Panklav 2X, 875 mg+125 mg 14 pcs

Periodontitis, Urinary tract infections, Osteomyelitis, Otitis media, Guillotine, cholecystitis, Angina, Lung inflammation (pneumonia), Skin infections, Pharyngitis, Tonsillitis, Bronchitis

To reduce the development of drug-resistant bacteria and to maintain the effectiveness of the combination of amoxicillin + clavulanic acid and other antibacterial drugs, the combination should be used only to treat infections for which sensitive bacteria are proven or reasonably suspected to cause them. When culture and sensitivity information is available, it should be considered when selecting or modifying antibiotic therapy. In the absence of such data, the local epidemiologic situation and sensitivity patterns may contribute to the empirical choice of therapy.

The combination amoxicillin + clavulanic acid is indicated for the treatment of infections caused by susceptible strains of the indicated bacteria for the conditions listed below (according to rxlist.com, 2020).

Lower respiratory tract infections caused by beta-lactamase-producing strains of Haemophilus influenzae and Moraxella catarrhalis.

Acute bacterial otitis media caused by strains of H. influenzae and M. catarrhalis producing beta-lactamase.

Sinusitis caused by strains of H. influenzae and M. catarrhalis producing beta-lactamase.

Infections of the skin and its appendages caused by strains of Staphylococcus aureus, Escherichia coli and Klebsiella species producing beta-lactamase.

Infections of the genitourinary tract caused by strains of E. coli, Klebsiella species and Enterobacter species producing beta-lactamase.

Limitations of use

When sensitivity test results show sensitivity to amoxicillin, indicating no beta-lactamase production, the combination amoxicillin + clavulanic acid should not be used.

Active ingredient

Composition

Active ingredients:

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 – 510.35 mg,

Sodium carboxymethyl starch (type A) – 32.8 mg,

Magnesium stearate – 32 mg,

Silicon dioxide colloidal anhydrous – 24 mg,

Butylhydroxyanisole – 0.85 mg.

Film jacket:

Hypromellose – 34.84 mg,

Titanium dioxide (E171) – 17.42 mg,

Propylene glycol – 8.17 mg,

Talc – 3.57 mg.

How to take, the dosage

Ingestion. Adults – 500 mg every 12 hours or 250 mg every 8 hours. In more severe infections and respiratory tract infections – 875 mg every 12 hours or 500 mg every 8 hours. The dose for children depends on age, body weight and severity of infection.

Patients with renal insufficiency. Patients with impaired renal function usually do not require dose reduction unless the impairment is severe. Patients with renal impairment with a GFR < 30 ml/min should not receive a dose of 875 mg. Patients with a GFR of 10 to 30 mL/min should receive 500 or 250 mg every 12 h, depending on the severity of the infection. Patients with a GFR less than 10 mL/min should receive 500 or 250 mg every 24 hours, depending on the severity of the infection.

Patients on hemodialysis should receive 500 or 250 mg every 24 hours depending on the severity of the infection. They should receive an additional dose both during and at the end of dialysis.

Interaction

Probenecid

Probenecid decreases secretion of amoxicillin by the renal tubules, but does not delay excretion of clavulanic acid through the kidneys. Concomitant use with a combination of amoxicillin + clavulanic acid may lead to higher concentrations and prolonged presence of amoxicillin in the blood. Concomitant use of probenecid is not recommended.

Peroral anticoagulants

Anomalous prolongation of PV (increased INR) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be performed when concomitant administration of anticoagulants with the combination of amoxicillin + clavulanic acid. Adjustment of the dose of oral anticoagulants may be required to maintain the desired level of anticoagulation.

Allopurinol

The simultaneous administration of allopurinol and amoxicillin increases the incidence of rash in patients receiving both drugs compared to patients receiving amoxicillin alone. It is unknown whether this increase in rash is due to allopurinol amoxicillin administration or to hyperuricemia present in these patients.

Peroral contraceptives

The combination of amoxicillin + clavulanic acid may affect the intestinal flora, leading to decreased estrogen reabsorption and decreased efficacy of combined estrogen/progesterone oral contraceptives.

