Mastodon

Amoxicillin + Clavulanic acid (Tablets, Powder) Instructions for Use

ATC Code

J01CR02 (Amoxicillin and beta-lactamase inhibitor)

Active Substances

Clavulanic acid (Rec.INN registered by WHO)

Amoxicillin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor

Pharmacotherapeutic Group

Systemic antibacterial agents; beta-lactam antibacterial agents, penicillins; combinations of penicillins, including combinations with beta-lactamase inhibitors

Pharmacological Action

A combined preparation of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It acts bactericidally by inhibiting the synthesis of the bacterial cell wall.

Active against aerobic gram-positive bacteria (including beta-lactamase-producing strains): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis.

The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic bacteria Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; and also aerobic gram-negative bacteria (including beta-lactamase-producing strains): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including beta-lactamase-producing strains): Bacteroides spp., including Bacteroides fragilis.

Pharmacokinetics

After oral administration, both components are rapidly absorbed from the gastrointestinal tract. Simultaneous food intake does not affect absorption. TCmax is 45 minutes.

After oral administration in a dose of 250/125 mg every 8 hours, Cmax of amoxicillin is 2.18-4.5 mcg/ml, of clavulanic acid is 0.8-2.2 mcg/ml; in a dose of 500/125 mg every 12 hours, Cmax of amoxicillin is 5.09-7.91 mcg/ml, of clavulanic acid is 1.19-2.41 mcg/ml; in a dose of 500/125 mg every 8 hours, Cmax of amoxicillin is 4.94-9.46 mcg/ml, of clavulanic acid is 1.57-3.23 mcg/ml; in a dose of 875/125 mg, Cmax of amoxicillin is 8.82-14.38 mcg/ml, of clavulanic acid is 1.21-3.19 mcg/ml.

The time to reach a maximum inhibitory concentration of 1 mcg/ml for amoxicillin is similar when administered every 12 hours and 8 hours, both in adults and children.

Plasma protein binding: amoxicillin – 17-20%, clavulanic acid – 22-30%.

Both components are metabolized in the liver: amoxicillin – about 10% of the administered dose, clavulanic acid – about 50%.

T1/2 after administration of 375 and 625 mg doses is 1 and 1.3 hours for amoxicillin, and 1.2 and 0.8 hours for clavulanic acid, respectively. It is primarily excreted by the kidneys (glomerular filtration and tubular secretion): 50-78% and 25-40% of the administered dose of amoxicillin and clavulanic acid, respectively, is excreted unchanged within the first 6 hours after administration.

Indications

Treatment of infectious and inflammatory diseases caused by susceptible pathogens: lower respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess); ENT infections (sinusitis, tonsillitis, otitis media); infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvic peritonitis, chancroid, gonorrhea); skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection); osteomyelitis; postoperative infections.

