What happens if I overdose Cefixime (Extacef Plus)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Cefixime (Extacef Plus):
Store Cefixime (Extacef Plus) 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. Cefixime (Extacef Plus) may also be stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine after 14 days. Keep Cefixime (Extacef Plus) out of the reach of children and away from pets.
Overdose of Cefixime (Extacef Plus) in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Symptoms: Limited information is available on the acute toxicity of Cefixime (Extacef Plus) in humans. In healthy adults who received Cefixime (Extacef Plus) in single doses up to 2 g, adverse effects were similar to those seen with usual doses of the drug and included mild to moderate adverse GI effects.
Treatment: There is no specific antidote for Cefixime (Extacef Plus) toxicity. In case of acute overdosage, gastric lavage may be indicated. Cefixime (Extacef Plus) is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
What should I avoid while taking Cefixime (Extacef Plus)?
Avoid using antacids within 1 hour before or after taking Cefixime (Extacef Plus). Antacids can make it harder for your body to absorb Cefixime (Extacef Plus).
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Cefixime (Extacef Plus) and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Cefixime (Extacef Plus) warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Hypersensitivity Reactions
Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of Cefixime (Extacef Plus).
Before therapy with Cefixime (Extacef Plus) is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefixime (Extacef Plus) occurs, discontinue the drug.
Clostridium difficile-Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefixime (Extacef Plus), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Dose Adjustment in Renal Impairment
The dose of Cefixime (Extacef Plus) should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully.
Coagulation Effects
Cephalosporins, including Cefixime (Extacef Plus), may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Development of Drug-Resistant Bacteria
Prescribing Cefixime (Extacef Plus) (Cefixime (Extacef Plus)) in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
What should I discuss with my healthcare provider before taking Cefixime (Extacef Plus)?
Some medical conditions may interact with Cefixime (Extacef Plus). 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin (eg, amoxicillin) or beta-lactam antibiotic (eg, imipenem)
if you have diarrhea, stomach or bowel problems (eg, inflammation), bleeding or blood clotting problems, liver problems, or poor nutrition
if you have a history of kidney problems or you are on dialysis treatment
Some MEDICINES MAY INTERACT with Cefixime (Extacef Plus). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Anticoagulants (eg, warfarin) or carbamazepine because the risk of their side effects may be increased by Cefixime (Extacef Plus)
BCG vaccine or a live typhoid vaccine because their effectiveness may be decreased by Cefixime (Extacef Plus)
Ask your health care provider if Cefixime (Extacef Plus) 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.
Cefixime (Extacef Plus) precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Cefixime (Extacef Plus) should be given with caution to patients with renal impairment, a dosage reduction may be necessary. Renal and hematological status should be monitored especially during prolonged and high-dose therapy.
Care is also necessary in patients with a history of allergy.
Cefixime (Extacef Plus) may interfere with the Jaffe's method of measuring creatinine concentrations and may produce falsely high values, this should be borne in mind when measuring renal functions. Positive results to the direct Coombs' test have been found during treatment with Cefixime (Extacef Plus) and these can interfere with blood cross-matching. The urine of the patients being treated with Cefixime (Extacef Plus) may give false positive reaction for glucose using copper reduction reactions.
Use in pregnancy: The safety of Cefixime (Extacef Plus) in the treatment of infection in pregnant women has not been established.
Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefixime (Extacef Plus). Because animal reproduction studies are not always predictive of human response, Cefixime (Extacef Plus) should be used during pregnancy only if the likely benefits of using Cefixime (Extacef Plus) outweighs the potential risk to the fetus and/or the mother.
What happens if I miss a dose of Cefixime (Extacef Plus)?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.
What happens if I overdose Ofloxacin (Extacef Plus)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Ofloxacin (Extacef Plus) may be harmful if swallowed.
Proper storage of Ofloxacin (Extacef Plus):
Store Ofloxacin (Extacef Plus) at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ofloxacin (Extacef Plus) out of the reach of children and away from pets.
Overdose of Ofloxacin (Extacef Plus) in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Information on overdosage with ofloxacin is limited. One incident of accidental overdosage has been reported. In this case, an adult female received 3 grams of ofloxacin intravenously over 45 minutes. A blood sample obtained 15 minutes after the completion of the infusion revealed an ofloxacin level of 39.3 μg/mL. In 7 h, the level had fallen to 16.2 μg/mL, and by 24 h to 2.7 μg/mL. During the infusion, the patient developed drowsiness, nausea, dizziness, hot and cold flushes, subjective facial swelling and numbness, slurring of speech, and mild to moderate disorientation. All complaints except the dizziness subsided within 1 h after discontinuation of the infusion. The dizziness, most bothersome while standing, resolved in approximately 9 h. Laboratory testing reportedly revealed no clinically significant changes in routine parameters in this patient.
In the event of an acute overdose, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Ofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.
What should I avoid while taking Ofloxacin (Extacef Plus)?
