Deltaclav 457 mg/5 ml Powder for oral suspension preparation 80 ml

Deltaclav 457 mg/5 ml Powder for oral suspension preparation 80 ml

Composition:

Active Ingredients: Each 5 mL of prepared suspension contains
Amoxicillin (as trihydrate) — 400 mg and Clavulanic Acid (as potassium salt) — 57 mg.
Excipients:
Xanthan gum, aspartame, succinic acid, colloidal silicon dioxide, hypromellose, orange flavor, caramel flavor, silicon dioxide.

Product Description:

• Deltaclav is a broad-spectrum combined antibacterial medication consisting of a semi-synthetic penicillin antibiotic (amoxicillin) and a bacterial enzyme inhibitor (clavulanic acid).
• Its mechanism of action relies on the inhibition of bacterial cell wall synthesis by amoxicillin, leading to bacterial cell death (bactericidal effect).
• Clavulanic acid inactivates a wide range of beta-lactamase enzymes produced by resistant microorganisms, preventing the degradation of amoxicillin and significantly expanding its spectrum of activity.
• The medication is active against Gram-positive and Gram-negative aerobic and anaerobic bacteria (including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes, Staphylococcus aureus, Escherichia coli, Enterococcus species, Neisseria gonorrhoeae, and Bacteroides species).
• Clavulanic acid is less effective against chromosomal class I beta-lactamases produced by Pseudomonas aeruginosa and certain other resistant strains.

Indications for Use:

• Treatment of bacterial infectious and inflammatory diseases caused by susceptible microorganisms:
• Upper Respiratory Tract and ENT Infections: Recurrent tonsillitis, sinusitis, otitis media.
• Lower Respiratory Tract Infections: Acute exacerbations of chronic bronchitis, lobar pneumonia, bronchopneumonia.
• Genitourinary Tract Infections: Cystitis, urethritis, pyelonephritis, female genital tract infections, uncomplicated gonorrhea.
• Skin and Soft Tissue Infections: Erysipelas, impetigo, secondarily infected dermatoses, wound infections.
• Bone and Joint Infections: Osteomyelitis.

Method of Administration and Dosage:

• Administered orally.
• To optimize absorption and minimize gastrointestinal side effects, it is recommended to take the medication at the start of a meal.
• Directions for Reconstitution:
  Add cooled boiled water to the bottle containing the powder up to the mark on the label, then shake thoroughly until a uniform suspension is formed.
• Shake well before each use.
• Children Over 3 Months of Age (Dosing Frequency — Twice Daily, Every 12 Hours):
  Low Dose (25 mg per kg body weight per day): Used for skin and soft tissue infections, as well as recurrent tonsillitis.
  High Dose (45 mg per kg body weight per day): Used for otitis media, sinusitis, lower respiratory tract infections, urinary tract infections, and bone and joint infections.
• Duration of Therapy: The minimum duration of treatment is 5 days.
• Treatment should not exceed 14 days without medical re-evaluation.

Contraindications:

• History of hypersensitivity to amoxicillin, clavulanic acid, penicillins, cephalosporins, or any excipients of the formulation.
• History of jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid combination therapy.
• Children under 3 months of age.
• Severe renal impairment (creatinine clearance less than 30 mL/min).
• Phenylketonuria (contains aspartame).

Precautions:

• Allergy History: Prior to initiating therapy, a detailed history regarding previous hypersensitivity reactions to beta-lactam antibiotics should be obtained. Discontinue immediately if an allergic reaction occurs.
• Administration with Food: Take at the start of meals to reduce gastrointestinal discomfort.
• Laboratory Monitoring: During prolonged therapy, periodically assess hepatic, renal, and hematopoietic functions.
• Hepatic Impairment: Use with caution in patients with impaired liver function.

Adverse Reactions / Side Effects:

• Infections: Frequently — mucocutaneous candidiasis.
• Gastrointestinal System: Very frequently — diarrhea; frequently — nausea, vomiting (nausea is more common with higher doses).
• Hematopoietic System: Rarely — reversible leukopenia, neutropenia, thrombocytopenia; very rarely — agranulocytosis, hemolytic anemia, prolonged bleeding time and prothrombin time.
• Hepato-biliary System: Uncommonly — moderate elevation of liver enzymes (AST/ALT).
• Nervous System: Uncommonly — dizziness, headache; very rarely — convulsions (especially in patients with renal impairment or high doses), insomnia, anxiety, behavioral changes.
• Allergic Reactions: Very rarely — skin rash, urticaria, angioedema, anaphylactic reactions, allergic vasculitis.

Pregnancy and Lactation:

Use during pregnancy and breastfeeding is permissible only when the expected benefit to the mother outweighs the potential risk to the fetus or child, strictly under medical supervision.

Storage Conditions:

Store the dry powder at a temperature not exceeding 25 °C in a place protected from light.
After reconstitution, store the prepared suspension in the refrigerator and use within 7 days.
Keep out of reach of children.

Packaging:

Cardboard box containing 1 plastic bottle of 80 mL powder for oral suspension and a patient information leaflet.