Dosage of Kétoprofène Biogaran 2.5% in details
Carefully consider the potential benefits and risks of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) and Oruvail and other treatment options before deciding to use Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) and Oruvail. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) and Oruvail, the dose and frequency should be adjusted to suit an individual patients needs.
Concomitant use of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) and Oruvail is not recommended.
If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) daily as compared to 200 mg, although in well-controlled clinical trials patients on 300 mg did not show greater mean effectiveness. They did, however, show an increased frequency of upper- and lower-GI distress and headaches. It is of interest that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day, the physician should observe sufficient increased clinical benefit to offset potential increased risk.
In patients with mildly impaired renal function, the maximum recommended total daily dose of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m or end-stage renal impairment), the maximum total daily dose of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail should not exceed 100 mg.
In elderly patients, renal function may be reduced with apparently normal serum creatinine and/or BUN levels. Therefore, it is recommended that the initial dosage of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail should be reduced for patients over 75 years of age.
It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dL, the maximum initial total daily dose of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels of free (biologically active) Kétoprofène Biogaran 2.5% and should be closely monitored. The dosage may be increased to the range recommended for the general population, if necessary, only after good individual tolerance has been ascertained.
Because hypoalbuminemia and reduced renal function both increase the fraction of free drug (biologically active form), patients who have both conditions may be at greater risk of adverse effects. Therefore, it is recommended that such patients also be started on lower doses of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail and closely monitored.
Rheumatoid Arthritis and Osteoarthritis
The recommended starting dose of Kétoprofène Biogaran 2.5% in otherwise healthy patients is for Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) 75 mg three times or 50 mg four times a day, or for Oruvail 200 mg administered once a day. Smaller doses of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of Kétoprofène Biogaran 2.5% is 300 mg/day for Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or 200 mg/day for Oruvail.
Dosages higher than 300 mg/day of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or 200 mg/day of Oruvail are not recommended because they have not been studied. Concomitant use of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) and Oruvail is not recommended. Relatively smaller people may need smaller doses.
As with other nonsteroidal anti-inflammatory drugs, the predominant adverse effects of Kétoprofène Biogaran 2.5% are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail be taken with antacids, food, or milk. Although food delays the absorption of both formulations, in most of the clinical trials Kétoprofène Biogaran 2.5% was taken with food or milk.
Physicians may want to make specific recommendations to patients about when they should take Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) or Oruvail in relation to food and/or what patients should do if they experience minor GI symptoms associated with either formulation.
Management of Pain and Dysmenorrhea
The usual dose of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) recommended for mild-to-moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. A smaller dose should be utilized initially in small individuals, in debilitated or elderly patients, or in patients with renal or liver disease. A larger dose may be tried if the patients response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give added analgesia. Daily doses above 300 mg are not recommended because they have not been adequately studied. Because of its typical nonsteroidal antiinflammatory drug-side-effect profile, including as its principal adverse effect GI side effects, higher doses of Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) should be used with caution and patients receiving them observed carefully.
Oruvail is not recommended for use in treating acute pain because of its extended-release characteristics.
How supplied
Kétoprofène Biogaran 2.5%® (Kétoprofène Biogaran 2.5%) Capsules are available as follows:
25 mg, NDC 0008-4186, dark-green and red capsule marked WYETH 4186 on one side and Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) 25 on the reverse side, in bottles of 100 capsules.
50 mg, NDC 0008-4181, dark-green and light-green capsule marked WYETH 4181 on one side and Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) 50 on the reverse side, in bottles of 100 capsules.
75 mg, NDC 0008-4187, dark-green and white capsule marked WYETH 4187 on one side and Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) 75 on the reverse side, in bottles of 100 and 500 capsules and in Redipak® cartons of 100 each containing 10 blister strips of 10 capsules.
Oruvail® (Kétoprofène Biogaran 2.5%) Extended-Release Capsules are available as follows:
100 mg, NDC 0008-0821, opaque pink and dark-green capsule marked with two radial bands and ORUVAIL 100 in bottles of 100 capsules.
150 mg, NDC 0008-0822, opaque pink and light-green capsule marked with two radial bands and ORUVAIL 150 in bottles of 100 capsules.
200 mg, NDC 0008-0690, opaque pink and off-white capsule marked with two radial bands and ORUVAIL 200 in bottles of 100 capsules and in Redipak® cartons each containing 10 blister strips of 10 capsules.
Keep tightly closed.
Store at room temperature, approximately 25° C (77° F).
Dispense in a tight container.
Oruvail capsules should be protected from direct light and excessive heat and humidity.
The appearance of these capsules is a registered trademark of Wyeth Pharmaceuticals.
