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Article about Trimox

The description

Round biconvex tablets, coated with a white to almost white shell, with a slight characteristic odor (for tablets containing 125 mg of amoxicillin); oval biconvex tablets, coated with a white to almost white shell, with a risk on both sides, with a characteristic weak odor (for tablets containing 250 mg, 500 mg, 750 mg, 1000 mg of amoxicillin).

Pharmacotherapeutic group

Antibacterial agents for systemic use. Antibacterial agents beta-lactams, penicillins. Broad-spectrum penicillins.

Pharmacological properties

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) with a broad spectrum of activity, which inhibits one or more enzymes involved in the biosynthesis of peptidoglycan in bacteria. Peptidoglycan is an integral part of the structure of a bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a weakening of the cell wall resistance, which generally results in lysis and cell death. Thus, amoxicillin has a bactericidal effect.

Amoxicillin can be destroyed by beta-lactamases - enzymes produced by bacteria resistant to antibiotics. Therefore, the spectrum of action of amoxicillin (when used as monotherapy) does not include microorganisms capable of producing these enzymes.

The main mechanisms that ensure bacterial resistance to amoxicillin are: inactivation by bacterial beta-lactamases;

a change in the structure of penicillin-binding proteins, which reduces the affinity of the antibiotic for the target.

Bacterial impermeability or efflux mechanisms can cause bacterial resistance or contribute to its development, especially in gram-negative bacteria.

The prevalence of resistance can vary by location and over time for some species. It is advisable to focus on local resistance information, 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.

Simultaneous feeding does not affect the absorption of amoxicillin. To remove amoxicillin from the circulation, hemodialysis can be used. In animal studies, there was no significant delay in the derivatives of the drug in body tissues. Amoxicillin, like most penicillins, is found in breast milk (see section "Use during pregnancy and lactation"). Amoxicillin crosses the placental barrier (see section "Use during pregnancy and lactation"). The main route of excretion of amoxicillin is through the kidneys. For each child in the first week of life (including premature infants), the interval between administrations should be at least 12 hours (twice a day) due to the immaturity of the path of excretion kidney. Since the elderly may have reduced kidney function, in this category of patients it is necessary to carefully select a dose and periodically monitor kidney function.

Trimox Online

Directions for use

Trimox can be used in children and adults to treat the following infections:

  • acute bacterial sinusitis;
  • acute otitis media;
  • acute streptococcal tonsillitis and pharyngitis;
  • exacerbation of chronic bronchitis;
  • community-acquired pneumonia;
  • acute cystitis;
  • asymptomatic bacteriuria in pregnant women;
  • acute pyelonephritis;
  • typhoid and paratyphoid fever;
  • paradental abscess with spread of cellulite;
  • prosthetic joint infections;
  • Eradication of Helicobacter pylori;
  • Lyme disease.

In addition, Trimox can be used to prevent endocarditis.

To decide on the prescription of the drug, Trimox should be based on the general principles of antibiotic therapy and on the information provided in the official guidelines for the proper use of antibacterial drugs.

Dosage and administration

Method of application

Trimox is intended for oral administration. Eating does not affect the absorption of amoxicillin. Therefore, the tablet can be taken regardless of the meal.

Treatment can be started with amoxicillin for parenteral (intravenous) administration (at doses recommended for this route of administration) and continued with the use of the drug Trimox in the form of tablets for oral administration.

Doses

When prescribing a certain dose of amoxicillin for the treatment of a specific infection, it is necessary to take into account:

  • the type of putative pathogen and the susceptibility / resistance profile to antibacterial agents characteristic of the given pathogen (see section "Special instructions and precautions");
  • severity and location of the infectious process;
  • age, body weight, kidney function status of the patient.

The duration of treatment should be determined according to the type of infection, the individual reactions of the patient to taking the drug. In general, the duration of the course should be as short as possible. Some infections require prolonged treatment with amoxicillin (see "Special Instructions and Precautions" for relatively prolonged treatment).

To decide on the prescription of the drug, Trimox should be based on the general principles of antibiotic therapy and on the information provided in the official guidelines for the proper use of antibacterial drugs.

Adults and children weighing more than 40 kg.

  1. Acute bacterial sinusitis: 250-500 mg every 8 hours or 750-1000 mg every 12 hours For severe infections - 750-1000 mg every 8 hours In case of acute cystitis, the following treatment regimen can be used: 3 g of amoxicillin 2 times a day, the duration of treatment is -1 day.
  2. Acute otitis media: 500 mg every 8 hours, 750-1000 mg every 12 hours. In severe infections, 750-1000 mg every 8 hours for 10 days.
  3. Community-acquired pneumonia: 500-1000 mg every 8 hours;
  4. Typhoid and paratyphoid fever: 500-2000 mg every 8 hours;
  5. Prosthetic joint infections: 500-1000 mg every 8 hours;
  6. Prevention of endocarditis: A single dose of 2 g should be prescribed 30 to 60 minutes before the procedure.
  7. Eradication of Helicobacter pylori: 750-1000 mg twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibacterial drug (e.g. clarithromycin, metronidazole); the duration of treatment is 7 days.
  8. Lyme disease: early stage: 500-1000 mg every 8 hours; the daily dose can be increased to 4 g (maximum daily dose), it should be divided into several doses; the duration of treatment is 14 days (10-21 days) Late stage (systemic disorders): 500-2000 mg every 8 hours; the daily dose can be increased to 6 g (maximum daily dose), it should be divided into several doses; course of treatment - 10-30 days;
  9. Children with acute bacterial sinusitis: 20 to 90 mg / kg / day; the daily dose should be divided into several doses.