ICD codes

ICD-10 code Indication
A46 Erysipelas
A54 Gonococcal infection
A57 Chancroid
H66 Suppurative and unspecified otitis media
J01 Acute sinusitis
J02 Acute pharyngitis
J03 Acute tonsillitis
J04 Acute laryngitis and tracheitis
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J31.2 Chronic pharyngitis
J32 Chronic sinusitis
J35.0 Chronic tonsillitis
J37 Chronic laryngitis and laryngotracheitis
J42 Unspecified chronic bronchitis
J85 Abscess of lung and mediastinum
J86 Pyothorax (pleural empyema)
L01 Impetigo
L02 Cutaneous abscess, furuncle and carbuncle
L03 Cellulitis
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
L30.3 Infectious dermatitis (infectious eczema)
M86 Osteomyelitis
N10 Acute tubulointerstitial nephritis (acute pyelonephritis)
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N30 Cystitis
N34 Urethritis and urethral syndrome
N37.0 Urethritis in diseases classified elsewhere
N41 Inflammatory diseases of prostate
N70 Salpingitis and oophoritis
N71 Inflammatory disease of uterus, excluding cervix (including endometritis, myometritis, metritis, pyometra, uterine abscess)
N72 Inflammatory disease of cervix uteri (including cervicitis, endocervicitis, exocervicitis)
N73.5 Unspecified female pelvic peritonitis
N74.3 Gonococcal inflammatory diseases of female pelvic organs
N76 Other inflammatory diseases of vagina and vulva
O08.0 Infection of genital tract and pelvic organs following abortion, ectopic and molar pregnancy
O85 Puerperal sepsis
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1A7Z Gonococcal infection, unspecified
1A90 Chancroid
1B70.0Z Erysipelas, unspecified
1B70.1 Streptococcal cellulitis of the skin
1B70.2 Staphylococcal cellulitis of the skin
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0 Bullous impetigo
1B72.1 Nonbullous impetigo
1B72.Z Impetigo, unspecified
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1B7Y Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44 Non-pyogenic bacterial infections of skin
AA9Z Unspecified suppurative otitis media
CA01 Acute rhinosinusitis
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05 Acute laryngitis or tracheitis
CA09.2 Chronic pharyngitis
CA0A.Z Chronic rhinosinusitis, unspecified
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0G Chronic laryngitis or laryngotracheitis
CA20.1Z Chronic bronchitis, unspecified
CA40.0Z Bacterial pneumonia, unspecified
CA42.Z Acute bronchitis, unspecified
CA43.Z Abscess of lung or mediastinum, unspecified
CA44 Pyothorax
EA50.3 Staphylococcal scarlet fever
EA88.0Z Infectious dermatitis, unspecified
EB21 Pyoderma gangrenosum
FB84.Z Osteomyelitis or osteitis, unspecified
GA00 Vulvitis
GA01.Z Inflammatory diseases of uterus, except cervix, unspecified
GA02.Z Unspecified vaginitis
GA05.2 Unspecified pelvic peritonitis in women
GA07.Z Salpingitis and oophoritis, unspecified
GA0Z Inflammatory diseases of female genital tract, unspecified
GA91.Z Inflammatory and other diseases of prostate, unspecified
GB50 Acute tubulo-interstitial nephritis
GB51 Acute pyelonephritis
GB55.Z Chronic tubulo-interstitial nephritis, unspecified
GB5Z Renal tubulo-interstitial diseases, unspecified
GC00.Z Cystitis, unspecified
GC02.1 Nonspecific urethritis
GC02.Z Urethritis and urethral syndrome, unspecified
JA05.0 Infection of genital tract or pelvic organs following abortion, ectopic or molar pregnancy
JB40.0 Postpartum sepsis
NF0A.3 Posttraumatic wound infection, not elsewhere classified
1A71 Gonococcal pelviperitonitis
GA05.Z Inflammatory diseases of female pelvic organs, unspecified
GA0Z Inflammatory diseases of female genital tract, unspecified
XA5WW1 Cervix uteri

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Doses are given in terms of amoxicillin. The dosage regimen is set individually depending on the patient’s age, severity and location of the infection, and the sensitivity of the pathogen.

Children under 12 years: 20-40 mg/kg/day in 2-3 divided doses.

Adults and children over 12 years or weighing 40 kg and more: 250-500 mg 2-3 times/day or 875 mg 2 times/day.

The maximum daily dose of amoxicillin for adults and children over 12 years is 6 g, for children under 12 years – 45 mg/kg of body weight.

Powder

Administer intravenously as injections or infusions.

Doses are given in terms of Amoxicillin. The dosage regimen is set individually depending on the patient’s age, severity and location of the infection, and the sensitivity of the pathogen.

Adults and adolescents over 12 years are administered 1 g (in terms of amoxicillin) 3 times/day, if necessary – 4 times/day. The maximum daily dose is 6 g. For children 3 months – 12 years – 25 mg/kg 3 times/day; in severe cases – 4 times/day; for children under 3 months: premature and in the perinatal period – 25 mg/kg 2 times/day, in the postperinatal period – 25 mg/kg 3 times/day.

Duration of treatment is 5-14 days, for acute otitis media – up to 10 days.

For the prevention of postoperative infections during operations lasting less than 1 hour, administer 1 g intravenously during induction anesthesia. For longer operations – 1 g every 6 hours for 24 hours. If there is a high risk of infection, administration may be continued for several days.

