Irbesartan Tablets for Treatment of Essential Hypertension

• Transport Package: Box
• Specification: 75mg*42tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC35
• Production Capacity: 10000PCS/

Product Description

Item Name:Irbesartan tablets
Molecular formula:C₂₅H₂₈N₆O

Item Description

Item nanme:Irbesartan tablets
Item character:This product is a white 

Indication:
Treatment of essential hypertension.
Treatment of type 2 diabetic nephropathy with hypertension

Item specifications:75mg*42tab/box

Usage and dosage:The recommended initial and maintenance dose is 150 mg per day, and diet has no effect on the medication. In general, irbesartan 150 mg once a day is better than 75 mg in controlling 24-hour blood pressure. However, for some special patients, especially those undergoing hemodialysis and over 75 years old, the initial dose of 75 mg can be considered.
If irbesartan 150 mg once a day can not effectively control blood pressure, the dosage of irbesartan can be increased to 300 mg, or other antihypertensive drugs can be added. In particular, the addition of diuretics such as hydrochlorothiazide has shown additional effects.
In hypertensive patients with type 2 diabetes, the initial dose should be 150 mg once daily, and increased to 300 mg once daily, as a better maintenance dose for the treatment of nephropathy. Clinical studies have shown that anbovir benefits the kidneys of patients with hypertension and type 2 diabetes. In the study, irbesartan was added with other antihypertensive drugs when necessary to reduce blood pressure and achieve the target value.
Renal function damage: Patients with renal function damage do not need to adjust the dose of this product, but for patients undergoing hemodialysis, low dose (75 mg) can be considered as the initial dose.
Hypovolemia: Patients with hypovolemia and / or sodium deficiency should be corrected before using this product.
Liver function damage: Patients with mild to moderate liver function damage do not need to adjust the dose of this product. There is no clinical experience for patients with severe liver function damage.
Elderly patients: although 75 mg may be considered as the starting dose for elderly patients over 75 years old, it is not necessary to adjust the dose for elderly patients.
Children: the safety and efficacy of anbovir in children have not yet been established.

Adverse reactions
The incidence of adverse reactions listed below is defined as follows:
It is very common (≥ 1/10); common (≥ 1/100); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 10000).
For hypertension: in the placebo-controlled trial of hypertension, the total incidence of adverse events was not different between the Irbesartan group (56.2%) and placebo group (56.5%). The incidence of termination due to clinical or laboratory adverse events was lower in the Irbesartan group (3.3%) than in the placebo group (4.5%). Adverse events were not associated with dose (within the recommended dose range), sex, age, race, or treatment period.
In the placebo-controlled trial, 1965 patients received irbesartan, and the following were reported adverse drug reactions:
Nervous system abnormality - common: Vertigo
Heart abnormality - unusual: tachycardia
Vascular abnormality - unusual: flushing
Abnormal breathing, chest, diaphragm - uncommon: cough
Gastrointestinal abnormalities - common: nausea / vomiting; uncommon: diarrhea, dyspepsia / heartburn
Reproductive system and breast abnormalities - uncommon: sexual dysfunction
Systemic abnormality and administration situation - common: fatigue; uncommon: chest pain
Check:
Common: the level of creatine kinase in plasma was significantly increased (1.7%) in the Irbesartan group, but none of the increased patients was related to clinically identifiable skeletal muscle events.
For hypertension with kidney disease and type 2 diabetes: in addition to the adverse drug reactions mentioned under hypertension, 0.5% of patients (i.e. uncommon) with postural vertigo and postural hypotension were reported in patients with microalbuminuria and normal renal function, which exceeded placebo group.
In diabetic hypertension patients with chronic renal insufficiency and proteinuria, 2% of the patients reported the following adverse reactions, and exceeded placebo group.
Nervous system abnormality - common: posture vertigo
Vascular abnormality - common: postural hypotension
Skeletal muscle, connective tissue, and bone abnormality - common: skeletal muscle pain
Inspection:
The incidence of hyperkalemia in patients with diabetes treated with irbesartan was higher than that of placebo. In patients with diabetic hypertension with microalbuminuria and normal renal function, 29.4% (very common) patients in the 300 mg group of irbesartan showed hyperkalemia (≥ 5.5 meq/l), while the incidence of high blood potassium in placebo group was 22%. In patients with diabetic hypertension with chronic renal insufficiency and obvious proteinuria, 46.3% (very common) patients in the 300 mg group of irbesartan showed hyperkalemia (≥ 5.5 meq/l), while the incidence of high blood potassium in placebo group was 26.3%. In the patients with hypertension with progressive diabetic nephropathy treated with irbesartan, 1.7% of patients (common) had decreased hemoglobin, but it was not clinically significant.
In addition, since the listing of irbesartan, the following adverse reactions have been reported
Immune system abnormality - rare: like other angiotension II receptor antagonists, a small number of cases have high sensitivity reactions such as rash, urticaria, vascular neuroedema, etc.
Metabolic and nutritional abnormalities - very rare: hyperkalemia
Nervous system abnormality - very rare: headache
Abnormal ears and lost ways - very rare: Tinnitus
Gastrointestinal abnormalities - very rare: loss of taste
Hepatobiliary abnormalities - very rare: abnormal liver function, hepatitis
Skeletal muscle, connective tissue, and bone abnormalities - very rare: myalgia, joint pain
Renal and urinary tract abnormalities - very rare: renal dysfunction, including one case of renal failure in a patient at risk. (see note)

