What happens if I overdose Rolacsin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Rolacsin spray:
Store unopened bottles of Rolacsin spray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened bottles of Rolacsin spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container out of direct sunlight. Store upright, away from heat, moisture, and light. Discard opened bottles of Rolacsin spray within 24 hours of opening. Do not store in the bathroom. Keep Rolacsin spray out of the reach of children and away from pets.
Overdose of Rolacsin in details
Symptoms and Signs
Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Treatment
Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.
Single overdoses of Rolacsin Tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.
What should I avoid while taking Rolacsin?
Ask your doctor before using Rolacsin nasal if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist before using any cold, allergy, or other pain medication. Many medicines available over the counter contain aspirin or other medicines similar to Rolacsin. 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, ketoprofen, or naproxen.
Rolacsin warnings
The total combined duration of use of oral Rolacsin Tromethamine and IV or IM dosing of Rolacsin Tromethamine is not to exceed 5 days in adults. Rolacsin Tromethamine is not indicated for use in pediatric patients.
The most serious risks associated with Rolacsin Tromethamine are:
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Gastrointestinal Effects – Risk of Ulceration, Bleeding and Perforation: Rolacsin Tromethamine is contraindicated in patients with previously documented peptic ulcers and/or gastrointestinal (GI) bleeding. Rolacsin Tromethamine can cause serious GI adverse events including 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 Rolacsin Tromethamine.
Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy.
The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with Rolacsin Tromethamine. Do not use Rolacsin Tromethamine for more than five days.
However, even short-term therapy is not without risk. In addition to past history of ulcer disease, 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, 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 Rolacsin Tromethamine until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.
Hemorrhage
Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet aggregation as well, use of Rolacsin Tromethamine in patients who have coagulation disorders should be undertaken very cautiously, and those patients should be carefully monitored. Patients on therapeutic doses of anticoagulants (e.g., heparin or dicumarol derivatives) have an increased risk of bleeding complications if given Rolacsin Tromethamine concurrently; therefore, physicians should administer such concomitant therapy only extremely cautiously. The concurrent use of Rolacsin Tromethamine and therapy that affects hemostasis, including prophylactic low-dose heparin (2500 - 5000 units q12h), warfarin and dextrans have not been studied extensively, but may also be associated with an increased risk of bleeding. Until data from such studies are available, physicians should carefully weigh the benefits against the risks and use such concomitant therapy in these patients only extremely cautiously. Patients receiving therapy that affects hemostasis should be monitored closely.
In postmarketing experience, postoperative hematomas and other signs of wound bleeding have been reported in association with the peri-operative use of IV or IM dosing of Rolacsin Tromethamine.
Therefore, peri-operative use of Rolacsin Tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical.
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 NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest 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.
Rolacsin Tromethamine and its metabolites are eliminated primarily by the kidneys, which, in patients with reduced creatinine clearance, will result in diminished clearance of the drug. Therefore, Rolacsin Tromethamine should be used with caution in patients with impaired renal function and such patients should be followed closely. With the use of Rolacsin Tromethamine, there have been reports of acute renal failure, interstitial nephritis and nephrotic syndrome.
Impaired Renal Function
Rolacsin Tromethamine is contraindicated in patients with serum creatinine concentrations indicating advanced renal impairment. Rolacsin Tromethamine should be used with caution in patients with impaired renal function or a history of kidney disease because it is a potent inhibitor of prostaglandin synthesis. Because patients with underlying renal insufficiency are at increased risk of developing acute renal decompensation or failure, the risks and benefits should be assessed prior to giving Rolacsin Tromethamine to these patients.
Anaphylactoid Reactions
As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Rolacsin Tromethamine. Rolacsin Tromethamine 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.
Cardiovascular Effects
Cardiovascular Thrombotic EventsClinical 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, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or 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 does increase the risk of serious GI events. 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.
Hypertension
NSAIDs, including Rolacsin Tromethamine, can lead to onset of new hypertension or worsening of pre-existing 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 Rolacsin Tromethamine, 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.
Congestive Heart Failure and Edema
Fluid retention, edema, retention of NaCl, oliguria, elevations of serum urea nitrogen and creatinine have been reported in clinical trials with Rolacsin Tromethamine. Therefore, Rolacsin Tromethamine should be used only very cautiously in patients with cardiac decompensation, hypertension or similar conditions.
Skin Reactions
NSAIDs, including Rolacsin Tromethamine, 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, Rolacsin Tromethamine should be avoided because it may cause premature closure of the ductus arteriosus.
What should I discuss with my healthcare provider before taking Rolacsin?
Some medical conditions may interact with Rolacsin tablets. 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 preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, Crohn disease)
- 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, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or you are at risk of any of these diseases
- if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke, drink alcohol, or have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Rolacsin tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin and other blood thinners (eg, dalteparin), pentoxifylline, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding may be increased
- Probenecid because it may increase the risk of Rolacsin tablets's side effects
- Cyclosporine, lithium, metformin, methotrexate, oral NSAIDs (eg, ibuprofen), or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Rolacsin tablets
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Rolacsin tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rolacsin tablets 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.
Rolacsin precautions
Hypovolemia should be corrected before treatment with Rolacsin is initiated.
Fluid retention, edema, retention of sodium chloride, oliguria, elevation of serum urea nitrogen and creatinine have been reported in clinical trials with Rolacsin. Therefore, Rolacsin should be used only very cautiously in patients with cardiac decompensation, hypertension or similar conditions.
Since nonsteroidal anti-inflammatory drugs affect platelet aggregation, use of Rolacsin in patients with coagulation disorders should be undertaken with caution. Concomitant use of Rolacsin and anticoagulants should be administered with extreme caution.
Patients with Impaired Liver Function: Rolacsin should be used with caution in patients with impaired hepatic function or a history of liver disease. Treatment with Rolacsin may cause elevations of liver enzymes. In patients with preexisting liver dysfunction, it may lead to the development of more severe hepatic reaction. The administration of Rolacsin should be discontinued in patients whom abnormal liver function tests have occurred as a result of Rolacsin therapy.
Patients with Impaired Kidney Function: Rolacsin should be used with caution in patients with impaired renal function or a history of kidney disease.
Use in the
Elderly: Elderly people are more sensitive to adverse events, therefore extra caution and reduced dosage is considered in these patients. The total dose should not exceed 60 mg for patients above 65 years.
What happens if I miss a dose of Rolacsin?
Since Rolacsin is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
References
- DrugBank. "ketorolac". http://www.drugbank.ca/drugs/DB00465 (accessed September 17, 2018).
- MeSH. "Cyclooxygenase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
