اتامبوتول
Ethambutol (Myambutol)
اتامبوتول

نام ژنریک

Ethambutol HCl

شکل دارویی

اشكال دارويي:


Tablet: 400mg


Tablet: Ethambutol 275mg + Isoniazid 75mg + Rifampin 150mg)


Tablet: Ethambutol 275mg + Isoniazid 75mg + Pirazinamide 400mg+ Rifampin 150mg)

موارد مصرف

موارد و مقدار مصرف


سل


بزرگسالان: mg/kg 25 - 15 يك بار در روز يا mg/kg 50 تا حداكثر 2.5 گرم دو بار در هفته يا mg/kg 30 - 25 تا حداكثر 2.5 گرم سه بار در هفته.


مكانيسم اثر


اتامبوتول اثر باكتريواستاتيك خود را از طريق اختلال در سنتز RNA ايجاد مي‌نمايد.

موارد منع مصرف

عوارض جانبي


اعصاب مركزي: تب، عدم تعادل، بي‌حالي، سردرد، گيجي، توهم.


چشم: نوريت عصب بينائي، خونريزي شبكيه.


دستگاه گوارش: تهوع، استفراغ، دل درد، بي‌اشتهايي، يرقان كلستاتيك، اختلال گذرا در عملكرد كبد.


ادراري - تناسلي: نفريت بينابيني.


خون: نوتروپني، ترومبوسيتوپني، كلوپني.


پوست: خارش، درماتيت، سندرم استيونس جانسون.


ساير عوارض: آنافيلاكسي، نوريت محيطي.

موارد قابل توجه

-

مکانیزم اثر

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: نورويت اپتيك، كودكان زير 13 سال.


موارد احتياط : نارسايي كليه، نقرس، اختلالات چشمي (كاتاراكت، التهابات مكرر چشمي، رتينوپاتي ديابتي).


تداخل دارويي


در صورت مصرف همزمان با داروهايي كه داراي عوارض جانبي دستگاه عصبي هستند، احتمال بروز عوارض عصبي (نوريت محيطي و تورم عصب بينائي) افزايش مي‌يابد.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: ضد سل نيمه صناعي.


طبقه‌بندي درماني: ضد سل.


طبقه‌بندي مصرف در بارداري: رده ‍C


ملاحظات اختصاصي


1- قبل از شروع درمان از طريق كشت و آنتي بيوگرام بايد از اثر بخش بودن اتامبوتول اطمينان حاصل كرد.


2- قبل از شروع درمان با اتامبوتول بيمار بايد تحت معاينات چشمي قرار گرفته و در حين درمان نيز اين معاينات ادامه يابد. بيماراني كه روزانه بيش از mg/kg 15 اتامبوتول دريافت مي‌كنند، به صورت ماهيانه بايد تحت معاينات افتالموسكوپي، سنجش بينايي و آزمون افتراق رنگ قرار گيرند.


3- در حين درمان بايد از بيمار در رابطه با علائم چشمي از جمله تاري ديد سؤال كرد.


4- با شروع اختلال در تيز بيني بيمار دارو بايد قطع شود.


5- چشم‌ها بايد به صورت جداگانه و با هم تحت معاينه قرار گيرند.


6- بيماران با نارسايي كليه بايد از لحاظ حجم دريافتي و دفعي تحت كنترل بوده و در صورت بروز هرگونه تغييري در حجم ادرار اقدامات پزشكي مورد نياز در نظر گرفته شود.


7- در طي درمان با اتامبوتول بيمار بايد از نظر عملكرد كليوي، كبدي، شمارش كامل گلبولي و سطح سري اسيداوريك تحت نظر باشد.


8- در صورت بروز تحريك گوارش دارو با غذا مصرف شود.


9- شايع ترين عارضه جانبي اتامبوتول، نوريت عصب بينايي است.


10- نوريت محيطي به صورت احساس مور مور شدن اندام‌ها و كرختي انگشتان تظاهر مي‌يابد.


نكات قابل توصيه به بيمار


1- بيمار بايد با رعايت دقيق رژيم درماني و ضرورت انجام آزمايش‌هاي ادواري آشنا شود.


2- بيمار بايد با طولاني بودن دوره درمان آشنا باشد.


3- بيمار بايد بلافاصله بعد از شروع علائمي از قبيل تاري ديد، تغيير در درك و ديد رنگ‌ها، كاهش ميدان ديد و يا هرگونه علامت ديگر چشمي به پزشك مراجعه نمايد.