Peritoneal dialysis patients

The maximum daily dose of amoxicillin is 500 mg.

Patients with hepatic impairment

In the presence of the indicated pathology, the dosage regimen should be selected with caution and regular monitoring of the state of hepatic function during treatment should be carried out (see sections "Special instructions and precautions" and "Side effects").

Warning !!! If the patient has forgotten to take the next dose of Trimox, it should be taken as soon as possible. The next scheduled dose should be taken at least 4 hours after taking the missed dose. Do not take a double dose to make up for the missed dose!

Side effect

The most commonly reported side effects are diarrhea, nausea, and rash.

  1. Candidiasis of the skin and mucous membranes;
  2. Reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia, prolonged bleeding time and prothrombin time;
  3. Severe allergic reactions, including angioedema, anaphylaxis, serum sickness and allergic vasculitis;
  4. Jarisch-Herxheimer reaction;
  5. hyperkinesis, dizziness, convulsions;
  6. Diarrhea, nausea;
  7. Vomiting;
  8. colitis associated with antibiotics (including pseudomembranous colitis and hemorrhagic colitis;
  9. Hepatitis, cholestatic jaundice, moderate increase
  10. rash
  11. Hives, itching
  12. They can be associated with fever, headache and pain throughout the body; drug reaction with eosinophilia and systemic symptoms (DRESS syndrome: flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood count, including increased white blood cells (eosinophilia) and liver enzymes).
  13. Interstitial nephritis, crystalluria.

Adverse reaction reporting

If you experience any side effects, it is recommended that you consult your doctor. This recommendation applies to all possible side effects, including those not listed in the package leaflet. You can also report side effects to the Adverse Drug Reaction Information Database, including reports of drug ineffectiveness. By reporting side effects, you can help get more information about the safety of the drug.

Cons-indications

The purpose and use of the drug Trimox is contraindicated in the following situations:

  • increased known individual sensitivity to amoxicillin and / or to any of the auxiliary components of the drug;
  • increased known individual sensitivity to any antibiotic in the penicillin series;
  • a severe immediate hypersensitivity reaction (for example, anaphylaxis) in the history, the occurrence of which is associated with the administration of another beta-lactam drug (for example, cephalosporins, carbapenems or monobactams).

Overdose

In case of overdose of amoxicillin, obvious violations of the gastrointestinal tract (nausea, vomiting, diarrhea), obvious violations of fluid and electrolyte balance can be observed. Crystallization has been reported with amoxicillin, in some cases causing renal failure. In patients with renal impairment or in patients taking large doses of amoxicillin, seizures may occur (see "Special instructions and precautions" and "Side effects").

The treatment

In case of violation of the gastrointestinal tract, symptomatic treatment is indicated. Particular attention must be paid to the normalization of the water-electrolyte balance. Amoxicillin can be removed from the vascular bed by hemodialysis.

Interaction with other drugs and other types of interaction

Probenecid

Concomitant use of probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin in the kidneys. Co-administration of probenecid may increase the concentration of amoxicillin and prolong its plasma half-life.

Allopurinol

The combined use of amoxicillin and allopurinol may increase the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic agents can affect the bactericidal effects of amoxicillin.

Oral anticoagulants

Oral anticoagulants and antibiotics from the penicillin group are widely used in clinical practice, with no evidence of drug interaction. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients undergoing treatment with amoxicillin while taking acenocoumarol or warfarin. If the combined use of oral anticoagulants and amoxicillin is deemed necessary, careful monitoring of the duration of prothrombin or INR should be performed with an increase in the dose of amoxicillin and after discontinuation of treatment with amoxicillin. In addition, an adjustment of the dose of oral anticoagulants may be necessary (see sections "Special instructions and precautions" and "Side effects").

Methotrexate

Penicillins can reduce the excretion of methotrexate, which will increase the likelihood of its toxic properties.

Special instructions and precautions

Hypersensitivity reactions

Before starting treatment with amoxicillin, it is necessary to know if the patient has ever had hypersensitivity reactions, the appearance of which was associated with taking an antibiotic from the group of penicillins, cephalosporins or other beta lactams (see sections “Contraindications” and “Side effects”).

Cases of severe hypersensitivity, sometimes fatal (including serious anaphylactoid and skin side effects), have been reported in patients receiving penicillin therapy. These reactions are more common in people with a history of penicillin and atopy. If an allergic reaction develops, it is necessary to stop taking amoxicillin and to consult a doctor.

