Pharmacological properties of the drug Panklav
Pharmacodynamics. Panclave is a combination drug of amoxicillin and clavulanic acid. Amoxicillin is a semi-synthetic penicillin with a wide spectrum of antibacterial activity. It has a bactericidal effect on gram-positive and gram-negative microorganisms. Resistant to the action of gastric juice, unstable to the action of bacterial beta-lactamases. Clavulanic acid is a beta-lactamase inhibitor; it forms a stable inactivated complex with it, protecting amoxicillin from a decrease in antibacterial activity caused by the action of this enzyme. This combination provides high bactericidal activity of Panklav against both amoxicillin-sensitive strains and strains that produce beta-lactamases. Panclave is active regarding:
- aerobic gram-positive bacteria: Streptococcus pneumonie, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus aureus (except methicillin-resistant strains), Corynobacterium spp., Enterococcus spp., Listeria monocytogenes;
- aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Campylobacter coli, Escherichia coli, Gardnerela vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Naisseria gonorrhoeae, Naisseria meningitides, Pasteurela multocida, Proteus spp. ., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica;
- anaerobic bacteria: Actinomyces israelii, Bacteroides spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp. The combination of amoxicillin and clavulanic acid should not be prescribed for infections for which amoxicillin alone is effective.
Pharmacokinetics. After oral administration, both components of the drug are rapidly absorbed, the maximum concentration in the blood plasma is reached 1 hour after administration. The presence of food does not affect the absorption of active substances. Both components penetrate well into most tissues and body fluids, through the placental barrier, in meningitis - through the BBB, and are detected in trace amounts in breast milk. The half-life of amoxicillin is about 1.3 hours, clavulanic acid - 1 hour. With a decrease in kidney function, this period lengthens. About 60% of amoxicillin and approximately 30% of clavulanic acid are excreted in the urine within 6 hours.
Panclave 2X, 875 mg+125 mg, film-coated tablets, 14 pcs.
Suction
Amoxicillin and clavulanic acid are rapidly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of amoxicillin and clavulanic acid is optimal when taken at the beginning of a meal.
The following shows the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in separate studies when healthy volunteers took it on an empty stomach:
- 2 tablets of amoxicillin + clavulanic acid, 875 mg/125 mg (1000 mg).
Drugs | Dose (mg) | Cmax (µg/ml) | Tmax (hours) | AUC (mg˟h/ml) | Т½ (hours) |
Amoxicillin | |||||
amoxicillin + clavulanic acid, 875 mg/125 mg | 1750 | 11,64±2,78 | 1,50 (1,0-2,5) | 53,52± 2,31 | 1,19±0,21 |
Clavulanic acid | |||||
amoxicillin + clavulanic acid, 875 mg/125 mg | 250 | 2,18±0,99 | 1,25 (1,0-2,0) | 10,16±3,04 | 0,96±0,12 |
Cmax - maximum concentration in blood plasma Tmax - time to reach maximum concentration in blood plasma AUC - area under the concentration-time curve T½ - half-life
Distribution
Therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (in the gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge).
Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma is bound to plasma proteins.
Animal studies have not demonstrated accumulation of amoxicillin and/or clavulanic acid in any organ. Amoxicillin, like most penicillins, passes into breast milk. Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of sensitization, diarrhea or candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants. Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.
Metabolism
10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicillic acid). Clavulanic acid undergoes extensive metabolism to 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys through Gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide.
Removal
Like other penicillins, amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. Approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged by the kidneys in the first 6 hours after taking the drug.
Concomitant administration of probenecid slows the excretion of amoxicillin, but does not slow down the renal excretion of clavulanic acid (see section "Interaction with other drugs").
Indications for use of the drug Panklav
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the ENT organs and upper respiratory tract (acute and chronic sinusitis, otitis media, tonsillitis, pharyngitis);
- lower respiratory tract infections (acute and chronic bronchitis, pneumonia);
- infections of the genitourinary system (cystitis, urethritis, pyelonephritis, salpingitis, salpingoophoritis, endometritis, bacterial vaginitis, postpartum sepsis, septic abortion, pelvioperitonitis, gonorrhea, chancroid);
- infections of bones and joints (including chronic osteomyelitis);
- infections of the skin and soft tissues (including cellulitis, wound infection);
- biliary tract infections (including cholecystitis, cholangitis);
- surgical infections;
- dental infections (during preparation for surgery);
- prevention of infectious and inflammatory complications during operations on the abdominal organs, pelvis, heart, kidneys, and maxillofacial surgery).