In case of renal failure, adjust the dose and frequency of administration depending on the creatinine clearance.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of hepatic transaminases, in isolated cases – cholestatic jaundice, hepatitis, hepatic failure (more often in the elderly, men, with long-term therapy), pseudomembranous and hemorrhagic colitis (may also develop after therapy), enterocolitis, black “hairy” tongue, darkening of tooth enamel.

From the hematopoietic organs: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions.

From the urinary system: interstitial nephritis, crystalluria, hematuria.

Allergic reactions: urticaria, erythematous rashes, rarely – multiform exudative erythema, anaphylactic shock, angioneurotic edema, extremely rarely – exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, serum sickness-like syndrome, acute generalized exanthematous pustulosis.

Other: candidiasis, development of superinfection.

Contraindications

Hypersensitivity to amoxicillin and other penicillins, clavulanic acid, to other beta-lactam antibiotics (cephalosporins, carbapenems, monobactams); cholestatic jaundice and/or other liver function disorders caused by the use of amoxicillin/clavulanic acid in history; severe renal impairment (creatinine clearance <30 ml/min) (for the dosage form intended for use in children from 3 months to 12 years); children under 3 months of age.

With caution

Impaired liver function, impaired renal function.

Use in Pregnancy and Lactation

Should be used with caution during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in episodes of jaundice or impaired liver function as a result of previous use of amoxicillin/clavulanic acid.

With caution: severe hepatic insufficiency.

Use in Renal Impairment

In chronic renal failure, adjust the dose and frequency of administration depending on creatinine clearance.

Pediatric Use

Used in children over 3 months of age according to indications and in age-appropriate dosage forms.

Special Precautions

Use of this combination is not recommended if infectious mononucleosis is suspected.

During course treatment, monitoring of the state of the hematopoietic organs, liver and kidney function is necessary.

To reduce the risk of gastrointestinal side effects, the drug should be taken with meals.

Development of superinfection due to the growth of flora insensitive to it is possible, which requires an appropriate change in antibacterial therapy.

May give false-positive results when determining glucose in urine. In this case, it is recommended to use the glucose-oxidase method for determining the concentration of glucose in urine.

In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

Drug Interactions

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption.

Bacteriostatic antibiotics (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

When combined with rifampicin, a mutual weakening of the antibacterial effect is observed.

Increases the effectiveness of indirect anticoagulants (by suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, blood clotting parameters should be monitored.

Reduces the effectiveness of oral contraceptives, drugs metabolized to form PABA, ethinylestradiol – risk of “breakthrough” bleeding.

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Concomitant use with methotrexate increases the toxicity of methotrexate.

Allopurinol increases the risk of skin rash.

Simultaneous use with probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin. With concomitant use, an increase and prolongation of the concentration of amoxicillin in the blood is possible, but not of clavulanic acid.

Simultaneous use with disulfiram should be avoided.

Concomitant use of amoxicillin and digoxin may lead to an increase in the plasma concentration of digoxin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Aurobindo Pharma, Ltd. (India)

Dosage Forms

Bottle Rx Icon Amoxicillin + Clavulanic acid Film-coated tablets, 250 mg+125 mg: 14 pcs.
Film-coated tablets, 500 mg+125 mg: 14 pcs.
Film-coated tablets, 875 mg+125 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oval in shape, with an engraving “A” on one side and “63” on the other side; on the cross-section: a light yellow core surrounded by a white or almost white film coating.

1 tab.
Amoxicillin (in the form of amoxicillin trihydrate) 250 mg (286.7 mg)
Clavulanic acid (in the form of potassium clavulanate) 125 mg (277.77 mg)

Excipients: microcrystalline cellulose – 80.58 mg, sodium carboxymethyl starch – 6.65 mg, colloidal silicon dioxide – 6.65 mg, magnesium stearate – 6.65 mg, Opadry white 06B58855 (hypromellose-5cP – 14.62 mg, hypromellose-15cP – 1.36 mg, macrogol 400 – 2.18 mg, titanium dioxide – 6.12 mg).

7 pcs. – blisters (2) – carton packs.

Film-coated tablets white or almost white, biconvex, oval in shape, with an engraving “A” on one side and “64” on the other side; on the cross-section: a light yellow core surrounded by a white or almost white film coating.

