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Sanzyme Pvt Ltd

Gynosis DT DT 500mg Tablet 1'S

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    Introduction About GYNOSIS DT DT 500MG TABLET

    GYNOSIS DT DT 500MG TABLET contains Progesterone which belongs to the group of medicines called Steroid hormones. It supplements your body with extra progesterone during the management of infertility that is caused due to progesterone deficiency or while you are undergoing any assisted fertility procedure.

    It can also be used to support new pregnancy by maintaining the thickness of the uterine lining. It helps to manage threatened abortions and pre-term delivery by increasing the serum progesterone level.

    It also manages problems associated with progesterone deficiency such as abnormal uterine bleeding, secondary amenorrhea (lack of periods due to hormonal problems or problems in the genital organs), natural cessation of menstruation in women) and used in combination with estrogen therapy to manage menopausal disorders.

    Before taking GYNOSIS DT DT 500MG TABLET inform your doctor if you have any liver, heart or kidney problems, diabetes, asthma, epilepsy, or depression. Do not take GYNOSIS DT DT 500MG TABLET if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding, or blood clots. During management with GYNOSIS DT DT 500MG TABLET, your doctor will instruct you to have periodic blood tests and regular physical examination (breast and uterine examination) as a precaution.

    GYNOSIS DT DT 500MG TABLET may be prescribed by your doctor during early stages of pregnancy to support the growth of fetus. However, consult your doctor before taking it. GYNOSIS DT DT 500MG TABLET is not recommended for use in breast-feeding women and in children and adolescents (below 18 years of age).

    The most common side effects of taking GYNOSIS DT DT 500MG TABLET are headache, hair loss, pain in the breast, stomach or abdominal cramps, bloating, nausea, vomiting, irregular vaginal bleeding or spotting, fluid retention and vaginal yeast infection. Consult your doctor if any of the side effect worsens.

    Uses Of GYNOSIS DT DT 500MG TABLET

    • Manage female infertility and other progesterone deficiency states such as abnormal uterine bleeding, menopausal disorders and secondary amenorrhea
    • Supports early pregnancy
    • Prevents threatened abortions and pre-term delivery

    How GYNOSIS DT DT 500MG TABLET Works

    GYNOSIS DT DT 500MG TABLET is a steroid hormone used to manage progesterone deficiency in the body. It supplements your body with sufficient levels of progesterone that is required for a successful implantation of fertilized egg in the uterus and for the maintenance of an early pregnancy.

    It sustains pregnancy among infertile women by increasing the thickness of uterine wall. It also regulates hormonal balance in the body and corrects abnormal uterine bleeding and other menstrual problems caused due to incorrect levels of progesterone in the body.

    How to use GYNOSIS DT DT 500MG TABLET

    Take GYNOSIS DT DT 500MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you based upon your age, body weight and disease condition.

    Side Effects Of GYNOSIS DT DT 500MG TABLET

    Common

    • headache
    • breast pain
    • irregular vaginal bleeding or spotting
    • stomach or abdominal cramps, bloating, nausea, vomiting, constipation
    • hair loss
    • fluid retention
    • vaginal yeast infection

    Stop taking GYNOSIS DT DT 500MG TABLET and contact your doctor immediately if you experience any of the following side effects:

    • signs of liver disease (such as yellow skin or white of the eyes)
    • severely high blood pressure (signs include headache, tiredness and dizziness)
    • migraine-like headaches (happening for the first time)
    • sudden or gradual, partial, or complete loss of eyesight
    • bulging of one or both eyes, double vision
    • swelling of the optic nerve
    • retinal vascular lesions (eye diseases)
    • signs of blood clot (such as painful swelling and redness of the legs, sudden chest pain and trouble breathing)

    How To Manage Side Effects

    Constipation

    Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly (such as daily walk). Consult your doctor if the symptom does not improve.

    Headache

    Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.

    Nausea And Vomiting

    Take GYNOSIS DT DT 500MG TABLET with or just after meals. Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.

    Warning & Precautions

    Pregnancy

    Safe

    GYNOSIS DT DT 500MG TABLET can be taken by pregnant women to support the growth of fetus during the early stages of pregnancy. However, consult your doctor before taking it.

    Breastfeeding

    Contraindicated

    GYNOSIS DT DT 500MG TABLET is not recommended for use during breast-feeding. Therefore, consult your doctor before taking it.

    Driving and Using Machines

    Use with Caution

    Do not drive or operate any machines if you feel dizzy or drowsy after taking GYNOSIS DT DT 500MG TABLET.

