Ophthaine

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Ophthaine uses


INDICATIONS AND USAGE

Ophthaine 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

Ophthaine 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 Ophthaine Hydrochloride Ophthalmic Solution, USP 0.5%. It is also not known whether Ophthaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ophthaine 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 Ophthaine hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Ophthaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of Ophthaine 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.

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ADVERSE REACTIONS

Occasional temporary stinging, burning and conjunctival redness may occur with the use of Ophthaine. 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 Ophthaine 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: Ophthaine 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

Ophthaine 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)

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Ophthaine pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Ophthaine available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Ophthaine destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Ophthaine Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Ophthaine pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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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 Ophthaine?

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

sdrugs.com conducted a study on Ophthaine, 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 Ophthaine 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

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