Universal reference book for medicines
Product name: PANCLAVE 2X (PANKLAV 2X)

Active substance: amoxicillin, clavulanic acid

Type: Antibiotic of a broad-spectrum penicillin group with a beta-lactamase inhibitor

Manufacturer: HEMOFARM (Serbia)
Composition, form of production and packaging
Powder for the preparation of a suspension for ingestion
from white to yellowish white;
When adding water, a suspension is obtained from white to yellowish white.
5 ml of finished couscous.

amoxicillin (in the form of amoxicillin trihydrate) 400 mg

clavulanic acid (in the form of a mixture of potassium clavulanate and siloid (1: 1)) 57 mg

Excipients: silicon dioxide - 436.143 mg, hypromellose - 100 mg, sodium saccharinate - 10 mg, xanthan gum - 10 mg, silicon dioxide colloid - 3.2 mg, succinic acid - 1.5 mg, strawberry flavor - 53.571 mg.

15 g - bottles (1) complete with a measuring spoon (volume 5 ml with a risk for volume 2.5 ml) - packs cardboard.

30 g - bottles (1) complete with a measuring spoon (5 ml volume with a risk for a volume of 2.5 ml) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Panklava 2X is a combination of amoxicillin - semi-synthetic penicillin with a broad spectrum of antibacterial activity - and clavulanic acid - an irreversible inhibitor of α-lactamase.

Amoxicillin - semisynthetic aminopenicillin, a broad-spectrum antibacterial agent, belongs to the group of beta-lactam antibiotics.
It inhibits transpeptidase, breaks the synthesis of peptidoglycan (the supporting protein of the cell wall) in the period of division and growth, causes bacterial lysis.
Clavulanic acid is an inhibitor of β-lactamase enzymes produced by certain bacteria and destroying penicillins and other P-lactam antibiotics.
Adding clavulanic acid to amoxicillin, preventing the inactivation of the antibiotic, expands its spectrum of action due to microorganisms, whose resistance to amoxicillin is due to the production of β-lactamases. Clavulanic acid forms a stable inactive complex with P-lactamases and protects amoxicillin from loss of antibacterial activity caused by the production of β-lactamases as the main pathogens and co-pathogens and opportunistic microorganisms. In addition, clavulanic acid has a weak intrinsic antibacterial activity.
Panklava 2X has a broad spectrum of action, is active against amoxicillin-sensitive microorganisms, including strains producing β-lactamases: gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus group of viridans, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria monocytogenes, Enteroccocus spp .;

Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp. Salmonella spp .. Shigella spp., Vibrio cholerae, Yersenia enterocolitica, Helicobacter pylori, Eikenella corrodens;

Gram-positive anaerobes: Peptococcus spp., Peptostreplococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp .;

Gram-negative anerobes: Bacteroides spp.

PHARMACOKINETICS

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
Both components are well absorbed after oral administration; the intake of food by the degree of absorption is not affected. Bioavailability is 90% for amoxicillin and 70% for clavulanic acid. The peak of plasma concentrations is reached approximately in 1,5 hours after reception. The maximum concentration of amoxicillin in the blood (C max ) is about 7 μg / ml, clavulanic acid is 1.1 μg / ml. The half-life (T 1/2 ) of amoxicillin and clavulanic acid is 1-1.5 hours. Connection with plasma proteins: amoxicillin - about 18%, clavulanic acid - 25%. Apparent volume of distribution of amoxicillin is 0.3 - 0.4 l / kg, clavulanic acid - 0.2 l / kg.
Both components are found in many organs and tissues of the body, biological fluids and pathological detachable: amoxicillin - in the lung tissue, bronchial secretion and saliva;
in the skin, subcutaneous, muscular and fatty tissues, in the palatine tonsils; in bone tissue and synovial fluid; mucous membrane of the intestine, liver, gall bladder, bile, female genital organs, fetal tissues; pleural and peritoneal fluid, the contents of skin blisters, sputum, bronchial secretion (to a lesser extent in purulent discharge), in exudate with inflammation of the middle ear and accessory sinuses of the nose; clavulanic acid - in the palatine tonsils, organs of the abdominal cavity, bone, muscle and fatty tissues, synovial and peritoneal fluids, bile and purulent discharge. Neither the active components of Panklava 2X nor their metabolites are cumulated in any organs and tissues.
Amoxicillin and clavulanic acid do not penetrate the unchanged blood-brain barrier.

