Amoxicillin Dispertab Dispersible pills 1000mg, 20pcs

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Active ingredient:	Amoxicillin
Dosage form:	Soluble tablets

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Categories: Antibiotics, Antibiotics, Medication

Description
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Composition

Composition per tablet:

Active ingredient, mg:

Amoxicillin trihydrate – 1,148,000 (in terms of amoxicillin) – 1,000,000,

Excipients, mg:

Giprolose – 98,000,

Crospovidone XL-10-67,200,

Sodium stearyl fumarate-21,000,

Lemon flavor – 10,500,

Tangerine flavor – 8,400,

A mixture of microcrystalline cellulose + sodium carmellose (microcrystalline cellulose-89%; sodium carmellose-11%) – 7.00,

Sucralose – 2,800,

Vanilla flavor-0.700 mg,

microcrystalline cellulose 102 to obtain a tablet weighing: 1400,000.

Pharmacological action

Pharmacotherapeutic group: antibiotic-penicillin semi-synthetic.

ATX code: J01CA04.

Pharmacological properties

Pharmacodynamics :

Mechanism of action

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (known as penicillin-binding proteins – PSBs) that play a role in peptidoglycan biosynthesis. Peptidoglycan is a structural element of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a weakening of the cell wall, which is usually followed by lysis and death of the bacterial cell.

Amoxicillin is broken down by beta-lactamases, which can be produced by some bacteria, making them resistant to amoxicillin. Thus, the spectrum of activity of unprotected amoxicillin does not cover microorganisms that produce these enzymes.

Time exceeding the minimum inhibitory concentration (T > MPC) is considered the main determining factor for the effectiveness of amoxicillin.

Mechanisms of resistance

The main mechanisms of amoxicillin resistance are:

enzymatic inactivation by beta-lactamases;

mutation of PSB, resulting in a decrease in the affinity of the antibiotic to the target.

Impenetrability of the bacterial cell wall or active removal of the antibiotic from the cell (efflux) can cause bacterial resistance or contribute to it in gram-negative bacteria.

The prevalence of resistance can vary by geographic location and over time for certain species. It is advisable to focus on local information about resistance, especially in the treatment of severe infections. If necessary, seek qualified advice if the local prevalence of resistance is such that the effectiveness of the drug in treating specific types of infections is questionable.

MPC boundary values

Borderline values of minimum inhibitory concentrations (MPC) for amoxicillin according to the criteria of the European Committee for the Determination of Sensitivity to Antibiotics (EUCAST), version 5.0:

Micro-organisms	Borderline MPC value (mg / L)
Micro-organisms	Sensitive ≤	Resistant > >
Enterobacteriaceae	81	8
Staphylococcus spp.	note 2	note 2
Enterococcus spp. 3	4	8
Group A, B, C and G streptococci	Note 4	Note 4
Streptococcus pneumoniae	Note 5	Note 5
Viridans group streptococci	0.5	2
Haemophilus influenzae	26	26
Moraxella catarrhalis	note 7	note 7
Neisseria meningitidis	0.125	1
Gram-positive anaerobes other than Clostridium difficile8	4	8
Gram negative anaerobes 8	0.5	2
Helicobacter pylori	0.1259	0.1259
Pasteandrella multocida	1	1
Highly specific borderline values 10	2	8
1 Wild-type Enterobacteriaceae strains are classified as sensitive to aminopenicillins. In some countries, E isolates are used. E. coli and P. Wild-type mirabilis are moderately resistant. In this case, the MPC limit value S ≤ 0.5 mg/l is used. 2 Most staphylococci produce penicillinases and are resistant to amoxicillin. Methicillin-resistant strains of staphylococci, with rare exceptions, are resistant to all beta-lactam antibiotics. 3 Sensitivity to amoxicillin is assessed by ampicillin. 4 The sensitivity of streptococci of groups A, B, C and G to penicillins is evaluated based on their sensitivity to benzylpenicillin. 5 Borderline values refer to isolates isolated for all types of infection, except for meningitis. If the isolate is assessed as moderately resistant to ampicillin, amoxicillin should not be administered orally. Sensitivity is assessed by the MPC of ampicillin. 6 Borderline values are based on intravenous use. Strains that produce beta-lactamases are considered resistant. 7 Microorganisms that produce beta-lactamases are classified as resistant. 8 Sensitivity to amoxicillin is evaluated by sensitivity to benzylpenicillin. 9 The boundary values are set at the level of the epidemiological cut-off point (ECOFF) value, which distinguishes wild-type isolates from isolates with reduced sensitivity. 10 Highly specific borderline values are based on doses of 0.5 g 3 or 4 times a day (1.5 to 2 g / day).

