Zenflox-PLUS Overdose

How do you administer this medicine?
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Consists of cefixime, ofloxacin

What happens if I overdose Cefixime (Zenflox-PLUS)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Cefixime (Zenflox-PLUS):

Store Cefixime (Zenflox-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 (Zenflox-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 (Zenflox-PLUS) out of the reach of children and away from pets.

Overdose of Cefixime (Zenflox-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 (Zenflox-PLUS) in humans. In healthy adults who received Cefixime (Zenflox-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 (Zenflox-PLUS) toxicity. In case of acute overdosage, gastric lavage may be indicated. Cefixime (Zenflox-PLUS) is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis.

What should I avoid while taking Cefixime (Zenflox-PLUS)?

Avoid using antacids within 1 hour before or after taking Cefixime (Zenflox-PLUS). Antacids can make it harder for your body to absorb Cefixime (Zenflox-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 (Zenflox-PLUS) and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Cefixime (Zenflox-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 (Zenflox-PLUS).

Before therapy with Cefixime (Zenflox-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 (Zenflox-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 (Zenflox-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 (Zenflox-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 (Zenflox-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 (Zenflox-PLUS) (Cefixime (Zenflox-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 (Zenflox-PLUS)?

Some medical conditions may interact with Cefixime (Zenflox-PLUS). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Cefixime (Zenflox-PLUS). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Ask your health care provider if Cefixime (Zenflox-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 (Zenflox-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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Hypersensitivity Reactions: Careful inquiry should be made prior to Cefixime (Zenflox-PLUS) 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 Cefixime (Zenflox-PLUS), 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 Cefixime (Zenflox-PLUS). When severe cutaneous adverse reactions occur, Cefixime (Zenflox-PLUS) 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 Cefixime (Zenflox-PLUS), 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: Cefixime (Zenflox-PLUS) 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 Cefixime (Zenflox-PLUS). 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 Cefixime (Zenflox-PLUS), 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, Cefixime (Zenflox-PLUS) may cause acute renal failure including tubulointerstitial nephritis. In case of renal failure, Cefixime (Zenflox-PLUS) 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, Cefixime (Zenflox-PLUS) should be discontinued and anticonvulsant therapy initiated as clinically indicated.

Other Precautions: As with other broad-spectrum antibiotics, Cefixime (Zenflox-PLUS) should be given with caution in individuals with a history of colitis. The safety and efficacy of Cefixime (Zenflox-PLUS) have not been established in patients with gastrointestinal malabsorption.

Prescribing Cefixime (Zenflox-PLUS) 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 Cefixime (Zenflox-PLUS) is excreted in human milk. Consideration should be given to discontinuing breastfeeding temporarily during treatment with Cefixime (Zenflox-PLUS).

Use in children: The safety and efficacy of Cefixime (Zenflox-PLUS) in children <6 months have not been established. The incidence of gastrointestinal adverse reactions eg, diarrhea and loose stools, in children receiving Cefixime (Zenflox-PLUS), was comparable to the incidence seen in adults receiving Cefixime (Zenflox-PLUS) 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 Cefixime (Zenflox-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 (Zenflox-PLUS)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Ofloxacin (Zenflox-PLUS) may be harmful if swallowed.

Proper storage of Ofloxacin (Zenflox-PLUS):

Store Ofloxacin (Zenflox-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 (Zenflox-PLUS) out of the reach of children and away from pets.

Overdose of Ofloxacin (Zenflox-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 (Zenflox-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:

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 (Zenflox-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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Tendinopathy and Tendon Rupture

Fluoroquinolones, including Ofloxacin (Zenflox-PLUS)® (ofloxacin), are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ofloxacin (Zenflox-PLUS)® (ofloxacin) should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

THE SAFETY AND EFFICACY OF OFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

In the immature rat, the oral administration of ofloxacin at 5 to 16 times the recommended maximum human dose based on mg/kg or 1-3 times based on mg/m² increased the incidence and severity of osteochondrosis. The lesions did not regress after 13 weeks of drug withdrawal. Other quinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including Ofloxacin (Zenflox-PLUS)® (ofloxacin), have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Ofloxacin (Zenflox-PLUS)® (ofloxacin) in patients with a known history of myasthenia gravis.

Central Nervous System Effects

Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ofloxacin. Quinolones, including ofloxacin, may also cause central nervous system stimulation which may lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ofloxacin, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with ofloxacin than some other products in the quinolone class. As with all quinolones, ofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including ofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. This drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ofloxacin. Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ofloxacin (Zenflox-PLUS)® (ofloxacin), 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 strains 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.

Ofloxacin has not been shown to be effective in the treatment of syphilis.

Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with ofloxacin for gonorrhea should have a follow-up serologic test for syphilis after three months and, if positive, treatment with an appropriate antimicrobial should be instituted.

What should I discuss with my healthcare provider before taking Ofloxacin (Zenflox-PLUS)?

Some medical conditions may interact with Ofloxacin (Zenflox-PLUS). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Ofloxacin (Zenflox-PLUS). Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ofloxacin (Zenflox-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.

Ofloxacin (Zenflox-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 (Zenflox-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 (Zenflox-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:

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 (Zenflox-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

  1. 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).
  2. DailyMed. "NITAZOXANIDE: 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).
  3. 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).

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