What is Ketoprofen Kombivet?
Ketoprofen Kombivet is a nonsteroidal anti-inflammatory drug (NSAID). Ketoprofen Kombivet works by reducing hormones that cause inflammation and pain in the body.
Ketoprofen Kombivet is used to treat pain or inflammation caused by arthritis.
The Ketoprofen Kombivet regular capsule is also used to treat mild to moderate pain, or menstrual pain.
Only Ketoprofen Kombivet extended-release capsules are used for treating arthritis. This form of Ketoprofen Kombivet will not work fast enough to treat acute pain.
Ketoprofen Kombivet may also be used for purposes not listed in this medication guide.
Ketoprofen Kombivet indications
Carefully consider the potential benefits and risks of Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet and other treatment options before deciding to use Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ketoprofen Kombivet is not recommended for treatment of acute pain because of its extended-release characteristics is indicated for the management of pain. Ketoprofen Kombivet (Ketoprofen Kombivet) is also indicated for treatment of primary dysmenorrhea.
How should I use Ketoprofen Kombivet?
Use Ketoprofen Kombivet extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ketoprofen Kombivet extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ketoprofen Kombivet extended-release capsules refilled.
- Take Ketoprofen Kombivet extended-release capsules by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- Swallow Ketoprofen Kombivet extended-release capsules whole. Do not break, crush, or chew before swallowing.
- Take Ketoprofen Kombivet extended-release capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
- If you miss a dose of Ketoprofen Kombivet extended-release capsules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about the proper use of Ketoprofen Kombivet extended-release capsules.
Uses of Ketoprofen Kombivet in details
Ketoprofen Kombivet is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks.
How to use Ketoprofen Kombivet
If you are taking the over-the-counter product, read all directions on the product package before taking this medication. If your doctor has prescribed this medication, read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking Ketoprofen Kombivet and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth, usually 3 to 4 times a day with a full glass of water (8 ounces or 240 milliliters), or as directed by your doctor. Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid.
Dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Do not take the over-the-counter product for more than 10 days unless otherwise directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.
If you are taking this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well.
If you are taking this medication for migraine headache and the pain is not relieved, or if it worsens after the first dose, tell your doctor right away.
For certain conditions (such as arthritis), it may take up to 2 weeks of taking this drug regularly until you get the full benefit.
If your condition worsens, if you develop new symptoms, or if you think you may have a serious medical problem, seek immediate medical attention.
Ketoprofen Kombivet description
Each 100-g gel contains Ketoprofen [2-(3-benzoyl-phenyl)-propionic acid] 2.5 g and the following excipients: Carboxypolymethylene 2 g; ethyl alcohol 40 mL; esters of p-hydroxybenzoic acid 0.1 g; neroli oil 0.05 mL; lavender oil 0.1 mL; triethanolamine 1.35 g; distilled water qs.
Ketoprofen Kombivet dosage
Carefully consider the potential benefits and risks of Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet and other treatment options before deciding to use Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet, the dose and frequency should be adjusted to suit an individual patients needs.
Concomitant use of Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet 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 Kombivet (Ketoprofen Kombivet) 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 Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet 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 Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet 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 Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet 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 Ketoprofen Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet 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 Kombivet 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 Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet and closely monitored.
Rheumatoid Arthritis and Osteoarthritis
The recommended starting dose of Ketoprofen Kombivet in otherwise healthy patients is for Ketoprofen Kombivet (Ketoprofen Kombivet) 75 mg three times or 50 mg four times a day, or for Ketoprofen Kombivet 200 mg administered once a day. Smaller doses of Ketoprofen Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of Ketoprofen Kombivet is 300 mg/day for Ketoprofen Kombivet (Ketoprofen Kombivet) or 200 mg/day for Ketoprofen Kombivet.
Dosages higher than 300 mg/day of Ketoprofen Kombivet (Ketoprofen Kombivet) or 200 mg/day of Ketoprofen Kombivet are not recommended because they have not been studied. Concomitant use of Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet is not recommended. Relatively smaller people may need smaller doses.
As with other nonsteroidal anti-inflammatory drugs, the predominant adverse effects of Ketoprofen Kombivet are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that Ketoprofen Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet be taken with antacids, food, or milk. Although food delays the absorption of both formulations, in most of the clinical trials Ketoprofen Kombivet was taken with food or milk.
Physicians may want to make specific recommendations to patients about when they should take Ketoprofen Kombivet (Ketoprofen Kombivet) or Ketoprofen Kombivet 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 Ketoprofen Kombivet (Ketoprofen Kombivet) 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 Ketoprofen Kombivet (Ketoprofen Kombivet) should be used with caution and patients receiving them observed carefully.
Ketoprofen Kombivet is not recommended for use in treating acute pain because of its extended-release characteristics.
How supplied
Ketoprofen Kombivet® (Ketoprofen Kombivet) Capsules are available as follows:
25 mg, NDC 0008-4186, dark-green and red capsule marked WYETH 4186 on one side and Ketoprofen Kombivet (Ketoprofen Kombivet) 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 Ketoprofen Kombivet (Ketoprofen Kombivet) 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 Ketoprofen Kombivet (Ketoprofen Kombivet) 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.
Ketoprofen Kombivet® (Ketoprofen Kombivet) Extended-Release Capsules are available as follows:
100 mg, NDC 0008-0821, opaque pink and dark-green capsule marked with two radial bands and Ketoprofen Kombivet 100 in bottles of 100 capsules.
150 mg, NDC 0008-0822, opaque pink and light-green capsule marked with two radial bands and Ketoprofen Kombivet 150 in bottles of 100 capsules.
