Perindopril 8mg Tablets

Perindopril is a prodrug that is hydrolyzed to perindoprilat, its active metabolite. Perindoprilat is an angiotensin-converting enzyme (ACE) inhibitor. It prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to decreased angiotensin II levels, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water reabsorption and increased potassium retention), and decreased sympathetic nervous system activity. It also inhibits the degradation of bradykinin, a vasodilator, which may contribute to its antihypertensive effect and some side effects like cough and angioedema.

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
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 taking this medication do not experience severe side effects. However, some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Cough
Dizziness
Back pain

Reporting Side Effects

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 allergic reaction you experienced, including any symptoms that occurred.
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 your ability to take this medication.
If you are currently taking a medication that contains aliskiren and you also have diabetes or kidney problems.
* If you have taken a medication containing sacubitril within the last 36 hours.

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 in combination with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

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 understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Monitoring Your Condition
Regularly check your blood pressure as instructed by your healthcare provider. Additionally, have your blood work and other laboratory tests done as directed 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
Discuss your alcohol consumption with your doctor before drinking.

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 necessary in conjunction with this drug. If you have questions, consult 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, discuss the potential risks to your baby with your doctor.

• Aliskiren (in patients with diabetes or renal impairment (GFR <60 mL/min/1.73 m²))
• Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of perindopril

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
• Potassium supplements
• Lithium
• NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) - including selective COX-2 inhibitors
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus)
• Neprilysin inhibitors (e.g., sacubitril)

• Diuretics (thiazide or loop) - may cause excessive hypotension
• Other antihypertensives (e.g., beta-blockers, calcium channel blockers) - additive hypotensive effect
• Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia
• Allopurinol - increased risk of hypersensitivity reactions
• Immunosuppressants (e.g., azathioprine, cyclosporine) - increased risk of hematologic effects
• Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)

• Alcohol - additive hypotensive effect
• Antacids - may decrease bioavailability (separate administration)

• Angioedema (swelling of face, lips, tongue, glottis, larynx)
• Persistent dry cough
• Dizziness or lightheadedness (especially upon standing)
• Fatigue
• Signs of hyperkalemia (muscle weakness, irregular heartbeat)
• Signs of infection (fever, sore throat) - rare, but indicates neutropenia

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

Perindoprilat is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. 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, especially considering potential for decreased renal function.

• Perindopril is a prodrug; its active metabolite is perindoprilat. Take it before meals for optimal absorption.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate switching to an ARB.
• Monitor renal function and serum potassium closely, especially at initiation, with dose changes, or in patients with pre-existing renal impairment or on concomitant medications affecting potassium.
• Angioedema is a rare but potentially life-threatening side effect; educate patients on symptoms and to seek immediate medical attention.
• Avoid concomitant use with sacubitril/valsartan (Entresto) due to increased risk of angioedema; a 36-hour washout period is required.
• Perindopril is particularly effective in patients with stable coronary artery disease for reducing cardiovascular events.

• Other ACE inhibitors (e.g., lisinopril, enalapril, ramipril)
• Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, candesartan)
• Calcium Channel Blockers (CCBs)
• Thiazide diuretics
• Beta-blockers

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 overdose, including the medication taken, the amount, and the time it occurred.