Oftaine

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Oftaine uses


INDICATIONS AND USAGE

Oftaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated; corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies and for short corneal and conjunctival procedures.

CONTRAINDICATIONS

Oftaine hydrochloride ophthalmic solution is contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

WARNINGS

NOT FOR INJECTION INTO THE EYE - FOR TOPICAL OPHTHALMIC USE ONLY

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity or possible impairment of fertility in males or females.

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with Oftaine Hydrochloride Ophthalmic Solution, USP 0.5%. It is also not known whether Oftaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Oftaine hydrochloride should be administered to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oftaine hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Oftaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of Oftaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

Geriatric Use

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

ADVERSE REACTIONS

Occasional temporary stinging, burning and conjunctival redness may occur with the use of Oftaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes iritis with descemetitis has been reported.

Allergic contact dermatitis from Oftaine with drying and fissuring of the fingertips has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

Usual

Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.

Short corneal and conjunctival procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses.

NOTE: Oftaine Hydrochloride Ophthalmic Solution, USP 0.5% should be clear, colorless to faint yellow color. If the solution becomes darker, discard the solution.

FOR TOPICAL OPHTHALMIC USE ONLY

HOW SUPPLIED

Oftaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following size:

NDC 24208-730-06 – 15 mL bottle

Storage

Refrigerate at 2°-8°C (36°- 46°F). Protect from light. Keep tightly closed.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9114403 (Folded)

9114503 (Flat)

Oftaine pharmaceutical active ingredients containing related brand and generic drugs:


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References

  1. Dailymed."PROPARACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "proparacaine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "proparacaine". http://www.drugbank.ca/drugs/DB0080... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Oftaine?

Depending on the reaction of the Oftaine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Oftaine 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 Oftaine 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.

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

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