Panclave 2X 875 mg/125 mg amoxicillin + clavulanic acid, 14 film-coated tablets
Registration Certificate Holder
HEMOFARM (Serbia)
Dosage form
Medicine – Panklav 2X (Panklav 2X)
Description
Film-coated tablets
from white to almost white, oval, biconvex, with a notch on one side; On a cross section, the kernel is almost white to white with a yellowish tint.
1 tab.
amoxicillin (in the form of amoxicillin trihydrate) 875 mg clavulanic acid (in the form of a mixture of potassium clavulanate and microcrystalline cellulose (1:1)) 125 mg
Excipients
: microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, colloidal anhydrous silicon dioxide, butylated hydroxyanisole.
Excipients (shell):
hypromellose, titanium dioxide, propylene glycol, talc.
14 pcs. — dark glass jars with first opening control (1) — cardboard packs.
Indications
Infectious and 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);
- lower respiratory tract infections (acute bronchitis with bacterial superinfection, exacerbation of chronic bronchitis, pneumonia);
- urinary tract infections;
- pelvic organ infections;
- infections of the skin and soft tissues (including after animal and human bites);
- infections of bones and joints (including osteomyelitis);
- biliary tract infections (cholecystitis, cholangitis);
- infections in dentistry.
Contraindications for use
- hypersensitivity to the active and/or auxiliary components of the drug Panklav 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;
- impaired renal function (creatinine clearance less than 30 ml/min);
- Infectious mononucleosis;
- breastfeeding (lactation period);
- children under 12 years of age and/or body weight less than 40 kg (for tablets 875 mg/125 mg).
With caution
: Liver failure, chronic renal failure (creatinine clearance more than 30 ml/min), history of pseudomembranous colitis, old age (over 65 years, hyperkalemia, pregnancy.
pharmachologic effect
Panclave 2X is a combination of amoxicillin, a semi-synthetic penicillin with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible β-lactamase inhibitor.
Amoxicillin is a semisynthetic aminopenicillin, a broad-spectrum bactericidal agent, belongs to the group of beta-lactam antibiotics. Inhibits transpeptidase, disrupts the synthesis of peptidoglycan (supporting protein of the cell wall) during division and growth, and causes lysis of bacteria.
Clavulanic acid is an inhibitor of β-lactamases - enzymes produced by some bacteria and destroying penicillins and other (3-lactam antibiotics. The addition of clavulanic acid to amoxicillin, preventing inactivation of the antibiotic, expands its spectrum of action due to microorganisms whose resistance to amoxicillin is due to the production of β- lactamase 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 by both the main pathogens and co-pathogens and opportunistic microorganisms. In addition, clavulanic acid has weak intrinsic antibacterial activity.
Panclave 2X has a wide spectrum of action, is active against amoxicillin-sensitive microorganisms, including strains that produce β-lactamases: gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, viridans group Streptococcus, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis ( except for methicillin-resistant strains), Staphylococcus saprophytics, Listeria monocytogenes, Enteroccocus spp.;
gram -negative aerobes: bordetella perussis, Brucella spp., Campylobacter Jejuni, Escherichia Coli, Gardnerella vaginalis, Haemophilus Influenzae, Haemophilus Ducreyi, KlebsIella SPP. Oraxella 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., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp.;
gram-negative anaerobes: Bacteroides spp.
Drug interactions
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 intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators.
Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing “breakthrough” bleeding.
Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
Allopurinol increases the risk of developing skin rashes.
Dosage regimen
Inside, with water; at the beginning of a meal (in order to reduce the risk of side effects from the gastrointestinal tract), 2 times a day, strictly observing the interval between doses of 12 hours.
Adults and children over 12 years old.
Adults and children over 12 years old (body weight 40 kg or more) - take 1 tablet 2 times a day, every 12 hours.
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.
The course of treatment is 5-14 days; is established individually, taking into account the characteristics of the pathogen, localization and severity of the infection.
Dosing for renal failure
Tablets 875 mg/125 mg should be used only in patients with creatinine clearance more than 30 ml/min, and no dose adjustment is required.
Patients on peritoneal dialysis do not require dose adjustment. Patients on hemodialysis may require dose adjustment of the drug.
