Safety Data Sheet CLOBAZAM TABLETS Strength: 10 mg and 20 mg Pack Size: 100 s Tablets per HDPE Bottle and Carton of 10 Tablets (1 x 10 unit Dose),

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1 EMERGENCY OVERVIEW Each Clobazam tablets intended for oral administration contains Clobazam 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: Clobazam Tablets C 16 H 13 O 2 N 2 Cl 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4(3h,5h)- dione 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 Clobazam Tablets are benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older Restriction on Use / Contraindications: Somnolence or Sedation: Monitor for central nervous system (CNS) depression. Risk may be increased with concomitant use of other CNS depressants Withdrawal: Symptoms may occur with rapid dose reduction or discontinuation. Discontinue Clobazam gradually

2 Section 2. Hazard(s) Identification Dose and Administration A daily dose of clobazam tablets greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability. Each dose in Table 1 (e.g., 5 mg to 20 mg in 30 kg weight group) has been shown to be effective, although effectiveness increases with increasing dose [Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state. Recommended Total Daily Dosing by Weight Group 30 kg Body Weight > 30 kg Body Weight Starting Dose 5 mg 10 mg Starting Day 7 10 mg 20 mg Starting Day mg 40 mg Adverse Effects Over Dose Effect Contraindications Clinically significant adverse reactions that appear in other sections of the labeling include the following: Risks from Concomitant Use with Opioids Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants Somnolence or Sedation Withdrawal Symptoms Serious Dermatological Reactions Physical and Psychological Dependence Suicidal Behavior and Ideation Overdose and intoxication with benzodiazepines, including clobazam, may lead to CNS depression, associated with drowsiness, confusion and lethargy, possibly progressing to ataxia, respiratory depression, hypotension, and, rarely, coma or death. The risk of a fatal outcome is increased in cases of combined poisoning with other CNS depressants, including opioids and alcohol. Clobazam tablets are contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.

3 Pregnancy Comments Pregnancy Category Risk Summary There are no adequate and well-controlled studies of clobazam in pregnant women. Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies. Although some early epidemiological studies suggested a relationship between benzodiazepine drug use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations. More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies. There is insufficient evidence to assess the effect of benzodiazepine pregnancy exposure on neurodevelopment. There are clinical considerations regarding exposure to benzodiazepines during the second and third trimester of pregnancy or immediately prior to or during childbirth. These risks include decreased fetal movement and/or fetal heart rate variability, floppy infant syndrome, dependence, and withdrawal [see Clinical Considerations and Human Data]. Administration of clobazam to pregnant rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation resulted in developmental toxicity, including increased incidences of fetal malformations and mortality, at plasma exposures for clobazam and its major active metabolite, N-desmethylclobazam, below those expected at therapeutic doses in patients [see Animal Data]. Data for other benzodiazepines suggest the possibility of long-term effects on neurobehavioral and immunological function in animals following prenatal exposure to benzodiazepines at clinically relevant doses. Clobazam should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Advise a pregnant woman and women of childbearing age of the potential risk to a fetus. Not available

4 Section 3. Composition / information on ingredients Component Exposure Limit CAS No. Principle Component: Clobazam Not Found Inactive ingredients: Corn Starch Not Found Lactose Monohydrate Not Found Silicon Dioxide Not Found & Talc Not Found Magnesium Stearate Not Found Section 4. First -aid measures General After inhalation: Move to fresh air in case of accidental inhalation. assure fresh air breathing. After skin contact: Rinse skin with water/shower After eye contact: Rinse with water while holding the eyes wide open. Contact lenses should be removed. After swallowing: Rinse mouth out with water Information for doctor: Most important symptoms and effects, both acute and delayed- No further relevant information available. Indication of any immediate medical attention and special treatment needed- No further relevant information available.

5 Overdose Treatment Section 5. Fire -fighting measures Specific hazards arising from the chemical Special protective equipment and precautions for firefighters General fire hazards The management of clobazam overdose may include gastric lavage and/or administration of activated charcoal, intravenous fluid replenishment, early control of airway and general supportive measures, in addition to monitoring level of consciousness and vital signs. Hypotension can be treated by replenishment with plasma substitutes and, if necessary, with sympathomimetic agents. The efficacy of supplementary administration of physostigmine (a cholinergic agent) or of flumazenil (a benzodiazepine antagonist) in clobazam overdose has not been assessed. The administration of flumazenil in cases of benzodiazepine overdose can lead to withdrawal and adverse reactions. Its use in patients with epilepsy is typically not recommended. Extinguishing media Suitable extinguishing agents: Use extinguishing media appropriate for surrounding fire. Extinguishing blanket. Carbon dioxide. Dry powder Special hazards arising from the substance or mixture Stable under normal conditions. Advice for firefighters Small amounts: Use normal individual fire protective equipment. Large amounts: Not Protective equipment: Hand protection : Gloves Skin and body protection : Lab coat Respiratory protection : Quarter mask (DIN EN 140) No additional information available Use normal individual fire protective equipment No unusual fire or explosion hazards noted Section 6. Accidental Release Measures Personal precautions, protective Avoid raising dust. Wear suitable protective clothing, gloves equipment and emergency and eye or face protection. procedures Environmental precautions: No additional information available

6 Methods and material for containment and cleaning up: Section 7. Handling and Storage Storage: Section 8. Exposure controls / personal protection Sweep spilled substance into containers; if appropriate, moisten first to prevent dusting. Ensure waste is collected and contained. Clean thoroughly. Poorly soluble in water. Clean with the help of detergents. Store clobazam tablets between 68 F to 77 F (20 C to 25 C). Keep clobazam tablets in a dry place. Keep clobazam tablets and all medicines out of the reach of children Precautions for safe handling: Keep it dry & in a cool, well ventilated place away from heat. Store in original container Information about fire - and explosion protection: No special measures required. Respiratory Protection Skin protection Eye/face protection Protective Clothing Biological limit values Exposure guidelines Thermal hazards Quarter mask (DIN EN 140) 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.

7 General hygiene considerations 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 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 Clobazam Tablets 10 mg is a white to offwhite, modified capsule-shaped, biconvex tablet debossed with '13' and '25' on either side of functional score line on one side and plain on other side. Description of Clobazam Tablets 20 mg is a white to offwhite, modified capsule-shaped, biconvex tablet debossed with '13' and 26 on either side of functional score line on one side and plain on other side Solubility Not available Odour Not available. 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. Section 10. Stability and Reactivity Conditions to avoid Contact with incompatible materials. Stable Chemical stability Hazardous reactions 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.

8 Decomposition products Incompatible materials Section 11. Toxicological information General When heated to decomposition, emits dangerous fumes. Strong Oxidizing agent 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. Ingestion 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. Other Not Available Symptoms related to the Not available physical, chemical and Toxicological characteristics Information on toxicological effects Acute toxicity Not available Further information Not available Section 12. Ecological information Poorly soluble in water. No data available on ecotoxicity. 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). In accordance with ADR / RID / IMDG / IATA / ADN Section 15. Regulatory Information Generic Medicine. Under Approval by USFDA & the ANDA Number is Section 16. Other information None Date of issue: 20/08/18 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.