Arlet - Instructions For Use, Indications, Doses

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Arlet

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Terms and conditions of storage

Prices in online pharmacies:

from 341 rub.

Buy

Arlet is a broad-spectrum antibacterial drug.

Release form and composition

The dosage form of Arleta is film-coated tablets: white or almost white, biconvex, oblong (in glass or polymer jars of 10, 14, 20, 21 pcs., 1 can each in a package of combined material, in a cardboard box 1 package 5, 7, 10 pieces in blisters, 1-3 packages in a bag made of combined material, in a cardboard box 1 package).

Active ingredients in 1 tablet:

• amoxicillin - 250, 500 or 875 mg (as trihydrate);
• clavulanic acid 125 mg (as potassium salt)

Additional components (250/125 mg, 500/125 mg, 875/125 mg): low molecular weight povidone (medical low molecular weight polyvinylpyrrolidone 12 600 ± 2700) - 14/20/30 mg, talc - 12.8 / 21.4 / 33 mg, pregelatinized starch (starch 1500) - 119.4 / 191.2 / 249 mg, calcium stearate (stearic acid calcium) - 6.4 / 10.7 / 16.5 mg, colloidal silicon dioxide (aerosil) - 6.4 / 10.7 / 16.5 mg, microcrystalline cellulose - 45.2 / 90.2 / 51.7 mg.

Sheath: hydroxypropyl methylcellulose (hypromellose) - 8/13 / 19.1 mg, propylene glycol - 6/10 / 15.5 mg, polyethylene glycol 4000 (macrogol 4000) - 3.9 / 6.5 / 10 mg, titanium dioxide - 2, 1 / 3.5 / 5.4 mg.

Indications for use

Arlet is prescribed for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the action of active substances, including the following infections:

• ENT organs: tonsillitis, sinusitis in acute / chronic course, retropharyngeal abscess, otitis media, pharyngitis;
• digestive system: salmonellosis, dysentery, salmonella carriage;
• soft tissues and skin: impetigo, abscess, erysipelas, phlegmon, secondarily infected dermatoses, wound infection, including after bites of humans / animals;
• oral cavity: odontogenic infections;
• lower respiratory tract: acute bronchitis with bacterial superinfection, chronic bronchitis during exacerbation, community-acquired pneumonia;
• genitourinary system, including in gynecology / obstetrics, and biliary tract: chancroid, cystitis, cholangitis, pyelonephritis, urethritis, cholecystitis, pyelitis, septic abortion, pelvioperitonitis, salpingo-oophoritis, cervicitis, salpingitis, bacterial vaginitis, endometritis;
• connective / bone tissue: connective / bone infections, including osteomyelitis.

Contraindications

Absolute:

• anamnestic data on the development of functional disorders of the liver (including jaundice) when using a combination of amoxicillin and clavulanic acid;
• infectious mononucleosis or lymphocytic leukemia (due to the danger of developing exanthema);
• chronic renal failure (with creatinine clearance <30 ml / min; for a dosage of 875/125 mg);
• age up to 6 years; in the presence of chronic renal failure - up to 12 years;
• hypersensitivity to the components of the drug, as well as other beta-lactam antibiotic drugs (penicillins and cephalosporins).

Relative (when prescribing Arlet, care must be taken in the presence of the following diseases / conditions):

• renal failure in a chronic course;
• severe hepatic impairment;
• diseases of the digestive system, including a history of colitis associated with the use of penicillins;
• pregnancy and lactation.

Method of administration and dosage

Arlet is taken orally with a glass of water, preferably at the beginning of a meal (helps to reduce the likelihood of adverse reactions from the gastrointestinal tract). Do not chew and divide the tablets.

The doctor sets the scheme for using Arlet individually, taking into account age, weight, functional state of the kidneys, and the severity of the disease.

The recommended dosage regimen for adults and children over 12 years old (or with a weight over 40 kg):

• mild / moderate infection (excluding diseases of the lower respiratory tract): 3 times a day, 1 tablet 250/125 mg, or 2 times a day, 1 tablet 500/125 mg;
• severe infection; Respiratory tract infections: 3 times a day, 1 tablet 500/125 mg, or 2 times a day, 1 tablet 875/125 mg;
• oral infections: 3 times a day, 1 tablet 250/125 mg, or 2 times a day, 1 tablet 500/125 mg; course - 5 days.

