Tebrazid

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Tebrazid uses


INDICATIONS AND USAGE:

Tebrazid is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and Tebrazid given for 2 months, followed by isoniazid and rifampin for 4 months.*4)

(Patients with drug-resistant disease should be treated with regimens individualized to their situation. Tebrazid frequently will be an important component of such therapy.)

(In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment).

It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.

Tebrazid should only be used in conjunction with other effective antituberculous agents.

*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4

CONTRAINDICATIONS:

Tebrazid is contraindicated in persons:

  • with severe hepatic damage.
  • who have shown hypersensitivity to it.
  • with acute gout.

WARNINGS:

Patients started on Tebrazid should have baseline serum uric acid and liver function determinations. Those patients with preexisting liver disease or those at increased risk for drug related hepatitis (e.g., alcohol abusers) should be followed closely.

Tebrazid should be discontinued and not be resumed if signs of hepatocellular damage or hyperuricemia accompanied by an acute gouty arthritis appear.

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PRECAUTIONS:

General:

Tebrazid inhibits renal excretion of urates, frequently resulting in hyperuricemia which is usually asymptomatic. If hyperuricemia is accompanied by acute gouty arthritis, Tebrazid should be discontinued.

Tebrazid should be used with caution in patients with a history of diabetes mellitus, as management may be more difficult.

Primary resistance of M. tuberculosis to Tebrazid is uncommon. In cases with known or suspected drug resistance, in vitro susceptibility tests with recent cultures of M. tuberculosis against Tebrazid and the usual primary drugs should be performed. There are few reliable in vitro tests for Tebrazid resistance. A reference laboratory capable of performing these studies must be employed.

Information for Patients:

Patients should be instructed to notify their physicians promptly if they experience any of the following: fever, loss of appetite, malaise, nausea and vomiting, darkened urine, yellowish discoloration of the skin and eyes, pain or swelling of the joints.

Compliance with the full course of therapy must be emphasized, and the importance of not missing any doses must be stressed.

Laboratory Tests:

Baseline liver function studies [especially ALT, AST (SGOT) determinations] and uric acid levels should be determined prior to therapy. Appropriate laboratory testing should be performed at periodic intervals and if any clinical signs of symptoms occur during therapy.

Drug/Laboratory Test Interactions:

Tebrazid has been reported to interfere with ACETEST® and KETOSTIX® urine tests to produce a pink-brown color.5

Carcinogenesis, Mutagenesis, Impairment of Fertility:6,7,8

In lifetime bioassays in rats and mice, Tebrazid was administered in the diet at concentrations of up to 10,000 ppm. This resulted in estimated daily doses for the mouse of 2 g/kg, or 40 times the maximum human dose, and for the rat of 0.5 g/kg, or 10 times the maximum human dose. Tebrazid was not carcinogenic in rats or male mice and no conclusion was possible for female mice due to insufficient numbers of surviving control mice.

Tebrazid was not mutagenic in the Ames bacterial test, but induced chromosomal aberrations in human lymphocyte cell cultures.

Pregnancy:

Teratogenic Effects-Pregnancy Category C

Animal reproduction studies have not been conducted with Tebrazid. It is also not known whether Tebrazid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tebrazid should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

Tebrazid has been found in small amounts in breast milk. Therefore, it is advised that Tebrazid be used with caution in nursing mothers taking into account the risk-benefit of this therapy.9

Pediatric Use:

Tebrazid regimens employed in adults are probably equally effective in pediatric patients.4,10,11 Tebrazid appears to be well tolerated in pediatric patients.

Geriatric Use:12

Clinical studies of Tebrazid did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or renal function, and of concomitant disease or other drug therapy.

It does not appear that patients with impaired renal function require a reduction in dose. It may be prudent to select doses at the low end of the dosing range, however.13

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ADVERSE REACTIONS:

General:

Fever, porphyria and dysuria have rarely been reported. Gout.

Gastrointestinal:

The principal adverse effect is a hepatic reaction. Hepatotoxicity appears to be dose related, and may appear at any time during therapy. GI disturbances including nausea, vomiting and anorexia have also been reported.

Hematologic and Lymphatic:

Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug. Adverse effects on blood clotting mechanisms have also been rarely reported.

Other:

Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, and pruritis have been reported. Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.

OVERDOSAGE:

Overdosage experience is limited. In one case report of overdose, abnormal liver function tests developed. These spontaneously reverted to normal when the drug was stopped. Clinical monitoring and supportive therapy should be employed. Tebrazid is dialyzable.13

DOSAGE AND ADMINISTRATION:

Tebrazid should always be administered with other effective antituberculous drugs. It is administered for the initial 2 months of a 6-month or longer treatment regimen for drug-susceptible patients. Patients who are known or suspected to have drug-resistant disease should be treated with regimens individualized to their situation.

Tebrazid frequently will be an important component of such therapy.

Patients with concomitant HIV infection may require longer courses of therapy. Physicians treating such patients should be alert to any revised recommendations from CDC for this group of patients.

