Isoniazid 300 Mg

Isoniazid


Health Department, Oklahoma State
Human Prescription Drug
NDC 83112-071
Isoniazid 300 Mg also known as Isoniazid is a human prescription drug labeled by 'Health Department, Oklahoma State'. National Drug Code (NDC) number for Isoniazid 300 Mg is 83112-071. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Isoniazid 300 Mg drug includes Isoniazid - 300 mg/1 . The currest status of Isoniazid 300 Mg drug is Active.

Drug Information:

Drug NDC: 83112-071
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Isoniazid 300 Mg
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Isoniazid
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Health Department, Oklahoma State
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ISONIAZID - 300 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Feb, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 26 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA080936
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Health Department, Oklahoma State
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:197832
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
NUI:N0000175483
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:V83O1VOZ8L
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Antimycobacterial [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Antimycobacterial [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
83112-071-021 TABLET in 1 PACKET (83112-071-02)01 Feb, 2023N/ANo
83112-071-3030 TABLET in 1 PACKAGE (83112-071-30)01 Feb, 2023N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Isoniazid 300 mg isoniazid isoniazid isoniazid b;071;300

Dosage and Administration:

Dosing and administration for treatment of tuberculosis isoniazid is used in conjunction with other effective anti-tuberculous agents. drug susceptibility testing should be performed on the organisms initially isolated from all patients with newly diagnosed tuberculosis. if the bacilli becomes resistant, therapy must be changed to agents to which the bacilli are susceptible. usual oral dosage (depending on the regimen used): adults 5 mg/kg up to 300 mg daily in a single dose; or 15 mg/kg up to 900 mg/day, two or three times/week children 10 mg/kg to 15 mg/kg up to 300 mg daily in a single dose; or 20 mg/kg to 40 mg/kg up to 900 mg/day, two or three times/week patients with pulmonary tuberculosis without hiv infection there are 3 regimen options for the initial treatment of tuberculosis in children and adults: option 1 daily isoniazid, rifampin and pyrazinamide for 8 weeks followed by 16 weeks of isoniazid and rifampin daily or 2 to 3 times weekly. ethambutol or streptomycin should be a
dded to the initial regimen until sensitivity to isoniazid and rifampin is demonstrated. the addition of a fourth drug is optional if the relative prevalence of isoniazid-resistant mycobacterium tuberculosis isolates in the community is less than or equal to four percent. option 2 daily isoniazid, rifampin, pyrazinamide and streptomycin or ethambutol for 2 weeks followed by twice weekly administration of the same drugs for 6 weeks, subsequently twice weekly isoniazid and rifampin for 16 weeks. option 3 three times weekly with isoniazid, rifampin, pyrazinamide and ethambutol or streptomycin for 6 months. *all regimens given twice weekly or 3 times weekly should be administered by directly observed therapy [see also directly observed therapy (dot)]. the above treatment guidelines apply only when the disease is caused by organisms that are susceptible to the standard antituberculous agents. because of the impact of resistance to isoniazid and rifampin on the response to therapy, it is essential that physicians initiating therapy for tuberculosis be familiar with the prevalence of drug resistance in their communities. it is suggested that ethambutol not be used in children whose visual acuity cannot be monitored. patients with pulmonary tuberculosis and hiv infection the response of the immunologically impaired host to treatment may not be as satisfactory as that of a person with normal host responsiveness. for this reason, therapeutic decisions for the impaired host must be individualized. since patients co-infected with hiv may have problems with malabsorption, screening of antimycobacterial drug levels, especially in patients with advanced hiv disease, may be necessary to prevent the emergence of mdrtb. patients with extra pulmonary tuberculosis the basic principles that underlie the treatment of pulmonary tuberculosis also apply to extra pulmonary forms of the disease. although there have not been the same kinds of carefully conducted controlled trials of treatment of extra pulmonary tuberculosis as for pulmonary disease, increasing clinical experience indicates that a 6 to 9 month short-course regimen is effective. because of the insufficient data, miliary tuberculosis, bone/joint tuberculosis and tuberculous meningitis in infants and children should receive 12 month therapy. bacteriologic evaluation of extra pulmonary tuberculosis may be limited by the relative inaccessibility of the sites of disease. thus, response to treatment often must be judged on the basis of clinical and radiographic findings. the use of adjunctive therapies such as surgery and corticosteroids is more commonly required in extra pulmonary tuberculosis than in pulmonary disease. surgery may be necessary to obtain specimens for diagnosis and to treat such processes as constrictive pericarditis and spinal cord compression from pott’s disease. corticosteroids have been shown to be of benefit in preventing cardiac constriction from tuberculous pericarditis and in decreasing the neurologic sequelae of all stages of tuberculosis meningitis, especially when administered early in the course of the disease. pregnant women with tuberculosis the options listed above must be adjusted for the pregnant patient. streptomycin interferes with in utero development of the ear and may cause congenital deafness. routine use of pyrazinamide is also not recommended in pregnancy because of inadequate teratogenicity data. the initial treatment regimen should consist of isoniazid and rifampin. ethambutol should be included unless primary isoniazid resistance is unlikely (isoniazid resistance rate documented to be less than 4%). treatment of patients with multi-drug resistant tuberculosis (mdrtb) multiple-drug resistant tuberculosis (i.e., resistance to at least isoniazid and rifampin) presents difficult treatment problems. treatment must be individualized and based on susceptibility studies. in such cases, consultation with an expert in tuberculosis is recommended. directly observed therapy (dot) a major cause of drug-resistant tuberculosis is patient noncompliance with treatment. the use of dot can help assure patient compliance with drug therapy. dot is the observation of the patient by a health care provider or other responsible person as the patient ingests anti-tuberculosis medications. dot can be achieved with daily, twice weekly or thrice weekly regimens and is recommended for all patients. for preventative therapy of tuberculosis before isoniazid preventive therapy is initiated, bacteriologically positive or radiographically progressive tuberculosis must be excluded. appropriate evaluations should be performed if extra pulmonary tuberculosis is suspected. adults over 30 kg: 300 mg per day in a single dose. infants and children: 10 mg/kg (up to 300 mg daily) in a single dose. in situations where adherence with daily preventative therapy cannot be assured, 20 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration8. continuous administration of isoniazid for a sufficient period is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. in the treatment of tuberculosis, resistant organisms may multiply and the emergence of resistant organisms during the treatment may necessitate a change in the regimen. for following patient compliance: the potts-cozart test9, a simple colorimetric6 method of checking for isoniazid in the urine, is a useful tool for assuring patient compliance, which is essential for effective tuberculosis control. additionally, isoniazid test strips are also available to check patient compliance. concomitant administration of pyridoxine (b6) is recommended in the malnourished and in those predisposed to neuropathy (e.g., alcoholics and diabetics).

Package Label Principal Display Panel:

Packaging isoniazid card isoniazid card front


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