Panklav 2X - instructions for use, dose, side effects, contraindications

5 ml of the finished suspension contain active ingredients: amoxicillin (in the form of amoxicillin trihydrate) 400.00 mg; clavulanic acid (in the form of a mixture of potassium, clavulanate and siloid (1: 1)) 57.00 mg; Excipients: silicon dioxide 436.143 mg, hypromellose 100.00 mg, sodium saccharinate 10.00 mg, xanthan gum 10.00 mg, silicon dioxide colloid 3.20 mg, succinic acid 1.50 mg, strawberry flavor 53.571 mg.

Description:Powder from white to yellowish white. When adding water, a suspension is obtained from white to yellowish white.

Pharmacotherapeutic group:antibiotic - penicillin semisynthetic + beta-lactamase inhibitor.

ATX: & nbsp

J.01.C.R.02 Amoxicillin in combination with enzyme inhibitors

Pharmacodynamics:

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

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 β-lactam antibiotics.

Adding clavulanic acid to amoxicillin, preventing the inactivation of the antibiotic, extends the spectrum of its action due to microorganisms whose resistance to amoxicillin is due to the production of β-lactamases. Clavulanic acid forms a stable inactive complex with β-lactamases and protects amoxicillin from the loss of antibacterial activity caused by the production of β-lactamases as the main pathogens and co-pathogens, and conditionally pathogenic microorganisms. In addition, clavulanic acid has a weak intrinsic antibacterial activity.

Panklava 2X has a wide spectrum of action, is active against sensitive to amoxicillin of microorganisms, including strains producing β-lactamases:

Gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus groups 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, Pasteur ella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersenia enterocolitica, Helicobacter pylori, Eikenella corrodensy.

gram positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp.

Gram-negative anaerobes: Bacteroides spp.

Pharmacokinetics:

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after oral administration; eating on, 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_m_Oh) is about 7 μg / ml, clavulanic acid -1,1 mcg / ml. The half-life (T1/2) of amoxicillin and clavulanic acid is 1-1,5 hours.

Connection with plasma proteins: amoxicillin - about 18%, clavulanic acid - 25%. The apparent volume of distribution of amoxicillin is 0.3-0.4 l / kg, clavulan 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 palatine tonsils; in bone tissue and synovial fluid; mucous membrane of the intestine, liver, gallbladder, bile,female genital organs, fetal tissues; pleural and peritoneal fluid, contents of skin blisters, sputum, bronchial secretion (to a lesser degree 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 metabolized to inactive penicillic acid; clavulanic acid is metabolized intensively, its metabolites are excreted from the body 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.

Patients with severe renal insufficiency 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);

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

- urinary tract infections;

- infections of the pelvic organs;

- infection of the skin and soft tissues (including after bites of animals and humans);

- infection of bones and joints (including osteomyelitis);

- infection of the biliary tract (cholecystitis, cholangitis;

- infection in dentistry.

Contraindications:

Hypersensitivity to the active and / or auxiliary components of the preparation Panklav 2X, increased sensitivity to beta-lactam antibiotics (penicillins, cephalosporins, carbapenems and others.), A history of cholestatic jaundice and / or liver dysfunction induced by administration of antibiotic penicillin or a combination amoxicillin / clavulanic acid; infectious mononucleosis, breast-feeding (lactation), children up to 3 months.

Carefully:

Liver failure, chronic renal failure, pseudomembranous colitis in history, advanced age (over 65 years of age (see. Section "Pharmacokinetics")), hyperkalemia (see. Section Cautions "), 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.

Dosing and Administration:

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 receptions 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 5-14 days, set individually.

For infections requiring long-term therapy (for example, with osteomyelitis), exceeding the maximum recommended course of therapy in 14 days is possible only after careful assessment by the doctor of the patient's condition, achieved and expected therapeutic effect and risks (see also section "Special instructions").

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)

The daily dose (for amoxicillin)	Weight of child	Correspondence to age	The amount of finished, suspension, in ml
25 mg / kg	13-21 kg	2-6 years	2.5 ml 2 times a day
	22-40 kg	7-12 years old	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 old	10 ml 2 times a day

Children from 3 months to 3 years

Weight of child	The daily dose of 25 mg / kg (for amoxicillin)	The daily dose of 45 mg / kg (for amoxicillin)
5 kg	on 0,8 ml 2 times a day	on 1,4 ml 2 times a day
<6 kg	on 0,9 ml 2 times a day	1.7 ml 2 times a day
7 kg	1.1 ml 2 times a day	2.0 ml 2 times a day
8 kg	on 1,3 ml 2 times a day	2.3 ml 2 times a day
9 kg	on 1,4 ml 2 times a day	2.5 ml 2 times a day
10 kg	1.6 ml 2 times a day	on 2,8 ml 2 times a day
11 kg	1.7 ml 2 times a day		on 3,1 ml 2 times a day
12 kg	on 1,9 ml 2 times a day		3.4 ml twice a day

The daily dose for children older than 3 months and up to 12 years (body weight> 40 kg) is 25 - 45 mg / kg / day (based on 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.

DChildren 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. Allowed as reduction of the dose of the drug, so increasing the interval between doses.

Preparation of a suspension for oral administration

In a bottle of 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.

Ready suspension should be stored in the refrigerator (at a temperature of 2-8 ° C) no 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 intervals of time between meals - 12 hours. Never take a double dose to refund missed medication!

Side effects:

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%; rarely - less than 0.01%.

From the central nervous system: infrequently - dizziness, headache; very rarely - agitation, anxiety, reversible, hyperactivity, insomnia, behavior change, convulsions.

From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, diarrhea; infrequently - dyspepsia, moderate asymptomatic increase in activity 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 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.

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.

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 processthe metabolism of which forms para-aminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs drugs, etc., drugs that block tubular secretion, increase concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Allopurinol increases the risk of skin rash.

Special instructions:

With a long course of treatment, it is necessary to ensure control of the status of the function of the 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 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.

Unchanged 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 more bacterial or fungal superinfection (Pseudomonas spp., Candida albicans) 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 toxin C. Difficile possibly the development of pseudomembranous colitis. 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, antidiarrhoeic drugs 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 coloration of the skin, eye whites, darkening of the color of urine - and / or clarification of the stool, it is necessary to urgently consult a doctor.

Havepatients with increased sensitivity to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

It is not recommended to use Panklav2X for infectious mononucleosis and if it is suspected, as the drug can cause an erythematous skin rash, which aggravates the symptoms of the disease, making it difficult to diagnose.

In neonates born to mothers who received preventive therapy with amoxicillin / clavulanic acid for premature rupture of the membranes (fetal bladder) with premature pregnancy, there is an increased risk of advanced necrotizing enterocolitis.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Powder for the preparation of suspension for ingestion (400 mg + 57 mg) / 5 ml.

Packaging:For 15 g or 30 g of powder in a bottle of glass III of hydrolytic class, sealed with a screwed plastic lid with the control of the first opening. On the top The side of the lid is marked with a vial opening scheme. 1 bottle complete with a measuring spoon with a volume of 5 ml (m1) with a risk for a volume of 2.5 ml and instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature of no higher than 30 ° C in its original packaging in a dry, dark place.

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

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001491

Date of registration:08.02.2012

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp08.02.2012

Illustrated instructions

Instructions

Panklaw 2X (Panklav 2X)