Aceon 4mg Tablets

Perindopril is a prodrug that is hydrolyzed to perindoprilat, its active metabolite. Perindoprilat inhibits angiotensin-converting enzyme (ACE), which catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasoconstriction, decreased aldosterone secretion (resulting in increased sodium and water excretion and decreased potassium excretion), and decreased systemic vascular resistance. ACE also degrades bradykinin, a vasodilator; inhibition of ACE leads to increased levels of bradykinin, contributing to the hypotensive effect.

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help 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
Persistent cough
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)
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

Most people experience few or no side effects when taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

Cough
Dizziness
Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced, such as rash, itching, swelling, or difficulty breathing.
If you have 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.
If you have kidney disease, as this may affect how your body processes the medication.
If you are currently taking a medication containing aliskiren and have diabetes or kidney problems, as this combination may increase your risk of adverse effects.
* If you have taken a medication containing sacubitril within the last 36 hours, as this may interact with the new medication.

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 medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Monitoring Your Condition
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor.

Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Over-the-Counter (OTC) Products and Interactions
If you have high blood pressure and are taking this medication, talk to your doctor before using 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, and certain natural products or aids.

Alcohol Consumption
Consult with your doctor before consuming alcohol while taking this medication.

Heat and Fluid Loss
Be cautious in hot weather or during 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 conditions may lead to low blood pressure.

Effectiveness in Black Patients
This medication may be less effective in lowering blood pressure in Black patients. In some cases, another medication may be prescribed in conjunction with this one. If you have any questions or concerns, discuss them with your doctor.

Risk of Angioedema
A severe and potentially life-threatening reaction called angioedema has been reported. 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 moderate-to-severe renal impairment (GFR < 60 mL/min/1.73 m²))
• Sacubitril/valsartan (Entresto) (due to increased risk of angioedema; must have a 36-hour washout period between doses)

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements (increased risk of hyperkalemia)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective COX-2 inhibitors) (may reduce antihypertensive effect and increase risk of renal impairment, especially in elderly or volume-depleted patients)
• Lithium (increased serum lithium levels and symptoms of lithium toxicity)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) (increased risk of angioedema)
• Neprilysin inhibitors (e.g., sacubitril) (increased risk of angioedema)

• Diuretics (thiazide or loop) (may cause excessive hypotension, especially with initial dose)
• Antidiabetic agents (insulin, oral hypoglycemics) (may enhance glucose-lowering effect, increasing risk of hypoglycemia)
• Gold (parenteral) (nitritoid reactions including facial flushing, nausea, vomiting, and hypotension have been reported rarely in patients receiving concomitant gold and ACE inhibitor therapy)
• Other antihypertensives (additive hypotensive effect)

• Alcohol (may enhance hypotensive effect)
• Allopurinol (may increase risk of hypersensitivity reactions)

• Signs of angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
• Persistent dry cough
• Symptoms of hypotension (dizziness, lightheadedness, fainting)
• Symptoms of hyperkalemia (muscle weakness, fatigue, paresthesias, bradycardia)
• Signs of infection (fever, sore throat) due to rare neutropenia/agranulocytosis
• Jaundice or signs of hepatic dysfunction

Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is also generally not recommended due to potential risks.

Not recommended during breastfeeding. Perindopril and its active metabolite perindoprilat are excreted into human milk in very small amounts. However, due to the potential for serious adverse reactions in the breastfed infant (e.g., hypotension, hyperkalemia), an alternative medication is preferred, or breastfeeding should be discontinued.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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 (e.g., 2 mg once daily) and titrate carefully, monitoring renal function and potassium levels closely due to increased likelihood of decreased renal function in this population.

• Perindopril is a prodrug that needs to be converted to its active form, perindoprilat, in the liver. Take it on an empty stomach (e.g., before breakfast) to optimize absorption and conversion.
• A common side effect of ACE inhibitors is a persistent, dry, hacking cough, which is not dose-related and typically resolves upon discontinuation of the drug.
• Angioedema (swelling of the face, lips, tongue, or throat) is a rare but potentially life-threatening side effect. Patients should be educated on its signs and symptoms and advised to seek immediate medical attention if it occurs.
• First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, low sodium diet). Consider discontinuing diuretics 2-3 days prior to initiation or starting with a lower dose.
• Monitor renal function and serum potassium regularly, especially in patients with pre-existing renal impairment, diabetes, or those taking potassium-sparing diuretics or NSAIDs.
• Perindopril is effective for both hypertension and reducing cardiovascular events in patients with stable coronary artery disease.

• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
• Calcium Channel Blockers (CCBs) (e.g., Amlodipine, Nifedipine)
• Thiazide Diuretics (e.g., Hydrochlorothiazide)
• Beta-blockers (e.g., Metoprolol, Atenolol)
• Other ACE inhibitors (e.g., Lisinopril, Ramipril, Enalapril)

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'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 medication, including the amount taken and the time it happened, to facilitate prompt and appropriate care.