Amoxicillin and clavulanic acid penetrate the placental barrier and into breast milk.

Amoxicillin partially (10 - 25% of the absorbed dose) is masturbated to inactive penicillic acid;
Clavulanic acid is metabolized intensively, its metabolites are excreted through the kidneys, intestines and lungs. Amoxicillin is excreted mainly by the kidneys through tubular secretion and glomerular filtration. The total clearance of the combination amoxicillin / clavulanic acid is 25 l / h. During the first 6 hours after a single dose of the drug, 60% and 40% of the administered dose of amoxicillin and clavulanic acid are excreted unchanged from the body, respectively.
Both components are removed during hemodialysis, to a lesser extent - with peritoneal dialysis.

Elderly patients;
Because of the possible age-related decline in the excretory function of the kidneys, use with caution is recommended.
In patients with severe renal failure, the elimination half-life increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.

INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to amoxicillin / clavulanic acid:

- infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, peritonsillar abscess, tonsillitis, pharyngitis);

- infections of the lower respiratory tract (acute bronchitis with bacterial superinfection, exacerbation of chronic bronchitis, pneumonia);

- urinary tract infections;

- infection of the pelvic organs;

- skin and soft tissue infections (including after animal and human bites);

- infections of bones and joints (including osteomyelitis);

- bile duct infection (cholecystitis, cholangitis);

infection in dentistry.

DOSING MODE

Inside, washing down with water;
at the beginning of food intake (to reduce the risk of side effects from the gastrointestinal tract), 2 times a day, strictly observing the interval between meals at 12 hours.
Dosing with a measuring spoon, considering that 5 ml of the finished suspension contain amoxicillin 400 mg / clavulanic acid 57 mg.
Drink 0.5-1 glass of water. The dose of Panklava 2X is prescribed by a doctor, taking into account the characteristics of the pathogen, localization and severity of the infection. The dosage regimen is set individually, depending on the age, body weight (for children) and kidney function. The course of treatment is 5 to 14 days; is set individually.
For infections requiring a prolonged course of therapy (for example, with osteomyelitis), exceeding the maximum recommended course of therapy in 14 days is possible only after a thorough assessment by the doctor of the patient's condition, achieved and expected therapeutic effect and risks.
The maximum daily dose of amoxicillin for adults is 6 g, for children - 45 mg / kg / day. The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children -10 mg / kg / day.
Adults and children over 12 years of age (body weight> 40 kg)

Standard dosing regimen for all indications: 2 scoops (800 mg / 114 mg) 2 times a day, every 12 hours.

Children from 2 to 12 years (body weight> 40 kg)

Daily dose (for amoxicillin) Weight of the child Conformity to age The amount of the finished suspension, in ml

25 mg / kg 13-21 kg 2-6 years for 2.5 ml 2 times a day

22-40 kg 7-12 years on 5 ml 2 times a day

45 mg / kg 13-21 kg 2-6 years 5 ml 2 times a day

22-40 kg 7-12 years for 10 ml 2 times a day

Children from 3 months to 3 years

weight of the child Daily dose of 25 mg / kg (for amoxicillin) Daily dose of 45 mg / kg (for amoxicillin)

