Infectocure 250 mg/5 ml Suspension 60 ml

Infectocure 250 mg/5 ml Suspension 60 ml

Composition:

Each 5 ml of reconstituted suspension contains: Clarithromycin — 250 mg.

Product Description:

• Infectocure (clarithromycin) is a second-generation macrolide semi-synthetic antibiotic.
• Mechanism of Action: Binds to the 50S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis and bacterial growth; exerts a bacteriostatic effect and, at higher concentrations, a bactericidal effect.
• Spectrum of Activity: Active against gram-positive and gram-negative microorganisms (pyogenic streptococcus, Haemophilus influenzae, Staphylococcus aureus), atypical pathogens (Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila), Helicobacter pylori, and mycobacteria in immunocompromised patients.
• Pharmacokinetics: Stable in gastric acid, rapidly absorbed from the gastrointestinal tract; metabolized in the liver to an active metabolite (14-hydroxyclarithromycin); penetrates well into tissues and body fluids.

Indications for Use:

• Upper Respiratory Tract and ENT Infections: Pharyngitis, tonsillitis, sinusitis, otitis media.
• Lower Respiratory Tract Infections: Bronchitis, community-acquired pneumonia.
• Skin and Soft Tissue Infections: Folliculitis, furunculosis, erysipelas, impetigo.
• Eradication of Helicobacter pylori: In peptic ulcer disease of the stomach and duodenum (as part of combination therapy).
• Mycobacterial Infections: Prevention and treatment of disseminated infections caused by Mycobacterium avium complex in immunocompromised patients.

Method of Administration and Dosage:

• Method of Administration: Oral use, independent of meals (taking with food or milk may improve gastrointestinal tolerance).
• Reconstitution:
  Add the required volume of purified water to the bottle containing powder (up to the mark or according to instructions) and shake thoroughly to form a uniform suspension.
  Shake well before each use.
• Children (6 months to 12 years):
• Recommended dose is 7.5 mg/kg body weight twice daily (maximum daily dose is 500 mg twice daily).
• Duration of Treatment: Typically 5 to 10 days, depending on infection severity and pathogen.
• Dose Adjustment: Reduced dosage or increased dosing interval is required in patients with severe renal impairment (creatinine clearance < 30 ml/min).

Contraindications:

• Hypersensitivity to clarithromycin, other macrolides, or any excipients.
• Concomitant administration with astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine, lovastatin, or simvastatin.
• History of QT interval prolongation or ventricular arrhythmias.
• Severe hepatic impairment combined with renal impairment.
• Children under 6 months of age (efficacy and safety not established).

Precautions:

• Drug Interactions: Clarithromycin inhibits CYP3A4; use with caution alongside oral anticoagulants, theophylline, carbamazepine, digoxin, cyclosporine, and statins.
• Cardiovascular Effects: Caution is advised in patients with coronary artery disease, severe heart failure, hypokalemia, or bradycardia due to the risk of QT prolongation.
• Hepatic and Renal Function: Discontinue treatment immediately if signs of hepatitis (jaundice, dark urine, pruritus) occur.
• Superinfection: Prolonged use may lead to overgrowth of non-susceptible bacteria and fungi, as well as pseudomembranous colitis.

Adverse Reactions / Side Effects:

• Gastrointestinal System: Nausea, vomiting, abdominal pain, diarrhea, dyspepsia, dysgeusia ("metallic" or bitter taste), stomatitis.
• Central Nervous System: Headache, insomnia, dizziness; rarely — confusion, hallucinations, nightmares.
• Allergic Reactions: Skin rash, pruritus, urticaria; rarely — Stevens-Johnson syndrome, anaphylaxis.
• Laboratory Parameters: Transient elevation of liver enzymes, leukopenia, neutropenia.

Pregnancy and Lactation:

Pregnancy:
Safety during pregnancy has not been established.
Use only when clearly necessary, when expected benefit to the mother outweighs potential risk to the fetus.
Lactation Period:
Clarithromycin is excreted into breast milk.
Discontinue breastfeeding during treatment if use is required.

Storage Conditions:

Dry Powder: Store in a light-protected place at a temperature not exceeding 25°C.
Reconstituted Suspension: Store at room temperature (15–25°C) for up to 14 days (do not refrigerate or freeze).
Keep out of reach of children.

Packaging:

Powder for oral suspension (60 ml reconstituted volume) in a bottle.
1 bottle per carton box with a measuring spoon or dosing syringe and package insert.