Bisoprolol Fumarate Capsules

1 Pharmacology This product is a selective beta 1 adrenergic receptor blocker, clinically used to lower blood pressure. Within the therapeutic dose range, this product has no obvious membrane stabilizing effect or intrinsic sympathomimetic effect. At high doses (320 mg), it can inhibit beta 2 adrenergic receptors (beta 2 receptors are mainly located in bronchial and vascular smooth muscle). The selectivity for beta 1 receptors is 4 times that of atenolol. 2 Toxicology Mice took this product at 250 mg/kg/day for 20 to 24 months, and rats took this product at 125 mg/kg/day for 26 months, and no potential carcinogenic events were observed. Calculated by body weight, these two doses are 625 times and 312 times the maximum recommended human dose of 20 mg (or 0.4 mg/kg/day for 50 kg individuals); calculated by body surface area, they are 59 times and 64 times the maximum recommended human dose. In microbial mutagenicity tests, mutation tests in Chinese hamster V76 cells, mice and rats, no potential mutagenic events were found. Rat reproductive studies have shown that this product does not impair reproductive function when the dose reaches 150 mg/kg/day, or when it reaches 375 times (body weight conversion) and 77 times (body surface area conversion) of the maximum recommended human dose. This product can be detected in the milk of lactating rats (at a dose of less than 2%).

The main ingredients and chemical name of this product: 1-[4-[[2-(1-methylethoxy)-ethoxy]-methyl]-phenoxy]-3-[(1-methylethyl)amino]-2-propanol fumarate. Molecular formula: (C18H31NO4)2C4H4O4 Molecular weight: 492.52

This product is a capsule, and the contents are white granules or powder.

For the treatment of hypertension, it can be used alone or in combination with other antihypertensive drugs.

The use of this product must be based on the principle of individualization. Usually the initial dose is 5 mg once a day, orally. Some patients may be suitable for an initial dose of 2.5 mg (such as bronchospasm). If the antihypertensive effect of 5 mg is not enough, the dose can be increased to 10 mg-20 mg. When the patient has liver damage (hepatitis or cirrhosis) or renal insufficiency (inosine clearance rate is less than 40 ml/min), the initial dose is 2.5 mg per day, and caution should be exercised when increasing the dose.

Same adverse reactions as other beta;1 adrenergic receptor blockers. The following adverse reactions are positively correlated with the dose: bradycardia, diarrhea, weakness, fatigue and sinusitis. Other common adverse reactions: Nervous system: dizziness, headache, paresthesia, dullness, drowsiness, anxiety, inattention, memory loss, dry mouth, dreaminess, insomnia, depression. Cardiovascular: palpitations or other arrhythmias, cold limbs, claudication, hypotension, orthostatic hypotension, chest pain, heart failure, breath holding. Digestive system: abdominal pain, indigestion, nausea, vomiting, diarrhea. Motor system: joint pain, back/neck pain, muscle spasm, twitching/tremor. Skin and mucous membranes: acne, eczema, skin irritation, itching, flushing, sweating, hair loss, angioedema, exfoliative dermatitis, cutaneous vasculitis. Special senses: visual disturbances, eye pain/pressure, abnormal tearing, tinnitus, ear pain, abnormal taste. Metabolism: gout. Respiratory system: bronchospasm, bronchitis, cough, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection. Genitourinary system: hypersexuality/impotence, Peyronie's disease, cystitis, urinary colic. Hematological system: purpura. Others: fatigue, weakness, chest pain, edema, weight gain. All adverse reactions reported with other beta; adrenergic receptor blockers should be considered as potential adverse reactions of this product. Laboratory abnormalities: There are reports of serum triglycerides, abnormal liver function such as increased aspartate aminotransferase (SGOT)/alanine aminotransferase (SGPT), uric acid, creatinine, urea nitrogen (BUN), blood potassium, blood sugar, blood phosphorus, and decreased white blood cells and platelets. This product can be continued if there is no clinical impact. Like other beta; adrenergic receptor blockers, it has been reported that about 15% of patients who use this product for a long time have positive antinuclear antibody titer tests, but about 1/3 of patients can turn negative after stopping the drug.

1. Allergy to this product. 2. Cardiogenic shock. 3. Hypotension. 4. Obvious heart failure. 5. Sick sinus syndrome and clear sinus bradycardia. 6. Second or third degree atrioventricular block. 7. Bronchial asthma

Precautions for children: There is no experience of using bisoprolol in pediatric patients, so this product cannot be used in children. Precautions for pregnancy and lactation: Not clear. Precautions for the elderly: No dosage adjustment is required.

This product should not be used in combination with other beta blockers. When this product is used in combination with reserpine and guanethidine, the beta receptor blocking effect of this product can be increased, resulting in excessive reduction of sympathetic activity, and close monitoring should be performed. Patients receiving clonidine treatment should stop taking this product a few days before clonidine is stopped if the medication is to be discontinued. This product should be used with caution when used in combination with drugs that have myocardial depression or atrioventricular conduction blockade, such as verapamil, diltiazem, and disopyramide, because additive effects may occur. Reserpine increases the metabolism of this product and shortens its elimination half-life, but the initial dose does not need to be adjusted. This product has no effect on the prothrombin time of patients taking warfarin.

Keep away from light and store in sealed container.

5 mg

24 months

YANGTZE River Pharmaceutical Group Jiangsu JOINT STOCK Co., Ltd.

• Founded in:

  1994-07-28

• Address:

  No. 2 Tongjiang East Road, Gaogang District, Taizhou City, Jiangsu Province

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  91321200703973749K

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  202.679 million yuan

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