Perindopril Arginine & Amlodipine Tablets 5/5mg, 10/5mg, 5/10mg, 10/10mg Tablet

Perindopril Arginine & Amlodipine Tablets 5/5mg, 10/5mg, 5/10mg, 10/10mg Tablet

Product Name :

Ramipril Xr Tablets 7.5mg Tablet

Available Strength :

Ramipril 7.5 mg

Packing :

3x10 Alu-Alu Blister / As per your requirement

Pack Insert/ Leaflet :

Available upon request

Therapeutical Use :

Antihypertensive therapy

Production Capacity :

10 Million Tablets/Month

Description:

What is Perindopril Arginine & Amlodipine Tablets 5/5mg, 10/5mg, 5/10mg, 10/10mg Tablet?

Perindopril Arginine and Amlodipine Tablets are an oral combination formulation containing an ACE inhibitor and a calcium channel blocker. The available strengths combine perindopril arginine and amlodipine in different dose ratios and are used in the management of hypertension and certain cardiovascular conditions according to approved product information.

Uses / Indications

Perindopril arginine and amlodipine tablets may be used in the management of:

  • Hypertension
  • Patients requiring combination antihypertensive therapy
  • Cardiovascular conditions where treatment with an ACE inhibitor and calcium channel blocker is clinically appropriate

The specific indication and strength selected should follow the approved product information and healthcare professional assessment.

Benefits

  • Combines two antihypertensive medicines in a single oral tablet.
  • Perindopril arginine provides ACE inhibitor activity.
  • Amlodipine provides calcium channel blocker activity.
  • The combination provides multiple complementary mechanisms for blood pressure control.
  • Available in multiple dose combinations to support different prescribed treatment requirements.

Side Effects

Common Side Effects

Possible adverse effects may include:

  • Headache
  • Dizziness
  • Peripheral oedema
  • Flushing
  • Cough
  • Fatigue
  • Nausea
  • Abdominal discomfort

Less Common or Serious Side Effects

Clinically important reactions may include:

  • Excessive reduction in blood pressure
  • Angioedema
  • Significant changes in kidney function
  • Increased potassium levels
  • Severe allergic reactions
  • Severe skin reactions
  • Liver-related adverse effects
  • Palpitations or changes in heart rate

Angioedema involving the face, lips, tongue, or throat requires immediate medical attention.

How Does It Work?

Perindopril Arginine

Perindopril arginine is a prodrug that is converted to its active metabolite, perindoprilat. Perindoprilat inhibits angiotensin-converting enzyme (ACE), reducing the formation of angiotensin II. This promotes vasodilation and decreases aldosterone-related effects, contributing to lower blood pressure.

Amlodipine

Amlodipine is a dihydropyridine calcium channel blocker. It inhibits calcium influx into vascular smooth muscle, producing relaxation of peripheral arterial blood vessels and reducing vascular resistance.

Combination Action

The two components reduce blood pressure through complementary mechanisms: perindoprilat acts on the renin-angiotensin system, while amlodipine primarily produces arterial vasodilation.

Dosage Guidelines

The appropriate strength and dosage depend on blood pressure control, previous treatment, clinical condition, kidney function, age, and other medicines being used.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For oral tablets:

  • Take exactly as prescribed.
  • Swallow the tablet with sufficient water unless otherwise directed.
  • Take the medicine at the same time each day where instructed.
  • Do not change the strength or dosage without professional advice.
  • Do not stop treatment without consulting a healthcare professional.

Dose adjustment or additional monitoring may be required in patients with renal impairment or other relevant medical conditions.

When Not to Use

This combination should generally not be used in patients with known hypersensitivity to perindopril, other ACE inhibitors, amlodipine, other dihydropyridine calcium channel blockers, or any component of the formulation.

ACE inhibitor-containing products are generally contraindicated in:

  • Previous ACE inhibitor-associated angioedema
  • Hereditary or idiopathic angioedema
  • Pregnancy, particularly during the second and third trimesters
  • Concomitant use with certain medicines such as aliskiren in patients with diabetes or significant renal impairment, where contraindicated
  • Concomitant use with sacubitril/valsartan without the required washout interval

Medical advice is particularly important in patients with kidney disease, liver impairment, low blood pressure, electrolyte abnormalities, or significant cardiovascular disease.

Drug / Product Interactions

Clinically relevant interactions may occur with medicines affecting blood pressure, kidney function, potassium levels, or the renin-angiotensin system.

Important interaction categories may include:

  • Potassium supplements and potassium-containing salt substitutes
  • Potassium-sparing diuretics
  • Other antihypertensive medicines
  • Diuretics
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Lithium
  • Other medicines affecting the renin-angiotensin system
  • Sacubitril/valsartan
  • Aliskiren
  • Certain medicines that may increase amlodipine exposure

Patients taking multiple medicines should inform their healthcare professional before treatment.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Overdose may cause excessive hypotension, dizziness, fainting, or other cardiovascular effects.