    Kidney

    Use with Caution

    GYNOSIS DT DT 500MG TABLET should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking GYNOSIS DT DT 500MG TABLET.

    Liver

    Consult your doctor

    GYNOSIS DT DT 500MG TABLET is not recommended for use in patients who had or have liver disease and with abnormal liver function test. It should be used with caution in patients with benign liver tumor. Therefore, consult your doctor before taking GYNOSIS DT DT 500MG TABLET.

    Allergy

    Contraindicated

    Do not take GYNOSIS DT DT 500MG TABLET if you are allergic to Progesterone.

    Lungs

    Consult your doctor

    GYNOSIS DT DT 500MG TABLET is not recommended for use in patients who had or have blood clot in the lungs (pulmonary embolism). It should be used with caution in patients with asthma. Therefore, consult your doctor before taking GYNOSIS DT DT 500MG TABLET.

    Heart Disease

    Consult your doctor

    GYNOSIS DT DT 500MG TABLET is not recommended for use in patients with recent heart attack or chest pain. It should be used with caution in patients with high blood pressure. Therefore, consult your doctor before taking GYNOSIS DT DT 500MG TABLET.

    Use In Pediatrics

    Contraindicated

    GYNOSIS DT DT 500MG TABLET is not recommended for use in children and adolescents (under 18 years of age). Therefore, consult your doctor before administering in children.

    Use In Geriatrics

    Use with Caution

    GYNOSIS DT DT 500MG TABLET should be used with caution in elderly patients. Therefore, consult your doctor before taking GYNOSIS DT DT 500MG TABLET.

    Others

    GYNOSIS DT DT 500MG TABLET is not recommended for use if you:

    • have known or suspected cancer of the breast or womb lining (endometrium)
    • have unusual vaginal bleeding
    • had or have blood clots in the legs (deep venous thrombosis) or in the veins (thrombosis)
    • have bleeding on the brain (cerebral hemorrhage) or stroke
    • have blood clotting disorder (like protein C, protein S, or antithrombin deficiency)
    • have porphyria (rare genetic blood disorder)

    Before taking GYNOSIS DT DT 500MG TABLET, inform your doctor if you:

    • have problems in your uterus (such as fibroid growths or endometriosis (womb lining growth outside your womb)
    • have a history of excessive womb lining growth (endometrial hyperplasia)
    • have increased risk of blood clot formation (when you are unable to walk for long time after major surgery, injury or illness, obese and older age)
    • have a family history of having breast cancer
    • have diabetes
    • have gallstones
    • have migraine or severe headaches
    • have systemic lupus erythematosus (an immune system disease that affects many organs of the body)
    • have epilepsy (fits)
    • have otosclerosis (disease affecting the eardrum and hearing)
    • have ever had depression
    • have skin sensitivity towards light

    Interactions

    A. Drug - Drug interactions:

    Before taking GYNOSIS DT DT 500MG TABLET, inform your doctor if you are taking any of the following medicines:

    • medicines used to manage epilepsy (Ex. carbamazepine, phenytoin, phenobarbital)
    • medicines used to manage bacterial infections (Ex. rifampicin, rifabutin, ampicillin and tetracyclines such as doxycycline, minocycline)
    • medicines used to manage HIV infection (Ex. nelfinavir, nevirapine, efavirenz, ritonavir)
    • St. John’s Wort (a medicine used to manage depression)
    • bromocriptine (a medicine used to stop breast milk production, manage infertility or parkinsonism)
    • cyclosporine (a medicine used to manage graft rejection)
    • medicines used to manage fungal infections (Ex. griseofulvin, ketoconazole, terbinafine)
    • spironolactone (a medicine used to manage fluid retention)
    • other progesterone medicines used to manage hormonal problems (such as medroxyprogesterone acetate and megestrol)
    • medicines used to manage or manage blood clots blood (Ex. warfarin, phenindione)
    • medicines used to manage diabetes (Ex. glimepiride, metformin)
    • ulipristal (a medicine used to manage pregnancy in emergencies)
    • tizanidine (a medicine used to manage multiple sclerosis)

    B. Drug – Food interactions:

    Do not take GYNOSIS DT DT 500MG TABLET with food as it may increase the bioavailability of this medicine.

    Overdosage:

    If you or anyone else accidentally take too much of GYNOSIS DT DT 500MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are dizziness, tiredness, drowsiness or sleepiness.

