Instructions Meratin combi vaginal tablets blister with applicators No. 10
Composition
active ingredients: ornidazole, neomycin sulfate, nystatin, prednisolone;
1 tablet contains: ornidazole 500 mg, neomycin sulfate 100 mg, nystatin 100,000 IU, prednisolone 3 mg;
Excipients: corn starch, microcrystalline cellulose, propyl gallate, sodium methylparaben (E 219), sodium propylparaben (E 217), colloidal anhydrous silica, talc, magnesium stearate, sodium starch glycolate (type A), carmellose sodium.
Dosage form
Vaginal tablets.
Main physicochemical properties: cream-colored, cartridge-shaped, biconvex, uncoated tablets, embossed with “MERATIN COMBI” on one side. Small dark spots and marbling are allowed.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives and corticosteroids. ATX code G01B F.
Pharmacological properties
Pharmacodynamics
Ornidazole. The mechanism of action of ornidazole is associated with disruption of the DNA structure in microorganisms sensitive to it. The drug easily penetrates the microbial cell and, binding to DNA, disrupts the replication process. Ornidazole is active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as some anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp. and anaerobic cocci. Neomycin is an antibiotic belonging to the aminoglycoside group. Aminoglycosides have high activity against gram-negative and gram-positive bacteria. Nystatin is an antifungal drug belonging to the polyene group. Nystatin affects the membrane of fungi by binding to one of the components - ergosterol. As a result, the structure of the fungal cell is disrupted and it dies. This component of the drug has selective toxicity for fungi, because human cells or bacterial cells contain cholesterol instead of ergosterol. Prednisolone is a synthetic corticosteroid drug used to reduce inflammation. Prednisolone inhibits the secretion and release of inflammatory mediators. Prednisolone inhibits proliferative processes in inflammatory diseases and reduces the likelihood of scarring.
Pharmacokinetics
With topical application, the concentration of the drug in the vaginal tissues significantly exceeds the concentration achieved with oral and intravenous administration; no systemic effect is observed.
Indication
Meratin Combi is used:
- for the treatment of gynecological diseases such as bacterial vaginosis and vaginitis, trichomonas vaginitis, fungal vaginitis caused by Candida albicans; vaginitis caused by mixed infections (trichomonas, anaerobic flora, including gardnerella and yeast-like fungi);
- for prophylactic purposes before surgical treatment of gynecological diseases, for vaginal sanitation before childbirth or abortion, before and after the introduction of intrauterine contraceptives, before and after diathermocoagulation of cervical erosions, before intrauterine examination.
The drug can be used as part of complex therapy together with the oral form of ornidazole.
Contraindication
Hypersensitivity to any of the components of the drug, other imidazole derivatives.
Special safety measures.
Intravaginal drugs, such as Meratin Combi, can damage latex contraceptives and reduce the effectiveness of contraceptives, so during treatment with the drug, you should refrain from sexual intercourse and do not use contact contraceptives.
Patients need to use separate personal hygiene products (washcloth, towel, etc.) and wear underwear made of natural cotton.
Interaction with other medicinal products and other types of interactions
No clinically significant drug interactions have been identified to date.
Application features
Meratin Combi is a non-toxic drug that does not cause sensitization. The drug is well tolerated. It is necessary to simultaneously carry out appropriate treatment of the sexual partner to avoid re-infection.
Use during pregnancy or breastfeeding
Contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible, since due to the low absorption of the drug, the concentration of its components in the systemic bloodstream is minimal and if the expected benefit to the mother outweighs the possible risk to the fetus. The drug can be used during breastfeeding. When using the drug as part of complex therapy with oral ornidazole, breastfeeding should be discontinued.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
1 tablet is administered deep into the vagina at night; after administration, the patient should lie down for at least 15 minutes. The average duration of treatment is 10 days. Treatment is not interrupted during menstruation. The drug can be used simultaneously with the oral form of ornidazole.
Entry procedure:
2. Immerse the applicator with the tablet in warm (30–40 °C) boiled water or saline solution (for people prone to allergic reactions) for 15–30 seconds.
3. Carefully insert the applicator with the tablet as deep as possible into the vagina (preferably while lying on your back).
4. Leave the tablet in the vagina after removing it from the applicator.
Children
Meratin Combi is not used in children or before the onset of sexual activity.
Overdose
Due to the local effect of the drug, overdose has not been observed, but increased manifestations of adverse reactions are possible.
Treatment is symptomatic.
Adverse reactions
Allergic reactions to the active ingredients of the drug, including urticaria, skin rash; reactions at the site of application, which may manifest, for example, as burning, pain, itching, tingling or irritation; erosions; hypersensitivity.
Systemic effects: with local application, slight absorption of the drug components is possible. If systemic effects from corticosteroids occur, delayed healing of wounds and cracks, atrophy of the mucous membrane are possible.
Treatment: Discontinue use if hypersensitivity or irritation occurs during use.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of the reach of children.
Packaging
10 tablets in a blister. 1 blister together with 10 applicators in a cardboard box.
Vacation category
According to the recipe.
Producer
Mepro Pharmaceuticals Pvt. Ltd, India/Mepro Pharmaceuticals Pvt. Ltd, India.
Manufacturer location
(Unit II) Q-Road, Phase IV, GIDC Wadhwan City-363 035 Surendranagar, Gujarat, India.
Applicant
Mili Healthcare Limited, Great Britain.
Applicant's location
Fairfax House 15, Fulwood Place, London, WC1V 6AY, Great Britain.