200 mg, NDC 0008-0690, opaque pink and off-white capsule marked with two radial bands and Ketoprofen Kombivet 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.
Ketoprofen Kombivet 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.
Ketoprofen Kombivet (Ketoprofen Kombivet) Capsules manufactured and distributed by Wyeth Pharmaceuticals
Ketoprofen Kombivet Capsules distributed by Wyeth Pharmaceuticals
Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101
Rev 07/05
FDA rev date: 01/18/06
Ketoprofen Kombivet interactions
See also:
What other drugs will affect Ketoprofen Kombivet?
The following drug interactions were studied with Ketoprofen Kombivet doses of 200 mg/day. The possibility of increased interaction should be kept in mind when Ketoprofen Kombivet doses greater than 50 mg as a single dose or 200 mg of Ketoprofen Kombivet 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 Ketoprofen Kombivet administered as Ketoprofen Kombivet.
2. Aspirin: Ketoprofen Kombivet does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased Ketoprofen Kombivet protein binding and increased Ketoprofen Kombivet 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 Ketoprofen Kombivet is not recommended.
3. Diuretic: Hydrochlorothiazide, given concomitantly with Ketoprofen Kombivet, 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 Ketoprofen Kombivet and digoxin were concomitantly administered, Ketoprofen Kombivet did not alter the serum levels of digoxin.
5. Warfarin: In a short-term controlled study in 14 normal volunteers, Ketoprofen Kombivet 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 Ketoprofen Kombivet treatment. Because prostaglandina play an important role in hemostasis and Ketoprofen Kombivet has an effect on platelet function as well, concurent therapy with Ketoprofen Kombivet and warfarin requires close monitoring of patients on both drugs.
6. Probenecid: Probenecid increases both free and bound Ketoprofen Kombivet by reducing the plasma clearance of Ketoprofen Kombivet to about one-third, as well as decreasing its protein binding. Therefore, the combination of Ketoprofen Kombivet and probenecid is not recommended.
7. Methotrexate: Ketoprofen Kombivet, 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 Ketoprofen Kombivet is coadministered with lithium.
DRUG/LABORATORY TEST INTERACTIONS: EFFECT ON BLOOD COAGULATION
Ketoprofen Kombivet 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.
Ketoprofen Kombivet side effects
See also:
What are the possible side effects of Ketoprofen Kombivet?
The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Ketoprofen Kombivet (Ketoprofen Kombivet) -treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Ketoprofen Kombivet-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 Kombivet (Ketoprofen Kombivet) once a day or 75 mg of Ketoprofen Kombivet (Ketoprofen Kombivet) 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.
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. 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.
Incidence Greater than 1% (Probable Causal Relationship)
Digestive: Dyspepsia (11%), nausea*, abdominal pain*, diarrhea*, constipation*, flatulence*, anorexia, vomiting, stomatitis.
Nervous System: Headache*, dizziness, CNS inhibition (i.e., pooled reports of somnolence, malaise, depression, etc.) or excitation (i.e., insomnia, nervousness, dreams, etc.)*.
Special Senses: Tinnitus, visual disturbance.
Skin and Appendages: Rash.
Urogenital: Impairment of renal function (edema, increased BUN)*, signs or symptoms of urinary-tract irritation.
* Adverse events occurring in 3 to 9% of patients.
Incidence Less than 1% (Probable Causal Relationship)
Body as a Whole: Chills, facial edema, infection, pain, allergic reaction, anaphylaxis.
Cardiovascular: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation.
Digestive: Appetite increased, dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, peptic ulcer, gastrointestinal perforation, hematemesis, intestinal ulceration, hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice.
Hemic: Hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, thrombocytopenia.
Metabolic and Nutritional: Thirst, weight gain, weight loss, hyponatremia.
Musculoskeletal: Myalgia.
Nervous System: Amnesia, confusion, impotence, migraine, paresthesia, vertigo.
Respiratory: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema.
Skin and Appendages: Alopecia, eczema, pruritus, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.
Special Senses: Conjunctivitis, conjunctivitis sicca, eye pain, hearing impairment, retinal hemorrhage and pigmentation change, taste perversion.
Urogenital: Menometrorrhagia, hematuria, renal failure, interstitial nephritis, nephrotic syndrome.
Incidence Less than 1% (Causal Relationship Unknown)
The following rare adverse reactions, whose causal relationship to Ketoprofen Kombivet is uncertain, are being listed to serve as alerting information to the physician.
Body as a Whole: Septicemia, shock.
Cardiovascular: Arrhythmias, myocardial infarction.
Digestive: Buccal necrosis, ulcerative colitis, microvesicular steatosis, pancreatitis.
Endocrine: Diabetes mellitus (aggravated).
Nervous System: Dysphoria, hallucination, libido disturbance, nightmares, personality disorder, aseptic meningitis.
Urogenital: Acute tubulopathy, gynecomastia.
Ketoprofen Kombivet contraindications
See also:
What is the most important information I should know about Ketoprofen Kombivet?
Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet are contraindicated in patients who have shown hypersensitivity to Ketoprofen Kombivet.
Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet 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 Kombivet have been reported in such patients.
Ketoprofen Kombivet (Ketoprofen Kombivet) and Ketoprofen Kombivet are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Active ingredient matches for Ketoprofen Kombivet:
Ketoprofen in Netherlands.
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).
- PubChem. "ketoprofen". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ketoprofen". http://www.drugbank.ca/drugs/DB01009 (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