1 tab.
Amoxicillin (in the form of amoxicillin trihydrate) 500 mg (573.4 mg)
Clavulanic acid (in the form of potassium clavulanate) 125 mg (277.77 mg)

Excipients: microcrystalline cellulose – 118.83 mg, sodium carboxymethyl starch – 10 mg, colloidal silicon dioxide – 10 mg, magnesium stearate – 10 mg, Opadry white 06B58855 (hypromellose-5cP – 21.49 mg, hypromellose-15cP – 1.99 mg, macrogol 400 – 3.21 mg, titanium dioxide – 8.99 mg).

7 pcs. – blisters (2) – carton packs.

Film-coated tablets white or almost white, biconvex, oval in shape, with an engraving “A” on one side and a score between the engravings “6” and “5” on the other side; on the cross-section: a light yellow core surrounded by a white or almost white film coating.

1 tab.
Amoxicillin (in the form of amoxicillin trihydrate) 875 mg (1003.44 mg)
Clavulanic acid (in the form of potassium clavulanate) 125 mg (277.77 mg)

Excipients: microcrystalline cellulose – 110.74 mg, sodium carboxymethyl starch – 14.35 mg, colloidal silicon dioxide – 14.35 mg, magnesium stearate – 14.35 mg, Opadry white 06B58855 (hypromellose-5cP – 30.96 mg, hypromellose-15cP – 2.88 mg, macrogol 400 – 4.62 mg, titanium dioxide – 12.96 mg).

7 pcs. – blisters (2) – carton packs.

Marketing Authorization Holder

Aurobindo Pharma, Ltd. (India)

Dosage Forms

Bottle Rx Icon Amoxicillin + Clavulanic acid Powder for the preparation of oral suspension (strawberry) 125 mg+31.25 mg/5 ml: bottle 1 pc. in set with measuring cap
Powder for the preparation of oral suspension (strawberry) 250 mg+62.5 mg/5 ml: bottle 1 pc. in set with measuring cap

Dosage Form, Packaging, and Composition

Powder for the preparation of oral suspension (strawberry) granulated, white or almost white; reconstituted suspension is white or almost white, with a strawberry taste.

5 ml of finished susp.
Amoxicillin trihydrate 143.35 mg,
   Equivalent to amoxicillin content 125 mg
Potassium clavulanate* 37.23 mg,
   Equivalent to clavulanic acid content 31.25 mg

* as a mixture of potassium clavulanate + anhydrous colloidal silicon dioxide in a ratio (1:1) – 76.39 mg.

Excipients: colloidal silicon dioxide – 12.5 mg, succinic acid – 0.42 mg, hypromellose – 39.825 mg, xanthan gum – 6.25 mg, strawberry flavor – 5.625 mg, aspartame – 5 mg, silicon dioxide – 60.64 mg.

7.35 g – high-density polyethylene bottles with a capacity of 150 ml (1) in a set with a measuring cap – carton packs.

Powder for the preparation of oral suspension (strawberry) granulated, white or almost white; reconstituted suspension is white or almost white, with a strawberry taste.

5 ml of finished susp.
Amoxicillin trihydrate 286.7 mg,
   Equivalent to amoxicillin content 250 mg
Potassium clavulanate* 74.46 mg,
   Equivalent to clavulanic acid content 62.5 mg

* as a mixture of potassium clavulanate + anhydrous colloidal silicon dioxide in a ratio (1:1) – 152.78 mg.

Excipients: colloidal silicon dioxide – 25 mg, succinic acid – 0.84 mg, hypromellose – 79.65 mg, xanthan gum – 12.5 mg, strawberry flavor – 11.25 mg, aspartame – 10 mg, silicon dioxide – 121.28 mg.

14.7 g – high-density polyethylene bottles with a capacity of 150 ml (1) in a set with a measuring cap – carton packs.

Marketing Authorization Holder

AlTro, LLC (Russia)

Manufactured By

Reyoung Pharmaceutical, Co., Ltd. (China)

Dosage Forms

Bottle Rx Icon Amoxicillin + Clavulanic acid Powder for solution for intravenous infusion 500 mg+100 mg: bottle 1, 10 or 50 pcs.
Powder for solution for intravenous administration 1000 mg+200 mg: vial 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous administration white or almost white.

