Sanolevox 15 mg Eye drops 5 ml

Sanolevox 15 mg Eye drops 5 ml

Composition:

Active Ingredient:
Levofloxacin 15 mg/ml (75 mg per 5 ml solution).
Excipients:
Sterile aqueous vehicle, tonicity/buffering agents, preservative.

Product Description:

Sanolevox is a broad-spectrum fluoroquinolone antibacterial ophthalmic solution.
The active ingredient, levofloxacin (the L-enantiomer of ofloxacin), exerts a bactericidal effect by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV enzymes, which halts bacterial DNA replication and cell division.
It is effective against a wide range of Gram-positive and Gram-negative ocular pathogens, including Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Indications for Use:

• Treatment and prevention of superficial bacterial eye infections caused by levofloxacin-susceptible microorganisms:
  Bacterial conjunctivitis.
  Superficial ocular infections (blepharitis, keratoconjunctivitis).
  Prevention of post-operative and post-traumatic ocular infectious complications.

Method of Administration and Dosage:

• For topical ophthalmic use (instillation into the conjunctival sac of the affected eye/eyes) in adults and children aged 1 year and older:
• Days 1–2: Instill 1–2 drops into the affected eye(s) every 2 hours (up to 8 times daily).
• Days 3–7: Instill 1–2 drops 4 times daily until complete recovery (typical treatment duration is 5–7 days).
• The total duration of therapy should not exceed 7 days without medical re-evaluation.

Contraindications:

Hypersensitivity or allergy to levofloxacin, other fluoroquinolones, or any excipients in the formulation.
Children under 1 year of age (due to insufficient safety data).

Precautions:

• For topical ophthalmic use only; do not inject subconjunctivally or directly into the anterior chamber of the eye.
• To prevent contamination of the solution, avoid touching the dropper tip to the eyelids, eyelashes, or surrounding skin.
• Contact lenses should not be worn during treatment for bacterial eye infections.
• Prolonged antibiotic use may promote the overgrowth of non-susceptible organisms, including fungi.

Adverse Reactions / Side Effects:

Ocular Reactions:
Transient burning or stinging, decreased visual acuity, mucinous discharge, conjunctival hyperemia, dry eye, eye pain, or eyelid edema.
Systemic Reactions:
Rarely, headache, rhinitis, dysgeusia (taste disturbance), or allergic reactions (skin rash, pruritus).

Pregnancy and Lactation:

Pregnancy:
Use during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.
Lactation:
Levofloxacin is excreted in human milk following systemic administration, but systemic absorption following topical ophthalmic use at recommended doses is minimal.
Exercise caution when administering to nursing mothers.

Storage Conditions:

Store at temperatures not exceeding 25°C in a dry, light-protected place. 
Keep out of reach of children.
Once opened, use within the recommended period (typically 28 days).

Packaging:

5 ml dropper bottle packed in a cardboard box with a patient information leaflet.