Isoniazid 300 mg Tablet, 90-count — NDC 62135-709-90 (Billing 62135-0709-90)
This is a package of 90 tablets of Isoniazid 300 mg Tablet from Chartwell RX, LLC, marketed since Jun 1988 and currently FDA-listed; retail pharmacies pay about $3.40 per tablet (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 009416
- GCN: 41742
- GPI-14 (Medi-Span): 09000060000310
- HICL (First Databank): 004080
- AHFS class code: 08:16.04.00
- RxCUI (RxNorm): 197832
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antimycobacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Isoniazid is used to treat tuberculosis (TB; a serious infection that mainly affects the lungs) and to prevent TB in certain people at risk of TB infection. Isoniazid is in a class of medications called antituberculosis agents. It works by killing the bacteria that cause tuberculosis.
Read the full MedlinePlus article ↗- It treats tuberculosis (TB) caused by susceptible bacteria and is also used to prevent TB infection from becoming active disease in people at higher risk. For active TB, you will t...
- Take it exactly as your prescriber directs, without food, since food reduces how much your body absorbs. It is usually taken daily or a few times a week. Some schedules are given w...
- Some people have nausea, stomach upset, or tingling in the hands and feet. Mild liver enzyme rises are fairly common and are checked with blood tests. Call your doctor if the tingl...
- Call right away for loss of appetite, nausea or vomiting, dark urine, yellow skin or eyes, belly pain on the upper right, unusual tiredness, or fever lasting more than 3 days. Also...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Isoniazid — tap one for details:
Isoniazid may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.402 | $306.18 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | $12.66 | $1,139.39 / 90 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.7357 | $66.21 / 90 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62135-0709-90 You're viewing this Main listing | 90 TABLET in 1 BOTTLE | 2023-10-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Isoniazid 300 mg 00555-0071-01 | Teva | 30 tablets | $3.402 | — | Availability likely | — |
| Isoniazid 300 mg 51079-0083-20 | Mylan | 100 tablets | $3.402 | — | Availability likely | — |
| Isoniazid 300 mgthis 62135-0709-90 | Chartwell | 90 tablets | $3.402 | — | Availability likely | — |
| Isoniazid 300 mg 64950-0217-03 | Genus | 30 tablets | $3.402 | — | Availability likely | — |
| isoniazid 300 mg 81665-0108-10 | OMNIVIUM | 100 tablets | $3.402 | AA | Availability likely | — |
| Isoniazid 300 mg 60687-0553-01 | American | 100 tablets | $3.512 | — | Discontinued | +3% |
| isoniazid 300 mg 10135-0805-01 | Marlex | 100 tablets | — | AA | FDA listed | — |
| Isoniazid 300 mg 50090-0370-00 | A-S | 50 tablets | — | — | FDA listed | — |
| isoniazid 300 mg 50090-7660-03 | A-S | 30 tablets | — | AA | FDA listed | — |
| Isoniazid 300 mg 63187-0978-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Isoniazid 300 mg 67046-1570-03 | Coupler | 30 tablets | — | — | FDA listed | — |
| isoniazid 300 mg 67046-1617-03 | Coupler | 30 tablets | — | AA | FDA listed | — |
| Isoniazid 300 mg 68788-9405-01 | Preferred | 100 tablets | — | — | Discontinued | — |
| Isoniazid 300 mg 70518-4315-00 | REMEDYREPACK | 30 tablets | — | — | FDA listed | — |
| isoniazid 300 mg 70518-4540-00 | REMEDYREPACK | 12 tablets | — | AA | FDA listed | — |
| Isoniazid 300 mg 71335-2760-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Isoniazid 300 mg 71335-2800-01 | Bryant | 100 tablets | — | — | FDA listed | — |
| Isoniazid 300 mg 71610-0395-30 | Aphena | 30 tablets | — | — | FDA listed | — |
| isoniazid 300 mg 72162-2445-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
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UNII 4846Q921YM
Calcium sulfate dihydrate is a white, crystalline mineral salt. It works as a filler and binder in tablets and capsules, helping give them structure and hold ingredients together.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. The risk of developing hepatitis is age related. Approximate case rates by age are: less than 1 per 1,000 for persons under 20 years of age, 3 per 1,000 for persons in the 20 to 34 year age group, 12 per 1,000 for persons in the 35 to 49 year age group, 23 per 1,000 for persons in the 50 to 64 year age group and 8 per 1,000 for persons over 65 years of age.
