Amoxiclav powder for preparation of oral suspension 312mg 5ml 100ml
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Active ingredients
Amoxicillin + Clavulanic Acid
Release form
Powder
Composition
5 ml of the prepared suspension contains: Amoxicillin (in the form of trihydrate) 250 mg Clavulanic acid (in the form of potassium salt) 62.5 mg Auxiliary substances: citric acid (anhydrous) - 2.167 mg, sodium citrate (anhydrous) - 8.335 mg, sodium benzoate - 2.085 mg microcrystalline cellulose and sodium carmellose - 28.1 mg, xanthan gum - 10 mg, colloidal silicon dioxide - 16.667 mg, silicon dioxide - 217 mg, wild cherry flavors - 4 mg, sodium saccharinate - 5.5 mg, mannitol - 1250 mg.
Pharmacological effect
Amoxiclav is a combination of amoxicillin - semi-synthetic penicillin with a wide spectrum of antibacterial activity and clavulanic acid - an irreversible inhibitor β-lactamase. Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of β-lactamase produced by microorganisms. Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. It has a wide range of antibacterial activity. Amoxicillin strains, including strains producing β-lactamase, including Aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (methicillin-apart resistant strains), Staphylococcus epidermidis (methicillin-apart resistant strains), Staphylococcus saprophyticus, Listeria spp, Enterococcus spp .;. Aerobatic Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Helicobacter pylori, Eikenella corrodens; anaerobic gram-positive bacteria: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces Israel, Fusobacterium spp., Prevotella spp., gram-negative anaerobes: Bacteroides spp.
Pharmacokinetics
Absorption: Both components are well absorbed after taking the drug inside, food intake does not affect the degree of absorption. Cmax in plasma is achieved 1 h after administration. Cmax values for amoxicillin (depending on the dose) are 3-12 mcg / ml, for clavulanic acid - about 2 mcg / ml. Distribution Both components are characterized by a good volume of distribution in body fluids (lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries, etc.). Amoxicillin also penetrates the synovial fluid, liver, prostate gland, palatine tonsils, muscle tissue, gallbladder, the secret of the paranasal sinuses, saliva,bronchial secretions. Amoxicillin and clavulanic acid do not penetrate the BBB in non-inflammatory cerebral membranes. Amoxicillin and clavulanic acid penetrate the placental barrier and in trace concentrations are excreted in breast milk. Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins. Metabolism Amoxicillin is partially metabolized, clavulanic acid, apparently, undergoes intensive metabolism. Excretion Amoxicillin is eliminated by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can be excreted through the intestines and lungs. T1 / 2 amoxicillin and clavulanic acid is 1-1.5 hours. Pharmacokinetics in special clinical situations. In severe renal failure, T1 / 2 increases to 7.5 hours for amoxicillin and 4.5 hours for clavulanic acid. Both components are removed by hemodialysis and minor amounts of peritoneal dialysis.
Indications
Infections caused by susceptible strains of microorganisms: - infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis); - infections of the lower respiratory tract (in Acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); - urinary tract infections; - gynecological infections; - skin and soft tissue infections, including animal and human bites; - bone and connective tissue infections; Tey (cholecystitis, cholangitis); - odontogenic infections.
Contraindications
- Hypersensitivity to any of the components of the drug; - Hypersensitivity in history to penicillins, cephalosporins and other beta-lactam antibiotics; - A history of indications of cholestatic jaundice and / or other abnormalities of liver function caused by amoxicillin / clavulanic acid; - infection; mononucleosis and lymphocytic leukemia.
Precautionary measures
With caution should use the drug for pseudomembranous colitis in history, with liver failure, severe renal impairment, as well as during lactation.
Use during pregnancy and lactation
Amoxiclav can be prescribed during pregnancy in the presence of clear indications. Amoxicillin and clavulanic acid are excreted in small quantities with breast milk.
