools

Contraindicated in 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 avoided due to potential risks. If pregnancy is detected, discontinue as soon as possible.

Both amlodipine and benazepril (and its active metabolite benazeprilat) are excreted in human milk. Use with caution during breastfeeding. Monitor the infant for signs of hypotension (lethargy, poor feeding) or other adverse effects. Consider alternative agents, especially for preterm or newborn 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 at the lower end of the dosing range and titrate slowly due to potential for decreased renal function and increased sensitivity to hypotensive effects.

• This fixed-dose combination is not indicated for initial therapy of hypertension. It is intended for patients whose blood pressure is not adequately controlled on monotherapy or who are already on separate components.
• The most common side effect of ACE inhibitors like benazepril is a persistent dry cough, which typically resolves upon discontinuation.
• Angioedema (swelling of the face, lips, tongue, or throat) is a rare but potentially life-threatening side effect of ACE inhibitors. Patients should be educated on its symptoms and instructed to seek immediate medical attention if it occurs.
• Amlodipine can cause dose-dependent peripheral edema, which is typically mild to moderate and can be managed by dose reduction or addition of a diuretic.
• 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 levels.
• 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, diltiazem, verapamil)
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, irbesartan)
• Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Alpha-blockers (e.g., prazosin, doxazosin)

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.