|
|||
|
DRUGS & SUPPLEMENTS
|
Active ingredient: Ketoprofen Sodium
How often in a day do you take medicine? How many times? |
Ketoprofen Sodium uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- Ketoprofen capsule
- Ketoprofen
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ketoprofen Sodium capsules USP and other treatment options before deciding to use Ketoprofen Sodium capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ketoprofen Sodium capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ketoprofen Sodium capsules USP are indicated for the management of pain. Ketoprofen Sodium capsules USP are also indicated for treatment of primary dysmenorrhea.
CONTRAINDICATIONS
Ketoprofen Sodium capsules are contraindicated in patients who have shown hypersensitivity to Ketoprofen Sodium.
Ketoprofen Sodium 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 Sodium have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma).
Ketoprofen Sodium capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
WARNINGS
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 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. However, patients with known CV
disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events,
due to their increased baseline rate. Some observational studies found that this increased risk of
serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV
thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest
effective dose for the shortest duration possible. Physicians and patients should remain alert for
the development of such events, throughout the entire treatment course, even in the absence of
previous CV symptoms. Patients should be informed about the symptoms of serious CV events
and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of
serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an
NSAID, such as Ketoprofen Sodium, increases the risk of serious gastrointestinal (GI) events (see
WARNINGS).
Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the
first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS).
Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients
treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related
death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the
incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated
patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the
absolute rate of death declined somewhat after the first year post-MI, the increased relative risk
of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of Ketoprofen Sodium capsules in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Ketoprofen Sodium capsules are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension
NSAIDs, including Ketoprofen Sodium capsules, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Ketoprofen Sodium capsules, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Heart Failure and Edema
The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of Ketoprofen Sodium may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers ] (see DRUG INTERACTIONS).
Avoid the use of Ketoprofen Sodium capsules in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Ketoprofen Sodium capsules are used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
NSAIDs, including Ketoprofen Sodium capsules, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation, of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10 fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Renal Effects
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a non-steroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of Ketoprofen Sodium capsules in patients with advanced renal disease. Therefore, treatment with Ketoprofen Sodium capsules is not recommended in these patients with advanced renal disease. If Ketoprofen Sodium capsule therapy must be initiated, close monitoring of the patient's renal function is advisable.
Anaphylactoid Reactions
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Ketoprofen Sodium capsules. Ketoprofen Sodium capsules should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Skin Reactions
NSAIDs, including Ketoprofen Sodium capsules, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Pregnancy
In late pregnancy, as with other NSAIDs, Ketoprofen Sodium capsules should be avoided because they may cause premature closure of the ductus arteriosus.
PRECAUTIONS
General
Ketoprofen Sodium capsules cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
If steroid dosage is reduced or eliminated during therapy, it should be reduced slowly and the patients observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
The pharmacological activity of Ketoprofen Sodium capsules in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Ketoprofen Sodium and other non-steroidal anti-inflammatory drugs cause nephritis in mice and rats associated with chronic administration. Rare cases of interstitial nephritis or nephrotic syndrome have been reported in humans with Ketoprofen Sodium since it has been marketed.
A second form of renal toxicity has been seen in patients with conditions leading to a reduction in renal blood flow or blood volume, where renal prostaglandins have a supportive role in the maintenance of renal blood flow. In these patients, administration of a non-steroidal anti-inflammatory drug results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in renal blood flow which may precipitate overt renal failure. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly. Discontinuation of non-steroidal anti-inflammatory drug therapy is typically followed by recovery to the pretreatment state.
Since Ketoprofen Sodium is primarily eliminated by the kidneys and its pharmacokinetics are altered by renal failure, patients with significantly impaired renal function should be closely monitored, and a reduction of dosage should be anticipated to avoid accumulation of Ketoprofen Sodium and/or its metabolites (see DOSAGE AND ADMINISTRATION).
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Ketoprofen Sodium capsules. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice, and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Ketoprofen Sodium capsules. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Ketoprofen Sodium capsules should be discontinued.
In patients with chronic liver disease with reduced serum albumin levels, ketoprofen’s pharmacokinetics are altered (see CLINICAL PHARMACOLOGY). Such patients should be closely monitored, and a reduction of dosage should be anticipated to avoid high blood levels of Ketoprofen Sodium and/or its metabolites (see DOSAGE AND ADMINISTRATION).
Hematological Effects
Anemia is sometimes seen in patients receiving NSAIDs, including Ketoprofen Sodium capsules. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Ketoprofen Sodium capsules, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Ketoprofen Sodium capsules who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Preexisting Asthma
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other non-steroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Ketoprofen Sodium capsules should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Information for Patients
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.
