GYNOZOL 200 mg / 400 mg Vaginal Soft Capsules and GYNOZOL 2% Vaginal Cream
1. Disclaimer
This information is intended for general educational and reference purposes and does not replace the current Egyptian package leaflet, a physician’s diagnosis, or advice from a qualified pharmacist or healthcare professional. Product formulations, indications, dosing instructions, regulatory status, and availability may change, and the instructions accompanying the specific product should always take precedence.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
GYNOZOL is a brand of vaginal miconazole products manufactured by Pharco Pharmaceuticals. Publicly available Egyptian-market records currently identify three same-brand presentations: Gynozol 200 mg vaginal soft capsules, Gynozol 400 mg vaginal soft capsules, and Gynozol 2% vaginal cream in a 40-g tube. Pharco's product documentation identifies the 200 mg and 400 mg presentations as soft vaginal capsules containing miconazole nitrate.
Miconazole is an imidazole antifungal used primarily for vulvovaginal candidiasis caused by susceptible Candida species. Modern clinical guidance does not support treating nonspecific vaginal discharge or presumed bacterial vaginosis with miconazole alone; vaginal symptoms are not specific for candidiasis and may require appropriate clinical assessment.
3. Brand Name
GYNOZOL
Current Egyptian-market presentations identified in publicly available retail listings include:
- Gynozol 200 mg — 6 vaginal soft capsules
- Gynozol 400 mg — 3 vaginal soft capsules
- Gynozol 2% Vaginal Cream — 40 g
The three presentations are currently listed under the Gynozol brand in an Egyptian pharmacy catalogue.
4. Category
Therapeutic category: Vaginal antifungal / antimycotic.
Pharmacological class: Imidazole antifungal.
WHO ATC: G01AF04 — Miconazole, classified under gynecological anti-infectives and antiseptics, imidazole derivatives. The WHO ATC/DDD Index was updated on January 20, 2026.
5. Active Ingredient
The active ingredient is miconazole, supplied in the products as miconazole nitrate.
- Gynozol 200: miconazole nitrate 200 mg per vaginal soft capsule
- Gynozol 400: miconazole nitrate 400 mg per vaginal soft capsule
- Gynozol 2% vaginal cream: miconazole nitrate 2% w/w; the 40-g Egyptian-market product is identified as containing miconazole nitrate 2%.
6. Pharmaceutical Form & Strength
Gynozol 200 mg: Vaginal soft gelatin capsules; pack of 6.
Gynozol 400 mg: Vaginal soft gelatin capsules; pack of 3.
Gynozol 2%: Vaginal cream; 40-g tube.
Pharco documentation identifies the 200 mg and 400 mg products specifically as soft vaginal capsules. Current Egyptian listings also use the terms “vaginal capsules,” “vaginal ovules,” or “vaginal suppositories” for the products.
7. Manufacturer & Marketing Authorization Holder
Manufacturer: Pharco Pharmaceuticals, Alexandria, Egypt. Pharco's own product portfolio lists Gynozol 200 mg, Gynozol 400 mg, and Gynozol cream among its pharmaceutical products, while Egyptian-market listings identify Pharco as the manufacturer/brand company.
Marketing Authorization Holder (MAH): Pharco Pharmaceuticals is the company publicly associated with the Gynozol brand and its product documentation. However, a current publicly searchable Egyptian Drug Authority registration record explicitly separating the Egyptian MAH from the manufacturer was not located; therefore, the exact current Egyptian MAH designation should be verified against the latest EDA registration record or the current package leaflet.
8. Mechanism of Action
Miconazole is an imidazole antifungal that primarily inhibits fungal lanosterol 14-α-demethylase, a cytochrome-P450-dependent enzyme involved in ergosterol biosynthesis. Depletion and alteration of ergosterol disrupt the structure and function of the fungal cell membrane, increasing membrane permeability and causing leakage of intracellular contents and loss of cellular integrity. Miconazole may also interfere with other fungal membrane and metabolic processes. Its activity can be fungistatic or fungicidal depending on organism and concentration.
9. Spectrum of Activity
Miconazole has activity against susceptible Candida species and other fungi. Pharco's current Gynozol product information specifically lists Candida albicans, C. parapsilosis, C. krusei, C. famata, C. guilliermondii, and C. tropicalis for the Gynozol vaginal capsules.
Miconazole also has activity against some Gram-positive bacteria in laboratory and pharmacological studies; however, this should not be interpreted as making Gynozol an appropriate treatment for bacterial vaginosis or other bacterial vaginal infections. Current WHO recommendations use antibacterial regimens such as metronidazole or clindamycin for bacterial vaginosis rather than miconazole.
10. Pharmacokinetics
Gynozol is administered locally into the vagina, where the intended therapeutic exposure is predominantly local. Vaginal miconazole is nevertheless not completely unabsorbed: measurable systemic concentrations have been demonstrated after vaginal administration.
Following a 1,200-mg vaginal miconazole pessary in healthy women, one pharmacokinetic study reported approximately 1.4% systemic bioavailability, with substantial interindividual variability. Another study demonstrated measurable serum concentrations after vaginal administration and found that systemic exposure was much lower than that associated with oral or intravenous administration.
