Profecom Uses

sponsored
Is this medication very expensive?

What is Profecom?

Profecom is a nonsteroidal anti-inflammatory drug (NSAID). Profecom works by reducing hormones that cause inflammation and pain in the body.

Profecom is used to treat pain or inflammation caused by arthritis.

The Profecom regular capsule is also used to treat mild to moderate pain, or menstrual pain.

Only Profecom extended-release capsules are used for treating arthritis. This form of Profecom will not work fast enough to treat acute pain.

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

Profecom indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
sponsored

Carefully consider the potential benefits and risks of Profecom (Profecom) and Profecom and other treatment options before deciding to use Profecom (Profecom) and Profecom. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Profecom (Profecom) and Profecom are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Profecom is not recommended for treatment of acute pain because of its extended-release characteristics is indicated for the management of pain. Profecom (Profecom) is also indicated for treatment of primary dysmenorrhea.

How should I use Profecom?

Use Profecom extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Profecom extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Profecom extended-release capsules refilled.
  • Take Profecom 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 Profecom extended-release capsules whole. Do not break, crush, or chew before swallowing.
  • Take Profecom extended-release capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • If you miss a dose of Profecom 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 Profecom extended-release capsules.

Uses of Profecom in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
sponsored

Use: Labeled Indications

Osteoarthritis: Management of the signs and symptoms of osteoarthritis

Pain (immediate release only): Management of pain

Primary dysmenorrhea (immediate release only): Treatment of primary dysmenorrhea

Rheumatoid arthritis: Management of the signs and symptoms of rheumatoid arthritis

Off Label Uses

Ankylosing spondylitis

Data from a multicenter, randomized, double-blind, placebo- and active-comparator controlled trial supports the use of Profecom in the treatment of ankylosing spondylitis.

Profecom 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.

Profecom dosage

Carefully consider the potential benefits and risks of Profecom (Profecom) and Profecom and other treatment options before deciding to use Profecom (Profecom) and Profecom. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Profecom (Profecom) and Profecom, the dose and frequency should be adjusted to suit an individual patients needs.

Concomitant use of Profecom (Profecom) and Profecom 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 Profecom (Profecom) 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 Profecom (Profecom) or Profecom 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 Profecom (Profecom) or Profecom 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 Profecom (Profecom) or Profecom 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 Profecom (Profecom) or Profecom 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) Profecom 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 Profecom (Profecom) or Profecom and closely monitored.

Rheumatoid Arthritis and Osteoarthritis

The recommended starting dose of Profecom in otherwise healthy patients is for Profecom (Profecom) 75 mg three times or 50 mg four times a day, or for Profecom 200 mg administered once a day. Smaller doses of Profecom (Profecom) or Profecom should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of Profecom is 300 mg/day for Profecom (Profecom) or 200 mg/day for Profecom.

Dosages higher than 300 mg/day of Profecom (Profecom) or 200 mg/day of Profecom are not recommended because they have not been studied. Concomitant use of Profecom (Profecom) and Profecom is not recommended. Relatively smaller people may need smaller doses.

As with other nonsteroidal anti-inflammatory drugs, the predominant adverse effects of Profecom are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that Profecom (Profecom) or Profecom be taken with antacids, food, or milk. Although food delays the absorption of both formulations, in most of the clinical trials Profecom was taken with food or milk.

Physicians may want to make specific recommendations to patients about when they should take Profecom (Profecom) or Profecom 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 Profecom (Profecom) 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 Profecom (Profecom) should be used with caution and patients receiving them observed carefully.

Profecom is not recommended for use in treating acute pain because of its extended-release characteristics.

How supplied

Profecom® (Profecom) Capsules are available as follows:

25 mg, NDC 0008-4186, dark-green and red capsule marked WYETH 4186 on one side and Profecom (Profecom) 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 Profecom (Profecom) 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 Profecom (Profecom) 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.

Profecom® (Profecom) Extended-Release Capsules are available as follows:

100 mg, NDC 0008-0821, opaque pink and dark-green capsule marked with two radial bands and Profecom 100 in bottles of 100 capsules.

150 mg, NDC 0008-0822, opaque pink and light-green capsule marked with two radial bands and Profecom 150 in bottles of 100 capsules.

200 mg, NDC 0008-0690, opaque pink and off-white capsule marked with two radial bands and Profecom 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.

Profecom 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.

Profecom (Profecom) Capsules manufactured and distributed by Wyeth Pharmaceuticals

Profecom Capsules distributed by Wyeth Pharmaceuticals

Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101

Rev 07/05

FDA rev date: 01/18/06

Profecom interactions

See also:
What other drugs will affect Profecom?

sponsored

The following drug interactions were studied with Profecom doses of 200 mg/day. The possibility of increased interaction should be kept in mind when Profecom doses greater than 50 mg as a single dose or 200 mg of Profecom 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 Profecom administered as Profecom.

2. Aspirin: Profecom does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased Profecom protein binding and increased Profecom 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 Profecom is not recommended.

3. Diuretic: Hydrochlorothiazide, given concomitantly with Profecom, 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 Profecom and digoxin were concomitantly administered, Profecom did not alter the serum levels of digoxin.

5. Warfarin: In a short-term controlled study in 14 normal volunteers, Profecom 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 Profecom treatment. Because prostaglandina play an important role in hemostasis and Profecom has an effect on platelet function as well, concurent therapy with Profecom and warfarin requires close monitoring of patients on both drugs.

6. Probenecid: Probenecid increases both free and bound Profecom by reducing the plasma clearance of Profecom to about one-third, as well as decreasing its protein binding. Therefore, the combination of Profecom and probenecid is not recommended.

