Safety Data Sheet Allopurinol Tablets, USP

Transcription

1 EMERGENCY OVERVIEW Each intended for oral administration contains Allopurinol 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: C 5 H 4 N 4 O Chemical Name: 1, 5-dihydro-4H-pyrazolo [3, 4-d] pyrimidin-4-one 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 / Therapeutic Category Restriction on Use / Contraindications: Orally / Muscle Relaxant ALLOPURINOL SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE AN ALLERGIC REACTION. In some instances a skin rash may be followed by more severe hypersensitivity reactions such as exfoliative, urticarial and purpuric lesions as well as Stevens-Johnson syndrome (erythema multiforme exudativum), and/or generalized vasculitis, irreversible hepatotoxicity, and, on rare occasions, death. Page 1 of 8

2 Section 2. HAZARD(S) IDENTIFICATION Dose and Administration Dosage should be individualized with careful monitoring of patient response. The dosage of allopurinol to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to 300 mg/day for patients with mild gout and 400 to 600 mg/day for those with moderately severe tophaceous gout. The appropriate dosage may be administered in divided doses or as a single equivalent dose with the 300 mg tablet. Dosage requirements in excess of 300 mg should be administered in divided doses. The minimal effective dosage is 100 to 200 mg daily and the maximal recommended dosage is 800 mg daily. To reduce the possibility of flare-up of acute gouty attacks, it is recommended that the patient start with a low dose of allopurinol (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dl or less is attained but without exceeding the maximal recommended dosage. Adverse Effects The most frequent adverse reaction to allopurinol is skin rash. Skin reactions can be severe and sometimes fatal. Therefore, treatment with allopurinol should be discontinued immediately if a rash develops. Gastrointestinal: Diarrhea, nausea, alkaline phosphatase increase, SGOT/SGPT increase. Metabolic and Nutritional: Acute attacks of gout. Over Dose Effect Massive overdosing or acute poisoning by allopurinol has not been reported. In mice, the 50% lethal dose (LD50 ) is 160 mg/kg given intraperitoneally (IP) with deaths delayed up to 5 days and 700 mg/kg orally (PO) (approximately 140 times the usual human dose) with deaths delayed up to 3 days. In rats, the acute LD50 is 750 mg/kg IP and 6000 mg/kg PO (approximately 1200 times the human dose). Page 2 of 8

3 Contraindications Patients who have developed a severe reaction to allopurinol should not be restarted on the drug. A few cases of reversible clinical hepatotoxicity have been noted in patients taking allopurinol, and in some patients, asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed. Pregnancy Comments There are no adequate and well controlled studies in pregnant women. Experience with allopurinol during human pregnancy has been limited partly because woman of reproductive age rarely require treatment with allopurinol. Allopurinol and oxipurinol have been found in the milk of a mother who was receiving allopurinol. Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when allopurinol is administered to a nursing woman. Pregnancy Category Pregnancy Category C Section 3. COMPOSITION/INFORMATION ON INGREDIENTS Component Exposure Limit CAS No. Principle Component: Allopurinol Not Found Inactive Ingredients: Lactose Monohydrate Not Found Pregelatinized Starch Not Found Croscarmellose Sodium Not Found Povidone Not Found Colloidal Silicon Dioxide Not Found Magnesium Stearate Not Found FD& C Yellow No. 6 Aluminum Lake (Only for 300 mg) Not Found Page 3 of 8

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. FIRST FIGHTING MEASURES Flash Point Not applicable Extinguishing Media Water, Carbon Dioxide, Dry Chemical, Foam. Unusual Fire and Explosion Toxic emissions may be given off in a fire. Hazards Fire Fighting Instructions 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. Section 6. ACCIDENTAL RELEASE MEASURES Spill Clean Up Procedures 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. Page 4 of 8

5 Treatment and Disposal 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]. Precautions for safe handling Avoid prolonged exposure. Avoid contact with eyes. Avoid release to environment. Use with adequate ventilation. When handling, use proper personal protective equipment. Wash thoroughly after handling. Keep container tightly closed when not in in use. Section 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Respiratory Protection Skin protection Eye/face protection Protective Clothing Biological limit values Exposure guidelines Thermal hazards No personal respiratory protective equipment normally required. Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits. Not normally needed. For prolonged or repeated skin contact use suitable protective gloves. Not normally needed. 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 ingredients(s). General ventilation normally adequate. Wear appropriate thermal protective clothing, when necessary. Page 5 of 8

6 General hygiene considerations Engineering controls 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 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 Solid Color 100 mg: White to off-white, 300 mg: Light peach to peach color Odor Pure/Mixture No unpleasant odor. Mixture Section 10. STABILITY AND REACTIVITY Stability Normally stable but formation of toxic gases is possible during heating or in case of fire. Incompatibility materials to avoid keep away from Acids. Peroxides, Phenols. Polymerization No Conditions of Polymerization Will not occur Page 6 of 8

7 Section 11. TOXILOGICAL INFORMATION Allopurinol Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard. Skin contact May cause an allergic skin reaction. Eye contact Health injuries are not known or expected under normal use. Direct contact with eyes may cause temporary irritation. Carcinogenesis, Mutagenesis, Impairment of Fertility No data available to indicate product or any components present at greater than 0.1% are mutagenic or genotoxic. Not classifiable as to carcinogenicity to humans. Carcinogenic effects are not expected as a result of occupational exposure. Reproductive studies have been performed in rats and rabbits at doses up to twenty times the usual human dose (5 mg/kg per day), and it was concluded that there was no impaired fertility or harm to the fetus due to allopurinol. Section 12. ECOLOGICAL INFORMATION Do not allow product to enter drinking water supplies, waste water or soil. Section 13. DISPOSAL CONSIDERATION Disposal Recommendations Dispose the waste in accordance with all applicable Federal, State and local laws. Section 14. TRANSPORT INFORMATION The product is not hazardous when shipping via air (IATA), ground (DOT), or sea (IMDG). Section 15. REGULATORY INFORMATION Generic Medicine, ANDA Number Page 7 of 8

8 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..2 Fire..0 Reactivity 0 Date of issue: March 14, 2018 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. Page 8 of 8