Zenflox-PLUS Side effects

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Consists of cefixime, ofloxacin

What are the possible side effects of Cefixime (Zenflox-PLUS)?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Less common Incidence not known

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.

Side effects of Cefixime (Zenflox-PLUS) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Applies to Cefixime (Zenflox-PLUS): oral capsule, oral powder for suspension, oral tablet, oral tablet chewable

As well as its needed effects, Cefixime (Zenflox-PLUS) (the active ingredient contained in Cefixime (Zenflox-PLUS)) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Cefixime (Zenflox-PLUS), check with your doctor immediately:

More common:

Less common: Incidence not known:

Minor Side Effects

Some Cefixime (Zenflox-PLUS) side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

What is the most important information I should know about Cefixime (Zenflox-PLUS)?

Cefixime (Zenflox-PLUS) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Do not take this medication if you are allergic to Cefixime (Zenflox-PLUS), or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin).

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefixime (Zenflox-PLUS) will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What are the possible side effects of Ofloxacin (Zenflox-PLUS)?

Get emergency medical help if you have signs of an allergic reaction to Ofloxacin (Zenflox-PLUS): hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.

Ofloxacin may cause swelling or tearing of (rupture) a tendon. Ofloxacin can also have serious effects on your nerves, and may cause permanent nerve damage.

Stop using Ofloxacin (Zenflox-PLUS) and call your doctor at once if you have:

Common Ofloxacin (Zenflox-PLUS) side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Ofloxacin (Zenflox-PLUS) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Ofloxacin (Zenflox-PLUS): The following is a compilation of the data for ofloxacin based on clinical experience with both the oral and IV formulations. The incidence of drug-related adverse reactions in patients during phase 2 and 3 clinical studies (conducted by innovator) was reported to be 11%. Among patients receiving multiple-dose therapy, 4% discontinued ofloxacin due to adverse experiences.

In reported clinical studies, the following events were considered likely to be drug-related in patients receiving multiple doses of ofloxacin: Nausea 3%, insomnia 3%, headache 1%, dizziness 1%, diarrhea 1%, vomiting 1%, rash 1%, pruritus 1%, external genital pruritus in women 1%, vaginitis 1% and dysgeusia 1%.

In reported clinical studies, the most frequently reported adverse events, regardless of relationship to drug, were: Nausea 10%, headache 9%, insomnia 7%, external genital pruritus in women 6%, dizziness 5%, vaginitis 5%, diarrhea 4%, vomiting 4%.

In reported clinical studies, the following events, regardless of relationship to drug, occurred in 1-3% of patients: Abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances and constipation.

Additional events, reported in clinical studies at a rate of <1%, regardless of relationship to drug, were: Body as a Whole: Asthenia, chills, malaise, extremity pain, pain, epistaxis.

Cardiovascular System: Cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation.

Gastrointestinal System: Dyspepsia.

Genital/Reproductive System: Burning, irritation, pain and rash of the female genitalia; dysmenorrhea; menorrhagia; metrorrhagia.

Musculoskeletal System: Arthralgia, myalgia.

Nervous System: Seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion.

Nutritional/Metabolic: Thirst, weight loss.

Respiratory System: Respiratory arrest, cough, rhinorrhea.

Skin/Hypersensitivity: Angioedema, diaphoresis, urticaria, vasculitis.

Special Senses: Decreased hearing acuity, tinnitus and photophobia.

Urinary System: Dysuria, urinary frequency and retention.

The following laboratory abnormalities appeared in ≥1% of patients receiving multiple doses of ofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying conditions being treated.

Hematopoietic: Anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, elevated ESR.

Hepatic: Elevated: Alkaline phosphatase, AST (SGOT), ALT (SGPT).

Serum Chemistry: Hyperglycemia, hypoglycemia, elevated creatinine, elevated BUN.

Urinary: Glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria.

Post-Marketing Adverse Events: Additional adverse events, regardless of relationship to drug, reported from worldwide marketing experience with quinolones, including ofloxacin: Clinical: Cardiovascular System: Cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope, Torsades de pointes.

Endocrine/Metabolic: Hyper- or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents.

Gastrointestinal System: Hepatic dysfunction including: Hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis; intestinal perforation; hepatic failure (including fatal cases); pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment), gastrointestinal hemorrhage; hiccough, painful oral mucosa, pyrosis.

Genital/Reproductive System: Vaginal candidiasis.

Hematopoietic: Anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/bruising.

Musculoskeletal: Tendinitis/rupture; weakness; rhabdomyolysis.

Nervous System: Nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy, ataxia, incoordination; possible exacerbation of: Myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness.

Respiratory System: Dyspnea, bronchospasm, allergic pneumonitis, stridor.

Skin/Hypersensitivity: Anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption.