1 vial
Amoxicillin 500 mg
Clavulanic acid 100 mg

Colorless glass vials (1) – carton packs.
Colorless glass vials (10) – contour plastic packaging (1) (trays) – carton packs.
Colorless glass vials (50) – contour plastic packaging (1) (trays) – carton packs.

Powder for solution for intravenous administration white or almost white.

1 vial
Amoxicillin 1000 mg
Clavulanic acid 200 mg

Colorless glass vials (1) – carton packs.
Colorless glass vials (10) – contour plastic packaging (1) (trays) – carton packs.
Colorless glass vials (50) – contour plastic packaging (1) (trays) – carton packs.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid Powder for solution for intravenous infusion 500 mg+100 mg: bottle 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous administration 1 vial
Amoxicillin (in the form of sodium salt) 500 mg
Clavulanic acid (in the form of potassium salt) 100 mg

Vials (1) – carton packs.
Vials (10) – carton boxes.
Vials (50) – carton boxes.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid Powder for solution for intravenous administration 1 g+200 mg: vial 1, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous administration 1 vial
Amoxicillin (in the form of sodium salt) 1 g
Clavulanic acid (in the form of potassium salt) 200 mg

Vials (1) – carton packs.
Vials (10) – carton boxes.
Vials (50) – carton boxes.

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid Film-coated tablets 250 mg+125 mg: 5, 14 or 16 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex; in cross-section from white to light yellow.

1 tab.
Amoxicillin trihydrate 286.95 mg,
   Equivalent to amoxicillin content 250 mg
Clavulanic acid (in the form of a mixture of potassium clavulanate and microcrystalline cellulose (1:1)) 297.82 mg,
   Equivalent to clavulanic acid content 125 mg

Excipients: sodium carboxymethyl starch – 13 mg, copovidone – 16.25 mg, colloidal silicon dioxide (aerosil) – 6.5 mg, magnesium stearate – 6.5 mg, microcrystalline cellulose 302 – 22.98 mg.

Film coating composition Opadry® AMB II 88A180021 White – 33 mg (polyvinyl alcohol – 13.04 mg, talc – 12.54 mg, titanium dioxide – 4.95 mg, glyceryl monocaprylocaprate/glycerol esters of fatty acids – 1.48 mg, sodium lauryl sulfate – 0.99 mg).

7 pcs. – contour cell packaging (PVC/PVDC/aluminum foil) (1) – combined material packaging (2) – carton packs.
8 pcs. – contour cell packaging (PVC/PVDC/aluminum foil) (1) – combined material packaging (2) – carton packs.
5 pcs. – polypropylene bottles (1) with a capacity of 28 ml – carton packs.

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid Film-coated tablets 500 mg+125 mg: 5, 14 or 16 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex; in cross-section from white to light yellow.

1 tab.
Amoxicillin trihydrate 573.89 mg,
   Equivalent to amoxicillin content 500 mg
Clavulanic acid (in the form of a mixture of potassium clavulanate and microcrystalline cellulose (1:1)) 297.82 mg,
   Equivalent to clavulanic acid content 125 mg

Excipients: sodium carboxymethyl starch – 21 mg, copovidone – 26.25 mg, colloidal silicon dioxide (aerosil) – 10.5 mg, magnesium stearate – 7.27 mg, microcrystalline cellulose 302 – 113.27 mg.

Film coating composition Opadry® AMB II 88A180021 White – 53 mg (polyvinyl alcohol – 20.94 mg, talc – 20.14 mg, titanium dioxide – 7.95 mg, glyceryl monocaprylocaprate/glycerol esters of fatty acids – 2.38 mg, sodium lauryl sulfate – 1.59 mg).

7 pcs. – contour cell packaging (PVC/PVDC/aluminum foil) (1) – packaging (2) made of combined material – carton packs.
8 pcs. – contour cell packaging (PVC/PVDC/aluminum foil) (1) – packaging (2) made of combined material – carton packs.
5 pcs. – polypropylene bottles (1) with a capacity of 28 ml – carton packs.