Dosage and administration
Daily dosages of suspensions 125 mg + 31.25 mg / 5 ml and 250 mg + 62.5 mg / 5 ml (to facilitate the correct dosing of 125 mg + 31.25 mg / 5 ml and 250 mg suspensions + 62.5 mg / 5 ml in each package, a dosing spoon with a capacity of 5 ml or graduated dosing pipette). For newborns and children up to 3 months prescribed at 30 mg / kg (for amoxicillin) / day, divided into 2 doses (every 12 hours); children older than 3 months - from 20 mg (for amoxicillin) / kg / day for mild to moderate infections up to 40 mg / kg (for amoxicillin) / day for severe infections and respiratory infections, divided into 3 doses (every 8 h). Recommended doses of suspensions depending on the child's body weight and severity of infection. Body weight (kg) Age (approximately) Infections mild / moderately severe Severe infections 125 mg + 31.25 mg / 5 ml 250 mg + 62.5 mg / 5 ml 125 mg + 31.25 mg / 5 ml 250 mg + 62.5 mg / 5 ml 5-10 3-12 months 3 × 2.5 ml (1/2 l.) 3 × 1.25 ml (1/4 l.) 3 × 3.75 ml (3/4 l .) 3 × 2 ml (1 / 4-1 / 2 l.) 10-12 1-2 years 3 × 3.75 ml (3/4 l.) 3 × 2 ml (1 / 4-1 / 2 l.) 3 × 6.25 ml (11/4 l.) 3 × 3 ml (1 / 2-3 / 4 l.) 12-15 2-4 years 3 × 5 ml (1 l.) 3 × 2.5 ml (1/2 l). 3 × 7.5 ml (11/2 l.) 3 × 3.75 ml (3/4 l.) 15-20 4-6 years 3 × 6.25 ml (11/4 l.) 3 × 3 ml (1 / 2-3 / 4 l.) 3 × 9.5 ml (13 / 4-2 l.) 3 × 5 ml (1 l.) 20-30 6-10 years 3 × 8.75 ml (13/4 l.) 3 × 4.5 ml ( 3 / 4-1 l.) - 3 × 7 ml (11 / 4-11 / 2 l.) 30-40 10-12 years - 3 × 6.5 ml (11/4 l.) - 3 × 9.5 ml (13 / 4-2 l.) ≥ 40 ≥ 12 years Amoxiclav is prescribed in pills
Side effects
On the part of the digestive system: loss of appetite, nausea, vomiting, diarrhea; rarely - abdominal pain, abnormal liver function, increased activity of liver enzymes (ALT or AST); in rare cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: itching, urticaria, erythematous rash; rarely - erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis; in rare cases - exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exantmatous pustules. From the hematopoietic system and lymphatic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - hemolytic anemia, reversible increase in prothrombin time (when used together with anticoagulants), eosinophilia, pancytopenia. On the nervous system: dizziness, headache; very seldom - convulsions (may occur in patients with impaired renal function when taking the drug in high doses), hyperactivity, anxiety, insomnia. . h. candidiasis).
Overdose
There are no reports of fatal or life-threatening side effects due to overdose of the drug. Symptoms: in most cases - disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), also anxiety, insomnia, dizziness; in rare cases - convulsive seizures. Treatment: the patient must be under medical supervision; symptomatic therapy. In the case of a recent administration of the drug (less than 4 hours), it is necessary to carry out a gastric lavage and to appoint activated charcoal to reduce the absorption of the drug. Amoxicillin / potassium clavunate is removed by hemodialysis.
Interaction with other drugs
With simultaneous use of the drug Amoxiclav with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, with ascorbic acid it increases. filtration). With the simultaneous use of Amoxiclav increases the toxicity of methotrexate. With the simultaneous use of Amoxiclav with allopurinol p the frequency of development of exanthema is increased. Simultaneous administration with disulfiram is to be avoided. In some cases, taking the drug may prolong the prothrombin time, therefore care should be taken when co-prescribing anticoagulants and Amoxiclav. Amoxiclav should not be used simultaneously with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to Possible reduction in the effectiveness of Amoxiclav. Probecid reduces the excretion of amoxicillin, increasing its serum concentration. Antibiotics reduce the effectiveness of oral contraceptives.
special instructions
In a course of treatment, the functions of the blood-forming organs, liver and kidneys should be monitored. In patients with severely impaired renal function, an adequate correction of the dosing regimen or an increase in the intervals between dosing is required. : High concentrations of amoxicillin give a false positive reaction to urine glucose using Benedict's reagent or Felling's solution.It is recommended to use enzymatic reactions with glucosidase. Effect on ability to drive motor vehicles and control mechanisms There are no data on the negative effect of Amoksiklav at recommended doses on ability to drive a car or work with mechanisms.