The recommended dosage regimen for children 6-12 years old (or weighing up to 40 kg): 2-3 times a day, 1 tablet 250/125 mg, or 2 times a day, 1 tablet 500/125 mg. In severe cases, the dose is doubled. Average daily dose: amoxicillin - 20-30 mg / kg, clavulanic acid - 5-7.5 mg / kg.

It should be borne in mind that 2 tablets of 250/125 mg are not equivalent to 1 tablet of 500/125 mg.

Maximum daily doses:

• adults and children over 12 years old (weighing 40 kg): amoxicillin - 6000 mg, clavulanic acid - 600 mg;
• children 6–12 years old (weighing up to 40 kg): amoxicillin - 45 mg / kg, clavulanic acid - 10 mg / kg.

The duration of the treatment course is determined by the doctor, but is not less than 5 and not more than 14 days (if a repeated medical examination was not carried out). The duration of the use of the drug in acute uncomplicated otitis media is from 5 to 7 days.

For elderly patients without renal dysfunction, Arlet is prescribed according to the standard scheme. With functional disorders of the liver, therapy is carried out with caution, regularly monitoring liver function.

Recommendations for adjusting the dosage regimen for adults and children over 12 years old or weighing 40 kg or more with functional impairment of the kidneys (determined by creatinine clearance):

• from 30 ml / min: standard dosing regimen;
• 10-30 ml / min: mild / moderate infections: 2 times a day, 1 tablet 250/125 mg; severe infections, lower respiratory tract infections: 2 times a day, 1 tablet 500/125 mg;
• up to 10 ml / min: 1 tablet of 250/125 mg once a day; severe infections, lower respiratory tract infections: 1 tablet 500/125 mg once a day.

With anuria, the interval between doses of a single dose should be increased to 48 hours or more.

Patients on hemodialysis:

• adults: every 24 hours Arlet is prescribed in one of two daily doses: 1 tablet 500/125 mg or 2 tablets 250/125 mg;
• children: once a day at 15 / 3.75 mg / kg.

In order to compensate for the decrease in the serum concentration of the active ingredients during dialysis, patients of all ages are additionally prescribed 1 dose during and after the end of the dialysis session.

Side effects

Possible side reactions (often (1-10%); infrequently (0.1-1%); rarely (0.01-0.1%); very rarely (up to 0.01%)):

• digestive system: often - abdominal pain, nausea, diarrhea, vomiting, liver failure (in most cases in elderly patients, men, during prolonged treatment), increased activity of hepatic transaminases; rarely - cholestatic jaundice, hepatitis; very rarely - stomatitis, glossitis, gastritis, hemorrhagic colitis (it may develop after the end of the course), enterocolitis, pseudomembranous colitis, darkening of tooth enamel, black “hairy” tongue. An increase in the activity of aspartate aminotransferase / alanine aminotransferase, alkaline phosphatase and bilirubin is observed, as a rule, in men and in elderly patients (especially from 65 years old), the likelihood of their occurrence increases with a course of 14 days or more. In children, such violations are canceled in very rare cases. The above reactions can develop during / immediately or several weeks after the end of therapy. Most often, disorders of the gastrointestinal tract are insignificant and transient, sometimes pronounced;
• central nervous system: often - headache, dizziness, reversible convulsions (in the presence of functional impairment of the kidneys or while taking Arlet in high doses) and hyperactivity; very rarely - behavior change, agitation, insomnia, anxiety;
• urinary system: very rarely - hematuria;
• hematopoietic system: rarely - thrombocytopenia, reversible leukopenia (including neutropenia), reversible hemolytic anemia and agranulocytosis; very rarely - thrombocytosis, prolonged bleeding time, eosinophilia, anemia;
• allergic reactions: infrequently - erythematous rash, urticaria, itching; rarely - exudative erythema multiforme; very rarely - anaphylactic shock, exfoliative dermatitis, malignant exudative erythema, angioedema, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis; in some cases, the development of the so-called "rash of the fifth day" (koreidny exanthema);
• others: often - exanthema, development of superinfection (including candidiasis); rarely - crystalluria, reversible increase in prothrombin time, vasculitis, interstitial nephritis.

