Bottle pack of 30, 60, 90, 100 & 500 tablets unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Revision No.: 00

Transcription

1 EMERGENCY OVERVIEW Each Oxybutynin chloride ER Tablets intended for oral administration contains Oxybutynin chloride 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: Oxybutynin chloride ER Tablets 5 mg, 10 mg and 15 mg. Formula: C 22 H 31 NO 3 HCl. Chemical Name: d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride Manufacturer / supplier identification Company: Address: Cadila Healthcare Ltd. Ahmedabad, India Sarkhej Bavla. N.H. 8A, Moraiya. Tal. Sanand. Dist. Ahmedabad State: Gujarat. India Contact for information: Tel.: Fax: Emergency Telephone No. Tel.: Recommended use / Therapeutic Category antispasmodic, muscarinic antagonist Page 1 of 10

2 Restriction on Use / Contraindications: Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema SECTION 2. HAZARD(S) IDENTIFICATION Dose and Administration Adverse Effects Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6)]. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how oxybutynin chloride extended-release tablets affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Page 2 of 10

3 Oxybutynin chloride extended-release tablets should be used with caution in patients with pre-existing dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms. Oxybutynin chloride extended-release tablets should be used with caution in patients with Parkinson s disease due to the risk of aggravation of symptoms Worsening of Symptoms of Myasthenia Gravis Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of symptom aggravation. Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy Oxybutynin chloride extended-release tablets should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility. Urinary Retention Oxybutynin chloride extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention Gastrointestinal Adverse Reactions Oxybutynin chloride extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention Oxybutynin chloride extended-release tablets, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony. Oxybutynin chloride extended-release tablets should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis. As with any other nondeformable material, caution should be used when administering oxybutynin chloride extended-release tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations. Page 3 of 10

4 Over Dose Effect Pregnancy Comments The continuous release of oxybutynin from oxybutynin chloride extended-release tablets should be considered in the treatment of over dosage. Patients should be monitored for at least 24 hours. Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Over dosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Pregnancy Category B. There are no adequate and well-controlled studies using oxybutynin chloride extended-release tablets in pregnant women. Oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and foetus. Women who become pregnant during oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. Perphenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Section 3. COMPOSITION / INFORMATION ON INGREDIENTS Component Exposure limit CAS no. Principle component Oxybutynin chloride Not found Inactive ingredients Micro crystalline cellulose Not found Lactose monohydrate Not found Alginic acid Not found Hypromellose Not found Povidone K30 Not found Isopropyl alcohol Not found Hydrogenated castor oil Not found Magnesium sterate Not found Methacrylic acid Not found Talc Not found Triethyl citrate Not found Purified water Not found Page 4 of 10

5 Section 4. FIRST -AID MEASURES Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention. Skin Contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention. Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Serious Inhalation: Not available. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or waistband. Serious Ingestion: Not available. Section 5. FIRE FIGHTING MEASURES Flammability of the Product: May be combustible at high temperature. Auto-Ignition Temperature: Not available. Flash Points: Not available. Flammable Limits: Not available. Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...). Fire Hazards in Presence of Various Substances: Not available. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Fire Fighting Media and Instructions: SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet. Special Remarks on Fire Hazards: Not available. Special Remarks on Explosion Hazards: Not available. Page 5 of 10

6 Section 6. ACCIDENTAL RELEASE MEASURES Small Spill Large Spill Spill Clean Up Procedures Treatment and Disposal Environmental precautions Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system. 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. 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 Precautions for safe handling Keep the container tightly closed in a cool well-ventilated area. It should be stored and handled as per the instructions mentioned in the label. Glass, polyethylene or polypropylene containers are recommended. Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes Section 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Respiratory Protection Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an effective respirator program in place Page 6 of 10

7 Skin protection Eye/face protection Protective Clothing Hand protection Engineering Controls General hygiene Considerations Exposure Limits (applicable U.S. regulation OSHA 29 CFR ). For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant quantities are handled, work clothing may be necessary to prevent take-home contamination. Safety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area. Protective clothing is not normally necessary, however it is good practice to use apron. Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic non latex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally preferred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the effectiveness of engineering controls. Effectiveness of engineering controls intended for use with highly potent materials should be assessed by use of nontoxic surrogate materials. Local exhaust ventilation such as a laboratory fume hood or other vented enclosure is recommended, particularly for grinding, crushing, weighing, or other dust-generating procedures. Handle in accordance with good industrial hygiene and safety practice. Not available Section 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance Physical state Description Tablets 15 mg White to off white, round bevel edged biconvex coated tablets debossed on one side with 257 and plain on other side. Pack Style Page 7 of 10

8 Odour Pure/Mixture NDC in bottle of 30 tablets NDC in bottle of 60 tablets NDC in bottle of 90 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NDC in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 10 mg white to off-white, round, beveled-edged, biconvex, coated-tablets debossed on one side with 256 and plain on other side. Pack Style NDC in bottle of 30 tablets NDC in bottle of 60 tablets NDC in bottle of 90 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NDC in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 5 mg white to off-white, round, beveled-edged, biconvex, coated-tablets debossed on one side with 255 and plain on other side. Pack Style NDC in bottle of 30 tablets NDC in bottle of 60 tablets NDC in bottle of 90 tablets NDC in bottle of 100 tablets NDC in bottle of 500 tablets NDC in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Odourless Mixture Section 10. STABILITY AND REACTIVITY Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Not available. Incompatibility with various substances: Not available. Corrosivity: Not available. Special Remarks on Reactivity: Not available. Special Remarks on Corrosivity: Not available. Polymerization: Will not occur. Page 8 of 10

9 Section 11. TOXICOLOGICAL INFORMATION Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Toxicity to Animals: Acute oral toxicity (LD50): 400 mg/kg [Dog]. Chronic Effects on Humans: DEVELOPMENTAL TOXICITY: Classified Development toxin [POSSIBLE]. May cause damage to the following organs: blood,lungs, central nervous system (CNS). Other Toxic Effects on Humans: Hazardous in case of skin contact (irritant), of inhalation (lung irritant). Special Remarks on Toxicity to Animals: Not available. Special Remarks on Chronic Effects on Humans: Not available. Special Remarks on other Toxic Effects on Humans: Not available. Section 12. ECOLOGICAL INFORMATION Ecotoxicity: Not available. BOD5 and COD: Not available. Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself. Special Remarks on the Products of Biodegradation: Not available. 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 Page 9 of 10

10 Section 16. OTHER INFORMATION Additional Information NFPA (National Fire Protection Association (U.S.A).) 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 Flammability: 1 Reactivity: 0 Date of issue: July 11, 2017 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 10 of 10

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