Inagen Uses

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What is Inagen?

Inagen is used to treat tuberculosis (TB). It is used with other medicines for TB. Inagen 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 Inagen 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.

Inagen 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, Inagen is used in certain patients with the following medical condition:

Inagen indications

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Inagen 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:

In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, Inagen 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 Inagen 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 Inagen?

Use Inagen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Inagen.

Uses of Inagen in details

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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, Inagen, 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, Inagen, 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 Inagen, 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 Inagen in this condition.

Based on the ATS/IDSA Guideline for the Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases Inagen, 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, Inagen, in combination with other antitubercular drugs, is effective and recommended for initial treatment of tuberculous meningitis.

Inagen description

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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)

Inagen dosage

Inagen 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:

Usual Pediatric Dose for:

Additional dosage information:

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 Inagen, 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 Inagen, 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 Inagen, 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 Inagen, 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

Inagen is contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be administered. Inagen 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 Inagen, caution should be used when treating patients with preexisting neuritis or other vision defects. Inagen 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 Inagen should be instructed to report any vision changes or disturbances. Testing of visual acuity should be performed before beginning Inagen 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 Inagen, 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.

Inagen 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 Inagen in elderly patients. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on Inagen 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

Inagen is slightly dialyzable (5% to 20%). The dose should be administered post-dialysis.

Other Comments

Inagen or streptomycin are used as part of a combination therapy with isoniazid, rifampin, and pyrazinamide. If susceptibility to isoniazid and rifampin is shown, Inagen may be discontinued.

More about Inagen

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Related treatment guides

Inagen interactions

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What other drugs will affect Inagen?

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Aluminum Hydroxide: May decrease the serum concentration of Inagen. Management: Avoid concurrent administration of Inagen and aluminum hydroxide. If coadministration cannot be avoided administer Inagen 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

Inagen side effects

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What are the possible side effects of Inagen?

Applies to Inagen: oral tablet

In addition to its needed effects, some unwanted effects may be caused by Inagen (the active ingredient contained in Inagen). 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 Inagen:

Less common:

Rare

Minor Side Effects

Some of the side effects that can occur with Inagen 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:

Inagen contraindications

See also:
What is the most important information I should know about Inagen?

Inagen 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. Inagen 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 Inagen:

Ethambutol in Spain.

Ethambutol hydrochloride in Spain.


List of Inagen substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Globutal 800 mg Tablet (Globus Remedies Ltd)$ 0.05
Kokbutol 800 mg Tablet (Dial Pharmaceuticals Pvt. Ltd.)$ 0.05
KOXI Capsule/ Tablet / 600mg / 10 units (Shreya Life Sciences Pvt. Ltd)$ 0.36
KOXI Capsule/ Tablet / 400mg / 10 units (Shreya Life Sciences Pvt. Ltd)$ 0.20
KOXI Capsule/ Tablet / 800mg / 10 units (Shreya Life Sciences Pvt. Ltd)$ 0.57
KOXI Capsule/ Tablet / 1gm / 10 units (Shreya Life Sciences Pvt. Ltd)$ 0.60
Koxi 1gm TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.60
Koxi 400mg TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.20
Koxi 600mg TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.36
Koxi 800mg TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.48
1 g x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.60
400 mg x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.20
600 mg x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.36
800 mg x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.48
Koxi 600 mg Tablet (Shreya Life Sciences Pvt. Ltd)$ 0.04
Koxi 800 mg Tablet (Shreya Life Sciences Pvt. Ltd)$ 0.06
Koxi 1000 mg Tablet (Shreya Life Sciences Pvt. Ltd)$ 0.07
Koxi 400 mg Tablet (Shreya Life Sciences Pvt. Ltd)$ 0.02
KOXI 800MG TABLET 1 strip / 10 tablets each (Shreya Life Sciences Pvt. Ltd)$ 0.45
KOXI tab 1 g x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.60
KOXI tab 400 mg x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.20
KOXI tab 600 mg x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.36
KOXI tab 800 mg x 10's (Shreya Life Sciences Pvt. Ltd)$ 0.48
Koxi 1gm TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.60
Koxi 400mg TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.20
Koxi 600mg TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.36
Koxi 800mg TAB / 10 (Shreya Life Sciences Pvt. Ltd)$ 0.48
KOXYLAR Capsule/ Tablet / 200mg / 10 units (Lark Laboratories (India) Ltd.)$ 0.10
KOXYLAR Capsule/ Tablet / 400mg / 10 units (Lark Laboratories (India) Ltd.)$ 0.18
KOXYLAR Capsule/ Tablet / 600mg / 10 units (Lark Laboratories (India) Ltd.)$ 0.27
KOXYLAR Capsule/ Tablet / 800mg / 10 units (Lark Laboratories (India) Ltd.)$ 0.35
KOXYLAR Capsule/ Tablet / 1gm / 10 units (Lark Laboratories (India) Ltd.)$ 0.44
Koxylar 600 mg Tablet (Lark Laboratories (India) Ltd.)$ 0.03
Koxylar 800 mg Tablet (Lark Laboratories (India) Ltd.)$ 0.04
Koxylar 1000 mg Tablet (Lark Laboratories (India) Ltd.)$ 0.04
Koxylar 400 mg Tablet (Lark Laboratories (India) Ltd.)$ 0.02
KOXYLAR 1000MG TABLET 1 strip / 10 tablets each (Lark Laboratories (India) Ltd.)$ 0.44
KOXYLAR 400MG TABLET 1 strip / 10 tablets each (Lark Laboratories (India) Ltd.)$ 0.18
KOXYLAR 600MG TABLET 1 strip / 10 tablets each (Lark Laboratories (India) Ltd.)$ 0.27
KOXYLAR 800MG TABLET 1 strip / 10 tablets each (Lark Laboratories (India) Ltd.)$ 0.42
Koxylar 1000mg Tablet (Lark Laboratories (India) Ltd.)$ 0.04
Koxylar 400mg Tablet (Lark Laboratories (India) Ltd.)$ 0.02
Koxylar 600mg Tablet (Lark Laboratories (India) Ltd.)$ 0.03
Koxylar 800mg Tablet (Lark Laboratories (India) Ltd.)$ 0.04
Lambutol 400 mg x 10 x 50's (Atlantic Lab)
Lambutol 500 mg x 10 x 50's (Atlantic Lab)
Lambutol tab 400 mg 10 x 50's (Atlantic Lab)
Lambutol tab 500 mg 10 x 50's (Atlantic Lab)
LINCAMBUTOL 800MG TABLET 1 strip / 10 tablets each (Lincoln Pharmaceuticals Ltd)$ 0.51
Litamol 400 mg x 10 Blister x 10 Tablet

References

  1. 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).
  2. PubChem. "ethambutol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "ethambutol". http://www.drugbank.ca/drugs/DB00330 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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