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid Film-coated tablets 875 mg+125 mg: 5, 14 or 16 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex; in cross-section from white to light yellow.

1 tab.
Amoxicillin trihydrate 1004.43 mg,
   Equivalent to amoxicillin content 800 mg
Clavulanic acid (in the form of a mixture of potassium clavulanate and microcrystalline cellulose (1:1)) 297.82 mg,
   Equivalent to clavulanic acid content 125 mg

Excipients: sodium carboxymethyl starch – 29 mg, copovidone – 36.25 mg, colloidal silicon dioxide (aerosil) – 10 mg, magnesium stearate – 14.5 mg, microcrystalline cellulose 302 – 58 mg.

Film coating composition Opadry® AMB II 88A180021 White – 73 mg (polyvinyl alcohol – 28.84 mg, talc – 27.74 mg, titanium dioxide – 10.95 mg, glyceryl monocaprylocaprate/glycerol esters of fatty acids – 3.28 mg, sodium lauryl sulfate – 2.19 mg).

7 pcs. – contour cell packaging (PVC/PVDC/aluminum foil) (1) – packaging (2) made of combined material – carton packs.
8 pcs. – contour cell packaging (PVC/PVDC/aluminum foil) (1) – packaging (2) made of combined material – carton packs.
5 pcs. – polypropylene bottles (1) with a capacity of 28 ml – carton packs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Jeung Pharmaceutical, Co., Ltd. (China)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid – Vial Film-coated tablets, 250 mg+125 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oval, with a score on one side; on the cross-section: a core of white with a yellowish tint.

1 tab.
Amoxicillin trihydrate 287 mg,
   Equivalent to amoxicillin content 250 mg
Potassium clavulanate 149 mg,
   Equivalent to clavulanic acid content 125 mg

Excipients: microcrystalline cellulose – 231 mg, sodium carboxymethyl starch – 24 mg, magnesium stearate – 5 mg.

Film coating composition hypromellose – 28.2 mg, macrogol-4000 – 0.9 mg, titanium dioxide – 0.9 mg.

10 pcs. – blisters (2) in a set with a silica gel packet (1 pc.) – carton packs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Jeung Pharmaceutical, Co., Ltd. (China)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid – Vial Film-coated tablets, 500 mg+125 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oval, with a score on one side; on the cross-section: a core of white with a yellowish tint.

1 tab.
Amoxicillin trihydrate 574 mg,
   Equivalent to amoxicillin content 500 mg
Potassium clavulanate 149 mg,
   Equivalent to clavulanic acid content 125 mg

Excipients: microcrystalline cellulose – 248 mg, sodium carboxymethyl starch – 86 mg, magnesium stearate – 42 mg.

Film coating composition hypromellose – 41.36 mg, macrogol-4000 – 1.32 mg, titanium dioxide – 1.32 mg.

10 pcs. – blisters (2) complete with a silica gel packet (1 pc.) – cardboard packs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Jeung Pharmaceutical, Co., Ltd. (China)

Dosage Form

Bottle Rx Icon Amoxicillin + Clavulanic acid – Vial Film-coated tablets, 875 mg+125 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oval, with a score on one side; on the cross-section: the core is white with a yellowish tint.

1 tab.
Amoxicillin trihydrate 1004.5 mg,
   Equivalent to amoxicillin content 875 mg
Potassium clavulanate 149 mg,
   Equivalent to clavulanic acid content 125 mg

Excipients: microcrystalline cellulose – 250 mg, sodium carboxymethyl starch – 180 mg, magnesium stearate – 90 mg.

Film coating composition: hypromellose – 70.5 mg, macrogol-4000 – 2.25 mg, titanium dioxide – 2.25 mg.

7 pcs. – blisters (2) complete with a silica gel packet (1 pc. or 2 pcs.) – cardboard packs.

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Forms

Bottle Rx Icon Amoxicillin + Clavulanic acid EXPRESS Dispersible tablets 125 mg+31.25 mg: 14 or 16 pcs.
Dispersible tablets 250 mg+62.5 mg: 14 or 16 pcs.
Dispersible tablets 500 mg+125 mg: 10, 14, or 16 pcs.
Dispersible tablets 875 mg+125 mg: 5, 14, or 16 pcs.

