Trade Name: Tranexamic Acid

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amring Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 650 mg/1

Storage and handling

TRANEXAMIC ACID Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]

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  1. These products are not for sale in US territories. We offer them for exports outside US territories to trade professionals or patients with a valid prescription.
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Tranexamic Acid (Tranexamic Acid) which is also known as Tranexamic Acid and Manufactured by Amring Pharmaceuticals, Inc.. It is available in strength of 650 mg/1.

Tranexamic Acid (Tranexamic Acid) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Tranexamic Acid USP Tablets are indicated for the treatment of cyclic heavy menstrual bleeding [see ].
  • Prior to prescribing tranexamic acid USP tablets,exclude endometrial pathology that can be associated with heavy menstrual bleeding.
  • Tranexamic Acid USP Tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding.()
  • No data
  • 1,300 mg (two 650 mg tablets) three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation ()
  • Renal impairment: Dosage adjustment is needed if serum creatinine concentration (Cr) is higher than 1.4 mg/dL ()n
  • 650 mg tablets
  • Tablets: 650 mg ()
  • No data
  • Women who are using combination hormonal contraception ()
  • Women with active thromboembolic disease or a history or intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion ()
  • Hypersensitivity to tranexamic acid ()
  • Concomitant use of tranexamic acid USP tablets with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral tretinoin) may increase the risk of thrombosis. ()
  • Visual or ocular adverse effects may occur with tranexamic acid USP tablets. Immediately discontinue use if visual or ocular symptoms occur. ()
  • In case of severe allergic reaction, discontinue tranexamic acid USP tablets and seek immediate medical attention. ()
  • Cerebral edema and cerebral infarction may be caused by use of tranexamic acid USP tablets in women with subarachnoid hemorrhage. ()
  • Ligneous conjunctivitis has been reported in patients taking tranexamic acid. ()
  • Most common adverse reactions in clinical trials (u2265 5%, and more frequent in tranexamic acid USP tablets subjects compared to placebo subjects) are headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641) or FDA at 1-800-FDA-1088 or n
  • No drug-drug interaction studies were conducted with tranexamic acid USP tablets.
  • Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic acid USP tablets and tissue plasminogen activators. ()
  • No data
  • Geriatric Use: Tranexamic Acid USP Tablets is not indicated for use in postmenopausal women ()
  • Renal impairment: Dosage adjustment is needed. (, )
  • Hepatic impairment: No dosage adjustment is needed. ()
  • There are no known cases of intentional overdose with tranexamic acid USP tablets and no subjects in the clinical program took more than 2 times the prescribed amount of tranexamic acid USP tablets in a 24-hour period (>7800 mg/day). However, cases of overdose of tranexamic acid have been reported. Based on these reports, symptoms of overdose may include gastrointestinal (nausea, vomiting, diarrhea); hypotensive (e.g., orthostatic symptoms); thromboembolic (arterial, venous, embolic); visual impairment; mental status changes; myoclonus; or rash. No specific information is available on the treatment of overdose with tranexamic acid USP tablets. In the event of overdose, employ the usual supportive measures (e.g., clinical monitoring and supportive therapy) as dictated by the patientu2019s clinical status.
  • Tranexamic Acid USP Tablets is an antifibrinolytic drug. The chemical name is trans-4-aminomethyly-clohexanecarboxylic 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 CHNO and the molecular weight is 157.2.
  • Tranexamic Acid USP Tablets are provided as white oval-shaped tablets and are not scored. Each tablet is debossed with the marking u201cFP650.u201d The active ingredient in each tablet is 650 mg tranexamic acid. The inactive ingredients contained in each tablet are: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.
  • No data
  • No data
  • The efficacy and safety of tranexamic acid USP tablets in the treatment of heavy menstrual bleeding (HMB) was demonstrated in one 3-cycle treatment and one 6-cycle treatment, randomized, double-blind, placebo-controlled study [see ]. In these studies, HMB was defined as an average menstrual blood loss of u2265 80 mL as assessed by alkaline hematin analysis of collected sanitary products over two baseline menstrual cycles. Subjects were 18 to 49 years of age with a mean age of approximately 40 years, had cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m. On average, subjects had an HMB history of approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic origin.
  • In these studies, the primary outcome measure was menstrual blood loss (MBL), measured using the alkaline hematin method. The endpoint was change from baseline in MBL, calculated by subtracting the mean MBL during treatment from the mean pretreatment MBL.