Important! If a dose is missed, you should take the tablet as soon as possible without waiting for the next dose. Next, observe equal intervals of time between doses - 12 hours each. Never take a double dose to make up for a missed dose of medication!
Overdose
Symptoms:
nausea, vomiting, abdominal pain, diarrhea, water and electrolyte imbalance; possible agitation, insomnia; There are isolated cases of the development of seizures and crystalluria in patients with initially impaired renal function. There are no reports of death or life-threatening adverse events following an overdose of the drug.
Treatment:
symptomatic; Gastric lavage and absorbent intake are effective if the drug was taken less than 4 hours ago. Hemodialysis is effective.
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%.
From the central nervous system:
infrequently - dizziness, headache; very rarely - agitation, anxiety, reversible hyperactivity, insomnia, behavior changes, convulsions.
From the gastrointestinal tract:
often - loss of appetite, nausea, vomiting, diarrhea; uncommon - dyspepsia, moderate asymptomatic increase in the activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and/or increase in bilirubin concentration; rarely - pseudomembranous colitis, discoloration of teeth (reversible, removed with hygienic means); very rarely - “black hairy tongue”, hepatitis, cholestatic jaundice, liver failure (more often in the elderly, in men, with long-term therapy), stomatitis, glossitis.
From the hematopoietic organs:
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, itching; rarely - erythema multiforme; frequency not known - angioedema, anaphylaxis, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), bullous exfoliative dermatitis, acute generalized exanthematous pustules, a syndrome similar to serum sickness.
Other:
often - candidiasis of the skin and mucous membranes; very rarely - development of superinfection.
special instructions
With a long course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.
In patients with severe renal impairment, adequate dose adjustment or increased intervals between doses of the drug are required.
In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal.
In order to prevent the development of crystalluria, the drug should be taken with a relatively large amount of water (0.5 - 1 glass).
Unchanged amoxicillin is excreted in the urine. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Felling's solution. It is recommended to use enzymatic reactions with glucose oxidase.
It is possible to develop bacterial or fungal superinfection (Pseudomonas spp., Candida albicans) due to the growth of microflora insensitive to the drug, which requires a corresponding change in antibacterial therapy.
During drug therapy, pseudomembranous colitis may develop as a result of exposure to C. Difficile toxin. If severe diarrhea develops, or if the diarrhea lasts for 2-3 days, you should consult a doctor as soon as possible. If mild diarrhea develops against the background of Panclava 2X, antidiarrheal drugs that inhibit intestinal motility should be avoided; You can use kaolin or attapulgite-containing antidiarrheals.
Since Panclave 2X contains potassium, caution is recommended when prescribing it to patients with baseline hyperkalemia.
It is recommended to exercise caution when prescribing Panclava 2X to patients with liver failure and ensure regular laboratory monitoring of liver function.
If icteric discoloration of the skin, whites of the eyes, darkening of the color of urine and/or lightening of stool appears, you should immediately consult a doctor.
In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. It is not recommended to use Panclave 2X for infectious mononucleosis or if it is suspected, since the drug can cause an erythematous skin rash, which aggravates the symptoms of the disease / complicates diagnosis.
Newborns born to mothers receiving prophylactic therapy with amoxicillin/clavulanic acid for premature rupture of membranes (membrane sac) during preterm pregnancy have an increased risk of developing necrotizing enterocolitis.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, it is recommended to be careful when driving vehicles and engaging in other potentially hazardous activities, since dizziness may develop.
Storage conditions
Store at a temperature not exceeding 30°C in the original packaging. Keep out of the reach of children.
Best before date
Shelf life: 2 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions during breastfeeding - Contraindicated. Can be used during pregnancy when the benefit of its use for the mother significantly outweighs the risk to the fetus. If it is necessary to use the drug during lactation, breastfeeding is suspended.
Use for renal impairment
Restrictions for impaired renal function - With caution.
Contraindicated in case of impaired renal function (creatinine clearance less than 30 ml/min); use with caution in chronic renal failure (creatinine clearance more than 30 ml/min),
Use for liver dysfunction
Restrictions for liver dysfunction - With caution.
Contraindicated in case of liver dysfunction. Use the drug with caution in case of liver failure.
Use in elderly patients
Restrictions for elderly patients - With caution. Due to the possible age-related (over 65 years) decrease in renal excretory function, use with caution is recommended.
Use in children
Restrictions for children - Contraindicated.
Contraindicated for children under 12 years of age and children weighing less than 40 kg.
