Subject: : To understand the in-clinic usage pattern of TRAPIC MF Tablet for treatment of primary dysmenorrhea and relief of mild to moderate pain associated with menorrhagia in real-life clinical practice
Dysmenorrhea is painful menstruation, either cramps with no visible cause, primary dysmenorrhea, or secondary to specific pelvic pathology. The pain is due to uterine cramps, hypoxia or ischemia, due to overproduction of prostaglandins, leukotrienes or vasopressin. Primary dysmenorrhea occurs in as many as 50% of young women, only in ovulatory cycles, and usually limited to the first 48 or 72 hours of menstruation. Secondary dysmenorrhea can be caused by any of a dozen or so disorders adenomyosis, uterine myomas or polyps,etc that may also result in menorrhagia.1 Tranexamic acid is a synthetic amino acid used in order to decrease menstrual blood loss. Its anti fibrinolytic effects are achieved by preventing the plasminogen from binding to fibrin filaments and so, it prevents clot dissolution. Mefenamic acid is an NSAID (Non-steroidal anti-inflammatory drugs) and exerts its anti-prostaglandin effects by inhibiting prostaglandin synthesis, so it balances prostaglandins and decreases menstrual bleeding. Anti fibrinolytic drugs such as tranexamic acid and anti-prostaglandin drugs such as mefenamic acid are preferred to hormonal drugs when contraception is not a goal, as they are used only during menstrual period.2
We have planned this surveillance to assess the in-practice usage and prescription pattern of ‘TRAPIC MF Tablet’ for primary dysmenorrhea/ mild to moderate pain associated with menorrhagia.
We invite you to participate in this surveillance and share your experience of patients with Primary dysmenorrhea/ mild to moderate pain associated with menorrhagia in your routine clinical practice. Thus, this is not an experimental study because the product is already received by patients at a dosage prescribed by you.
If you agree to participate, we request you to provide us a copy of relevant information from the patient’s case papers, and investigational reports, if any (which we call source documents), in the standard data collection forms (which we call DCF). You will be responsible for seeking patient consent and for verifying the DCF with the source documents to ensure that the DCF signed by you are free from errors or omissions. The DCF will not contain the patient’s names so as to ensure confidentiality.
We trust you and we are partners in ensuring safe and effective drug therapy. In that spirit we hope you will consent to participate in this surveillance. If you do, please sign and return the enclosed reply document along with your visiting card for accuracy of records.
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