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Flagenase SUSP 250mg 120mg, Metronidazole, Diiodohydroxyquinoline

INDICATIONS: Amebicide, indicated for the treatment of intra-and extraintestinal amebiasis. Diyodohidroxiquinoleína Associates, amebicide luminal (eliminates trophozoites and cysts), metronidazole, and extraintestinal intra amebicide, effective on trophozoites. Amebic liver abscess.

Pharmacokinetics in Humans: Metronidazole is rapidly absorbed orally and is not affected significantly by concomitant administration of food. The oral bioavailability is 100%, the volume of distribution is ~ 40 l (0.65 l / kg) in adults and infants from 0.54 to 0.81 l / kg. Dispatched to saliva, bile, seminal fluid, cerebrospinal fluid, breast milk, bone, liver and liver abscesses, lung and vaginal secretions. Crosses the placental barrier and is excreted in breast milk. Its low protein binding is <20% and hepatic biotransformation is metabolized mainly through oxidation of the lateral chain and to conjugation with glucuronic acid 2-hidrometilación (also active) and other metabolites.

In adults: The elimination half-life with normal hepatic function is 11 hours (average 6-14 hours). In liver damage from alcohol: 18 hours (average 10 to 29 hours).

In infants: 28-30 weeks gestational age, about 75 hours, 32-35 weeks gestational age, about 35 hours, 36-40 weeks gestational age, approximately 25 hours.

Renal elimination of 60-80% of this amount ~ 6-18% is excreted unchanged in the urine. Renal clearance is approximately 10 mL/minute/1.73 m2. Fecal is removed from 6 to 15% and fecal metabolites are inactive. For hemodialysis metronidazole and its metabolites are rapidly removed (its short half-life of approximately 2.6 hours). However, metronidazole is not significantly removed by peritoneal dialysis.

Diyodohidroxiquinoleína is poorly absorbed through the gastrointestinal tract and is recovered in urine little <10% of the ingested in the form of glucuronides and sulfates. It is excreted in feces.

Metronidazole is an antibacterial and antiprotozoal. It is most active against anaerobic bacteria and protozoa, causes an intracellular reductive chemical reaction, by unique mechanisms of anaerobic metabolism. Metronidazole is a cytotoxic reduced short life which interacts with DNA, causing loss of the helical structure and the bridges rupture of the molecule, resulting in inhibition of nucleic acid synthesis and cell death. Amebicide Diyodohidroxiquinoleína a selective action on hystolitica Entamoeba both in its active form (trophozoite) as cystic on its way.

Hypersensitivity to metronidazole. Do not take with alcohol, coumarin anticoagulants or disulfiram. Organic disease of the CNS. History of blood dyscrasias. Hypersensitivity to any 8-hydroxyquinoline or preparations containing iodine. Previous liver damage.

PRECAUTIONS:

Metronidazole: May induce neurological deterioration in patients with active CNS pathology due to its neurotoxic potential. Metronidazole is metabolized slowly build it up and its metabolites as a result of advanced liver disease, in which case it will use lower doses than those indicated. In patients with known prior or candidiasis symptoms can worsen during therapy with metronidazole and require specific treatment. Patients under treatment with metronidazole should avoid alcohol intake for at least three days after treatment, due to the effect disulfiram. If given prolonged metronidazole, is recommended on a regular blood tests, especially leukocyte count and close monitoring due to the risk of adverse reactions such as central or peripheral neuropathy, paresthesia, ataxia, dizziness or seizures.

We recommend close monitoring of patients with hepatic encephalopathy. Notice that metronidazole may darken urine. Metronidazole may cause confusion, dizziness, hallucinations, convulsions and transient visual disturbances, so you should avoid driving or operating machinery.

Diyodohidroxiquinoleína: In patients with thyroid disease, can interfere with determination of protein bound iodine for more than six months. Because optical and neurological toxicity, avoid prolonged use in patients with neurological disorders.

RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING Metronidazole not be used during pregnancy and lactation.

If administration is necessary, breastfeeding will reinstall postsuspensión 24-48 hours of treatment.

Diyodohidroxiquinoleína security has not been established during pregnancy and lactation.

ADVERSE REACTIONS:

Metronidazole: Gastrointestinal disorders (gastritis, nausea, vomiting, dysgeusia, dry mouth and metallic taste), transient headache and rash. Rarely, high doses: coated tongue, dizziness, depression, insomnia, drowsiness, dysuria and dark urine, peripheral neuropathy (pain, numbness, cramping or fatigue in the hands or feet) with high doses and prolonged use.

Also reported CNS toxicity: ataxia, tonic-clonic movements, encephalopathy, tremor and changes in mood, hypersensitivity: urticaria, papules and pruritus, leukopenia fever and oral lesions; pancreatitis: abdominal pain and lumbar , anorexia, nausea and vomiting. All these symptoms disappear immediately after the treatment.

Diyodohidroxiquinoleína: Found furunculosis, yodotoxicodermia, chills, fever, dermatitis, anal irritation, transient abdominal discomfort and diarrhea, headache, goiter and hair loss, optic neuritis, optic atrophy, peripheral neuropathy and subacute mieloóptica neuropathy (SMON) in patients treated hydroxyquinoline high dose.

DRUG INTERACTIONS AND OTHER GENDER: Concomitant use of metronidazole with warfarin inhibits the metabolism of this and can cause bleeding. Coadministration with disulfiram can cause acute psychosis or confusional state. With ethanol observed palpitations, tachycardia, nausea and vomiting.

Barbiturates induce therapeutic failure by shortening the lifetime of metronidazole, in which case they increase the initial dose of metronidazole.

Concurrent use of cimetidine may decrease the hepatic metabolism of metronidazole, which slows its elimination, increases serum and its potential toxicity.

Phenobarbital, to induce hepatic microsomal enzymes, metronidazole biotransformation increases, which decreases its half-life.

Metronidazole inhibits diphenylhydantoin purification by increasing the serum concentration thereof.

Diyodohidroxiquinoleína: no reports to date.

CHANGES IN RESULTS OF LABORATORY TESTS

Metronidazole: Interferes with serum determination: SGPT, SGOT, DHL, (hence may give false results of these enzymes).

Diyodohidroxiquinoleína: can elevate serum protein iodine.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: Metronidazole has been shown to be carcinogenic in mice and rats, and is mutagenic in bacteria and fungi, but these findings have not been confirmed in humans.

Diyodohidroxiquinoleína: There are no adequate and well-controlled.

DOSAGE AND ADMINISTRATION: Oral.

Children over 10 and adults: One capsule every 8 hours for 10 days, preferably after meals.

Average dose: 1.2 g / day of metronidazole.

Maximum dose: 2 g / day of metronidazole in severe or complicated amebiasis.

Children 1-9 years: The dose will be calculated at the rate of 40 mg of metronidazole and diyodohidroxiquinoleína per kg body weight / day. Built on 3 times daily for 10 days.

Average dose: 125-250 mg (1-2 teaspoons every 8 hours).

Maximum dose: 1.25 g / day in 3 doses. A teaspoon is 5 ml = 125 mg of metronidazole and 100 mg of diyodohidroxiquinoleína.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION: No specific antidote for metronidazole both to the diyodohidroxiquinoleína. Treatment of overdose should be symptomatic metronidazole with general supportive measures and gastric lavage.
Drug Name: Flagenase
Comparative Brand: Flagenase
Active ingredient: Metronidazole
Presentation: Suspension
Concentración: 400mg 30 tabs
Response time: No
Laboratory Liomont, S. A. de CV
Manufactured in: Mexico