The effect on laboratory tests

High concentrations of amoxicillin in the urine may lead to false positive results when testing for glucose in the urine using the CLINITEST® test, Benedict’s solution, or Fehling’s solution. Because this effect may also occur with the amoxicillin + clavulanic acid combination, the use of glucose tests based on enzymatic glucose oxidase reactions is recommended.

When using amoxicillin in pregnant women, a temporary decrease in plasma concentrations of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol was noted.

Special Instructions

Hypersensitivity reactions

Serious and sometimes fatal hypersensitivity reactions (anaphylactic) have been reported in patients receiving beta-lactam antibacterial drugs, including the combination amoxicillin + clavulanic acid. These reactions occur more frequently in people with a history of hypersensitivity to penicillin and/or sensitivity to multiple allergens. Before starting therapy with amoxicillin + clavulanic acid combination, information about previous hypersensitivity reactions to penicillins, cephalosporins or other allergens should be carefully studied. In case of an allergic reaction, the use of amoxicillin + clavulanic acid combination should be discontinued and an appropriate therapy should be prescribed.

Hepatic dysfunction

Hepatic dysfunction, including hepatitis and cholestatic jaundice, has been associated with the use of amoxicillin + clavulanic acid combination. Hepatic toxicity is usually reversible; however, fatal cases have been reported. Liver function should be monitored regularly in patients with hepatic impairment.

Diarrhea associated with Clostridium difficile

Diarrhea associated with Clostridium difficile has been reported with virtually all antibacterials, including the combination amoxicillin + clavulanic acid; it can range in severity from mild diarrhea to fatal colitis. Treatment with antibacterials leads to a modification of the normal flora of the large intestine and an overgrowth of C. difficile.

The C. difficile strains produce toxins A and B, which cause the development of diarrhea. C. difficile strains producing hypertoxin lead to an increased risk of morbidity and mortality because these infections may be resistant to antimicrobial therapy and require colectomy. The possibility of C. difficile-associated diarrhea should be considered in all patients who present with complaints of diarrhea after antimicrobial use. A thorough history should be taken, as C. difficile-associated diarrhea may develop within two months after antimicrobial use.

Contraindications

Serious hypersensitivity reactions. The combination amoxicillin + clavulanic acid is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

Cholestatic jaundice/hepatic dysfunction. The combination amoxicillin + clavulanic acid is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with the combination.

Side effects

The following side effects are described in more detail in the Precautions section.

Anaphylactic reactions (see “Precautions”);

Hepatic dysfunction (see “Precautions”);

Clostridium-difficile-associated diarrhea (see “Precautions”).

Clinical trial experience

Because clinical trials are conducted with a different set of conditions, the incidence of adverse reactions observed in these clinical trials may not match that obtained in other clinical trials and observed in clinical practice.

The most common adverse reactions were diarrhea/liquid stool (9%), nausea (3%), skin rash and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-associated adverse reactions. The overall incidence of adverse reactions, particularly diarrhea, increased with the higher recommended dose. Other less common adverse reactions (< 1%) included abdominal discomfort, flatulence, and headache.

In pediatric patients (ages 2 months to 12 years), 1 U.S./Canada clinical trial was conducted comparing the combination of amoxicillin + clavulanic acid at a dose of 45/6.4 mg/kg/day (divided for administration every 12 hours) for 10 days and at a dose of 40/10 mg/kg/day (divided every 8 hours) for 10 days in the treatment of acute otitis media. A total of 575 patients were included and only the suspension was used in this study. Overall, the adverse reactions observed were comparable to those noted above; however, there were differences in the frequency of diarrhea, skin rash/rash, and diaper rash (see Clinical Studies).

Postmarketing experience

In addition to adverse reactions reported in clinical trials, the following have been identified during postmarketing use of the amoxicillin + clavulanic acid combination. Because reports of these cases are voluntary, from a population of uncertain size, it is not always possible to estimate their frequency reliably. These cases were chosen for inclusion because of a combination of their severity, frequency of reporting, or possible causal relationship to taking the combination of amoxicillin + clavulanic acid.

