Isoniazid 50 mg/5mL
isoniazid · SOLUTION · CMP Pharma, Inc.
Isoniazid is a solution containing isoniazid at 50 mg/5mL, taken oral. Manufactured by CMP Pharma, Inc..
Key Facts
- Brand Name
- Isoniazid
- Generic Name
- isoniazid
- NDC Code (Product)
46287-009- Manufacturer
- CMP Pharma, Inc.
- Strength
- 50 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA088235
- Drug Class
- Antimycobacterial [EPC]
- Marketing Start
- 11/11/1983
Recall History
West-Ward Pharmaceutical Corp.
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Aidapak Services, LLC
Labeling: Label Mixup: ISONIAZID, Tablet, 300 mg may have potentially been mislabeled as one of the following drugs: hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003690, EXP: 6/26/2014; CETIRIZINE HCL, Tablet, 5 mg, NDC 00378363501, Pedigree: AD32757_13, EXP: 5/13/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD32757_47, EXP: 5/13/2014; DULoxetine HCl DR,
West-ward Pharmaceutical Corp.
Failed Dissolution Specifications; 36 month stability timepoint
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Isoniazid tablets, USP 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, USP 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…
Dosage & 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 …
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 tablets 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 tablets if symptoms or signs of cerebellar syndrome occur.
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.
Drug Interactions
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…
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". Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis. 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 ). 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 …
Frequently Asked Questions
What is Isoniazid used for?
Isoniazid contains isoniazid. It is a solution taken oral. Consult your doctor for specific uses.
Is Isoniazid a controlled substance?
Isoniazid is not classified as a controlled substance by the DEA.
What is the generic name for Isoniazid?
The generic name for Isoniazid is isoniazid. There are 4 other brand versions of isoniazid.
What is the NDC code for Isoniazid 50 mg/5mL?
The NDC (National Drug Code) for Isoniazid 50 mg/5mL is 46287-009, listed by CMP Pharma, Inc..