Amoxicillin FT powder for oral suspension 250mg/5ml in 33.3g vial #1

Amoxicillin FT Powder for Oral Suspension 250mg/5ml – Comprehensive Information and Usage Guide

Product Name:

Amoxicillin FT Powder for Oral Suspension 250mg/5ml

Dosage Form:

Powder for suspension for oral use

Description:

Amoxicillin FT powder for oral suspension is a broad-spectrum antibiotic used to treat bacterial infections. This formulation provides 250mg of amoxicillin trihydrate in each 5ml dose.

Appearance:

The powder is white or almost white with a fruity odor. When mixed with carbon dioxide-free water (freshly boiled and cooled), it forms a pink suspension with white inclusions and a characteristic strawberry odor.

Active Ingredient:

Amoxicillin trihydrate (equivalent to 250mg amoxicillin)

Excipients:

Xanthan gum, anhydrous colloidal silicon dioxide, calcium stearate, sodium benzoate, sodium citrate, aspartame, carmoisine dye, “Aromatic” Vanillin AP220 flavoring, “Aromatic” Strawberry AP1943 flavoring, granulated sugar

Pharmacotherapeutic Group:

Beta-lactam antibiotic – penicillin

ATC Code:

J01C A04

Mechanism of Action:

Amoxicillin is a penicillin antibiotic that inhibits bacterial cell wall synthesis, leading to bacterial death. It is active against a wide range of both gram-positive and gram-negative bacteria.

Sensitive Bacteria:

• Gram-positive: Streptococci (groups A, B, C, G, H, I, M), Streptococcus pneumoniae, penicillinase-non-producing staphylococci, Erysipelothrix rhusiopathiae, Corynebacterium, Bacillus anthracis, Actinomycetes, Streptobaccili
• Gram-negative: Escherichia coli, Proteus mirabilis, Salmonella, Shigella, Campylobacter, Haemophilus influenzae, Bordetella pertussis, Leptospira, Chlamydia
• Others: Spirillium minus, Pastereulla multocida, Listeria, Spirochaeta (Leptospira, Treponema, Borrelia)

Pharmacokinetic Properties:

• Absorption: Almost completely absorbed from the gastrointestinal tract. Food does not affect absorption.
• Peak Plasma Concentration: Reached within 1-2 hours after ingestion.
• Distribution: Penetrates well into tissues and body fluids, including sputum. High concentrations are observed in bile.
• Excretion: Mainly excreted by the kidneys, approximately 50% unchanged.
• Half-life: 1-2 hours

Indications for Use:

Amoxicillin FT is used to treat a variety of bacterial infections, including:

• Upper respiratory tract and ENT infections: Sinusitis, otitis media, pharyngitis, tonsillitis
• Lower respiratory tract infections: Acute and chronic bronchitis, pneumonia, lung abscesses, initial stages of whooping cough
• Genitourinary infections: Acute and chronic pyelonephritis, pyelitis, prostatitis, epididymitis, cystitis, urethritis, asymptomatic bacteriuria during pregnancy
• Gonorrhea
• Gynecological infections: Septic abortion, adnexitis, endometritis
• Typhoid and paratyphoid fever: Including complications like septicemia (in combination with aminoglycosides)
• Salmonellosis
• Shigellosis
• Biliary tract infections: Cholangitis, cholecystitis (in the absence of cholestasis)
• Skin and soft tissue infections
• Leptospirosis
• Acute and latent listeriosis

Prevention:

Amoxicillin FT can be used for short-term (24-48 hours) prevention of infectious complications during minor surgical procedures.

Other Uses:

• Infective endocarditis (in combination with aminoglycosides)
• Meningitis
• Septicemia (when parenteral therapy is not required)

Dosage and Administration:

Preparation of Suspension:

1. Shake the powder in the vial.
2. Add boiled and cooled drinking water to the “60 ml” mark (for 20.0g of powder) or the “100 ml” mark (for 33.3g of powder).
3. Shake vigorously.
4. After the foam settles, add water to the final volume of 60ml or 100ml.
5. Shake thoroughly.