مصرف در كودكان: كارخانه سازنده مصرف اين دارو را در كودكان زير 13 سال ممنوع اعلام كرده است.


مصرف در شيردهي: تامبوتول در شير وارد شده بنابراين مصرف آن در دوران شيردهي تنها در موارد ارجع بودن منافع بر خطرات آن مجاز مي‌باشد.

Ethambutol (Myambutol)

MYAMBUTOL
(ethambutol hcl) Tablets

DRUG DESCRIPTION

MYAMBUTOL ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. The structural formula is:

MYAMBUTOL (ethambutol hcl)   structural formula illustration

(+)-2,2'(Ethylenediimino)-di-1-butanol dihydrochloride

MYAMBUTOL (ethambutol) 100 and 400 mg tablets contain the following inactive ingredients: Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl Sulfate, Sorbitol, Stearic Acid, Sucrose, Titanium Dioxide and other ingredients.

What are the possible side effects of ethambutol (Myambutol)?

If you experience any of the following serious side effects, stop taking ethambutol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • vision changes (e.g., blurring, red-green color blindness);
  • a rash;
  • numbness or tingling in your fingers, toes, hands, or feet;
  • confusion, disorientation, or hallucinations; or
  • fever.

Other, less serious side effects may be more likely to occur. Continue to...

Read All Potential Side Effects and See Pictures of Myambutol »

What are the precautions when taking ethambutol (Myambutol)?

Before taking ethambutol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as optic neuritis, cataracts, diabetic retinopathy), liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

During pregnancy, this...

Read All Potential Precautions of Myambutol »

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

MYAMBUTOL (ethambutol) 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, ie, initial treatment, the most frequently used regimens have been the following:

MYAMBUTOL (ethambutol) plus isoniazid

MYAMBUTOL (ethambutol) 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, MYAMBUTOL (ethambutol) 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 MYAMBUTOL (ethambutol) 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.

DOSAGE AND ADMINISTRATION

MYAMBUTOL (ethambutol) should not be used alone, in initial treatment or in retreatment. MYAMBUTOL (ethambutol) 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.

MYAMBUTOL (ethambutol) is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.

Initial Treatment: In patients who have not received previous antituberculous therapy, administer MYAMBUTOL (ethambutol) 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 MYAMBUTOL (ethambutol) 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 MYAMBUTOL (ethambutol) administration, decrease the dose to 15 mg/kg (7mg/ 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

Weight-Dose Table Weight Range Pounds 15 mg/kg (7 mg/lb) Schedule
Kilograms Dose 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

HOW SUPPLIED

MYAMBUTOL® (Ethambutol Hydrochloride) Tablets USP

100 mg - round, convex, white, film coated tablets engraved M6 on one side are supplied as follows:

NDC 68850-010-01 - Bottle of 100

400 mg - round, convex, white, scored, film coated tablets engraved with M to the left and 7 to the right of the score on one side are supplied as follows:

NDC 68850-012-01 - Bottle of 100
NDC 68850-012-03 - Bottle of 1000
NDC 68850-012-02 - 10 Blister-packs x 10 tablets

Store at controlled room temperature 20° to 25°C (68°C to77°F)

Manufactured by Patheon Inc. Toronto, Ontario, Canada. For Stat-Trade, Inc. Distributed by X-GEN Pharmaceuticals, Inc., Northport, NY 11768. Revised January 2007. FDA Rev date: 10/30/2008

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

MYAMBUTOL (ethambutol) may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterized by one or more of the following events: decreased visual acuity, scotoma, color blindness, and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis.

Patients should be advised to report promptly to their physician any change of visual acuity.

The change in visual acuity may be unilateral or bilateral and hence each eye must be tested separately and both eyes tested together. Testing of visual acuity should be performed before beginning MYAMBUTOL (ethambutol) therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg per kilogram per day. Snellen eye charts are recommended for testing of visual acuity. Studies have shown that there are definite fluctuations of one or two lines of the Snellen chart in the visual acuity of many tuberculous patients not receiving MYAMBUTOL (ethambutol) .

The following table may be useful in interpreting possible changes in visual acuity attributable to MYAMBUTOL (ethambutol) .

