1. Name Of The Medicinal Product
Menadiol Diphosphate Tablets 10mg
2. Qualitative And Quantitative Composition
Each tablet contains 10mg of Menadiol Diphosphate (as Menadiol Sodium Diphosphate USP).
3. Pharmaceutical Form
The tablets are round, white to pale pink with CL 1L3 imprinted on one face and a single break bar on the other.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of haemorrhage or threatened haemorrhage associated with a low blood level of prothrombin or factor vii. The main indication is obstructive jaundice (before and after surgery).
4.2 Posology And Method Of Administration
Menadiol Diphosphate Tablets 10mg are for oral administration.
Adults
Usual therapeutic dose: 10-40mg daily
Children
If, on the recommendation of a physician, a children's dosage is required, it is suggested that 5-20mg daily be given.
The elderly
Recommendations for use in the elderly do not differ from those for other adults.
4.3 Contraindications
Administration to neonates, infants or to mothers in the pre- and post-natal periods.
4.4 Special Warnings And Precautions For Use
None.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Large doses of menadiol sodium diphosphate may decrease patient sensitivity to anticoagulants.
4.6 Pregnancy And Lactation
There is evidence of hazard if menadiol sodium diphosphate is used in human pregnancy. It is known to be associated with a small risk of haemolytic anaemia, hyperbilirubinaemia and kernicterus in the infant if administered to the mother in late pregnancy or during labour. Menadiol sodium diphosphate is therefore contra-indicated during late pregnancy.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Menadiol sodium diphosphate may induce haemolysis (especially in the newborn infant) in the presence of erythrocyte glucose-6-phosphate dehydrogenase deficiency or low concentrations of alpha-tocopherol in the blood.
4.9 Overdose
No information is available.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Menadiol sodium diphosphate is a water-soluble vitamin K analogue. The presence of vitamin K is essential for the formation within the body of prothrombin, factor VII, factor IX and factor X. Lack of vitamin K leads to increased tendency to haemorrhage.
5.2 Pharmacokinetic Properties
Menadione is absorbed from the gastro-intestinal tract without being dependent upon the presence of bile salts. Vitamin K is rapidly metabolised and excreted by the body.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose
Maize starch
Talc
Magnesium stearate
6.2 Incompatibilities
No information is available.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Recommended maximum storage temperature 30°C.
Protect from light.
6.5 Nature And Contents Of Container
White HDPE bottles containing 100 tablets.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Alliance Pharmaceuticals Ltd
Avonbridge House
2 Bath Road
Chippenham
Wiltshire
SN15 2BB
UK
8. Marketing Authorisation Number(S)
PL 16853/0110
9. Date Of First Authorisation/Renewal Of The Authorisation
30 April 1992
10. Date Of Revision Of The Text
10th August 2010
11. DOSIMETRY (IF APPLICABLE)
Text
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Text
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