[Drug Name]

Generic name: doxofylline for injection

Commodity name: Xi Si Nuo

English name: Doxofylline for Injection

Chinese Pinyin: Zhusheyong Duosuochajian

[Ingredients] The main ingredient of this product is doxofylline.

Its chemical name is 1,3-dimethyl-7-(1,3-dioxolan-2-yl)methyl-3,7-dihydro-1H-purine-2,6-dione.

The chemical structure is as follows:

Molecular formula: C11H14N404

Molecular weight: 266.26

Excipients: mannitol, lactic acid, sodium hydroxide.

[Properties] This product is white or off-white loose lumps or powder.

[Indications] Difficulty breathing caused by bronchial asthma, wheezing chronic bronchitis and other bronchospasm.

[Specifications] 0.1g (calculated as doxofylline).

[Dosage]

For adults, 200mg each time, once every 12 hours, dilute with 25% glucose injection to 40ml and slowly intravenously, the time should be more than 20 minutes, 5-10 days as a course of treatment or follow the doctor's advice. You can also add 300mg of this product to 100ml of 5% dextrose injection or normal saline injection for slow intravenous drip, once a day.

[Adverse reactions]

The use of xanthine derivatives may cause nausea, vomiting, upper abdominal pain, headache, insomnia, irritability, tachycardia, extrasystole, shortness of breath, hyperglycemia, and proteinuria. Severe arrhythmia, paroxysmal cramps, etc. may occur if overdose. This manifestation is the initial symptoms of poisoning. At this time, the medication should be suspended, and the doctor should diagnose and monitor the blood concentration. However, it can still be used after the above signs and symptoms of poisoning have completely disappeared.

[Taboo] It is forbidden for those who are allergic to doxofylline or xanthine derivatives, patients with acute myocardial infarction and breastfeeding women.

[Precautions]

1. Theophylline drugs vary greatly among individuals, and the dosage of doxofylline should be selected according to the individual's condition changes, and the optimal dosage and medication method should be selected, and the blood drug concentration should be monitored.

2. Patients suffering from heart disease, hypertension, the elderly, and severe blood oxygen insufficiency, hyperthyroidism, chronic pulmonary heart disease, insufficient blood supply to the heart, arrhythmia, liver disease, peptic ulcer, renal insufficiency, or patients with co-infection should be used with caution.

3. Doxofylline should not be used with other xanthine drugs at the same time. It is recommended not to drink caffeinated beverages and eat caffeinated foods at the same time. Be cautious when using it with ephedrine or other adrenaline drugs.

4. When increasing the dosage, pay attention to monitoring the blood drug concentration (the treatment is effective within the range of 10μg/ml, and the toxic concentration above 20μg/ml)

[Medication for pregnant women and breastfeeding women] Since there is not enough clinical trials during pregnancy, it should be used with caution for pregnant women and forbidden for breastfeeding women.

[Children's medication] is not clear yet.

[Medication for the elderly] Use with caution in the elderly.

[Drug Interactions] Doxofylline should not be used with other xanthine drugs at the same time; it should be used with caution when using ephedrine or other epinephrine drugs at the same time.

[Drug overdose] If overdose is used, severe arrhythmia, paroxysmal cramps, etc. will occur. This manifestation is the initial symptoms of poisoning, the medication should be suspended and the blood drug concentration should be monitored, but it can still be used intermittently after the above signs and symptoms of poisoning have completely disappeared.

[Pharmacology and Toxicology]

Doxofylline is a derivative of methylxanthine. It is a bronchodilator and can directly act on the bronchus. By inhibiting the phosphodiesterase in smooth muscle cells, it relaxes the bronchial smooth muscles, thereby achieving the effect of inhibiting asthma.

[Pharmacokinetics]

According to literature reports, in patients with chronic bronchitis, intravenous injection of doxofylline 100mg (injection time> 10 minutes), plasma drug peak time (Tmax) after administration is about 0.10 hours, and the peak blood concentration (Cmax) is about 2.50μg /ml, elimination half-life (T1/2) is about 1.83 hours, can be quickly distributed to various body fluids and organs, the total clearance rate is 683.6±197.8ml/min.

[Storage] Protect from light, sealed (at 10～30℃) and store.

[Packing] Antibiotics in bottles, 10 bottles/box. 60 boxes/carton.

[Validity] 18 months

[Executive standard] National Food and Drug Administration Standard YBH33382005

[Approval Number] National Medicine Standard H20052247

[manufacturer]

Company Name: Anshi Pharmaceutical (Zhongshan) Co., Ltd.

Production address: National Health Technology Industry Base in Zhongshan City

Phone number: 0760-23898866

Fax number: 0760-23898833

Postal Code: 528437