Neo - penotran vaginal suppositories, No. 14

• vaginal candidiasis,

• bacterial vaginosis,

• trichomonas vaginitis,

• vaginitis caused by mixed infections.

Intravaginally.

1 vaginal suppository at night and 1 vaginal suppository in the morning for 7 days. For recurrent vaginitis or vaginitis resistant to other treatments, Neo-Penotran should be used for 14 days.

Vaginal suppositories should be inserted deep into the vagina using the disposable fingertips provided in the package.

Elderly patients (over 65 years of age): the same recommendations as for younger patients.

Each vaginal suppository contains:

• active ingredients: 500 mg metronidazole and 100 mg miconazole nitrate

• excipients: 1900 mg witepsol S 55

Known hypersensitivity to the active components of the drug or their derivatives, the first trimester of pregnancy, porphyria, epilepsy, severe liver dysfunction, patients under the age of 18 due to insufficient data on the use in this age category, virgins.

Trade name Neo-PenotranЃ

International non-proprietary name or grouping name Metronidazole + Miconazole

Dosage form
Vaginal suppositories

Composition
Each vaginal suppository contains:

• active ingredients: 500 mg metronidazole and 100 mg miconazole nitrate

• excipients: 1900 mg witepsol S 55

Description
Vaginal suppositories in the form of a flat body with a rounded end, white or almost white.

Pharmacotherapeutic group
Antimicrobial combined agent (antimicrobial and antiprotozoal agent + antifungal agent).

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Neo-PenotranЃ suppositories contain metronidazole, which has an antibacterial and anti-trichomonas effect, and mycoiazole, which has an antifungal effect. Metronidazole is an antibacterial and antiprotozoal agent and is active against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococcus and Trichomonas vaginalis. Miconazole nitrate has a broad spectrum of action (especially active against pathogenic fungi, including Candida albicans - the causative agent of thrush), effective against gram-positive bacteria.

Pharmacokinetics The
bioavailability of metronidazole with intravaginal administration is 20% compared with oral administration. After vaginal administration of the drug Neo-Penotran, when the equilibrium state was reached, the concentration of metronidazole in the plasma was 1.6-7.2 ?g / ml. The systemic absorption of miconazole nitrate with this route of administration is very low (approximately 1.4% of the dose), miconazole nitrate was not detected in plasma.

Metronidazole is metabolized in the liver. The hydroxyl metabolite is active. The half-life of metronidazole is 6-11 hours. Approximately 20% of the dose is excreted unchanged at night.

INDICATIONS FOR USE

• vaginal candidiasis,

• bacterial vaginosis,

• trichomonas vaginitis,

• vaginitis caused by mixed infections.

CONTRAINDICATIONS
Known hypersensitivity to the active ingredients of the drug or their derivatives, the first trimester of pregnancy, porphyria, epilepsy, severe liver dysfunction, patients under the age of 18 due to insufficient data on the use in this age category, virgins.

PREGNANCY AND LACTATION
Neo-PenotranЃ suppositories can be used after the first trimester of pregnancy under medical supervision, provided that the intended benefit to the mother outweighs the potential risk to the fetus.

During treatment, breastfeeding should be discontinued, since metronidazole passes into breast milk. Breastfeeding can be resumed 24 to 48 hours after the end of treatment.

DOSAGE AND APPLICATION

Intravaginally.

1 vaginal suppository at night and 1 vaginal suppository in the morning for 7 days. For recurrent vaginitis or vaginitis resistant to other treatments, Neo-Penotran should be used for 14 days.

Vaginal suppositories should be inserted deep into the vagina using the disposable fingertips provided in the package.

Elderly patients (over 65 years of age): the same recommendations as for younger patients.

SIDE EFFECTS
In rare cases, hypersensitivity reactions (skin rash) and side effects such as abdominal pain, headache, vaginal itching, burning and irritation of the vagina may occur.

Local reactions: miconazole nitrate, like all other antifungal agents based on imidazole derivatives that are injected into the vagina, can cause vaginal irritation (burning, itching) (2-6%). Due to inflammation of the vaginal mucosa during vaginitis, vaginal irritation (burning, itching) may increase after the introduction of the first suppository or by the third day of treatment. These complications quickly disappear as treatment continues. If severe irritation occurs, treatment should be discontinued. Systemic side effects are very rare, as plasma metronidazole levels are very low with vaginal absorption. Side effects associated with systemic absorption of metronidazole include: hypersensitivity reactions (rare); leukopenia; ataxia; mental changes (anxiety, mood lability), convulsions; rarely: diarrhea, dizziness;headache; loss of appetite; nausea; vomiting; abdominal pain or cramps; change in taste (rare); constipation; dry mouth; metallic taste; increased fatigue.

OVERDOSE
There are no data on overdose in humans with intravaginal use of metronidazole. However, when administered into the vagina, metronidazole can be absorbed in quantities sufficient to cause systemic effects. In case of accidental ingestion of a large number of suppositories, gastric lavage can be performed if necessary. Improvement of the condition after this can be achieved in persons who have taken orally up to 12 g of metronidazole. There is no specific antidote. Symptomatic and supportive therapy is recommended. Symptoms of a metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses),leukopenia, darkening of urine. Symptoms of miconazole nitrate overdose have not been identified.

INTERACTION WITH OTHER MEDICINAL PREPARATIONS
Alcohol: The interaction of metronidazole with alcohol can cause disulfiram-like reactions.
Oral anticoagulants: enhancement of the anticoagulant effect.
Phenytoin: a decrease in the concentration of metronidazole in the blood while increasing the concentration of phenytoin.
Phenobarbital: a decrease in the concentration of metronidazole in the blood.
Disulfiram: possible side effects from the central nervous system (psychotic reactions).
Cimetidine: the concentration of metronidazole in the blood may increase and the risk of developing neurological side effects may increase.
Lithium: Increased toxicity of lithium may be observed.
Astemizole and terfenadine: metronidazole and miconazole inhibit the metabolism of these substances and increase their plasma concentrations.

SPECIAL INSTRUCTIONS
Preclinical data indicate the absence of specific risk to humans, based on the results of standard studies of safety, pharmacology, toxicity of repeated doses, genotoxicity, carcinogenic potential, toxicity to the reproductive system.

It is necessary to avoid alcohol intake during treatment and at least for 24-48 hours after the end of the course due to possible disulfiram-like reactions. Caution should be exercised when using suppositories simultaneously with contraceptive diaphragms and condoms due to possible damage to the rubber base of the suppository.

Patients diagnosed with Trichomonas vaginitis require simultaneous treatment of their sexual partner.

Do not swallow or otherwise use!

Laboratory Tests
The results may vary when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood.

Influence on the ability to drive a car and equipment
Neo-Penotran suppositories do not affect the ability to drive and operate machinery.

FORM OF RELEASE
Vaginal suppositories. 7 suppositories in a PVC / PE plastic blister. 1 or 2 blisters, together with a package of fingertips and instructions for use, are placed in a cardboard box

STORAGE CONDITIONS
At a temperature not exceeding 25 ? —. Do not refrigerate. Keep out of the reach of children.

SHELF LIFE
3 years. Do not use after the expiry date indicated on the package!

TERMS OF RELEASE FROM PHARMACIES
By prescription.