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Irbesartan and Hydrochlorothiazide Tablets (Ebeishatanqinglusaiqin Pian) 

Please peruse the instructions carefully before using and following the advice of a physician. 

 

[Drug Name]

Common Name: Irbesartan and Hydrochlorothiazide Tablets

English Name: Irbesartan and Hydrochlorothiazide Tablets

Chinese Pinyin: Ebeishatanqinglusaiqin Pian

 

[Ingredient] This drug is the compound preparation of Irbesartan and Hydrochlorothiazide. Its constituent is that each tablet contains 150mg of Irbesartan and 12.5mg of Hydrochlorothiazide.

 

[Characters] 

This drug is white tablet.

 

[Indications] 

It is used to cure primary hypertension.

This fixed-dose compound preparation is applied for patients whose blood pressure can not be effectively controlled only by Irbesartan or Hydrochlorothiazide.

 

[Specification] Each tablet contains 150mg of Irbesartan and 12.5mg of Hydrochlorothiazide.

 

[Usage and Dosage]

Orally taken on an empty stomach or at meals. Generally the initial and maintenance dose is one tablet each time, one time a day. According to the seriousness of patients’ illness, the dosage can be increased to two tablets each time, one time a day.

It is recommended that patients can adjust the dosage of single ingredient (or Irbesartan or Hydrochlorothiazide) of this drug.

It is not recommended that a daily dosage in a single time of Irbesartan and Hydrochlorothiazide of more than 300mg and 25mg respectively. When necessary, this drug can be taken together with other blood-pressure lowering medicines (see [Drug Interaction]).

 

[Adverse Reaction]

The adverse reactions occurring among the patients treated by this drug are mild and temporary on the whole. 

The incidences of following adverse reactions apply the following definitions: 

Very common (≥1/10); common (≥1/100); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); and very rare (<1/10000)

Irbesartan and Hydrochlorothiazide tablets: 

In the placebo controlled test for patients with elevated blood pressure, the total incidence of adverse reactions has no difference between the group of Irbesartan and Hydrochlorothiazide tablets and the group of placebos. As for the incidence of treatment termination caused by adverse events in clinical or experimental test, the group of Irbesartan and Hydrochlorothiazide tablets is lower than the group of placebos. The incidence is nothing to do with dosage (within the range of the recommended dosage), gender, age, race or treatment cycle. In the placebo controlled test, there are 898 patients with elevated blood pressure taking all kinds of dosages of Irbesartan and Hydrochlorothiazide tablets (the ranges are as follows: 37.5mg~300mg and 6.25mg~25mg for ingredients Irbesartan and Hydrochlorothiazide respectively). 

For adverse reactions of Irbesartan and Hydrochlorothiazide Tablets, see the following Table 1. 

Additional information of single ingredients is shown following: 

Apart from the above listed adverse reactions caused by compound agent, an adverse reactions caused by single ingredients among the previously reported applications should also be emphasized. For the reported adverse reactions caused by single ingredients Irbesartan and Hydrochlorothiazide (whether or not they are relevant to the taking of this drug), see Table 2. 

 

Table 1 Adverse Reactions of Irbesartan and Hydrochlorothiazide Tablets 

Adverse reactions

Very common

Common

Uncommon

Rare

Very rare

Neurologic abnormality

-

Dizziness

Positional dizziness

-

Headache

Cardiac abnormality

-

-

High blood pressure, dropsy, syncope and tachycardia

-

-

Vascular abnormality

-

-

Blush

-

-

Gastrointestinal abnormality

-

Nausea and vomiting

Diarrhea

-

Taste blindness and maldigestion

Abnormality of skeletal muscle, connective tissues and bones

-

-

Dropsy of distal ends of four limbs

-

Arthralgia and myalgia

Kidney and urethra abnormality

-

Abnormality of miction

-

-

Renal impairment, including individual renal failure among patients with high-risk

Abnormality of reproductive system and breast

-

-

Change of sexual desire and sexual disorder

-

-

Abnormality of whole body and situation of drug administration

-

Fatigue

-

-

-

Change of laboratory parameter (little clinical significance)

-

Increase of BUN (urea nitrogen), creatinine and creatine kinase

Decrease of serum potassium and sodium

-

-

Abnormality of immune system (the same as other angiotensin Ⅱ receptor antagonists)

-

-

-

Such hypersensibility as skin rash, urticaria, angioneurotic edema

-

Metabolic and nutritional abnormality

-

-

-

-

Hyperkalemia

Ear and nutritional abnormality

-

-

-

-

Tinnitus

Abnormality of respiration, chest and diaphragm

-

-

Cough

-

-

Liver and gall abnormality

-

-

-

-

Abnormality of liver function and hepatitis

 

Table 2 Adverse Reactions Caused by Single Ingredients Irbesartan and Hydrochlorothiazide (whether or not it is relevant to the taking of this drug) 

  Adverse reactions

1. Irbesartan

 

Systemic diseases and situation of drug administration

Uncommon: thoracodynia

2. Hydrochlorothiazide

 

The blood system and lymph system

Hypoplastic anemia, bone inhibition, hemolytic anemia, leucopenia, neutrophilic granulocyte/granulocytopenia and thrombocytopenia

Psychiatric disorder

Depressive illness and dyssomnia

Neurologic abnormality

Dizziness, paraesthesia, inquietude and drowsiness

Abnormality of eyes

Temporary blurred vision and xanthopsia

Cardiac abnormality

Arrhythmia

Vascular abnormality

Positional low blood pressure

Abnormality of respiration, chest and diaphragm

Dyspnea (including pneumonia and pneumonedema)

Gastrointestinal abnormality

Pancreatitis, anorexia, constipation, diarrhea, stomach excitation, anorexia, sialoadenitis

Liver and gall abnormality

Jaundice (intrahepatic cholestatic jaundice)

Abnormality of skin and hypoderm

Overreaction, toxic subcutaneous necrosis dissolution, lupus erythematosus reaction, necrotizing angitis (phlebitis and dermophlebitis), photoallergy, skin rash and urticaria

Abnormality of skeletal muscle, connective tissues and bones

Muscle spasm and weakness

Kidney and urethra abnormality

Interstitial nephritis and renal dysfunction

Abnormality of whole body and situation of drug administration

Pyrexia

Metabolic and nutritional abnormality

Electrolyte imbalance (including hypokalemia and hyponatremia), glucosuria, hyperglycemia, increase of blood uric acid and increase of cholesterol and triglyceride

 

From the fourth to ninth month of pregnancy (sees [Medication for [Medication for Pregnant Women or Women in Lactation]). Lactation (sees [Medication for Pregnant Women or Women in Lactation] ).

The known those allergic to the active ingredient of the drug or to other sulfanilamide derivatives (Hydrochlorothiazide is a kind of sulfanilamide derivative).

The following contraindications have something to do with Hydrochlorothiazide:

-Severe renal impairment (creatinine clearance rate <30ml/min);

-Intractable hypokalemia, hypercalcinemia;

-Severe liver dysfunction, biliary cirrhosis and cholestasis.