c
c



 
Vitamin K derivatives (vitamins).

  
 
Phytomenadione

 
Each Konakion MM Ampoule contains 10.0mg vitamin K1 (phytomenadione) Ph. Eur in 1ml.

  
Amber glass ampoules containing 10mg phytomenadione in 1ml. The ampoule solution is clear to slightly
opalescent, pale yellow in colour and contains the active constituent in a mixed micelles vehicle of glycocholic acid
and lecithin.



Konakion MM is indicated as an antidote to anticoagulant drugs of the coumarin type in the treatment of
haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII.


 
Ê
Ê



 

 

0



 
 

  Konakion MM therapy should be accompanied by a more immediate
effective treatment such as transfusions of whole blood or blood clotting factors. The anticoagulant should be
withdrawn and an intravenous injection of Konakion MM given slowly in a dose of 10 ± 20mg. The prothrombin level
should be estimated three hours later and, if the response has been inadequate, the dose should be repeated. Not
more than 40mg of Konakion MM should be given intravenously in 24 hours. Coagulation profiles must be monitored
on a daily basis until these have returned to acceptable levels; in severe cases more frequent monitoring is
necessary and where there is no immediate efficacy, transfusion of whole blood or blood clotting factors should be
used.


 
 
 Oral treatment with Konakion tablets may be used.

 
 
 
 





Konakion MM Ampoules are for intravenous injection and should be diluted with 55ml of 5% glucose before slowly
infusing the product. The solution should be freshly prepared and protected from light. Konakion MM Ampoule
solution should not be diluted or mixed with other injectables, but may be injected into the lower part of an infusion
apparatus.






There are few data available regarding use of Konakion MM in children over 1 year. There have been no dose
ranging studies in children with haemorrhage. Suggested dosages based on clinical experience are as follows:
- 


  2 ± 5mg i.v.

Ê 
 

 



 1 ± 5mg i.v.

Prothrombin levels should be measured 2 to 6 hours later and if the response has not been adequate, the dose may
be repeated. Frequent monitoring of vitamin K dependent clotting factors is essential in these patients.

Children on warfarin therapy who need to remain anticoagulated are not included in the above dosage
recommendations.

 



Konakion MM Paediatric should be used in these patients.


 
m  






It is advisable that a haematologist is consulted about appropriate investigation and treatment in any child in whom
Konakion MM is being considered.

Likely indications for using vitamin K in children are limited and may include:

1. Children with disorders that interfere with absorption of vitamin K (chronic diarrhoea, cystic fibrosis, biliary atresia,
hepatitis, coeliac disease).

2. Children with poor nutrition who are receiving broad spectrum antibiotics.

3. Liver disease.

4. Patients receiving anticoagulant therapy with warfarin in whom the INR is increased outside the therapeutic range
and therefore are at risk of, or are bleeding, and those with an INR in the therapeutic range who are bleeding.

For patients on warfarin therapy, therapeutic intervention must take into consideration the reason for the child being
on warfarin and whether or not anticoagulant therapy has to be continued (e.g. in a child with mechanical heart valve
or repeated thromboembolic complications) as vitamin K administration is likely to interfere with anticoagulation with
warfarin for 2 ± 3 weeks.

It should be noted that the earliest effect seen with vitamin K treatment is at 4 ± 6 hours and therefore in patients
with severe haemorrhage replacement with coagulation factors may be indicated (discuss with haematologist).


 
 
Elderly patients tend to be more sensitive to reversal of anticoagulation with Konakion MM; dosage in this group
should be at the lower end of the ranges recommended.



Use in patients with a known hypersensitivity to any of the constituents.
  
 
·hen treating patients with severely impaired liver function, it should be borne in mind that one Konakion MM
Ampoule 10mg/1ml contains 54.6mg glycocholic acid and this may have a bilirubin displacing effect.

At the time of use, the ampoule contents should be clear. Following incorrect storage, the contents may become
turbid or present a phase-separation. In this case the ampoule must no longer be used.

In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, intravenous injections of
Konakion MM must be administered slowly and not more than 40mg should be given during a period of 24 hours.
Konakion MM therapy should be accompanied by a more immediate effective treatment such as transfusion of
whole blood or blood clotting factors. ·hen patients with prosthetic heart valves are given transfusions for the
treatment of severe or potentially fatal haemorrhages, fresh frozen plasma should be used.

Large doses of Konakion MM (more than 40mg per day) should be avoided if it is intended to continue with
anticoagulant therapy because there is no experience with doses above this maximum of 40mg per day and higher
doses may give rise to unexpected adverse events. Clinical studies have shown a sufficient decrease in the
prothrombin time with the recommended dosage. If haemorrhage is severe, a transfusion of fresh whole blood may
be necessary whilst awaiting the effect of the vitamin K1.

Vitamin K1 is not an antidote to heparin.

 

No significant interactions are known other than antagonism of coumarin anticoagulants.

   

There are only few unconfirmed reports of the occurrence of possible anaphylactoid reactions after intravenous
injection of Konakion MM. Very rarely, venous irritation or phlebitis has been reported in association with
intravenous administration of Konakion mixed micelle solution. Injection site reactions have been reported after
intramuscular injection of Konakion.