Gastrointestinal disorders

Dyspepsia, gastritis, stomatitis, glossitis, black “hairy” tongue, cuticular candidiasis, enterocolitis and hemorrhagic/pseudomembranous colitis. Symptoms of pseudomembranous colitis may appear during or after antibiotic treatment (see Precautions).

Hypersensitivity reactions

. Pruritus, angioneurotic edema, serum-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and often fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitive vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) (see Precautions). “Precautions).

The liver

Hepatic dysfunction, including hepatitis and cholestatic jaundice, elevation of serum transaminases (AST and/or ALT), serum bilirubin and/or ALP have been reported when taking the combination amoxicillin + clavulanic acid. These adverse reactions have been reported more frequently in the elderly, in men, or in patients on long-term treatment. Histological findings on liver biopsy were consistent with predominantly cholestatic, hepatocellular or mixed cholestatic hepatocellular changes. Signs/symptoms of hepatic dysfunction may occur during or several weeks after discontinuation of therapy. The impairment of liver function, which can be severe, is usually reversible. Deaths have been reported (see Contraindications, Precautions).

Renal

Interstitial nephritis, hematuria, and crystalluria have been reported (see “Overdose”).

Blood and lymphatic system

Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible after discontinuation of therapy and are believed to be manifestations of hypersensitivity. Thrombocytosis has been reported in less than 1% of patients using the combination amoxicillin + clavulanic acid. An increase in PV has been reported in patients receiving simultaneously amoxicillin + clavulanic acid combination and anticoagulant therapy (see “Interactions”).

CNS

Axiety, anxiety, behavioral changes, confusion, seizures, dizziness, insomnia, and reversible hyperactivity have been reported.

Miscellaneous

Tooth discoloration (brown, yellow, or gray) was reported. Most reports were of pediatric patients. In most cases, the discoloration was reduced or eliminated with toothbrushing or brushing.

Overdose

In the event of an overdose, the drug should be discontinued, symptomatic treatment should be administered, and supportive measures should be taken if necessary. A prospective study of 51 pediatric patients in a toxicology center showed that an overdose of amoxicillin less than 250 mg/kg was not associated with significant clinical symptoms4.

Cases of interstitial nephritis leading to oliguric renal failure have been reported in patients after an overdose of the combination of amoxicillin + clavulanic acid.

Crystalluria, in some cases leading to renal failure, has also been observed after overdose of amoxicillin + clavulanic acid combination in adults and children. In case of overdose, adequate fluid intake and diuresis should be maintained to reduce the risk of crystalluria. Renal failure appears to be reversible after discontinuation of the drug. High blood levels may occur more frequently in patients with impaired renal function due to decreased renal clearance of the combination amoxicillin + clavulanic acid. The combination amoxicillin + clavulanic acid can be removed from the blood stream by hemodialysis.

Pregnancy use

Pregnancy

The FDA fetal category is B.

Teratogenic effects. Reproduction studies performed on pregnant rats and mice treated with the combination amoxicillin + clavulanic acid (2:1 amoxicillin:clavulanate composition) in oral doses up to 1200 mg/kg/day showed no evidence of fetal harm due to the combination. Doses of amoxicillin for rats and mice (based on body surface area) were approximately 4 and 2 times the MRDH for adults when given orally (875 mg every 12 hours).

For clavulanate, these multiple doses were about 9 and 4 times higher than the adult MRDMH when taken orally (125 mg every 8 h). However, adequate and well-controlled studies in pregnant women have not been performed. Because reproduction studies in animals do not always predict the effect in humans, this combination should be used during pregnancy only if absolutely necessary.

Parturition and delivery

The oral ampicillin class of antibiotics is poorly absorbed during labor. It is not known whether the use of amoxicillin + clavulanic acid combination in women during labor has immediate or delayed adverse effects on the fetus, increased duration of labor, or increased likelihood in the need for obstetric intervention.

Breastfeeding

Amoxicillin has been shown to be excreted into a woman’s breast milk. The use of the combination amoxicillin + clavulanic acid by breastfeeding mothers may lead to sensitization of the infants. Caution should be exercised when using the combination in a nursing woman.

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