  • The key secondary outcome measures were based on specific questions concerning limitations in social or leisure activities (LSLA) and limitations in physical activities (LPA). Large stains (soiling beyond the undergarment) were also included as a key secondary outcome measure.
  • Tranexamic Acid USP Tablets are provided as white oval-shaped tablets. Each tablet is debossed with the marking u201cFP650u201dand are supplied as:
  • Storage
  • Store at room temperature 25u00b0 C (77u00b0 F); excursions permitted to 15-30u00b0 C (59-86u00b0 F). [See USP controlled Room Temperature]
  • See n
  • Instruct patients that the usual schedule is to take two tablets with liquids, three times a day during menstruation. Patients should be instructed not to exceed 3 doses (6 tablets) in a 24-hour period or to take for more than 5 days in any menstrual cycle.
  • Inform patients that they should immediately stop tranexamic acid USP tablets if they notice any eye symptoms or change in their vision. Instruct them to report any such problems promptly to their physician and to follow-up with an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination of the retina.
  • Inform patients that they should stop tranexamic acid USP tablets and seek immediate medical attention if they notice symptoms of a severe allergic reaction (e.g., shortness of breath or throat tightening).
  • Instruct patients that common side effects of tranexamic acid USP tablets include headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia and fatigue.
  • Advise patients to contact their healthcare provider if their heavy menstrual bleeding symptoms persist or worsen.
  • Remind patients to read the Patient Labeling carefully.
  • TRANEXAMIC ACID, USP TABLETS
  • Read the Patient Information that comes with tranexamic acid USP tablets before you start using the drug and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
  • What is tranexamic acid USP tablets?
  • Tranexamic Acid USP Tablets is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. Tranexamic Acid USP Tablets does not contain any hormones. On average, tranexamic acid USP tablets has been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period.
  • Tranexamic Acid USP Tablets is taken only during your period and is not meant to treat pre-menstrual symptoms (symptoms that occur before your bleeding starts). Tranexamic Acid USP Tablets does not affect your fertility and cannot be used as birth control. Tranexamic Acid USP Tablets does not protect you against diseases that you may get if you have unprotected sex.
  • Tranexamic Acid USP Tablets has not been studied in adolescents younger than 18 years of age.
  • Tranexamic Acid is not for women who have already gone through menopause (post-menopausal).
  • Who should not take tranexamic acid USP tablets?
  • Do not take tranexamic acid USP tablets if you:
  • What should I tell my healthcare provider before taking tranexamic acid USP tablets?
  • Before taking tranexamic acid USP tablets, tell your healthcare provider about all of your medical conditions, including whether:
  • Tell your healthcare provider about all the medicines you take,
  • Especially tell your healthcare provider if you take:
  • Ask your healthcare provider if you are not sure if your medicine is one that is described above.
  • How should I take tranexamic acid USP tablets?
  • What are the possible side effects of tranexamic acid USP tablets?
  • Tranexamic Acid USP Tablets can cause serious side effects, including:
  • The most common side effects of tranexamic acid USP tablets include:
  • Tell your healthcare provider if you have any side effect that bothers you or does not go away.
  • These are not all of the possible side effects of tranexamic acid USP tablets.
  • For more information, ask your healthcare provider or pharmacist.
  • If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641).
  • How should I store tranexamic acid USP tablets?
  • Store tranexamic acid USP tablets at room temperature between 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C).
  • Keep tranexamic acid USP tablets and all medicines out of the reach of children.
  • General information about tranexamic acid USP tablets
  • Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use tranexamic acid USP tablets for a condition for which it was not prescribed. Do not give tranexamic acid USP tablets to other people, even if they have the same symptoms that you have. It may harm them.
  • This patient information leaflet summarizes the most important information about tranexamic acid USP tablets. If you would like more information about tranexamic acid USP tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about tranexamic acid USP tablets that is written for healthcare professionals. For more information, call 1-844-Amring1 (1-844-267-4641).
  • What are the ingredients of tranexamic acid USP tablets?
  • Active ingredient: tranexamic acid
  • Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:nAmring Pharmaceuticals Inc. nBerwyn, PA 19312n
  • Manufactured by:nMikart, LLC.nAtlanta, GA 30318 n
  • Rev. 03/2019
  • 1221E00
  • NDC 69918-301-30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rx Onlyu00a0
  • Tranexamic Acid, USP Tablets
  • 650 mg
  • 30 Tablets
  • AMRINGn PHARMACEUTICALS

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