Drug Interactions - summary

Vitamin + Anticoagulants

 effects antogonised, increase in anticogulant may be necessary

Mineral oils + Vitamin K

 minereal oil decrease GI absorption

Bile salts seques + Vitamin K

malabsorption of bile salts 

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)                                                 FROM JANUARY 1961 TILL NOVEMBER 2014

Coagulation disoders 

Allergic reaction:

anaphylactoid reactions may occur

Parentral administration: Rarely , pain, swelling, tenderness, at the injection site, after repeated injections, erythmatous, indurated pruritic plaques have occured.

These have rarely progressed to sclerodema-lke lesions that have persisted for long periods.

In other cases these lesions have resembled erythema perstans Trancient- Flushing sensation and - peculiar sensations of taste, rarely dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea and cyanosis

Hyperbilrubineamia Has been observed in new born following administratin of phytonadone This has occured rarely and primarily with doses above those recommended.

Deaths have occured after IV administration

Hypersensitivity to any component of the product

Special precautions:

Oral anticoagulant induced hypoprothrombinemia - Viatmin K will not counteract the anticoafulant action of heparin

Hepatic function impairment-  hyproprothrombinemia due to hepatocellular damage is not corrected by administration of vitamin K.

Repeated large doses of Vitamin K are not warrented in liver disease if the initial response is unsatisfactory

Benzyl alcohol- contained in some products have been associated with toxicity in newborns.

Pregnancy: It is not known whether Vitamin K can cause fetal harm to a pregnant woman or can affect reproduction capacity. Use only if clearly needed.

Lactation  -Vitamin K is excred in milk. Consider this if this drug is to be administered to a nursing mother.

Children: Safety and efficacy in children not established. Hemolysis,jaundice and hyperbilirubinemia is newborns, particulary in premature infants have been reported with Vitamin K. These effects are dose related. Therefore, do not exceed the dose.

Indication-

Coagulation disorders

Dosage-

Adults- 10 -20 mg by slow I V inj over 3-5 minutes or IV infusion over 20-30 minutes following withdrawal of anticoagulant Measure prothrombin levels after 3 hours Repeat dose if response inadequate Max imum 40 mg in 24 hours

Missed dose-

1. If you miss a dose of this medicine, take it as soon as possible.

2. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule.

3. Do not double doses.

4. Tell your doctor about the doses you miss.

VITAMIN K- INFORMATION ALSO APPLIES TO MENADIOL AND PHYTONADIONE - REFER VITAMIN K 

1. Allergy- Tell your dctor if you had any allergic reaction to Vitamin K, or any oter substances, food presrvatives, dyestuffs

2. Pregnancy- Vitamin K has not reported to cause anybirth defects in humans.

3. Breast feeding- Vitami K taken by the mother has not been reported to cause problems in ursing babies.

4. Children- Children may be especially sensitive to the effects of Vitami K especially menidiol. This may increase the chance of side effects during treatment.

5. Older adults- No specific information about the use of Vitamin K in the elderly.

6. Other medicines- Tell your doctor if you are taking anyof the following- Acetohydroxyamic acid or Antidiabetic oral, or Dapsone or Furazolidone or Methyldopa or Nitrofurantoin or Primaquine or Procainamide or Quinidine or Quinine or Sulfonamides - chance of serious side efects may be increased, especially with menadiol

Anticoagulants - Vitami K decreases the efects of these medicines and is sometimes used to treat bleeding caused by anticoagulants .

7. Other medical problems- Your doctor should know if you are have any of the following medical problems- Cystic fibrosis or Diarrhea or Intestinal problems - these conditions may intrefere with absorptio of Vitamin K into the body when it is taken doses may have to be injected

 8. Missed dose - If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses

9. Storage - Keep out of reach of children. Store away from heat or direct sunlight. Do not store the capsule in bathroom, near the kitchen sink, or in other damp places.

10. Outdated medicines - Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of reach of children.

Pharmacology:

Vitamin K promotes the hepatic synthesis of active prothrombin (factor II, proconvertin (factor VII, ) plasma thromboplastin (factor IX) and stuart (factor X).

The mechanism by which Vitamin K promotes formation of these clotting factors involves the post translational carboxylation of specific glutamate residues tof gamma- carboxyl -glutamate residues in proteins involved in coagulation, thus leading to their active activation.

Phytonadione (Vitamin K1 ) is lipid soluble synthetic analog of Vitamin K. Phtonadione possesses the same type and degree of activity as the naturally occuring vitamin K

Pharmacokinetics:

Phytonadione is only absorbed from the GI tract via the intestinal lmyphatics in the presence of bile salts. Although initially concentrated in the liver Vitamin K is rapidly metabolised and very little tissue accumulation occurs. Little is known about the metabolic fate of vitamin K.

Not available

Pregnancy:

It is not known whether Vitamin K can cause fetal harm to a pregnant woman or can affect reproduction capacity . Use only if clearly needed.

Lactation:

Vitamin K is excred in milk. Consider this if this drug is to be administered to a nursing mother.

Children:

Safety and efficacy in children not established. Hemolysis,jaundice and hyperbilirubinemia is newborns, particulary in premature infants have been reported with Vitamin K. These effects are dose related. Therefore, do not exceed the dose.