Iquix

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Contraindications

IQUIX® solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.

Undesirable effects

The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation. These reactions occurred in approximately 8-10% of patients. Adverse reactions occurring in approximately 1-2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation. Other reported ocular reactions occurring in less than 1% of patients included chemosis, corneal erosion, diplopia, floaters, hyperemia, lid edema, and lid erythema.

Therapeutic indications

IQUIX® solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:

Corynebacterium species
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumonia
Viridans group streptococci*

Pseudomonas aeruginosa
Serratia marcescens*

*Efficacy for this organism was studied in fewer than 10 infections

Pharmacokinetic properties

Levofloxacin concentration in plasma was measured in 14 healthy adult volunteers during a 16­day course of treatment with IQUIX® solution. The dosing schedule was 1-2 drops per eye once in the morning on Days 1 and 16; 1-2 drops per eye every two hours Days 2 through 8; and 1-2 drops per eye every four hours Days 9 through 15. The mean levofloxacin concentration in plasma 1 hour post dose ranged from 3.13 ng/mL on Day 1 to 10.4 ng/mL on Day 16.

Maximum mean levofloxacin concentrations increased from 3.22 ng/mL on Day 1 to 10.9 ng/mL on Day 16, which is more than 400 times lower than those reported after standard oral doses of levofloxacin.

Levofloxacin concentration in tears was measured in 100 healthy adult volunteers at various time points following instillation of 2 drops of IQUIX® solution. Mean tear concentration measured 15 minutes after instillation was 757 mcg/mL.

Date of revision of the text

Name of the medicinal product

Fertility, pregnancy and lactation

Pregnancy Category C

Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, at which systemic exposure was estimated to be 250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was estimated to be 120 times that observed at the maximum recommended human ophthalmic dose.

There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacinshould be used during pregnancy only if the potential benefit justifies the potential risk to thefetus.

Qualitative and quantitative composition

5 cc bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 1.5%.

IQUIX® (levofloxacin ophthalmic solution) 1.5% is supplied in a white, low density polyethylene bottle with a controlled dropper tip and a tan, high density polypropylene cap.

5mL fill in a 5cc container ---NDC 68669-145-05

Store at 15° – 25°C (59° – 77°F).

Manufactured by: Santen Oy, P.O. Box 33, FeN-33721 Tampere, Finland. Licensed from: Daiichi Sankyo Co., Ltd., Tokyo, Japan. Revised: November 2014

Special warnings and precautions for use

Included as part of the PRECAUTIONS section.

In patients receiving systemically administered quinolones, including levofloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema, (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. If an allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and where appropriate, fluorescein staining.

Wear Patients should be advised not to wear contact lenses if they have signs and symptoms of cornealulcer.

In a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary administration for 2 years at doses up to 100 mg/kg/day, corresponding to plasma levels that were 245 times maximum clinical exposure, based on Cmax.

Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli) CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the in vivo mouse sister chromatid exchange assay. It was positive in the in vitro chromosomal aberration (CHL cell line) and in vitro sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, at which systemic exposure was estimated to be 2,600 times that at the maximum recommended human ophthalmic dose.

Pregnancy Category C

Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, at which systemic exposure was estimated to be 250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was estimated to be 120 times that observed at the maximum recommended human ophthalmic dose.

There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacinshould be used during pregnancy only if the potential benefit justifies the potential risk to thefetus.

Levofloxacin has not been measured in human milk. Based on data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when IQUIX® is administered to a nursing mother.

Safety and effectiveness in children below the age of six years have not been established. Oral administration of systemic quinolones has been shown to cause arthropathy in immature animals. There is no evidence that the ophthalmic administration of levofloxacin has any effect on weight bearing joints.

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Dosage (Posology) and method of administration

Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.

Instill one to two drops in the affected eye(s) very 1 to 4 hours while awake.

Interaction with other medicinal products and other forms of interaction

The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation. These reactions occurred in approximately 8-10% of patients. Adverse reactions occurring in approximately 1-2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation. Other reported ocular reactions occurring in less than 1% of patients included chemosis, corneal erosion, diplopia, floaters, hyperemia, lid edema, and lid erythema.

No information provided.