Benzoak may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Benzocaine is reported as an ingredient of Benzoak in the following countries:
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Dramin may be available in the countries listed below.
Dimenhydrinate is reported as an ingredient of Dramin in the following countries:
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sterile
Ocufen® (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.
Chemical Name:
Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate.
Structural Formula:
Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of Ocufen® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.
Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, Ocufen® ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.
Ocufen® ophthalmic solution is indicated for the inhibition of intraoperative miosis.
Ocufen® ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.
With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that Ocufen® ophthalmic solution may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery.
There exists the potential for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Wound healing may be delayed with the use of Ocufen® (flurbiprofen sodium ophthalmic solution, USP) 0.03%.
It is recommended that Ocufen® ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Interaction of Ocufen® ophthalmic solution with other topical ophthalmic medications has not been fully investigated.
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with Ocufen® ophthalmic solution.
Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed.
Pregnancy category C. Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above.
There are no adequate and well-controlled studies in pregnant women. Ocufen® ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or efffectiveness have been observed between elderly and younger patients.
Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of Ocufen® ophthalmic solution. Other adverse reactions reported with the use of Ocufen® ophthalmic solution include: fibrosis, miosis, and mydriasis.
Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.
Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
A total of four (4) drops of Ocufen® ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.
Ocufen® (flurbiprofen sodium ophthalmic solution, USP) is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size:
Note: Store at 15° - 25°C (59°-77°F).
Rx Only
Revised May 2004
© 2004 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® Marks owned by Allergan, Inc.
71587US12P
ALLERGAN
NDC 11980-801-03
Rx Only
Ocufen®
(flurbiprofen
sodium ophthalmic
solution, USP)
0.03%
sterile
2.5 mL
ALLERGAN
NDC 11980-801-03 Rx Only
Ocufen®
(flurbiprofen sodium
ophthalmic solution, USP) 0.03%
2.5 mL sterile
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019404 | 01/01/1987 | |
| Labeler - Allergan, Inc. (144796497) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Allergan, Inc. | 362898611 | MANUFACTURE | |
Generic Name: lidocaine and prilocaine (Gingival route)
LYE-doe-kane, PRIL-oh-kane
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anesthetic, Amino Amide Combination
Chemical Class: Amino Amide
Lidocaine and prilocaine periodontal (gingival) gel is used on the gums to cause numbness or loss of feeling during dental procedures. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the gum.
This medicine is available only with your dentist's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of lidocaine and prilocaine periodontal gel in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and prilocaine periodontal gel in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine periodontal gel.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain lidocaine. It may not be specific to Oraqix. Please read with care.
A dentist or other trained health professional will give you this medicine in an office or clinic setting. The medicine is applied to the gums using a special dispenser.
It is very important that your dentist check you closely for any problems or unwanted effects that may be caused by this medicine.
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your dentist right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.
This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive this medicine.
During the time that the gum feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you have normal feeling in the area. Avoid foods or liquids that are very hot or very cold. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Oraqix side effects (in more detail)
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