Deltaclav 228.5 mg/5 ml Powder for oral suspension 80 ml

Deltaclav 228.5 mg/5 ml Powder for Oral Suspension 80 ml

Composition:
Each 5 ml of the prepared suspension contains:
Amoxicillin (as amoxicillin trihydrate) — 200 mg
Clavulanic acid (as potassium clavulanate) — 28.5 mg
Excipients:
Xanthan gum, aspartame, succinic acid, colloidal silicon dioxide, hypromellose, orange flavor, caramel flavor, silicon dioxide.
Pharmacological Properties:
Amoxicillin is a semi-synthetic broad-spectrum antibiotic active against many gram-positive and gram-negative microorganisms. However, it is susceptible to degradation by β-lactamases, and thus its activity does not extend to organisms that produce these enzymes.
Clavulanic acid is a β-lactamase inhibitor structurally related to penicillins. It inactivates a wide range of β-lactamase enzymes responsible for resistance to penicillins and cephalosporins. It is particularly effective against plasmid-mediated β-lactamases and less effective against chromosomal class 1 β-lactamases, which are not inhibited by clavulanic acid.
The presence of clavulanic acid in the formulation protects amoxicillin from enzymatic degradation, thus expanding its antibacterial spectrum.
Indications for Use:
Bacterial infections caused by microorganisms sensitive to the drug:
Upper respiratory tract and ENT infections (e.g., recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes;
Lower respiratory tract infections: exacerbation of chronic bronchitis, lobar pneumonia, bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis;
Urinary tract infections: cystitis, urethritis, pyelonephritis, infections of female reproductive organs, usually caused by Enterobacteriaceae (primarily Escherichia coli), Staphylococcus saprophyticus, and Enterococcus species;
Gonorrhea caused by Neisseria gonorrhoeae;
Skin and soft tissue infections, usually caused by Staphylococcus aureus, Streptococcus pyogenes, and Bacteroides species;
Bone and joint infections (e.g., osteomyelitis, usually caused by Staphylococcus aureus), particularly when long-term treatment is needed.
Dosage and Administration:
Administered orally.
The dosing regimen is determined individually, based on age, body weight, renal function, and severity of infection.
For optimal absorption and to reduce potential gastrointestinal side effects, take at the start of a meal.
Minimum duration of therapy: 5 days.
Maximum duration: 14 days without clinical reassessment.
Children over 3 months:
Administered twice daily.
Suspension 7:1 (400 mg/57 mg per 5 ml).
Low dose: 25 mg/kg/day.
High dose: 45 mg/kg/day.
Use low doses for skin and soft tissue infections and recurrent tonsillitis.
Use high doses for otitis media, sinusitis, lower respiratory tract infections, urinary tract infections, bone and joint infections.
Contraindications:
Hypersensitivity to amoxicillin, clavulanic acid, or any other components of the drug;
History of jaundice or liver dysfunction associated with amoxicillin/clavulanic acid therapy;
Children under 3 months of age (for 200 mg/28.5 mg and 400 mg/57 mg suspensions);
Severe renal impairment (creatinine clearance <30 ml/min) — for 200 mg/28.5 mg and 400 mg/57 mg suspensions;
Phenylketonuria.
Use with caution in hepatic impairment.
Precautions:
Before initiating therapy, obtain a detailed history of hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Severe (including fatal) hypersensitivity reactions such as anaphylaxis have been reported with penicillins. The risk is highest in patients with a known history of such reactions.
Discontinue the drug immediately if an allergic reaction occurs and initiate appropriate alternative therapy.
Side Effects:
Infections:
Common: Candidiasis of skin and mucous membranes.
Hematologic system:
Rare: Reversible leukopenia (including neutropenia), thrombocytopenia.
Very rare: Reversible agranulocytosis, hemolytic anemia, prolonged prothrombin time or bleeding time, anemia, eosinophilia, thrombocytosis.
Immune system:
Very rare: Angioedema, anaphylaxis, serum sickness-like syndrome, allergic vasculitis.
Nervous system:
Uncommon: Dizziness, headache.
Very rare: Reversible hyperactivity, seizures (especially in patients with renal impairment or receiving high doses), insomnia, agitation, anxiety, behavioral changes.
Gastrointestinal:
Adults: Very common — diarrhea; common — nausea, vomiting.
Children: Common — diarrhea, nausea, vomiting.
Nausea is more frequent with high doses.
Hepatobiliary system:
Uncommon: Moderate increases in AST and/or ALT (often transient and clinically insignificant).
Storage Conditions:
Store at temperatures below 25 °C.
After reconstitution, keep refrigerated and use within 7 days.
Packaging:
Carton box contains a plastic bottle (80 ml capacity) with powder for oral suspension.