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Flagimax Oral Suspension

Suitable for: Infections

Flagimax Oral Suspension, what is it indicated for and what is it

for?
Pediatric Flagimax is indicated for the treatment of giardiasis (infection of the small intestine,
caused by the flagellate protozoan, Giardia lamblia) and amoebiasis (infection caused by any
of several amoebas).

How does Flagimax Oral Suspension work?

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.

What are the contraindications of Flagimax Oral Suspension?

Flagimax Pediatric should not be used if you are allergic to metronidazole or other imidazole
derivatives and/or the other components of the product.

How to use Flagimax Oral Suspension?

Shake the bottle before administering Flagimax Pediatric.
Pediatric Flagimax should be administered orally. It is recommended to use the graduated
measuring cup that comes with the bottle in the package.

Flagimax Oral Suspension Dosage

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.

What should I do when I forget to use Flagimax Oral

Suspension?

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.

What precautions should I take when using Flagimax Oral

Suspension?
Intestinal parasites are widespread in children and adults of all social classes.
To avoid them, you must:
Wash your hands before eating and after defecating;
Eat, preferably, cooked foods;
Drink filtered or cooled water after boiling;
Keep your nails clipped;
Keep food away from insects;
Eat, preferably, fresh vegetables and washed with running water;
Avoid walking barefoot and do not step on or swim in stagnant water.
By following these recommendations, you can prevent intestinal parasites from affecting your
entire family.
The use of Pediatric Flagimax in long-term treatment should be carefully evaluated.
If treatment with metronidazole, for special reasons, requires a longer duration than is
generally recommended, consult your doctor for regular hematological (blood) tests,
especially white blood cell count (white blood cell count). Your doctor will monitor you for the
appearance of adverse reactions such as central or peripheral neuropathy (disease that
affects one or several nerves), for example: paresthesia, (abnormal sensation such as
burning, tingling and itching, perceived on the skin and for no apparent reason) , ataxia (lack
of coordination of movements), dizziness and convulsions.
Pediatric Flagimax may cause darkening of the urine due to metronidazole metabolites.
You should not drink alcoholic beverages or drugs that contain alcohol in their formulation
during and for at least 1 day after treatment with metronidazole, due to the possibility of an
antabuse effect [appearance of flushing (redness), vomiting and tachycardia (accelerated
heart rate)] .
Patients with hepatic encephalopathy (central nervous system dysfunction in association
with liver failure) should exercise caution when using Flagimax Pediatric, as it is metabolized
by the liver. Follow your doctor's advice.
Patients with severe disease of the central and peripheral nervous system, acute or chronic,
should exercise caution when taking Flagimax Pediatric, due to the risk of worsening the
neurological picture. Follow your doctor's advice.
Drug interactions
Alcohol:
Alcoholic beverages and drugs containing alcohol should not be taken during treatment with
metronidazole and for at least 1 day after it, due to the possibility of a disulfiram-like reaction
(antabuse effect), with the appearance of flushing (redness), vomiting and tachycardia
(acceleration heart rate).
Disulfiram:
Psychotic reactions have been reported in patients using metronidazole and disulfiram
concomitantly.
Oral anticoagulant therapy (warfarin type):
Potentiation of the anticoagulant effect and increase in hemorrhagic risk, caused by the
decrease in hepatic catabolism. In case of concomitant administration, more frequent
monitoring of prothrombin time and dose adjustment of anticoagulant therapy should be
performed during treatment with metronidazole.
Lithium:
Plasma lithium levels may be increased by metronidazole. Plasma concentrations of lithium,
creatinine and electrolytes should therefore be monitored in patients receiving lithium
treatment for the duration of metronidazole treatment.
Cyclosporine:
Risk of increased plasma levels of cyclosporine. The physician should closely monitor the
plasma levels of cyclosporine and creatinine.
Phenytoin or phenobarbital:
Increased elimination of metronidazole, resulting in reduced plasma levels.
5-fluorouracil:
Concomitant use with metronidazole increases its toxicity.
Busulfan:
Plasma busulfan levels can be increased by metronidazole, which can lead to severe busulfan
toxicity.
Tell your doctor if you are taking any other medicines.
Do not use medication without the knowledge of your doctor. It can be dangerous for your
health.
What are the adverse reactions and side effects of Flagimax
Oral Suspension?
Very common reaction (occurs in more than 10% of patients using this drug);
Common reaction (occurs between 1% and 10% of patients using this drug);
Unusual reaction (occurs between 0.1% and 1% of patients using this drug);
Rare reaction (occurs between 0.01% and 0.1% of patients using this drug);
Very rare reaction (occurs in less than 0.01% of patients using this drug).
gastrointestinal disorders
Epigastric pain (stomach pain), nausea, vomiting, diarrhea, oral mucositis (inflammation of the
soft tissues of the mouth), taste changes including metallic taste, anorexia, reversible cases
of pancreatitis (inflammation of the pancreas), tongue discoloration/feeling of rough tongue
(due to fungal growth, for example).
Immune system disorders
Angioedema (presence of edema of the skin, mucous membranes or viscera, accompanied
by hives), anaphylactic shock (severe allergic reaction).
Nervous system disorders
Peripheral sensory neuropathy (disease affecting one or more nerves), headaches, seizures,
dizziness, reports of encephalopathy (eg, confusion) and subacute cerebellar syndrome (eg,
ataxia, dysarthria (difficulty articulating words), abnormal gait (difficulty walking), nystagmus
(involuntary, rapid, repetitive movement of the eyeball) and tremor), which may resolve by
discontinuing treatment with the drug, aseptic meningitis (inflammation of the membranes
and tissues surrounding the brain without infectious cause).
psychiatric disorders
Psychotic changes including confusion and hallucinations, depressed mood.
visual disturbances
Transient visual changes such as diplopia (double vision) and myopia (short vision), blurred
vision, decreased visual acuity (quality) and altered color visualization, optic neuropathy
(disease that affects one or more nerves, in this case the optic nerve) /neuritis (inflammation
of the nerve).
Blood and lymphatic system disorders
Rare cases of agranulocytosis (a marked decrease in the white blood cell count), neutropenia
(a decrease in the number of neutrophils in the blood) and thrombocytopenia (a decrease in
the number of blood platelets) have been reported.
Hepatobiliary Disorders
There have been reports of increased liver enzymes (AST, ALT, alkaline phosphatase),
cholestatic or mixed hepatitis (types of liver inflammation), and liver cell damage,
sometimes manifesting with jaundice (yellow color of the skin and eyes). ;
Cases of liver function failure requiring transplantation have been reported in patients
treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders
Rash (skin rashes), pruritus (itching), flushing (redness), urticaria (skin rash, usually of allergic
origin, that causes itching).
Skin and subcutaneous tissue disorders
Rash (skin rash), pruritus (itching), flushing, urticaria (skin rash, usually of allergic origin, that
causes itching), pustular eruptions (small blisters with yellowish “pus” content), Stevens-
Johnson syndrome (severe form allergic reaction characterized by blisters on the mucous
membranes and in large areas of the body), toxic epidermal necrolysis (severe condition,
characterized by a generalized rash, with extensive shallow blisters and areas of epidermal
necrosis, similar to a large burn, resulting mainly from a toxic reaction to various drugs).
general disorders
Fever .
Inform your doctor, dentist or pharmacist of the appearance of undesirable reactions due to
the use of the medicine. Also inform the company through its customer service.

