Thrombophlebitis gel Common Side Effects of Divigel (Estradiol Gel) Drug Center - RxList
Sign up to bookmark this SPC already have an account? Find medicines with the same active ingredients, Thrombophlebitis gel. Find medicines from the same company. Contains Sorbic acid 0. Pharmaceutical form Vaginal gel 4.
For use during in-vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis linked sterility associated with normal ovulatory cycles, Thrombophlebitis gel. Intravaginal application Treatment of infertility Thrombophlebitis gel to inadequate luteal phase.
Use during in-vitro fertilisation. Crinone is applied directly from the specially designed sealed applicator into the vagina. The applicator should be removed from the sealed wrapper. The twist-off cap should not be removed at this time, Thrombophlebitis gel. The applicator should be gripped firmly by the thick end. It should be shaken down like a thermometer to ensure that the contents are at the thin end.
The tab should be twisted off and discarded. The applicator may be inserted while patient is in a sitting position or when lying on her back with the knees bent. The Thrombophlebitis gel end of applicator should be gently inserted well into Thrombophlebitis gel vagina. The thick end of the applicator should be pressed firmly to deposit gel. The applicator should be removed and discarded in a waste container. Hypersensitivity to the active substance or to any of the excipients listed in section 6, Thrombophlebitis gel.
Undiagnosed vaginal bleeding 3, Thrombophlebitis gel. Known or suspected progesterone-sensitive malignant tumours 4. Thrombophlebitis, thromboembolic disorder, cerebral apoplexy, Thrombophlebitis gel, or patients with an history of these conditions 6. Cautious use in severe hepatic insufficiency. In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, Thrombophlebitis gel, non-functional causes should be considered.
In cases of undiagnosed vaginal bleeding, Thrombophlebitis gel, adequate diagnostic measures should be undertaken, Thrombophlebitis gel. Crinone is not indicated in threatened abortion. Treatment should be discontinued in the event of a missed abortion. The physician should be alert to the early manifestations of thrombotic disorders thrombophlebitis, cerebrovascular disorder, pulmonary embolism and retinal thrombosis.
Should any of these symptoms occur or be suspected, the drug should be discontinued immediately, Thrombophlebitis gel. Patients who have risk factors for thrombotic disorders should be kept under careful observation. Although risk of thromboembolism has been associated with estrogens, a link with progestins remains questionable, Thrombophlebitis gel. Therefore, in women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with Crinone may further increase the risk.
In these women, the benefits of Crinone administration need to be weighed against the risks. It should be noted however, Thrombophlebitis gel, that pregnancy itself carries an increased risk of thrombo-embolic events. Because progestogens may cause some degree of fluid retention, conditions that might be influenced by this factor e. Patients who have a Thrombophlebitis gel of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
A decrease in glucose tolerance has been observed in a small number of patients on oestrogen- progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while Thrombophlebitis gel progestin therapy. The excipient sorbic acid may cause local skin reactions e. In case of corpus luteum deficiency, Crinone can be used during the first month of pregnancy.
Do not use during lactation. In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy. Common Headache, somnolence, abdominal pain, breast tenderness, itching or burning.
Post Marketing Reports In addition, intermenstrual bleeding spottingvaginal irritation, hypersensitivity reactions usually manifesting as skin rash, and other mild application site reactions have been reported post-marketing. Rare events of urticaria and pruritis were noted.
For adverse reactions identified during post-marketing surveillance, quantification of frequency has not been attempted, Thrombophlebitis gel, but it is most likely uncommon to very rare.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are Thrombophlebitis gel to report any suspected adverse reactions via Yellow Card Scheme at www. Sex hormones, ATC code: G03DA04 The pharmacological particulars of the product are those of the naturally occurring progesterone with induction of a full secretory endometrium.
A moderate vaginal irritation was found in rabbits after application of 2. Each applicator contains 1. Before you contact this company: Please check that this is the correct company before contacting them, Thrombophlebitis gel.
Marketing authorisation number s 9. Date of revision of the text. Name of the medicinal product. Thrombophlebitis gel of infertility due to inadequate luteal phase, Thrombophlebitis gel.
Posology Intravaginal application Treatment of infertility due to inadequate luteal phase One application 1. Paediatric population Not Thrombophlebitis gel Older people Not applicable Method of Administration Crinone is applied directly from the specially designed sealed applicator into the vagina.
The pre-treatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. Crinone is not recommended for use concurrently with other vaginal preparations. Pregnancy In case of corpus luteum deficiency, Crinone can be used during the first month of pregnancy, Thrombophlebitis gel. Breast-feeding Do not use during lactation.
