Amoxicillin Dispertab, 125 mg 20 pcs

Pharmacotherapeutic group: Antibiotic, semisynthetic penicillin

Pharmacological action

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;
typhus and paratyphoid;
dental abscess with inflammation of the subcutaneous tissue;
infections of prosthetic joints;
Lyme disease;
prevention of bacterial endocarditis during 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, official clinical guidelines for antibiotic therapy should be taken into account.

Pharmacological effect

Pharmacotherapeutic group: Antibiotic, semi-synthetic penicillin

Pharmacological action

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 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 hypersensitivity to penicillins and in people with atopy. If an allergic reaction occurs, discontinue treatment with amoxicillin and institute appropriate alternative treatment.

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, before prescribing amoxicillin, it is necessary to first establish the pathogen and its sensitivity to the drug, or make sure that the pathogen is likely to be treatable with amoxicillin. This particularly applies to patients with urinary tract infections and severe ear, nose and throat infections.

Convulsions

Convulsions may occur in patients with renal failure, in patients receiving high doses of the drug, as well as in patients with predisposing factors – a history of seizures, treatment for 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 and Administration”).

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 section “Side effects”). In this case, amoxicillin should be discontinued, and its subsequent use will be contraindicated in any situation.

The use of amoxicillin should be avoided in patients who are suspected of having infectious mononucleosis, since a measles-like rash (exanthema) may occur due to the use of amoxicillin for this disease.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been observed following the use of amoxicillin in patients with Lyme disease. This reaction is associated with the bactericidal effect of amoxicillin on the causative agent of Lyme disease, the spirochete Borrelia burgdorferi. Patients should be advised that this reaction is a common side effect of antibiotic treatment for Lyme disease and usually goes away on its own.

Excessive growth of non-susceptible microorganisms

Long-term use of the drug can sometimes lead to excessive growth of microorganisms that are not sensitive to amoxicillin (superinfection).

When using almost all antibacterial drugs, the development of colitis associated with taking antibiotics is possible. 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 antibiotic use. If diarrhea develops, the patient should immediately stop taking amoxicillin, consult a doctor and begin appropriate treatment. Medicines that inhibit peristalsis are contraindicated in this situation.

Long-term treatment

During long-term therapy, it is necessary to periodically monitor the function of the hematopoietic organs, kidneys and liver. Increased activity of liver enzymes and changes in the number of blood cells were reported.

Anticoagulants

Rare cases of increased prothrombin time have been reported in patients receiving amoxicillin. When prescribing the drug simultaneously with anticoagulants, appropriate monitoring should be carried out, and the dose of oral anticoagulants may need to be adjusted to maintain the required level of blood clotting (see sections “Interaction with other drugs” and “Side effects”).

Crystalluria

In patients with reduced diuresis, crystalluria was very rarely observed, 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 developing crystalluria associated with amoxicillin use. In patients with a catheterized bladder, catheter patency should be checked regularly.

Impact on diagnostic tests

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

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

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

Impact on the ability to drive vehicles and machinery

Studies of the effect of amoxicillin on the ability to drive vehicles or operate other machinery have not been conducted. However, side effects may occur (for example, allergic reactions, dizziness, convulsions) that affect the ability to drive vehicles or use other machinery.

Active ingredient

Amoxicillin

Composition

Composition per tablet:

Active ingredient:

Amoxicillin trihydrate – 143,500 mg (in terms of amoxicillin) – 125,000 mg

Excipients, mg:

Hyprolose – 14,750 mg,

Crospovidone XL-10 – 8,400 mg,

Sodium stearyl fumarate – 2.625 mg,

Lemon flavoring – 1.313 mg,

Tangerine flavor – 1,050 mg,

Microcrystalline cellulose + sodium carmellose mixture (microcrystalline cellulose – 89%; sodium carmellose – 11%) – 0.875 mg,

Sucralose – 0.350 mg,

Vanilla flavor – 0.088 mg,

Microcrystalline cellulose 102 to obtain a tablet weighing: 200 mg.

Pregnancy

Pregnancy

Animal studies have shown no direct or indirect harmful effects in terms of reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans does not indicate an increased risk of congenital malformations. Amoxicillin may be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Amoxicillin is excreted into breast milk in small quantities; if necessary, the drug can be used during breastfeeding. A breastfed baby 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 assessed the benefit/risk ratio.

Contraindications

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

History of severe immediate hypersensitivity reactions (eg, anaphylaxis) to another beta-lactam antibiotic (eg, cephalosporin, carbapenem, or monobactam).

With caution:

Allergic reactions (including bronchial asthma, polyposis, 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

Allergic reactions: urticaria, erythema, Quincke’s edema, rhinitis, conjunctivitis; rarely – fever, joint pain, eosinophilia; in isolated cases – anaphylactic shock.

Effects associated with chemotherapy: superinfections may develop (especially in patients with chronic diseases or reduced body resistance).

With long-term use in high doses: dizziness, ataxia, confusion, depression, peripheral neuropathies, convulsions.

Mainly when used in combination with metronidazole: nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely – hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, hematopoietic disorders.

Mainly when used in combination with clavulanic acid: cholestatic jaundice, hepatitis; rarely – erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis.

Interaction

Probenecid

The simultaneous use of amoxicillin and probenecid is not recommended. Probenecid reduces the secretion of amoxicillin in the renal tubules. Concomitant use of probenecid may lead to increased concentrations of amoxicillin in the blood.

Allopurinol

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

Tetracyclines

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

Oral anticoagulants

Oral anticoagulants and penicillin-based antibiotics are often used together in practice, with no reports of interaction. However, the literature describes cases of increased international normalized ratio in patients receiving treatment with acenocoumarol or warfarin during a prescribed course of amoxicillin. If simultaneous administration of drugs is necessary, it is necessary to carefully monitor the prothrombin time or international normalized ratio at the beginning of treatment and after discontinuation of treatment with amoxicillin. In addition, dosage adjustments of oral anticoagulants may be necessary.

Methotrexate

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

Overdose

Symptoms: dysfunction of the gastrointestinal tract – nausea, vomiting, diarrhea; Vomiting and diarrhea may result in water and electrolyte imbalance.
Amoxicillin-associated crystalluria has been observed, which in some cases can lead to renal failure. Convulsions 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); measures are taken to restore water and electrolyte balance, hemodialysis.

Storage conditions

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

Shelf life

2 years. Do not use after expiration date.

Manufacturer

ABVA RUS, Russia