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DRUGS & SUPPLEMENTS
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GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% contains Gynofort 2%, an imidazole derivative with antifungal activity. Its chemical name is (±)-1-[4-(p-chlorophenyl)-2- [(2,6-dichlorophenyl) thio]butyl] imidazole mononitrate, and it has the following chemical structure:
Gynofort is a white to off-white crystalline powder with a molecular weight of 474.79. It is sparingly soluble in methanol; slightly soluble in chloroform, methylene chloride, acetone, and ethanol; very slightly soluble in ethyl acetate; and practically insoluble in water. It melts at about 159°C with decomposition.
GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% contains 2% Gynofort in a cream of edetate disodium, glyceryl monoisostearate, methylparaben, mineral oil, polyglyceryl-3 oleate, propylene glycol, propylparaben, colloidal silicon dioxide, sorbitol solution, purified water, and microcrystalline wax.
Following vaginal administration of Gynofort vaginal cream, 2% to 3 women, 1.7% of the dose was absorbed on average. Peak plasma levels (13.6-18.6 ng radioequivalents/mL of plasma) of the drug and its metabolites are attained between 12 and 24 hours after vaginal administration.
The exact mechanism of the antifungal action of Gynofort is unknown; however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. Imidazoles generally inhibit the conversion of lanosterol to ergosterol, resulting in a change in fungal cell membrane lipid composition. This structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell.
Gynofort is an imidazole derivative that has fungicidal activity in vitro against Candida spp. and has been demonstrated to be clinically effective against vaginal infections due to Candida albicans. Candida albicans has been identified as the predominant species responsible for vulvovaginal candidiasis.
GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES).
Note: GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see PRECAUTIONS - Pregnancy).
GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
Vulvovaginal Candidiasis: Two studies were conducted that compared 2% Gynofort cream with clotrimazole tablets. There were 322 enrolled patients, 161 received 2.0% butoconazole vaginal cream and 161 patients inserted the 500-mg clotrimazole vaginal tablet. At the second follow-up visit (30 days post-therapy), 118 patients in the butoconzole group and 116 in the clotrimazole group were evaluable for efficacy analysis, respectively. All of these patients had infection caused by Candida albicans.
The efficacy of the study drugs was assessed by evaluating clinical, mycologic and therapeutic cure rates, which are summarized in Table 1.
The therapeutic cure was defined as complete resolution of signs and symptoms of vaginal candidiasis (clinical cure) along with a negative KOH examination and negative culture for Candida spp. (microbiologic eradication) at the long term follow-up (30 days). The therapeutic cure rate was 67% in the butoconazole group and 61% in the clotrimazole group.
This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with GYNAZOLE-1® Gynofort Vaginal Cream USP, 2% is not recommended.
Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.
If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.
Carcinogenesis - Long term studies in animals have not been performed to evaluate the carcinogenic potential of this drug.
Mutagenicity - Gynofort was not mutagenic when tested in the Ames bacterial test, yeast, chromosomal aberration assay in CHO cells, CHO/HGPRT point mutation assay, mouse micronucleus, and rat dominant lethal assays.
Impairment of Fertility - No impairment of fertility was seen in rabbits or rats administered Gynofort in oral doses up to 30 mg/kg/day or 100 mg/kg/day (10 times the human dose based on mg/m2), respectively.
In pregnant rats administered 6 mg/kg/day of Gynofort intravaginally during the period of organogenesis, there was an increase in resorption rate and decrease in litter size; however, no teratogenicity was noted. This dose represents a 130- to 353-fold margin of safety based on serum levels achieved in rats following intravaginal administration compared to the serum levels achieved in humans following intravaginal administration of the recommended therapeutic dose of Gynofort.
Gynofort has no apparent adverse effect when administered orally to pregnant rats throughout organogenesis at dose levels up to 50 mg/kg/day. Daily oral doses of 100, 300 or 750 mg/kg/day (10, 30 or 75 times the human dose based on mg/m2 respectively) resulted in fetal malformations (abdominal wall defects, cleft palate), but maternal stress was also evident at these higher dose levels. There were, however, no adverse effects on litters of rabbits who received Gynofort orally, even at maternally stressful dose levels (e.g., 150 mg/kg, 24 times the human dose based on mg/m2).
Gynofort, like other azole antifungal agents, causes dystocia in rats when treatment is extended through parturition. However, this effect was not apparent in rabbits treated with as much as 100 mg/kg/day orally (16 times the human dose based on mg/m2).
There are, however, no adequate and well-controlled studies in pregnant women. GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gynofort is administered to a nursing woman.
Safety and effectiveness in children have not been established.
Of the 314 patients treated with GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.
The recommended dose of GYNAZOLE - 1® Gynofort Vaginal Cream USP, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of Gynofort.
GYNAZOLE-1® Gynofort Vaginal Cream USP, 2% is available in cartons containing one single-dose prefilled disposable applicator (NDC 45802-396-01).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Avoid heat above 30°C (86°F)
Made in Israel
Manufactured By Perrigo
Yeruham 80500, Israel
Distributed By
Perrigo®
Allegan, MI 49010 - www.perrigo.com
Rev 11-14
:8F200 RC J1
GYNAZOLE-1®
Gynofort Vaginal Cream USP, 2%
IN ONE PREFILLED DISPOSABLE APPLICATOR
Using the GYNAZOLE- 1® Butoconazole Nitrate Vaginal Cream USP, 2%
Prefilled Disposable Applicator
3 Easy Steps:
Step 1: Preparing the Applicator
Peel back the protective foil and remove the prefilled applicator. Applicator is designed to be used with tip in place. Do not remove tip; do
Do not warm applicator before using. While holding the applicator firmly, pull the ring back to fully extend the plunger (see Figures 1 and 2 ).
Step 2: Inserting the Applicator
Gently insert the applicator into the vagina as far as it will comfortably go (see Figures 3A and 3B ).
Step 3: Applying the Cream
Push the plunger to release the cream (see Figures 4A, 4B and 4C ). Remove the empty applicator from the vagina and throw it away.
Important Instructions
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Rev 11-14
:8F200 RC J1
Figure 1 and 2.jpg Figure 3A Figure 3B.jpg Figure 4A Figure 4B Figure 4C.jpg
Rx Only
NDC 45802-396-01
GYNAZOLE-1®
Gynofort Vaginal Cream USP, 2%
The applicator delivers approximately 5 g cream, containing 100 mg butconazole nitrate.
IN ONE PREFILLED DISPOSABLE APPLICATOR
For Vaginal Use Only.
NET WT 5.8 g
Gynofort Image
Rx Only
NDC 45802-396-02
PROFESSIONAL SAMPLE NOT TO BE SOLD
GYNAZOLE-1®
Gynofort Vaginal Cream USP, 2%
The applicator delivers approximately 5 g cream, containing 100 mg butconazole nitrate.
IN ONE PREFILLED DISPOSABLE APPLICATOR
For Vaginal Use Only.
NET WT 5.8 g
Gynofort Gynofort Vaginal Cream USP Image 2
Depending on the reaction of the Gynofort after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Gynofort not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Gynofort addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Visitors | % | ||
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1 day | 3 | 100.0% |
Visitors | % | ||
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30-45 | 1 | 50.0% | |
16-29 | 1 | 50.0% |
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The information was verified by Dr. Rachana Salvi, MD Pharmacology