Sensitivity of microorganisms to amoxicillin in vitro

Usually sensitive microorganisms

Gram-positive aerobes:

Enterococcus faecalis

Beta-hemolytic streptococci (groups A, B, C and G)

Listeria monocytogenes

Microorganisms that may have mechanisms of acquired resistance to amoxicillin

Gram-negative aerobes:

Escherichia coli

Haemophilus influenzae

Helicobacter pylori

Proteus mirabilis

Salmonella typhi

Salmonella paratyphi

Shigella spp.

Pasteurella multocida

Gram-positive aerobes:

Coagulase negative staphylococci

Staphylococcus aureus2

Streptococcus pneumoniae

Group Streptococcus viridans

Gram-positive aerobes:

Clostridium spp.

Gram-negative aerobes:

Fusobacterium spp.

Other:

Borrelia burgdorferi

Microorganisms with natural resistance 1

Gram-positive aerobes:

Enterococcus faecium1

Gram-negative aerobes:

Acinetobacter spp.

Enterobacter spp.

Klebsiella spp.

Pseudomonas spp.

Gram-negative anaerobes:

Bacteroides spp. (some strains of Bacteroidesfra gilis are resistant)

Other:

Chlamydia spp.

Musoplazta spp.

Legionella spp.

1 Natural intermediate sensitivity in the absence of acquired resistance mechanisms.

2 Almost all strains of S. aureus are resistant to amoxicillin due to the production of penicillinases. Methicillin-resistant strains of Staphylococcus aureus (MRSA) are also resistant to amoxicillin.

Pharmacokinetics:

Suction:

Amoxicillin completely dissociates in an aqueous solution at physiological pH. Amoxicillin is rapidly and well absorbed after oral use. When taken orally, the bioavailability of amoxicillin is approximately 70%, and the time to reach the maximum concentration in blood plasma (tmax) is 1-2 hours.

Below are the results of pharmacokinetic studies obtained when taking amoxicillin 250 mg 3 times a day in groups of healthy volunteers on an empty stomach:

With_max	T_max*	AUC_(0-24_h)	Half
-life(mcg / ml)	(h)	(mcg × h / ml)	(h)
3,3±1,12	1,5 (1,0-2,0)	26,7±4,56	1,36±0,56
* Median (range)value

In the dose range of 250-3000 mg, bioavailability varies linearly with the dose (measured by cmax and AUC). Simultaneous food intake does not affect the absorption of amoxicillin.

Hemodialysis may be used to remove amoxicillin from circulation.

Distribution:

About 18% of the total amount of amoxicillin in plasma is bound to plasma proteins. The apparent volume of distribution is approximately 0.3-0.4 l / kg. After intravenous use, amoxicillin is found in the gallbladder, abdominal tissues, skin, adipose tissue, muscles, synovial and peritoneal fluids, bile and pus. Amoxicillin does not penetrate well into the cerebrospinal fluid.

Amoxicillin, like most penicillins, can be found in breast milk. Amoxicillin penetrates the placental barrier.

Biotransformation:

Amoxicillin is partially excreted in the urine as inactive penicillic acid in amounts equivalent to 10-25% of the dose taken.

Deduction:

Amoxicillin is mainly excreted through the kidneys.

