What is Vitoflox O?
Vitoflox O is used to treat tuberculosis (TB). It is used with other medicines for TB. Vitoflox O may also be used for other problems as determined by your doctor.
To help clear up your tuberculosis (TB) infection completely, you must keep taking Vitoflox O for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.
Vitoflox O is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Vitoflox O is used in certain patients with the following medical condition:
- Atypical mycobacterial infections, such as Mycobacterium avium complex (MAC)
Vitoflox O indications
Vitoflox O hydrochloride is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in-vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most frequently used regimens have been the following:
- Vitoflox O plus isoniazid
- Vitoflox O plus isoniazid plus streptomycin.
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, Vitoflox O should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in-vitro studies. Antituberculous drugs used with Vitoflox O have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
How should I use Vitoflox O?
Use Vitoflox O as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Vitoflox O by mouth with or without food at the same time each day.
- Do not take an antacid that has aluminum hydroxide in it within 4 hours after you take Vitoflox O.
- If you miss a dose of Vitoflox O, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Vitoflox O.
Uses of Vitoflox O in details
Use: Labeled Indications
Treatment of pulmonary tuberculosis in conjunction with other antituberculosis agents
Off Label Uses
Mycobacterium avium complex disease
Based on the Department of Health and Human Services (HHS) Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, Vitoflox O, in combination with other appropriate antimycobacterial drugs, is effective and recommended for the treatment and chronic maintenance therapy (secondary prophylaxis) of disseminated MAC disease in HIV-infected patients.
Based on the American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA) Guideline for the Diagnosis, Treatment, and Prevention of Nontuberculosis Mycobacterial Disease, Vitoflox O, in combination with other appropriate antimycobacterial drugs, is effective and recommended for the treatment of MAC pulmonary and/or disseminated disease.
Nontuberculous mycobacterial disease (M. kansasii)
Data from a small prospective, single-arm study and a larger retrospective study support the use of Vitoflox O, in combination with clarithromycin and rifampin, in the treatment of susceptible Mycobacterium kansasii pulmonary disease. Additional trials may be necessary to further define the role of Vitoflox O in this condition.
Based on the ATS/IDSA Guideline for the Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases Vitoflox O, in combination with rifampin and isoniazid, is effective and recommended for the treatment of susceptible M. kansasii pulmonary disease
Tuberculous meningitis (drug-susceptible)
Based on the American Thoracic Society (ATS)/Centers for Disease Control and Prevention (CDC)/Infectious Disease Society of America (IDSA) Treatment of Drug-Susceptible Tuberculosis guidelines, Vitoflox O, in combination with other antitubercular drugs, is effective and recommended for initial treatment of tuberculous meningitis.
Vitoflox O description
An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)
Vitoflox O dosage
Vitoflox O Dosage
Applies to the following strength(s): 100 mg; 400 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
- Tuberculosis - Active
- Mycobacterium avium-intracellulare - Treatment
- Mycobacterium avium-intracellulare - Prophylaxis
Usual Pediatric Dose for:
- Tuberculosis - Active
- Mycobacterium avium-intracellulare - Treatment
- Mycobacterium avium-intracellulare - Prophylaxis
Additional dosage information:
- Renal Dose Adjustments
- Liver Dose Adjustments
- Dose Adjustments
- Precautions
- Dialysis
- Other Comments
Usual Adult Dose for Tuberculosis - Active
Initial treatment: 15 mg/kg orally once a day for 6 to 8 weeks with concurrent isoniazid therapy.
Retreatment: 25 mg/kg orally once a day for 60 days concurrently with at least one other anti-TB drug. After 60 days, decrease dose to 15 mg/kg orally once a day.
As an alternative to single daily dose, a dose of 40 mg/kg orally twice a week or 30 mg/kg orally 3 times a week can be administered. This generally follows 2 weeks of daily therapy. This regimen allows directly observed therapy (DOT).
Usual Adult Dose for Mycobacterium avium-intracellulare - Treatment
900 mg orally once a day. Pulmonary AVI treatment consists of clarithromycin and 2 to 4 other drugs such as Vitoflox O, rifampin, clofazimine, and/or other agents. The duration of treatment is 18 to 24 months.
Disseminated MAI treatment consists of clarithromycin or azithromycin and 1 to 3 other drugs such as Vitoflox O, clofazamine, ciprofloxacin, ofloxacin, rifampin, rifabutin, or amikacin. As long as clinical and microbiological response is documented, therapy should be continued for life.
Usual Adult Dose for Mycobacterium avium-intracellulare - Prophylaxis
15 mg/kg orally once a day. Used in combination therapy with clarithromycin or azithromycin. Therapy should be continued for life.
Usual Pediatric Dose for Tuberculosis - Active
Greater than 13 years:
Initial treatment: 15 mg/kg orally once a day for 6 to 8 weeks with concurrent isoniazid therapy.
Retreatment: 25 mg/kg orally once a day for 60 days concurrently with at least one other anti-TB drug. After 60 days, decrease dose to 15 mg/kg orally once a day.
