Perindopril Erbumine 2mg 100 Tablets Cobasyl Tablets 2mg Perindopril Erbumine 2mg Hypertension

Perindopril tablets contain perindopril (ACE inhibitor), which can lower blood pressure by inhibiting angiotensin converting enzyme, improve heart function and protect kidney function. It is suitable for hypertension and congestive heart failure.

1. Basic information of the drug

1. Common name : Perindopril Erbumine
2. English Name : Perindopril Erbumine Tablets
3. Product name : コバシル 2mg, コバシル 4mg
4. Dosage form : Tablets (2mg identification code KH220, 4mg identification code KH221, both in PTP packaging)
5. Indications : Hypertension
6. Element :
   • 2mg Specification: Each tablet contains 2mg of Perindoprelebulumin;
   • 4mg Specification: Each tablet contains 4mg of Perindoprelebulumin;
   • Additives: yellow iron triphosphate, ruthenium acid, crystalline sulfonate, etc.
7. Properties : Tablets. The specific properties are not described in detail. The identification codes are KH220 (2 mg) and KH221 (4 mg).
8. Storage and shelf life : Store at room temperature, shelf life 3 years.

2. Usage and Dosage

• Adults usually take Perindoprelebulumin, 2-4 mg orally once a day (after breakfast).
• The dosage can be adjusted according to age and symptoms, and the maximum daily dose should not exceed 8 mg.

3. Taboo

1. Those who have a history of allergy to the ingredients of this drug.
2. Currently using the アンジオテンシン receptor body ネプリライシン blocking agent (such as Serotonin water and substance) or 36 days after stopping the drug patients within hours.
3. Patients with a history of angioedema (such as ACEI-induced, hereditary/acquired/idiopathic angioedema).
4. Patients who are undergoing dialysis using adsorbers such as the Adsorbent sulfuric acid-immobilized sulfate or the Adsorbent sulfuric acid immobilized sorbent membrane (AN69).
5. Women who are pregnant or may become pregnant.
6. Patients with diabetes who are taking arsenic sulfate (except those with extremely poor blood pressure control).

IV. Precautions

1. Special Populations :
   • Patients with renal artery stenosis: May worsen renal function; avoid use unless necessary.
   • Patients with hyperkalemia: Symptoms may be aggravated, so avoid use unless necessary; patients with renal dysfunction and diabetes need to monitor blood potassium.
   • For patients with severe hypertension/strict salt restriction: start with a low dose, increase the dose gradually, and be wary of sudden drops in blood pressure.
   • Patients with renal impairment: When creatinine clearance ≤30mL/min or serum creatinine ≥3mg/dL, the dose should be reduced or the dosing interval should be extended.
   • Hemodialysis patients: Initial low dose, increase gradually, and be cautious about sudden drop in blood pressure.
   • Females of reproductive potential: Use the drug only after confirming that you are not pregnant and have regular checkups; stop taking the drug immediately if you become pregnant.
   • Lactating women: Weigh the benefits of treatment against breast milk; animal studies show that the ingredients enter breast milk.
   • Children: No efficacy and safety data.
   • Elderly: Start at a low dose and monitor blood pressure and renal function (increases in BUN and creatinine may occur).
2. Medication Instructions :
   • May cause dizziness and vertigo, affecting driving or working at heights.
   • It is recommended to stop taking the medication 24 hours before surgery.
   • The tablets must be taken out of the PTP package before consumption to avoid accidental swallowing of PTP tablets which may cause damage to the esophagus.
3. Drug storage : Store at room temperature, valid for 3 years.