The elimination half-life is on average 1 hour, and the average total clearance is approximately 25 l / h in healthy individuals. Approximately 60-70% of amoxicillin is excreted unchanged in the urine within the first 6 hours after taking a single dose of 250 mg or 500 mg. In many studies, the urinary elimination period of 50-85% of amoxicillin was 24 hours.

Simultaneous use of probenecid slows down the elimination of amoxicillin.

Special patient groups

Age group

The half-life of amoxicillin is approximately the same in children aged 3 months to 2 years, in older children and in adults. In very young children (including premature newborns), amoxicillin is administered no more than twice a day during the first week of life, taking into account the immaturity of the renal excretion pathway. Since the elderly may experience a decrease in renal function, for this category of patients, it is necessary to select the dose with caution and periodically monitor renal function.

Gender

After oral use of amoxicillin by male and female participants in the study, there was no significant effect of gender on the pharmacokinetics of amoxicillin.

Impaired renal function

The total plasma clearance of amoxicillin decreases in proportion to the deterioration of renal function.

Liver failure

Caution should be exercised in patients with hepatic insufficiency, and periodic monitoring of liver function should also be performed.

Indications

Infections caused by microorganisms sensitive to the drug, including:

acute bacterial sinusitis,
acute otitis media;
acute streptococcal tonsillitis and pharyngitis;
exacerbation of chronic bronchitis;
community-acquired pneumonia;
acute cystitis;
asymptomatic bacteriuria during pregnancy;
acute pyelonephritis;
typhoid and paratyphoid fever;
dental abscess, inflammation of the subcutaneous tissues;
infection of prosthetic joints;
Lyme disease;
prophylaxis of bacterial endocarditis in surgical procedures in the oral cavity and upper respiratory tract.

In combination with other drugs, according to eradication schemes, it is used to treat diseases of the digestive tract associated with Helicobacter pylori.

When choosing an antibiotic, you should take into account the official clinical guidelines for antibacterial therapy.

Use during pregnancy and lactation

Pregnancy Results from animal studies have not revealed any direct or indirect harmful effects in relation to reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of birth defects. Amoxicillin may be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.

Breast-feeding periodamoxicillin is excreted in breast milk in small amounts, if necessary, the drug can be used during breastfeeding. A breastfed child may develop diarrhea, sensitization, and fungal infection of the mucous membranes, so it may be necessary to stop breastfeeding. Amoxicillin should be used during breastfeeding only after the attending physician has evaluated the benefit/risk ratio.

Contraindications

Hypersensitivity to amoxicillin, other penicillins, or any other component of the drug.

A history of severe immediate hypersensitivity reactions (e. g., anaphylaxis) to another beta-lactam antibiotic (e. g., cephalosporin, carbapenem, or monobactam).

With caution:

Allergic reactions (including bronchial asthma, polliposis, hypersensitivity to acetylsalicylic acid) in the anamnesis, diseases of the gastrointestinal tract in the anamnesis (especially colitis associated with the use of antibiotics), renal failure, infectious mononucleosis, lymphocytic leukemia, pregnancy, breastfeeding, prematurity, old age.

Side effects

The most common side effects are diarrhea, nausea, and skin rash.

The frequency of side effects is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (

