What are the adverse reactions of Fudosteine ​​Capsules

What are the adverse reactions of Fudosteine ​​Capsules

Every drug has its own incompatibility. While curing a disease, it will also have more or less negative effects on some aspects of the body. This is the so-called adverse reaction. Fudosteine ​​capsules are very effective in treating bronchial diseases. It is mainly used clinically to treat bronchitis, emphysema or other respiratory diseases. While treating the disease, it also has many adverse reactions and precautions. Let's take a look.

Fudosteine ​​capsules are indicated for the expectorant treatment of respiratory diseases such as bronchial asthma, chronic asthmatic bronchitis, bronchiectasis, tuberculosis, pneumoconiosis, emphysema, chronic obstructive pulmonary emphysema, atypical mycobacteria, pneumonia, and diffuse bronchitis.

Indications

Used for expectorant treatment of respiratory diseases such as bronchial asthma, chronic asthmatic bronchitis, bronchiectasis, tuberculosis, pneumoconiosis, emphysema, chronic obstructive pulmonary emphysema, atypical mycobacteria, pneumonia, diffuse bronchitis, etc.

Adverse Reactions

1. Digestive system: Common symptoms (>1/100, <1/10) include loss of appetite, nausea, and vomiting; uncommon symptoms (>1/1,000, <1/100) include abdominal pain, diarrhea, constipation, chest tightness, stomach pain, stomach discomfort, burning sensation in the stomach, abdominal distension, dry mouth, etc.

2. Sensory organs: tinnitus and abnormal taste are rare;

3. Mental and nervous system: Headache, numbness, and dizziness are rare;

4. Urinary system: elevated BUN and urine protein, both rare;

5. Skin and mucous membranes: rash, erythema, itching, all rare; urticaria (incidence unknown);

6. Sevens-Johnson disease, toxic epidermal necrolysis (Lyell disease): It has been reported that similar drugs to this product may cause the above symptoms. Therefore, if similar symptoms occur when administering this product, administration should be stopped and appropriate treatment measures should be taken;

7. Liver function damage: Liver function damage accompanied by elevated AST (GOT), ALT (GPT), and ALP may occur (all common), and should be closely observed. If abnormalities occur, medication should be stopped and appropriate treatment measures should be taken;

8. Other reactions: fever, flushed face, fatigue, chest tightness, frequent urination, all rare; palpitations, edema (incidence unknown).

Precautions

1. Patients with impaired liver function: This product may cause further deterioration of liver function in patients with impaired liver function;

2. Patients with heart dysfunction: It has been reported that similar drugs of this product may have adverse effects on patients with heart dysfunction.

Pregnant and lactating women

1. This product can only be given to pregnant women when it is judged that the benefits of treatment outweigh the risks (in the administration test during the period of fetal organ formation in rabbits, miscarriage occurred when 0.6g/kg of this product was taken orally, which is about 30 times the clinical dosage. Rats were given 0.2g/kg of this product during the perinatal and lactation period, which is equivalent to 100 times the clinical dosage, and the development of the offspring was inhibited).

2. Breastfeeding women should stop breastfeeding when taking this drug, because animal experiments (rat) have found that this product can enter breast milk.

Pharmacology and Toxicology

Pharmacological Action

This product is a mucolytic agent, which can inhibit the excessive formation of goblet cells that secrete mucous sputum in the trachea, and inhibit the production of high-viscosity fucoxomucin, thereby reducing the viscosity of sputum and making it easier to cough up. This product can also increase serous tracheal secretion and inhibit tracheal inflammation.

Toxicology studies

Reproductive toxicity: When rats were given a dose of 2g/kg, no effect on fertility was observed; when rabbits were given a dose of 0.6g/kg, a few animals experienced miscarriage, but no teratogenic effect was observed.

Genetic toxicity: The results of Ames test, Chinese hamster lung cell chromosome aberration test and mouse bone marrow micronucleus test were all negative.

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