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Drug Catalog - Product Detail

TRANEXAMIC ACID TB 650MG 30

NDC Mfr Size Str Form
00591-3720-30 ACTAVIS PHARMA 30 650MG TABLET
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Generic Name
TRANEXAMIC ACID
Substance Name
TRANEXAMIC ACID
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202093
Description
11 DESCRIPTION Tranexamic acid tablets are an antifibrinolytic drug administered orally. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is: Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic acid and is very slightly soluble in ethanol and practically insoluble in ether. The molecular formula is C 8 H 15 N0 2 and the molecular weight is 157.2. Tranexamic acid tablets are provided as white to off-white, oval-shaped, unscored, film coated tablets, debossed with “ WPI 3720 ” on one side of the tablet. The active ingredient in each tablet is 650 mg tranexamic acid. The inactive ingredients contained in each tablet are: colloidal silicon dioxide, copovidone, crospovidone, dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer, glyceryl behenate, lactose monohydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and triethyl citrate. Structural Formula for Tranexamic Acid
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Indications & Usage
1 INDICATIONS AND USAGE Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies ( 14 )] Tranexamic acid tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 1,300 mg three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation ( 2.1 ) Renal impairment: Lower dosage is needed (for a maximum of 5 days during menstruation) if serum creatinine concentration (Cr) is higher than 1.4 mg/dL ( 2.2 ) Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg two times a day (2,600 mg/day) Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg once a day (1,300 mg/day) Cr above 5.7 mg/dL: 650 mg once a day (650 mg/day) 2.1 Recommended Testing Prior to Tranexamic Acid Tablets Administration Prior to prescribing tranexamic acid tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding. 2.2 Recommended Dosage The recommended dosage of tranexamic acid tablets for patients with normal renal function is 1300 mg orally three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation. Tranexamic acid tablets may be administered with or without food. Swallow tablets whole; do not chew or break apart. 2.3 Dosage Recommendations in Patients with Renal Impairment The recommended dosage (for a maximum of 5 days during monthly menstruation) in patients with renal impairment with serum creatinine concentration higher than 1.4 mg/dL is described in Table 1. Table 1. Recommended Dosage of Tranexamic Acid Tablets in Patients with Renal Impairment Serum Creatinine (mg/dL) Recommended Dosage (maximum of 5 days during menstruation) Total Daily Dose Above 1.4 and ≤ 2.8 1300 mg two times a day 2600 mg Above 2.8 and ≤ 5.7 1300 mg once a day 1300 mg Above 5.7 650 mg once a day 650 mg