Special Senses: Diplopia, nystagmus, blurred vision, disturbances of: Taste, smell, hearing and equilibrium, usually reversible following discontinuation.

Urinary System: Anuria, polyuria, renal calculi, renal failure, interstitial nephritis, hematuria.

Laboratory: Hematopoietic: Prolongation of prothrombin time.

Serum Chemistry: Acidosis, elevation of serum triglycerides, cholesterol, potassium, liver function tests including GGTP, LDH and bilirubin.

Urinary: Albuminuria, candiduria.

In reported clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established.

Other reported adverse events includes fungal infection, enterocolitis (sometimes haemorrhagic), anorexia, paraesthesia, unsteady gait, increase in liver enzymes and/or bilirubin, disturbances of kidney function, acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure.

Crystalluria and cylindruria have been reported with other quinolones.

Ofloxacin (Zenflox-PLUS) OD: The overall frequency of adverse reactions from the clinical database is about 7%. The commonest events involved the gastrointestinal system (about 5%) and the nervous system (about 2%). The following provides a tabulation based on post-marketing experience with ofloxacin where occasional represents a frequency of 0.1-1%, rare <0.1%, very rare <0.01% and isolated cases <0.01%.

Digestive and Liver Side Effects: Occasional: Nausea and vomiting, diarrhoea, abdominal pain, gastric symptoms, (diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic). Rare: Loss of appetite, increase in liver enzymes and/or bilirubin. Very Rare: Cholestatic jaundice, hepatic or severe liver damage may develop. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium difficile). Even if Clostridium difficile is only suspected, administration of ofloxacin should be discontinued immediately and appropriate treatment given. Drugs that inhibit peristalsis should not be administered in such cases.

Central Nervous System: Occasional: Headache, dizziness, sleep disorders, restlessness. Rare: Confusion, nightmares, anxiety, depression, hallucinations and psychotic reactions, drowsiness, unsteady gait and tremor (due to disorders of muscular coordination), neuropathy, numbness and paraesthesiae or hyperaesthesiae, visual disturbances, disturbances of taste and smell (including, in exceptional cases, loss of function) extrapyramidal symptoms. Very Rare: Convulsions, hearing disorders (including, in exceptional cases, loss of hearing). These reactions have occurred in some patients after the 1st dose of ofloxacin; in such cases, discontinue treatment immediately.

Cardiovascular System: Tachycardia and a temporary decrease in blood pressure have been reported. Rare: Circulatory collapse (due to pronounced drop in blood pressure).

Haematological Side Effects: Very Rare: Anaemia, eosinophilia, reversible neutropenia, leucopenia (including agranulocytosis), thrombocytopenia, pancytopenia. Only in some cases are these due to bone marrow depression. In very rare cases, haemolytic anaemias may develop.

Renal Side Effects: Rare: Disturbances of kidney function. Isolated Cases: Acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure. Allergic and Skin Side Effects: Occasional: Skin rash, itching. Very Rare: Rash on exposure to strong sunlight, other severe skin reactions, hypersensitivity reactions, immediate or delayed, usually involving the skin (eg, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome and vasculitis) may occur. In exceptional circumstances, vasculitis can lead to skin lesions including necrosis and may also involve internal organs. There are rarely other signs of anaphylaxis eg, tachycardia, fever, dyspnoea, shock, angioneurotic oedema, vasculitic reactions, eosinophilia. In such cases, treatment should be discontinued immediately and where appropriate, supportive treatment given.

Isolated Cases: Pneumonitis.

Other Side Effects: Rare: Malaise. Very Rare: Excessive rise or fall in blood sugar levels, weakness, joint and muscle pains (in isolated cases, these may be symptoms of rhabdomyolysis). Isolated Cases: Tendon discomfort including inflammation and rupture of tendons (eg, the Achilles tendon) particularly in patients treated concurrently with corticosteroids. In the event of signs of inflammation of a tendon, treatment with ofloxacin must be stopped immediately and appropriate treatment must be initiated for the affected tendon.

The possibility cannot be ruled out that ofloxacin may trigger an attack of porphyria in predisposed patients.

Except in very rare instances (eg, isolated cases of smell, taste and hearing disorders), the adverse effects observed subsided after discontinuation of ofloxacin.

Laboratory Value Alterations: Serum Alkaline Phosphatase, SGOT, SGPT and Lactate Dehydrogenase: Values may be increased during ofloxacin treatment.

Urinary Opiates and Porphyrins: False positive results may occur.

What is the most important information I should know about Ofloxacin (Zenflox-PLUS)?

Ofloxacin (Zenflox-PLUS) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking ofloxacin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of Long QT syndrome.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time.

Ofloxacin 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. These effects 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. Stop taking ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you have.



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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The results of a survey conducted on ndrugs.com for Zenflox-PLUS are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Zenflox-PLUS. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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