Thursday, September 16, 2010

Desloratadine


des-lor-A-ta-deen


Commonly used brand name(s)

In the U.S.


  • Clarinex

  • Clarinex Reditabs

Available Dosage Forms:


  • Tablet, Disintegrating

  • Tablet

  • Syrup

Therapeutic Class: Respiratory Agent


Pharmacologic Class: Antihistamine, Less-Sedating


Chemical Class: Piperidine


Uses For desloratadine


Desloratadine is an antihistamine. It is used to relieve the symptoms of hay fever and hives of the skin.


Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some persons histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some persons to have hives, with severe itching of the skin.


desloratadine is available only with your doctor's prescription.


Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Before Using desloratadine


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 desloratadine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to desloratadine 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.


Pediatric


desloratadine has been tested in children 6 months of age and older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.


Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Geriatric


Desloratadine has been tested in patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older patients are more likely to have kidney or liver problems which may make them more sensitive to the effects of desloratadine. Your doctor may give you a different desloratadine dose if you have kidney or liver problems.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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.


Interactions with Medicines


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.


Interactions with Food/Tobacco/Alcohol


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.


Other Medical Problems


The presence of other medical problems may affect the use of desloratadine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Liver disease or

  • Kidney disease—Effects of desloratadine may be increased because of slower removal from the body.

  • Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse.

  • Slow metabolizers of desloratadine—May increase chances of unwanted effects

Proper Use of desloratadine


Dosing


The dose of desloratadine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of desloratadine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


For patients using the oral disintegrating tablet form of desloratadine:


  • Make sure your hands are dry.

  • Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.

  • Immediately place the tablet on top of the tongue.

  • The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

For patients using the syrup form of desloratadine: Use a calibrated measuring dropper or syringe to measure the direct dose for your child based on your doctor's instructions. Do not use a regular teaspoon. If you are unsure about how much of the syrup to give to your child, ask your doctor or pharmacist.


  • For oral dosage form (oral disintegrating tablets):
    • For symptoms of chronic hives:
      • Adults and children 12 years of age and older—5 milligrams (mg) once a day.

      • Children 6 to 11 years of age—2.5 mg once a day.

      • Children 4 to 6 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .


    • For symptoms of hay fever:
      • Adults and children 12 years of age and older—5 mg once a day.

      • Children 6 to 11 years of age—2.5 mg once a day.

      • Children 4 to 6 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .



  • For oral dosage form (tablets):
    • For symptoms of chronic hives:
      • Adults and children 12 years of age and older—5 mg once a day.

      • Children 4 to 12 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .


    • For symptoms of hay fever:
      • Adults and children 12 years of age and older—5 mg once a day.

      • Children 4 to 12 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .



  • For oral dosage form (syrup):
    • For symptoms of chronic hives:
      • Adults and children 12 years of age and older—2 teaspoonfuls (5 milligrams [mg] in 10 milliliters [mL]) once a day.

      • Children 6 to 11 years of age—1 teaspoonful (2.5 mg in 5 mL) once a day

      • Children 4 to 5 years of age—½ teaspoonful (1.25 mg in 2.5 mL) once a day

      • Children and infants up to 4 years of age—Use is not recommended .


    • For symptoms of hay fever:
      • Adults and children 12 years of age and older—2 teaspoonfuls (5 milligrams [mg] in 10 milliliters [mL]) once a day.

      • Children 6 to 11 years of age—1 teaspoonful (2.5 mg in 5 mL) once a day

      • Children 4 to 5 years of age—½ teaspoonful (1.25 mg in 2.5 mL) once a day

      • Children and infants up to 4 years of age—Use is not recommended .



Missed Dose


If you miss a dose of desloratadine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using desloratadine


If your symptoms do not improve within a few days or if they become worse, check with your doctor.


desloratadine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to desloratadine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.


desloratadine Side Effects


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 immediately if any of the following side effects occur:


Rare
  • Anaphylaxis, such as, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of eyelids or around the eyes or face or lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness, wheezing

  • dyspnea, such as, shortness of breath, difficult or labored breathing, tightness in chest, wheezing

  • edema, such as, swelling

  • pruritus, such as, itching skin

  • rash

  • tachycardia, such as, fast, pounding, or irregular heartbeat or pulse

  • urticaria, such as, hives or welts, itching, redness of skin, skin rash.

