What happens if I overdose Febrilek?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).
Overdose of Febrilek in details
There is no specific antidote to overdose with Ibuprofen (Febrilek). Gastric lavage may be performed and if necessary, blood electrolytes corrected.
What should I avoid while taking Febrilek?
Ask a doctor or pharmacist before using any other cough, cold, or pain medicine. Febrilek are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains Ibuprofen (Febrilek) or Pseudoephedrine (Febrilek).
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Febrilek warnings
General: Blurred and/or diminished vision, Fluid retention and edema,.
Liver effects: borderline elevations of one or more liver function tests may occur in up to 15% of patients. Severe hepatic reactions, including jaundice and cases of fatal hepatitis, have been reported.
Hemoglobin levels: in cross-study comparisons with doses ranging from 1200 mg to 3200 mg daily for several weeks, a slight dose-response decrease in hemoglobin/hematocrit was noted.
Aseptic meningitis: aseptic meningitis with fever and coma has been observed on rare occasions.
Renal effects: there have been reports of acute interstitial nephritis with hematuria, proteinuria, and occasionally nephrotic syndrome.
Since Ibuprofen (Febrilek) is eliminated primarily by the kidneys, patients with significantly impaired renal function should be closely monitored; and a reduction in dosage should be anticipated to avoid drug accumulation.
What should I discuss with my healthcare provider before taking Febrilek?
Do not use this medication just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Ibuprofen (Febrilek) may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.
Ibuprofen (Febrilek) may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Ibuprofen (Febrilek), especially in older adults.
Do not use Febrilek if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
You should not use this medication if you are allergic to Ibuprofen (Febrilek) or Pseudoephedrine (Febrilek), or if you have:
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a stomach ulcer or active bleeding in your stomach or intestines;
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polyps in your nose; or
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a history of allergic reaction to aspirin or other NSAIDs.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
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a history of stomach ulcers or bleeding;
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heart disease, congestive heart failure, high blood pressure;
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systemic lupus erythematosus (SLE);
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liver or kidney disease;
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a thyroid disorder;
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diabetes;
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enlarged prostate or problems with urination;
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a bleeding or blood clotting disorder; or
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if you smoke.
Taking Ibuprofen (Febrilek) during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not take this medication without medical advice if you are pregnant.
It is not known whether Febrilek passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Febrilek precautions
Febrilek should be given with care to the elderly, to patients with cardiovascular disease, and in liver or renal failure. Febrilek should be discontinued in patients who experience blurred or diminished vision, or changes in colour vision. Patients with collagen disease may be at increased risk of developing aseptic meningitis.
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Risk: 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 angiotensin-converting enzyme (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 Febrilek in patients with advanced renal disease. Therefore, treatment with Febrilek is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient’s renal function is advisable.
Syrup: Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion or renal insufficiency require local synthesis of vasodilating prostagalndins to maintain renal perfusion, and therefore, these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
Febrilek should be given with care to patients who have asthma or have suffered from asthma. If child's (aged >6 months) symptoms persist for >3 days, consult a physician. For children <6 months, medical advise should be sought after 24 hrs use (3 doses) if symptoms persist.
Use in pregnancy & lactation: Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen (Febrilek) during pregnancy should, if possible, be avoided.
In the limited studies so far available, Ibuprofen (Febrilek) appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.
Use in children: Consult the doctor if the child's symptoms (eg, earache) persist for >3 days.
What happens if I miss a dose of Febrilek?
Since cold medicine is usually taken only 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "PSEUDOEPHEDRINE SULFATE: 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).
- DailyMed. "IBUPROFEN: 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. "ibuprofen". http://www.drugbank.ca/drugs/DB01050 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