As an alternative to single daily dose, a dose of 40 mg/kg orally twice a week or 30 mg/kg orally 3 times a week can be administered. This generally follows 2 weeks of daily therapy. This regimen allows directly observed therapy (DOT).
Usual Pediatric Dose for Mycobacterium avium-intracellulare - Treatment
Greater than 13 years:
900 mg orally once a day. Pulmonary AVI treatment consists of clarithromycin and 2 to 4 other drugs such as Vitoflox O, rifampin, clofazimine, and/or other agents. The duration of treatment is 18 to 24 months.
Disseminated MAI treatment consists of clarithromycin or azithromycin and 1 to 3 other drugs such as Vitoflox O, clofazamine, ciprofloxacin, ofloxacin, rifampin, rifabutin, or amikacin. As long as clinical and microbiological response is documented, therapy should be continued for life.
Usual Pediatric Dose for Mycobacterium avium-intracellulare - Prophylaxis
Greater than 13 years:
15 mg/kg orally once a day. Used in combination therapy with clarithromycin or azithromycin. Therapy should be continued for life.
Renal Dose Adjustments
CrCl less than 10 mL/min: The usual dose may be administered every 48 hours.
CrCl 10 to 50 mL/min: The usual dose may be administered every 24 to 36 hours.
Liver Dose Adjustments
Data not available
Dose Adjustments
Patients with decreased renal function need the dosage reduced as determined by serum levels, since the main path of excretion of this drug is by the kidneys.
Precautions
Vitoflox O is contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be administered. Vitoflox O is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
Due to the risk of optic neuritis associated with Vitoflox O, caution should be used when treating patients with preexisting neuritis or other vision defects. Vitoflox O may produce decreases in visual acuity that appear to be due to optic neuritis. This effect may be related to dosage and duration of treatment. This effect is generally reversible when use of the drug is discontinued promptly. However, irreversible blindness has been observed. Since this drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination. In patients with visual defects such as cataracts, recurrent inflammatory conditions of the eye, optic neuritis, and diabetic retinopathy, the evaluation of changes in visual acuity is more difficult, and care should be taken to make sure that variations in vision are not due to the underlying disease conditions. In these patients, consideration should be given to relationship between benefits expected and possible visual deterioration since evaluation of visual changes is difficult. All patients receiving Vitoflox O should be instructed to report any vision changes or disturbances. Testing of visual acuity should be performed before beginning Vitoflox O and periodically during drug administration. Monthly visual acuity testing should be done for patients receiving more than 15 mg per kilogram per day.
Liver toxicities including fatalities have been observed. Baseline and periodic assessment of hepatic function should be performed.
Patients with decreased renal function should have the dosage reduced as determined by serum levels of Vitoflox O, since the main path of excretion of this drug is by the kidneys. Baseline and periodic assessment of renal function should be performed.
Baseline and periodic assessment of hematopoietic function should be performed.
Vitoflox O may elevate serum uric acid levels and should be used cautiously in patients with preexisting gout. Patients should be monitored for hyperuricemia.
There are limited data on the use of Vitoflox O in elderly patients. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on Vitoflox O therapy. No differences in safety or tolerability were reported in these patients compared with that reported in adults in general. Other observed clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Dialysis
Vitoflox O is slightly dialyzable (5% to 20%). The dose should be administered post-dialysis.
Other Comments
Vitoflox O or streptomycin are used as part of a combination therapy with isoniazid, rifampin, and pyrazinamide. If susceptibility to isoniazid and rifampin is shown, Vitoflox O may be discontinued.
More about Vitoflox O
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- En Espanol
- 1 Review - Add your own review/rating
Consumer resources
- Vitoflox O
- Vitoflox O (Advanced Reading)
- Other brands: Vitoflox O
Professional resources
- Vitoflox O Hydrochloride (AHFS Monograph)
- More (2) »
Related treatment guides
- Tuberculosis, Active
- Mycobacterium avium-intracellulare, Prophylaxis
- Mycobacterium avium-intracellulare, Treatment
Vitoflox O interactions
See also:
What other drugs will affect Vitoflox O?
Aluminum Hydroxide: May decrease the serum concentration of Vitoflox O. Management: Avoid concurrent administration of Vitoflox O and aluminum hydroxide. If coadministration cannot be avoided administer Vitoflox O first and then wait at least 4 hours before administering aluminum hydroxide-containing products. Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vitoflox O side effects
See also:
What are the possible side effects of Vitoflox O?
Applies to Vitoflox O: oral tablet
In addition to its needed effects, some unwanted effects may be caused by Vitoflox O (the active ingredient contained in Vitoflox O). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Vitoflox O:
Less common:
- Chills
- pain and swelling of joints, especially big toe, ankle, or knee
- tense, hot skin over affected joints
- Blurred vision, eye pain, red-green color blindness, or any loss of vision (more common with high doses)
- fever
- joint pain
- numbness, tingling, burning pain, or weakness in hands or feet
- skin rash
Minor Side Effects
Some of the side effects that can occur with Vitoflox O may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common:
- Abdominal pain
- confusion
- headache
- loss of appetite
- nausea and vomiting
Vitoflox O contraindications
See also:
What is the most important information I should know about Vitoflox O?
