Instructions for Macmirror film-coated tablets 200 mg blister No. 20
Composition
active ingredient: nifuratel;
1 tablet contains nifuratel 200 mg;
excipients: corn starch, rice starch, polyethylene glycol 6000, talc, magnesium stearate, gelatin, gum arabic, sucrose, magnesium carbonate, titanium dioxide
(E 171), wax E, purified water.
Dosage form
Film-coated tablets.
Main physicochemical properties: biconvex tablets, coated with a white coating.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Antimicrobial and antiseptic agents, except for combination preparations containing corticosteroids.
ATX code G01A X05.
Pharmacological properties
Pharmacodynamics
The active ingredient in the drug Macmirror is a nitrofuran derivative - nifuratel.
In vivo/in vitro studies have demonstrated a broad spectrum of activity against microorganisms, including genitourinary tract infections, and also possess antiprotozoal and antifungal activity. The mechanism of action is not fully understood; it is known that nifuratel, through its metabolites, affects enzymes involved in the growth of microorganisms. Nifuratel acts on Trichomonas in a similar manner.
Nifuratel acts as an antibacterial agent for gram-negative and gram-positive aerobic and anaerobic bacteria: Gardnerella vaginalis, Escherichia coli, Shigella, Salmonella spp., Bacillus sp., Proteus spp., Klebsiella pneumoniae. The minimum effective dose is 2.5-5 μg/ml. Bacteriostatic and bactericidal effects were studied in vitro, depending on the concentration of nifuratel.
Nifuratel showed strong inhibitory properties against the growth of Chlamydia trachomatis and less pronounced activity against Mycoplasma pneumonia and Ureaplasma urealyticum. The antifungal activity of nifuratel in in vivo studies is less pronounced compared to ketonazole and flutrimazole.
A wide spectrum of antibacterial, antiprotozoal and antifungal activity proves the effectiveness of Nifuratel in all types of genitourinary systemic infections. Nifuratel does not affect Lactobacillus spp., which are a natural component of the normal bacterial flora, due to which the drug promotes and accelerates the treatment of vaginal infection and prevents reinfection.
Studies on 2000 patients with vaginitis due to Trichomonas vaginalis showed that the effectiveness of treatment with nifuratel is determined by the absence of trichomonads in microscopic examinations: from 68-89% after the first course of treatment, from 82-89% after the second course of treatment, and 96% after the third course of treatment.
Studies on more than 900 patients with vaginitis due to various etiological factors, including mixed etiology, have shown that the effectiveness of treatment with nifuratel ranges from 88-96%. Nifuratel is more effective in the treatment of acute infections of the genitourinary system (effectiveness from 62-93%) than in the treatment of exacerbations of chronic infections (effectiveness - 50%).
High treatment efficacy is observed in patients with intestinal amebiasis and giardiasis, from 70-90% and 91-94%, respectively. There is also clinical data on the pronounced antiprotozoal activity of nifuratel.
Nifuratel does not cause cross-resistance of microorganisms to other drugs used in the treatment of infections. In 30 years, no case of resistance to nifuratel has been identified.
Pharmacokinetics
Pharmacokinetic studies were conducted on healthy volunteers taking 200 mg of nifuratel, during which two kinetic components were revealed. After taking a single dose of 200 mg, rapid absorption of nifuratel was noted; the concentration of the drug in the blood serum 2 hours after administration was 9.48 ± 3.6 μg / ml. Nifuratel was rapidly metabolized in almost all tissues of the body, the half-life was 2.75 ± 0.8 hours. Approximately 0.5% of nifuratel was excreted in the urine unchanged. The rest was excreted in the form of metabolites. Nifuratel shows significant affinity for fats and a significant total distribution, which is 17.428 l. Nifuratel was not detected in the intrahepatic circulation.
Indication
Vulvovaginal infections caused by pathogens sensitive to the drug (pathogenic microorganisms, trichomonads, fungi, yeasts, chlamydia, fungi of the genus Candida).
Diseases of the genitourinary system (cystitis, urethritis, pyelonephritis, pyelitis).
Intestinal amebiasis and giardiasis.
Contraindication
Known individual hypersensitivity to the active substance or to any of the other components of the drug. The drug should not be used in cases of impaired renal function, neuropathies and patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Interaction with other medicinal products and other types of interactions
Clinically significant drug interactions with other drugs have not been established.
Simultaneous intake of alcohol may lead to disulfiram-like reactions.
Application features
Use of the drug, especially over a long period of time, may cause hypersensitivity reactions.
During treatment with the drug, it is necessary to refrain from drinking alcohol to prevent the development of fatigue and nausea, which disappear on their own after some time.
While using the drug, you should refrain from sexual contact.
It is necessary to treat the sexual partner at the same time to avoid re-infection.
The drug contains sucrose, which should be taken into account by patients with diabetes.
Thrombocytopenic purpura, hepatotoxicity, blood abnormalities and pulmonary reactions have been reported with other nitrofuran compounds. However, a causal relationship between these clinical reactions and Macmirror 200 mg film-coated tablets has not been established. However, their occurrence cannot be completely ruled out.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy. Breastfeeding should be discontinued during treatment.
Method of administration and doses
Vulvovaginal infections.
Adults: 1 tablet of Macmirror 3 times a day after meals for 7 days for the treatment of the woman and her partner, if possible. For local treatment, use Macmirror Complex, soft vaginal capsules or Macmirror Complex, vaginal cream.
Important: Patients treated with tablets only should increase the dose to 4 tablets per day. Sexual intercourse should be avoided during treatment, otherwise Macmirror Complex vaginal cream should be used before each sexual act.
Children over 10 years of age: the recommended dose is 10 mg/kg body weight per day, divided into 2 doses. Take the drug after meals. The average duration of treatment is 10 days.
Urinary tract infections
Adults: the recommended dose of the drug depends on the severity of the disease and is 3-6 tablets per day (i.e. 200-400 mg 3 times a day) after meals. The course of treatment is on average 1-2 weeks.
Children over 6 years of age: the recommended dose is 10-20 mg/kg body weight per day, divided into 2 doses. Take after meals. Duration of treatment is 7-14 days.
As prescribed by a doctor, if necessary, the course of treatment with MACMIROR can be extended or a repeated course of treatment for urinary tract infections can be prescribed.
Intestinal amebiasis
Adults: 2 tablets 3 times a day, after meals, for 10 days.
Children over 6 years of age: the recommended daily dose is 30 mg/kg of body weight, divided into 3 doses, for 10 days.
Intestinal giardiasis
Adults: 2 tablets 2-3 times a day, after meals, for 7 days.
Children over 6 years of age: the recommended daily dose is 30 mg/kg of body weight, divided into 2 doses, after meals, for 7 days.
Children
The drug should be used in children over 6 years of age.
Overdose
Cases of overdose are unknown.
Adverse reactions
From the digestive tract
Short-term and minor gastroenterological disorders:
Rare (<1/10,000, <1/1,000): nausea, bitter taste in the mouth, diarrhea.
Very rare (<1/10,000): vomiting, dyspepsia.
Skin and subcutaneous tissue disorders
Possible hypersensitivity reactions, including:
Very rare (<1/10,000): skin rash, urticaria, itching.
From the nervous system
Peripheral neuropathies.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children!
Packaging
10 tablets in a blister, 2 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Doppel Farmaceutici Srl/Doppel Farmaceutici Srl
Location of the manufacturer and its business address
Via Volturno, 48 – Quinto De'Stampi – 20089 Rozzano (MI), Italy.
