Clamosar 1000mg+ 200mg 5 pcs powder for the preparation of solution for intravenous administration

Klamosar®

The dosage regimen is set individually depending on age, body weight, kidney function, and the severity of the infection.

Treatment should not continue for more than 14 days without reviewing the clinical situation.

The drug CLAMOSAR® is not intended for intramuscular administration (due to instability at the concentration that could be administered intramuscularly). Doses are given based on the content of active ingredients: amoxicillin and clavulanic acid.

Adults and children over 12 years of age or weighing 40 kg or more

Mild to moderate infections:

dose 1000 mg + 200 mg every 8 hours.

Severe infections

: dose 1000 mg + 200 mg every 4-6 hours.

Prevention in surgery

Interventions lasting less than 1 hour: dose 1000 mg + 200 mg during induction of anesthesia.

Interventions lasting more than 1 hour: dose 1000 mg + 200 mg during induction of anesthesia and then up to 4 doses, dose 1000 mg + 200 mg over 24 hours.

Special patient groups

Children

For children weighing less than 40 kg, the dose is calculated depending on body weight.

In children under 3 months of age, CLAMOSAR should only be administered slowly by infusion over 30-40 minutes.

Under 3 months and weighing less than 4 kg:

25 mg amoxicillin and 5 mg clavulanic acid per 1 kg of body weight every 12 hours.

Under 3 months and weighing more than 4 kg

: 25 mg amoxicillin and 5 mg clavulanic acid per 1 kg of body weight every 8 hours.

From 3 months to 12 years with body weight less than 40 kg:

25 mg amoxicillin and 5 mg clavulanic acid per 1 kg of body weight every 6-8 hours depending on the severity of the infection.

Elderly patients

No adjustment of the dosage regimen is required, dosing is the same as in adult patients.

Patients with impaired renal function

Correction of the dosage regimen is based on the maximum recommended dose of amoxicillin and is carried out taking into account CC values.

Adults

Children

Patients on hemodialysis

Dosage adjustments are based on the maximum recommended dose of amoxicillin.

Adults

First, 1 dose of 1000 mg + 200 mg is administered, then 500 mg + 100 mg every 24 hours and an additional 500 mg + 100 mg at the end of the hemodialysis session (to compensate for the decrease in the levels of amoxicillin and clavulanic acid in the blood plasma).

Children

25 mg amoxicillin + 5 mg clavulanic acid per 1 kg body weight every 24 hours and additionally 12.5 mg amoxicillin and 2.5 mg clavulanic acid per 1 kg body weight at the end of the hemodialysis session (to compensate for the decrease in plasma levels of amoxicillin and clavulanic acid blood) and then 25 mg of amoxicillin + 5 mg of clavulanic acid per 1 kg of body weight per day.

Patients with liver dysfunction

There are insufficient data to change dosage recommendations in these patients; treatment is carried out with caution; regularly monitor liver function.

Mode of application

Bolus administration

The powder is diluted with water for injection.

The drug can be administered as a slow intravenous injection lasting 3-4 minutes directly into a vein or through a catheter.

The resulting solution must be administered within 20 minutes after dilution.

Infusion administration

The drug is administered intravenously by drip over 30-40 minutes, having previously dissolved the powder in the volume of water for injection indicated in the table above, the resulting solution is added to 100 of the solvent.

The solution prepared at room temperature can be stored under the same conditions, and the infusion must be completed before the expiration date indicated in the table above.

If the prepared solution is to be stored at a temperature of 5°C, then it is added to a pre-cooled bottle with 100 ml of a suitable infusion fluid. Solutions that were stored at 5°C must be administered immediately after they reach room temperature.

The solution cannot be frozen!

The bottle with the drug cannot be used repeatedly.

Instructions for use AMOCLAV-1000 (AMOCLAV-1000)

Before starting treatment with Amoklav-1000, it is necessary to collect a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics (see sections “Contraindications” and “Side Effects”).

Serious, sometimes fatal, hypersensitivity reactions (anaphylactoid reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins and in individuals with atopy. If an allergic reaction occurs, treatment with amoxicillin/clavulanic acid should be discontinued and alternative therapy should be initiated.

If the infection is confirmed to be due to amoxicillin-susceptible organisms, a switch from amoxicillin/clavulanic acid therapy to amoxicillin therapy should be considered in accordance with official guidelines.

Amoklav-1000 tablets are not suitable for use in cases where there is a high risk that the suspected pathogens have reduced sensitivity or resistance to beta-lactams, which is not mediated by beta-lactamases inhibited by clavulanic acid. These dosage forms should not be used in the treatment of infections caused by penicillin-resistant Streptococcus pneumoniae.

In patients with impaired renal function or when taking high doses of the drug, seizures may occur (see section "Side effects").

The use of amoxicillin/clavulanic acid is not recommended for suspected infectious mononucleosis, since such patients experience a morbilliform rash after taking amoxicillin.

The combined use of allopurinol and amoxicillin increases the risk of allergic skin reactions.

Long-term treatment may lead to excessive proliferation of insensitive microorganisms.