Missed Dose

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose.

Pregnancy

Perindopril-containing medicines should not be used during pregnancy, particularly after the first trimester, because ACE inhibitors can cause serious fetal harm. Patients who become pregnant during treatment should contact their healthcare professional promptly.

Breastfeeding

The use of this combination during breastfeeding should be discussed with a healthcare professional, who can assess the suitability of treatment and available alternatives.

Children

Use in children and adolescents should follow the approved product information. This combination may not be appropriate for all paediatric patients.

Elderly Patients

Older patients may be more susceptible to blood pressure reduction and changes in kidney function. Appropriate monitoring may be required.

Renal Impairment

Renal function and potassium levels may require monitoring. The appropriate strength and treatment regimen should be determined according to renal function and approved product information.

Hepatic Impairment

Amlodipine is metabolized extensively by the liver. Patients with hepatic impairment may require careful dose selection and monitoring.

General Instructions

  • Take according to the prescribed schedule.
  • Swallow the tablet with sufficient water unless otherwise directed.
  • Take consistently at the recommended time.
  • Do not alter the prescribed strength without professional advice.
  • Monitor blood pressure as recommended.
  • Inform healthcare professionals about all medicines being taken.
  • Keep the medicine in its original packaging where appropriate.
  • Do not share prescription medicines.

Special Dietary / Lifestyle Tips

No specific dietary restriction is generally required unless advised by a healthcare professional.

Patients receiving ACE inhibitor therapy should discuss the use of potassium supplements or potassium-containing salt substitutes with their healthcare professional.

A balanced diet, appropriate physical activity, and other lifestyle measures may support blood pressure management where medically appropriate.

Comparison with Other Treatments

This formulation combines an ACE inhibitor with a calcium channel blocker, whereas other antihypertensive regimens may use an ACE inhibitor, calcium channel blocker, diuretic, or another class alone or in combination.

The choice of treatment depends on blood pressure control, cardiovascular risk, kidney function, concurrent medicines, tolerability, and the approved clinical indication.

Precautions & Warnings

  • Monitor for symptoms of excessive blood pressure reduction, particularly when treatment is initiated or adjusted.
  • Seek immediate medical attention for swelling of the face, lips, tongue, or throat.
  • Renal function and potassium levels may require monitoring.
  • Use caution with potassium supplements and potassium-containing salt substitutes.
  • NSAIDs may affect kidney function and may reduce the antihypertensive effect.
  • ACE inhibitors should not be used during pregnancy.
  • Inform the healthcare professional about any previous angioedema.
  • Patients with liver or kidney impairment may require additional monitoring.
  • Do not discontinue treatment without appropriate medical advice.

Can I Use It With Other Medicines?

Generally Compatible With

The combination may be used with other medicines when clinically appropriate and when the patient’s complete medication profile has been reviewed by a healthcare professional.

Use With Caution / Avoid

Particular caution is required with:

  • Potassium supplements and potassium-containing salt substitutes
  • Potassium-sparing diuretics
  • Other medicines affecting the renin-angiotensin system
  • NSAIDs
  • Lithium
  • Sacubitril/valsartan
  • Aliskiren
  • Other medicines that substantially lower blood pressure

Do not start, stop, or change other medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

  • Keep properly closed.
  • Protect from excessive heat.
  • Protect from moisture.
  • Keep out of reach of children.
  • Do not use after the expiry date.
  • Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What are Perindopril Arginine & Amlodipine Tablets used for?

They are used in the management of hypertension and in patients who require combination therapy with an ACE inhibitor and calcium channel blocker, according to approved product information.

2. What are the active ingredients?

The formulation contains perindopril arginine and amlodipine in the supplied strengths of 5/5 mg, 10/5 mg, 5/10 mg, and 10/10 mg.

3. How does the combination work?

Perindopril arginine acts through ACE inhibition and reduction of angiotensin II formation, while amlodipine promotes arterial vasodilation through calcium channel blockade.

4. How should these tablets be taken?

Take the prescribed strength exactly as directed by a healthcare professional. Swallow the tablet with sufficient water unless otherwise instructed.

5. Can these tablets be taken with other medicines?

Potential interactions can occur with potassium supplements, potassium-sparing medicines, NSAIDs, lithium, other renin-angiotensin system medicines, and certain other antihypertensive treatments. Professional advice is recommended.

6. Can Perindopril Arginine & Amlodipine Tablets be used during pregnancy?

Perindopril-containing medicines should not be used during pregnancy, particularly after the first trimester. Patients who become pregnant while taking the medicine should contact their healthcare professional promptly.

7. What should I do if I miss a dose?

Take the missed dose when remembered unless it is close to the next scheduled dose. Do not double the next dose.

8. How should these tablets be stored?

Store according to the conditions stated on the approved product label and package insert, and keep the product out of reach of children.

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