Amoxicillin, clavulanic acid | Flemoklav Solutab dispersible tablets 875 mg + 125 mg, 14 pcs.

Packing

14 pcs.

Pharmacological action

Flemoklav Solutab is a broad-spectrum antibiotic combined drug of amoxicillin and clavulanic acid, an -lactamase inhibitor. Active against gram-positive and gram-negative microorganisms (including strains, producing -lactamases).

Amoxicillin acts bactericidal, inhibits the synthesis of the bacterial wall.

Clavulanic acid inhibits β-lactamases of types II, III, IV and V, according to the Richmond-Sykes classification. Inactive against type I lactamases produced by: Enterobacter spp, Pseudomonas aeruginosa, Serratia spp, Acinetobacter spp.

Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of β-lactamase and expands its spectrum of action.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms:

- Infections of the upper respiratory tract and ENT organs: otitis media, sinusitis, tonsillitis, pharyngitis.

- Infections of the lower respiratory tract: chronic bronchitis and its exacerbation, community-acquired pneumonia.

- Infections of the skin and soft tissues.

- Infections of the kidneys and urinary tract.

Contraindications

- Impaired liver function (including jaundice) with a history of amoxicillin / clavulanic acid.

- Infectious mononucleosis or lymphocytic leukemia (danger of exanthema).

- Hypersensitivity to amoxicillin, clavulanic acid and other components of the drug.

- Hypersensitivity to other beta-lactam antibiotics such as penicillins and cephalosporins.

Caution is advised to prescribe the drug in the following cases:

- Severe liver failure.

- Chronic renal failure.

- Gastrointestinal diseases (including a history of penicillin-related colitis).

Use during pregnancy and lactation

When applying Flemoklav Solutab during pregnancy, its negative effect on the fetus or newborn was not noted.

The use of the drug in the II and III trimester of pregnancy is considered safe. In the first trimester of pregnancy, Flemoklav Solutab should be used with caution. Amoxicillin is excreted in breast milk.

There is no data on the secretion of clavulanic acid in breast milk. There was no adverse effect on the baby during breastfeeding while taking Flemoklav Solutab.

Composition

1 dispersible tablet contains:

amoxicillin 875 mg,

clavulanic acid 125 mg.

Excipients:

microcrystalline cellulose,

crospovidone,

vanillin,

apricot flavor,

saccharin,

magnesium stearate.

Dosage and administration

Inside, at the beginning of a meal (to prevent dyspeptic symptoms), without chewing, drinking with a glass of water or dissolving a tablet in half a glass of water (minimum 30 ml), stirring thoroughly before use.

The duration of treatment depends on the severity of the infection and should not exceed 14 days without special need.

Adults and children over 12 years of age, as well as children under 12 years of age with a body weight of more than 40 kg, are prescribed 500 mg + 125 mg 3 times a day or 875 mg + 125 mg 2 times a day. A single dose is taken at regular intervals. In severe recurrent and chronic infections, these doses can be doubled.

Flemoklav Solutab with smaller dosages is prescribed for children under 12 years of age with a body weight of up to 40 kg: 125 mg + 31.25 mg 250 mg + 62.5 mg 500 mg + 125 mg.

For children aged 2 to 12 years (weighing approximately 13ֳ7 kg), the daily dose is 20ֳ0 mg / kg of amoxicillin and 5ַ.5 mg / kg of clavulanic acid. Usually this is: for children 2ַ years old (body weight about 13ֲ5 kg) - 125 mg + 31.25 mg 3 times a day for children 7ֱ2 years old (body weight 25ֳ7 kg) - 250 mg + 62.5 mg 3 times a day. In severe infections, these doses can be doubled (maximum daily dose is 60 mg / kg of amoxicillin and 15 mg / kg of clavulanic acid).

