Neo - Penotran forte vaginal suppositories 750 + 200mg, No. 7

• vaginal candidiasis,

• bacterial vaginosis,

• trichomonas vaginitis,

• vaginitis caused by mixed infections.

Intravaginally.

1 vaginal suppository is inserted deep into the vagina for 7 days at night.

For recurrent vaginitis or vaginitis resistant to other treatments, Neo-PenotranЃ Forte should be used for 14 days.

Suppositories should be inserted deep into the vagina using the disposable fingertips that are included in the package.

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

Each vaginal suppository contains:

• active ingredients: 750 mg metronidazole (micronized) and 200 mg miconazole nitrate (micronized)

• excipients: 1550 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-Penotran Forte

International non-proprietary name or group name

Metronidazole + Miconazole

Dosage form
Vaginal suppositories

Composition
Each vaginal suppository contains:

• active ingredients: 750 mg metronidazole (micronized) and 200 mg miconazole nitrate (micronized)

• excipients: 1550 mg witepsol S 55

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

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

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Neo-PenotranЃ Forte suppositories contain metronidazole, which has an antibacterial and anti-trichomonas effect, and miconazole, 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% but compared with oral administration. After vaginal administration of the drug Neo-PenotranЃ Forte, 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 by the kidneys.

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
Suppositories Neo-PenotranЃ Forte 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 METHOD OF APPLICATION
Intravaginally. 1 vaginal suppository is inserted deep into the vagina for 7 days at night.

For recurrent vaginitis or vaginitis resistant to other treatments, Neo-PenotranЃ Forte should be used for 14 days.

Suppositories should be inserted deep into the vagina using the disposable fingertips that are included in the package.

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

SIDE EFFECTS
In rare cases, allergic reactions (skin rash) and side effects may occur, in particular abdominal pain, headache, vaginal irritation (burning, itching).

Local reactions: miconazole nitrate can cause irritation of the vagina (burning, itching), as with intravaginal use of any other antifungal drugs based on imidazole derivatives (2-6%). 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: allergic reactions (rarely), leukopenia, ataxia, mental changes (anxiety, mood lability), seizures, rarely: diarrhea, constipation, dizziness, headache, loss of appetite, nausea, vomiting, abdominal pain or cramps, change in taste (rare), dry mouth, metallic or unpleasant 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.

INTERACTIONS
Alcohol: 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 mstronidazole 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: mstronidazole 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-PenotranЃ Forte suppositories do not affect the ability to drive a car and work with mechanisms.

FORM OF RELEASE
Vaginal suppositories. 7 suppositories in a PVC / PE plastic blister. 1 blister, together with a package of finger cots and instructions for use, is placed in a cardboard box.

STORAGE CONDITIONS
At a temperature not exceeding 25 ? —. Refrigerated storage is not allowed. Keep out of the reach of children.

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

TERMS OF RELEASE FROM PHARMACIES
By prescription.