The suspension is now ready for use. Shake the bottle vigorously before each use and let the foam settle.

Dosage:

The dosage is individualized based on the severity of the infection, the sensitivity of the bacteria, and the patient’s age and renal function.

• Adults: 1.5-2g/day, up to 6g/day in severe cases. Usually given in 2 divided doses.
• Children: 30-60mg/kg/day, divided into 2 doses.

Treatment Duration:

• Continue treatment for 2-5 days after symptoms resolve.
• Treat streptococcal infections for at least 10 days to prevent complications.

Renal Impairment:

Reduce the dose and/or increase the dosing interval in patients with impaired renal function (creatinine clearance (CC) below 30 ml/min).

• CC 15-40 ml/min: Dosing interval should be at least 12 hours.
• Anuria: Maximum daily dose should not exceed 2g.

Side Effects:

• Gastrointestinal and Liver: Nausea, diarrhea, increased liver enzyme levels, glossitis, stomatitis, pseudomembranous colitis.
• Hematopoietic: Thrombocytopenia, leukopenia, eosinophilia, agranulocytosis.
• Nervous System and Psyche: Headache, fatigue, seizures (increased risk in patients with epilepsy, meningitis, or renal impairment).
• Allergic Reactions: Urticaria, fever, joint pain, erythema multiforme, exfoliative dermatitis, angioedema, anaphylactic shock (rare).
• Other: Interstitial nephritis (rare).

Contraindications:

• Infectious mononucleosis: May cause a life-threatening rash.
• Hypersensitivity to penicillins: Avoid use in patients with known allergies to penicillins.

Precautions:

• Cross-allergy: Patients with hypersensitivity to cephalosporins may have a cross-allergy to penicillins.
• Gastrointestinal Infections: Use with caution in patients with persistent diarrhea and vomiting, as absorption may be impaired.
• Allergic Diathesis: Use with caution in patients with allergic diathesis, bronchial asthma, or hay fever.
• Cholecystitis and Cholangitis: Only prescribe for mild disease and in the absence of cholestasis.
• Liver and Kidney Function Monitoring: Monitor liver and kidney function during prolonged use of high doses.
• Superinfection: Prolonged treatment may lead to superinfection with insensitive microorganisms, including fungi.
• Fluid Intake: Ensure adequate fluid intake and diuresis during therapy.
• Pseudomembranous Colitis: Suspect pseudomembranous colitis if watery diarrhea with mucus and blood, abdominal pain, fever, and tenesmus develop. Discontinue the drug and initiate appropriate treatment.
• Gonorrhea: Perform a dark field smear in patients with suspected primary syphilis before starting treatment for gonorrhea.
• Syphilis: All patients with suspected concomitant syphilis should have follow-up serological tests for at least 4 months.
• Diabetes: The powder for suspension contains granulated sugar.
• Blood Glucose Tests: Amoxicillin may cause false-positive results on blood glucose tests.

Drug Interactions:

• Allopurinol: Increases the risk of skin rash.
• Bacteriostatic Antibiotics: Avoid simultaneous use with bacteriostatic antibiotics.
• Probenecid: Increases amoxicillin blood levels by reducing renal excretion.
• Antacids: Reduces amoxicillin absorption.
• Oral Contraceptives: May reduce the effectiveness of oral contraceptives.

Storage:

• Store in a place protected from light and moisture at a temperature not higher than +25°C.
• Prepared suspension should be stored at +2˚С-+8˚С and used within 10 days.

Dispensing:

Available by prescription only.

Presentation:

• 20.0g and 33.3g in plastic bottles with a dosing cup, packaged with a leaflet in cardboard boxes.

Disclaimer:

This information is for educational purposes only and should not be considered medical advice. Always consult your doctor or pharmacist for diagnosis and treatment of any health condition.