*Infectious and parasitic diseases*
very rarely	candidiasis of the skin and mucous membranes.
*Blood and lymphatic system disorders*
very rarely	reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia; prolongation of bleeding time and prothrombin time.
*Immune system disorders*
very rarely	severe allergic reactions such as angioedema, anaphylaxis, serum sickness, and allergic vasculitis.
unknown	is the Yarisch-Gerksheimer reaction, an acute coronary syndrome associated with hypersensitivity (Kounis syndrome).
*Nervous system disorders*
very rarely	hyperkinesia, dizziness, convulsions.
unknown	aseptic meningitis.
*Disorders of the gastrointestinal tract*
Clinical data
* frequent	diarrhea and nausea.
* rarely	vomiting.
Post-marketing data
very rarely	antibiotic-related colitis (including pseudomembranous colitis and hemorrhagic colitis), black “hairy” tongue; superficial tooth discoloration. **
*Liver and biliary tract*
disorders very rarely	hepatitis, cholestatic jaundice, moderate increase in the activity of aspartate aminotransferase and/or alanine aminotransferase in blood plasma.
*Skin and subcutaneous tissue disorders*
Data from clinical studies
* often	skin rash.
* rarely	hives, pruritus.
Post-registration data
very rarely	skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis (OGEP), drug rash with eosinophilia and systemic symptoms (DRESS-syndrome).
*Renal and urinary tract*
disorders very rarely	interstitial nephritis, crystalluria.
* the frequency of these adverse reactions was derived from clinical trials involving a total of approximately 6,000 adults and children treated with amoxicillin. * * superficial tooth discoloration has been reported in children. Good oral hygiene helps prevent tooth discoloration, which is eliminated by brushing your teeth.

Interaction

Probenecid

Concomitant use of amoxicillin and probenecid is not recommended. Probenecid reduces the secretion of amoxicillin in the renal tubules. Simultaneous use of probenecid may lead to an increase in the concentration of amoxicillin in the blood.

Allopurinol

Concomitant use of allopurinol during treatment with amoxicillin increases the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic antibiotics may affect the bactericidal effect of amoxicillin.

Oral anticoagulants

Oral anticoagulants and penicillin-based antibiotics are often used together in practice, but there are no reports of interaction. However, the literature describes cases of an increase in the international normalized ratio in patients receiving treatment with acenocoumarol or warfarin against the background of the prescribed course of amoxicillin. If concomitant medication is necessary, prothrombin time or international normalized ratio should be carefully monitored at the start of treatment and after discontinuation of amoxicillin treatment. In addition, it may be necessary to adjust the dose of oral anticoagulants.

Methotrexate

Penicillin-type antibiotics may reduce the excretion of methotrexate, which may be accompanied by increased toxicity.

How to take, course of use and dosage

Amoxicillin Dispertab® is used orally regardless of food intake.

The tablet can be swallowed whole, washed down with a glass of water, or immediately before use, dilute in water (at least 50 ml) and mix thoroughly. The resulting mixture, which has a light fruity taste, should be taken immediately after cooking.

Doses

When choosing the dose of Amoxicillin Dispertab® for the treatment of certain infections, the following factors should be considered::

suspected pathogens and their probable sensitivity to antibacterial drugs;

severity and location of infection;

age, body weight, and kidney function of the patient, as described below.

The duration of treatment depends on the type of infection and the patient’s clinical response and should be as short as possible. Some infections require longer treatment. Adults and children ≥ 40 kg

Indications for use*	Dose*
Acute bacterial sinusitis	250-500 mg every 8 hours or 750 mg-1 g every 12 hours For severe infections,750 mg – 1 g every 8 hours For the treatment of acute cystitis, it is possible to take 3 g twice a day
Asymptomatic bacteriuria during pregnancy
Acute pyelonephritis
Dental abscess with inflammation of the subcutaneous tissue
Acute cystitis
Acute otitis	media 500 mg every 8 hours or 750 mg-1 g every 12 hours For severe infections,750 mg – 1 g every 8 hours for 10 days
Acute streptococcal tonsillitis and pharyngitis
Exacerbation of chronic bronchitis
Community-acquired pneumonia	500 mg-1 g every 8 hours
Typhoid and paratyphoid	500 mg-2 g every 8 hours
Prosthetic joint infections	500 mg-1 g every 8 hours
Prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract	2 g orally, a single dose 30-60 minutes before the surgical procedure in the oral cavity and upper respiratory tract
Eradication of Helicobacter pylori	750 mg-1 g twice daily in combination with a proton pump inhibitor (for example, omeprazole) and another antibiotic (for example, clarithromycin, metronidazole) for 7 days
Lyme Disease	Early stage: 500 mg-1 g every 8 hours, maximum daily dose of 4 g, divided into several doses, for 14 days (from 10 to 21 days) Advanced stage (systemic infection): 500 mg-2 g every 8 hours, maximum daily dose of 6 g, divided into several doses, for 10-30 days
*The official clinical guidelines for each indication should be taken into account.