- 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 health care provider immediately.
- Ketoprofen Sodium capsules, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation).
- Ketoprofen Sodium capsules, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
- Heart Failure and Edema
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS).
- Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
- Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS).
- In late pregnancy, as with other NSAIDs, Ketoprofen Sodium capsules should be avoided because they may cause premature closure of the ductus arteriosus.
NSAIDs are often essential agents in the management of arthritis and have a major role in the treatment of pain, but they also may be commonly employed for conditions which are less serious. Physicians may wish to discuss with their patients the potential risks (see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS) and likely benefits of NSAID treatment, particularly when the drugs are used for less serious conditions where treatment without NSAIDs may represent an acceptable alternative to both the patient and physician.
Because aspirin causes an increase in the level of unbound Ketoprofen Sodium, patients should be advised not to take aspirin while taking Ketoprofen Sodium (see Drug Interactions). It is possible that minor adverse symptoms of gastric intolerance may be prevented by administering Ketoprofen Sodium capsules with antacids, food, or milk. Because food and milk do affect the rate but not the extent of absorption (see CLINICAL PHARMACOLOGY), physicians may want to make specific recommendations to patients about when they should take Ketoprofen Sodium in relation to food and/or what patients should do if they experience minor GI symptoms associated with Ketoprofen Sodium therapy.
Laboratory Tests
Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs, should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, Ketoprofen Sodium capsules should be discontinued.
Drug Interactions
The following drug interactions were studied with Ketoprofen Sodium doses of 200 mg/day. The possibility of increased interaction should be kept in mind when Ketoprofen Sodium capsule doses greater than 50 mg as a single dose or 200 mg of Ketoprofen Sodium 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.
Antacids
Concomitant administration of magnesium hydroxide and aluminum hydroxide does not interfere with the rate or extent of the absorption of Ketoprofen Sodium administered as Ketoprofen Sodium capsules.
Aspirin
Ketoprofen Sodium does not alter aspirin absorption; however, in a study of 12 normal subjects, concurrent administration of aspirin decreased Ketoprofen Sodium protein binding and increased Ketoprofen Sodium plasma clearance from 0.07 L/kg/h without aspirin to 0.11 L/kg/h with aspirin. The clinical significance of these changes is not known; however, as with other NSAIDs, concomitant administration of Ketoprofen Sodium and aspirin is not generally recommended because of the potential of increased adverse effects.
Diuretics
NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. Hydrochlorothiazide, given concomitantly with Ketoprofen Sodium, 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. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
Digoxin
In a study in 12 patients with congestive heart failure where Ketoprofen Sodium and digoxin were concomitantly administered, Ketoprofen Sodium did not alter the serum levels of digoxin.
Lithium
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Methotrexate
Ketoprofen Sodium, like other NSAIDs, may cause changes in the elimination of methotrexate leading to elevated serum levels of the drug and increased toxicity. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Probenecid
Probenecid increases both free and bound Ketoprofen Sodium by reducing the plasma clearance of Ketoprofen Sodium to about one-third, as well as decreasing its protein binding. Therefore, the combination of Ketoprofen Sodium and probenecid is not recommended.
Warfarin
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. In a short-term controlled study in 14 normal volunteers, Ketoprofen Sodium 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 Sodium treatment. Because prostaglandins play an important role in hemostasis and Ketoprofen Sodium has an effect on platelet function as well, concurrent therapy with Ketoprofen Sodium and warfarin requires close monitoring of patients on both drugs.
Drug/Laboratory Test Interactions
Effect on Blood Coagulation
Ketoprofen Sodium 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chronic oral toxicity studies in mice did not indicate a carcinogenic potential for Ketoprofen Sodium. The maximum recommended human therapeutic dose is 300 mg/day for a 60 kg patient with a body surface area of 1.6 m2, which is 5 mg/kg/day or 185 mg/m2/day. Thus the mice were treated at 0.5 times the maximum human daily dose based on surface area.
A 2 year carcinogenicity study in rats, using doses up to 6.0 mg/kg/day (36 mg/m2/day), showed no evidence of tumorigenic potential. All groups were treated for 104 weeks except the females receiving 6.0 mg/kg/day (36 mg/m2/day) where the drug treatment was terminated in week 81 because of low survival; the remaining rats were sacrificed after week 87. Their survival in the groups treated for 104 weeks was within 6% of the control group. An earlier 2 year study with doses up to 12.5 mg/kg/day (75 mg/m2/day) also showed no evidence of tumorigenicity, but the survival rate was low and the study was therefore judged inconclusive. Ketoprofen Sodium did not show mutagenic potential in the Ames Test. Ketoprofen Sodium administered to male rats (up to 9 mg/kg/day; or 54 mg/m2/day) had no significant effect on reproductive performance or fertility. In female rats administered 6 or 9 mg/kg/day (36 or 54 mg/m2/day), a decrease in the number of implantation sites has been noted. The dosages of 36 mg/m2/day in rats represent 0.2 times the maximum recommended human dose of 185 mg/m2/day.
