Flagyl online in Australia

Use

Therapeutic indications

They arise from the antiparasitic and antibacterial activity of metronidazole and its characteristics.

Pharmacokinetics They take into account both the clinical studies that this drug has led to and its place in the range of anti-infective products currently available.

They are limited to infections caused by germs defined as sensitive:

- amebiasis

- urogenital trichomoniasis,

- non-specific vaginitis,

- lambliasis,

- curative treatment of medical-surgical infections with sensitive anaerobic germs,

- retransmission of curative treatments by injection of infections with sensitive anaerobic germs.

Official recommendations on the proper use of antibacterials should be taken into account.

Dosage and method of administration

- Amebiasis:

. Adults:

1.50 g per day in three doses.

. Children:

30 to 40 mg / kg / day in three doses.

In hepatic amebiasis, in the abscess stage, evacuation of the abscess should be performed in conjunction with metronidazole treatment.

The duration of treatment is seven consecutive days.

- Trichomoniasis:

. in women (Trichomonas urethritis and vaginitis), preferably, a ten-day mixed treatment comprising:

. 0.5 g per day orally in two doses,

. 1 egg per day.

Whether or not the partner shows clinical signs of Trichomonas vaginalis infestation, it is important that they be treated concurrently, even in the absence of a positive laboratory response.

. in humans (Trichomonas urethritis):

0.5 g orally in two divided doses over ten days.

Very exceptionally, it may be necessary to increase the daily dose to 0.750 g or 1 g.

- Lambliase:

. Adults:

0.75 g to 1 g per day for five consecutive days.

. Son of:

. 6 to 10 years: 375 mg / day.

. 10 to 15 years: 500 mg / day.

- Non-specific vaginitis:

500 mg twice a day for seven days.

The simultaneous treatment of the couple should be practiced.

- Treatment of anaerobic germ infections:

(in first intention or in relief treatment):

. Adults:

1 to 1.5 g / day.

. Children:

20 to 30 mg / kg / day.

Prescription and delivery conditions

List I.

Duration and special precautions for conservation

Shelf life: 3 years.

Special precautions for storage: Keep the ampoules in the outer packaging to protect them from light.

Preclinical safety data

Aimlessly.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

• Hypersensitivity to flagyl, the imidazole family or any of the excipients included in the Composition section.
• Wheat allergic patient (other than celiac disease) (see section 4.4).
• Children under 6 years, due to the pharmaceutical form (see section 4.4).

Pregnancy and lactation

Pregnancy:

Animal studies have not shown any teratogenic effects. In the absence of a teratogenic effect in animals, a malformation effect is not expected in the human species. In fact, to date, substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies in two species.

In clinical studies, analysis of large numbers of exposed pregnancies did not appear to reveal any particular malformation or fetotoxic effect of metronidazole. However, only epidemiological studies were able to verify the absence of risk. As a result, flagyl may be prescribed during pregnancy if necessary.

Lactation:

Since metronidazole passes into breast milk, avoid administration of this medication during lactation.

Warnings and precautions for use

Hypersensitivity / skin and appendages

Allergic reactions including life-threatening anaphylactic shock can occur (see section 4.8). In this case, flagyl should be discontinued and appropriate medical treatment should be implemented.

The appearance, at the start of treatment, of a generalized febrile erythema associated with pustules, should lead to suspicion of generalized acute exanthematous pustulosis (see section Adverse effects); requires cessation of treatment and contraindicates any further administration of metronidazole alone or in combination.

Central Nervous System

If symptoms suggestive of encephalopathy or cerebellar syndrome appear, patient treatment should be reevaluated immediately and treatment with flagyl should be discontinued.

Encephalopathy has been reported during post-marketing surveillance. Changes in MRI associated with encephalopathy have also been observed (see section 4.8). The observed lesions are located more frequently in the cerebellum (particularly in the dentate nucleus) and in the splenius of the corpus callosum. Most cases of encephalopathy and changes in MRI are reversible when treatment is stopped. Exceptional cases of fatal development have been reported.

Look out for signs of encephalopathy or worsening in patients with central neurological disease.

In the case of aseptic meningitis with metronidazole, reintroduction of the treatment is not recommended or should be subject to an assessment of the benefit-risk balance in case of severe infection.

Peripheral nervous system

Monitor for signs suggestive of peripheral neuropathy, particularly in prolonged treatment or in patients suffering from severe, chronic, or progressive peripheral neurological disorders.

Psychiatric disorders

Psychotic reactions with possible risk behavior for the patient can occur as soon as the first doses of treatment, particularly in the case of a psychiatric history (see section Unwanted effects). flagyl should be discontinued, inform the doctor and take the necessary therapeutic measures immediately.

Blood line

If there is a history of hematologic disorders, high dose treatment and / or prolonged treatment, periodic blood tests are recommended, particularly monitoring of the white blood cell formula.