Children weighing ≥ 40 kg

Children weighing more than 40 kg should take the recommended adult dose.

Children with body weight:

Indications for use*	Dose*
Acute bacterial sinusitis	20-90 mg / kg / day, divided into 2-3 doses**
Acute otitis media
Community-acquired pneumonia
Acute cystitis
Acute pyelonephritis
Dental abscess with inflammation of the subcutaneous tissue
Acute streptococcal tonsillitis and pharyngitis	40-90 mg / kg / day, divided into 2-3 doses * *
Typhoid and paratyphoid	fever 100 mg / kg / day, divided into 3 doses
Prosthetic joint infections	500 mg-1 g every 8 hours
Prevention of bacterial endocarditis during surgical procedures in the oral cavity and upper respiratory tract	50 mg / kg orally, a single dose 30-60 minutes before the surgical procedure in the oral cavity and upper respiratory tract
Lyme Disease	Early stage: 25-50 mg / kg / day, divided into 3 doses, for 10-21 days. Late stage (systemic infection): 100 mg / kg / day, divided into 3 doses, for 10-30 days.
* The official guidelines for each indication should be taken into account. **Only in the case of prescribing amoxicillin in the upper dose range should the possibility of using it twice a day be considered.

Dosage regimen for certain categories of patients

Elderly patients

No dose adjustment is required.

Patients with renal insufficiency

Glomerular filtration rate (ml / min)	Adults and children ≥ 40 kg	Children < 40%^% kg*
More than 30	There is no need for adjustment	There is no need for adjustment
10-30	Maximum 500 mg twice daily	15 mg / kg twice daily (maximum 500 mg twice daily)
Less than 10	Maximum 500 mg / day	15 mg / kg once daily (maximum 500 mg / day)
* In most cases, parenteral treatment is preferred

Patientsreceiving hemodialysis

Amoxicillin can be removed from the blood during hemodialysis.

Hemodialysis

Adults and children ≥ 40 kg

15 mg / kg / day once.

Before hemodialysis, one additional dose of 15 mg/kg should be administered. To restore the level of drug circulation after hemodialysis, an additional dose of 15 mg/kg should be administered.

Patientsreceiving peritoneal dialysis

The maximum dose of amoxicillin is 500 mg / day.

Patients with impaired liver function

Caution should be exercised and liver function monitored regularly.

Overdose

Symptoms: impaired gastrointestinal function – nausea, vomiting, diarrhea; vomiting and diarrhea may result in a violation of the water-electrolyte balance. Amoxicillin-associated crystalluria was observed, which in some cases can lead to renal failure. Seizures may occur in patients with impaired renal function or in patients receiving high doses of the drug.

Treatment: induce vomiting or perform gastric lavage followed by ingestion of activated charcoal and osmotic laxatives (sodium sulfate); apply measures to restore water and electrolyte balance, hemodialysis.

Description

Capsule-shaped biconvex tablets from almost white to light yellow in color with a risk with a specific smell.

Special instructions

Hypersensitivity reactions

Before starting treatment with amoxicillin, you should pay attention to the presence of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics in the anamnesis (see the sections “Contraindications” and “Side effects”).

Severe and sometimes fatal hypersensitivity reactions (including anaphylactic reactions and severe skin reactions) have been reported in patients receiving penicillin therapy. The development of these reactions is more likely in people with a history of penicillin hypersensitivity and in people with atopy. If an allergic reaction occurs, treatment with amoxicillin should be discontinued and an appropriate alternative treatment should be prescribed.

Acute coronary syndrome associated with hypersensitivity (Kounis syndrome)

In rare cases, hypersensitivity reactions (acute coronary syndrome associated with hypersensitivity) have been reported during treatment with amoxicillin. If this reaction occurs, amoxicillin should be discontinued and appropriate treatment should be prescribed.

