DRUGS & SUPPLEMENTS

Optimide Plus

advertisement
How is the drug helping you?

Optimide Plus uses

Optimide Plus consists of Phenylephrine Hydrochloride, Tropicamide.

Phenylephrine Hydrochloride:


Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Optimide Plus (Phenylephrine Hydrochloride) Hydrochloride 10 mg

Purpose

Antihistamine

Nasal Decongestant

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlargement of the prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes


Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever


If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

advertisement

Directions

Adults and children 12

years of age and over:

1 tablet every 4 to 6

hours, not to exceed

6 tablets in 24 hours

Children 6 to under 12

years of age:

1/2 tablet every 4 to

6 hours, not to

exceed 3 tablets in

24 hours

Children under 6 years

of age:

Consult a doctor


Other information

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Optimide Plus (Phenylephrine Hydrochloride) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions? Comments?

Call1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355 Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-782-60

Optimide Plus (Phenylephrine Hydrochloride)

Tablets

Antihistamine - Nasal Decongestant

Each tablet contains:

Dexbrompheniramine Maleate......................2 mg

Optimide Plus (Phenylephrine Hydrochloride) Hydrochloride......................10 mg

60 Tablets

Usual

Dosage: See product foldout for full prescribing information.

Tamper evident by foil seal under cap. Do not use if foil seal is

broken or missing.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

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

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

Rev. 02/12

Optimide Plus (Phenylephrine Hydrochloride) Tablets Packaging Optimide Plus (Phenylephrine Hydrochloride) Tablets Packaging

Tropicamide:


INDICATIONS AND USAGE

For mydriasis and cycloplegia for diagnostic procedures.

CONTRAINDICATIONS

Contraindicated in persons showing hypersensitivity to any component of this preparation.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION

This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.

Mydriatics may produce a transient elevation of intraocular pressure.

Remove contact lenses before using.

PRECAUTIONS

Pregnancy Category C. Animal reproduction studies have not been conducted with Optimide Plus. It is also not known whether Optimide Plus (Tropicamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Optimide Plus (Tropicamide) should be given to a pregnant woman only if clearly needed.

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the solution. Patients should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and wash their own hands and the child's hands following administration.

Drug Interactions

Optimide Plus may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using Optimide Plus (Tropicamide) in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Optimide Plus. It is also not known whether Optimide Plus (Tropicamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Optimide Plus (Tropicamide) should be given 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 Optimide Plus is administered to a nursing woman.

Pediatric Use

Optimide Plus (Tropicamide) may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. Keep this and all medications out of the reach of children.

Geriatric Use

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

advertisement

ADVERSE REACTIONS

Ocular

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of Optimide Plus (Tropicamide). Increased intraocular pressure has been reported following the use of mydriatics.

Non-Ocular

Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of Optimide Plus (Tropicamide). Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

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

For refraction, one or two drops of the 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, one or two drops of the 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.

HOW SUPPLIED

Optimide Plus (Tropicamide) Ophthalmic Solution, USP 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:

2 mL - NDC 24208-585-59

15 mL - NDC 24208-585-64

Optimide Plus (Tropicamide) Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size:

15 mL - NDC 24208-590-64

Storage: Store at 20° to 25C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)

.

Keep container tightly closed.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW 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

9115805 (folded)

9115905 (flat)

symbol

NDC 24208-590-64

Optimide Plus (Tropicamide)

Ophthalmic

Solution, USP

0.5% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton5mexico.jpg

NDC 24208-590-64

Optimide Plus (Tropicamide)

Ophthalmic

Solution, USP

0.5% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton5japan.jpg

NDC 24208-585-64

Optimide Plus (Tropicamide)

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton1mexico.jpg

NDC 24208-585-64

Optimide Plus (Tropicamide)

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton1japan.jpg

advertisement

Optimide Plus pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Optimide Plus available forms, composition, doses:

infoForm 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.


Optimide Plus destination | category:

infoDestination 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.


Optimide Plus Anatomical Therapeutic Chemical codes:

infoA 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.


Optimide Plus pharmaceutical companies:

infoPharmaceutical 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.


advertisement

References

  1. Dailymed."MEDIQUE MEDI-PHENYL (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED DOVER SUDANYL PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [UNIFIRST FIRS". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."TROPICAMIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE: 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).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Optimide Plus?

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

advertisement

Review

sDrugs.com conducted a study on Optimide Plus, 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 Optimide Plus 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.

Visitor reports

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 22 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2019 "sDrugs.com". All Rights Reserved