Kapron for prostatectomy and bladder surgery menorrhagia epistaxis and conisation of the cervix

 
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Kapron tablets

Compostion :

Each coated tablet contains:
500 mg Tranexamic acid
list of exedpients :
Croscarmellose Sodium, Sodium Slearyl fumerate, Prosolve 90, Crospovidone XL , Povidone k30 

Pharmacodynamic properties :

Traoexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. AI much higher” concentrations it is a non competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported 10 be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic add. The antifibrino/ytic activity oflranexamic acid is approximately ten times greater than that of aminocaproic acid.

Pharmacokinetic properties :

Absorption : Absorption of tranexamic acid after oral administration in humans represents approximately 30-50 % of the ingested dose and bioavailability is not affected by food intake
Distribution : the plasma peak level after 1 g orally is 8 mg per L and after 2 g , 15 mg per l both obtained three hours after dosing.
The plasma protein binding of tranexernic add is about 3 % at therapeutic plasma levels and seems to be fully accounted for by its binding to plasminogen. Tranexamic acid does not bind 10 serum albumin. An antifibrinolytic concentration of tranexamic acid remains in different tissues for about 17 hours, and in the serum, up 10 seven or eight hours. Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women.
Elimination : After oral administration of 10-15 mg per kB body weight, the cumulative urinary excretion at 24 hours is 39 % and at 48 hours, 41 % of the ingested dose or 78 % and 82 % of the absorbed material. only a small fraction of the drug is metabolized. After oral administration, 1 % of the dicarboxylic acid and 0.5 % of
the acetylated compound are excreted . Plasma concentrations are increased in patients with renal insufficiency.

Therapeutic indications :

Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. local fibrinolysis as occurs in the following conditions :
– Prostatectomy and bladder surgery
– Menorrhagia
– Epistaxis
– Conisation of the cervix
– Traumatic hyphaema
– Hereditary angioneurotic oedema
– Management of dental extraction in haemophiliacs

Posology and method of administration :

Route of administration: Oral.
1. local fibrinolysis: The recommended standard dosage ts 15-25 mglkg bodyweight fI.e. 2-3 tablets two to three times daily. For the indications listed below thefollowing doses may be used :
1 a. Prostatectomy : Prophyiaxis and treatment of haemontlage in high risk patients should commence pre or post operatively with Kapron Injection thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present
1 b. Menorrhagia : Recommended dosage is 2 tablets 3 limes daily as long as nccdecM0r up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Treatment with Kapron should not be initiated until mensbual bleeding has sterted
1 c. Epistaxis : Where recurrent bleeding is anticipated oral therapy (2 tablets three limes daily) should be administered for 7 days.
1 d. Conisation of the cervix: 3 tablets three times daity.
1 e. Traumatic hyphaema: 2-3 tablets three times daity. The dose is based on 25 mglkg three times a day.
2. Hereditary angioneurotic oedema: Some patients are aware of the onset of the illness suitable treatment for these patients is intermittently 2-3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage.
3. Haemophilia: In the management of dental extractions 2-3 tablets {!Very eight hours. The dose is based on 25 mg/kg.
Renal insufficiency: By extrapolation from clearance data relating to the intravenous dosage form, the folklowing reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency.
Serum                                          Dose tranexamic acid
Creatinine

120-249                                      15 mg/kg body weight twice daily
250-500                                     15 mg/kg body weight /day
children’s dosage: This should be calculated according to body weight at 25 mg/kg per dose. However, data on efficacy, posology and safety for these
indications are limited
Elderly patients: No reduction in dosage is necessary unless there is evderce of renal failure .

Contraindications :

– Hypersensitivity 10 tranexamic acid or any of the other ingredients
– Severe renal impainnent because of risk. of accumulation
– Active thromboembolic disease.
– History of venous or arterial thrombosis
– Fibrinolytic conditions following consumption coagulopathy
– History of convulsions

Special warnings and precautions for use :

In case of haematuria of renal origin (especially in haemophilia), there is a risk of mechanical anuria due to formation of a ureteral dot In the long-term treatment of patients “ith hereditary ang)oneurotic oedema, regular eye examinations (e.g. \isual acuity, slit lamp, intraocular pressure, visual fiekts) and liver function tests should be performed. Patients with irregular menstrual bleeding should not use Kapron until the cause of irregular bleedog has been established. tf menstrual bleeding is not adequately reduced by Kapron ,an alternative treatment should be considered Tranexamic acid should be administered with care in patients receiving oral
contraceptives because of the “increased risk of thrombosis. Patients with a previous furomboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Kapron only if there is a strong medical indication and under strict medical SUperviSIOll. The bcod levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended. The use oflranexamic acid in cases of increased fibril”KXysis due to disseminated intravascular coagulation is not recommended.
Patients who experience visual d~turbance should be withdrawn from treatment Clinical experience with Kapron in menorrhagic children under 15 years of age is not available.
Interacti$’ with other medicinal products and other forms of interaction Kapron will counteract the thrombolytic effect of fibrinolytic preparations.

Pregnancy and lactation :

Pregnancy : 
Although there is no eeideoce from animal studies of a teratogeniceffed, the usual caution with use of drugs in pregnancy should be observed. Tranex.amic acid crosses the placenta.
lactation :
Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Effects on abillity to drive and use machines :

None known.

Undesirable effects :

Adverse events are listed below by system organ dass and frequency. Frequencies are defined as: very common (cl/IO), common {c1{100 and <1/101, uncommon
{c 1/1000 and <I/lOO}, rare (;? 1{10,000 and <1/1000) and very rare «1/10,000) including isolated reports, not known (cannot be estimated from the available datal.
Immune system disorders
Very rare: Hypersensitivity reactions induding anaphylaxis
Eye disorders
Rare: Colour vision disturbances, retinaVartery occlusion
Vascular disorders
Rare: Thromboembolic events
Very rare: Merial or venous thrombosis at any sites
Gastro-intestinal disorders
Very rare: Digestive effects such as nausea, vomiting and darrboea may occur but disappear when the dosage is reduced.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions

Overd0s0 :

Symptoms may be nausea, vomiting. orthostatic symptoms and/or hypotension. Initiate vomiting, then stomach lavage,. and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk. of thrombosis in predisposed individuals. Anticoagulant treatment shoukt be considered

Preclinical safety data :

There are no preclinical data of relevance to the prescriber which are additional to that alreadY, included in other sections of the Summary of Product Characteristics.

How supplied :

Strips of 10 tablets in packs of 2 strips .
Keep all medicaments out of reach of children

Product of :

AMOUN PHARMACEUTICAL Co. SA£.
EI-Obour City, Cairo, Egypt

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