Revision No.: 00. Identification of the product. Nadolol Tablets, USP. Product Name: Formula: C 17 H 27 NO 4 Chemical Name:

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1 EMERGENCY OVERVIEW Each Nadolol Tablets, USP intended for oral administration contains Nadolol 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: Nadolol Tablets, USP Formula: C 17 H 27 NO 4 Chemical Name: 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1- naphthyl)oxy]-2-propanol. 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: Nonselective Beta-Adrenergic Receptor Blocking Agent Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure

2 Section 2. Hazard(s) Identification Dose and Administration Dosage must be individualized. Nadolol tablets may be administered without regard to meals. Angina Pectoris The usual initial dose is 40 mg nadolol once daily. Dosage may be gradually increased in 40 to 80 mg increments at 3 to 7 day intervals until optimum clinical response is obtained or there is pronounced slowing of the heart rate. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 160 or 240 mg administered once daily may be needed. The usefulness and safety in angina pectoris of dosage exceeding 240 mg per day have not been established. If treatment is to be discontinued, reduce the dosage gradually over a period of one to two weeks (see WARNINGS). Hypertension The usual initial dose is 40 mg nadolol once daily, whether it is used alone or in addition to diuretic therapy. Dosage may be gradually increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved. The usual maintenance dose is 40 or 80 mg administered once daily. Doses up to 240 or 320 mg administered once daily may be needed.

3 Adverse Effects Over Dose Effect Contraindications Most adverse effects have been mild and transient and have rarely required withdrawal of therapy. Cardiovascular Bradycardia with heart rates of less than 60 beats per minute occurs commonly, and heart rates below 40 beats per minute and/or symptomatic bradycardia were seen in about 2 of 100 patients. Symptoms of peripheral vascular insufficiency, usually of the Raynaud type, have occurred in approximately 2 of 100 patients. Cardiac failure, hypotension, and rhythm/ conduction disturbances have each occurred in about 1 of 100 patients. Single instances of first degree and third degree heart block have been reported; intensification of AV block is a known effect of beta-blockers In addition to gastric lavage, the following measures should be employed, as appropriate. In determining the duration of corrective therapy, note must be taken of the long duration of the effect of nadolol. Excessive Bradycardia Administer atropine (0.25 to 1 mg). If there is no response to vagal blockade, administer isoproterenol cautiously. Cardiac Failure Administer a digitalis glycoside and diuretic. It has been reported that glucagon may also be useful in this situation. Hypotension Administer vasopressors, e.g. epinephrine or levarterenol. (There is evidence that epinephrine may be the drug of choice.) Nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure Pregnancy Comments In animal reproduction studies with nadolol, evidence of embryoand fetotoxicity was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater (on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential was observed in any

4 of these species. There are no adequate and well-controlled studies in pregnant women. Nadolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates whose mothers are receiving nadolol at parturition have exhibited bradycardia, hypoglycemia, and associated symptoms. Pregnancy Category C Section 3. Composition / information on ingredients Component Exposure Limit CAS No. Principle Component: Nadolol Not Found Sodium Starch Glycolate Type A Not Found Microcrystalline Cellulose Not Found 101(COMPRECEL M101D+) Povidone K-30 (KOLLIDON 30, Not Found BASF), Corn Starch (PURE DENT B700), Not Found Citric Acid Anhydrous (POWDER Not Found GRADE), Microcrystalline Cellulose 102 (COMPRECEL Ml02D+), Not Found Colloidal Silicon Dioxide (AEROSIL 200 PHARMA), Not Found Sodium Starch Glycolate Type A, Not Found Magnesium Stearate Not Found Ferric Oxide (YELLOW) Not Found FD&C blue no. 2 aluminium lake Not Found

5 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. Overdose Treatment Section 5. Fire -fighting measures Specific hazards arising from the chemical Limited data are available related to overdosage in humans. If symptomatic hypotension occurs, initiate supportive treatment. 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 Special protective equipment and precautions for firefighters General fire hazards Use normal individual fire protective equipment No unusual fire or explosion hazards noted

6 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 Methods and material for containment and cleaning up: Section 7. Handling and Storage Storage: 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 at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Keep bottle tightly closed. 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. Section 8. Exposure controls / personal protection Respiratory Protection Quarter mask (DIN EN 140) Skin protection Eye/face protection Protective Clothing Biological limit values Exposure guidelines Thermal hazards 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 Nadolol Tablets USP 20 mg : White to off white colored, round Shaped flat faced, beveled edge Uncoated tablets, debossed with "N" on upper half of the break line and 20 on lower half of the break line on side and plain on other side. Description of Nadolol Tablets USP 40 mg : Light yellow colored, round shaped, flat faced, beveled edge uncoated tablets, debossed with "N" on upper half of the breakline and "40" on lower half of the break line on one side and on other side. Description of Nadolol Tablets USP 80 mg : Light blue colored, spotted, round shaped, flat faced, beveled edge uncoated tablets, debossed with "N" on upper half of the breakline and "80" on lower half of the breakline 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.

8 Section 10. Stability and Reactivity Conditions to avoid Stable Chemical stability Hazardous reactions Decomposition products 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. When heated to decomposition, emits dangerous fumes. Incompatible materials Strong Oxidizing agent Section 11. Toxicological information General Ingestion Other Symptoms related to the physical, chemical and Toxicological characteristics 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. Not Available Not available Information on toxicological effects Acute toxicity LD50 (mice-rat): mg/kg orally intravenous-rat: NA Oral Mouse:NA Further information Not available Section 12. Ecological information Poorly soluble in water. No data available on ecotoxicity.

9 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: 28/06/17 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.