Vietnam Product

Trantum Tablets

Trantum Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
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

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).
Immune system disorders
Very rare: Hypersensitivity reactions including anaphylaxis
Eye disorders
Rare: Colour vision disturbances, retinal/artery occlusion
Vascular disorders
Rare: Thromboembolic events
Very rare: Arterial or venous thrombosis at any sites
Gastro-intestinal disorders
Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Patients with irregular menstrual bleeding should not use Trantum  until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Trantum , 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 thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Trantum  only if there is a strong medical indication and under strict medical supervision.
The blood levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended.
The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended.
Patients who experience visual disturbance should be withdrawn from treatment.


What to do if you accidentally take too much (overdose) of the medicine?

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 should be considered.

Is it safe in pregnancy and breast-feeding?

Pregnancy
Although there is no evidence from animal studies of a teratogenic effect, the usual caution with use of drugs in pregnancy should be observed.
Tranexamic 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.

Storage Conditions:

Store at temperatures below 30° C.

Drug Description

Composition:
Each film coated tablet contains
Tranexamic acid……250 mg/ 500 mg

Additional Excipients: Microcrystalline cellulose (Avicel PH102), Low Substituted Hydroxypropyl cellulose, Povidone K-30, Microcrystalline cellulose (Avicel PH112), Croscarmellose sodium, Colloidal silicon dioxide, Purified talc, Magnesium stearate, Colorcoat FC4S white, Isopropyl alcohol, Purified water
General physic-chemical properties: White, Circular, biconvex film Coated tablets, plain on both sides.

Indications and dosage.

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

ADMINISTRATION AND DOSAGE:
Route of administration: Oral

1) Local fibrinolysis: The recommended standard dosage is 15-25 mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used:

a) Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.

b) Menorrhagia: Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4 g daily (8 tablets) should not be exceeded. Treatment with Trantum should not be initiated until menstrual bleeding has started.

c) Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.

d) Conisation of the cervix: 3 tablets three times daily.

e) Traumatic hyphaema: 2-3 tablets three times daily. The dose is based on 25 mg/kg 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 every eight hours. The dose is based on 25 mg/kg.

Renal insufficiency: By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency.

Serum Creatinine (μmol/l) : Dose tranexamic acid
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 evidence of renal failure.

 

Side effects and drug interactions.

  Adverse reactions:
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

Immune system disorders
Very rare: Hypersensitivity reactions including anaphylaxis

Eye disorders
Rare: Colour vision disturbances, retinal/artery occlusion

Vascular disorders
Rare: Thromboembolic events
Very rare: Arterial or venous thrombosis at any sites

Gastro-intestinal disorders
Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.

Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions

           Drug interactions
Trantum  will counteract the thrombolytic effect of fibrinolytic preparations.

Warnings and precautions

In case of haematuria of renal origin (especially in haemophilia), there is a risk of mechanical anuria due to formation of a ureteral clot.
In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, and visual fields) and liver function tests should be performed.
Patients with irregular menstrual bleeding should not use Trantum  until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Trantum , 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 thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Trantum  only if there is a strong medical indication and under strict medical supervision.
The blood levels are increased in patients with renal insufficiency. Therefore a dose reduction is recommended.
The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended.
Patients who experience visual disturbance should be withdrawn from treatment.
Clinical experience with Trantum in menorrhagic children under 15 years of age is not available.

 

Overdosage and Contraindications

Overdosage:
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 should be considered.             

Contraindications

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

 

Clinical pharmacology.

PHARMACOTHERAPEUTIC GROUP: Antifibrinolytic Agent

Code ATC: B02AA02

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamic properties
Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At 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 to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid. The antifibrinolytic activity of tranexamic acid is approximately ten times greater than that of aminocaproic acid.

Pharmacokinetics:
Absorption
Peak plasma Tranexamic acid concentration is obtained immediately after intravenous administration (500mg). Then concentration decreases until the 6th hour. Elimination half-life is about 3 hours.

Distribution
Tranexamic acid administered parenterally is distributed in a two compartment model. Tranexamic acid is delivered in the cell compartment and the cerebrospinal fluid with delay. The distribution volume is about 33% of the body mass.

Tranexamic acid crosses the placenta, and may reach one hundredth of the serum peak concentration in the milk of lactating women.

Elimination
Tranexamic acid is excreted in urine as unchanged compound. 90% of the administered dose is excreted by the kidney in the twelve first hours after administration (glomerular excretion without tubular reabsorption).
Following oral administration, 1.13% and 39% of the administered dose were recovered after 3 and 24 hours respectively.
Plasma concentrations are increased in patients with renal insufficiency.
DOSAGE FORMS AND PACKING AVAILABLE:
Tablets
Trantum  Tablets 250 mg & 500 mg are packed into PVC/PVDC aluminium blister pack. 1 blister contains 10 tablets. 1, 3 or 6 such blisters are packed in a carton alongwith pack insert.

SHELF- LIFE:
3 years

NAME AND ADDRESS OF MANUFACTURER:
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Industrial Area,
Chopanki, Bhiwadi (Raj.),
India.

 

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780