Insensitive microorganisms

Amoxicillin should only be used to treat infections if any of the following conditions are met:

  • the pathogen is identified and found to be sensitive to amoxicillin;
  • the suspected pathogen is very likely to be sensitive to amoxicillin (see Pharmacological properties).

This information is particularly important to consider when deciding on the administration of amoxicillin to patients with urinary tract infection or serious infection of the ear, nose and pharynx.

Cramps

Convulsions may occur in patients:

  • with renal failure;
  • take amoxicillin in large doses;
  • with the presence of predisposing factors (for example, the presence of a history of seizures, treated epilepsy or meningeal disorders) (see section “Undesirable effects”).
Impaired kidney function

In patients with renal insufficiency, the dose should be chosen according to the severity of the pathology (see section "Dosage and administration").

Skin reactions

Generalized erythema with fever and pustules, which occurred at the start of treatment with amoxicillin, may be a symptom of generalized acute exanthematic pustulosis (see section "Undesirable effects"). If such a reaction occurs, you should immediately stop taking amoxicillin; the subsequent administration of amoxicillin is in all cases contraindicated. Amoxicillin should be avoided if infectious mononucleosis is suspected. Taking amoxicillin against infectious mononucleosis can cause a rash similar to measles.

Jarisch-Herksheimer reaction

The Jarisch-Herxheimer reaction (fever, chills, headache, muscle pain and rash) has been noted with amoxicillin for the treatment of Lyme disease (see section “Undesirable effects”). Its appearance is a direct consequence of the bactericidal activity of amoxicillin against bacteria, which is the causative agent of Lyme disease (spirochete Borrelia burgdorferi). Patients should be aware that such a reaction is common, usually goes away on its own, and is considered a natural consequence of antibiotic therapy for Lyme disease.

Excessive spread of insensitive microorganisms

Long-term administration of amoxicillin can sometimes lead to excessive reproduction of insensitive microorganisms. When taking almost all antibacterial drugs, cases of colitis associated with antibiotics have been reported. Its severity can vary from mild to potentially fatal (see section "Undesirable effects"). If during or after treatment with an antibiotic, the patient develops diarrhea, this diagnosis should always be assumed. If colitis associated with antibiotics is suspected or if this diagnosis is confirmed, it is necessary to immediately stop taking amoxicillin and start appropriate treatment. In this situation, antiperistaltic drugs are contraindicated.

Long-term treatment

With prolonged treatment with amoxicillin, it is recommended to regularly monitor the function of organ systems, including the kidneys, liver and hematopoiesis. When taking amoxicillin, there have been cases of increased activity of liver enzymes and changes in the cellular composition of the blood (see section "Undesirable effects").

Anti coagulants

In rare cases, prolonged prothrombin time has been reported in patients taking amoxicillin. Appropriate monitoring should be performed if the patient is taking amoxicillin with anticoagulants. Adjusting the dose of an oral anticoagulant may be necessary to keep the level of anticoagulation at the desired level (see "Interaction with other drugs and other types of interaction" and "Side effects").

Crystalluria

In very rare cases, crystalluria has been observed in patients with reduced urine flow (decrease in diuresis), mainly when the antibiotic was administered parenterally. When prescribing amoxicillin in large doses, it is recommended to ensure the introduction of a sufficient quantity of fluid and to maintain urination at a sufficient level in order to reduce the probability of crystalluria associated with taking amoxicillin . In patients with urinary catheters, it is necessary to regularly check the permeability of the urinary tract (see sections "Undesirable effects" and "Overdose").

Impact on laboratory research

High concentrations of amoxicillin in serum and urine may affect the results of some laboratory tests.

Due to high concentrations of amoxicillin in the urine, false positive results are often seen when using chemical diagnostic methods. In the process of treatment with amoxicillin, if necessary, determine the concentration of glucose in the urine, it is recommended to use enzymatic methods of glucose oxidase.

In the presence of amoxicillin, a distortion of the results of the determination of the concentration of estriol in pregnant women is possible.

Use during pregnancy and lactation

The pregnancy

In animal studies, no direct or indirect negative effects have been identified as manifestations of reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in men do not indicate an increased risk of birth defects. Amoxicillin can only be used in pregnant women when the expected benefits from using the medicine outweigh the potential risks.

Lactation

Amoxicillin is excreted in small amounts in breast milk, which creates a possible risk of sensitization. Therefore, in breastfed infants, diarrhea and fungal mucosal infections may occur; therefore, before starting amoxicillin, breastfeeding should be stopped. Amoxicillin should only be used during lactation after a thorough risk / benefit assessment by the doctor.

Fertility

There is no evidence of the effect of amoxicillin on human fertility. Animal reproduction studies have not shown any effect on fertility.

Use in children

In children under 6 months of age, it is recommended that Amoxicillin be used as a suspension.

In children weighing more than 40 kg, the dosage regimen for amoxicillin is similar to that for adults.

Influence on ability to drive and work with mechanisms

No special studies on the effect of amoxicillin on the ability to drive or use other means of movement have been performed. However, it should be borne in mind that during treatment with amoxicillin, undesirable effects may occur and affect the indicated capacity (for example, allergic reactions, dizziness, convulsions) (see section "Undesirable effects").

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