Siptrogyl - instructions for use, dose, side effects, contraindications

Composition:One bottle (100) contains:
Active Ingredient:
Metronidazole 500.0 mg
Excipients:
Sodium chloride 790.0 mg
Water for injection q.s. up to 100 ml.

Description:Transparent solution from colorless to light yellow color.

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 high activity against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (sporo- and asporogenous) - Bacteroides spp. (B. fragilis, B.ovatus, B.distasonis, B.thetaiotaomicron, B.vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., Sensitive strains of Eubacterium.
Metronidazole is not sensitive to aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against conventional aerobes. The mechanism of action of metronidazole is the 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:When intravenously, T1 / 2 metronidazole is 7.3 hours; The stas in the blood is determined 1 h after the cessation of the administration; the drug content is maintained at the therapeutic level for 6-8 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. Kidney clearance is about 10 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 infusions is recommended for the treatment of infections caused by microorganisms that are sensitive to the drug:
- 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;
- infections of the 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,
- nursing mothers - according to indications, with simultaneous cessation of breastfeeding.
- not recommended for patients under 18 years of age in combination with amoxicillin.

Carefully:- II and III trimesters of pregnancy - only for life indications;
renal / hepatic insufficiency.

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 is 500 mg, the rate of intravenous continuous (jet) or dropping is 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 pelvic organs and urinary tracts for adults and children over 12 years of age metronidazole prescribe in the form of infusions in a dose of 500-1000 mg, on the day of the operation 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 (KC less than 30 ml / min) and / or liver, the daily dose of metronidazole is 1000 mg (the frequency of reception is 2 times a day).
Metronidazole for intravenous fluids should not be mixed with other medications!

Side effects:From the gastrointestinal tract: nausea, vomiting, diarrhea, lack of appetite, unpleasant metallic taste in the mouth, abdominal pain;
From the central nervous system: with prolonged use - headache, dizziness, increased excitability, depression, sleep disturbance, weakness, ataxia, fainting; in some cases - confusion, hallucinations, convulsions;
From the genitourinary system: a burning sensation in the urethra, excessive development of the fungal flora of the vagina (candidiasis);
Dermatological reactions: allergic reactions (erythematous skin rash, itching, urticaria);
From the side of the musculoskeletal system: arthralgia;
From the hematopoietic system: leukopenia, phlebitis.
During the reception of Metronidazole, a reddish-brown color of the urine may be observed.

Interaction:When using metronidazole for infusions, interaction with other drugs is negligible, but caution should be exercised when concomitant administration with certain medications:
Warfarin and other indirect anticoagulants. Metronidazole increases the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation. Disulfiram. 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 metronidazole metabolism, which can lead to an increase in its serum concentration 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 who receive long-term treatment with lithium preparations in high doses, with the use of metronidazole, an increase in the concentration of lithium in the blood plasma and the development of symptoms of intoxication are possible.
The antimicrobial effect of metronidazole is enhanced in combination with sulfonamides and antibiotics.

Special instructions:With caution appoint for diseases of the kidneys, liver.In the treatment of metronidazole, alcohol consumption can cause serious adverse reactions - abdominal colic, nausea, vomiting, headache. Besides, 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.

Form release / dosage:Solution for infusions 5 mg / ml.

Packaging:100 ml of the drug in polyethylene bottles. Each vial is placed in a polypropylene bag, then in a cardboard bundle together with instructions for use

Storage conditions:In a place protected from light, out of reach of children, at a temperature of no higher than 25 ° C. Do not freeze.

Shelf life:5 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005609/09

Date of registration:13.07.2009

Expiration Date:Unlimited

The owner of the registration certificate:Akühr Labs Pvt.LtdAkühr Labs Pvt.Ltd India

Manufacturer: & nbsp

ACCURE LABS, Pvt.Ltd. India

Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company

Information update date: & nbsp22.12.2016

Illustrated instructions

Instructions

Siptrogyl (Ciptrogil)