In the case of leukopenia, the advisability of continuing treatment depends on the severity of the infection.

Excipient with known effect.

This medicine can be used for celiac disease. Wheat starch may contain gluten, but only in small amounts, making it considered safe for people with celiac disease.

Pediatric population

Taking tablets is contraindicated in children under the age of 6, as it can lead to a false route. There are other metronidazole based presentations suitable for young children.

Pharmacological interactions

The concomitant use of flagyl and alcohol is not recommended (see section Interactions with other medicinal products and other forms of interaction).

The concomitant use of metronidazole and busulfan is not recommended (see section Interactions with other medicinal products and other forms of interaction).

The concomitant use of flagyl and disulfiram is not recommended (see section Interactions with other medicinal products and other forms of interaction).

Interactions with paraclinical exams.

Metronidazole can immobilize treponemes and is therefore false positive in a Nelson test.

Interaction with other medicinal products and other forms of interaction

Reaction against abuse

There are many drugs that cause an alcohol abuse reaction, and their combination with alcohol is not recommended.

Associations not recommended

+ Alcohol (drink or excipient)

Antabuse effect (heat, redness, vomiting, tachycardia). Avoid drinking alcoholic beverages and drugs that contain alcohol.

+ Busulfan

With high-dose busulfan: doubling of busulfan concentrations by flagyl.

+ Disulfiram

Risk of episodes of acute psychosis or confusional state, reversible when the association is stopped.

Associations subject to precautions for use.

+ Enzyme inducing anticonvulsants

Decreased plasma concentrations of metronidazole by increasing hepatic metabolism by the inducer.

Clinical monitoring and possible flagyl dose adjustment during inducer therapy and after discontinuation.

+ Rifampicin

Decreased plasma concentrations of metronidazole with increased liver metabolism by rifampicin.

Clinical follow-up and possible flagyl dose adjustment during rifampicin treatment and after discontinuation.

+ Lithium

Increased lithhemia that can reach toxic values, with signs of lithium overdose.

Strict monitoring of lithhemia and possible adaptation of the lithium dose.

Associations to consider

+ Fluorouracil (and by extrapolation, tegafur and capecitabine)

Increased fluorouracil toxicity by reducing its clearance.

Specific problems of INR imbalance:

Many cases of increased oral anticoagulant activity have been reported in patients receiving antibiotics. The marked infectious or inflammatory context, the age and the general condition of the patient seem to be risk factors. In these circumstances, it seems difficult to draw a line between infectious pathology and its treatment in the appearance of INR imbalance. However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, cyclins, cotrimoxazole, and certain cephalosporins.

Caution

Undesirable effects

Gastrointestinal system

• mild digestive disorders (epigastric pain, nausea, vomiting, diarrhea),
• glossitis with a dry mouth, stomatitis, taste disorders, anorexia,
• reversible pancreatitis when treatment is stopped.
• discoloration or change in the appearance of the tongue (yeast infection).

Skin and appendages

• flushing, itching, sometimes feverish rash,
• urticaria, angioedema, anaphylactic shock (see section 4.4),
• very rare cases of generalized acute exanthematous pustulosis (see section 4.4),

Nervous system

• peripheral sensory neuropathies,
• headache
• dizziness
• confusion
• seizures
• encephalopathy, which may be associated with changes in the MRI, generally reversible upon stopping treatment. Exceptional cases of fatal development have been reported (see Warnings and Precautions for Use section),
• subacute cerebellar syndrome (ataxia, dysarthria, gait disturbances, nystagmus, tremors) (see section Warnings and precautions for use),
• Aseptic meningitis (see section 4.4).

Psychiatric disorders

• hallucinations
• psychotic reactions with paranoia and / or delirium that may be accompanied in isolation by suicidal thoughts or acts (see section Warnings and precautions for use),
• depressed state

Visual disturbances

• transient visual disorders such as blurred vision, diplopia, myopia, reduced visual acuity, change in color vision,
• optic neuropathy / neuritis.

Blood line

• neutropenia, agranulocytosis, thrombocytopenia.

Liver manifestations

• elevations of liver enzymes (ALT, ASAT, alkaline phosphatases), very rare cases of acute liver damage of a cytolytic (sometimes icteric), cholestatic, or mixed nature. Isolated cases of hepatocellular failure that may require liver transplantation have been reported.

Diverse

• appearance of a reddish-brown coloration of the urine due to the presence of water soluble pigments that originate in the metabolism of the product.

Overdose

Single dose cases of up to 12 g have been reported in suicide attempts and accidental overdose.

Symptoms were limited to vomiting, ataxia, and mild disorientation. There is no specific antidote for metronidazole overdose. In case of massive overdose, the treatment is symptomatic.