Phytonadione Tablets

Name: Phytonadione Tablets

What are some things I need to know or do while I take Phytonadione Tablets?

For all uses of this medicine (phytonadione tablets):

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (phytonadione tablets) while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

For undoing the effects of a blood thinner:

  • People are treated with drugs to thin the blood when they have health problems that raise the chance of blood clots. This medicine is used to undo the effects of a blood thinner. The chance of blood clots may be raised after using this medicine. Follow what the doctor has told you about preventing blood clots after use of this medicine (phytonadione tablets).

How is this medicine (Phytonadione Tablets) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Phytonadione Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Warnings

An immediate coagulant effect should not be expected after administration of phytonadione.

Phytonadione will not counteract the anticoagulant action of heparin.

When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy.

Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.

Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.

Overdosage

The intravenous and oral LD50s in the mouse are approximately 1.17 g/kg and greater than 24.18 g/kg, respectively.

PRINCIPAL DISPLAY PANEL – Carton 5 mg

NDC 68682-170-05

Rx only

Phytonadione
Tablets

5 mg

100 Tablets

OCEANSIDE
PHARMACEUTICAL

PHYTONADIONE 
phytonadione tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68682-170
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
phytonadione (phytonadione) phytonadione 5 mg
Inactive Ingredients
Ingredient Name Strength
Acacia  
Silicon Dioxide  
Magnesium stearate  
Starch, Corn  
Talc  
CALCIUM PHOSPHATE, UNSPECIFIED FORM  
LACTOSE, UNSPECIFIED FORM  
Product Characteristics
Color YELLOW (pale yellow) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code VRX;405
Contains     
Packaging
# Item Code Package Description
1 NDC:68682-170-05 1 BOTTLE in 1 CARTON
1 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA010104 03/31/2017
Labeler - Oceanside Pharmaceuticals (832011691)
Establishment
Name Address ID/FEI Operations
Valeant Pharmaceuticals International, Inc. 253292734 MANUFACTURE(68682-170)
Revised: 11/2016   Oceanside Pharmaceuticals
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