The risk of hepatitis is increased with daily consumption of alcohol. Precise data to provide a fatality rate for isoniazid-related hepatitis is not available; however, in a U.S. Public Health Service Surveillance Study of 13,838 persons taking isoniazid, there were 8 deaths among 174 cases of hepatitis.
Therefore, patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT [formerly SGOT and SGPT, respectively]) should be measured prior to starting isoniazid therapy and periodically throughout treatment. Isoniazid-associated hepatitis usually occurs during the first three months of treatment.
Usually, enzyme levels return to normal despite continuance of drug, but in some cases progressive liver dysfunction occurs. Other factors associated with an increased risk of hepatitis include daily use of alcohol, chronic liver disease and injection drug use. A recent report suggests an increased risk of fatal hepatitis associated with isoniazid among women, particularly black and Hispanic women.
The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring. If abnormalities of liver function exceed three to five times the upper limit of normal, discontinuation of isoniazid should be strongly considered.
Liver function tests are not a substitute for a clinical evaluation at monthly intervals or for the prompt assessment of signs or symptoms of adverse reactions occurring between regularly scheduled evaluations. Patients should be instructed to immediately report signs or symptoms consistent with liver damage or other adverse effects. These include any of the following: unexplained anorexia, nausea, vomiting, dark urine, icterus, rash, persistent paresthesias of the hands and feet, persistent fatigue, weakness or fever of greater than 3 days duration and/or abdominal tenderness, especially right upper quadrant discomfort.
If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage. Patients with tuberculosis who have hepatitis attributed to isoniazid should be given appropriate treatment with alternative drugs. If isoniazid must be reinstituted, it should be reinstituted only after symptoms and laboratory abnormalities have cleared.
The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent liver involvement. Preventive treatment should be deferred in persons with acute hepatic diseases.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Isoniazid Tablets are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy.
Isoniazid Tablets are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high.
Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy. Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source.
If the repeat skin test is positive (greater than 5 mm), therapy should be continued. Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category.
Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Intravenous drug users known to be HIV-seronegative (greater than 10 mm).
Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin's disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake).
Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly. Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups: Foreign-born persons from high-prevalence countries who never received BCG vaccine.
Medically underserved low-income populations, including high-risk racial or ethnic minority populations, especially blacks, Hispanics and Native Americans. Residents of facilities for long-term care (e.g., correctional institutions, nursing homes and mental institutions). Children who are less th… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION (See also INDICATIONS AND USAGE ) NOTE For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following publications: (1) the recommendations of the Advisory Council for the Elimination of Tuberculosis, published in the MMWR: vol 42; RR-4, 1993 and (2) Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, American Journal of Respiratory and Critical Care Medicine: vol 149; 1359-1374, 1994. 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 added 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… [Excerpted — this section continues on DailyMed.]
⛔ Contraindications ▾
CONTRAINDICATIONS Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug- induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to isoniazid such as drug fever, chills, arthritis; and acute liver disease of any etiology.
⚠️ Warnings ▾
WARNINGS See the boxed warning . Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of isoniazid (see ADVERSE REACTIONS ). Symptoms can be serious and potentially life threatening.
If symptoms or signs of SCARs develop, discontinue isoniazid immediately and institute appropriate therapy. Cerebellar Syndrome Cerebellar syndrome which may include abnormal motor coordination presenting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, has been reported in postmarketing case reports with the use of isoniazid (see ADVERSE REACTIONS ). Most cases of cerebellar syndrome involved patients with chronic kidney disease (CKD), however, cerebellar syndrome was also reported in patients without CKD.