Initial Snellen Reading Reading Indicating Significant Decrease Significant Number of Lines Decrease Number of Points
20/13 20/25 3 12
20/15 20/25 2 10
20/20 20/30 2 10
20/25 20/40 2 15
20/30 20/50 2 20
20/40 20/70 2 30
20/50 20/70 1 20

In general, changes in visual acuity less than those indicated under "Significant Number of Lines" and "Decrease Number ofPoints" may be due to chance variation, limitations of the testing method, or physiologic variability. Conversely, changes in visual acuity equaling or exceeding those under "Significant Number of Lines" and "Decrease Number of Points" indicate need for retestingand careful evaluation of the patient's visual status. If careful evaluation confirms the magnitude of visual change and fails to reveal another cause, MYAMBUTOL (ethambutol) should be discontinued and the patient reevaluated at frequent intervals. Progressive decreases in visual acuity during therapy must be considered to be due to MYAMBUTOL (ethambutol) .

If corrective glasses are used prior to treatment, these must be worn during visual acuity testing. During 1 to 2 years of therapy, a refractive error may develop which must be corrected in order to obtain accurate test results. Testing the visual acuity through a pinhole eliminates refractive error. Patients developing visual abnormality during MYAMBUTOL (ethambutol) treatment may show subjective visual symptoms before, or simultaneously with, the demonstration of decreases in visual acuity, and all patients receiving MYAMBUTOL (ethambutol) should be questioned periodically about blurred vision and other subjective eye symptoms.

Recovery of visual acuity generally occurs over a period of weeks to months after the drug has been discontinued. Some patients have received MYAMBUTOL (ethambutol hydrochloride) again after such recovery without recurrence of loss of visual acuity. Other adverse reactions reported include: hypersensitivity, anaphylactic/anaphylactoid reaction, dermatitis, erythema multiforme, pruritus, and joint pain; anorexia, nausea, vomiting, gastrointestinal upset, and abdominal pain; fever, malaise, headache, and dizziness; mental confusion, disorientation, and possible hallucinations; thrombocytopenia, leucopenia, and neutropenia. Numbness and tingling of the extremities due to peripheral neuritis have been reported. Elevated serum uric acid levels occur and precipitation of acute gout has been reported. Pulmonary infiltrates, with or without eosinophilia, also have been reported during MYAMBUTOL (ethambutol) therapy. Liver toxicities, including fatalities, have been reported. (See WARNINGS). Since MYAMBUTOL (ethambutol) is recommended for therapy in conjunction with one or more other antituberculous drugs, these changes may be related to the concurrent therapy. Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, pericarditis. Fever and lymphadenopathy may be present.

Read the Myambutol (ethambutol) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

The results of a study of coadministration of MYAMBUTOL (ethambutol) (50mg/kg) with an aluminum hydroxide containing antacid to 13 patients with tuberculosis showed a reduction of mean serum concentrations and urinary excretion of ethambutol of approximately 20% and 13%, respectively, suggesting that the oral absorption of ethambutol may be reduced by these antacid products. It is recommended to avoid concurrent administration of ethambutol with aluminum hydroxide containing antacids for at least 4 hours following ethambutol administration.

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

MYAMBUTOL (ethambutol) 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 PRECAUTIONS and ADVERSE REACTIONS).

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

PRECAUTIONS

MYAMBUTOL ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.

Patients with decreased renal function need the dosage reduced as determined by serum levels of MYAMBUTOL (ethambutol) , since the main path of excretion of this drug is by the kidneys.

Because 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 be sure the variations in vision are not due to the underlying disease conditions. In such patients, consideration should be given to relationship between benefits expected and possible visual deterioration since evaluation of visual changes is difficult. (For recommended procedures, see paragraphs under ADVERSE REACTIONS.)

As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.

Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. There are reports of ophthalmic abnormalities occurring in infants born to women on antituberculous therapy that included MYAMBUTOL (ethambutol) . MYAMBUTOL (ethambutol) should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

MYAMBUTOL (ethambutol) has been shown to be teratogenic in pregnant mice and rabbits when given in high doses. When pregnant mice or rabbits were treated with high doses of ethambutol hydrochloride, fetal mortality was slightly but not significantly (P > 0.05) increased. Female rats treated with ethambutol hydrochloride displayed slight but insignificant (P > 0.05) decreases in fertility and litter size. In fetuses born of mice treated with high doses of MYAMBUTOL (ethambutol) during pregnancy, a low incidence of cleft palate, exencephaly and abnormality of the vertebral column were observed. Minor abnormalities of the cervical vertebra were seen in the newborn of rats treated with high doses of ethambutol hydrochloride during pregnancy. Rabbits receiving high doses of MYAMBUTOL (ethambutol) during pregnancy gave birth to two fetuses with monophthalmia, one with a shortened right forearm accompanied by bilateral wrist-joint contracture and one with hare lip and cleft palate.