5. Adverse Reactions

1. Serious side effects :
   • Angioedema (frequency unknown): manifested as swelling of the face, tongue, larynx, etc. accompanied by difficulty breathing. The drug should be discontinued immediately and symptomatic treatment (such as epinephrine injection, airway assurance) should be given.
   • Acute renal failure (<0.1%), hyperkalemia (frequency unknown).
2. Other side effects :
   • Allergic reactions: rash, itching (0.1~5%).
   • Kidney: increased BUN and serum creatinine (0.1-5%).
   • Blood: Decreased red blood cells, decreased hemoglobin, etc. (0.1~5%).
   • Psychoneural system: dizziness, headache (0.1~5%); sleepiness, tinnitus, etc. (<0.1%).
   • Circulator: hypotension (0.1~5%); palpitations, etc. (<0.1%).
   • Digestive system: nausea, stomach discomfort (0.1~5%); constipation, abdominal pain, etc. (<0.1%).
   • Metabolism: increased total cholesterol, increased triglycerides, etc. (0.1~5%).
   • Liver: elevated AST and ALT (0.1-5%).
   • Respirator: Cough (more than 5%); Tightness of laryngeal area (0.1~5%).

6. Drug Interactions

1. Prohibited use :
   • Certain adsorbers (e.g., Dextran sulfuric acid-immobilized celulus), AN69 dialysis membrane: May cause shock or allergic reaction.
   • Co-administration of arifumarate in diabetic patients (except those with extremely poor blood pressure control): may increase the risk of renal damage and hyperkalemia.
2. Use with caution :
   • Potassium-sparing diuretics and potassium supplements: may increase serum potassium and require monitoring.
   • Aliskilen fumarate (non-diabetic patients): May increase the risk of renal damage and hyperkalemia. Patients with renal impairment should avoid co-use.
   • Angiotensin II receptor antagonists: may increase the risk of renal damage and hyperkalemia.
   • Diuretic antihypertensive drugs: may cause a rapid drop in blood pressure, so give them at low doses initially.
   • Lithium preparations: may cause lithium poisoning, blood lithium concentration needs to be monitored.
   • Nonsteroidal anti-inflammatory drugs: May reduce the antihypertensive effect and increase the risk of renal damage.
   • Caldigogenase: May cause excessive blood pressure decrease.

7. Pharmacological Action

• Mechanism of action : As a prodrug, it is metabolized into the active substance ペリンドプリラート, which inhibits angiotensin converting enzyme (ACE), reduces the production of angiotensin II (reduces peripheral vascular resistance), and inhibits the decomposition of bradykinin (enhances the antihypertensive effect).
• Antihypertensive effect : It can stably lower blood pressure for 24 hours without affecting cardiac output and blood flow to major organs, and improve hypertensive cardiac hypertrophy and vascular remodeling.

8. Pharmacokinetics

• Absorption : It is rapidly absorbed after oral administration on an empty stomach and metabolized into active substances, with a Tmax of approximately 5.0~10.7 hours; food delays the absorption rate but does not affect the amount absorbed.
• Distribution : The plasma protein binding rate of the active substance is 10.2~18.2%. It is widely distributed in tissues such as the bladder, liver, and kidney, and the concentration in the brain is low.
• Metabolism : Mainly hydrolyzed into active substances, and there are also metabolic pathways such as cyclization and glucuronic acid conjugation.
• Excretion : 21-26% is excreted in urine as unchanged form and 3-10% as active substance; excretion is slower in patients with renal dysfunction and blood concentration is higher in the elderly.

IX. Clinical Research

• Monotherapy for mild to moderate hypertension: effective rate 69.5~77.8%, long-term medication (1 year) effective rate 78.0~94.7%.
• Combined diuretics/calcium antagonists: effective rate 80.0~82.1%.
• The main side effect was cough (5.9-16.1%), and the overall safety was good.

10. Packaging specifications

• Cosmetics tablets 2mg: PTP packaging, 100 tablets (10 tablets × 10).
• Cosmetics tablets 4mg: PTP packaging, 100 tablets (10 tablets × 10).

11. Production Information

1. Manufacturer : Kyowa Kirin Co., Ltd.
2. Company address : 1-9-2 Otemachi, Chiyoda-ku, Tokyo