Vitoflox O hydrochloride is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgement determines that it may be used. Vitoflox O hydrochloride is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
Active ingredient matches for Vitoflox O:
| Unit description / dosage (Manufacturer) | Price, USD |
| VITOFLOX O TABLET 1 strip / 10 tablets each (View Laboratories) | $ 0.87 |
| Vitoflox O 800mg Tablet (View Laboratories) | $ 0.09 |
List of Vitoflox O substitutes (brand and generic names): | |
| Tibitol (India, Indonesia) | |
| TIBITOL tab 600 mg x 10's (Pharma Corp Inc.) | $ 0.10 |
| TIBITOL tab 800 mg x 10's (Pharma Corp Inc.) | $ 0.15 |
| Tibitol 800mg Tablet (Pharma Corp Inc.) | $ 0.03 |
| Tibutol (Peru) | |
| Tobutol (Thailand) | |
| Tobutol 400 mg x 500's (General Drugs House) | |
| Tobutol / foil 400 mg x 50 x 10's (General Drugs House) | |
| Tobutol tab 400 mg / foil 50 x 10's (General Drugs House) | |
| Tobutol tab 400 mg 500's (General Drugs House) | |
| Tubertam (Georgia) | |
| Tubetam (Mexico) | |
| Tubiriv 4 | |
| Tubiriv 4 Kit Kit (East African (I) Remedies Pvt Ltd) | $ 0.14 |
| Turresis (Portugal) | |
| ULTICOX | |
| ULTICOX 800MG TABLET 1 strip / 10 tablets each (Concept Pharmaceuticals Ltd) | $ 0.36 |
| ULTIFLOX (CONCEPT) | |
| ULTIFLOX SUSPENSION 1 bottle / 30 ML suspension each (Concept Pharmaceuticals Ltd) | $ 0.18 |
| Upbutol (Russia) | |
| Tablet; Oral; Ethambutol Hydrochloride 1 g (Unique) | |
| Tablet; Oral; Ethambutol Hydrochloride 200 mg (Unique) | |
| Tablet; Oral; Ethambutol Hydrochloride 400 mg (Unique) | |
| Tablet; Oral; Ethambutol Hydrochloride 600 mg (Unique) | |
| Tablet; Oral; Ethambutol Hydrochloride 800 mg (Unique) | |
| Vero-Ethambutol | |
| Tablet; Oral; Ethambutol Hydrochloride 200 mg | |
| Tablet; Oral; Ethambutol Hydrochloride 400 mg | |
| Tablet; Oral; Ethambutol Hydrochloride 600 mg | |
| Winbutol (Taiwan) | |
| Winbutol 400 mg | |
| Z Butol | |
| Z Butol 800 mg Tablet (Zota Pharmaceuticals (Zota Healthcare Pvt Ltd)) | $ 0.05 |
| Zibutol | |
| Zibutol 800 mg Tablet (Mexon Healthcare Ltd.) | $ 0.05 |
| Zytham (India) | |
| Zytham 200mg TAB / 200 (Zydus Cadila) | $ 2.27 |
| Zytham 400mg TAB / 200 (Zydus Cadila) | $ 4.58 |
| Zytham 600mg TAB / 200 (Zydus Cadila) | $ 0.06 |
| Zytham 800mg TAB / 100 (Zydus Cadila) | $ 4.22 |
| 200 mg x 200's (Zydus Cadila) | $ 2.27 |
| 400 mg x 200's (Zydus Cadila) | $ 4.58 |
| 600 mg x 200's (Zydus Cadila) | $ 0.06 |
| 800 mg x 100's (Zydus Cadila) | $ 4.22 |
| ZYTHAM 800 MG TABLET 1 strip / 10 tablets each (Zydus Cadila) | $ 0.47 |
| ZYTHAM tab 200 mg x 10's (Zydus Cadila) | $ 0.13 |
| ZYTHAM tab 400 mg x 10's (Zydus Cadila) | $ 0.23 |
| ZYTHAM tab 600 mg x 10's (Zydus Cadila) | $ 0.30 |
| ZYTHAM tab 800 mg x 10's (Zydus Cadila) | $ 0.42 |
| Zytham 200mg Tablet (Zydus Cadila) | $ 0.01 |
| Zytham 400mg Tablet (Zydus Cadila) | $ 0.02 |
| Zytham 600mg Tablet (Zydus Cadila) | $ 0.03 |
See 568 substitutes for Vitoflox O | |
References
- DailyMed. "ETHAMBUTOL HYDROCHLORIDE: 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).
- PubChem. "ethambutol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ethambutol". http://www.drugbank.ca/drugs/DB00330 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Vitoflox O 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 Vitoflox O. 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.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
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Information checked by Dr. Sachin Kumar, MD Pharmacology