Usual dose: Tebrazid is administered orally, 15 to 30 mg/kg once daily. Older regimens employed 3 or 4 divided doses daily, but most current recommendations are for once a day. Three grams per day should not be exceeded. The CDC recommendations do not exceed 2 g per day when given as a daily regimen.

Alternatively, a twice weekly dosing regimen (50 to 75 mg/kg twice weekly based on lean body weight) has been developed to promote patient compliance with a regimen on an outpatient basis. In studies evaluation the twice weekly regimen, doses of Tebrazid in excess of 3 g twice weekly have been administered. This exceeds the recommended maximum 3 g/daily dose. However, an increased incidence of adverse reactions has not been reported.

This table is taken from the CDC-American Thoracic Society joint recommendations.4

Daily Dose Doses based on weight should be adjusted as weight changes.
Drug Children Adults
Isoniazid

10 to 20 mg/kg

PO or IM


5 mg/kg

PO or IM

Rifampin

10 to 20 mg/kg

PO


10 mg/kg

PO

Tebrazid

15 to 30 mg/kg

PO


15 to 30 mg/kg

PO

Streptomycin

20 to 40 mg/kg

IM


15 mg/kgIn persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.

IM

Ethambutol

15 to 25 mg/kg

PO


15 to 25 mg/kg

PO

Maximal Daily Dose in Children and Adults
Drug
Isoniazid 300 mg
Rifampin 600 mg
Tebrazid 2 g
Streptomycin 1 gIn persons older than 60 yr of age the daily dose of streptomycin should be limited to 10 mg/kg with a maximal dose of 750 mg.
Ethambutol 2.5 g
Twice Weekly Dose
Drug Children Adults
Isoniazid

20 to 40 mg/kg

Max. 900 mg


15 mg/kg

Max. 900 mg

Rifampin

10 to 20 mg/kg

Max. 600 mg


10 mg/kg

Max. 600 mg

Tebrazid 50 to 70 mg/kg 50 to 70 mg/kg
Streptomycin

25 to 30 mg/kg

IM


25 to 30 mg/kg

IM

Ethambutol 50 mg/kg 50 mg/kg

Definition of abbreviations: PO = per-orally; IM = intramuscularly.

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HOW SUPPLIED:

Product: 50090-0520

NDC: 50090-0520-0 100 TABLET in a CONTAINER

REFERENCES:

1.Drug Information, American Hospital Formulary Service. American Society of Hospital Pharmacists. Bethesda, Md. 1991.

2. USPDI, Drug Information for the Health Care Professional. United States Pharmacopeial Convention, Inc. Rockville, Md. 1991: 1 B : 2226-2227.

3. Goodman-Gilman A, Rall TW, Nies AS, Taylor P. The Pharmacological Basis of Therapeutics, ed 8. New York, Pergamon Press. 1990; 1154.

4. Treatment of tuberculosis and tuberculosis infection in adults and children. Am Rev Respir Dis. 1986 ; 134 : 363-368.

5. Reynolds JEF, Parfitt K, Parsons AV, Sweetman SC. Martindale The Extra Pharmacopoeia, ed 29. London, The Pharmaceutical Press. 1989; 569-570.

6. Bioassay of Tebrazid for possible carcinogenicity. National Cancer Institute Carcinogenesis Technical Report Series No. 48, 1978.

7. Zerger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen. 1987; 9 (Suppl 9) : 1109.

8. Roman IC, Georgian L. Cytogenetic effects of some antituberculosis drugs in vitro. Mutation Research. 1977; 48: 215- 224.

9. Holdiness M. Antituberculosis drugs and breast-feeding. Arch Intern Med. 1984; 144: 1888.

10. Turcios N, Evans H. Preventing and managing tuberculosis in children. J Resp Dis. 1989; 10 (6) (Jun): 23.

11. Starke JR. Multidrug therapy for tuberculosis in children. Pediatr Infec Dis J. 1990; 9: 785793.

12. Specific requirements on content and format of labeling for human prescription drugs; proposed addition of "geriatric use" subsection in the labeling. Federal Register. 1990; 55 (212) (Nov 1): 46134-46137.

13. Stamathakis G, Montes C, Trouvin JH, et al. Tebrazid and pyrazinoic acid pharmacokinetics in patients with chronic renal failure. Clinical Nephrology. 1988 ; 30 : 230-234.

Tebrazid

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Tebrazid pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Tebrazid available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Tebrazid destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Tebrazid Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Tebrazid pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PYRAZINAMIDE TABLET [A-S MEDICATION SOLUTIONS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PYRAZINAMIDE: 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/dailym... (accessed August 28, 2018).
  3. "pyrazinamide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Tebrazid?

Depending on the reaction of the Tebrazid after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tebrazid not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Tebrazid addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Tebrazid, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Tebrazid consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

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One visitor reported doses

What is the dose of Tebrazid drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 201-500mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
201-500mg1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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