Supradol

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Supradol uses


1 INDICATIONS AND USAGE

Supradol ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Supradol ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Supradol ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for:

2 DOSAGE AND ADMINISTRATION

One drop of Supradol should be applied to the affected eye four times a day for relief of ocular itching due to seasonal allergic conjunctivitis.

For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of Supradol should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. (2.1)

2.1 Recommended Dosing

Patient Dosing

The recommended dose of Supradol ophthalmic solution is one drop four times a day to the affected eye(s) for relief of ocular itching due to seasonal allergic conjunctivitis.

For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of Supradol ophthalmic solution should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

2.2 Use with Other Topical Medications

Supradol ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

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3 DOSAGE FORMS AND STRENGTHS

Supradol Ophthalmic Solution 0.5% is supplied sterile in white opaque LDPE plastic bottles with white opaque droppers with grey opaque ophthalmic HDPE plastic caps as follows


Ophthalmic solution containing 5 mg/mL Supradol. (3)

4 CONTRAINDICATIONS

Supradol solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Hypersensitivity to any component of this product. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Delayed Healing

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

5.2 Cross-Sensitivity or Hypersensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. There have been reports of bronchospasm or exacerbation of asthma associated with the use of Supradol ophthalmic solution in patients who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

5.3 Increased Bleeding Time

With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues in conjunction with ocular surgery.

It is recommended that Supradol ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

5.4 Corneal Effects

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

5.5 Contact Lens Wear

Supradol should not be administered while wearing contact lenses.

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6 ADVERSE REACTIONS

The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation.

To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The most frequent adverse reactions reported with the use of Supradol ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials.

Other adverse reactions occurring approximately 1 to 10% of the time during treatment with Supradol ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

Other adverse reactions reported rarely with the use of Supradol ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-marketing use of Supradol ophthalmic solution 0.5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical Supradol ophthalmic solution 0.5% or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. .

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects. Pregnancy Category C

Pregnancy Category C: Supradol, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg to affected eyes on a mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), Supradol resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Supradol solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Supradol solution solution during late pregnancy should be avoided.

8.3 Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when Supradol is administered to a nursing woman.

8.4 Pediatric Use

Safety and efficacy in pediatric patients below the age of 2 have not been established.

8.5 Geriatric Use

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

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11 DESCRIPTION

Supradol ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure

Supradol Ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Supradol Ophthalmic Solution is a racemic mixture of R-(+) and S-(-) - Supradol. Supradol may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of Supradol is 376.41. The osmolality of Supradol Ophthalmic Solution is 290 mOsmol/kg.

Each mL of Supradol Ophthalmic Solution contains: Active: Supradol 0.5%. Preservative: Benzalkonium chloride 0.01%. Inactives: Edetate disodium dihydrate 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and water for injection.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Supradol is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

12.3 Pharmacokinetics

Two drops of 0.5% Supradol ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

One drop of 0.5% Supradol ophthalmic solution was instilled into 1 eye and 1 drop of vehicle into the other eye TID in 26 healthy subjects. Five (5) of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at Day 10 during topical ocular treatment. The range of concentrations following TID dosing of 0.5% Supradol ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (290 ± 70 ng/mL).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Supradol was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 125 times and 50 times higher respectively than the maximum recommended human topical ophthalmic daily dose given as QID for itching to affected eyes on a mg/kg basis.

Supradol was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, Supradol did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.

Supradol did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 225 and 400 times higher than the typical human topical ophthalmic daily dose.

14 CLINICAL STUDIES

Two controlled clinical studies showed that Supradol ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis.

Two controlled clinical studies showed that patients treated for two weeks with Supradol ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle.

Results from clinical studies indicate that Supradol has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

16 HOW SUPPLIED/STORAGE AND HANDLING

Supradol Ophthalmic Solution 0.5% is supplied sterile in white opaque LDPE plastic bottles with white opaque droppers with grey opaque ophthalmic HDPE plastic caps as follows: 5 mL - NDC 60505-1003-1 and 10 mL - NDC 60505-1003-2.

Store at 20° to 25°C (68° to 77°F). Protect from light.

17 PATIENT COUNSELING INFORMATION

17.1 Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs.

17.2 Avoiding Contamination of the Product

Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Also, to avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye following bilateral ocular surgery. The use of the same bottle of topical eye drops for both eyes following bilateral ocular surgery is not recommended.

17.3 Contact Lens Wear

Patients should be advised that Supradol solution should not be administered while wearing contact lenses.

17.4 Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of Supradol.

17.5 Concomitant Topical Ocular Therapy

Patients should be advised that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.

Rx only.

Apotex Inc.

Supradol Ophthalmic Solution 0.5%

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, FL
Canada M9L 1T9 33326

October 2015

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL - 0.5% BOTTLE LABEL

APOTEX CORP. NDC 60505-1003-1

Supradol OPHTHALMIC SOLUTION 0.5%

Rx only

5 ml

Supradol 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.


Supradol 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.


Supradol 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.


Supradol 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.


Supradol 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."KETOROLAC TROMETHAMINE SOLUTION/ DROPS [APOTEX CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "ketorolac". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "ketorolac". http://www.drugbank.ca/drugs/DB0046... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Supradol?

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

No survey data has been collected yet

Two visitors reported side effects

Did you get side effects while taking the Supradol drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Supradol medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
It has side effects1
50.0%
No side effects1
50.0%

Visitor reported price estimates

No survey data has been collected yet

Five visitors reported frequency of use

How often in a day do you take the medicine?
Are you taking the Supradol drug as prescribed by the doctor?

Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Supradol is mentioned below.
Visitors%
Twice in a day4
80.0%
4 times in a day1
20.0%

21 visitors reported doses

What is the dose of Supradol drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 11-50mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
11-50mg11
52.4%
6-10mg9
42.9%
1-5mg1
4.8%

Two visitors reported time for results

What is the time duration Supradol drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 2 days to notice the result from using Supradol drug. The time needed to show improvement in health condition after using the medicine Supradol need not be same for all the users. It varies based on other factors.
Visitors%
2 days1
50.0%
> 3 month1
50.0%

Two visitors reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Supradol drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
After food1
50.0%
Before food1
50.0%

Seven visitors reported age

Visitors%
> 603
42.9%
30-453
42.9%
16-291
14.3%

Visitor reviews


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

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