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miconazole Oral gel 2 % - 20 g, 30 g, 40 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #28191

This company is a pharmaceutical manufacturer with over three decades of experience established in 1992. They specialize in producing sterile ophthalmic products and non-sterile dermatological products, including ointments, creams, lotions, emulsions, gels, and medicated shampoos. Their key therapy areas focus on eye health and skin conditions. They offer a diverse range of dosage forms to cater to various patient needs. The company boasts several GMP certifications, including US FDA cGMP, WHO-GMP, ISO 13485:2016, ISO 9001:2015, Health-Canada, and PIC/S-Malaysia, demonstrating their commitment to quality and international standards. Their products are distributed across numerous countries globally, primarily in the EU and North America. They also hold product patents for several of their formulations.

MICONAZOLE

Miconazole is an azole antifungal called imidazole. As an antifungal, it is used to treat skin infections like athlete's foot, jock itch, ringworm. It is also used to treat other candidiasis and skin condition known as pityriasis, a fungal infection that causes darkening or lightening of the skin of the neck, chest, arms, or legs. It works by preventing the growth of fungus. Vaginal miconazole treats and prevents vaginal yeast infections in adults and children 12 years of age and older.  Miconazole is sold under the brand names like Aloe Vesta Antifungal, Baza Antifungal, Carrington Antifungal amongst others.  INSIGHT Pharmaceuticals as a topical cream file for the first patent patented in 1968 and approved for medical use in 1971. Due to its efficacy, Micanazole is on the World Health Organization's List of Essential Medicines. While First synthesized in 1969 and it was only granted its first FDA approval in 1974. Miconazole is sold as a variety of prescription and OTC products. 

Forms, Usage and Dosage:

Miconazole is applied only to the skin. Before application, the individual has to clean and thoroughly dry the intended area. It is applied usually twice a day or as directed by the doctor. If using the spray, shake well before applying. The type of infection being treated determines the dosage and length of treatment. The condition of the patient will not clear faster, but side effects may be increased. When being used for Vaginal Candidiasis, the For Vaginal suppository doses for one day is to use a1200 mg suppository intravaginally at bedtime. Whereas for the 3 and 7-day therapy the dose is 200 mg suppository for 3 days and 100 mg suppository 7 days. For women using the Vaginal cream, the dose is 2% cream, that is Inserted one applicatorful at bedtime for 3 to 7 days. if using the 4% cream, the treatment lasts for only 3 days. And for those using it Topically are advised to apply to the external vulvar area twice a day for up to 7 days. The treatment for Tinea Corporis and Tinea Pedis is done through Topical cream, ointment, powder, spray, or tincture for 4 weeks and has to applied twice a day. This duration is only two weeks for Cutaneous Candidiasis, Tinea Cruris, Tinea Versicolor. 

The Price of Miconazole:

In the USA, the consumers have to pay an average retail price of $61.32 for 3 suppositories of 200mg. whereas the OTC antifungal cream costs around USD8 for 2 ounces of 2% dose. In India, the prices are significantly cheaper, where the Ointment with 5 gm cost USD0.60 and the cream with 30mg of medicine cost the same.

How does it work?

Miconazole actions stop the fungal enzyme 14α-sterol demethylase. It results in reduced production of ergosterol. Miconazole acts as an antagonist of the glucocorticoid receptor in addition to its antifungal actions, it is the primary mechanism of action is in its inhibition of the CYP450 14α-lanosterol demethylase enzyme. It results in altered ergosterol production and impaired cell membrane composition and permeability. The final result is a cation, phosphate and low molecular weight protein leakage. In can also inhibit fungal peroxidase and catalase while not affecting NADH oxidase activity. This finally results in increased production of reactive oxygen species.  

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