Bacimex - instructions for use, doses, side effects, contraindications

Active ingredient:
Metronidazole	500.00 mg
Excipients:
Sodium chloride	790.00 mg
Citric acid monohydrate	22.90 mg
Sodium hydrophosphate anhydrous	47.6 mg
Water for injections	up to 100 ml

Description:Clear solution from colorless to pale yellow.

Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug

ATX: & nbsp

P.01.A.B Nitroimidazole derivatives

P.01.A.B.01 Metronidazole

Pharmacodynamics:

Metronidazole is an effective antiprotozoal and antibacterial agent of a wide spectrum of action.

The drug shows a high activity in a relationship Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as in respect of obligate anaerobes (sporo- and non-spore forming) Bacteroides spp. (B.fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., sensitive strains Eubacterium.

To Metronidazole not sensitive Aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against conventional aerobes.

Mechanism of action

Metronidazole is a biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Pharmacokinetics:

With the intravenous administration of 500 mg of metronidazole for 20 minutes to patients with anaerobic infection, the concentration of the drug in the blood serum was 35.2 μg / ml in an hour, 33.9 μg / ml in 4 hours, 25.7 μg / ml after 8 hours . The drug has a high penetrating ability, reaching bactericidal concentrations in most tissues and body fluids, including lungs, kidneys, liver, skin, cerebrospinal fluid, brain, bile, saliva, amniotic fluid, abscess cavities, vaginal secretion, seminal fluid, breast milk. Binding to blood proteins is weak and does not exceed 10-20%. With normal bile formation, the concentration of metronidazole in the bile after intravenous administration may significantly exceed the concentration of metronidazole in the blood plasma.

Metronidazole is excreted by the kidneys - 63% of the dose (20% of the drug is excreted unchanged). The half-life of metronidazole is 6-7 hours. The renal clearance is 10.2 ml / min.

In patients with impaired renal function after repeated administration of the drug cumulation of metronidazole in serum can be observed. Therefore, in patients with severe renal failure, the frequency of metronidazole should be reduced.

Indications:

Metronidazole for injection is recommended for the treatment of infections caused by drug-susceptible microorganisms:

- prevention and treatment of anaerobic infections during surgical interventions, mainly on the organs of the abdominal cavity and urinary tract;

- combined therapy of severe mixed aerobic-anaerobic infections;

- severe form of intestinal and hepatic amebiasis;

- sepsis;

- peritonitis;

- osteomyelitis;

- gynecological infections;

- abscesses of small pelvis and brain;

- abscessed pneumonia;

- gas gangrene;

- infection of skin and soft tissues, bones and joints.

Contraindications:

- Hypersensitivity to metronidazole or other nitroimidazole derivatives;

- organic lesions of the central nervous system;

- Diseases of the blood;

- I trimester of pregnancy;

- lactation period;

- nursing mothers - according to indications, with simultaneous cessation of breastfeeding.

Carefully:I and III trimesters of pregnancy; renal / hepatic insufficiency.

Pregnancy and lactation:See the sections "Contraindications", "With caution".

Dosing and Administration:

Intravenous administration of metronidazole is indicated in severe infections, as well as in the absence of the possibility of taking the drug inside.

For adults and children over 12 years a single dose of 500 mg, the rate of intravenous continuous (jet) or dropwise administration - 5 ml per minute. The interval between administrations is 8 hours. The duration of treatment is determined individually. The maximum daily dose is no more than 4 g. According to the indications, depending on the nature of the infection, a transition to maintenance therapy with oral forms of metronidazole is carried out.

Children under the age of 12 years metronidazole 7.5 mg / kg of body weight is administered in 3 divided doses at a rate of 5 ml per minute.

For the prevention of anaerobic infection before the planned operation on the pelvic organs and urinary tract adults and children over 12 years Metronidazole is administered in the form of infusions in a dose of 500-1000 mg, on the day of surgery and the next day at a dose of 1500 mg / day (500 mg every 8 hours). After 1-2 days usually go to maintenance therapy with oral forms of metronidazole.

For patients with severe renal dysfunction (SC less than 30 ml / min) and / or liver daily dose of metronidazole 1000 mg; (the frequency of reception 2 times).

Metronidazole for intravenous fluids should not be mixed with other medications!

Side effects:

From the gastrointestinal tract: nausea, vomiting, diarrhea, absence appetite, unpleasant metallic taste in the mouth, epigastric pain;

From the central nervous system: ataxia, peripheral neuropathy, with prolonged use - headache, dizziness, increased excitability, depression, sleep disturbance, weakness; in some cases - confusion, hallucinations, convulsions;

From the genitourinary system: burning sensation in the urethra, excessive development of the fungal flora of the vagina (candidiasis);

Dermatological reactions: allergic reactions (skin rash, itching, urticaria);

From the side of the musculoskeletal system: arthralgia;

From the hematopoietic system: leukopenia.

During the administration of metronidazole, a red-brown staining of urine can be observed.

Local Reactions: thrombophlebitis (pain, flushing or swelling at the injection site).

Interaction:

Metronidazole for intravenous administration is not recommended to be mixed with other drugs.

When using metronidazole for injections, interaction with other drugs is negligible, but caution should be exercised when concomitant administration with certain medicines:

Warfarin and other indirect anticoagulants. Metronidazole increases the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation.

Disulfiram (esperal). Simultaneous application can lead to the development of various neurological symptoms, so one should not prescribe Metronidazole patients who took disulfiram in the last two weeks.

Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of side effects.

Simultaneous administration of drugs stimulating enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin), can accelerate the elimination of metronidazole, as a result of which its concentration in the plasma decreases.

In patients receiving long-term treatment with drugs lithium in high doses,when taking metronidazole, an increase in the concentration of lithium in the blood plasma and the development of symptoms of intoxication are possible.

Sulfonamides enhance the antimicrobial effect of metronidazole.

It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

Special instructions:

With caution appoint for diseases of the kidneys, liver.

Do not drink alcohol while taking the drug, since metronidazole has the ability to induce aversion to alcoholic beverages.

Long-term use of the drug is desirable to be carried out under the control of peripheral blood.

The appearance of ataxia, dizziness and any other deterioration in the neurological status of patients requires discontinuation of treatment.

Can immobilize treponema and lead to Nelson's false positive test.

Form release / dosage:Solution for infusion, 5 mg / ml.

Packaging:

On 100 ml in bottles from polyethylene of average pressure of mark "Lupolen3020 D"producer firms"ELENAC"A lid is put on the neck of the bottle and each bottle is wrapped with polypropylene film BOPR.

Each bottle, along with instructions for medical use, is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

3 years

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005201/09

Date of registration:29.06.2009 / 23.07.2015

Expiration Date:Unlimited

The owner of the registration certificate:Clarice Otsuka Private LimitedClarice Otsuka Private Limited India

Manufacturer: & nbsp

Claris Otsuka Private Ltd. India

Representation: & nbspClarice Otsuka Private Limited Clarice Otsuka Private Limited India

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Bacimex (Bacimex)