Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Zetax-O suspension:
Store Zetax-O suspension 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. Zetax-O suspension 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 Zetax-O suspension out of the reach of children and away from pets.
Overdose of Zetax-O 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.
Symptoms: Limited information is available on the acute toxicity of Zetax-O in humans. In healthy adults who received Zetax-O 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 Zetax-O toxicity. In case of acute overdosage, gastric lavage may be indicated. Zetax-O is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.
What should I avoid while taking Zetax-O?
Avoid using antacids within 1 hour before or after taking Zetax-O. Antacids can make it harder for your body to absorb Zetax-O.
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 Zetax-O and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
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.
Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of Zetax-O.
Before therapy with Zetax-O 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 Zetax-O occurs, discontinue the drug.
Clostridium difficile-Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Zetax-O, 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 Zetax-O 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.
Cephalosporins, including Zetax-O, 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 Zetax-O (Zetax-O) 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 Zetax-O?
Some medical conditions may interact with Zetax-O chewable 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 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, poor nutrition, or phenylketonuria
if you have a history of kidney problems or you are on dialysis treatment
Some MEDICINES MAY INTERACT with Zetax-O chewable tablets. 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 Zetax-O chewable tablets
BCG vaccine or a live typhoid vaccine because their effectiveness may be decreased by Zetax-O chewable tablets
Ask your health care provider if Zetax-O chewable 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.
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.
Hypersensitivity Reactions: Careful inquiry should be made prior to Zetax-O therapy to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. Use with caution in penicillin-sensitive patients since cross-hypersensitivity among β-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of allergy to penicillin. In case of an allergic reaction to Zetax-O, the drug should be discontinued.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous (IV) fluids, IV antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.
Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions including toxic epidermal necrolysis, Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on Zetax-O. When severe cutaneous adverse reactions occur, Zetax-O should be discontinued and appropriate treatment and/or measures should be taken.
Clostridium difficile-Associated Diarrhea (CDAD): This has been reported with the use of nearly all antibacterial agents, including Zetax-O, and may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
Hemolytic Anemia: Zetax-O should not be used in patients with a history of cephalosporin-associated hemolytic anemia since the recurrence of hemolysis is much more severe.
An immune-mediated hemolytic anemia has been observed in patients receiving cephalosporin antibiotics, including Zetax-O. Severe cases of hemolytic anemia, including fatalities, have been reported with cephalosporins in both adults and children. If a patient develops anemia anytime during, or within 2-3 weeks following the administration of Zetax-O, the diagnosis of a cephalosporin-associated anemia should be considered and the drug discontinued until the etiology is determined.
Periodic monitoring of signs and symptoms of hemolytic anemia, including measurement of hematological parameters or drug-induced antibody testing, where appropriate, is recommended.
Acute Renal Failure: As with other cephalosporins, Zetax-O may cause acute renal failure including tubulointerstitial nephritis. In case of renal failure, Zetax-O should be discontinued and appropriate therapy instituted.
Prothrombin Time: Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with kidney or liver 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.
Seizures: These have been reported with several cephalosporins (eg, cefuroxime, ceftazidime), particularly in patients with renal impairment in whom dosage of the drug was not reduced. If seizures occur during treatment with a cephalosporin, Zetax-O should be discontinued and anticonvulsant therapy initiated as clinically indicated.
Other Precautions: As with other broad-spectrum antibiotics, Zetax-O should be given with caution in individuals with a history of colitis. The safety and efficacy of Zetax-O have not been established in patients with gastrointestinal malabsorption.
Prescribing Zetax-O in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of antibiotic resistance.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Renal Impairment: Experience in children with renal impairment is very limited.
Use in pregnancy: (Pregnancy Category B). Reproduction studies performed in mice and rats up to 400 times the human dose have not revealed evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women, and the drug should be used during pregnancy only when clearly needed.
Use in lactation: It is not known whether Zetax-O is excreted in human milk. Consideration should be given to discontinuing breastfeeding temporarily during treatment with Zetax-O.
Use in children: The safety and efficacy of Zetax-O in children <6 months have not been established. The incidence of gastrointestinal adverse reactions eg, diarrhea and loose stools, in children receiving Zetax-O suspension, was comparable to the incidence seen in adults receiving Zetax-O tablets.
Use in the
Elderly: Elderly patients are more likely to have decreased renal function, therefore, care should be taken in dose selection and renal function should be monitored.
What happens if I miss a dose of Zetax-O?
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.
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).