Nursing Mothers

MYAMBUTOL (ethambutol) is excreted into breast milk. The use of MYAMBUTOL (ethambutol) should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.

Pediatric Use

MYAMBUTOL (ethambutol hydrochloride) is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.

Geriatric Use

There are limited data on the use of MYAMBUTOL (ethambutol) in the elderly. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on MYAMBUTOL (ethambutol) . No differences in safety or tolerability were observed in these patients compared with that reported in adults in general. Other reported 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.

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

MYAMBUTOL (ethambutol) 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 judgment determines that it may be used. MYAMBUTOL (ethambutol) is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

MYAMBUTOL (ethambutol) , following a single oral dose of 25 mg/kg of body weight, attains a peak of 2 to 5 mcg/mL in serum 2 to 4 hours after administration. When the drug is administered daily for longer periods of time at this dose, serum levels are similar. The serum level of MYAMBUTOL (ethambutol) falls to undetectable levels by 24 hours after the last dose except in some patients with abnormal renal function. The intracellular concentrations of erythrocytes reach peak values approximately twice those of plasma and maintain this ratio throughout the 24 hours. During the 24-hour period following oral administration of MYAMBUTOL (ethambutol) approximately 50 percent of the initial dose is excreted unchanged in the urine, while an additional 8 to 15 percent appears in the form of metabolites. The main path of metabolism appears to be an initial oxidation of the alcohol to an aldehydic intermediate, followed by conversion to a dicarboxylic acid. From 20 to 22 percent of the initial dose is excreted in the feces as unchanged drug. No drug accumulation has been observed with consecutive single daily doses of 25 mg/kg in patients with normal kidney function, although marked accumulation has been demonstrated in patients with renal insufficiency. MYAMBUTOL (ethambutol) diffuses into actively growing Mycobacterium cells such as tubercle bacilli. MYAMBUTOL (ethambutol) appears to inhibit the synthesis of one or more metabolites, thus causing impairment of cell metabolism, arrest of multiplication, and cell death. No cross resistance with other available antimycobacterial agents has been demonstrated.

MYAMBUTOL (ethambutol) has been shown to be effective against strains of Mycobacterium tuberculosis but does not seem to be active against fungi, viruses, or other bacteria. Mycobacterium tuberculosis strains previously unexposed to MYAMBUTOL (ethambutol) have been uniformly sensitive to concentrations of 8 or less mcg/mL, depending on the nature of the culture media. When MYAMBUTOL (ethambutol) has been used alone for treatment of tuberculosis, tubercle bacilli from these patients have developed resistance to MYAMBUTOL (ethambutol hydrochloride) by in-vitro susceptibility tests; the development of resistance has been unpredictable and appears to occur in a step- like manner. No cross resistance between MYAMBUTOL (ethambutol) and other antituberculous drugs has been reported. MYAMBUTOL (ethambutol) has reduced the incidence of the emergence of mycobacterial resistance to isoniazid when both drugs have been used concurrently. An agar diffusion microbiologic assay, based upon inhibition of Mycobacterium smegmatis (ATCC 607) may be used to determine concentrations of MYAMBUTOL (ethambutol) in serum and urine.

Animal Pharmacology

Toxicological studies in dogs on high prolonged doses produced evidence of myocardial damage and failure, and depigmentation of the tapetum lucidum of the eyes, the significance of which is not known. Degenerative changes in the central nervous system, apparently not dose-related, have also been noted in dogs receiving ethambutol hydrochloride over a prolonged period. In the rhesus monkey, neurological signs appeared after treatment with high doses given daily over a period of several months. These were correlated with specific serum levels of ethambutol and with definite neuroanatomical changes in the central nervous system. Focal interstitial carditis was also noted in monkeys which received ethambutol hydrochloride in high doses for a prolonged period.

