Perindopril 4mg Tablets

Perindopril is a prodrug that is hydrolyzed to perindoprilat, an angiotensin-converting enzyme (ACE) inhibitor. Perindoprilat inhibits 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 (leading to increased sodium and water excretion and decreased potassium excretion), and increased plasma renin activity. It also inhibits the degradation of bradykinin, a potent vasodilator, contributing to its antihypertensive effect.

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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Cough
Dizziness
Back pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Describe the allergic reaction you experienced, including the 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 the dosage or use of this medication.
If you are currently taking a medication that contains aliskiren and you also have diabetes or kidney problems, as this combination may increase the risk of certain complications.
* If you have taken a medication containing sacubitril within the last 36 hours, as this may interact with this 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 dosage 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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.

Monitoring and Follow-Up
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, consult with 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
- Certain natural products or aids

Alcohol Consumption
Discuss your alcohol consumption with your doctor before drinking.

Precautions in Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these 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, additional medication may be necessary. If you have 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 years 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 potential risks to your baby.

• Aliskiren (in patients with diabetes or moderate to severe renal impairment)
• Sacubitril/valsartan (Entresto) - due to increased risk of angioedema; must not be co-administered within 36 hours of the last dose of sacubitril/valsartan.

• 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, increase risk of renal impairment and hyperkalemia)
• Lithium (increased serum lithium levels and toxicity)
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• Racecadotril (increased risk of angioedema)

• Diuretics (thiazide or loop) - increased risk of symptomatic hypotension, especially with initial doses
• Other antihypertensives (additive hypotensive effects)
• Antidiabetics (insulin, oral hypoglycemics) - increased risk of hypoglycemia
• Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) have been reported rarely in patients receiving concomitant gold and ACE inhibitors.

• Not available

• Dizziness or lightheadedness (especially with first dose or dose increase)
• Persistent dry cough
• Swelling of face, lips, tongue, throat (angioedema)
• Difficulty breathing or swallowing
• Yellowing of skin or eyes (jaundice)
• Signs of infection (fever, sore throat) - rare
• Muscle weakness or irregular heartbeat (signs of hyperkalemia)

Contraindicated. Perindopril can cause injury and death to the developing fetus. If pregnancy is detected, discontinue as soon as possible.

Not recommended. Perindopril and its active metabolite perindoprilat are excreted into breast milk. Due to the potential for serious adverse effects in the breastfed infant, 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., 2mg once daily) and titrate slowly, especially in those with impaired renal function.

• Administer perindopril once daily in the morning before a meal, as food decreases the conversion to the active metabolite, perindoprilat.
• Monitor for first-dose hypotension, especially in patients who are volume-depleted (e.g., on diuretics) or have severe heart failure. Consider discontinuing diuretics 2-3 days prior to initiation if possible.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate switching to an Angiotensin Receptor Blocker (ARB) if intolerable.
• Educate patients on the signs and symptoms of angioedema and to seek immediate medical attention if it occurs.
• Regularly monitor renal function and serum potassium, especially in patients with pre-existing renal impairment, diabetes, or those on potassium-sparing diuretics or NSAIDs.

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

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 occurred.