Strength: 60 mg and 120 mg Pack Size: 90 and 100 Tablets per bottle Revision No.: 00

Transcription

1 EMERGENCY OVERVIEW Each Nateglinide Tablets intended for oral administration contains Nateglinide 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: C19H27NO3 R)-2-({[trans-4-(1-methylethyl)cyclohexyl]carbonyl}amino)-3- phenylpropanoic acid Manufacturer / supplier identification Company Cadila Healthcare Ltd., Matoda, India Address Cadila Healthcare Limited, Plot No- 1A/1 & 2, Pharmez Special Economic Zone, Sarkhej- Bavla N.H. No. 8A, Near Village Matoda, Tal. Sanand, Dist. Ahmedabad , India Contact for information Tel: Fax: Emergency Telephone No. Tel: Recommended use / Therapeutic Category Restriction on Use / Contraindications: Hypoglycemic Nateglinide is an oral antidiabetic agent used in the management of Type 2 diabetes (also known as non-insulin dependent diabetes mellitus (NIDDM) or adult-onset diabetes)

2 Section 2. Hazard(s) Identification Dose and Administration Nateglinide Tablets 60 mg and 120 mg, USP is available as Conventional Tablets - each containing 60 mg and 120 mg Nateglinide. Dosage: The size and frequency of the dosage must be adjusted to the needs of the individual patient. Conventional Tablets - should be taken 1 to 30 minutes prior to meals The recommended starting and maintenance dose of Nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals. The 60 mg dose of Nateglinide, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1c when treatment is initiated. Adverse Effects In clinical trials approximately 2,600 patients with Type 2 diabetes were treated with nateglinide. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Hypoglycemia was relatively uncommon in all treatments arms of the clinical trials. Only 0.3% of nateglinide patients discontinued due to hypoglycemia. Symptoms suggestive of hypoglycemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue and weakness. Gastrointestinal symptoms, especially diarrhea and nausea, were no more common inpatients using the combination of nateglinide and metformin than in patients receiving metformin alone. Likewise, peripheral edema was no more common in patients using the combination of nateglinide and rosiglitazone than in patients receiving rosiglitazone alone. Over Dose Effect An overdose of oral nateglinide elicited prompt but mild, relatively short lived and reversible hypo-glycemia. These features of hypoglycemia resembled the hypoglycemic effects of nateglinide in regular therapeutic dosages.

3 Contraindications Nateglinide Tablets are contraindicated in patients with: 1. Known hypersensitivity to the drug or its inactive INGREDIENTS 2. Type-1 diabetes 3. Diabetic Ketoacidosis. This condition should be treated with insulin Pregnancy Comments Pregnancy Category Nateglinide was not teratogenic in rats at doses up to 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended Nateglinide dose of 120 mg, three times daily before meals). In the rabbit, embryonic development was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 40 times the human therapeutic exposure with a recommended Nateglinide dose of 120 mg, three times daily before meals). There are no adequate and well-controlled studies in pregnant women. Nateglinide should not be used during pregnancy C Section 3. Composition / information on ingredients Component Exposure Limit CAS No. Principle Component: Nateglinide Not Found Inactive Ingredients: Lactose Monohydrate Not Found Citric Acid Anhydrous Not Found Corn Starch Not Found Crospovidone (Type-A) Not Found Colloidal Silicon Dioxide Not Found Polysorbate 80 Not Found Povidone (K-25) Not Found Crospovidone(Type-A) Not Found Colloidal Silicon Dioxide Not Found Magnesium Stearate Not Found Hpmc 2910/Hypromellose 6 Cp Not Found Titanium Dioxide Not Found Macrogol/Peg 4000 Not Found Talc Not Found Yellow Iron Oxide Not Found Red Iron Oxide Not Found

4 Section 4. First -aid measures General After inhalation : Supply fresh air; consult doctor in case of complaints. After skin contact :Immediately wash with water and soap and rinse thoroughly. After eye contact : Rinse opened eye for several minutes under running water. After swallowing: Rinse mouth. Do not induce vomiting. Overdose Treatment Section 5. Fire -fighting measures Extinguishing media Advice for firefighters Specific hazards arising from the chemical Special protective equipment and precautions for firefighters Specific methods General fire hazards Section 6. Accidental Release Measures An overdose of oral nateglinide elicited prompt but mild, relatively short lived and reversible hypo-glycemia. These features of hypoglycemia resembled the hypoglycemic effects of nateglinide in regular therapeutic dosages Suitable extinguishing agents: CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Special hazards arising from the substance or mixture: Formation of toxic gases is possible during heating or in case of fire. Protective equipment: Wear self-contained respiratory protective device. CO2, Powder or water spray. Fight larger fires water spray or alcohol resistant foam. Formation of toxic gases is possible during heating or in case of fire. Wear self-contained respiratory protective device. Use standard firefighting procedures and consider the hazards of other involved materials. No unusual fire or explosion hazards noted Personal precautions, protective equipment and emergency procedures Environmental precautions Avoid formation of dust. Do not allow to enter sewers/ surface or ground water.

5 Section 7. Handling and Storage Storage Handling Section 8. Exposure controls / personal protection Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Dispense in tightly container. Store in cool, dry place in tightly closed receptacles. Respiratory Protection Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits. Skin protection No personal respiratory protective equipment normally required. Eye/face protection For prolonged or repeated skin contact use suitable protective gloves. Protective Clothing 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. Biological limit values Exposure guidelines Thermal hazards General hygiene considerations Engineering controls No biological exposure limits noted for the ingredient(s) General ventilation normally adequate. Wear appropriate thermal protective clothing, when necessary. Keep away from foodstuffs, beverages and feed. Wash hands before breaks and at the end of work. 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 Appearance Description of 60 mg: White to off white, round, biconvex with bevel edge, uncoated tablets debossed '721'on one side and plain on the other side. Description of 120 mg: Light orange to orange, oval, biconvex with bevel edge, film coated tablets debossed '722' on one side and plain on the Other side.

6 Solubility Very Soluble in Odor Not available. water Boiling point Not available. Melting Point Not available. Evaporation rate Not available. Vapour density Not available. Reactivity in water Not available. Vapour pressure Not available. % Volatile by volume Not available. Specific gravity Not available. Other information Section 10. Stability and Reactivity Conditions to avoid Stable Chemical stability Hazardous reactions Decomposition products Incompatible materials Contact with incompatible materials. Reactivity: The product is stable and non-reactive under normal conditions of use, storage and transport. Material is stable under normal conditions. No dangerous reaction known under conditions of normal use. None known. Formation of toxic gases is possible during Heating or in case of fire Strong Oxidizing agent Section 11. Toxicological information General Ingestion Handling of formulated product is not expected to cause any toxicological affects. The data pertains to the ingredient in formulations, rather than this specie formulation. Health injuries are not known or expected under normal use. Expected to be a low ingestion hazard. However, ingestion is not likely to be a primary route of occupational exposure. Symptoms related to the physical, chemical and Toxicological characteristics Acute toxicity Further information Symptoms suggestive of hypoglycemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue and weakness. Fatal if swallowed. May cause an allergic skin reaction. Caution - Pharmaceutical agent. Occupational exposure to the substance or mixture may cause adverse effects.

7 Section 12. Ecological information Do not allow product to enter drinking water supplies, waste water or soil. Section 13. Disposal Consideration 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 Section 16. Other information Generic Medicine. Approved by USFDA & the ANDA Number is None Date of issue: 06/10/16 Supersedes edition: New Edition The information contained herein is based on the state of our knowledge. It characterizes the product with regard to the appropriate safety precautions. It does not represent a guarantee of the properties of the product.