Download Safety Data Sheet for Lansoprazole Delayed-Release Capsules and more Study notes Medicine in PDF only on Docsity!
SAFETY DATA SHEET
Section 1: Identification
Section 1, Identification
GHS Product identifier
Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg
Trade Name Not Applicable
Chemical name
2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)- pyridyl]methyl] sulfinyl] benzimidazole
Recommended use/Therapeutic Category Antacid
Restriction on Use/Contraindications
Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation of lansoprazole delayed- release capsules.
Manufacturer
Hetero Labs Limited, Unit-III Plot No. 22-110, Part-II, IDA, Jeedimetla, Hyderabad 500055, Telangana, India (IND).
Distributor
Camber Pharmaceuticals, Inc., Piscataway, NJ,
Section 2: Hazard(s) Information
Dose and Administration
Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Lansoprazole should be taken before eating. You should swallow lansoprazole delayed-release capsules whole. Do not crush or chew lansoprazole delayed-release capsules. If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take lansoprazole delayed-release capsules with certain foods and juices.
Adverse Effects
Most commonly reported adverse reactions (≥ 1%): diarrhea, abdominal pain, nausea and constipation.
Over Dose Effect
Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction.
Medical Conditions
Tell your doctor if you: have been told that you have low magnesium levels in your blood, have liver problems, have any other medical conditions,
are pregnant or plan to become pregnant. It is not known if lansoprazole delayed-release capsules will harm your unborn baby, are breastfeeding or plan to breastfeed. It is not known if lansoprazole passes into your breast milk. You and your doctor should decide if you will take lansoprazole delayed-release capsules or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take lansoprazole delayed-release capsules.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Lansoprazole delayed release capsules may affect how other medicines work, and other medicines may affect how lansoprazole delayed- release capsules work.
Especially tell your doctor if you take: atazanavir (Reyataz ®$^ ), digoxin (Lanoxin®$^ ), a product that contains iron, ketoconazole (Nizoral®$^ ), warfarin (Coumadin®$^ ,Jantoven®$^ ), tacrolimus (Prograf ®$), theophylline (Theo-24®$^ , Elixophyllin ®$, Theochron®$^ , Theolair®$^ ), an antibiotic that contains ampicillin or clarithromycin ,methotrexate
Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Contraindications
Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation of lansoprazole delayed-release capsules.
Pregnancy Comments
There are no adequate or well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Pregnancy Category B
Section 3: Composition/Information on Ingredients
Principle Component Lansoprazole CAS No.: 103577-45-
Ingredient (^) NumberCAS EU EINECS/ELINCSList ClassificationGHS %
Hard gelatin capsules Mixture Not Listed Not Listed *
Additional Information
- Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety.
Section 7, Handling and storage
Storage
Store at 20° to 25°C (68° to 77°F). Protect from moisture.
Incompatibilities Reacting with oxidizing substance.
Section 8: Exposure Controls/Personal Protection
Section 8, Exposure controls/personal protection
Respiratory Protection
Protection from inhalation is not normally necessary. If ventilation is inadequate or dust is likely to generate, use of suitable dust mask would be appropriate.
Skin Protection
Skin protection is not normally necessary, however it is good practice to avoid contact with chemical to use suitable gloves when handling.
Eye protection
Eye protection is not normally necessary. If concerned wear protective goggles or glasses. Wash hands prior to touching eye and in particular handling contact lenses.
Protective Clothing Protective clothing is not normally necessary, however it isgood practice to use apron.
Engineering Control
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
Section 9, Physical and chemical properties
Physical State Capsules
Solubility Freely soluble in dimethylformamide, insoluble in hot and cold water.
Odor (^) Odorless
Appearance
Lansoprazole Delayed Release Capsules, 15 mg Pink/Green colored size ‘3’ hard gelatin capsules imprinted with ‘H’ on cap and ‘166’ on body filled with white to off white pellets. Bottle of 30 capsules NDC 31722-570- Bottle of 100 capsules NDC 31722-570- Bottle of 500 capsules NDC 31722-570- Bottle of 1000 capsules NDC 31722-570- Lansoprazole Delayed Release Capsules, 30 mg Pink/Black colored size ‘1’ Hard gelatin capsules imprinted with ‘H’ on cap and ‘167’ on body filled with white to off white pellets. Bottle of 30 capsules NDC 31722-571- Bottle of 100 capsules NDC 31722-571- Bottle of 500 capsules NDC 31722-571- Bottle of 1000 capsules NDC 31722-571-
Boiling point: Not available Melting Point : 152° C to 162° C
Evaporation rate: Not Available Vapour density: Not Available
Reactivity in water: Not Available Vapour pressure: Not Available
Percentage Volatile by volume: Not Available Specific gravity: Not Available
Section 10: Stability and Reactivity
Condition to avoid: Avoid exposure to extreme heat, light and moisture. Stable:^ Product is stable Incompatibilities: Reacting with oxidizing substance. Hazardous Reaction: No data available
Section 11: Toxicological Information
General Information
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.
Target Organ Eye contact, Skin contact and inhalation is not greatrisk as this product is capsule.
Other
Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.
Section 12: Ecological Information
Do not allow product to enter drinking water supplies, waste water or soil.
Section 13: Disposal Considerations
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. Approved by USFDA
Section 16: Other Information, including date of preparation or last revision
Text of CLP/GHS Classification abbreviations mentioned in Section 3
None
Issue Date: 20-05-
Version: 00
Revision note: New
The information and recommendations in this safety data sheet are, to the best of our knowledge,
accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express or
implied. It is the responsibility of the user to determine the applicability of this information and the
suitability of the material or product for any particular purpose.
Hetero Labs Limited shall not be held liable for any damage resulting from handling or from contact with
the above product. Hetero Labs Limited reserves the right to revise this SDS.
