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Pharmacies pay attention to a variety of common drug modification instructions

Release date: 2020-01-13 Views: 0

Source: Pharmacy Manager

Recently, according to the results of the evaluation of adverse drug reactions, in order to further ensure the safety of public medication, the State Administration of Supervision has implemented ginkgo leaves, ginkgo leaf capsules, ginkgo leaf soft capsules, ginkgo leaf particles, ginkgo leaf pills, ginkgo leaf dispersible tablets, ginkgo leaf drop pills, Ginkgo tea granules 8 ginkgo biloba oral solid preparations, ginkgo biloba, ginkgo biloba drops, ginkgo biloba oral liquid 3 liquid preparations, gingko ketone ester dispersible tablets, gingko ketone ester pills, gingko ketone ester capsules, gingko ketone Ginkgolide ester granules, Xingling dispersible tablets, Xingling dripping pills 7 ginkgolide oral preparations drug manual [adverse reactions], [taboos], [notes] items to be revised.

Ginkgo biloba leaves, Ginkgo biloba capsules, Ginkgo biloba soft capsules, Ginkgo biloba granules, Ginkgo biloba pills, Ginkgo biloba dispersible tablets, Ginkgo biloba drip pills, Ginkgo biloba tea 8 ginkgo biloba oral solid preparation instructions for revision

1. [Adverse reactions] should be increased:

Post-marketing adverse reaction monitoring data show that the following adverse reactions can be seen in oral preparations such as ginkgo biloba:

Gastrointestinal system: nausea, vomiting, dry mouth, bloating, abdominal pain, abdominal discomfort, hyperacidity, etc. There are cases of gastrointestinal bleeding.

Nervous system: dizziness, headache, etc. There are cases of local numbness.

Skin and accessories: rash, itching, etc.

Cardiovascular system: chest tightness, palpitations, etc. There are cases of increased or decreased blood pressure.

Others: Weakness, allergies or allergic reactions, etc. Case reports of bleeding gums and nosebleeds.

2. The taboo items should be increased:

Those who are allergic to this product and its ingredients are prohibited.

3. [Notes] Item should be added:

(1) Use with caution in patients with heart failure, pregnant women and those with allergies;

(2) Use strictly in accordance with the directions for use and dosage, and those who need long-term medication should use it under the guidance of a doctor;

(3) For patients with bleeding tendency or using anticoagulant and antiplatelet therapy, this product should be used under the guidance of a doctor;

(4) Preparations containing ginkgo biloba may increase the risk of bleeding and should be used by a doctor after evaluation during the perioperative period.

Ginkgo Biloba, Ginkgo Biloba Drops, Ginkgo Biloba Oral Liquid

1. [Adverse reactions] should be increased:

Post-marketing adverse reaction monitoring data show that the following adverse reactions can be seen in oral preparations such as ginkgo biloba:

Gastrointestinal system: nausea, vomiting, dry mouth, bloating, abdominal pain, abdominal discomfort, hyperacidity, etc. There are cases of gastrointestinal bleeding.

Nervous system: dizziness, headache, etc. There are cases of local numbness.

Skin and accessories: rash, itching, etc.

Cardiovascular system: chest tightness, palpitations, etc. There are cases of increased or decreased blood pressure.

Others: Weakness, allergies or allergic reactions, etc. Case reports of bleeding gums and nosebleeds.

2. The taboo items should be increased:

Those who are allergic to this product and its ingredients are prohibited.

3. [Notes] Item should be added:

(1) Use with caution in patients with heart failure, pregnant women and those with allergies;

(2) Use strictly in accordance with the directions for use and dosage, and those who need long-term medication should use it under the guidance of a doctor;

(3) For patients with bleeding tendency or using anticoagulant and antiplatelet therapy, this product should be used under the guidance of a doctor;

(4) Preparations containing ginkgo biloba may increase the risk of bleeding, and should be used after evaluation by a doctor during the perioperative period;

(5) This product contains alcohol. It should be prohibited or used with caution for alcohol-related dangerous diseases or individuals (such as patients with liver disease, alcoholic cardiomyopathy, drivers, aerial workers, etc.);

(6) Attention should be paid to the interaction of this product with the following drugs: disulfiram, cefmendo, cefoperazone, oxycephalosporin, chloramphenicol, mesotrione, glibenclamide, glipizide, toluene Sulfacarbazone, griseofulvin, 5-nitroimidazole, ketoconazole, procarbazine, central nervous system inhibitors, etc.

Ginkgolide ester dispersible tablets, ginkgolide ester drops pills, ginkgolide ester capsules, ginkgolide ester tablets, ginkgolide ester particles, apricot spirit dispersible tablets, xingling drip pills

1. [Adverse reactions] should be increased:

Post-marketing adverse reaction monitoring data show that the following adverse reactions can be seen in oral preparations such as ginkgolide esters:

Gastrointestinal system: nausea, vomiting, dry mouth, bloating, abdominal pain, abdominal discomfort, hyperacidity, etc.

Nervous system: dizziness, headache, etc.

Skin and accessories: rash, itching, etc.

Cardiovascular system: chest tightness, palpitations, etc.

Others: fatigue, allergies or allergic reactions.

2. The taboo items should be increased:

Those who are allergic to this product and its ingredients are prohibited.

3. [Notes] Item should be added:

(1) Use with caution in patients with heart failure, pregnant women and those with allergies;

(2) Use strictly in accordance with the directions for use and dosage, and those who need long-term medication should use it under the guidance of a doctor;

(3) For patients with bleeding tendency or using anticoagulant and antiplatelet therapy, this product should be used under the guidance of a doctor;

(4) Preparations containing ginkgo biloba may increase the risk of bleeding and should be used by a doctor after evaluation during the perioperative period. In addition, the State Food and Drug Administration also issued the "Announcement of the State Food and Drug Administration on Revising the Instructions for Huaying Reconstruction Pills", which was banned by pregnant women.

Revision requirements for Huaying Reconstituted Pill Manual

1. [Adverse reactions] should increase:

Post-marketing monitoring data show that the following adverse reactions can be seen with this product:

Gastrointestinal system: nausea, vomiting, abdominal pain, bloating, diarrhea, constipation, dry mouth, bitter mouth, heartburn, acid reflux, etc.

Nervous system: dizziness, headache, etc. There are cases of numbness of the limbs and numbness of the tongue.

Cardiovascular system: chest tightness, palpitations, etc. Skin: rash, itching, etc.

Other: fever, cases of shortness of breath, abnormal liver function, and abnormal renal function.

Second, [taboos] should be added:

1. Those who are allergic to this product and its ingredients are prohibited.

2. Disable pregnant women.

3. [Precautions] should be added:

1. This product should be used in accordance with the [Usage and Dosage] stipulated in the drug manual, and it should not be used in excess or for a long time.

2. Patients with abnormal liver and kidney function should be used with caution.

Delete the item "3. Commonly used amount: 8g (g) each time (about 48 ~ 50 pills), take it once in the morning and evening. Take it for 10 days, stop taking it for 1 day, 30 days is a course of treatment, you can take it even 3 courses of treatment. The preventive and maintenance doses are 4g (grams) each time, once in the morning and evening. "

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