Abnormal spermatogenesis or inhibition of spermatogenesis developed in rats and dogs at high doses, and a decrease in the weight of the testes occurred in dogs and baboons at high doses.
Pregnancy
Teratogenic Effects
Pregnancy category C
In teratology studies Ketoprofen Sodium administered to mice at doses up to 12 mg/kg/day and rats at doses up to 9 mg/kg/day (54 mg/m2/day), the approximate equivalent of 0.2 times the maximum recommended therapeutic dose of 185 mg/m2/day, showed no teratogenic or embryotoxic effects. In separate studies in rabbits, maternally toxic doses were associated with embryotoxicity but not teratogenicity. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Ketoprofen Sodium capsules should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects
Because of the known effects of non-steroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
Labor and Delivery
The effects of Ketoprofen Sodium on labor and delivery in pregnant women are unknown. Studies in rats have shown Ketoprofen Sodium at doses of 6 mg/kg prolongs pregnancy when given before the onset of labor. Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), use of Ketoprofen Sodium during late pregnancy should be avoided.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Data on secretion in human milk after ingestion of Ketoprofen Sodium do not exist. In rats, Ketoprofen Sodium at doses of 9 mg/kg (54 mg/m2/day; approximately 0.3 times the maximum human therapeutic dose) did not affect perinatal development. Upon administration to lactating dogs, the milk concentration of Ketoprofen Sodium was found to be 4 to 5% of the plasma drug level. As with other drugs that are excreted in milk, Ketoprofen Sodium is not recommended for use in nursing mothers.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 18 have not been established.
Geriatric Use
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older). In pharmacokinetic studies, Ketoprofen Sodium clearance was reduced in older patients receiving Ketoprofen Sodium capsules, compared with younger patients. Peak Ketoprofen Sodium concentrations and free drug AUC were increased in older patients (see Special Populations). The glucuronide conjugate of Ketoprofen Sodium, which can serve as a potential reservoir for the parent drug, is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. It is recommended that the initial dosage of Ketoprofen Sodium capsules should be reduced for patients over 75 years of age and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION). In addition, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients may be more sensitive to the antiprostaglandin effects of NSAIDs (on the gastrointestinal tract and kidneys) than younger patients (see WARNINGS and PRECAUTIONS). In particular, elderly or debilitated patients who receive NSAID therapy seem to tolerate gastrointestinal ulceration or bleeding less well than other individuals, and most spontaneous reports of fatal GI events are in this population. Therefore, caution should be exercised in treating the elderly, and when individualizing their dosage, extra care should be taken when increasing the dose (see DOSAGE AND ADMINISTRATION).
In Ketoprofen Sodium capsule clinical studies involving a total of 1540 osteoarthritis or rheumatoid arthritis patients, 369 (24%) were ≥ 65 years of age, and 92 (6%) were ≥ 75 years of age. For Ketoprofen Sodium capsule acute pain studies, 23 (5%) of 484 patients were ≥ 60 years of age. No overall differences in effectiveness were observed between these patients and younger patients.
ADVERSE REACTIONS
The incidence of common adverse reactions (above 1%) was obtained from a population of 835 ketoprofen-treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 patients treated with Ketoprofen Sodium extended-release capsules 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 Sodium extended-release capsules once a day or 75 mg of Ketoprofen Sodium immediate-release capsules TID (255 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 WARNINGS).
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 DOSAGE AND ADMINISTRATION). 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 Sodium 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
OVERDOSAGE
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 Sodium 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 or following a large overdose (5 to 10 times the usual dose). This should be accomplished via emesis and/or activated charcoal (60 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 to 2 hours after ingesting an unknown quantity of Ketoprofen Sodium and 1 or 2 tablets of acetaminophen with hydrocodone. Her Ketoprofen Sodium level was 1128 mg/L (56 times the upper therapeutic level of 20 mg/L) 3 to 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 Sodium 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.
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of Ketoprofen Sodium capsules and other treatment options before deciding to use Ketoprofen Sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Ketoprofen Sodium capsules, the dose and frequency should be adjusted to suit an individual patient's needs.