Insensitive microorganisms

For some types of infections, it is necessary to first identify the pathogen and its sensitivity to the drug before prescribing amoxicillin, or make sure that the pathogen is highly likely to be treated with amoxicillin. In particular, this applies to patients with urinary tract infections and severe infections of the ear, nose and throat.

Convulsions

Seizures can occur in patients with renal insufficiency, in patients receiving high doses of the drug, as well as in patients with predisposing factors – the presence of seizures in the anamnesis, treatment of epilepsy or meningitis, etc. (see section “Side effects”).

Kidney failure

In patients with renal insufficiency, the dose should be adjusted according to the degree of renal insufficiency (see section “Dosage anduse”).

Skin reactions

The occurrence of generalized erythema with fever accompanied by pustules at the initial stage of treatment may be a symptom of OHEP (see fig. section “Side effects”). In this case, the use of amoxicillin should be discontinued, and its subsequent use will be contraindicated in all situations.

The use of amoxicillin should be avoided in patients who are suspected of infectious mononucleosis, since the appearance of a crust-like rash (exanthema) associated with the use of amoxicillin in this disease is possible.

The Yarish-Gerksheimer reaction

The Yarisch-Herxheimer reaction was observed after the use of amoxicillin in patients with Lyme disease. This reaction is associated with the bactericidal action of amoxicillin on Lyme disease pathogens, Borrelia burgdorferi spirochetes. Patients should be told that this reaction is a common side effect of treating Lyme disease with antibiotics, and it usually resolves on its own.

Excessive growth of insensitive microorganisms

Prolonged use of the drug can sometimes lead to excessive growth of amoxicillin-insensitive microorganisms (superinfections).

With the use of almost all antibacterial drugs, colitis associated with taking antibiotics may develop. Its severity can range from mild to severe (life-threatening). Therefore, it is important to consider the possibility of this diagnosis in patients who develop diarrhea during or after the use of antibiotics. If diarrhea develops, the patient should immediately stop taking amoxicillin, consult a doctor and start appropriate treatment. Medications that inhibit peristalsis are contraindicated in this situation.

Long-term treatment

With long-term therapy, it is necessary to periodically monitor the state of function of the hematopoietic organs, kidneys and liver. An increase in the activity of “liver” enzymes and a change in the number of formed blood elements were reported.

Anticoagulants

Rare cases of increased prothrombin time have been reported in patients treated with amoxicillin. When the drug is co-administered with anticoagulants, appropriate monitoring should be carried out, and it may be necessary to adjust the dose of oral anticoagulants to maintain the necessary level of blood clotting (see sections “Interaction with other medicinal products” and “Side effects”).

Crystalluria

Crystalluria was very rarely observed in patients with reduced diuresis, mainly during parenteral therapy. When using high doses of amoxicillin, it is recommended to maintain adequate fluid intake and diuresis to reduce the likelihood of crystalluria associated with the use of amoxicillin. In patients with a catheterized bladder, it is necessary to regularly check the patency of the catheter.

Impact on diagnostic studies

Increased levels of amoxicillin in the blood serum and urine may affect some laboratory tests. Due to the high concentrations of amoxicillin in the urine, chemical methods often give false positive results.

When determining glucose in the urine during treatment with amoxicillin, it is recommended to use enzymatic glucose oxidase tests.

The use of amoxicillin may affect the results of quantitative determination of estradiol in the urine of pregnant women.

Influence on the ability to drive vehicles and mechanisms

Studies of the effect of amoxicillin on the ability to drive motor vehicles or work with other mechanisms have not been conducted. However, there may be side effects (such as allergic reactions, dizziness, seizures) that affect the ability to drive vehicles or other mechanisms.

Form of production

Dispersible tablets 1000 mg.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date.

Active ingredient

Amoxicillin

Conditions of release from pharmacies

By prescription

Dosage form

tablets soluble

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