Flagyl (Metronidazole) over the counter (otc).

Composition

Metronidazole - 200 mg/400 mg

Indications Flagyl

Infections caused by microorganisms sensitive to the drug: amebiasis, urogenital trichomoniasis, non-specific vaginitis, giardiasis, surgical infections caused by anaerobic microorganisms sensitive to metronidazole.

Flagyl is an antiprotozoal and antibacterial drug to treat infections caused by anaerobic bacteria and certain parasites like giardia and ameba.

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For giardiasis, tablets are prescribed for 5 days, for adults - 750-1000 mg / day, for children aged 10-15 years - 500 mg / day in 2 doses.
For trichomonas urethritis and vaginitis in women, Flagyl is prescribed for a course of treatment for 10 days: 1 tablet 2 times a day and 1 vaginal suppository (500 mg) per day. The sexual partner should be treated simultaneously, regardless of the presence or absence of clinical signs of trichomonas infection, even if the laboratory test result is negative.
For trichomonas urethritis in men, Flagyl is prescribed for a 10-day course of treatment: 1 tablet 2 times a day.
In isolated cases, it may be necessary to increase the daily dose to 0.75 or 1 g.
For non-specific vaginitis, 500 mg of Flagyl is prescribed 2 times a day for 7 days. The partner should be treated at the same time.
For the treatment of anaerobic infections (first-line therapy or replacement therapy), adults are prescribed 1.0–1.5 g/day, children over 6 years of age (weight ≥16 kg) — at the rate of 20–30 mg/kg/day (1 tablet 2 times a day).

Contraindications

hypersensitivity to imidazole derivatives; hypersensitivity to gluten (since the drug contains wheat starch (gluten)); children under 6 years of age, due to the dosage form of the drug. Breastfeeding period. It is not recommended to use the drug in combination with disulfiram or alcohol.

Side effects

Gastrointestinal tract: mild forms of gastrointestinal dysfunction (epigastric pain, nausea, vomiting, diarrhea); inflammation of the oral mucosa with a feeling of dryness, stomatitis, metallic taste in the mouth, anorexia; exceptional cases of pancreatitis after completion of reversible treatment.
Skin and its appendages: prolonged hyperemia, itching of the skin, rash (in isolated cases - pustular rash); sometimes - febrile manifestations; urticaria, angioedema, exceptional cases of anaphylactic shock.

CNS and peripheral nervous system: headache; sensory peripheral neuropathy; convulsions, dizziness, ataxia; very rare - encephalopathy (eg, confusion) and subacute cerebellar syndrome (eg, ataxia, dysarthria, gait disturbance, nystagmus, tremor), which may resolve after discontinuation of the drug.
Visual impairment: temporary visual impairment such as diplopia, myopia.
Psychiatric disorders: psychotic disorders, including confusion, hallucinations.
Hematopoietic system: in isolated cases - agranulocytosis, neutropenia and thrombocytopenia.
Hepatic dysfunction: in isolated cases - abnormal liver function tests of a reversible nature; cholestatic hepatitis.
Others. During treatment, urine may acquire a red-brown color, which is due to the presence of water-soluble pigments that are a product of metronidazole metabolism.

Special instructions

When taking Flagyl, do not drink alcohol due to the possibility of a disulfiram-like reaction (antabuse effect) (flushing, vomiting, tachycardia).
It is necessary to stop treatment with Flagyl if ataxia, dizziness or confusion occurs.
It is important to remember the possible risk of deterioration of neurological status in patients with severe, chronic or active disorders of the central nervous system or peripheral nervous system.
Precautionary measures for use. The drug is not considered to pose any risk of carcinogenicity in humans, although a carcinogenic effect was noted in some species of mice. However, this effect was not detected in rats and hamsters.
In case of a history of hematological disorders or during treatment with metronidazole in high doses and/or prolonged use, it is recommended to regularly monitor the number of leukocytes.
If leukopenia develops, it is important to carefully weigh the expected benefit of continuing treatment against the possible risk. In case of long-term treatment, it is necessary to monitor for signs of side effects, such as central and peripheral neuropathy (paresthesia, ataxia, dizziness or convulsive crisis).

Pregnancy and lactation

Pregnancy. Animal studies have not demonstrated a teratogenic effect. Since a teratogenic effect is not observed in animals, malformations are not expected in humans. According to data, substances that cause malformations in humans have a teratogenic effect in animals during adequately conducted studies on two species. No fetotoxic effect on the course of pregnancy was detected after the analysis.
However, further epidemiological studies are required to confirm the absence of risk. Therefore, metronidazole can be prescribed during pregnancy only if necessary, when the benefit from using the drug outweighs the potential risk.
Lactation. Metronidazole penetrates into breast milk. Flagyl should not be used during breastfeeding.
Children. The drug in the form of 250 mg tablets can be used in children over 6 years of age.
Ability to influence the reaction rate when driving vehicles and working with other mechanisms. Persons driving vehicles and working with mechanisms should remember about the possible occurrence of confusion, dizziness, hallucinations, convulsions during the use of this drug and refrain from driving vehicles and working with mechanisms during treatment with metronidazole.

Interactions

Combinations that are not recommended
Alcohol: Do not drink alcoholic beverages or take alcohol-containing medications during treatment with metronidazole and for at least 1 day after its completion due to the risk of a disulfiram-like reaction (antabuse effect) (flushing, vomiting, tachycardia).
Disulfiram: Cases of delirium, confusion have been reported in patients receiving metronidazole and disulfiram simultaneously.
Busulfan: Metronidazole may increase the plasma level of busulfan, which may lead to significant toxic effects of busulfan.
Combinations that should be used with caution
Oral anticoagulant therapy: Increased anticoagulant effect and increased risk of bleeding due to decreased hepatic metabolism. When used concomitantly, it is necessary to more frequently monitor prothrombin time, monitor the coagulation system and adjust anticoagulant therapy during treatment with metronidazole and for 1 week after its discontinuation.

Combinations requiring caution

Special instructions regarding the international normalized ratio (INR)
There have been many cases of increased activity of oral anticoagulants in patients treated with antibiotics. Risk factors may include infectious, inflammatory diseases and general health. It is difficult to determine the role of infectious pathology and its treatment in changing the INR. However, some types of antibacterial agents require special attention. This applies to fluoroquinolones, macrolides, cyclines, co-trimoxazole and some cephalosporins.

Effect on paraclinical tests

It should be remembered that metronidazole is able to immobilize treponemas, which leads to a false-positive test.

Overdose

A single dose of up to 12 g has been reported in suicide attempts and accidental overdose.

Symptoms included vomiting, ataxia and mild disorientation, leukopenia, neuropathy. There is no specific antidote. In case of significant overdose, symptomatic therapy is recommended.
A prescription from a doctor is not required to order, and this document is not required to purchase generics over the counter. Before taking the drug, talk to your doctor.

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