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Flagimax Suspension Leaflet
Flagimax Suspension Leaflet
Flagimax Suspension Leaflet
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Pediatric Flagimax has the benzoyl derivative of metronidazole as its active ingredient, which
allows it to be presented in the suspension pharmaceutical form.
Pediatric Flagimax is an anti-infective that presents antimicrobial activity, which exclusively
covers anaerobic microorganisms (which grow in the presence of low concentrations of
oxygen or even in its absence), and antiparasitic activity.
The maximum concentration reached in the blood appears four hours after administration of
the product.
giardiasis
Children aged 1 to 5 years:
5 mL, 2 times a day for 5 days.
Children aged 5 to 10 years:
5 mL, 3 times a day for 5 days.
amoebiasis
Intestinal amoebiasis:
20 mg (0.5 mL)/kg 4 times a day for 5 to 7 days.
Hepatic amoebiasis:
20 mg (0.5 mL)/kg 4 times a day for 7 to 10 days.
Each ml of suspension contains 40 mg of benzoylmetronidazole which corresponds to 25 mg
of metronidazole.
There are no studies of the effects of Pediatric Flagimax given by non-recommended routes.
Therefore, for safety and efficacy of this drug, administration should only be taken orally as
recommended by the doctor.
Follow your doctor's advice, always respecting the times, doses and duration of treatment.
Do not stop treatment without your doctor's knowledge.
If you forget to take a dose, take it as soon as possible, however, if it is close to the time for
the next dose, wait for this time, always respecting the interval determined by the dosage.
Never take two doses at the same time.
If in doubt, seek advice from your pharmacist or doctor.
Special Population
Changes in the ability to drive and operate machinery
You should not drive a vehicle or operate machinery if these symptoms occur: confusion,
dizziness, hallucinations, seizures or visual disturbances and advised not to drive a vehicle or
operate machinery if these symptoms occur.
pregnancy and breastfeeding
The use of metronidazole during pregnancy should be carefully evaluated as it crosses the
placental barrier and its effects on human fetal organogenesis (formation of the cells that are
forming the fetus) are still unknown.
This medicine should not be used by pregnant women without medical advice.
As metronidazole is excreted in breast milk, unnecessary exposure to the drug should be
avoided.
elderly
There are no special warnings and recommendations on the proper use of this drug in elderly
patients.
The efficacy of this drug in giardiasis can be confirmed in Misra's open-label randomized
comparative study with albendazole, involving 64 children aged 2 to 12 years with giardiasis.
The efficacy index was similar in the two groups, confirming the action of metronidazole
suspension in the treatment of giardiasis in children (MISRA, 1995).
Another multicenter, randomized study by Dutta compared the efficacy and safety of
metronidazole and albendazole in the treatment of giardiasis in children. In this study, 150
children between 2 and 12 years of age were randomized and received doses of
metronidazole and albendazole suspension. The cure rate in the treatment of both groups
(metronidazole and albendazole) was 97%, confirming that metronidazole is a safe drug with
minimal side effects (DUTTA, 1994).
Homeida also confirmed the efficacy of metronidazole suspension in the treatment of 11
children aged 3 years to 7 years with a confirmed diagnosis of giardiasis. Treatment with
metronidazole oral suspension was successful in the presence of giardiasis (HOMEIDA, 1986).
Pharmacological Characteristics
Pharmacodynamics
This medication has the benzoyl derivative of metronidazole as its active ingredient, which
allows it to be presented in the suspension pharmaceutical form. Each 200 mg of
benzoylmetronidazole corresponds to 125 mg of metronidazole.
Metronidazole is an anti-infective from the nitromidazole family, which has a spectrum of
antimicrobial activity that exclusively covers anaerobic microorganisms:
Commonly susceptible species (more than 90% of strains in the species are susceptible):
Peptostreptococcus, Clostridium perfringens, Clostridium difficile, Clostridium sp,
Bacteroides sp, Bacteroides fragilis, Prevotella, Fusobacterium , Veillonella.
Species with variable sensitivity:
The percentage of acquired resistance is variable. Sensitivity is unpredictable in the absence
of an antibiogram. Bifidobacterium, Eubacterium.
Usually resistant species (at least 50% of the strains of the species are resistant):
Propionibacterium, Actinomyces, Mobiluncus.
Anti-parasitic activity:
Entamoeba histolytica, Trichomonas vaginalis, Giardia intestinalis.
Pharmacokinetics
Absorption
After oral administration, metronidazole is rapidly absorbed, at least 80% in less than 1 hour.
The serum peak obtained after oral administration is similar to that obtained after
administration of equivalent doses intravenously. Oral bioavailability is 100% and is not
modified by food intake. Benzoylmetronidazole hydrolysis is carried out progressively during
its passage through the digestive tract.
The absorption of benzoylmetronidazole is 30% less than that of metronidazole. At the same
dosages, metronidazole and benzoylmetronidazole do not present significantly different
therapeutic results.
The plasma peak appears in the fourth hour after administration of the product.
Distribution
After administration of a single 500 mg dose of metronidazole, the mean plasma level is 10
μg/mL one hour after administration. Plasma half-life is 8 -10 hours. Binding to plasma
proteins is low: less than 20%. The volume of distribution is high, on average 40 liters (0.65
L/kg). Distribution is rapid and tissue concentrations are similar to serum concentrations in
the following tissues: lungs, kidneys, liver, skin, bile, CSF, saliva, seminal fluid, and vaginal
secretions. Metronidazole crosses the placental barrier and is excreted in breast milk.
biotransformation
Metronidazole is metabolized in the liver by oxidation to two metabolites. The main
metabolite is the alcoholic, which has a bactericidal activity against anaerobic
microorganisms, of approximately 30% when compared to metronidazole, and an elimination
half-life of 11 hours. The acid metabolite has a bactericidal activity of 5%.
Excretion
Liver and bile concentrations are high, while colonic and fecal concentrations are low.
Excretion of metronidazole and its metabolites is mainly urinary and represents 35 to 65% of
the ingested dose. In patients with renal insufficiency, the elimination half-life is identical,
with no need for dose adjustment. In case of hemodialysis, metronidazole is rapidly
eliminated and the elimination half-life is reduced to 2 hours and 30 minutes.
Sources consulted
Source: Bull of the Medicine Professional Benzoylmetronidazole - Prati Donaduzzi.
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