SAFETY DATA SHEET BUMETANIDE TABLETS, USP

Transcription

1 EMERGENCY OVERVIEW Each Bumetanide Tablets intended for oral administration contains Bumetanide and excipients generally considered to be non- toxic and non-hazardous in small quantities and under conditions of normal occupational exposure. Section 1. IDENTIFICATION Identification of the product Product Name: Formula: Chemical Name: Bumetanide Tablets, USP C17H20N2O5S 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid Manufacturer / supplier identification Company: Cadila Healthcare Limited Baddi, India Address: Cadila Healthcare Limited, Swaraj Majra, Judi Kalan, Post - Baddi, Tehsil - Nalagarh, District - Solan, Himachal Pradesh Contact for information: Tel: Fax: Emergency Telephone No. Tel: Recommended use / Orally /Diuretic Therapeutic Category Restriction on Use / Contraindications: Bumetanide is contraindicated in anuria. Although bumetanide tablets can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with Bumetanide Tablets. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug.

2 Section 2. HAZARD(S) IDENTIFICATION Dose and Administration Adverse Effects Over Dose Effect Dosage should be individualized with careful monitoring of patient response. Oral Administration: The usual total daily dosage of Bumetanide tablets is 0.5 mg to 2 mg and in most patients is given as a single dose. If the diuretic response to an initial dose of Bumetanide tablets is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4 to 5 hour intervals up to a maximum daily dose of 10 mg. An intermittent dose schedule, whereby Bumetanide tablets is given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema. In patients with hepatic failure, the dosage should be kept to a minimum, and if necessary, dosage increased very carefully. The most frequent clinical adverse reactions considered probably or possibly related to Bumetanide are muscle cramps, dizziness, hypotension, headache, nausea and encephalopathy (in patients with preexisting liver disease). Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with Bumetanide use. Less frequent clinical adverse reactions to Bumetanide are impaired hearing, pruritus, electrocardiogram changes, weakness, hives, abdominal pain, arthritic pain, musculoskeletal pain, rash and vomiting. Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, premature ejaculation and difficulty maintaining an erection. Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.

3 Contraindications Pregnancy Comments Pregnancy Category Bumetanide is contraindicated in anuria. Although Bumetanide tablets can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with Bumetanide tablets. Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. Bumetanide is contraindicated in patients hypersensitive to this drug. There are no adequate and well-controlled studies in pregnant women. A small investigational experience in the United States and marketing experience in other countries to date have not indicated any evidence of adverse effects on the fetus, but these data do not rule out the possibility of harmful effects. Bumetanide should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. Pregnancy Category C Section 3. COMPOSITION / INFORMATION ON INGREDIENTS Component Exposure Limit CAS No. Principle Component: Bumetanide Not Found Inactive Ingredients: Colloidal Silicon Dioxide Not Found Corn Starch (Maize Starch B) Not Found Lactose Monohydrate (Pharmatose 200 M) Not Found Lactose Monohydrate (Flowlac 100) Not Found Magnesium stearate Not Found Povidone K30 (Plasdone K 29-32) Not Found Talc Not Found D & C Yellow No. 10 Not Found FD & C Blue No. 1 Not Found Ferric Oxide Black Not Found Ferric Oxide Red Not Found

4 Section 4. FIRST -AID MEASURES Inhalation Remove to fresh air. If discomfort occurs or persists, get medical attention. Skin contact Remove contaminated clothing and shoes. Wash skin with soap and plenty of water. If irritation occurs or persists, get medical attention. Wash clothing and shoes before reuse. Eye contact Immediately flush eyes with plenty of water. If irritation occurs or persists, get medical attention. Ingestion If large quantities of this material are swallowed, get medical attention immediately. If swallowed, rinse mouth with water (only if the person is conscious). Do not induce vomiting unless directed by medical personnel. Never give anything by mouth to an unconscious person. Section 5. FIRE FIGHTING MEASURES Flash Point Not applicable Extinguishing Media Unusual Fire and Explosion Hazards Fire Fighting Instructions Section 6. ACCIDENTAL RELEASE MEASURES Spill Clean Up Procedures Treatment and Disposal Water, Carbon Dioxide, Dry Chemical, Foam. Toxic emissions may be given off in a fire. Wear NIOSH/MSHA approved positive pressure, self contained breathing apparatus and full protective turn out gear. Use caution in approaching fire. Use water to keep fire exposed containers cool. Use proper personal protective equipment and clothing. Shut off the source of the spill or leak if it is safe to do so. Scoop or shovel spilled material into a suitable labeled open head drum. Secure the drum cover and move the container to a safe holding area. Wash spill area thoroughly with soapy water. Decontaminate equipment. Dispose of protective clothing with spilled material. Environmental precautions Avoid release to the environment. Prevent further leakage or spillage if safe to do so. Avoid discharge into drains, water courses or onto the ground. Inform appropriate managerial or supervisory personnel of all environmental releases. Section 7. HANDLING AND STORAGE Storage Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container (USP).

5 Precautions for safe handling Avoid contact with eyes. Avoid breathing dust. Use with adequate ventilation. When handling, use proper personal protective equipment specified in section 8. Wash thoroughly after handling. Keep container tightly closed when not in in use. Store in a dry area at room temperature. Section 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Respiratory Protection Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits. No personal respiratory protective equipment normally required. Skin protection Eye/face protection Protective Clothing Biological limit values Exposure guidelines Thermal hazards General hygiene considerations For prolonged or repeated skin contact use suitable protective gloves. If contact is likely, safety glasses with side shields are recommended. Protective clothing is not normally necessary, however it is good practice to use apron. No biological exposure limits noted for the ingredient(s). General ventilation normally adequate. Wear appropriate thermal protective clothing, when necessary. Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants. For advice on suitable monitoring methods, seek guidance from a qualified environment, health and safety professional. Engineering controls Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section. Section 9. PHYSICAL AND CHEMICAL PROPERTIES Physical state Tablets Color Light green (0.5 mg), Light Yellow (1 mg) and Light Orange (2 mg) Odor Odorless Pure/Mixture Mixture

6 Section 10. STABILITY AND REACTIVITY Stability Incompatibility materials to avoid Polymerization Normally stable in even under fire exposure conditions and not water reactive. Unknown No Conditions of Polymerization Will not occur Section 11. TOXICOLOGICAL INFORMATION Bumetanide Irritation Skin May cause skin reaction. Reproductive Reproduction studies were performed to evaluate general reproductive performance and fertility in rats at oral dose levels of 10 mg/kg/day, 30 mg/kg/day, 60 mg/kg/day or 100 mg/kg/day. The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant. Teratogenicity Bumetanide is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose. Carcinogenicity and Mutagenicity Bumetanide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system. Section 12. ECOLOGICAL INFORMATION Do not allow product to enter drinking water supplies, waste water or soil. Section 13. DISPOSAL CONSIDERATION Disposal Recommendations Section 14. TRANSPORT INFORMATION Dispose the waste in accordance with all applicable Federal, State and local laws. The product is not hazardous when shipping via air (IATA), ground (DOT), or sea (IMDG). Section 15. REGULATORY INFORMATION Generic Medicine, ANDA Number

7 Section 16. OTHER INFORMATION Additional Information NFPA Rating: These ratings are based on NFPA code 704 and are intended for use by emergency personnel to determine the immediate hazards of a material Health..1 Fire..0 Reactivity 0 Date of issue: October 26, 2016 Supersedes edition: New Edition The information presented in the safety data sheet is, to the best our knowledge, accurate and reliable. It characterizes the product with regard to the appropriate safety precautions. It does not represent a guarantee of the properties of the product.