Therapeutic Category:Ophthalmic drugs
Pharmacologic Category:Antibiotic, Ophthalmic - Antibiotic, Quinolone
Pharmaceutical Form:Eye Drops - Single Dose
Sterile Single Dose Eye Drops
MINI-TAVOX is a sterile ophthalmic solution of levofloxacin that is a fluoroquinolone antibacterial agent. Levofloxacin is active against abroad spectrum of Gram-positive and Gram-negative ocular pathogens, and it is often bactericidal at concentration equal to or slightly greater than inhibitory concentration.
Levofloxacin may be active against bacteria resistant to betalactam antibiotics and aminoglicoside.
Levofloxacin undergoes a limited systemic absorption following its topical ophthalamic administration.
Mini-tavox solution is indicatedfor the treatment of bacterial conjunctivitis caused by susceptible organism.
MINI-TAVOX is contraindicated in persons with a history of hypersensitivity to levofloxacin ,to other quinolones , or to any of the components in the medication.
5-DOSAGE & ADMINISTRATION:
Days 1 and 2: Instill 1 to 2 drops in the affected eye(s) every 2 hours while awake. Do not put drops in more 8 times in day.
Days 3 through 5: Instill 1 to 2 drops in the affected eye(s) every 4 hours while awake. Do not put drops in more than 4 times per day.
* Wash your hands .
* Open the pouch along the dashed line .
* Detach one single dose container from the strip .
* Put the remaining strip back in the pouch and fold the edge to close the pouch.
* Make sure that the solution is in the bottom part of the single dose container.
* To open the container, twist off the tab.
* Tilt your head backwards While seated, or lie down on your back.
* Place the tip of the container close to your eye.
* Pull the lower eyelid downwards and look up.
* Press the container slightly and let one drop fall into the space between the lower eyelid and the eye.
6-WARNINGS AND PRECAUTIONS:
- MINI-TAVOX solution should not be injected subconjunctivally, nor should it be introduced directly into the interior chamber of the eye.
- If superinfection occurs, consult the doctor.
- Patients should be advised not to wear contact lenses if they have sign\s and symptoms of bacterial conjunctivitis.
- Avoid contaminating the applicator tip with material from the eye or other source.
- Levofloxacine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (Pregnancy category C)
- Caution should be exercised when MINI-TAVOX is administered to nursing mothers as levofloxacin may be excreted in human milk.
- Safety and effectiveness in infants below the age of one year have not established.
Vision problems (e.g. temporarily decreased or blurred vision), fever, headache, eye irritation or stinging, swelling of eyelid, eye dryness and itching, or sore throat. If any of these effects persist or worsen, notify your doctor promptly.
An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, and dizziness.
There are no reports about specific drug interactions with ophthalmic Levofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives.
9-OVERDOSEAGE AND TREATMENT:
Accidental ingestion of the ophthalmic solution in not expected to cause serious side effects as a one whole bottle contains 25 mg of levofloxacin. In the event of an acute overdosage, the patient should be observed and appropriate hydration maintained.
10-PACKAGING & COMPOSITION:
MINI TAVOX - Single Dose Eye Drops: A pack of 10 or 30 plastic containers contain 0.5 mL as single dose in external package. Each 1 mL of MINI TAVOX contains Levofloxacin Hemihydrate equivalent to 5 mg of Levofloxacin.
Store at room temperature (15-25)°C, away from sunlight and moisture.