| GYNECURE™ |
|Pfizer Consumer |
|Antifungal Agent |
|Action And Clinical Pharmacology: Tioconazole is a member of the imidazole class of antifungal agents. Although the mode of action of tioconazole has not as yet been determined, several studies have demonstrated that the imidazoles inhibit ergosterol synthesis in fungi by blocking C-14 demethylation. As a result, there is an accumulation of C-14 methyl sterol intermediates like langosterol, and a decrease in ergosterol. Langosterol cannot support yeast growth in the absence of ergosterol, and the inhibition of ergosterol synthesis or the accumulation of langosterol may be the primary antifungal mechanism of this class of drugs. At high drug concentrations the imidazoles have been postulated to exert a fungicidal effect by rapid membrane damage of the fungi. tag_IndicationsIndications
Indications And Clinical Uses: Tioconazole vaginal ointment and ovule are indicated for the local treatment of vulvo-vaginal candidiasis (moniliasis). Cream in the Tandempak may help to relieve the vulvar itching and irritation that is commonly associated with vaginal yeast infection.
The diagnosis of vulvo-vaginal candidiasis should be confirmed by KOH smears and/or cultures before initiating therapy with the vaginal ointment or ovule.
Tioconazole vaginal ointment and ovule may be used in patients taking oral contraceptives.
Contra-Indications: In those patients who have a history of sensitization to tioconazole or to any of the other components of the vaginal ointment, the ovule, the vulvar cream or to other imidazole antifungal agents. tag_WarningWarnings
Manufacturers' Warnings In Clinical States: Pregnancy: There are no adequate and well controlled studies which establish the safety of tioconazole vaginal ointment, ovule and the Tandempak in pregnant women.
In limited uncontrolled clinical use, the vaginal ointment and ovule applied as a single dose to about 20 patients during various stages of pregnancy did not appear to interfere with the normal progress of the pregnancy and at delivery.
However, local and systemic administration to rats indicate that adverse effects of parturition and/or fetal development were observed.
Accordingly, the vaginal ointment, ovule or Tandempak should be used during pregnancy only if in the opinion of the physician the potential benefit outweighs the potential risk to the fetus.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, nursing should be temporarily discontinued while tioconazole preparations are administered. Tioconazole should not be used by nursing women unless, in the judgment of a physician, the potential benefit outweighs the possible risk.
Children: Safety and effectiveness in children have not been established.
Others: The ointment and the vulvar cream component of the Tandempak are not for ophthalmic use; the vaginal ovules are not for oral use.
Precautions: Constituents of the vaginal ointment, ovule, and Tandempak, may be incompatible with rubber in both contraceptive condoms and diaphragms.
Skin and mucosal sensitization may occur. Use of tioconazole vaginal ointment, ovule or Tandempak should be discontinued should such reaction occur, and appropriate therapy instituted.
The vaginal ointment or ovule is intended for single dose intravaginal administration only.
The safety and effectiveness of repeated application of the vaginal ointment or ovule for the use and suppression of recurrent candidiasis has not been established.
Adverse Reactions: Vaginal Ointment: In 1 000 patients treated with tioconazole vaginal ointment, the most frequently observed local side effects were burning (6%) and itching (5%). In most instances these did not interfere with the course of therapy and were not transmitted to the sexual partner.
Isolated local vaginal symptoms such as irritation, discharge, labial swelling, swelling, vaginal pain, dysuria, nocturia, dyspareunia, dryness of vaginal secretions, vulva edema, desquamation and inflamed sensation, were observed.
Vaginal Ovules: Out of 173 patients treated with tioconazole vaginal ovule, 3 patients (1.7%) reported burning as a sole side effect, one of which required symptomatic treatment. However, the possibility of occurrence of side effects similar to those reported for tioconazole ointment should be considered.
Vulvar Cream Component of the Tandempak: This cream is the same as the dermal cream Trosyd AF and the following reactions are those associated with this cream. Symptoms of local irritation have been reported by some patients (7.2%). They are usually seen during the first week of treatment and are most often transient. The most commonly observed symptoms of local irritation reported in clinical studies were burning sensation (3.2%), itching (2.8%), erythema (1.5%), rash (0.8%) and edema (0.2%).
Treatment was discontinued in 1.9% of the patients. The principal reason for termination of treatment was the development of eczematous reactions or dermatitis.
Vulvar cream component of the Tandempak is well tolerated upon local application and no systemic adverse reactions have been observed with the dermal application of the drug.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: None known. tag_DosageDosage
Dosage And Administration: Vaginal Ointment, Vaginal Ovules, Tandempak: The recommended single dose treatment is 1 applicator full of ointment 6.5% w/w or 1 ovule 300 mg inserted intravaginally, preferably at bedtime. Vaginal candidiasis may be accompanied by vulval infection. Therefore, concomitant local treatment with the cream component of the Tandempak applied to the vulva and as far as the anal region once or twice daily is advisable. A small amount of the cream should be gently rubbed onto the irritated area, moving from front to back for up to 7 days as needed. The cream should not be used for vulvar itching or irritation due to causes other than a yeast infection.
In vulvo-vaginal candidiasis concomitant topical treatment of consort(s) is not necessary unless candidal dermatitis of the penis is present. To treat the male partner, a small amount of cream should be applied onto the glans penis once or twice daily for up to 7 days as needed or to help prevent reinfection by the partner.
Availability And Storage: Vaginal Ointment: Each g of vaginal ointment contains: tioconazole 6.5% w/w. Nonmedicinal ingredients: aluminum magnesium silicate, butylated hydroxyanisole and white soft paraffin. Each ready to use prefilled single dose vaginal applicator delivers 4.6 g of ointment containing tioconazole 300 mg.
Vaginal Ovule: Each off-white, opaque soft gelatin ovule containing a cream-colored viscous suspension contains: tioconazole 300 mg. Nonmedicinal ingredients: beeswax, gelatin, glycerin, glycine, hydrogenated vegetable fat, lecithin, liquid paraffin, polysorbate, potassium sorbate, titanium dioxide and water. Single-unit package with 1 disposable applicator.
Tandempak: Vaginal Ointment: Each g of vaginal ointment contains: tioconazole 6.5% w/w. Nonmedicinal ingredients: aluminum magnesium silicate, butylated hydroxyanisole and white soft paraffin. Prefilled single dose vaginal disposable applicator sealed in individual wallet with a vulvar 1% cream 10 g tube in a Tandempak.
Vaginal Ovules: Each off-white, opaque soft gelatin ovule contains: tioconazole 300 mg. Nonmedicinal ingredients: beeswax, gelatin, glycerin, glycine, hydrogenated vegetable fat, lecithin, liquid paraffin, polysorbate, potassium sorbate, titanium dioxide and water. Single dose and 1 disposable applicator with a vulvar 1% cream 10 g tube in a Tandempak.
Store between 15 and 30°C. Avoid freezing.
(Shown in Product Recognition Section)