By arrangement with Rhone-Poulenc Rorer France.
Kétoprofène Biogaran 2.5% (Kétoprofène Biogaran 2.5%) Capsules manufactured and distributed by Wyeth Pharmaceuticals
Oruvail Capsules distributed by Wyeth Pharmaceuticals
Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101
Rev 07/05
FDA rev date: 01/18/06
What other drugs will affect Kétoprofène Biogaran 2.5%?
Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with Kétoprofène Biogaran 2.5% may cause you to bruise or bleed easily.
Before taking Kétoprofène Biogaran 2.5%, tell your doctor if you are taking any of the following drugs:
- cyclosporine (Gengraf, Neoral, Sandimmune);
- lithium (Eskalith, Lithobid);
- methotrexate (Rheumatrex, Trexall);
- probenecid (Benemid);
- a blood thinner such as warfarin (Coumadin), or an anti-platelet medication such as clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and others;
- steroids (prednisone and others);
- aspirin, or other NSAIDs such as diclofenac (Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.
This list is not complete and there may be other drugs that can interact with Kétoprofène Biogaran 2.5%. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Kétoprofène Biogaran 2.5% interactions
The following drug interactions were studied with Kétoprofène Biogaran 2.5% doses of 200 mg/day. The possibility of increased interaction should be kept in mind when Kétoprofène Biogaran 2.5% doses greater than 50 mg as a single dose or 200 mg of Kétoprofène Biogaran 2.5% per day are used concomitantly with highly bound drugs.
1. Antacids: Concomitant administration of magnesium hydroxide and aluminum hydroxide does not interfere with the rate or extent of the absorption of Kétoprofène Biogaran 2.5% administered as Kétoprofène Biogaran 2.5%.
2. Aspirin: Kétoprofène Biogaran 2.5% does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased Kétoprofène Biogaran 2.5% protein binding and increased Kétoprofène Biogaran 2.5% plasma clearance from 0.07 L/kg/h without aspirin to 0.11 L/kg/h with aspirin. The clinical significance of these changes has not been adequately studied. Therefore, concurrent use of aspirin and Kétoprofène Biogaran 2.5% is not recommended.
3. Diuretic: Hydrochlorothiazide, given concomitantly with Kétoprofène Biogaran 2.5%, produces a reduction in urinary potassium and chloride excretion compared to hydrochlorothiazide alone. Patients taking diuretics are at a greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition.
4. Digoxin: In a study in 12 patients with congestive heart failure where Kétoprofène Biogaran 2.5% and digoxin were concomitantly administered, Kétoprofène Biogaran 2.5% did not alter the serum levels of digoxin.
5. Warfarin: In a short-term controlled study in 14 normal volunteers, Kétoprofène Biogaran 2.5% did not significantly interfere with the effect of warfarin on prothrombin time. Bleeding from a number of sites may be a complication of warfarin treatment and GI bleeding a complication of Kétoprofène Biogaran 2.5% treatment. Because prostaglandina play an important role in hemostasis and Kétoprofène Biogaran 2.5% has an effect on platelet function as well, concurent therapy with Kétoprofène Biogaran 2.5% and warfarin requires close monitoring of patients on both drugs.
6. Probenecid: Probenecid increases both free and bound Kétoprofène Biogaran 2.5% by reducing the plasma clearance of Kétoprofène Biogaran 2.5% to about one-third, as well as decreasing its protein binding. Therefore, the combination of Kétoprofène Biogaran 2.5% and probenecid is not recommended.
7. Methotrexate: Kétoprofène Biogaran 2.5%, like other NSAIDs, may cause changes in the elimination of methotrexate leading to elevated serum levels of the drug and increased toxicity.
8. Lithium: Nonsteroidal anti-inflammatory agents have been reported to increase steadystate plasma lithium levels. It is recommended that plasma lithium levels be monitored when Kétoprofène Biogaran 2.5% is coadministered with lithium.
DRUG/LABORATORY TEST INTERACTIONS: EFFECT ON BLOOD COAGULATION
Kétoprofène Biogaran 2.5% decreases platelet adhesion and aggregation. Therefore, it can prolong bleeding time by approximately 3 to 4 minutes from baseline values. There is no significant change in platelet count, prothrombin time, partial thromboplastin time, or thrombin time.
References
- DailyMed. "KETOPROFEN: 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/dailyme... (accessed September 17, 2018).
- MeSH. "Anti-Inflammatory Agents, Non-Steroidal". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Ketoprofen: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Kétoprofène Biogaran 2.5% are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Kétoprofène Biogaran 2.5%. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