O
  




   
  

ë  

   
  

ë Ê
   
  

ë Y

  
  

ë    
  

ë m 

 
  
  

ë    

 
  
  
ë ‰   



 
   is used in the treatment of chronic liver disease in which the flow of bile has stopped for some reason
(eg.Ô
 

 



, Ô
 
  


 



and 


 


-related cholestasis.
Ô






   
  






 ÔÔ
   



 
 


 


 




    

 


 
Ô


  

 


   

 

   


 
 






 


 
 



 




 
  

 



 
    
 

Ô
  

Ê 
   
Y



  


 




ë =
=


  




m


 


Ô
 


ë u 


  





ë  
  

Ô

 
 

Ô
 
  

m


ë  



Ô
 

  

ë Y

 =
u 

 


 
 



  Ô
 
  


 
 


Ô

Ô
 


 



  =
Ô
     
  

Ô

 

 
 


  

Ô
 


 
Ô

   

Y
  occurs in up to 3% of cases. Pruritus may be experienced at initiation of treatment.
Ô
   

Ê 

 

    
 

 
 
 
 

ë   
 



ë 
 




ë  Ô

  
|

Oeneric Name: Hyoscine ButylBromide

Brand Name: Buscopan

Classification: Belladona alkaloid, antimuscarinic

Indication & Dosages:

ë Spastic states
Adults: 0.4 to 0.8 mg P.O.

ë Delirium, preanesthetic sedation and obstetric amnesia with analgesics

Adults: 0.3 to 0.65 mg I.V., I.M., or subcutaneously. Dilute solution with sterile water for injection
before giving I.V.

Children: 0.006mg/kg I.V., I.M., or subcutaneously. Maximum dose, 0.3 mg. Dilute solution with
sterile water for solution before giving I.V.

ë To prevent nausea and vomiting from motion sickness

Adults: One Transderm-Scop, formulated to deliver 1mg scopolamine over 3 days, applied to the
skin behing the ear at least 4 hours before antiemetic is needed. Or, 0.3 to 0.65 mg hydrobromide
I.V., I.M. or subcutaneously. Or, 0.25 to 0.8 mg P.O. 1 hour before exposure to motion. Further
doses of 0.25 to 0.8 mg may be given t.i.d., p.r.n.

Children: 6 mcg/k or 200 mcg hydrobromide I.V., I.m., or subcutaneously

Mode of Action:

ë Inhibits muscarinic actions of acetylcholine on autonomic effectors innervated by

postganglionic cholinergic neurons. May effect neural pathways originating in the inner ear to
inhibit nausea and vomiting.
Contraindication:

ë Contraindicated in patients with angleclosure glaucoma, obstructive uropathy, obstructive

disease of the OI tract, asthma, chronic pulmonary disease, myasthenia gravis, paralytic ileus,
intestinal atony, unstable CV status in acute hemorrhage, tachycardia from cardiac
insufficiency, or toxic megacolon.
ë Contraindicated in patients with hypersensitive to belladonna or barbiturates.
 ë Use cautiously in patients with autonomicneuropathy, hyperthyroidism, coronary artery disease,
arrhythmias, heart failure, hypertension, hiatal hernia with ferlux esophagitis, hepatc or renal
disease, known as suspected OI infection, or ulcerative colitis.
ë Use cautiously in children.
ë Use cautiously in patients in hot or humid environments; drug can cause heat stroke.
Side Effects:

ë Frequent: Dry mouth (sometimes severe), decreased sweating, constipation.

ë Occasional: Blurred vision; bloated feeling; urinary hesitancy; somnolence (with high dosage);
headache; intolerance to light; loss of taste; nervousness; flushing; insomnia; impotence;
mental confusion or excitement (particularly in the elderly and children); temporary light-
headedness (parenteral form); local irritation(with parenteral form).
Adverse Reaction:

ë Overdose may produce temporary paralysis of ciliary muscle; papillary dilation; tachycardia;
palpitations; hot, dry, or flushed skin; absence of bowel sounds; hyperthermia; increased
respiratory rate; EKO abnormalities; nausea; vomiting; rash over face or upper trunk;
CNSstimulations; and psychosis (marked by agitation, restlessness, rambling speech, visual
hallucinations, paranoid behavior, and delusions, followed by depression).
Nursing Responsibilities:

ë Advise patient to apply patch the night before a planned trip. Transdermal method releases a
controlled therapeutic amount of drug. Transderm-Scop is effective if applied 2 or 3 hours
before experiencing motion but is more effective if applied 12 hours before.
ë Instruct patient to remove one patch before applying another
ë Instruct patient to wash and dry hands thoroughly before and after applying the transdermal
patch (on dry skin behind the ear) and before touching the eye because pupil may dilate. Tell
patient to discard patch after removing it and to wash application site thoroughly.
ë Tell patient that if patch becomes displaced, he should remove it and apply another patch on a
fresh skin site behind the ear.
ë Alert patient to possible withdrawal signs or symptoms (nausea, vomiting, headache, dizziness)
when transdermal system is used for longer than 72 hours.
ë Advice patient that eyes may be ore sensitive to light while wearing patch. Advice patient to
wear sunglasses for comfort
ë Urge patient to report urinary hesitancy or urine retention.
|