Miconazole undergoes hepatic metabolism, and systemic concentrations after vaginal administration are generally low. Consequently, systemic adverse effects are less prominent than with systemic azole therapy, but clinically important drug interactions cannot automatically be excluded, particularly with warfarin.
11. Indications
The principal indication is the local treatment of vulvovaginal candidiasis caused by susceptible Candida species. Pharco's product information specifically lists susceptible Candida infections for Gynozol 200 mg and 400 mg.
Symptoms such as vaginal itching, burning, soreness, or abnormal discharge are not specific for candidiasis. Alternative causes, including bacterial vaginosis and sexually transmitted infections, may produce similar symptoms and require different treatment.
The former broad wording suggesting treatment of “leukorrhea” or mixed bacterial-fungal infection should not be used as a general indication without establishing the underlying diagnosis.
12. Administration
Gynozol 200 mg: The current Pharco product information specifies one vaginal soft capsule at bedtime for 6 consecutive days.
Gynozol 400 mg: The current Pharco product information specifies one vaginal soft capsule at bedtime for 3 consecutive days.
The capsule should be inserted deeply into the vagina at bedtime, with clean hands before and after administration. It is for intravaginal use only and must not be taken orally.
Gynozol 2% vaginal cream: Current Egyptian-market product information identifies a 40-g product and an Egyptian retail listing specifies one full applicator intravaginally once daily at bedtime for 3 consecutive days. However, internationally recognized guidance for generic miconazole 2% vaginal cream uses different regimens, including 5 g daily for 7 days. Therefore, the dosing instructions for the specific Egyptian Gynozol product leaflet should be followed rather than substituting a regimen from another miconazole formulation.
13. Method of Preparation
No reconstitution or special preparation is required.
Gynozol vaginal soft capsules are supplied ready for direct intravaginal administration.
For the cream, the supplied applicator should be used according to the product leaflet. The medication must not be swallowed or prepared for oral administration.
14. Contraindications
The principal established contraindication is hypersensitivity to miconazole, other imidazole derivatives, or any component/excipient of the particular formulation. Pharco's current Gynozol information explicitly identifies hypersensitivity as a contraindication.
The statement that “no contraindications are known” is therefore not accurate and should not be retained.
15. Warnings & Precautions
Vaginal miconazole should be used with appropriate diagnostic caution, particularly when the symptoms are new, atypical, severe, recurrent, or associated with abdominal/back pain, fever, chills, nausea, vomiting, or foul-smelling discharge. Such findings may indicate another condition requiring medical evaluation.
Recurrent vulvovaginal symptoms should not simply be repeatedly self-treated without evaluation. The CDC recommends clinical evaluation and appropriate testing when symptoms persist or recur shortly after treatment.
Vaginal miconazole products may weaken latex condoms and diaphragms, potentially reducing their effectiveness for contraception and prevention of sexually transmitted infections during treatment. Patients should consult the specific product labeling regarding alternative protection.
16. Drug Interactions
Although vaginal administration produces lower systemic exposure than oral administration, clinically relevant interactions remain possible.
The most important documented interaction is with warfarin. Miconazole can inhibit CYP2C9 and may increase warfarin exposure and anticoagulant effect, resulting in elevated INR and potentially serious bleeding. Careful medical supervision and appropriate INR monitoring are warranted when miconazole is used by a patient receiving warfarin.
Patients should inform their physician or pharmacist about all prescription medicines, over-the-counter medicines, supplements, and anticoagulants before using vaginal miconazole.
17. Side Effects
Vaginal miconazole is generally well tolerated, but local adverse effects can occur.
Possible effects include:
- Increased vaginal burning, itching, irritation, or discomfort.
- Local hypersensitivity or allergic reactions, which are uncommon but clinically important.
- Skin irritation or rash involving the external genital area.
Severe or persistent symptoms should not automatically be attributed to the medication; medical evaluation may be required, particularly if symptoms worsen, persist, or are accompanied by fever, abdominal pain, vomiting, or foul-smelling discharge.
18. Use in Special Populations
Pregnancy: Vaginal/topical miconazole has low systemic absorption, and available human data are generally reassuring regarding major birth defects. A 2026 MotherToBaby review notes that topical or vaginal miconazole is poorly absorbed and is unlikely to increase the risk of birth defects, while also recommending medical assessment of suspected vaginal infection during pregnancy.
However, it is not scientifically appropriate to describe Gynozol simply as “safe during pregnancy” without qualification. Current WHO recommendations for vulvovaginal candidiasis during pregnancy specifically suggest clotrimazole or nystatin rather than miconazole. Therefore, Gynozol should be used during pregnancy only when its use has been appropriately assessed by the treating healthcare professional.
Breastfeeding: Vaginal miconazole is poorly absorbed, and available information indicates that clinically significant exposure of a breastfed infant is unlikely. Nevertheless, breastfeeding patients should discuss treatment with a healthcare professional when clinically appropriate.
