Product Details
PHYTONADIONE 1 MG EML SDV 10X0.5 ML
Manufacturer: CIPLA USA, INC.
MFG#: 69097-0709-96
NDC: 69097-0709-96
PID: 249474
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Product Properties:
| Description | - |
|---|---|
| DESI Drug Ind | - |
| DESI2 Drug Ind | AB |
| Drug Category | - |
| Drug Type Code | N |
| FDA Approval Date | 05/03/2022 |
| FDA Therap Equiv | ML |
| HCPCS | Vitamin k phytonadione inj, 1 MG |
| Market Entry Date | - |
| Medical Coverage | J3430 |
| Termination Date | 1 |
| Unit | 5 |
| Units Per Pkg | 04/22/2022 |
| Active Ingredients | 1038 phytonadione (vitamin K1) 84800 |
| AHFS Class | 88240000 VITAMIN K ACTIVITY; 92120000 ANTIDOTES |
| DEA Class | NC |
| Dose Form | VIAL (ML) |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 83330 phytonadione (vit K1) INJECTION VIAL 1MG/0.5ML |
| Inactive Ingredients | 3192 benzyl alcohol 100516; 915 dextrose 5996101; 9290 cremophor el (polyethoxlated castor oil) |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Strength | 1MG |
| Common Brand Name | COMMON BRAND NAME(S): Aqua-Mephyton, Vitamin K |
| Drug Interaction | DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: "blood thinners" (such as warfarin). |
| Allocation Period | - |
| Case Quantity | 24 |
| Drug Form Pack Size | 5 |
| Form | SINGLE DOSE VIAL |
| Hazard Code | - |
| Listed Chemical | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit Size | 10X0.5 |
| How to Use | HOW TO USE: This medication is given by injection under the skin or into a muscle or vein as directed by your doctor. If this medication is given into a vein, it should be injected very slowly (no more than 1 milligram per minute) to reduce the risk of serious side effects. (See also Warning section.) Dosage is based on your medical condition and response to treatment. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. The solution is normally clear and yellow in color. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. If you are using a certain "blood thinner" drug (warfarin), vitamin K can decrease the effects of warfarin for up to 2 weeks. Be sure to take your vitamin K and warfarin exactly as directed by your doctor or pharmacist. If you develop easy bruising or bleeding, get medical help right away. You may need another dose of vitamin K. |
| Missed Dose | MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up. |
| Notes | NOTES: Lab and/or medical tests (such as prothrombin time, INR) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details. Vitamin K is commonly found in leafy green vegetables such as spinach, collards, and broccoli. Follow any dietary guidelines recommended by your health care professional. |
| Overdose | OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. |
| Precautions | PRECAUTIONS: Before using vitamin K, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, kidney disease, liver disease. This product may contain aluminum, which can rarely build up to dangerous levels in the body. The risk may be increased if this product is used for an extended time, especially in people with kidney disease. Tell your doctor right away if you notice any symptoms of too much aluminum in the body such as muscle weakness, bone pain, or mental changes. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Vitamin K passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Pain, swelling, or soreness at the injection site may occur. Temporary flushing, taste changes, dizziness, rapid heartbeat, sweating, shortness of breath, or bluish lips/skin/nails may also rarely occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Storage | STORAGE: Store at room temperature away from light. Discard any unused portion from single use containers. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Uses | USES: Vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. These substances help your blood to thicken and stop bleeding normally (such as after an accidental cut or injury). Low levels of blood clotting factors increase the risk for unusual bleeding. Low levels may be caused by certain medications (such as warfarin) or medical conditions (such as obstructive jaundice). Vitamin K helps to treat and prevent unusual bleeding by increasing the body's production of blood clotting factors. |
Frequently Asked Questions (FAQs)
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PHYTONADIONE 1 MG EML SDV 10X0.5 ML is manufactured by CIPLA USA, INC..
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