Ethambutol label

Ethambutol

Ethambutol Recall

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Side Effects & Adverse Reactions

Ethambutol hydrochloride tablets may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported. (See PRECAUTIONSand ADVERSE REACTIONS).

Liver toxicities including fatalities have been reported (See ADVERSE REACTIONS). Baseline and periodic assessment of hepatic function should be performed.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Ethambutol hydrochloride tablets are 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 freguently used regimens have been the following:

  •  Ethambutol Hydrochloride Tablets plus isoniazid
  •  Ethambutol Hydrochloride Tablets plus isoniazid plus streptomycin.

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

History

There is currently no drug history available for this drug.

Other Information

Ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. Ethambutol hydrochloride is a white, crystalline powder.  The structural formula is:

Structural Formula

Structural Formula

Each tablet, for oral administration, contains 100 mg or 400 mg ethambutol hydrochloride.

In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Docusate Sodium, Lactose Monohydrate, Magnesium Stearate, Polyvinyl Pyrrolidone, Stearic Acid, Sugar. Film Coating and Polishing contains: Hydroxypropyl Methylcellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide.

Ethambutol Manufacturers

  • Physicians Total Care, Inc.
    Ethambutol | Physicians Total Care, Inc.
    No Recall

    Ethambutol | Physicians Total Care, Inc.

    Ethambutol | Physicians Total Care, Inc.

    Ethambutol hydrochloride tablets should not be used alone, in initial treatment or in retreatment. Ethambutol hydrochloride tablets should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

    Ethambutol hydrochloride tablets are not recommended for use in pediatric patients under 13 years of age since safe conditions for use have not been established.

    Initial Treatment:

    In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride tablets 15 mg/kg (7 mg/lb) of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose.

    Retreatment:

    In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride tablets 25 mg/kg (11 mg/lb) of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of ethambutol hydrochloride tablets administration, decrease the dose to 15 mg/kg (7 mg/lb) of body weight, and administer as a single oral dose once every 24 hours.

    During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.

    See Table for easy selection of proper weight-dose tablet(s).

    Weight-Dose Table      15 mg/kg (7 mg/lb) Schedule  Weight Range  Daily Dose  Pounds    Kilograms  In mg  Under 85 lbs.    Under 37 kg  500  85 - 94.5    37 – 43  600  95 - 109.5    43 – 50  700  110 - 124.5    50 – 57  800  125 - 139.5    57 – 64  900  140 - 154.5    64 – 71  1000  155 - 169.5    71 – 79  1100  170 - 184.5    79 – 84  1200  185 - 199.5    84 – 90  1300  200 - 214.5    90 – 97  1400  215 and Over    Over 97  1500      25 mg/kg (11 mg/lb) Schedule  Under 85 lbs.    Under 38 kg  900  85 - 92.5    38 - 42  1000  93 - 101.5    42 - 45.5  1100  102 - 109.5    45.5 – 50  1200  110 - 118.5    50 – 54  .1300  119 - 128.5    54 – 58  1400  129 - 136.5    58 – 62  1500  137 - 146.5    62 – 67  1600  147 - 155.5    67 – 71  1700  156 - 164.5    71 – 75  1800  165 - 173.5    75 – 79  1900  174 - 182.5    79 – 83  2000  183 - 191.5    83 – 87  2100  192 - 199.5    87 – 91  2200  200 - 209.5    91 – 95  2300  210 - 218.5    95 – 99  2400  219 and Over    Over 99  2500
  • Versa Pharmaceutical
    Ethambutol | It Cosmetics, Llc
    No Recall

    Ethambutol | It Cosmetics, Llc

    Ethambutol | It Cosmetics, Llc

    There is currently no dosage information available for this product. We apologize for any inconvenience.