Conversion of a single oral formulation of dextromethorphan hydrobromide to a prescription drug

On December 27, the State Drug Administration issued an announcement stating that in order to ensure the safety of public use of drugs, in accordance with the "Regulations for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)" (formerly State Drug Administration Order No.

details as follows:

1.

2.

The holders of the relevant drug marketing licenses, production and operation enterprises, and clinical use units shall produce, sell and use this product in strict accordance with the relevant management requirements of prescription drugs

3.

4.

Annex 1.

Annex 2.

Post-marketing monitoring found that the following adverse reactions occurred with the use of dextromethorphan hydrobromide oral single preparations:

Nervous system: drowsiness, dizziness, headache, dizziness, fatigue, involuntary muscle contraction

Digestive system: nausea, vomiting, lack of appetite, belching, dry mouth, abdominal discomfort (such as stomach pain), constipation

Immune system: Hypersensitivity and allergic reactions, including skin rash, urticaria, edema, itching, and cardiopulmonary dysfunction

Mental disorders: irritability, visual hallucinations, confusion, these adverse reactions are more obvious in the case of overdose

Skin and subcutaneous tissue: skin rash, urticaria, pruritus, erythema, allergic dermatitis

2.

1.
People who are allergic to dextromethorphan hydrobromide or any other ingredients of this medicine should not be used
.

2.
It is forbidden for women within 3 months of pregnancy and breastfeeding women
.

3.
People with a history of mental illness are prohibited
.

4.
Patients who are taking linezolid, monoamine oxidase inhibitors, serotonin reuptake inhibitors (such as fluoxetine, paroxetine), bupropion and other drugs or those who have been taking these drugs for less than two weeks are contraindicated
.

3.
[Precautions] item should include:

1.
After taking the medicine for 7 days, if the symptoms are not relieved or the condition worsens, please consult a physician
.

2.
Pregnant women use it with caution
.

3.
Use with caution in patients with liver and kidney dysfunction
.

4.
Patients with persistent or chronic cough, severe lung disease and cough variant asthma should be used with caution
.

5.
Use with caution in patients with excessive sputum
.

6.
People with CYP2D6 gene polymorphism should consult a physician before taking this product
.

7.
Patients who are taking sedatives, physically weak or bedridden, should consult a physician before taking this product
.

8.
During the period of taking the medicine, it is not allowed to drive locomotives or ships, engage in high-altitude operations, mechanical operations and operate precision instruments
.

9.
This product cannot be taken at the same time with alcoholic beverages
.

4.
[Interaction] item should include:

1.
This product should not be used concurrently with monoamine oxidase inhibitors and antidepressants
.
It is forbidden to take this product within 2 weeks after you are taking or stop taking the following drugs, because it will cause adverse reactions such as excitement, high blood pressure and high fever (body temperature ≥40℃): linezolid, monoamine oxidase inhibitors (such as moclobemide) , Tranylcypromine, niclosamide, promethazine and isocarboxazid), selective serotonin reuptake inhibitors (such as fluoxetine, sertraline or paroxetine), bupropion, propyl Carbachol, selegiline
.

2.
Before starting to take this product, if you are taking any of the following drugs, you should consult a physician, because you may need to adjust the dose of any of these drugs or stop treatment: amiodarone, quinidine, non-steroidal anti-inflammatory drugs (Such as celecoxib, parecoxib or valdecoxib), central nervous system depressants (some of which are used in the treatment of mental illness, allergies, Parkinson’s disease, etc.
), expectorants and mucolytics, CYP2D6 inhibitors ( Such as haloperidol)
.

3.
This product should not be used in combination with alcohol and other central nervous system inhibitory drugs, because it can enhance the inhibitory effect on the central nervous system
.

5.
[Drug Overdose] item should include:

Overdose of dextromethorphan may produce the following symptoms: confusion, excitement, nervousness, irritability, confusion, bronchospasm, respiratory depression, etc.
These symptoms may vary according to the degree of poisoning
.

Children overdose of dextromethorphan may produce the following symptoms: lethargy, nervousness, nausea, vomiting, and changes in gait
.

There have been reports abroad that adolescents who abuse drugs containing dextromethorphan have serious adverse reactions, such as tachycardia, drowsiness, high blood pressure or hypotension, dilated pupils, restlessness, dizziness, gastrointestinal discomfort, hallucinations, delirium, eyeballs Tremor, fever, shortness of breath, brain damage, ataxia, seizures, respiratory depression, loss of consciousness, arrhythmia, and death
.
Symptomatic treatment should be used in the case of poisoning, which includes intravenous naloxone and gastric lavage
.

6.
[Pharmacological action] item

Delete the relevant expressions of "long-term use without addiction and tolerance"
.