Fastum Gel

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 WARNINGS ). 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 CLINICAL PHARMACOLOGY: Pharmacokinetics ).

• 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 WARNINGS )
• 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 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. …

• Safety and effectiveness
• In pediatric patients below the age of 18 have not been established

As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older). In pharmacokinetic studies, ketoprofen clearance was reduced in older patients receiving ketoprofen extended-release capsules, compared with younger patients. Peak ketoprofen concentrations and free drug AUC were increased in older patients (see PHARMACOKINETICS: Special Populations ). …

• Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy
• Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. 1
• Cardiovascular Thrombotic Events: Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS ). 2. …

• 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 WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: General: Preexisting Asthma ). …

The following drug interactions were studied with ketoprofen doses of 200 mg/day. The possibility of increased interaction should be kept in mind when ketoprofen immediate-release doses greater than 50 mg as a single dose or 200 mg of ketoprofen per day are used concomitantly with highly bound drugs. ACE Inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. …

Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. …

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 ketoprofen 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. …

Pregnancy Risk Summary Use of NSAIDs, including ketoprofen extended-release capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. …

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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.