Discontinue isoniazid if symptoms or signs of cerebellar syndrome occur.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequent reactions are those affecting the nervous system and the liver. Nervous System Reactions Peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics) and is usually preceded by paresthesias of the feet and hands.
The incidence is higher in "slow inactivators". Cerebellar syndrome, which may include abnormal motor coordination manifesting as gait, trunk, and limb ataxia, dysmetria and dysdiadochokinesia, intention tremor, dysarthria, or nystagmus, have been reported in post marketing case reports (see WARNINGS ). Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis.
Hepatic Reactions See boxed warning . Elevated serum transaminase (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms of hepatitis are anorexia, nausea, vomiting, fatigue, malaise and weakness.
Mild hepatic dysfunction, evidenced by mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of patients taking isoniazid. This abnormality usually appears in the first 1 to 3 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal and generally, there is no necessity to discontinue medication during the period of mild serum transaminase elevation.
In occasional instances, progressive liver damage occurs, with accompanying symptoms. If the SGOT value exceeds three to five times the upper limit of normal, discontinuation of the isoniazid should be strongly considered. The frequency of progressive liver damage increases with age.
It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age. Gastrointestinal Reactions Nausea, vomiting, epigastric distress, and pancreatitis. Hematologic Reactions Agranulocytosis; hemolytic, sideroblastic or aplastic anemia, thrombocytopenia; and eosinophilia.
Hypersensitivity Reactions Fever, skin eruptions (morbilliform, maculopapular, purpuric or exfoliative), lymphadenopathy, vasculitis, acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, and drug reaction with eosinophilia syndrome (DRESS) (See WARNINGS ). Metabolic and Endocrine Reactions Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis and gynecomastia. Miscellaneous Reactions Rheumatic syndrome and systemic lupus erythematosus-like syndrome.
🆘 Overdosage ▾
OVERDOSAGE Signs and Symptoms Isoniazid overdosage produces signs and symptoms within 30 minutes to 3 hours after ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring of vision and visual hallucinations (including bright colors and strange designs) are among the early manifestations. With marked overdosage, respiratory distress and CNS depression, progressing rapidly from stupor to profound coma, are to be expected, along with severe, intractable seizures.
Severe metabolic acidosis, acetonuria and hyperglycemia are typical laboratory findings. Treatment Untreated or inadequately treated cases of gross isoniazid overdosage, 80 mg/kg to 150 mg/kg, can cause neurotoxicity 6 and terminate fatally, but good response has been reported in most patients brought under adequate treatment within the first few hours after drug ingestion. For the Asymptomatic Patient Absorption of drugs from the GI tract may be decreased by giving activated charcoal.
Gastric emptying should also be employed in the asymptomatic patient. Safeguard the patient's airway when employing these procedures. Patients who acutely ingest greater than 80 mg/kg should be treated with intravenous pyridoxine on a gram per gram basis equal to the isoniazid dose.
If an unknown amount of isoniazid is ingested, consider an initial dose of 5 grams of pyridoxine given over 30 to 60 minutes in adults or 80 mg/kg of pyridoxine in children. For the Symptomatic Patient Ensure adequate ventilation, support cardiac output and protect the airway while treating seizures and attempting to limit absorption. If the dose of isoniazid is known, the patient should be treated initially with a slow intravenous bolus of pyridoxine, over 3 to 5 minutes, on a gram per gram basis, equal to the isoniazid dose.
If the quantity of isoniazid ingestion is unknown, then consider an initial intravenous bolus of pyridoxine of 5 grams in the adult or 80 mg/kg in the child. If seizures continue, the dosage of pyridoxine may be repeated. It would be rare that more than 10 grams of pyridoxine would need to be given.
The maximum safe dose for pyridoxine in isoniazid intoxication is not known. If the patient does not respond to pyridoxine, diazepam may be administered. Phenytoin should be used cautiously, because isoniazid interferes with the metabolism of phenytoin.
