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Changes to Clotrimazole Vaginal Tablet Approval Requirements

When taking clotrimazole single pill (vaginal tablet), an antifungal drug used to treat vaginitis, if symptoms such as anaphylactic reaction or vascular (blood vessel) edema appear, the drug should be stopped.

The Ministry of Food and Drug Safety announced on the 3rd: “Based on the review of the safety and effectiveness of clotrimazole as a single agent (vaginal tablets), we will unify and adapt the approval requirements for 18 items, including Kamazol vaginal tablets “.

Representative products are Canesten 1 Vaginal Tablets and Canesten 1 Vaginal Tablets from Bayer Korea. Additionally, these products include “Caneclozil Tablet” by Ilyang Pharmaceutical, “Readiclosil Tablet” by Taegeuk Pharmaceutical, “Daily Vaginal Tablet” by Icure, “Candizil Tablet” by Korea Syntex Pharmaceutical, and “Evetoc Vaginal Tablet” by Ilyang Biopharm.

The main novelty is that drugs for breastfeeding mothers can be administered during breastfeeding subject to the doctor’s advice.

Specifically, “There are no data on the transfer of clotrimazole into human breast milk. However, systemic absorption after topical administration is low and is unlikely to cause systemic effects. Clotrimazole can be used during breastfeeding, but it is necessary consult a doctor.” A new phrase is added.

Previously, it was stated that “according to data from pharmacodynamic or toxicity tests, clotrimazole and its metabolites have been reported to be excreted through breast milk. Therefore, breastfeeding should be discontinued during the period of treatment with clotrimazole”.

Precautions for use include the following: “If immune system disorders such as ‘anaphylactic reaction’, ‘vascular (blood vessel) edema’ or ‘hypersensitivity’ occur, the drug should be discontinued and a doctor should be consulted.”

Additionally, if you experience skin and subcutaneous tissue (under the skin) disorders such as “hives” and “itching,” as well as general disorders and administration site conditions such as “application site irritation” or “pain,” discontinue the hiring. the medicine and consult a hospital.

These permit changes apply to 18 items from 17 companies.

“Canesten Vaginal Tablets” and “Canesten 1 Vaginal Tablets” by Bayer Korea, “Caneclo Vaginal Tablets” by Ilyang Pharmaceutical, “Readyclo Vaginal Tablets” by Taegeuk Pharmaceutical, iCure “Daily Vaginal Tablets”, “Candi Vaginal Tablets” by Korea Syntex Pharmaceuticals and Ilyang “Eve” by Biopharm These include “Tok Vaginal Tablets”, “Colpit Vaginal Tablets 100mg” by Light Pharmtech, “Candisten Vaginal Tablets 100mg” by The U Pharmaceuticals and “Carnetrisol Vaginal Tablets” by Hyundai Pharmaceuticals.

Clotrimazole primarily treats candida vaginitis. Candida vaginitis is a common disease that approximately 75% of women of childbearing age experience at least once.

It is infected with a fungus called “Candida albicans” and the main symptoms are itching and burning, pain when urinating and white, cloudy discharge.

Candida causes symptoms of vaginitis due to causes such as long-term use of antibiotics, diabetes or wearing tight clothing, when the immune system is weakened due to steroid use.

The Ministry of Food Safety and Drugs explained: “In the case of articles for which precautions for use relating to additives and information for experts are established separately, this item is not subject to change, so the information must be registered and managed independently. “

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