5 kg of 0.8 ml 2 times a day for 1.4 ml 2 times a day

6 kg of 0.9 ml 2 times a day for 1.7 ml 2 times a day

7 kg of 1.1 ml 2 times a day for 2.0 ml 2 times a day

8 kg of 1.3 ml 2 times a day for 2.3 ml 2 times a day

9 kg of 1.4 ml 2 times a day for 2.5 ml 2 times a day

10 kg of 1.6 ml 2 times a day for 2.8 ml 2 times a day

11 kg of 1.7 ml 2 times a day for 3.1 ml 2 times a day

12 kg of 1.9 ml 2 times a day for 3.4 ml 2 times a day

The daily dose for children over 3 months and up to 12 years (body weight> 40 kg) is 25 - 45 mg / kg / day (calculated for amoxicillin) divided into two doses every 12 hours.
Low doses of the drug (25 mg / kg / day) are used to treat infections of the skin and soft tissues, as well as relapsing tonsillitis. High doses of the drug (45 mg / kg / day) are used to treat diseases such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections. The duration of treatment of acute uncomplicated otitis media is 5-7 days, in children under 2 years - 7-10 days.
Children and adults with renal insufficiency

When creatinine clearance is less than 30 ml / min the drug in this dose is not recommended;
with a creatinine clearance of more than 30 ml / min - insufficiently justified data for the development of special recommendations on the dosage regimen. It is allowed as a reduction in the dose of the drug, so an increase in the interval between doses.
Preparation of a suspension for oral administration

In the bottle with powder, gradually add water to the mark (distilled water or boiled and cooled) and shake until the powder is evenly soaked (about 30 seconds).
If the level of the prepared suspension is below the label on the vial label, re-add water to the label and shake.
The prepared suspension must be shaken before each intake.

The ready suspension should be stored in the refrigerator (at a temperature of 2-8 ° C) for not more than 7 days.

Important!
If the drug is missed, you should take the suspension as soon as possible without waiting for the next time. Further, to observe equal time intervals between doses - 12 hours. Never take a double dose to compensate for missed medication!
SIDE EFFECT

Very often - more than 10%;
often - more than 1 and less than 10%; infrequently - more than 0.1 and less than 1%; rarely - more than 0.01 and less than 0.1%; very rarely - less than 0.01%.
Very often - more than 10%;
often - more than 1 and less than 10%; infrequently - more than 0.1 and less than 1%; rarely - more than 0.01 and less than 0.1%; very rarely - less than 0.01%.
From the side of the central nervous system: infrequently - dizziness, headache;
very rarely - excitement, anxiety, reversible hyperactivity, insomnia, behavior change, convulsions.
From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, diarrhea;
infrequent - dyspepsia, mild asymptomatic increase in activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and / or increased bilirubin concentration; rarely - pseudomembranous colitis, discoloration of the teeth (reversible, removed hygienic means); very rarely - "black hairy tongue", hepatitis, cholestatic jaundice, liver failure (usually in the elderly, in men, with prolonged therapy), stomatitis, glossitis.
From the hematopoiesis: rarely - neutropenia, thrombocytopenia / thrombocytosis, hemolytic anemia;
very rarely - leukopenia, agranulocytosis, increased prothrombin time and bleeding time, eosinophilia.
From the side of the urinary system: very rarely - interstitial nephritis, crystalluria, hematuria.

Allergic reactions: infrequently - urticaria, rash, itchy skin;
rarely erythema multiforme; frequency is not known - angioedema, anaphylaxis, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), bullous exfoliative dermatitis, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness.
Other: often - Candidiasis of the skin and mucous membranes;
very rarely - the development of superinfection.
CONTRAINDICATIONS

- hypersensitivity to the active and / or auxiliary components of Panklaw 2X;

- hypersensitivity to beta-lactam antibiotics (penicillins, cephalosporins, carbapenems, etc.);

- a history of cholestatic jaundice and / or liver dysfunction caused by taking a penicillin antibiotic or a combination of amoxicillin / clavulanic acid;

- Infectious mononucleosis;

- Breastfeeding (lactation period);

- Children under 3 months.

Carefully

Hepatic failure, chronic renal failure, pseudomembranous colitis in history, elderly age (over 65 years), hyperkalemia, pregnancy.