In the event of the appearance / aggravation of any of the above adverse reactions, as well as in the event of the occurrence of any violations not described, it is necessary to consult a specialist.

special instructions

Before the appointment of Arleta, it is required to collect a detailed history of previous hypersensitivity reactions to antibiotics of the penicillin / cephalosporin series, as well as to other allergens.

There are reports of serious and sometimes fatal hypersensitivity reactions to penicillins. The likelihood of their occurrence is higher in patients with a burdened history. With the development of allergic reactions, therapy is discontinued and alternative treatment is prescribed. In severe cases, immediate administration of adrenaline (epinephrine) and other measures (intravenous glucocorticosteroids, oxygen therapy, airway management, including intubation) are indicated.

After using the drug for the prevention of pregnant women with premature rupture of the membranes, neonates may develop necrotizing colitis.

Against the background of treatment of mild diarrhea caused by Clostridium difficile, the use of antidiarrheal drugs that reduce intestinal motility, it is recommended to avoid. If necessary, it is possible to use attapulgite or kaolin-containing antidiarrheal drugs. Severe diarrhea should be consulted with a specialist.

After the disappearance of clinical signs of the disease, therapy should be continued for 48–72 hours.

It is recommended to avoid combined use with estrogen-containing oral contraceptives (use of other or additional methods of contraception is shown).

The active substances of Arleta can provoke the development of nonspecific binding to the membrane of erythrocytes of albumin and immunoglobulins (with Coombs' test, there may be a false positive reaction).

With functional disorders of the liver, therapy requires caution.

During the treatment period, due to the growth of microflora insensitive to the action of Arleta, superinfections can develop (changes in antibiotic therapy are required).

With the combined use of Arlet with anticoagulants, it is necessary to control the prothrombin time (it may increase).

With reduced diuresis, crystalluria may develop in very rare cases. When using high doses, to reduce the likelihood of the formation of crystals of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis.

During the period of therapy, it is necessary to monitor the state of the function of the kidneys, liver, hematopoietic organs.

In the presence of functional disorders of the kidneys in severe course, it is necessary to carry out an adequate dose adjustment or increase the interval between taking single doses.

Amoxicillin in high concentrations gives a false positive reaction to urine glucose when using Fehling's solution / Benedict's reagent (the use of enzymatic reactions with glucosidase is recommended).

In the presence of hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics may occur.

Care should be taken when driving vehicles and performing work that requires quick psychomotor reactions and high concentration of attention.

Drug interactions

With the combined use of Arlet with some drugs / substances, the following effects may develop:

• aminoglycosides, antacids, laxatives, glucosamine: slowing and decreasing absorption;
• ascorbic acid: increased absorption;
• allopurinol: increased incidence of exanthema;
• bactericidal antibiotic drugs (including rifampicin, aminoglycosides, vancomycin, cephalosporins, cycloserine): mutual enhancement of action;
• bacteriostatic drugs (lincosamides, chloramphenicol, macrolides, tetracyclines): antagonistic action;
• indirect anticoagulants: suppression of their action (by suppressing the intestinal microflora, reducing the synthesis of vitamin K and prothrombin index; monitoring of blood clotting indicators is necessary);
• oral contraceptives, ethinylestradiol, drugs, in the process of metabolism of which para-aminobenzoic acid is formed: a decrease in their effectiveness;
• non-steroidal anti-inflammatory drugs that block tubular secretion, diuretics, allopurinol, phenylbutazone: increasing the concentration of amoxicillin;
• methotrexate: increased toxicity.

Terms and conditions of storage

Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.

Shelf life is 2 years.

Arlet: prices in online pharmacies

Drug name Price Pharmacy

Arlet 500 mg + 125 mg film-coated tablets 14 pcs. 341 r Buy

Arlet 875 mg + 125 mg film-coated tablets 14 pcs. 423 r Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!