The appearance of pustules on erythematous areas of the skin with fever at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. The occurrence of this adverse reaction requires discontinuation of the drug and is a contraindication to further use of amoxicillin. The amoxicillin/clavulanic acid combination should be used with caution in patients with symptoms of liver failure (see sections “Dosage regimen”, “Contraindications”).

Adverse liver events have been observed primarily in men and elderly patients and may be associated with long-term therapy. These adverse events are very rarely observed in children. Signs and symptoms of liver dysfunction usually occur during or immediately after completion of therapy, but in some cases may not appear until several weeks after completion of therapy. As a rule, they are reversible. Adverse effects from the liver can be severe, and in extremely rare cases there have been reports of death. In almost all cases, these were persons with serious comorbidities or persons receiving concomitantly potentially hepatotoxic drugs.

Antibiotic-associated colitis has been reported with virtually all antibacterial agents. This adverse reaction can vary in severity from mild to life-threatening (see section "Side effects"). Therefore, this diagnosis should be considered in patients who develop diarrhea during treatment or after administration of any antibiotics. If antibiotic-associated colitis occurs, the drug should be discontinued immediately. The patient should consult a doctor who will prescribe appropriate treatment. In such a situation, the use of drugs that inhibit peristalsis is contraindicated.

During long-term therapy with Amoclav-1000, it is recommended to periodically monitor renal, liver and hematopoietic function.

In patients receiving a combination of amoxicillin and clavulanic acid, prolongation of prothrombin time has been observed in rare cases. When co-prescribing a combination of amoxicillin and clavulanic acid with anticoagulants, appropriate monitoring should be carried out. To maintain the desired level of anticoagulation, dose adjustment of the anticoagulant may be necessary (see sections “Drug Interactions” and “Side Effects”).

In patients with impaired renal function, the dose of Amoclav-1000 should be adjusted according to the degree of impairment (see section "Dosage regimen").

In patients with reduced diuresis, the development of crystalluria has been reported in very rare cases, mainly with parenteral use of the drug. While taking high doses of amoxicillin, it is recommended to drink enough fluids and maintain adequate diuresis to reduce the chance of amoxicillin crystal formation. In patients with urinary catheters, catheter patency should be checked regularly (see section "Overdose").

During treatment with amoxicillin, if tests for the presence of glucose in urine are necessary, enzymatic methods for determining glucose oxidase should be used due to the possibility of obtaining a false positive result when using non-enzymatic methods. The presence of clavulanic acid in the drug may cause nonspecific binding of IgG and albumin to red blood cell membranes, which may lead to a false-positive Coombs test result.

Patients taking the amoxicillin/clavulanic acid combination may experience a false-positive test result for Aspergillus infection when using the Platelia Aspergillus EIA tests. Cross-reactions between the Platelia Aspergillus EIA test and non-Aspergillus polysaccharides and polyfuranoses have been reported. Therefore, positive test results in patients taking the combination of amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.

Impact on the ability to drive vehicles and machinery

No special studies have been conducted, but adverse reactions may occur (allergic reactions, dizziness, convulsions), which may affect the ability to drive vehicles and other mechanisms.

Clamosar

Inside, intravenously. Doses are given in terms of amoxicillin. The dosage regimen is set individually depending on the severity and location of the infection and the sensitivity of the pathogen. Children under 12 years old

- in the form of a suspension, syrup or drops for oral administration.
A single dose is set depending on age: children under 3 months
- 30 mg/kg/day in 2 doses;
3 months and
older - for
mild infections
- 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for
severe infections
- 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses.
Adults and children over 12 years of age
or weighing 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day.
For severe infections and respiratory tract infections - 875 mg 2 times / day or 500 mg 3 times / day. The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age - 45 mg/kg body weight. The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg body weight. If swallowing is difficult in adults, the use of a suspension is recommended. When preparing suspension, syrup and drops, water should be used as a solvent. When administered intravenously,
adults and adolescents over 12 years of age are administered 1 g (amoxicillin) 3 times a day, if necessary - 4 times a day.
The maximum daily dose is 6 g. For children 3 months to 12 years old - 25 mg/kg 3 times a day; in severe cases - 4 times a day; for children under 3 months: premature and in the perinatal period - 25 mg/kg 2 times a day, in the postperinatal period - 25 mg/kg 3 times a day. Duration of treatment - up to 14 days, acute otitis media - up to 10 days. To prevent postoperative infections during operations

lasting less than 1 hour,
a dose of 1 g is administered intravenously during induction of anesthesia.
For longer operations
- 1 g every 6 hours during the day.
If the risk of infection is high, administration may be continued for several days. In case of chronic renal failure,
the dose and frequency of administration are adjusted depending on the CC: with
CC more than 30 ml/min,
no dose adjustment is required;
with CC 10-30 ml/min
: orally - 250-500 mg/day every 12 hours;
IV - 1 g, then 500 mg IV; with CC less than 10 ml/min
- 1 g, then 500 mg/day IV or 250-500 mg/day orally in one dose.
For children, doses should be reduced in the same way. Patients on hemodialysis
- 250 mg or 500 mg orally in one dose or 500 mg intravenously, 1 additional dose during dialysis and 1 additional dose at the end of the dialysis session.