Dosage Form, Packaging, and Composition

Dispersible tablets from white to light yellow, oval, biconvex, with a score on one side, marbling and the presence of single brown inclusions are allowed.

1 tab.
Amoxicillin trihydrate 143.47 mg,
   Equivalent to amoxicillin content 125 mg
Potassium clavulanate 74.46 mg,
   Equivalent to clavulanic acid content 31.25 mg

Excipients: microcrystalline cellulose 302 – 21.77 mg, crospovidone – 50.3 mg, vanillin – 0.25 mg, saccharin – 2.25 mg, magnesium stearate – 1.25 mg, apricot flavor – 2.25 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
8 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
14 pcs. – bottles (1) – cardboard packs.

Dispersible tablets from white to light yellow, biconvex, marbling and the presence of single brown inclusions are allowed.

1 tab.
Amoxicillin trihydrate 286.95 mg,
   Equivalent to amoxicillin content 250 mg
Potassium clavulanate 148.91 mg,
   Equivalent to clavulanic acid content (as potassium salt) 62.5 mg

Excipients: microcrystalline cellulose 302 – 43.54 mg, crospovidone – 100.6 mg, vanillin – 0.5 mg, saccharin – 4.5 mg, magnesium stearate – 2.5 mg, apricot flavor – 4.5 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
8 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
14 pcs. – bottles (1) – cardboard packs.

Dispersible tablets from white to light yellow, biconvex, marbling and the presence of single brown inclusions are allowed.

1 tab.
Amoxicillin trihydrate 573.89 mg,
   Equivalent to amoxicillin content 500 mg
Potassium clavulanate 297.82 mg,
   Equivalent to clavulanic acid content (as potassium salt) 125 mg

Excipients: microcrystalline cellulose 302 – 87.09 mg, crospovidone – 201.2 mg, vanillin – 1 mg, saccharin – 9 mg, magnesium stearate – 5 mg, apricot flavor – 9 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
8 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
10 pcs. – bottles (1) – cardboard packs.

Dispersible tablets from white to light yellow, oval, biconvex, marbling and the presence of single brown inclusions are allowed.

1 tab.
Amoxicillin trihydrate 1004.43 mg,
   Equivalent to amoxicillin content 875 mg
Potassium clavulanate 297.82 mg,
   Equivalent to clavulanic acid content (as potassium salt) 125 mg

Excipients: microcrystalline cellulose 302 – 1.7 mg, crospovidone – 421.51 mg, vanillin – 1 mg, saccharin – 16.11 mg, magnesium stearate – 7.43 mg, tangerine flavor – 9 mg, lemon flavor – 11 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
8 pcs. – contour cell packs (1) – packs (2) – cardboard packs.
5 pcs. – bottles (1) – cardboard packs.

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

NORTH CHINA PHARMACEUTICAL CORPORATION, Ltd. (China)

Or

Pharmland SP, LLC (Republic of Belarus)

Dosage Forms

Bottle Rx Icon Amoxicillin + Clavulanic acid-ALVILS Powder for solution for intravenous administration 500 mg+100 mg: vial 1, 5 or 10 pcs.
Powder for solution for intravenous administration 1000 mg+200 mg: vial. 1 pc.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous administration white or slightly yellowish.

1 vial
Amoxicillin (as amoxicillin sodium) 500 mg
Clavulanic acid (as potassium clavulanate) 100 mg

Colorless glass vials (1) – cardboard packs.
Colorless glass vials (5) – cardboard packs.
Colorless glass vials (10) – cardboard packs with an insert.

Powder for solution for intravenous administration white or slightly yellowish.

1 vial
Amoxicillin (as amoxicillin sodium) 1000 mg
Clavulanic acid (as potassium clavulanate) 200 mg

Colorless glass vials (1) – cardboard packs.
Colorless glass vials (5) – cardboard packs.
Colorless glass vials (10) – cardboard packs with an insert.

Table of Contents

→ TABLE OF CONTENTS