- Approval Id
- 6fabc222df461724
- Drug Name
- CYKLOKAPRON INJECTION 100 MG/ML
- Product Name
- CYKLOKAPRON INJECTION 100 MG/ML
- Approval Number
- SIN02488P
- Approval Date
- 1989-03-09
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p><strong>TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL ADMINISTRATION.</strong></p>
<p>The recommended standard dose is 5 mL to 10 mL by slow intravenous injection at a rate of 1 mL/minute or 2 to 3 tablets of 0.5 g 2 to 3 times daily.</p>
<p>For the indications listed below, the following doses are recommended:</p>
<p><em>General fibrinolysis</em>: 1.0 g (2 ampoules of 5 mL) by slow intravenous injection every 6 to 8 hours.</p>
<p><em>Prostatectomy</em>: 0.5 g to 1.0 g (1 to 2 ampoules of 5 mL) by slow intravenous injection every 6 to 8 hours (the first injection being given during the operation) for the first 3 days after surgery, thereafter 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily until macroscopic haematuria is no longer present.</p>
<p><em>Haematuria</em>: 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily until macroscopic haematuria is no longer present.</p>
<p><em>Epistaxis</em>: 1.5 g orally (3 tablets) 3 times a day should be administered for 4 to 10 days.<br>
Cyklokapron solution for injection may be applied topically to the nasal mucosa of patients suffering from epistaxis. This can be done by soaking a gauze strip in the solution, and then packing the nasal cavity.</p>
<p><em>Menorrhagia</em>: 1 g to 1.5 g orally (2 to 3 tablets) 3 to 4 times daily for 3 to 4 days.<br>
Cyklokapron therapy is initiated when bleeding has become profuse.</p>
<p><em>Conisation of the cervix</em>: 1.5 g orally (3 tablets) 3 times a day for 12 to 14 days postoperatively.</p>
<p><em>Dental extraction in patients with coagulopathies</em>: Immediately before surgery, Cyklokapron 10 mg/kg body weight should be given intravenously. After surgery, 25 mg/kg body weight is given orally 3 to 4 times daily for 6 to 8 days. Coagulation factor concentrate might be necessary to administrate. This decision should be taken after consulting specialists on coagulation.</p>
<p><em>Hereditary angioneurotic oedema</em>: 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily as intermittent or continuous treatment, depending on whether the patient has prodromal symptoms or not.</p>
<p>For patients with moderate to severe impaired renal function, the following dosages are recommended:</p>
<img src="/TGIF/Cyklokapron-Table1_270824.png" alt="Cyklokapron Dosage Table 1" /><br><br>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<ul>
<li><p>Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis.</p>
<p>Local fibrinolysis may occur in the following conditions: Menorrhagia, prostatectomy and bladder surgery, haematuria, gastrointestinal haemorrhage, epistaxis, ulcerative colitis, conisation of the cervix, and dental extraction in patients with coagulopathies.</p>
<p>General fibrinolysis may occur in the following conditions and situations: Prostatic and pancreatic cancer, after thoracic and other major surgery, in obstetrical complications such as ablatio placentae and postpartum haemorrhage, leukaemia, liver diseases, in connection with thrombolytic therapy with streptokinase.</p></li>
<li><p>Hereditary angioneurotic oedema.</p></li>
</ul>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<p>Intrathecal and epidural administration of tranexamic acid is contraindicated.</p>
<p>Active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism and cerebral thrombosis.</p>
<p>Subarachnoid haemorrhage. The limited clinical experience shows that a reduced risk for re-bleeding is offset by an increase in the rate of cerebral ischaemia.</p>
<p>Hypersensitivity to tranexamic acid or any of the ingredients.</p>
- Atc Code
- B02AA02
- Atc Item Name
- tranexamic acid
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