You may be taking certain other medicines that should not be taken at the same time as ofloxacin. Avoid taking the following medicines within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time:
antacids that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate);
didanosine (Videx) powder or chewable tablets;
vitamin or mineral supplements that contain aluminum, calcium, iron, magnesium, or zinc.
Avoid exposure to sunlight or tanning beds. Ofloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ofloxacin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Ofloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Ofloxacin (Extacef Plus) warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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PATIENT INFORMATION Patients should be advised:
- to drink fluids liberally
- that mineral supplements, vitamins with iron or minerals, calcium-, aluminum-, or magnesium-based antacids, sucralfate or Videx, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin;
- that ofloxacin can be taken without regard to meals;
- that ofloxacin may cause neurologic adverse effects (e. g., dizziness, lightheadedness) and that patients should know how they react to ofloxacin before they operate an automobile or machinery or engage in activities requiring mental alertness and coordination
- to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded;br
- that ofloxacin may be associated with hypersensitivity reactions, even following the first dose, to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e. g., swelling of the lips, tongue, face; tightness of the throat, hoarseness), or any other symptom of an allergic reaction
- to avoid excessive sunlight or artificial ultraviolet light while receiving ofloxacin and to discontinue therapy if phototoxicity (e. g., skin eruption) occurs;
- that if they are diabetic and are being treated with insulin or an oral hypoglycemic drug, to discontinue ofloxacin immediately if a hypoglycemic reaction occurs and consult a physician
- that convulsions have been reported in patients taking quinolones, including ofloxacin, and to notify their physician before taking this drug if there is a history of this condition.
What should I discuss with my healthcare provider before taking Ofloxacin (Extacef Plus)?
You should not use Ofloxacin (Extacef Plus) if you are allergic to ofloxacin or other fluoroquinolones (ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and others).
To make sure Ofloxacin (Extacef Plus) is safe for you, tell your doctor if you have:
tendon problems, arthritis or other joint problems (especially in children);
a history of myasthenia gravis or other nerve-muscle disorder;
slow heartbeats or other heart rhythm disorder (especially if you take medication to treat it);
personal or family history of long QT syndrome;
liver or kidney disease;
a history of seizures;
diabetes (especially if you take oral diabetes medication);
low levels of potassium in your blood (hypokalemia); or
if you use a blood thinner (warfarin, Coumadin, Jantoven) and have "INR" or prothrombin time tests.
Ofloxacin (Extacef Plus) may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop taking this medicine. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.
Ofloxacin (Extacef Plus) is not approved for use by anyone younger than 18 years old.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ofloxacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Ofloxacin (Extacef Plus).
Ofloxacin (Extacef Plus) precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
General: As with other anti-infective preparations, prolonged use may result in over-growth of nonsusceptible organisms, including fungi. If the infection is not improved after one week, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.
The systemic administration of quinolones, including ofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.
Young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution showed no systemic effects, lesions or erosions of the cartilage in weightbearing joints, or other signs of arthropathy. No drug-related structural or functional changes of the cochlea and no lesions in the ossicles were noted in the guinea pig following otic administration of 0.3% ofloxacin for one month.
No signs of local irritation were found when 0.3% ofloxacin was applied topically in the rabbit eye. Ofloxacin was also shown to lack dermal sensitizing potential in the guinea pig maximization study.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies to determine the carcinogenic potential of ofloxacin have not been conducted. Ofloxacin was not mutagenic in the Ames test, the sister chromatid exchange assay (Chinese hamster and human cell lines), the unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or the mouse micro-nucleus assay. Ofloxacin was positive in the rat hepatocyte UDS assay, and in the mouse lymphoma assay. In rats, ofloxacin did not affect male or female reproductive performance at oral doses up to 360 mg/kg/day. This would be over 1000 times the maximum recommended clinical dose, based upon body surface area, assuming total absorption of ofloxacin from the ear of a patient treated with Ofloxacin (Extacef Plus)® Otic (ofloxacin otic solution) twice per day.
Pregnancy
Teratogenic effects: Pregnancy Category C.
Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day.
These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively.
Ofloxacin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of ofloxacin that will be delivered ototopically at the recommended clinical doses.
Nonteratogenic Effects: Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin (Extacef Plus)® Otic (ofloxacin otic solution) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: In nursing women, a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not
known whether ofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed
Indications:
six months and older: otitis externa with intact tympanic membranes
one year and older: acute otitis media with tympanostomy tubes
twelve years and older: chronic suppurative otitis media with perforated tympanic membranes
Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product.
No changes in hearing function occurred in 30 pediatric subjects treated with ofloxacin otic and tested for audiometric parameters. Although quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution for one month showed no systemic effects, quinoloneinduced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy.
What happens if I miss a dose of Ofloxacin (Extacef Plus)?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of ofloxacin otic unless otherwise directed by your doctor.
References
DailyMed. "OFLOXACIN: 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. "CEFIXIME: 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).
