India Product

Tramza tablets

Tramza tablets

Why you have been prescribed this medicine?

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

Tranexamic Acid 500 mg film coated tablets are indicated for short term use for haemorrhage or risk of haemorrhage in those with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:

1. a) Prostatectomy and bladder surgery
b) Menorrhagia
c) Epistaxis
d) Conisation of the cervix
e) Traumatic hyphaema

2. Management of dental extraction in haemophiliacs.
3. Hereditary angioneurotic oedema.

When you should consult your doctor?

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

Adverse effects have been ranked under headings of frequency using the following convention:

Very common (≥ 1/10)

Common (≥1/100, <1/10)

Uncommon (≥1/1000, <1/100)

Rare (≥ 1/10,000, <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data).

The following undesirable effects have been reported

Immune system disorders
Very rare: Hypersensitivity reactions including anaphylaxis

Gastrointestinal disorders
Common: nausea, vomiting, diarrhoea.
These effects disappear when the dosage is reduced.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions.

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

Eye disorders
Rare: impaired colour vision and other visual disturbances, retinal/artery occlusion.

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?

In massive haematuria from the upper urinary tract (especially in haemophilia) since, in a few cases, ureteric obstruction has been reported.

When disseminated intravascular coagulation is in progress.

In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.

Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Tranexamic Acid, 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 tranexamic acid 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 tranexamic acid in menorrhagic children under 15 years of age is not available.

Influence on velocity reactions while driving motor transport and operating other mechanisms:

None known.

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:

Do not store above 30°C. Store in the original package.

Drug Description

Active substances: Each film coated tablet contains:   Tranexamic acid 500 mg.

Excipients: Tablet core: Cellulose microcrystalline, povidone (K 90), croscarmellose sodium, silica colloidal anhydrous, talc, magnesium stearate;
Film coating: methacrylate polymers, titanium dioxide (E171), talc, magnesium stearate, macrogol (8000).

Indications and dosage.

Indications:
Tranexamic Acid 500 mg film coated tablets are indicated for short term use for haemorrhage or risk of haemorrhage in those with increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:

1. a) Prostatectomy and bladder surgery
b) Menorrhagia
c) Epistaxis
d) Conisation of the cervix
e) Traumatic hyphaema

2. Management of dental extraction in haemophiliacs.
3. Hereditary angioneurotic oedema.

 

Dosage:
Route of administration: Oral.
Adults:
Local Fibrinolysis: The recommended standard dose is 15-25mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily. For the indications listed below the following doses may be used:
1a. Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with an injectable form; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.
1b. 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 4g daily (8 tablets) should not be exceeded. Treatment with tranexamic acid should not be initiated until menstrual bleeding has started.
1c. Epistaxis: When repeated bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.
1d. Cervix Conisation: 3 tablets three times daily
1e. Traumatic Hyphaema: 2-3 tablets 3 times daily. The dose is based on 25mg/kg three times a day.
2. Haemophilia: In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25mg/kg.
3. Hereditary angioneurotic oedema: Some patients are aware of the onset of 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.
Children:
This should be calculated according to bodyweight at 25mg/kg per dose. However, data on efficacy, posology and safety for these indications are limited.
Elderly:
No reduction in dosage is necessary unless there is evidence of renal failure (see guidelines below).
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)

Oral Dose

Dose Frequency

120-249

15 mg/kg body weight

twice daily

250-500

15 mg/kg body weight

daily

Side effects and drug interactions.

Side effects:
Adverse effects have been ranked under headings of frequency using the following convention:

Very common (≥ 1/10)

Common (≥1/100, <1/10)

Uncommon (≥1/1000, <1/100)

Rare (≥ 1/10,000, <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data).

The following undesirable effects have been reported

Immune system disorders
Very rare: Hypersensitivity reactions including anaphylaxis

Gastrointestinal disorders
Common: nausea, vomiting, diarrhoea.
These effects disappear when the dosage is reduced.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions.

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

Eye disorders
Rare: impaired colour vision and other visual disturbances, retinal/artery occlusion

 Drug interactions
Tranexamic acid will counteract the thrombolytic effect of fibrinolytic preparations.

Warnings and precautions

In massive haematuria from the upper urinary tract (especially in haemophilia)  since, in a few cases, ureteric obstruction has been reported.

When disseminated intravascular coagulation is in progress.

In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.

Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by Tranexamic Acid, 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 tranexamic acid 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 tranexamic acid 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

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

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Pharmacotherapeutic group: antifibrinolytic agent. ATC code: B02AA02
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.

Pharmacokinetic properties
Tranexamic acid crosses the blood brain barrier.
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. 

Pharmaceutical characteristics:

General physic-chemical properties:   Tablets.
Tranexamic Acid 500 mg film coated tablets are white to off white, capsule shaped, biconvex film-coated tablets. They are marked with TXA 500 with a break line.

Shelf-life:
3 years.

Storage:
Do not store above 30°C. Store in the original package.

Package:
The blister pack (PVC/aluminium) contains 60 tablets.

Conditions of supply.
Without prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575