Warfarin Sodium (Page 8 of 8)
15 REFERENCES
OSHA Hazardous Drugs. OSHA.http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC: 71335-1786-1: 90 TABLETs in a BOTTLE
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Instructions for Patients
Advise patients to:
- Strictly adhere to the prescribed dosage schedule [see Dosage and Administration (2.1) ].
- If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses [see Dosage and Administration (2.6) ].
- Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy [see Dosage and Administration (2.1) ].
- Be aware that if therapy with warfarin sodium is discontinued, the anticoagulant effects of warfarin sodium may persist for about 2 to 5 days [see Clinical Pharmacology (12.2) ].
- Avoid any activity or sport that may result in traumatic injury [see Use in Specific Populations (8.4) ]. And to tell their physician if they fall often as this may increase their risk for complications.
- Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables [see Drug Interactions (7.5) ].
- Contact their physician to report any serious illness, such as severe diarrhea, infection, or fever [see Warnings and Precautions (5) and Adverse Reactions (6)].
- Immediately contact their physician when experiencing pain and discoloration of the skin (a purple bruise like rash) mostly on areas of the body with a high fat content, such as breasts, thighs, buttocks, hips and abdomen [see Warnings and Precautions (5.2) ].
- Immediately contact their physician when experiencing any unusual symptom or pain since warfarin sodium may cause small cholesterol or athero emboli. On feet it may appear as a sudden cool, painful, purple discoloration of toe(s) or forefoot [see Warnings and Precautions (5.5) ].
- Immediately contact their physician when taking warfarin sodium after any heparin formulation therapy and experiencing bloody or black stools or appearence of bruises, or bleeding [see Warnings and Precautions (5.6) ].
- To tell all of their healthcare professionals and dentists that they are taking warfarin sodium. This should be done before they have any surgery or dental procedure [see Dosage and Administration (2.7) ].
- Carry identification stating that they are taking warfarin sodium.
Bleeding Risks
Advise patients to:
- Notify their physician immediately if any unusual bleeding or symptoms occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Box Warning and Warnings and Precautions (5.1)].
Concomitant Medications and Botanicals (Herbals)
Advise patients to:
- Not take or discontinue any other drug, including salicylates (e.g., aspirin and topical analgesics), other over-the-counter drugs, and botanical (herbal) products except on advice of your physician [see Drug Interactions (7) ].
Pregnancy and Nursing
Advise patients to:
- Notify their physician if they are pregnant or planning to become pregnant or considering breast feeding [see Use in Specific Populations (8.1, 8.2, 8.3)].
- Avoid warfarin sodium during pregnancy except in pregnant women with mechanical heart valves, who are at risk of thromboembolism [see Contraindications (4) ]. Use effective measures to avoid pregnancy while taking warfarin sodium. This is very important because their unborn baby could be seriously harmed if they take warfarin sodium while they are pregnant [see Use in Specific Populations (8.1, 8.3)].
Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad 382220, INDIA
Distributed by:
Amneal Pharmaceuticals LLC Bridgewater, NJ 08807
Rev. 12-2021-04
| MEDICATION GUIDE Warfarin (WAR-far-in) Sodium Tablets, USP (Crystalline) What is the most important information I should know about warfarin sodium? Warfarin sodium can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium is a blood thinner medicine that lowers the chance of blood clots forming in your body.
Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above. Many other medicines can interact with warfarin sodium and affect the dose you need or increase warfarin sodium side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider. Do not take other medicines that contain warfarin sodium while taking warfarin sodium tablets.
See “What are the possible side effects of warfarin sodium?” for more information about side effects. What is warfarin sodium? Warfarin sodium is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs. Who should not take warfarin sodium? Do not take warfarin sodium if:
Before taking warfarin sodium, tell your healthcare provider about all of your medical conditions, including if you:
Tell all of your healthcare providers and dentists that you are taking warfarin sodium. They should talk to the healthcare provider who prescribed warfarin sodium for you before you have any surgery or dental procedure. Your warfarin sodium may need to be stopped for a short time or you may need your dose adjusted. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way warfarin sodium works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about warfarin sodium? ” How should I take warfarin sodium?
What should I avoid while taking warfarin sodium?
These are not all of the side effects of warfarin sodium. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store warfarin sodium tablets?
Keep warfarin sodium tablets and all medicines out of the reach of children. General information about the safe and effective use of warfarin sodium. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use warfarin sodium for a condition for which it was not prescribed. Do not give warfarin sodium to other people, even if they have the same symptoms that you have. It may harm them.You can ask your healthcare provider or pharmacist for information about warfarin sodium that is written for health professionals. If you would like more information, go to www.amneal.com or call 1-877-835-5472. What are the ingredients in warfarin sodium tablets? Active ingredient: Warfarin Sodium Inactive ingredients: Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate and Pregelatinized Starch. The following tablets contain: 1 mg: D&C Red No. 6 Barium Lake2 mg: FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake2-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake3 mg: FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake4 mg: FD&C Blue No. 1 Aluminum Lake5 mg: FD&C Yellow No. 6 Aluminum Lake6 mg: FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake7-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIADistributed by:Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2021-04 |
Dispense with Medication Guides available at:
documents.amneal.com/mg/warfarin-sodium.pdf
Warfarin Sodium 3mg Tablet
| WARFARIN SODIUM warfarin tablet | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| Labeler — Bryant Ranch Prepack (171714327) |
| Registrant — Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bryant Ranch Prepack | 171714327 | REPACK (71335-1786), RELABEL (71335-1786) | |
Revised: 05/2022 Bryant Ranch Prepack
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/warfarin-sodium-28/page/8/