ECOREX 6 VAGINAL OVULATIONS 150MG

ECOREX VAGINATION

active ingredients

Vaginal cream 1%: 100 g of cream contain: Active ingredient: Econazole nitrate 1,00 g. Excipients: propylene glycol 10 g, methylhydroxybenzoate (E218) 0.2 g, propylhydroxybenzoate (E216) 0.08 g. Ovules 150 mg: each egg contains: Active ingredient: Econazole nitrate 150 mg. Vaginal wash 0.1%: every 150 ml vaginal lavender contains: Active ingredient: Econazole 150 mg. Excipients: propylene glycol 10 g, methylhydroxybenzoate (E218) 0.2 g, propylhydroxybenzoate (E216) 0.02 g. For the complete list of excipients, see paragraph 6.1.

Excellent

Vaginal cream 1%: Polyglycolic aesthetics of saturated fatty acids – propylene glycol – Metilidroxybenzoate (E218) – Propilidroxybenzoate (E216) – Deonized water. Ovuli: Solid semisynthetic glycerides – Policarbofil. Vaginal wash: Propylene glycol – Lactic acid – Metilidroxybenzoate (E218) – Propilidroxybenzoate (E216) – Trimethylcetylammonium p–toluensulphonate – Lavender Perfume – Purified Water.

Therapeutic indications

Vaginal cream and eggs: treatment of localized symptoms, such as itching, leucorrea, redness and feeling of swelling of the vaginal mucosa, burning to the passage of urine, if such symptoms are resulting in vulvovaginal infections from candida, previously diagnosed by the doctor. Lavender: assisting in the treatment of localized symptoms, such as itching, leucorrea, redness and swelling of the vaginal mucosa, burning to the passage of urine, if such symptoms are related to vulvovaginal infections of candida, previously diagnosed by the doctor.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Population

Cream: introduce deep into the vagina an applicator filled with vaginal cream (5 cc.) for 15 days each evening before bedtime, preferably in supine position. Treatment should also be protracted after the disappearance of subjective disorders (pruritus, leucorrea). Ovuli: introduce deeply into the vagina, preferably in supine position a 150 mg ovum each evening before bedtime, for three consecutive days. In case of relapse and in case after a week of treatment the control is positive, a second cycle of therapy will be repeated. Vaginal lavender: the recommended dosage is a lavender per day for five days; make lavender using the entire bottle. Vaginal lavender can be used at room temperature or warm by placing the bottle under a hot water flow. 1. Eliminate, pushing sideways, the seal of guarantee and closure. 2. Extract from the protective casing the cannula, grafting it on the bottle, to ensure its stable positioning. 3. To prepare in such a way that the solution can carry out its detersion and therapy action (by joining or sitting on toilets). 4. The cannula ends with an apical dispenser that has 3 holes for irrigation and 3 grooves for the discharge of the liquid. 5. Gently introduce in the vagina only the apical dispenser until the insertion limit. 6. Compress the bottle until completely emptying. Keep the liquid in the vagina for a few minutes to allow the solution to carry out its therapeutic action.

Conservation

Vaginal cream: no particular education. Ovuli: Store at a temperature below 25° C. Vaginal wash: Store at a temperature not exceeding 30 ° C

Warnings

The drug (vaginal cream and vaginal lavender) contains methylhydroxybenzoate and propylhydroxybenzoate that can cause allergic reactions (also delayed); also contains propylene glycol that can cause skin irritation. The internal vaginal irrigation must be done gently, especially in the presence of a mucosa altered by the inflammatory process. Keep the medicine out of reach and view of children.

Interactions

Econazole is a well-known cytochrome inhibitor CYP3A4 and CYP2C9. However, due to limited systemic distribution after skin application, it is unlikely that there are interactions with other medicines, although some have been reported with oral anticoagulants. In patients with oral anticoagulants, such as warfarin or acenocumarol, it is necessary to use caution and monitor the anticoagulant effect.

Effects

Vaginal cream – Ovuli: with medications of this type were reported, in the early days of treatment, burning and vaginal irritation, pelvic cramps, skin rashes and cephalee. Lavender: The therapy with Ecorex vaginal lavender is generally well tolerated. Rarely it may appear burning and vaginal irritation. In this case it is necessary to suspend therapy and to establish a suitable treatment.

Overdosing

The methods of application and the particularity of the pharmaceutical form make it extremely unlikely to overdose, whose effects are however local and irritative, to be treated symptomaticly. The available pharmaceutical forms are intended exclusively for the topical application, cases of acute overdose for ingestion are extremely unlikely and so far never reported. In case of accidental ingestion, treat symptoms that may occur, such as nausea, vomiting and diarrhea with symptomatic therapy. If the product accidentally enters into contact with the eyes, wash with clean water or physiological solution and turn to the doctor if the symptoms persist.

In pregnant women and children, the product should be administered in case of actual need under the direct control of the doctor. In studies of nitrate econazole, it has not shown teratogenic effects but has shown fetotoxic effects in rodents at subcutaneous maternal doses of 20 mg/kg/day and at oral maternal doses of 10 mg/kg/day. It is not known the relevance of this effect in humans. There are no adequate and controlled studies, nor epidemiological data, on the undesirable effects of using Ecorex during pregnancy. Post-marketing studies have not reported side effects on pregnancy or health of the fetus and the newborn due to Ecorex. Due to systemic absorption, Ecorex should not be used during the first trimester of pregnancy if not indicated by the doctor. Ecorex can be used during the second and third trimester of pregnancy if the potential benefit for the mother exceeds the possible risks for the fetus. Breasting After oral administration of nitrate econazole in rats during breastfeeding, econazole and/or its metabolisms were excreted in breast milk and detected in small ones. It is not known if the vaginal administration of Ecorex can cause a systemic absorption of econazole sufficient to produce detectable concentrations of the same in human breast milk. It must be used caution when Ecorex is given to women during breastfeeding.

Source: Farmadati