Levophta

How old is patient? < 1 1-5 6-15 16-29 30-45 46-60 > 60

Levophta uses

• Indications and usage
• Contraindications
• Warning
• Precautions
• Pregnancy
• Adverse reactions
• Dosage and administration
• How supplied
• Levophta reviews

INDICATIONS AND USAGE

LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic suspension) is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

CONTRAINDICATIONS

This product is contraindicated in persons with known or suspected hypersensitivity to any of its components. It should not be used while soft contact lenses are being worn.

WARNING

For topical use only. Not for injection.

PRECAUTIONS

Information for Patients

SHAKE WELL BEFORE USING. To prevent contaminating the dropper tip and suspension, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. Do not use if the suspension has discolored. Store at controlled room temperature. Protect from freezing.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Levocabastine was not carcinogenic in male or female rats or in male mice when administered in the diet for up to 24 months. In female mice, levocabastine doses of 5,000 and 21,500 times the maximum recommended ocular human use level resulted in an increased incidence of pituitary gland adenoma and mammary gland adenocarcinoma possibly produced by increased prolactin levels. The clinical relevance of this finding is unknown with regard to the interspecies differences in prolactin physiology and the very low plasma concentrations of levocabastine following ocular administration.

Mutagenic potential was not demonstrated for levocabastine when tested in Ames’ Salmonella reversion test or in Escherichia coli, Drosophila melanogaster, a mouse Dominant Lethal Assay or in rat Micronucleus test.

In reproduction studies in rats, levocabastine showed no effects on fertility at oral doses of 20 mg/kg/day (8,300 times the maximum recommended human ocular dose).

PREGNANCY

Teratogenic Effects

Pregnancy Category C.

Levocabastine has been shown to be teratogenic in rats when given in doses 16,500 times the maximum recommended human ocular dose. Teratogenicity (polydactyly, hydrocephaly, brachygnathia), embryotoxicity, and maternal toxicity were observed in rats at 66,000 times the maximum recommended ocular human dose. There are no adequate and well-controlled studies in pregnant women. Levocabastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Based on determinations of levocabastine in breast milk after ophthalmic administration of the drug to one nursing woman, it was calculated that the daily dose of levocabastine in the infant was about 0.5 µg.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

ADVERSE REACTIONS

The most frequent adverse experiences reported with the use of LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic suspension) were mild, transient stinging and burning (29%) and headache (5%).

Other adverse experiences reported in approximately 1-3% of patients treated with LIVOSTIN™ were visual disturbances, dry mouth, fatigue, pharyngitis, eye pain/dryness, somnolence, red eyes, lacrimation/discharge, cough, nausea, rash/erythema, eyelid edema, and dyspnea.

DOSAGE AND ADMINISTRATION

SHAKE WELL BEFORE USING. The usual dose is one drop instilled in affected eyes four times per day.

HOW SUPPLIED

LIVOSTIN™ 0.05% (levocabastine hydrochloride ophthalmic suspension), 2.5 mL, 5 mL, and 10 mL is provided in white, polyethylene dropper tip squeeze bottles.

Keep tightly closed when not in use.

Do not use if the suspension has discolored.

Store at controlled room temperature 15°to 30°C (59° to 86°F).

Protect from freezing. NDC 58768-610-10 (10.0 mL)NDC 58768-610-05 (5.0 mL)NDC 58768-610-99 (2.5 mL)

Rx Only

Levophta is an original product of Janssen Pharmaceutica Inc.

Mfd. by OMJ Pharmaceuticals, Inc., San Germán, P.R., 00683 for:Novartis Ophthalmics, Duluth, GA 30097

5035-E

Levophta pharmaceutical active ingredients containing related brand and generic drugs:

• Levocabastine Hydrochloride

Levophta available forms, composition, doses:

• Solution; Ophthalmic; Levocabastine Hydrochloride 0.05%

Levophta destination | category:

• Human:
• Antiallergic agents

Levophta Anatomical Therapeutic Chemical codes:

• R01AC02 - Levocabastine
• S01GX02 - Levocabastine

Levophta pharmaceutical companies:

• Bausch and Lomb
• Dr. Winzer Pharma
• Novartis

References

1. Dailymed."LIVOSTIN (LEVOCABASTINE HYDROCHLORIDE) SUSPENSION [NOVARTIS OPHTHALMICS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."LEVOCABASTINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "levocabastine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Levophta?

Depending on the reaction of the Levophta after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Levophta not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Levophta addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Levophta, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Levophta consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology