Prinagel Vaginal Gel

Prinagel Vaginal Gel is used for: Assisted Reproductive Technology (ART), Secondary Amenorrhea

Intravaginal gel Assisted Reproductive Technology (ART) 90 mg (8% gel) intravaginal once daily Women with partial or complete ovarian failure 90 mg (8% gel) twice daily intravaginal If pregnancy occurs, treatment may be continued up to 10-12 weeks. postconception until placental autonomy. Secondary Amenorrhea 45 mg (4% gel) intravaginal every other day up to a total of 6 doses. If no response, try 90 mg (8% gel) every other day up to a total of 6 doses if the response is inadequate. Uterine cramps and bleeding associated with Threatened Abortion 1.5 gm (90 mg progesterone) once/ twice daily Vaginal pessary 400 mg bid starting at oocyte retrieval. Continue for 38 days if pregnancy has been confirmed.

Instructions for Applicator Use: Step 1. Open the sealed wrapper and remove the applicator. Step 2. Insert the tip of the applicator into the tube. Step 3. Press down the tube and squeeze the specified amount of gel into the applicator tube. Step 4. Remove the applicator from the tube. Step 5. Gently insert the rounded tip of the applicator. Step 6. Push the plunger to release the gel. Step 7. Remove the applicator. (It is normal for a small amount of gel to be left in the applicator. You will still get the right dose of medicine.) Keep the applicator clean and germfree for later use.

Documented hypersensitivity to drug or excipients Known or suspected malignancy of the breast or genital organ Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Liver disease, liver tumors Undiagnosed abnormal vaginal bleeding Known missed abortion or ectopic pregnancy

Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses; no adequate evidence is available to show that they are effective for this purpose Caution in patients with a family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy). The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis); should any of these occur or be suspected, the drug should be discontinued immediately The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, and increased risk of thromboembolic complications after surgery. Discontinue 4 weeks before major surgery or prolonged immobilization. Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted). Some studies link OCP use with an increased risk of breast cancer, whereas other studies have not shown a change in risk. Woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity. Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer.; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk; increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use. Do not use other intravaginal meds 6 hr before or after progesterone vaginal Vaginal insert not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered; in cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken Patients who have a history of psychic depression should be carefully observed The pathologist should be advised of progesterone therapy when relevant specimens are submitted Use with caution in patients with diseases that could become exacerbated by fluid retention including epilepsy, migraine, renal dysfunction, or asthma In cases of partial or complete vision loss, diplopia, sudden onset of proptosis, discontinue permanently if pepilledema or retinal vascular lesions are observed upon examination A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen­ progestin combination drugs; the mechanism of this decrease is not known; for this reason, diabetic patients should be carefully observed while receiving progestin therapy

Pregnancy & Lactation If pregnancy occurs, Progesterone vaginal prep may be continued until placental autonomy is achieved, up to 10-12 weeks or more as per the requirement of the patient. Lactation:Use caution Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined.

Side effects of Progesterone vaginal prep : >10% Breast enlargement (40%) Breast tenderness (27%) Somnolence (27%) Cramps (15-26%) Mood swings (22-23%) Nausea (6-22%) Depression (11-19%) Dizziness (15-24%) Sleep disorder (18%) Perineal pain (17%) Nervousness (16%) Urinary difficulties (11%) Musculoskeletal pain (12%) Headache (13%) Breast pain (13%) Abdominal pain (5-12%) 1-10% Dizziness (5%) Constipation (2-3%) Cough (8%) Vaginal discharge (10%) Chest pain (7%) Fatigue (8%) Irritability (8%) Worry (8%) Diarrhea (7-8%) Constipation (<5%) Cholecystectomy (<5%) Frequency Not Defined Arthralgia Bloating Vaginal candidiasis General pruritus Ectopic pregnancy Dysarthria Drunk feeling Jaundice

Progesterone gel supplementation helps to maintain uterine lining for successful embryo implantation. As it mimics body’s own progesterone and make a suitable environment for embryo implantation and early pregnancy development. It’s transdermal application allows gradual absorption through the skin and enters into the bloodstream. It ensures excellent bioavailability (>90%) as it bypasses First pass effect Sustain release manner helps to maintain consistent progesterone level, which is crucial for IVF/maintaining pregnancy With this adequate progesterone support, uterine lining is better prepared for embryo implantation and pregnancy.

Prinagel 8% Vaginal Gel manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Progesterone vaginal prep. Prinagel is availble in Bangladesh. Farmaco BD drug index information on Prinagel Vaginal Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.