Terms of sale
On prescription.
Contacts for inquiries
STADA (Russia)
603950 Nizhny Novgorod st. Salganskaya, 7 Tel. Fax E-mail
Use of the drug Panklav
Adults and children over 12 years of age (or weighing more than 40 kg) are prescribed 1 tablet of Panclava 500 mg/125 mg 2–3 times a day, depending on the severity of the infectious disease, or 1 tablet of Panclava 875 mg/125 mg 2 once a day (every 12 hours). The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg body weight for children. The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg body weight for children. The tablets should be taken with meals, without chewing, with a small amount of water. The course of treatment is 5–14 days. Treatment should not be continued for more than 14 days without repeated medical examination. Dosing for renal failure The dose of the drug depends on creatinine clearance. If creatinine clearance is 10–30 ml/min, prescribe 1 tablet of Panclava 500 mg/125 mg every 12 hours; if creatinine clearance is less than 10 ml/min, prescribe 1 tablet of Panclava 500 mg/125 mg every 24 hours. For anuria, the interval between dosing should be increased to 48 hours or more.
Panklav 2x
Inside, with water; at the beginning of a meal (in order to reduce the risk of side effects from the gastrointestinal tract), 2 times a day, strictly observing the interval between doses of 12 hours.
Dosage with a measuring spoon, taking into account that 5 ml of the finished suspension contains amoxicillin 400 mg / clavulanic acid 57 mg. Take 0.5-1 glass of water. The dose of Panclava 2X is prescribed by a doctor, taking into account the characteristics of the pathogen, the location and severity of the infection. The dosage regimen is set individually, depending on age, body weight (for children) and kidney function. The course of treatment is 5 - 14 days; installed individually.
For infections that require a long course of therapy (for example, osteomyelitis), exceeding the maximum recommended course of therapy of 14 days is possible only after a thorough assessment by the doctor of the patient’s condition, the 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 clavulaate) is 600 mg, for children - 10 mg/kg/day.
Adults and children over 12 years old (body weight > 40 kg)
Standard dosage regimen for all indications: 2 scoops (800 mg/114 mg) 2 times a day, every 12 hours.
Children from 2 to 12 years old (body weight > 40 kg)
Daily dose (for amoxicillin) | Child's weight | Age appropriate | 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 | 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 | 10 ml 2 times a day |
Children from 3 months to 3 years
baby's weight | Daily dose 25 mg/kg (for amoxicillin) | Daily dose 45 mg/kg (for amoxicillin) |
5 kg | 0.8 ml 2 times a day | 1.4 ml 2 times a day |
6 kg | 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 | 1.3 ml 2 times a day | 2.3 ml 2 times a day |
9 kg | 1.4 ml 2 times a day | 2.5 ml 2 times a day |
10 kg | 1.6 ml 2 times a day | 2.8 ml 2 times a day |
11 kg | 1.7 ml 2 times a day | 3.1 ml 2 times a day |
12 kg | 1.9 ml 2 times a day | 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 (based on amoxicillin), divided into two doses every 12 hours. Low doses of the drug (25 mg/kg/day) are used to treat skin and soft tissue infections, as well as recurrent tonsillitis. High doses of the drug (45 mg/kg/day) are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections. The duration of treatment for acute uncomplicated otitis media is 5-7 days, in children under 2 years old - 7-10 days.
Children and adults with kidney failure
If creatinine clearance is less than 30 ml/min, the drug at this dose is not recommended; when creatinine clearance is more than 30 ml/min, there is insufficient substantiated data to develop special recommendations on the dosage regimen. It is possible to reduce the dose of the drug or increase the interval between doses.
Preparation of suspension for oral administration
Water is gradually added to the bottle with the powder up to the mark (distilled water or boiled and cooled) and shaken until the powder is evenly wet (about 30 seconds). If the level of the prepared suspension is below the mark on the bottle label, add water again to the mark and shake.
The prepared suspension must be shaken before each dose.
The prepared suspension should be stored in the refrigerator (at a temperature of 2-8°C) for no more than 7 days.
Important! If a dose is missed, you should take the suspension as soon as possible without waiting for the next dose. Next, maintain equal intervals between doses - 12 hours. Never take a double dose to make up for a missed dose!