PREGNANCY AND LACTATION

In pregnancy, it can be used when the benefits of using it for the mother greatly exceed the risk to the fetus.
If you need to use the drug during lactation, breastfeeding is suspended.
APPLICATION FOR FUNCTIONS OF THE LIVER

Use with caution in chronic kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Use with caution in liver failure.

APPLICATION FOR CHILDREN

Contraindicated for children under 3 months.
Use in children older than 3 months is possible according to the dosing regimen.
APPLICATION IN ELDERLY PATIENTS

Apply with caution to elderly people (over 65 years of age).

SPECIAL INSTRUCTIONS

With a long course of treatment, it is necessary to provide control over the status of the function of the organs of hematopoiesis, liver and kidneys.

Patients with severe renal dysfunction require adequate dose adjustment or an increase in intervals between doses of the drug.

To reduce the risk of side effects from the gastrointestinal tract, you should take the drug at the beginning of food intake.

To prevent the development of crystalluria, the drug should be washed down with a relatively large amount of water (0.5-1 glass).
Compliance with this recommendation is especially important for patients with the original oliguria.
Unmodified amoxicillin is excreted by the kidneys.
High concentrations of amoxicillin give a false positive reaction to urine glucose when using a Benedict reagent or Felling solution. It is recommended to use enzymatic reactions with glucose oxidase.
Perhaps the development of bacterial or fungal superinfection (Pseudomonasspp., Candidaalbicans) due to the growth of insensitive to the drug microflora, which requires a corresponding change in antibacterial therapy.

During therapy with the drug as a result of exposure to C. Difficile toxin, the development of pseudomembranous colitis is possible. In case of severe diarrhea, as in the case of diarrhea lasting 2-3 days, it is necessary to see a doctor as soon as possible.
With the development of mild diarrhea against the background of Panklava 2X, antidiarrheal drugs should be avoided that inhibit intestinal peristalsis; it is possible to use kaolin or attapulgite-containing antidiarrhoeic agents.
Since Panklav 2X contains potassium, caution should be exercised when prescribing it to patients with initial hyperkalemia.

It is advisable to use caution when administering Panklava 2X to patients with hepatic insufficiency and to provide regular laboratory monitoring of liver function.

When jaundice coloring of the skin, eye whites, darkening of the color of urine and / or clarification of the stool, it is necessary to consult a doctor immediately.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.
It is not recommended to use Panklav2X for infectious mononucleosis and for suspected it, as the drug can cause an erythematous skin rash, which aggravates the symptoms of the disease / complicates the diagnosis.
In neonates born to mothers who received preventive therapy with amoxicillin / clavulanic acid for premature rupture of the membranes (premature bladder) with premature pregnancy, there is an increased risk of developing necrotizing enterocolitis.

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, it is recommended to use caution when driving vehicles and engaging in other potentially hazardous activities, as vertigo is possible.

OVERDOSE

Symptoms: nausea, vomiting, abdominal pain, diarrhea, disturbance of water-electrolyte balance;
there may be excitement, insomnia; There are isolated cases of seizures and crystalluria in patients with initially impaired renal function. No reports of death or development of life-threatening adverse events in an overdose of the drug.
Treatment: symptomatic;
Gastric lavage and intake of absorbent are effective if the drug was taken less than 4 hours ago. Hemodialysis is effective.
DRUG INTERACTION

Antacids, glucosamine, laxatives, aminoglycosides - slow down and reduce absorption;
ascorbic acid increases absorption.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect;
bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.
Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index).
With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulability. Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produces paraaminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough".
Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs, and others. Drugs that block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived largely by glomerular filtration).
Allopurinol increases the risk of skin rash.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not higher than 30 ° C in original package in a dry place, protected from light. The finished slurry should be stored in refrigerator (at a temperature of 2-8 ° C) of not more than 7 days.
Keep out of the reach of children.
Shelf life - 2 years.

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