General Obtain blood samples for immediate determination of gases, electrolytes, BUN, glucose, etc.; type and cross-match blood in preparation for possible hemodialysis. Rapid Control of Metabolic Acidosis Patients with this degree of INH intoxication are likely to have hypoventilation. The administration of sodium bicarbonate under these circumstances can cause exacerbation of hypercarbia.
Ventilation must be monitored carefully, by measuring blood carbon dioxide levels and supported mechanically, if there is respiratory insufficiency. Dialysis Both peritoneal and hemodialysis have been used in the management of isoniazid overdosage. These procedures are probably not required if control of seizures and acidosis is achieved with pyridoxine, diazepam and bicarbonate.
Along with measures based on initial and repeated determination of blood gases and other laboratory tests as needed, utilize meticulous respiratory and other intensive care to protect against hypoxia, hypotension, aspiration, pneumonitis, etc.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Within 1 to 2 hours after oral administration, isoniazid produces peak blood levels which decline to 50 percent or less within 6 hours. It diffuses readily into all body fluids (cerebrospinal, pleural and ascitic fluids), tissues, organs and excreta (saliva, sputum and feces). The drug also passes through the placental barrier and into milk in concentrations comparable to those in the plasma.
From 50 to 70 percent of a dose of isoniazid is excreted in the urine in 24 hours. Isoniazid is metabolized primarily by acetylation and dehydrazination. The rate of acetylation is genetically determined.
Approximately 50 percent of Blacks and Caucasians are "slow inactivators" and the rest are "rapid inactivators"; the majority of Eskimos and Orientals are "rapid inactivators." The rate of acetylation does not significantly alter the effectiveness of isoniazid. However, slow acetylation may lead to higher blood levels of the drug and, thus, to an increase in toxic reactions. Pyridoxine (vitamin B 6 ) deficiency is sometimes observed in adults with high doses of isoniazid and is considered probably due to its competition with pyridoxal phosphate for the enzyme apotryptophanase.
Mechanism of Action Isoniazid inhibits the synthesis of mycoloic acids, an essential component of the bacterial cell wall. At therapeutic levels isoniazid is bactericidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms . Resistance Resistance to isoniazid occurs because of mutations in the katG, inhA, kasA and ahpC genes.
Resistance in M. tuberculosis develops rapidly when isoniazid monotherapy is administered. Susceptibility Testing For specific information regarding susceptibility test criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: www.fda.gov/STIC.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Isoniazid Tablets, USP for oral administration, are available as following strength: 300 mg White to off white, round scored tablets, debossed with " CE " above bisect " 172 ” on one side and plain on other side and supplied as: Bottles of 90 tablets NDC 62135-709-90 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense contents in a well-closed, light-resistant container as defined in the USP with a child-resistant closure, as required.
📋 Description ▾
DESCRIPTION Isoniazid, USP is an antibacterial available as 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: calcium sulfate dihydrate, pregelatinized starch, croscarmellose sodium, povidone, purified water, and calcium stearate. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide.
It has a molecular formula of C 6 H 7 N 3 O and a molecular weight of 137.14. It has the following structural formula: Isoniazid, USP is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether.
Isoniazid, USP is slowly affected by exposure to air and light. Isoniazid Structure
⚠️ Precautions ▾
PRECAUTIONS General All drugs should be stopped and an evaluation made at the first sign of a hypersensitivity reaction. If isoniazid therapy must be reinstituted, the drug should be given only after symptoms have cleared. The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent hypersensitivity reaction.
Use of isoniazid should be carefully monitored in the following: Daily users of alcohol. Daily ingestion of alcohol may be associated with a higher incidence of + isoniazid hepatitis. Patients with active chronic liver disease or severe renal dysfunction.
Age greater than 35. Concurrent use of any chronically administered medication. History of previous discontinuation of isoniazid.
Existence of peripheral neuropathy or conditions predisposing to neuropathy. Pregnancy. Injection drug use.
