Pevaryl Vaginal Cream 78g 1%+ 16 Applicators

NAME
PEVARYL

PHARMACOTHERAPEUTIC CATEGORY
Antimicrobials and antiseptics, excluding associations with corticosteroids.

ACTIVE PRINCIPLES
Econazole nitrate.

EXCIPIENTS
Vaginal cream: mixture of stearic acid esters with glycols; mixture of fatty acids with macrogol; Vaseline oil; butylated hydroxyanisole; benzoic acid; purified water. Ovules 50 mg: mixture of synthetic triglycerides; mixture of synthetic glycerides. Ovules 150 mg: mixture of synthetic triglycerides; mixture of synthetic glycerides. Prolonged-release eggs 150 mg: galactomannan polysaccharide; colloidal silica; mixture of triglycerides of saturated fatty acids; mixture of synthetic triglycerides; stearyl heptanoate. Cutaneous solution for external genitalia: polysorbate 20; benzyl alcohol; sorbitan monolaurate; N- [2-hydroxyethyl] -N- [2- (laurylamino) -ethyl] -aminoacetic acid sodium salt of 3,6,9-trioxadocosyl sulfate; macrogol 6000 distearate; lactic acid; perfume 4074; purified water.

INDICATIONS
Vulvovaginal mycoses; mycotic balanitis.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the listed excipients.

DOSAGE
>> Women. Vaginal cream: 1 applicator (5cc) filled with vaginal cream inserted into the vagina for 15 days every night before bed. The treatment must be continued even after the disappearance of subjective disturbances (pruritus, leucorrhoea). 50 mg eggs: 1 egg inserted deeply into the vagina, preferably in the supine position, every evening for 15 days. The treatment must be continued even after the disappearance of the subjective disorders (itching, leucorrhoea). 150 mg eggs: 1 egg inserted deeply into the vagina, preferably in the supine position, every evening for three consecutive days. In the event of a relapse or in the event that the control culture test is positive one week after treatment, a second course of therapy will be repeated. Prolonged-release ovules of 150 mg: the therapy involves a one-day treatment and consists in introducing deeply into the vagina, preferably in the supine position, one egg in the morning and one in the evening. Cutaneous solution for external genitalia: this pharmaceutical form is a suitable complement to therapy with ovules or vaginal cream. Cleanse the external genitals with 10 cc (1 dose) of solution dissolved in hot water. The treatment can be done once or twice a day. Partner Treatment: Both vaginal cream and cutaneous solution for external genitalia can be used. The cream is applied once a day for 15 days after washing the glans and foreskin with warm water. The solution is used dissolved in hot water. Do not rinse. Children (2-16 years): safety and efficacy in children have not been established. Elderly: there are insufficient data on the use of the drug in elderly patients over the age of 65.

STORAGE
Prolonged-release pessaries and pessaries: do not store above 30 degrees C. Vaginal cream: do not store above 25 degrees C.

WARNINGS
The vaginal cream and pessary drug are for intravaginal use only. The medicine is not for ophthalmic or oral use. The simultaneous use of latex condoms or diaphragms with vaginal antimicrobial preparations may decrease the effectiveness of the latex contraceptive. Therefore, products such as the drug should not be used in conjunction with latex diaphragms or condoms. Patients using spermicides should consult their doctor as any local vaginal treatment can render the spermicide inactive. The medicinal product must not be used together with other products for internal or external treatment of the genitals. Should marked irritation or sensitization occur, treatment should be discontinued. Patients sensitive to imidazoles may be sensitive to econazole nitrate. Contains butylated hydroxyanisole.

INTERACTIONS
Econazole is a known inhibitor of CYP3A4 and CYP2C9 cytochromes. Despite the limited systemic availability of the product after vaginal application, clinically relevant interactions may occur which have been reported in patients receiving oral anticoagulants. In patients taking oral anticoagulants such as warfarin or acenocoumarol, caution should be used and the anticoagulant effect should be monitored. . A dosage adjustment of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

SIDE EFFECTS
Based on the safety data collected from these clinical trials, the most commonly reported Adverse Drug Reactions (ADRs) (incidence> = 1%), were (with% incidence): pruritus (1.2%) and burning sensation of the skin (1.2%) The list below shows the ADRs of the gynecological formulations of the drug, deriving from both clinical studies and post-marketing experience, including the adverse reactions already mentioned above. The frequencies are reported according to the following convention: very common (1/10); common (1/100, <1/10); uncommon (1 / 1,000, <1/100); rare (1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known. Immune system disorders: Not known: hypersensitivity '. Skin and subcutaneous tissue disorders. Common: itching, burning sensation of the skin; uncommon: rash; rare: erythema; not known: angioedema, urticaria, contact dermatitis, skin exfoliation. Reproductive system and breast disorders. Uncommon: vulvovaginal burning sensation. General disorders and administration site conditions. Not known: application site pain, application site irritation, application site swelling. In addition, cases of local allergic reactions have been reported. With the cutaneous solution, in particular, local sensitization phenomena may occur.The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.

PREGNANCY AND BREASTFEEDING
Animal studies have shown reproductive toxicity. Due to vaginal absorption, the drug should not be used in the first trimester of pregnancy unless the doctor considers it necessary for the patient's health. The medicine can be used during the second and third trimesters if the potential benefits outweigh the possible risks to the fetus. After oral administration of econazole nitrate to lactating rats, econazole and its metabolites were excreted in milk and found in pups. It is not known whether econazole nitrate is excreted in human milk. Use the drug with caution in breastfeeding patients. Results from animal reproduction studies did not show effects on fertility.