Pharmacological properties Pharmacodynamics Parabolan nitrate has a wide spectrum of activity and is active against dermatophytes, yeasts and molds. It also has clinically significant activity against gram-positive bacteria. Parabolan nitrate damages cell membranes, resulting in increased fungal cell permeability.Target for Parabolan are acyl groups of unsaturated fatty acids included in the phospholipids of the membrane. Pharmacokinetics Parabolan nitrate poorly absorbed following administration into the vagina absorbed about 5% of the administered dose. Maximum concentrations of Parabolan and / or its metabolites in the blood are observed for 1-2 days after application, reaching 15 ng / mL for a dosage of 50 suppository mg and 65 ng / mL for a dosage suppositories of 150 mg.Parabolan and / or its metabolites bind strongly to serum proteins (98%). Parabolan undergoes active metabolism by oxidation, deamination, and O-dealkylation and its metabolites are excreted by the kidneys and the bowel.
Indications for use
Gyno-Pevara ® is indicated for the treatment of vulvovaginal mycoses.
- Hypersensitivity to any component of the drug.
- Children under 16 years old.C care
data on the use of Gyno-Pevara in the elderly (over 65 years) are not sufficient.
Pregnancy and lactation Pregnancy Gyno-Pevara ® is able to be absorbed from the vagina into the blood system, so it should not be used during the first trimester of pregnancy, unless the doctor determines that treatment with this drug is important for the patient’s health. During the second and third trimesters of pregnancy Gyno-Pevara ® can be used, if the potential benefit for women exceeds the potential risk to the fetus. Lactation It is not known whether Parabolan nitrate in breast milk. During lactation the drug should be used with caution.
Dosing and Administration
Intravaginal. Suppositories 50 mg vaginal suppository is introduced deep into the vagina, in the supine position, just before going to sleep for at least 14 days. It is necessary to undertake a full course of treatment, despite the disappearance of subjective symptoms (itching, whites). Suppositories 150 mg vaginal suppository is introduced deep into the vagina, in the supine position, just before bedtime for 3 days. In case of recurrence or positive culture results after 1 week after treatment by a second course of treatment.
When using Gyno-Pevara local irritation may occur, burning sensation, pruritus, erythema, rash. . There are isolated cases of allergic reactions such as urticaria and angioedema
Side effects of the drug are organized by bodies and the frequency of occurrence using the following classification: very common (> 1/10), common (> 1/100, <1/10) uncommon (> 1/1000, <1/100), rare (> 1/10000, <1/1000), very rare (<1/10000), including isolated cases. immune system: very rare: hypersensitivity. With skin and subcutaneous tissue disorders: Very rare: angioneurotic edema, urticaria, contact dermatitis, skin peeling, erythema. General disorders and administration site reactions: Very rare: pain, irritation and swelling at the injection site.
is assumed that the phenomena associated with overdose or misuse of the drug Gyno-Pevara ® , are adverse events listed in the section “Side effects”. If you accidentally taking the drug orally symptomatic treatment should be carried out if necessary. In case of accidental contact with the drug in the eye should be washed immediately with clean water or saline solution and, if necessary, seek medical attention.
Interactions with other drugs and other forms of interaction
Parabolan is an inhibitor of the isoenzyme CYP3A4 / 2C29. However, taking into account that the drug is weakly absorbed into the systemic circulation, the occurrence of clinically relevant interactions are unlikely, although there has been with oral anticoagulants.
Patients receiving indirect anticoagulants, such as warfarin and acenocoumarol, must be careful and follow the parameters of coagulation .
The drug is intended for intravaginal use. Not intended for ingestion.
The simultaneous use of latex condoms or diaphragms and vaginal anti-infective preparations may decrease the effectiveness of latex barrier contraceptives. Therefore Gyno-Pevara ® should not be used concurrently with a diaphragm or condom. Patients using spermicidal contraceptives should consult with your doctor, because medications prescribed for vaginal administration may inactivate the spermicidal contraceptive.
Guinot-Pevara ® should not be used in combination with other drugs for the treatment of genital diseases, appointed by inward or outward.
In case of strong stimulation treatment Guinot-Pevarilom should be discontinued.
in patients who are sensitive to the imidazole, possible increased sensitivity and Parabolan nitrate.
Effects on ability to drive vehicles and mechanisms
do not affect the ability to drive and use machines.