Women belonging to minority groups, particularly in the postpartum period. HIV seropositive patients. Information for Patients Patients should be counseled to notify their healthcare provider immediately if they experience any of the following: rash with fever or blisters, with or without peeling skin, slurred speech, unsteady gait, loss of coordination, intentional tremor, or involuntary eye movements.
Laboratory Tests Because there is a higher frequency of isoniazid associated hepatitis among certain patient groups, including Age greater than 35, daily users of alcohol, chronic liver disease, injection drug use and women belonging to minority groups, particularly in the post-partum period, transaminase measurements should be obtained prior to starting and monthly during preventative therapy or more frequently as needed. If any of the values exceed three to five times the upper limit of normal, isoniazid should be temporarily discontinued and consideration given to restarting therapy.
Drug Interactions Food Isoniazid should not be administered with food. Studies have shown that the bioavailability of isoniazid is reduced significantly when administered with food. Tyramine- and histamine-containing foods should be avoided in patients receiving isoniazid.
Because isoniazid has some monoamine oxidase inhibiting activity, an interaction with tyramine-containing foods (cheese, red wine) may occur. Diamine oxidase may also be inhibited, causing exaggerated response (e.g., headache, sweating, palpitations, flushing, hypotension) to foods containing histamine (e.g., skipjack, tuna, other tropical fish). Acetaminophen A report of severe acetaminophen toxicity was reported in a patient receiving Isoniazid.
It is believed that the toxicity may have resulted from a previously unrecognized interaction between isoniazid and acetaminophen and a molecular basis for this interaction has been proposed. However, current evidence suggests that isoniazid does induce P-450IIE1, a mixed-function oxidase enzyme that appears to generate the toxic metabolites, in the liver. Furthermore it has been proposed that isoniazid resulted in induction of P-450IIE1 in the patient's liver which, in turn, resulted in a greater proportion of the ingested acetaminophen being converted to the toxic metabolites.
Studies have demonstrated that pretreatment with isoniazid potentiates acetaminophen hepatotoxicity in rats 1,2 . Carbamazepine Isoniazid is known to slow the metabolism of carbamazepine and increase its serum levels. Carbamazepine levels should be determined prior to concurrent administration with isoniazid, signs and symptoms of carbamazepine toxicity should be monitored closely and appropriate dosage adjustment of the anticonvulsant should be made 3 .
Ketoconazole Potential interaction of Ketoconazole and Isoniazid may exist. When Ketoconazole is given in combination with isoniazid and rifampin the AUC of ketoconazole is decreased by as much as 88 percent after 5 months of concurrent Isoniazid and Rifampin therapy 4 . Phenytoin Isoniazid may increase serum levels of phenytoin.
To… [Excerpted — this section continues on DailyMed.]
📚 References ▾
REFERENCES Murphy, R., et al: Annuals of Internal Medicine; 1990: November 15; volume 113: 799-800. Burke, R.F., et al: Res Commun Chem Pathol Pharmacol; 1990: July; vol. 69: 115-118.
Fleenor, M. F., et al: Chest (United States) Letter; 1991; June; 99 (6): 1554. Baciewicz, A.M. and Baciewicz, Jr.
F.A.: Arch Int Med 1993: September; volume 153: 1970-1971. Jonviller, A.P., et al: European Journal of Clinical Pharmacol (Germany), 1991: 40 (2) p198. American Thoracic Society/Centers for Disease Control: Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children.
Amer. J. Respir Crit Care Med.1994;149: p1359-1374.
Hoglund P., et al: European Journal of Respir Dis (Denmark) 1987: February; 70 (2) p110-116. Committee on Infectious Diseases American Academy of Pediatrics:1994, Red Book: Report of the Committee on Infectious Diseases; 23 edition; p487. Schraufnagel, DE; Testing for Isoniazid; Chest (United States) 1990: August; 98 (2) p314-316.
To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Chartwell RX, LLC Congers, NY 10920 Rev. 02/2025 L71690
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Isoniazid Tablets, USP 300 mg- NDC 62135-709-90 -90s Bottle Label Isoniazid Tablets, USP 300 mg- NDC 62135-709-90 -90s Bottle Label