    Synopsis

    Drug :   Progesterone
    Pharmacological Category :   Progestins (female hormones)
    Therapeutic Indication :   Manages female infertility, dysfunctional uterine bleeding, menopausal disorders (in combination with estrogen therapy), secondary amenorrhoea, for maintenance of pregnancy, manages threatened abortion and pre-term delivery
    Dosage Forms :   Tablet, Soft gel Capsule, Pessaries, Injection, Vaginal Gel, Vaginal spray

    More Information

    • Keep GYNOSIS DT DT 500MG TABLET out of reach of children
    • Store GYNOSIS DT DT 500MG TABLET at room temperature

    FAQs About GYNOSIS DT DT 500MG TABLET

    Q. Is GYNOSIS DT DT 500MG TABLET safe to use in patients with liver problems?

    A. GYNOSIS DT DT 500MG TABLET is not recommended for use in patients who had or have blood clot in the lungs (pulmonary embolism) and it should be used with caution in patients with asthma. Consult your doctor before taking GYNOSIS DT DT 500MG TABLET

    Q. Does GYNOSIS DT DT 500MG TABLET make you feel tired?

    A. Yes. GYNOSIS DT DT 500MG TABLET may cause tiredness in some individuals. To manage this, drink plenty of fluids and eat balanced diet and frequent meals. Get enough rest and follow regular sleep schedule.

    Q. What are the common side effects of GYNOSIS DT DT 500MG TABLET?

    A. The most common side effects of taking GYNOSIS DT DT 500MG TABLET are headache, hair loss, pain in the breast, stomach or abdominal cramps, bloating, nausea, vomiting, irregular vaginal bleeding or spotting, fluid retention and vaginal yeast infection. Consult your doctor if any of the side effect worsens.

    Q. What to do If I forget to take a dose of GYNOSIS DT DT 500MG TABLET?

    A. You should take GYNOSIS DT DT 500MG TABLET immediately when you remember. If it is time for your next dose skip the dose and follow your regular dose schedule. Do not double the dose to match up your missed dose. 

    Q. Why is GYNOSIS DT DT 500MG TABLET necessary for pregnancy?

    A. GYNOSIS DT DT 500MG TABLET supplements your body with sufficient levels of progesterone that is required for a successful implantation of fertilized egg in the uterus and for the maintenance of an early pregnancy. It sustains pregnancy among infertile women and in women who face repeated/threatened abortions by increasing the thickness of uterine wall.

    Q. When is progesterone produced in the reproductive cycle?

    A. The typical menstrual cycle takes approximately 28 to 32 days and is divided into three distinct phases namely the follicular phase, the ovulatory phase, and the luteal phase. The luteal phase is the period when the body produces progesterone, the hormone that makes the uterus prepare its lining to receive the egg.

    Q. What precautions need to be followed while taking GYNOSIS DT DT 500MG TABLET?

    A. Before taking GYNOSIS DT DT 500MG TABLET inform your doctor if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding, heart problems, blood clots, diabetes, or asthma. Take GYNOSIS DT DT 500MG TABLET regularly as instructed by the physician without fail. Do not miss a dose of GYNOSIS DT DT 500MG TABLET to achieve maximum benefits.

    References

    1. KD. Tripathi. Estrogens, Progestins, and Contraceptives. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 316.

    2. Michaela Jewson, Prashant Purohit, Mary Ann Lumsden. Progesterone and abnormal uterine bleeding/menstrual disorders. ScienceDirect. November 2020. [Accessed on 22nd July 2022] https://www.sciencedirect.com/science/article/abs/pii/S152169342030081X

    3. R Erny, A Pigne, C Prouvost, M Gamerre, C Malet, H Serment, J Barrat. The effects of oral administration of progesterone for premature labor. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 1986. [Accessed on 22nd July 2022] https://pubmed.ncbi.nlm.nih.gov/3513581/

    4. Cyndea Pharma. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 22nd July 2022] https://www.medicines.org.uk/emc/files/pil.352.pdf

    5. Torrent Pharmaceuticals Ltd. herNMP SR (Progesterone Sustained Release Tablets). [Revised in July 2016] [Accessed on 22nd July 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2686.pdf

    6. Catalent Pharma Solutions. U.S. Food & Drug Administration. [Accessed on 22nd July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf

    Useful Diagnostic Tests

    • Saline-infusion sonography
    • Ultrasound
    • Anti-mullerian hormone

    Author Details

    Written By Dr. R. Dinesh John Rajkumar - Pharm.D
    Reviewed For Accuracy By Dr. M N Himaja - MBBS
    Last updated on 19 May 2023 | 04:51 PM(IST)
    Lab updated