What happens if I overdose Ketoret?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.
Proper storage of Ketoret extended-release capsules:
Store Ketoret extended-release capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketoret extended-release capsules out of the reach of children and away from pets.
Overdose of Ketoret in details
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 Ketoret 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 Ketoret’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 Ketoret and 1 or 2 tablets of acetaminophen with hydrocodone. Her Ketoret 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 Ketoret 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.
What should I avoid while taking Ketoret?
Do not take Ketoret regular capsules and extended-release capsules at the same time.
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin while you are taking Ketoret.
Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to Ketoret. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, Ketoret, or naproxen.
Ketoret warnings
Ketoret or Ketoret contain Ketoret. Like other drugs of its class, Ketoret is not free of side effects. The side effects of these drugs can cause discomfort and rarely, there are more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes. 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 and likely benefits of NSAID treatment, particularly when the drugs are used for less serious conditions where treatment without NSAIDs might represent an acceptable altemative to both the patient and physicisn.
Because aspirin causes an increase in the level of unbound Ketoret, patients should be advised not to take aspirin while taking Ketoret. It is possible that minor adverse symptoms of gastric intolerance may be prevented by administering Ketoret with antacids, food or milk. Ketoret has not been studied with antacids. 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 Ketoret in relation to food and/ or what patients should do if they experience minor Gi symptoms associated with Ketoret therapy.
What should I discuss with my healthcare provider before taking Ketoret?
Some medical conditions may interact with Ketoret extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal product, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
- if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
- if you have high blood pressure, blood disorders (eg, low blood albumin levels), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
- if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Ketoret extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because risk of stomach bleeding may be increased
- Probenecid because it may increase the risk of Ketoret extended-release capsules's side effects
- Cyclosporine, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Ketoret extended-release capsules
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Ketoret extended-release capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ketoret extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Ketoret precautions
General
Ketoret (Ketoret) and Ketoret 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 Ketoret (Ketoret) and Ketoret in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Ketoret and other nonsteroidal 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 Ketoret 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 nonsteroidal 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 nonsteroidal anti-inflammatory drug therapy is typically followed by recovery to the pretreatment state.
Since Ketoret 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 Ketoret and/or its metabolites.
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Ketoret (Ketoret) and Ketoret. 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 Ketoret (Ketoret) or Ketoret. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Ketoret (Ketoret) or Ketoret should be discontinued.
In patients with chronic liver disease with reduced serum albumin levels, ketoprofens pharmacokinetics are altered. Such patients should be closely monitored, and a reduction of dosage should be anticipated to avoid high blood levels of Ketoret and/or its metabolites.
Hematological Effects
Anemia is sometimes seen in patients receiving NSAIDs, including Ketoret (Ketoret) and Ketoret. 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 Ketoret (Ketoret) or Ketoret, 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 Ketoret (Ketoret) or Ketoret 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 nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Ketoret (Ketoret) or Ketoret should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Laboratory Tests
Because serious GI-tract ulceration 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, Ketoret (Ketoret) and Ketoret should be discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chronic oral toxicity studies in mice (up to 32 mg/kg/day; 96 mg/m/day; approximately 0.3 times the maximum human therapeutic dose) did not affect perinatal development. Upon administration to lactating dogs, the milk concentration of Ketoret was found to be 4 to 5% of the plasma drug level. As with other drugs that are excreted in milk, Ketoret is not recommended for use in nursing mothers.
Pediatric Use
Safety and effectiveness in pediatric patients blow 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, Ketoret clearance was reduced in older patients receiving Ketoret or Ketoret, compared with younger patients. Peak Ketoret concentrations and free drug AUC were increased in older patients. The glucuronide conjugate of Ketoret, 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 Ketoret (Ketoret) or Ketoret should be reduced for patients over 75 years of age and it may be useful to monitor renal function. 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. 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.
In Ketoret (Ketoret) 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 Ketoret (Ketoret) acute pain studies, 23 (5%) of 484 patients were ≥60 years of age. In Ketoret clinical studies, 356 (42%) of 840 osteoarthritis or rheumatoid arthritis patients were ≥65 years of age, and less than 100 of these were ≥75 years of age. No overall differences in effectiveness were observed between these patients and younger patients.
What happens if I miss a dose of Ketoret?
Since Ketoret is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
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).
- DrugBank. "ketoprofen". http://www.drugbank.ca/drugs/DB01009 (accessed September 17, 2018).
- MeSH. "Anti-Inflammatory Agents, Non-Steroidal". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