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.

What does Flagimax Oral Suspension contain?

Presentation
Oral suspension 40mg/ml.
Bottle containing:
100 ml of suspension accompanied by a measuring cup.
Oral use.
Pediatric use above 1 year of age.
Composition
Each ml of suspension contains:
40 mg of benzoylmetronidazole.
Excipients: benzoylmetronidazole, colloidal cellulose, glycerol, methylparaben, propylparaben,
sodium saccharin, lemon essence, polysorbate 80, ethyl alcohol and purified water.

Overdose: What happens if I take a larger dose of Flagimax Oral

Suspension than recommended?
Single oral ingestions of doses up to 12 g of metronidazole have been reported in suicide
attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia (lack of
coordination of
movements), mild disorientation. There is no specific antidote for overdoses with
metronidazole. In case of suspected massive overdose, symptomatic and supportive
treatment will be instituted by the physician.
In case of using a large amount of this medicine, seek medical help quickly and take the
medicine package or package insert, if possible. Call 0800 722 6001 if you need further
advice.

Drug interaction: what are the effects of taking Flagimax Oral

Suspension with other medicines?
Oral anticoagulant therapy (warfarin type)
Potentiation of the anticoagulant effect and increase in hemorrhagic risk, caused by the
decrease in hepatic catabolism. In case of concomitant administration, more frequent
monitoring of prothrombin time and dose adjustment of anticoagulant therapy should be
performed during treatment with metronidazole.
Lithium
Plasma lithium levels may be increased by metronidazole. Plasma concentrations of lithium,
creatinine and electrolytes should therefore be monitored in patients receiving lithium
treatment for the duration of metronidazole treatment.
cyclosporine
Risk of increased plasma levels of cyclosporine. Plasma levels of cyclosporine and creatinine
should be closely monitored when concomitant administration is necessary.
Phenytoin or phenobarbital
Increased elimination of metronidazole, resulting in reduced plasma levels.
5-fluorouracil
Decreased clearance of 5-fluorouracil, resulting in increased toxicity.
busulfan
Plasma busulfan levels can be increased by metronidazole, which can lead to severe busulfan
toxicity.

Food Interaction: Can I use Flagimax Oral Suspension with

food?
Alcohol
Alcoholic beverages and drugs containing alcohol should not be ingested during treatment
with metronidazole and for at least 1 day after it, due to the possibility of a disulfiram-like
reaction (antabuse effect), with the appearance of flushing, vomiting and tachycardia.

How does the substance in Flagimax Oral Suspension

(Benzoylmetronidazole) work?
Effectiveness Results

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.

How should I store Flagimax Oral Suspension?

Pediatric Flagimax should be kept at room temperature (between 15 and 30ºC), protected
from light.
Batch number and manufacturing and expiration dates: see packaging.
Do not use medicine with the expiry date. Store it in its original packaging.
Characteristics of the drug
White suspension, opaque, homogeneous and easy to redisperse.
Before use, observe the appearance of the medicine. If it has expired and you notice any
change in appearance, consult your pharmacist to see if you can use it.
All medication must be kept out of the reach of children.

Legal Sayings of Flagimax Oral Suspension

MS 1.0571.0103.
Farm. Answer:
Rander Maia.
CRF-MG No. 2546.
Belfar Ltd.
Rua Alair Marques Rodrigues, 516
Belo Horizonte/MG
CEP: 31.560-220.
CNPJ: 18.324.343/0001-77
Brazilian Industry.
SAC: 0800 031 0055
Sale under medical prescription.
Follow the instructions for use correctly, if the symptoms do not disappear, seek medical
advice.

Sources consulted
Source: Bull of the Medicine Professional Benzoylmetronidazole - Prati Donaduzzi.

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