Side effects of the drug Panklav
The drug is usually well tolerated. Side effects are rare and transient. From the gastrointestinal tract: diarrhea, nausea, vomiting, colitis (especially in children), candidiasis of the mucous membranes. Hypersensitivity reactions: skin rash, itching, urticaria, rarely - angioedema, anaphylactic reactions, interstitial nephritis. From the kidneys: rarely - crystalluria. From the liver: moderate increase in liver enzymes, rarely - hepatitis, cholestatic jaundice. From the blood system: very rarely - reversible leukopenia, thrombocytopenia, hemolytic anemia, reversible increase in prothrombin time. From the central nervous system: dizziness, headache, convulsions, fear, insomnia.
Special instructions for the use of the drug Panklav
Panclave is prescribed with extreme caution to patients with a history of allergies, including to cephalosporins (due to the possibility of a cross-reaction). The drug is used with extreme caution in patients with renal or hepatic insufficiency, and regular laboratory monitoring is recommended. Panclave 875 mg/125 mg is not prescribed to patients with creatinine clearance ≤30 ml/min. In patients with infectious mononucleosis or lymphocytic leukemia, it is not recommended to use the drug due to the possible appearance of a skin rash. During treatment, there is a possibility of developing superinfection with bacteria or fungi (for example Pseudomonas spp., Candida albicans ). In this case, you must stop using the drug. Due to the possibility of crystalluria, it is recommended to drink large amounts of fluid while taking the drug. If the amount of urine decreases, you should consult a doctor. The drug contains potassium, so it is recommended to prescribe it with caution to patients on a diet with a reduced potassium content (for example, with hyperkalemia). In order to reduce the risk of developing dyspeptic side effects, the drug should be taken with meals. During pregnancy and breastfeeding. Use in case of emergency. Since Panclave is excreted in breast milk and can cause allergic reactions in an infant, the drug is recommended to be used with caution during breastfeeding. Effect on laboratory tests. When determining glucosuria by chemical methods, due to the high concentration of the drug in the urine, a false positive result can be obtained (therefore, during drug therapy, enzymatic methods should be used to determine the amount of glucose in the urine). A false positive result from the Coombs test may occur. Use of amoxicillin or a combination of amoxicillin and clavulanic acid during pregnancy may reduce the concentration of total conjugated estriol, estriol glucuronoid, conjugated estrone and estradiol in the blood plasma.
Panclav
Before starting treatment with Panklav, it is necessary to obtain a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient. Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins.
If an allergic reaction occurs, treatment with Panclave should be discontinued and appropriate alternative therapy should be initiated. In case of serious anaphylactic reactions, the patient should be given epinephrine immediately. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.
If infectious mononucleosis is suspected, Panklav should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult.
Long-term treatment with Panklav may lead to excessive proliferation of insensitive microorganisms.
Antibiotic-associated colitis has been observed during therapy with almost all antibacterial drugs, including amoxicillin, and the severity can range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea that occurs during or after administration of any of the antibiotics. If antibiotic-associated colitis develops, the use of the drug Panklav should be immediately discontinued, consult a doctor and begin appropriate treatment. In this situation, drugs that inhibit intestinal motility are contraindicated.
In general, the combination of amoxicillin with clavulanic acid is well tolerated and has the low toxicity characteristic of all penicillins. During long-term drug therapy, it is recommended to periodically evaluate renal, liver and hematopoietic function.
Hepatic side effects were observed predominantly in men and elderly patients and may be associated with prolonged treatment. In children, these phenomena were observed very rarely. In all groups of patients, signs and symptoms usually appear during or shortly after the end of treatment, but in some cases they may appear several weeks after the end of treatment. They are usually reversible. Liver side effects can be severe, and deaths have been reported very rarely. In almost all cases, they were observed in patients with a severe underlying disease or during the simultaneous use of other drugs that can affect the liver.
In patients receiving a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in INR) has been reported in rare cases. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, monitoring of relevant indicators is necessary. Dosage adjustments may be required to maintain the desired effect of oral anticoagulants.
In patients with impaired renal function, the dose of the drug should be reduced according to the degree of impairment (see section “Dosage and Administration” - Patients with impaired renal function).
In patients with reduced diuresis, crystalluria very rarely occurs, mainly during parenteral therapy. During administration of large doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation (see section "Overdose").
Taking a combination of amoxicillin and clavulanic acid orally leads to a high level of amoxicillin in the urine, which can lead to false-positive results when determining glucose in the urine (for example, Venedikt's test, Fehling's test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine.
Clavulanic acid may cause nonspecific binding of immunoglobulin G and albumin to red blood cell membranes, leading to false-positive Coombs test results.