Concomitant use of Ketoprofen Sodium capsules and Ketoprofen Sodium 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 Sodium 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 Sodium capsules is 150 mg. In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m2 or end-stage renal impairment), the maximum total daily dose of Ketoprofen Sodium 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 Sodium capsules should be reduced for patients over 75 years of age (see Geriatric Use).
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 Sodium 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 Sodium 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 Sodium capsules and closely monitored.
Rheumatoid Arthritis and Osteoarthritis
The recommended starting dose of Ketoprofen Sodium capsules in otherwise healthy patients is 75 mg three times or 50 mg four times a day. Smaller doses of Ketoprofen Sodium capsules should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of Ketoprofen Sodium capsules is 300 mg/day.
Dosages higher than 300 mg/day of Ketoprofen Sodium capsules are not recommended because they have not been studied. Concomitant use of Ketoprofen Sodium capsules and Ketoprofen Sodium extended-release capsules is not recommended. Relatively smaller people may need smaller doses.
As with other non-steroidal anti-inflammatory drugs, the predominant adverse effects of Ketoprofen Sodium are gastrointestinal. To attempt to minimize these effects, physicians may wish to prescribe that Ketoprofen Sodium capsules be taken with antacids, food, or milk. Although food delays the absorption of Ketoprofen Sodium capsules (see CLINICAL PHARMACOLOGY), in most of the clinical trials Ketoprofen Sodium was taken with food or milk.
Physicians may want to make specific recommendations to patients about when they should take Ketoprofen Sodium capsules in relation to food and/or what patients should do if they experience minor GI symptoms associated with Ketoprofen Sodium capsules.
Management of Pain and Dysmenorrhea
The usual dose of Ketoprofen Sodium capsules 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 (see PRECAUTIONS). A larger dose may be tried if the patient’s 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 non-steroidal anti-inflammatory drug-side-effect profile, including as its principal adverse effect GI side effects (see WARNINGS and ADVERSE REACTIONS), higher doses of Ketoprofen Sodium capsules should be used with caution and patients receiving them observed carefully.
HOW SUPPLIED
Product: 50090-2729
NDC: 50090-2729-0 45 CAPSULE in a BOTTLE
NDC: 50090-2729-1 20 CAPSULE in a BOTTLE
| Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) | |
| What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? | |
| NSAIDs can cause serious side effects, including: | |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|
|
|
|
|
|
|
|
| NSAIDs should only be used: | |
| |
| |
| |
| What are NSAIDs? | |
| NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. | |
| Who should not take NSAIDs? | |
| Do not take NSAIDs: | |
| |
| |
| Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: | |
| |
| |
| |
| |
| |
| Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. | |
| What are the possible side effects of NSAIDs? | |
| NSAIDs can cause serious side effects, including: | |
| See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” | |
|
|
|
|
|
|
| |
| |
| Get emergency help right away if you get any of the following symptoms: | |
|
|
|
|
| |
| Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: | |
|
|
|
|
| is black and sticky like tar |
|
|
|
|
|
|
| |
| If you take too much of your NSAID, call your healthcare provider or get medical help right away. | |
| These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. | |
| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
| Other information about NSAIDs | |
| |
| |
| General information about the safe and effective use of NSAIDs | |
| Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. | |
| If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. | |
| This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised July 2015 | |
Ketoprofen Sodium CAPSULE
Ketoprofen Sodium
Ketoprofen Sodium available forms, composition, doses:
Indications and Usages:
ATC codes:
ICD-10 codes:
Ketoprofen Sodium destination | category:
Drugs with same active ingredients (Pharmaceutical companies):
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/dailym... (accessed August 28, 2018).
- "ketoprofen". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
- "ketoprofen". http://www.drugbank.ca/drugs/DB0100... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Ketoprofen Sodium?Depending on the reaction of the Ketoprofen Sodium after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ketoprofen Sodium not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Ketoprofen Sodium addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
sdrugs.com conducted a study on Ketoprofen Sodium, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ketoprofen Sodium consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.Visitor reports
Visitor reported useful
No survey data has been collected yetVisitor reported side effects
No survey data has been collected yetVisitor reported price estimates
No survey data has been collected yetVisitor reported frequency of use
No survey data has been collected yetVisitor reported doses
No survey data has been collected yetVisitor reported time for results
No survey data has been collected yetVisitor reported administration
No survey data has been collected yetVisitor reported age
No survey data has been collected yetVisitor reviews
There are no reviews yet. Be the first to write one! |
The information was verified by Dr. Rachana Salvi, MD Pharmacology