Reaptan Plus SR (perindopril arginine, amlodipine, indapamide)
Reaptan Plus SR (slow release) is approved as a substitution therapy for the treatment of hypertension, in patients already controlled with perindopril, amlodipine and indapamide, taken at the same dose level. Treatment should not be initiated with this combination. Reaptan Plus SR contains the active ingredients perindopril arginine, amlodipine (as besilate) and indapamide.
Reaptan Plus 10/5/1.5 SR
Reaptan Plus 10/10/1.5 SR
Reaptan Plus SR (slow release) has been approved to treat high blood pressure in people whose blood pressure is well controlled with the same doses of the 3 active ingredients - perindopril, amlodipine and indapamide. Reaptan Plus SR is a new combination therapy that can be prescribed to replace the separate tablets.
Blood pressure is the force of blood moving through your arteries (blood vessels), and the pressure pushing against artery walls, after it leaves your heart. Blood pressure measurements may vary at different times of the day, depending on stress, your activity level and general health.
High blood pressure, also called hypertension, occurs when blood pressure stays higher than is needed, even when a person is calm or relaxed. If it is not treated it can lead to serious health problems. About 1 in every 3 Australian adults has high blood pressure.
Reaptan Plus SR combines all 3 active ingredients, perindopril, amlodipine and indapamide, that work together, using complementary actions to control blood pressure in people with hypertension.
Reaptan Plus SR is a new combination therapy containing perindopril arginine, amlodipine besilate and indapamide.
Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors reduce blood pressure by blocking the actions of ACE; the enzyme responsible for narrowing blood vessels through the production of Angiotensin II in your body. ACE inhibitors can help relax and widen your blood vessels, lowering your blood pressure and reducing the strain on your heart and your kidneys.
Amlodipine belongs to a group of medicines called calcium channel blockers. Calcium channel blockers do not change the amount of calcium in your blood or bones. They work by stopping calcium from entering the cells of your heart and arteries, which helps the muscle walls of your blood vessels relax. This can lower your blood pressure.
Indapamide belongs to a group of medicines called chlorosulfamoyl diuretics, which are a type of fluid or water tablet. Your kidneys help control the amount of water and electrolytes, also known as salts, in your blood. Indapamide makes your kidneys release more electrolytes and water into your urine. This increases urine production and helps remove extra fluid from the body. Diuretics can help lower blood pressure and reduce fluid build-up caused by heart, liver or kidney problems.
Other effects of indapamide also help lower blood pressure, such as reducing left ventricular hypertrophy (wall thickening of the lower left heart) and thickening of artery (blood vessel) walls. Indapamide is released progressively over 24 hours.
The effectiveness and safety of Reaptan Plus SR were mainly assessed in bioequivalence studies. These studies compared Reaptan Plus SR with perindopril arginine, amlodipine and indapamide taken together as 3 separate tablets. Bioequivalence means that two medicines work in a similar way in the body and can usually be used in place of each other. Three main bioequivalence studies supported this application.
- Study PKH-05183-005: A single-dose BE study of Reaptan Plus SR containing perindopril arginine 10 mg/amlodipine 10 mg/indapamide 1.5 mg versus a single dose of one tablet of each component, under fasting conditions. The study was performed in 80 healthy, male and female volunteers from 18 - 65 years of age.
- Study PKH-05183-002: A single-dose BE study of Reaptan Plus SR containing perindopril arginine 10 mg/amlodipine 10 mg/indapamide 1.5 mg versus a single dose of one tablet of each component, in fed (allowed to eat) conditions. The study was performed in 80 healthy, male and female volunteers from 18 - 65 years of age.
- Study PKH-05182-004: A multiple-dose BE study of indapamide SR 1.5 mg tablets used in the new fixed dose combinations versus the reference drug product Arifon Retard 1.5 mg tablets (indapamide 1.5 mg tablets) under fasting conditions.
Key findings from clinical studies
Study PKH-05183-005
- Comparing Reaptan Plus SR with the same medicines taken as separate tablets, the results showed that the body absorbed the 3 active ingredients at similar levels from both treatments.
- Therefore, Reaptan Plus SR is considered bioequivalent to the 3 medicines separately, in healthy volunteers under fasting conditions.
Study PKH-05183-002
- Comparing Reaptan Plus SR with the same medicines taken as separate tablets, the results showed that the body absorbed the 3 active ingredients at similar levels from both treatments.
- Therefore, Reaptan Plus SR is considered bioequivalent to taking the 3 medicines separately in healthy volunteers, under fed conditions.
Study PKH-05182-004
- When comparing the slow-release 1.5 mg of indapamide in Reaptan Plus SR and the reference product (Arifon Retard prolonged-release film-coated tablet containing 1.5 mg of indapamide) bioequivalence was demonstrated in healthy, non-smoking volunteers under fasting conditions.
- Safety data from the clinical studies showed that the drug product was well tolerated and safe in the evaluated dosages.
- Side effects or health problems that started or became worse after people began taking the study treatment. were similar between the different treatment groups in all studies. Overall, headache and low blood pressure (hypotension) were the most frequently observed side effects.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Reaptan Plus SR and the medicine can be registered in Australia.
More detailed information on why the TGA approved Reaptan Plus SR will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
- REAPTAN PLUS 10/10/1.5 SR perindopril arginine 10 mg/amlodipine (as besilate) 10 mg/indapamide 1.5 mg modified release capsule bottle (485988)
- REAPTAN PLUS 10/5/1.5 SR perindopril arginine 10 mg/amlodipine (as besilate) 5 mg/indapamide 1.5 mg modified release capsule bottle (485989)
- REAPTAN PLUS 5/5/1.5 SR perindopril arginine 5 mg/amlodipine (as besilate) 5 mg/indapamide 1.5 mg modified release capsule bottle (485990)
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Treatment should not be initiated with this combination. If a change in dosage is required, titration should be done with the individual components.