Taboo:
Allergy to the ingredients of this product is known.
The fourth to ninth month of pregnancy. (refer to [precautions] and [medication for pregnant and lactating women])
lactation.

Matters needing attention:
Hypovolemic patients: for patients with hypovolemia caused by taking powerful diuretics, strict salt restriction in diet, diarrhea and vomiting, symptomatic hypotension may occur when taking this product, especially after the first dose. These conditions should be corrected before starting taking this product.
Renovascular hypertension: Patients with bilateral renal artery stenosis or single functional renal artery stenosis have an increased risk of severe hypotension and renal insufficiency when using drugs that affect the renin angiotensin aldosterone system. Although this condition was not found in the study of this product, the similar effect of angiotensin II receptor antagonist should be considered when using it.
Renal impairment and kidney transplantation: when patients with renal impairment use this product, regular monitoring of serum potassium and creatinine is recommended. There is no experience of using this product in recent renal transplant patients.
Hypertensive patients with type 2 diabetes and kidney disease: in all subgroups, analysis of patients with advanced kidney disease showed that the effects of irbesartan on renal and cardiovascular events were inconsistent. In particular, this product seems to benefit women and non white people less.
Hyperkalemia: like other drugs that affect the renin angiotensin aldosterone system, hyperkalemia may occur during the use of this product, especially renal function damage, obvious proteinuria caused by diabetic renal damage and / or heart failure. It is recommended that the serum potassium levels of these patients be closely monitored.
Lithium agent: it is not recommended to use this product with lithium agent.
Aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy: as with other vasodilators, patients with aortic and mitral stenosis and hypertrophic obstructive cardiomyopathy should be cautious when using this product.
Primary aldosteronism: Patients with primary aldosteronism usually do not respond to antihypertensive drugs that inhibit the renin-angiotensin system. Therefore, this product is not recommended for these patients.
General notes Objective: for those patients whose vascular tension and renal function mainly depend on the activity of renin angiotensin aldosterone system (such as patients with severe congestive heart failure or renal diseases, including renal artery stenosis), the use of angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists that can affect the system is associated with acute hypotension, azotemia and oliguria Or rare acute renal failure. As with any antihypertensive drug, excessive hypotension in patients with ischemic cardiomyopathy or ischemic cardiovascular disease may lead to myocardial infarction or stroke.
As observed with angiotensin-converting enzyme inhibitors, irbesartan and other angiotensin antagonists were significantly less effective in lowering blood pressure in black people than in non black people, possibly due to the higher proportion of low renin levels in black people with hypertension.
Effect on driver and machine operation ability: the effect of irbesartan on driver and machine operation ability has not been studied, but according to its pharmacodynamic characteristics, irbesartan may not affect such ability. When driving or operating the machine, it should be considered that occasionally dizziness or fatigue may occur in the treatment of hypertension.

Medication for pregnant and lactating women:
Pregnancy:
As an insurance measure, it is better not to use this product in the first three months of pregnancy. Appropriate replacement therapy should be used before pregnancy planning. In the fourth to ninth month of pregnancy, substances directly acting on renin-angiotensin system can cause renal failure of fetus and newborn, fetal head dysplasia and fetal death. Therefore, this product is forbidden to pregnant women from April to September of pregnancy. If found pregnant, should stop using this product as soon as possible, if due to negligence treatment for a long time, should be ultrasound examination of head and kidney function.
Lactation:
This product is forbidden during lactation. Whether irbesartan is secreted into human milk is unclear. Irbesartan can be secreted into the milk of mice.


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