Drug abuse and dependence
There was no drug dependence, addiction, or euphoric reactions associated with the use of a combination of amoxicillin and clavulanic acid.
Interactions of the drug Panklav
The simultaneous use of Panclave with magnesium hydroxide or aluminum hydroxide causes a decrease in the resorption of amoxicillin; with cimetidine - increases the concentration and increases the half-life of amoxicillin and clavulanic acid. Probenecid slows down the elimination of amoxicillin from the body and increases its concentration in the blood without affecting the level of clavulanic acid. In patients taking anticoagulants, the use of the drug may cause prolongation of the bleeding period and prothrombin time. Concomitant use with allopurinol increases the incidence of skin rash; with oral contraceptives - reduces the effectiveness of the latter. In combination with aminoglycosides, amoxicillin exhibits a synergistic antibacterial effect against a larger number of bacteria, including enterococci and group B streptococci. Simultaneous use with bacteriostatic antibiotics (for example, chloramphenicol, macrolides, tetracyclines) can reduce the bactericidal effect of amoxicillin. Rifampicin reduces the effectiveness of the drug.
Overdose of the drug Panklav, symptoms and treatment
Unlikely. Taking the drug in a high dose can cause gastrointestinal complications (abdominal pain, nausea, vomiting, diarrhea). Rarely, skin rash, hyperactivity or drowsiness, and convulsions appear. When prescribed in high doses, amoxicillin can concentrate in the urine, which is why crystalluria is likely to occur. To prevent this, you should drink a large amount of fluid, which will ensure the necessary removal of the drug. Treatment: drug withdrawal and symptomatic therapy. Particular attention should be paid to maintaining water and electrolyte balance. If no more than 4 hours have passed since the poisoning and there are no complications, you can induce vomiting, rinse the stomach and use activated charcoal. Amoxicillin and clavulanic acid are removed from the bloodstream during hemodialysis.
PANCLAV (tablets)
current and, on the advice of the pharmacist, bought the antibiotic Panklav 2x.
Believe it or not, after a couple of hours from taking the first pill, I already felt that it became a little easier to swallow. Let's move on to the description:
1 package
The top packaging is a cardboard box. It contains information about the name of the drug, their form, quantity, main components, storage conditions, manufacturer, expiration dates.
The inner packaging is a dark glass jar with a white lid. Information about the name, composition, expiration date, etc. is duplicated on the can.
The lid opens easily, but then latches quite tightly
2. The tablets themselves
They are white, biconvex, covered with a shell. And one more thing - they are huge... Swallowing pills has been a problem for me since childhood. I can't swallow them. Just chew it. But this tablet is too gigantic for me. I had to remember my distant childhood, my grandmother’s method - crumble the tablet in a spoon. This is how I drank them. Therefore, I can safely say that inside, like all the antibiotics I have tried, they taste disgusting. The form of my tablets is 875 mg + 125 mg. This is the largest form. There are smaller dosages. But you need to drink them more often.
4. Instructions As with most medications, this drug comes with footcloth instructions.
4. Method of application
I took 1 tablet 2 times a day. With an interval between doses of 12 hours. Advice: choose the optimal time for the first appointment. I was in such a hurry to relieve my pain that I took the first pill at 16-00. Accordingly, the next tablet is at 04-00 in the morning. As I wrote above, there is a smaller dosage of tablets, but with an increased frequency of doses. The course of admission is from 5 days.
5. Indications for use These are infections of the upper and lower respiratory tract, urinary and biliary tract, infections in dentistry, infections of the pelvic organs, bones and joints. The spectrum is quite wide.
6. Contraindications There are clear ones, there are also those in which taking the pills should be done with caution.
7. Side effects Possible from all sides (CNS, gastrointestinal tract, etc.). But where are they not? I did not accompany the antibiotic intake with drugs for intestinal microflora. Fortunately, I didn’t have any problems in this regard. But I recommend taking drugs like Linex together with an antibiotic.
8. Manufacturer: Hemofarm, Serbia. International pharmaceutical company. On the market for over 50 years.
9. Price I can say the price is reasonable. I bought it at a regular pharmacy near my house for 369 rubles.
As a result, I can recommend this antibiotic to you. Especially with a sore throat. There is definitely an effect, and a quick one at that. Combine, of course, with rinsing and other medications. Better yet, don't get sick! Health to you!!!