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Ketoprofen (Ketoprofen)

Trade Name : Ketoprofen

Mylan Pharmaceuticals Inc.

CAPSULE, EXTENDED RELEASE

Strength 200 mg/1

KETOPROFEN Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ketoprofen (Ketoprofen) which is also known as Ketoprofen and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 200 mg/1 per ml. Read more

Ketoprofen (Ketoprofen) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cardiovascular Thrombotic Events
  • Gastrointestinal Risk
  • Ketoprofen is a nonsteroidal anti-inflammatory drug. The chemical name for ketoprofen is (u00b1)--Benzoylhydratropic acid with the following structural formula:
  • Its molecular formula is CHO, with a molecular weight of 254.29. It has a pKa of 5.94 in methanol:water (3:1) and an n-octanol:water partition coefficient of 0.97 (buffer pH 7.4).
  • Ketoprofen, USP is a white or off-white, odorless, nonhygroscopic, fine to granular powder, melting at about 95u00b0C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20u00b0C.
  • Each ketoprofen extended-release capsule, USP for oral administration contains 200 mg of ketoprofen, USP. In addition, each capsule contains the following inactive ingredients: ammonium hydroxide, black iron oxide, colloidal anhydrous silica, dibutyl sebacate, ethylcellulose, FD&C Blue No. 2, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer type B, oleic acid, polyacrylate dispersion, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate and yellow iron oxide.
  • In addition, the black imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
  • Ketoprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties.
  • The anti-inflammatory, analgesic, and antipyretic properties of ketoprofen have been demonstrated in classical animal and test systems. In anti-inflammatory models ketoprofen has been shown to have inhibitory effects on prostaglandin and leukotriene synthesis, to have antibradykinin activity, as well as to have lysosomal membrane-stabilizing action. However, its mode of action, like that of other nonsteroidal anti-inflammatory drugs, is not fully understood.
  • Carefully consider the potential benefits and risks of ketoprofen extended-release capsules before deciding to use ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • Ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
  • Ketoprofen extended-release capsules are not recommended for treatment of acute pain because of its extended-release characteristics (see ).
  • Ketoprofen extended-release capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen.
  • Ketoprofen extended-release capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see and ).
  • Ketoprofen extended-release capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
  • No data
  • No data
  • The incidence of common adverse reactions (above 1%) was obtained from a population of 835 ketoprofen immediate-release capsules-treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 ketoprofen extended-release capsules treated (200 mg/day) patients in trials lasting from 4 to 16 weeks.
  • Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of ketoprofen extended-release capsules once a day or 75 mg of ketoprofen immediate-release capsules TID (225 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%.
  • The incidence of peptic ulceration in patients on NSAIDs is dependent on many risk factors including age, sex, smoking, alcohol use, diet, stress, concomitant drugs such as aspirin and corticosteroids, as well as the dose and duration of treatment with NSAIDs (see ).
  • Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness. The incidence of some adverse reactions appears to be dose-related (see ). Rare adverse reactions (incidence less than 1%) were collected from one or more of the following sources: foreign reports to manufacturers and regulatory agencies, publications, U.S. clinical trials, and/or U.S. postmarketing spontaneous reports.
  • Reactions are listed below under body system, then by incidence or number of cases in decreasing incidence.
  • Signs and symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Respiratory depression, coma, or convulsions have occurred following large ketoprofen overdoses. Gastrointestinal bleeding, hypotension, hypertension, or acute renal failure may occur, but are rare.
  • Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Gut decontamination may be indicated in patients with symptoms seen within 4 hours (longer for sustained-release products) or following a large overdose (5 to 10 times the usual dose). This should be accomplished via emesis and/or activated charcoal (60 g to 100 g in adults, 1 to 2 g/kg in children) with a saline cathartic or sorbitol added to the first dose. Forced diuresis, alkalinization of the urine, hemodialysis or hemoperfusion would probably not be useful due to ketoprofen's high protein binding.
  • Case reports include twenty-six overdoses: 6 were in children, 16 in adolescents, and 4 in adults. Five of these patients had minor symptoms (vomiting in 4, drowsiness in 1 child). A 12-year-old girl had tonic-clonic convulsions 1-2 hours after ingesting an unknown quantity of ketoprofen and 1 or 2 tablets of acetaminophen with hydrocodone. Her ketoprofen level was 1128 mg/L (56 times the upper therapeutic level of 20 mg/L) 3-4 hours post ingestion. Full recovery ensued 18 hours after ingestion following management with intubation, diazepam, and activated charcoal. A 45-year-old woman ingested twelve 200 mg extended-release ketoprofen capsules and 375 mL vodka, was treated with emesis and supportive measures 2 hours after ingestion, and recovered completely with her only complaint being mild epigastric pain.
  • Carefully consider the potential benefits and risks of ketoprofen extended-release capsules and other treatment options before deciding to use ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • After observing the response to initial therapy with ketoprofen extended-release capsules, the dose and frequency should be adjusted to suit an individual patient's needs.
  • Concomitant use of ketoprofen extended-release capsules 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 ketoprofen immediate-release capsules 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 ketoprofen extended-release capsules 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 ketoprofen extended-release capsules 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 ketoprofen extended-release capsules should be reduced for patients over 75 years of age (see ).
  • 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 ketoprofen extended-release capsules 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) ketoprofen 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 ketoprofen extended-release capsules and closely monitored.
  • The recommended starting dose of ketoprofen in otherwise healthy patients is for ketoprofen extended-release capsules 200 mg administered once a day. Smaller doses of ketoprofen extended-release capsules should be utilized initially in small individuals, or in debilitated or elderly patients. The recommended maximum daily dose of ketoprofen is 200 mg/day for ketoprofen extended-release capsules.
  • Dosages higher than 200 mg/day of ketoprofen extended-release capsules are not recommended because they have not been studied. Concomitant use of ketoprofen extended-release capsules is not recommended. Relatively smaller people may need smaller doses.
  • As with other nonsteroidal anti-inflammatory drugs, the predominant adverse effects of ketoprofen are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that ketoprofen extended-release capsules be taken with antacids, food, or milk. Although food delays the absorption of both formulations (see ) in most of the clinical trials ketoprofen was taken with food or milk.
  • Physicians may want to make specific recommendations to patients about when they should take ketoprofen extended-release capsules in relation to food and/or what patients should do if they experience minor GI symptoms associated with either formulation.
  • Ketoprofen extended-release capsules are not recommended for use in treating acute pain because of its extended-release characteristics.
  • Ketoprofen Extended-Release Capsules, USP are available containing 200 mg of ketoprofen, USP.
  • The 200 mg capsules are hard-shell gelatin capsules with a blue green opaque cap and an iron gray opaque body filled with white to off-white beads. The capsules are axially printed with over in black ink on both the cap and body. They are available as follows:
  • NDC 0378-8200-01bottles of 100 capsules
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from direct light and excessive heat and humidity.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PHARMACIST:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Mylan Pharmaceuticals Inc.
  • Revised: 6/2019KETO:R13m/MG:KETO:R3m
  • NDC 0378-8200-01
  • Ketoprofenn- Extended-Releasen- Capsules, USPn- 200 mg
  • PHARMACIST: Dispense the accompanying n- MedicationGuide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a0 100 Capsules
  • Each capsule contains:Ketoprofen, USP200 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from direct light andn- excessive heat and humidity.
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM8200A6

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