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Ethambutol Hcl 100 Mg Tabs 100 By Lupin Pharma.

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Ethambutol Hcl 100 Mg Tabs 100 By Lupin Pharma.

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Ethambutol Hcl 100 Mg Tabs 100 By Lupin Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4238911/RXB10091330/RXA320671
Size : 100
Selling UoM : EA
NDC: 68180-0280-01
UPC Barcode : 368180280019
Supplier:0050000373 LUPIN PHARMACEUTICALS/PGN
Supplier Material : 028001
Generic Code : 009425 ETHAMBUTOL HCL ORAL TABLET 100 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Gener

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Product Description.:

LU, C31
tablet , film-coated , white , round round
DebossedBiconvexWhite to off-white

Precautions: Use with caution in patients with decreased renal function due to the risk of drug accumulation ethambutol dosage should be reduced.

Ethambutol may inhibit the response to BCG vaccine.

Periodic assessment of systemic functions, including renal, hepatic and hematopoietic should be made during long-term therapy.

Pregnancy: Reproductive studies in mice or rabbits have shown slight increases in fetal mortality when ethambutol was given at doses 10 times greater than the maximum human use dose. A low incidence of fetal abnormality was seen among animals receiving 4 to 10 times the maximum human use dose. The possibility that these findings are drug-related cannot be ruled out. Clinical experience has not shown an increase in the risk of abnormalities when the drug was administered throughout pregnancy. Although it appears that the possibility of fetal harm is remote, because of the findings in animals, ethambutol should be used during pregnancy only if clearly needed. Loss of fertility and testicular regression among male rats administered ethambutol has been reported. No effects on the testes were seen in other rat studies, or among other species treated with very high doses, for extended periods of time. There have been no reports of an antifertility effect in humans.

Lactation: Ethambutol is excreted in the milk of nursing mothers.

Children: Ethambutol is not recommended for use in children under 13 years of age, although it has been used in children older than 6 years of age. It should only be used in children whose visual acuity and color vision can be accurately determined and monitored.

Adverse Effects: Ophthalmologic: optic neuritis, decreased visual acuity, constriction of visual fields, central and peripheral scotomata, color vision defects (especially red-green color discrimination).

Dermatologic: dermatitis, pruritus.

Hypersensitivity: anaphylactoid reactions, fever, malaise. Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal: rarely, interstitial nephritis, nephrotoxicity (may be related to other antituberculous therapy).

Hematologic: rare case reports of thrombocytopenia, and neutropenia.

Gastrointestinal: anorexia, nausea, vomiting, abdominal pain, metallic taste.

CNS: headache, dizziness, mental confusion, possible hallucinations. Peripheral neuritis has been reported infrequently.

Hepatic: rarely, jaundice. Since ethambutol is recommended for therapy in conjunction with one or more other antituberculous drugs, these changes may be related to concurrent therapy.

Other: Elevated serum uric acid levels and precipitation of gout have been reported. Joint pain has also been reported.

tag_OverdoseOverdose: Symptoms: anorexia, nausea, vomiting, gastrointestinal upset, abdominal pain, fever, malaise, headache, dizziness, mental confusion, disorientation and possible hallucinations.

Treatment: No specific antidote. Stop ethambutol administration. Remove drug by emesis or gastric lavage. Anaphylactoid reactions may necessitate emergency treatment.

Dosage: M. tuberculosis: Ethambutol should not be used alone in initial treatment or in retreatment. The drug should be administered on a once every 24 hour basis only. In general, therapy should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

The duration of therapy should be a minimum of 6 to 9 months for initial treatment cases. Cases of drug-resistant tuberculosis, immunocompromised patients and retreatment cases may require 12 to 18 months or longer of therapy.

Initial Treatment: As part of a multi-drug regimen in adult patients who have not received previous antituberculous therapy, administer ethambutol 15 mg/kg as a single oral dose every 24 hours. The maximum recommended daily dose is 2.5 g.

Retreatment: In adult patients who have received previous antituberculous therapy, administer ethambutol 25 mg/kg as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculosis agent not previously used and to which the organisms have been demonstrated to be susceptible by appropriate in vitro tests. After 60 days of therapy, or when bacteriologic cultures become negative, decrease the dose to 15 mg/kg once every 24 hours. During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.

Twice Weekly Therapy: After an initial period of daily therapy, ethambutol may be given as part of a multiple-drug regimen at an adult dose of 50 mg/kg (up to 2.5 g) twice a week for the remainder of the chosen treatment period. The duration of the initial daily therapy period will depend on the number and combination of antituberculosis agents used as well as the patient's clinical status. Alter