Cefadroxyl Vatchem (Granules) Instructions for Use

Marketing Authorization Holder

Waltham-Pharmacy, LLC (Russia)

ATC Code

J01DB05 (Cefadroxil)

Active Substance

Cefadroxil (Rec.INN registered by WHO)

Dosage Form

Cefadroxil Vatchem

Granules for the preparation of an oral suspension 250 mg/5 ml of the prepared susp.: bottle 45 g

Dosage Form, Packaging, and Composition

Granules for the preparation of an oral suspension white or white with a yellowish tint.

Excipients: saccharin, gum, magnesium stearate, colloidal silicon dioxide, titanium dioxide, peach and apricot flavor, talc, sucrose.

45 g – bottles (1) complete with a measuring spoon – cardboard packs.

Clinical-Pharmacological Group

First generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A first-generation broad-spectrum cephalosporin antibiotic for oral administration. It has a bactericidal effect.

It is active against gram-positive bacteria: Staphylococcus spp. (penicillinase-producing and non-producing strains), Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae, Bacillus anthracis; gram-negative bacteria: Shigella spp., Salmonella spp., Haemophilus influenzae, Escherichia coli, Klebsiella spp., some strains of Proteus spp.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefadroxil, including: diseases of the urinary tract, upper and lower respiratory tract, skin, soft tissues, bones.

ICD codes

Dosage Regimen

The dosage is set individually, taking into account the severity and localization of the infection, and the sensitivity of the pathogen. For oral administration in adults and children with a body weight over 40 kg, the average dose is 1-2 g/day in 1-2 doses. For children with a body weight less than 40 kg – 25-50 mg/kg/day (preferably in the form of a suspension) in 1-2 doses. The course of treatment is 7-14 days. The minimum duration of treatment for infectious and inflammatory diseases caused by group A beta-hemolytic streptococcus is 10 days.

For patients with impaired renal excretory function, the single dose is 500 mg, the intervals between doses are determined depending on the CC values: with CC 0-10 ml/min – 36 h; with CC 10-25 ml/min – 24 h; with CC 25-50 ml/min – 12 h.

Adverse Reactions

Allergic reactions are possible (urticaria, skin itching, eosinophilia; in isolated cases – angioedema, anaphylactic shock); rarely – nausea, vomiting, diarrhea, candidiasis, headache, dizziness; in some cases – changes in the peripheral blood picture (reversible leukopenia, neutropenia, thrombocytopenia).

Contraindications

Hypersensitivity to cephalosporins.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or child.

Use in Renal Impairment

For patients with impaired renal excretory function, the single dose is 500 mg, the intervals between doses are determined depending on the CC values: with CC 0-10 ml/min – 36 h; with CC 10-25 ml/min – 24 h; with CC 25-50 ml/min – 12 h.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible.

Alcohol should not be consumed during treatment.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.