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 1/8/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Myambutol Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ETHAMBUTOL - ORAL

(eth-AM-bue-tol)

COMMON BRAND NAME(S): Myambutol

USES: Ethambutol is used with other medications to treat tuberculosis (TB). Ethambutol is an antibiotic and works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used with other medications to help treat a certain serious infection (Mycobacterium avium complex-MAC). It may also be used with other medications to prevent the MAC infection from occurring again in people with advanced HIV disease.

HOW TO USE: Take this medication by mouth with or without food, usually once daily or as directed by your doctor. This medication may sometimes be taken twice weekly. Take this medication exactly as directed by your doctor.

If you also take antacids that contain aluminum, take this medication at least 4 hours before the antacid.

The dosage is based on your age, weight, medical condition, and response to treatment.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).

Tell your doctor if your condition persists or worsens.

Disclaimer

Myambutol Consumer (continued)

SIDE EFFECTS: Headache, loss of appetite, upset stomach, or nausea/vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes (such as blurred/decreased vision, color blindness), symptoms of liver disease (such as persistent nausea/vomiting, unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), numbness/tingling of arms/legs, toe/joint pain.

Tell your doctor immediately if any of these rare but serious side effects occur: mental/mood disorders (such as confusion, hallucinations), signs of a new infection (such as fever, persistent sore throat), easy bleeding/bruising.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Myambutol (ethambutol) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking ethambutol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as optic neuritis, cataracts, diabetic retinopathy), liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. If you have HIV disease, do not breast-feed because breast milk can transmit HIV.

Disclaimer

Myambutol Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as sputum test, eye/vision exams, kidney/liver function, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to take each scheduled dose of this medication as directed. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Myambutol Patient Information Including Side Effects

Brand Names: Myambutol

Generic Name: ethambutol (Pronunciation: eth AM bue tol)

What is ethambutol (Myambutol)?

Ethambutol is an antibiotic. It prevents growth of the tuberculous bacteria in the body.

Ethambutol is used to treat tuberculosis (TB).

Ethambutol may also be used for purposes other than those listed in this medication guide.

Ethambutol 400 mg-BAR

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Ethambutol 400 mg-VER

round, white, imprinted with VP, 1 4

Myambutol 400 mg

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What are the possible side effects of ethambutol (Myambutol)?

If you experience any of the following serious side effects, stop taking ethambutol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • vision changes (e.g., blurring, red-green color blindness);
  • a rash;
  • numbness or tingling in your fingers, toes, hands, or feet;
  • confusion, disorientation, or hallucinations; or
  • fever.

Other, less serious side effects may be more likely to occur. Continue to take ethambutol and talk to your doctor if you experience

  • stomach upset, nausea, vomiting, abdominal pain, or decreased appetite;
  • headache;
  • mild dizziness;
  • worsening gout; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Myambutol (ethambutol) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ethambutol (Myambutol)?

Take all of the ethambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Call your doctor immediately if you experience changes in vision (e.g., blurring, red-green color blindness) or a rash.

Side Effects Centers

Myambutol Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking ethambutol (Myambutol)?

Before taking this medication, tell your doctor if you have

  • ever had an allergic reaction to ethambutol;
  • cataracts, diabetic retinopathy, or optic neuritis; or
  • kidney disease.

You may not be able to take ethambutol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether ethambutol will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is also not known whether ethambutol will be harmful to a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take ethambutol (Myambutol)?

Take ethambutol exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water.

Ethambutol can be taken with or without food. Taking ethambutol with food may decrease stomach upset.

Take all of the ethambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethambutol is usually combined with one or more other tuberculosis medicines.

Store this medication at room temperature away from moisture and heat.

Side Effects Centers

Myambutol Patient Information including If I Miss a Dose

What happens if I miss a dose (Myambutol)?

Take the missed dose as soon as you remember. If it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose (Myambutol)?

Seek emergency medical attention if an overdose is suspected.

Symptoms of an ethambutol overdose are unknown.

What should I avoid while taking ethambutol (Myambutol)?

There are no restrictions on foods, beverages, or activities during treatment with ethambutol unless otherwise directed by your doctor.

What other drugs will affect ethambutol (Myambutol)?

Do not take antacids that contain aluminum within several hours of taking a dose of ethambutol. Aluminum will decrease the amount of ethambutol that is absorbed by the body. If you need an antacid, ask your doctor or pharmacist to recommend one that is aluminum free.

Drugs other than those listed here may also interact with ethambutol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about ethambutol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.06. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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