7. Methotrexate: Profecom, 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 Profecom is coadministered with lithium.

DRUG/LABORATORY TEST INTERACTIONS: EFFECT ON BLOOD COAGULATION

Profecom 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.

Profecom side effects

See also:
What are the possible side effects of Profecom?

sponsored

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Profecom (Profecom) -treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Profecom-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 Profecom (Profecom) once a day or 75 mg of Profecom (Profecom) 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 Profecom 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.

Profecom contraindications

See also:
What is the most important information I should know about Profecom?

Profecom (Profecom) and Profecom are contraindicated in patients who have shown hypersensitivity to Profecom.

Profecom (Profecom) and Profecom 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 Profecom have been reported in such patients.

Profecom (Profecom) and Profecom are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Active ingredient matches for Profecom:

Ketoprofen in Indonesia.


Unit description / dosage (Manufacturer)Price, USD
Profecom 100 mg x 10's$ 11.16

List of Profecom substitutes (brand and generic names):

Capsule; Oral; Ketoprofen 100 mg (Sanofi Group Indonesia)
Capsule; Oral; Ketoprofen 50 mg (Sanofi Group Indonesia)
Gel; Local; Ketoprofen 2.5% (Sanofi Group Indonesia)
Injectable; Injection; Ketoprofen 50 mg / ml (Sanofi Group Indonesia)
Injectable; Subcutaneous; Ketoprofen 100 mg (Sanofi Group Indonesia)
Suppositories; Rectal; Ketoprofen 100 mg (Sanofi Group Indonesia)
Tablet, Film-Coated; Oral; Ketoprofen 100 mg (Sanofi Group Indonesia)
Profenid 200 mg x 14 Tablet (Sanofi Group Indonesia)
Profenid 200 mg x 50's (Sanofi Group Indonesia)$ 54.48
Profenid 100 mg x 100's (Sanofi Group Indonesia)$ 51.38
Profenid 100 mg/2 mL x 2 mL x 6's (Sanofi Group Indonesia)$ 18.89
Profenid 2.5 % x 30 g x 1's (Sanofi Group Indonesia)$ 5.74
Profenid 100 mg x 10's (Sanofi Group Indonesia)$ 13.29
Capsules, Controlled Release; Oral; Ketoprofen 200 mg (Sanofi Group Indonesia)
Capsules; Oral; Ketoprofen 100 mg (Sanofi Group Indonesia)
Capsules; Oral; Ketoprofen 50 mg (Sanofi Group Indonesia)
Gel; Topical; Ketoprofen 2.5% (Sanofi Group Indonesia)
Injectable; Injection; Ketoprofen 100 mg (Sanofi Group Indonesia)
Tablets, Enteric Coated; Oral; Ketoprofen 100 mg (Sanofi Group Indonesia)
Tablets, Film-Coated; Oral; Ketoprofen 100 mg (Sanofi Group Indonesia)
Capsule; Oral; Ketoprofen 100 mg
Capsule; Oral; Ketoprofen 50 mg
Gel; Local; Ketoprofen 2.5%
Injectable; Injection; Ketoprofen 50 mg / ml
Injectable; Subcutaneous; Ketoprofen 100 mg
Suppositories; Rectal; Ketoprofen 100 mg
Tablet, Film-Coated; Oral; Ketoprofen 100 mg
Profenid 200 mg x 14 Tablet
Profenid 200 mg x 50's$ 54.48
Profenid 100 mg x 100's$ 51.38
Profenid 100 mg/2 mL x 2 mL x 6's$ 18.89
Profenid 2.5 % x 30 g x 1's$ 5.74
Profenid 100 mg x 10's$ 13.29
Capsules, Controlled Release; Oral; Ketoprofen 200 mg
Capsules; Oral; Ketoprofen 100 mg
Capsules; Oral; Ketoprofen 50 mg
Gel; Topical; Ketoprofen 2.5%
Injectable; Injection; Ketoprofen 100 mg
Tablets, Enteric Coated; Oral; Ketoprofen 100 mg
Tablets, Film-Coated; Oral; Ketoprofen 100 mg
Capsule; Oral; Ketoprofen 100 mg
Capsule; Oral; Ketoprofen 50 mg
Gel; Local; Ketoprofen 2.5%
Injectable; Injection; Ketoprofen 50 mg / ml
Injectable; Subcutaneous; Ketoprofen 100 mg
Suppositories; Rectal; Ketoprofen 100 mg
Tablet, Film-Coated; Oral; Ketoprofen 100 mg
Profenid 200 mg x 14 Tablet
Profenid 200 mg x 50's$ 54.48
Profenid 100 mg x 100's$ 51.38
Profenid 100 mg/2 mL x 2 mL x 6's$ 18.89
Profenid 2.5 % x 30 g x 1's$ 5.74
Profenid 100 mg x 10's$ 13.29
Capsules, Controlled Release; Oral; Ketoprofen 200 mg
Capsules; Oral; Ketoprofen 100 mg
Capsules; Oral; Ketoprofen 50 mg
Gel; Topical; Ketoprofen 2.5%
Injectable; Injection; Ketoprofen 100 mg
Tablets, Enteric Coated; Oral; Ketoprofen 100 mg
Tablets, Film-Coated; Oral; Ketoprofen 100 mg

References

  1. 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).
  2. PubChem. "ketoprofen". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "ketoprofen". http://www.drugbank.ca/drugs/DB01009 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Profecom 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 Profecom. 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

Consumer reported useful

No survey data has been collected yet


Consumer reported price estimates

No survey data has been collected yet


Consumer reported time for results

No survey data has been collected yet


Consumer reported age

No survey data has been collected yet


Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 18 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2021 ndrugs.com All Rights Reserved