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:


More common
  • Headache

Less common
  • Dizziness

  • dry mouth

  • dysmenorrhea, such as, difficult or painful menstruation

  • dyspepsia, such as, acid or sour stomach, belching, heartburn, indigestion, stomach discomfort , upset or pain,

  • fatigue, such as, unusual tiredness or weakness

  • myalgia, such as, joint pain, swollen joints, muscle aching or cramping, muscle pains or stiffness, difficulty in moving

  • pharyngitis, such as, body aches or pain, congestion, cough, dryness or soreness of throat, fever, hoarseness, runny nose, tender swollen glands in neck, trouble in swallowing, voice changes.

  • somnolence, such as, sleepiness or unusual drowsiness

  • nausea

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: desloratadine side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


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More desloratadine resources


  • Desloratadine Side Effects (in more detail)
  • Desloratadine Use in Pregnancy & Breastfeeding
  • Desloratadine Drug Interactions
  • Desloratadine Support Group
  • 8 Reviews for Desloratadine - Add your own review/rating


  • Desloratadine Prescribing Information (FDA)

  • Desloratadine Professional Patient Advice (Wolters Kluwer)

  • Desloratadine Monograph (AHFS DI)

  • Desloratadine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Clarinex Consumer Overview

  • Clarinex Prescribing Information (FDA)

  • Clarinex Reditabs Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare desloratadine with other medications


  • Hay Fever
  • Urticaria


Thursday, August 5, 2010

Doc-Q-Lace


Generic Name: docusate (DOK ue sate)

Brand Names: Calcium Stool Softener, Colace, Correctol Softgel Extra Gentle, D-S Caps, Diocto, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docusoft S, DocuSol, DOK, DOS, DSS, Dulcolax Stool Softener, Enemeez Mini, Fleet Sof-Lax, Kao-Tin, Kaopectate Stool Softener, Kasof, Phillips Stool Softener, Silace, Sur-Q-Lax


What is Doc-Q-Lace (docusate)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.


Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.


Docusate may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Doc-Q-Lace (docusate)?


You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist before using docusate if you are on a low-salt diet, if you are pregnant or breast-feeding, or if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.


What should I discuss with my healthcare provider before using Doc-Q-Lace (docusate)?


You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist if it is safe for you to take docusate:



  • if you are on a low-salt diet; or




  • if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.




It is not known whether docusate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether docusate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 2 years old without the advice of a doctor.

How should I use Doc-Q-Lace (docusate)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.


Take docusate tablets or capsules with a full glass of water. Drink plenty of liquids while you are taking docusate. Do not crush, chew, or break a docusate capsule. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.


Do not take docusate rectal enema by mouth. It is for use only in your rectum. Wash your hands before and after using docusate rectal enema.

Try to empty your bowel and bladder just before using the enema.


Twist off the applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it.


After using docusate, you should have a bowel movement within 12 to 72 hours. Call your doctor if you have not had a bowel movement within 1 to 3 days.


Do not use docusate for longer than 7 days unless your doctor has told you to. Overuse of a stool softener can lead to serious medical problems. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since docusate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting or stomach pain.


What should I avoid while using Doc-Q-Lace (docusate)?


Avoid using laxatives or other stool softeners unless your doctor has told you to.

Avoid using the bathroom just after using docusate enema.


Doc-Q-Lace (docusate) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using docusate and call your doctor at once if you have a serious side effect such as:

  • rectal bleeding or irritation;




  • numbness or a rash around your rectum;




  • severe diarrhea or stomach cramps; or




  • continued constipation.



Less serious side effects may include:



  • mild diarrhea; or




  • mild nausea.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Doc-Q-Lace (docusate)?


There may be other drugs that can interact with docusate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Doc-Q-Lace resources


  • Doc-Q-Lace Side Effects (in more detail)
  • Doc-Q-Lace Use in Pregnancy & Breastfeeding
  • Drug Images
  • Doc-Q-Lace Drug Interactions
  • Doc-Q-Lace Support Group
  • 0 Reviews for Doc-Q-Lace - Add your own review/rating


  • Docusate Professional Patient Advice (Wolters Kluwer)

  • Colace MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diocto Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Docusate Salts Monograph (AHFS DI)

  • Dostinex Monograph (AHFS DI)

  • Enemeez Mini Enema MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Doc-Q-Lace with other medications


  • Constipation


Where can I get more information?


  • Your pharmacist can provide more information about docusate.

See also: Doc-Q-Lace side effects (in more detail)



Saturday, June 26, 2010

Durezol



difluprednate

Dosage Form: ophthalmic emulsion
FULL PRESCRIBING INFORMATION

Indications and Usage for Durezol


Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.



Durezol Dosage and Administration


Instill one drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.



DOSAGE STRENGTHS


Durezol contains 0.05% difluprednate as a sterile preserved emulsion for topical ophthalmic administration.



Contraindications


The use of Durezol, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures.