Children: The appropriate age range depends on the specific product and its local labeling. Vaginal miconazole products should not be routinely used in children without appropriate medical assessment.
Older adults: No specific age-related dosage adjustment is established for local vaginal miconazole solely on the basis of age; clinical assessment remains important because vaginal atrophy and other conditions can alter symptoms and potentially affect absorption.
19. Storage Conditions
Storage requirements should follow the current package labeling for the specific Gynozol presentation.
Where the current product-specific storage condition is not publicly documented in an authoritative Egyptian source, the product should be kept in its original packaging under the temperature and environmental conditions stated on the package/leaflet, protected from excessive heat and moisture, and kept out of the reach of children.
The commonly cited storage range of 15–30°C is reported for some miconazole vaginal products, but it should not automatically be assumed to be the exact approved storage condition for every Gynozol presentation.
20. Additional Sections
Current Egyptian-market presentations: Publicly accessible Egyptian pharmacy listings currently show three Gynozol presentations: 200 mg/6 vaginal capsules, 400 mg/3 vaginal capsules, and 2% vaginal cream/40 g.
Diagnostic consideration: Vulvovaginal candidiasis should be distinguished from bacterial vaginosis, trichomoniasis, sexually transmitted infections, dermatitis, and other causes of vulvovaginal symptoms. The presence of symptoms alone does not establish Candida infection.
Treatment duration: Regimens depend on the exact miconazole formulation and strength. The 200-mg and 400-mg Gynozol soft-capsule regimens should therefore not be replaced by dosing schedules from another miconazole product.
Barrier contraception: Because intravaginal miconazole formulations may compromise latex barrier contraceptives, patients should consult the specific product leaflet and use an appropriate alternative where necessary.
21. Frequently Asked Questions (FAQ)
What is Gynozol used for?
Gynozol vaginal products are primarily used for the local treatment of vulvovaginal fungal infections, particularly susceptible Candida infections.
What is the difference between Gynozol 200 mg and Gynozol 400 mg?
Both contain miconazole nitrate but have different strengths and product-specific treatment durations. Pharco currently specifies 200 mg once nightly for 6 consecutive days and 400 mg once nightly for 3 consecutive days.
Is Gynozol an antibiotic?
No. It is principally an antifungal medicine. Although miconazole has activity against some Gram-positive bacteria, Gynozol should not be regarded as a general treatment for bacterial vaginal infections or bacterial vaginosis.
Can Gynozol be used during pregnancy?
Vaginal miconazole has low systemic absorption and available human evidence is generally reassuring, but pregnancy requires appropriate medical assessment. Current WHO guidance recommends clotrimazole or nystatin for vulvovaginal candidiasis during pregnancy.
Can Gynozol affect condoms?
Yes. Intravaginal miconazole products may weaken latex condoms and diaphragms. The product leaflet should be consulted for the appropriate precautions during treatment.
Can Gynozol interact with warfarin?
Yes. Miconazole can increase the anticoagulant effect of warfarin, and clinically important bleeding has been reported. Medical supervision and INR monitoring are particularly important in patients receiving warfarin.
What if symptoms do not improve?
Persistent, recurrent, or worsening symptoms should be medically evaluated rather than repeatedly treating empirically, because several non-Candida conditions can cause similar symptoms.
22. References
- Pharco Pharmaceuticals — Product Portfolio/Brochure. Gynozol 200 Vaginal Soft Gelatin Capsules, Gynozol 400 Vaginal Soft Gelatin Capsules, and Gynozol Cream 40 g.
- Pharco — Gynozol 200 mg, current product information. Composition, presentation, indications, dosage and contraindications.
- Pharco — Gynozol 400 mg, current product information. Composition, presentation, indications, dosage and contraindications.
- Tdawi Egypt — Gynozol brand listing, current market listing. Identifies three Gynozol presentations in Egypt.
- World Health Organization — Recommendations for the treatment of Candida albicans and other selected sexually transmitted infections. Current WHO treatment recommendations, including pregnancy recommendations.
- Centers for Disease Control and Prevention (CDC) — Vulvovaginal Candidiasis, STI Treatment Guidelines. Diagnostic considerations, treatment regimens, recurrent disease, and intravaginal miconazole information.
- DailyMed — Miconazole Nitrate Vaginal Products. Warnings, administration, adverse effects, latex-barrier precautions, and product labeling.
- Daneshmend T. — Systemic absorption of miconazole from the vagina. Journal of Antimicrobial Chemotherapy. Pharmacokinetic study of vaginal miconazole.
- Stevens R, et al. — Bioavailability study of a 1200 mg miconazole nitrate vaginal ovule in healthy female adults. Pharmacokinetic evaluation following vaginal administration.
- MotherToBaby — Miconazole, January 2026. Current evidence regarding pregnancy and breastfeeding exposure.
- NIH/NLM LactMed — Miconazole. Information concerning lactation and systemic absorption.
- WHO Collaborating Centre for Drug Statistics Methodology — ATC/DDD Index. G01AF04: miconazole; last updated January 20, 2026.