In patients with renal failure, elimination of clavulanic acid and amoxicillin through the kidneys is slowed down. Flemoklav Solutab at a dose of 875 mg + 125 mg can be used only at a glomerular filtration rate> 30 ml / min. In this case, dose adjustment is not required.

Side effects of

Infections: infrequently (? 1/1000,

From the blood and hematopoietic organs: rarely (? 1/10000,

Allergic reactions: often (? 1/100, <1/10) - skin rashes and pruritus-like exanthema, appearing on the 5-11th day after the start of therapy. The appearance of urticaria immediately after starting to take the drug with a high degree of probability is a manifestation of an allergic reaction and requires discontinuation of the drug rarely (? 1/10000,

From the nervous system: rarely (? 1/10000,

From the cardiovascular system: rarely (? 1/10000,

Reactions from the digestive system: often (? 1/100, Clostridium difficile rarely (? 1/10000,

from the hepatobiliary system: often (? 1/100,

From the genitourinary system: infrequently (? 1 / 1000.1 / 10000,

Drug Interactions

Other antimicrobial agents. When combined with certain bacteriostatic drugs (e.g. chloramphenicol, sulfonamides, etc.), antagonism with amoxicillin / clavulanic acid in vitro was noted.

Disulfiram. Amoxicillin / clavulanic acid should not be used concomitantly with disulfiram.

Medicines, inhibiting renal excretion of amoxicillin. The simultaneous administration of probenecid, phenylbutazone, oxyphenbutazone and, at least, acetylsalicylic acid, indomethacin and sulfinpyrazone contributes to an increase in the concentration and longer residence of amoxicillin in blood plasma and bile. The excretion of clavulanic acid is not impaired.

Antacids, glucosamine, laxatives, aminoglycosides slow down and decrease the absorption of ascorbic acid increases the absorption of amoxicillin.

Allopurinol. Prescribing allopurinol and amoxicillin may increase the risk of skin rash.

sulfasalazine. Aminopenicillins can reduce serum sulfasalazine concentration.

methotrexate. Amoxicillin reduces renal clearance of methotrexate, which can lead to an increase in the risk of its toxic effect. With simultaneous administration with amoxicillin, monitoring of the concentration of methotrexate in serum is necessary.

digoxin. While taking amoxicillin / clavulanic acid, an increase in the absorption of digoxin is possible.

Anticoagulants. With simultaneous administration with indirect anticoagulants, an increased risk of bleeding is possible.

Hormonal contraceptives. In rare cases, amoxicillin has been shown to decrease the effectiveness of oral contraceptives, so patients should be advised to use non-hormonal methods of contraception.

Overdose

Symptoms:

nausea, vomiting, diarrhea with possible impaired water and electrolyte balance.

Treatment:

is prescribed activated charcoal, it is necessary to maintain water and electrolyte balance, symptomatic therapy is carried out. With convulsions, diazepam is prescribed. In severe renal failure, hemodialysis is performed.

Storage Conditions

The product should be stored at a temperature not exceeding 25 РC.

Deystvuyuschee substances

Amoxicillin, Clavulanic acid



pharmacy terms for

Form of Treatment

tablets dlya rassas vaniya

Appointment

Pregnant doctor, Nursing moms, Children 12 and older, Adults doctor, Prescription

Indications

From skin infections, Otitis, Otitis From pharyngitis, From respiratory tract infections, From osteomyelitis, From pneumonia, From sinusitis, From cholecystitis, From urinary tract infections, Bronchitis, From sore throat, From periodontitis

Possible product names

World of Childhood plate with handle 5+ China (art17302)

Flemoklav Sol. tab d. 875mg + 125mg x 14

FLEMOKLOV SOLUTAB 0.875 + 0.125 N14 TABLE DISPERS

Flemoklav Solutab 875 + 125mg Tab. Disp. X14 (R)

FLEMKLAV SOLUTAB 875MG. + 125MG. No. 14 TAB.DISPERG.

Astellas Pharma Europe BV, Netherlands