Warnings and Precautions



IOP Increase


Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.



Cataracts


Use of corticosteroids may result in posterior subcapsular cataract formation.



Delayed Healing


The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.



Bacterial Infections


Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.



Viral Infections


Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).



Fungal Infections


Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.



Topical ophthalmic use only


Durezol is not indicated for intraocular administration.



Adverse Reactions


Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.


Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with Durezol included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber _are, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse events occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, scleral hyperemia, and uveitis. Most of these events may have been the consequence of the surgical procedure.



USE IN SPECIFIC POPULATIONS



Pregnancy


Teratogenic Effects


Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal) anomalies when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 μg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 μg/kg/day, and 10 μg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 μg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 μg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of Durezol, since Durezol is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, Durezol should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.



Nursing Mothers


It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Durezol is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in pediatric patients has not been established.



Geriatric Use


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



Durezol Description


Durezol (difluprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula:



Difluprednate has a molecular weight of 508.56, and the empirical formula is C27H34F2O7.


Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, sodium EDTA, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%.



Durezol - Clinical Pharmacology



Mechanism of Action


Corticosteroids inhibit the inflammatory response to a variety of inciting agents that may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of in_ammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.


Difluprednate is structurally similar to other corticosteroids.



Pharmacokinetics


Difluprednate undergoes deacetylation in vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate.


Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01% or 0.05%) QID for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating the systemic absorption of difluprednate after ocular instillation of Durezol is limited.



Nonclinical Toxicology



Carcinogenesis, Mutagenesis, and Impairment of Fertility


Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters). An in vivo micronucleus test of difluprednate in mice was also negative. Treatment of male and female rats with subcutaneous difluprednate up to 10 μg/kg/day prior to and during mating did not impair fertility in either gender. Long term studies have not been conducted to evaluate the carcinogenic potential of difluprednate.



Animal Toxicology and/or Pharmacology


In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests of difluprednate showed systemic effects such as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic glands and adrenal gland; and for local effects, thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well known glucocorticosteroid effects. Most, if not all of these effects were reversible after drug withdrawal. The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1-1.25 μg/kg per day.



Clinical Studies



Postoperative Ocular Inflammation and Pain


Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade ≥ "2" (a cell count of 11 or higher) after cataract surgery were assigned to Durezol or placebo (vehicle) following surgery. One drop of Durezol or vehicle was self instilled either 2 (BID) or 4 (QID) times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 8 and 15 days post-surgery using a slit lamp binocular microscope. In the intent-to-treat analyses of both studies, a signifocant benefit was seen in the QID Durezol-treated group in ocular inflammation and reduction of pain when compared with placebo. The consolidated clinical trial results are provided below.






















Ocular Inflammation and Pain Endpoints (Studies Pooled)
Durezol QID N = 107Vehicle

N = 220
Day815815
Anterior Chamber cell clearing (% subjects)24 (22%)*44 (41%)*17 (7%)25 (11%)
Pain free (% subjects)62 (58%)*67 (63%)*59 (27%)76 (35%)
* Statistically significantly better than vehicle, p<0.01

How Supplied/Storage and Handling


Durezol (difluprednate ophthalmic emulsion) 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following size: 5 mL in a 5 mL bottle (NDC 0065-9240-05).


Storage


Store at 15-25°C (59-77°F). Do not freeze. Protect from light. When not in use keep the bottles in the protective carton.



Patient Counseling Information


This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. If pain develops or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing a preservative, patients should be advised not to wear contact lenses when using Durezol.


Revised: August 2010


U.S. Patent: 6,114,319


©2010 Alcon , Inc. ®


Manufactured for:


ALCON®


Alcon Laboratories, Inc.


6201 South Freeway


Fort Worth, Texas 76134 USA


1-800-757-9195


MedInfo@AlconLabs.com


Manufactured By:


Catalent Pharma Solutions


Woodstock, IL 60098


9005602-0810



PRINCIPAL DISPLAY PANEL


NDC 0065-9240-05


Rx Only


Durezol®


(difluprednate ophthalmic


Emulsion) 0.05%


Alcon®


5 mL


Sterile











Durezol 
Durezol  emulsion










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0065-9240
Route of AdministrationOPHTHALMICDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIFLUPREDNATE (DIFLUPREDNATE)DIFLUPREDNATE0.5 mg  in 1 mL


















Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
CASTOR OIL 
GLYCERIN 
POLYSORBATE 80 
WATER 
SODIUM ACETATE 
SODIUM HYDROXIDE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10065-9240-055 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02221201/25/2011


Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)









Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions043911403MANUFACTURE
Revised: 01/2011Alcon Laboratories, Inc.

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