Drivers and users of machines are warned that risk of somnolence may occur. The adverse reactions reported below are classified according to frequency of occurrence as follows: The progesterone vaginal gel is based on a polycarbophil delivery system which attaches to the vaginal mucosa and provides a prolonged release of progesterone for at least three days.
In rabbits, Crinone was an eye irritant categorised class IV minimal effects clearing in less than 24 hoursbut not a dermal irritant. No Thrombophlebitis gel were found Thrombophlebitis gel the usual contraceptive devices. A single use, one piece, white polyethylene applicator with a twist-off top, designed for intravaginal Thrombophlebitis gel. Date Thrombophlebitis gel first authorisation: Find out more here.
What is Phlebitis? Treatment & Symptoms for Thrombophlebitis Thrombophlebitis gel
The carrier vehicle is an oil Thrombophlebitis gel water emulsion containing the water swellable, but insoluble polymer, Thrombophlebitis gel, polycarbophil. The progesterone is partially soluble in both the oil and water phase of the vehicle, with the majority of the progesterone existing as a suspension.
Physically, Crinone has the appearance of a soft, white to off-white gel. The chemical name for progesterone is pregnene-3,dione. It has an empirical formula of C 21 H 30 O 2 Thrombophlebitis gel a molecular weight of Progesterone exists Thrombophlebitis gel two polymorphic forms. Each applicator delivers 1. Get emergency medical help if you have any Thrombophlebitis gel these signs of an allergic reaction: If pregnancy occurs, Thrombophlebitis gel, treatment may be continued until placental autonomy is achieved, up to 10 to 12 weeks.
Increasing the volume of gel administered does not increase the amount of progesterone absorbed, Thrombophlebitis gel. Each applicator contains 1. The physician should be alert to the earliest manifestations of thrombotic disorders thrombophlebitisThrombophlebitis gel, cerebrovascular disorders, pulmonary embolismand retinal thrombosis. Should any of these occur or be suspected, Thrombophlebitis gel, the drug should be discontinued immediately.
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.
The product should not be used concurrently with other local intravaginal therapy. If other local intravaginal therapy is to be used concurrently, there should be at least a 6-hour period before or after Crinone administration, Thrombophlebitis gel. Small, white globules may appear as a vaginal discharge possibly due to gel accumulation, even several days after usage.
Nonclinical toxicity studies to determine the potential of Crinone to cause carcinogenicity or mutagenicity have not been performed. The effect of Crinone on fertility has not been evaluated in animals. The Thrombophlebitis gel of these 26 pregnancies were as follows: Of the 47 newborns delivered, one had a teratoma associated with a cleft palate ; one had respiratory distress syndrome ; 44 were apparently normal and one was lost to follow-up, Thrombophlebitis gel.
Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not Thrombophlebitis gel determined. There have been no reports of overdosage with Crinone, Thrombophlebitis gel. In the case of overdosage, however, discontinue Crinone, treat the patient symptomatically, and institute supportive measures. Progesterone is a naturally occurring steroid that is secreted by the ovary, placenta, and adrenal gland.
In the presence of adequate estrogenprogesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is essential for the development of decidual tissue, and the effect of progesterone on the differentiation of glandular epithelia and stroma has been extensively studied.
Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy. Normal or near-normal endometrial responses to oral Thrombophlebitis gel and intramuscular progesterone have been noted in functionally agonadal women through the sixth decade of life, Thrombophlebitis gel.
Progesterone Thrombophlebitis gel decreases the circulatory levels of gonadotropins. Due to the sustained release properties of Crinone, progesterone absorption is prolonged with an absorption half-life of approximately 25 to 50 hours, and an elimination half-life of 5 to 20 minutes. Therefore, the pharmacokinetics of Crinone are rate-limited by absorption rather than by elimination, Thrombophlebitis gel.
The bioavailability of progesterone in Crinone was determined relative to progesterone administered intramuscularly. Steady state was achieved within the first 24 hours after initiation of treatment. Progesterone undergoes both biliary and renal elimination. Only a small portion of unchanged progesterone is excreted in the bile. The study was divided into three phases Pilot, Donor Egg and Treatment, Thrombophlebitis gel.
The first phase of the study consisted of a test Pilot Cycle to ensure that the administration of transdermal estradiol and progesterone would adequately prime the endometrium to receive the donor egg. The second phase was the Donor Egg Cycle during which a fertilized oocyte was implanted. Subjects with partial ovarian function also underwent a Pre-Pilot Cycle and a Pre-Donor Egg Cycle during which time they were administered only leuprolide acetate to suppress remaining ovarian function.
The third phase of the study consisted of a week treatment period to maintain a pregnancy until placental autonomy was achieved. All women received a GnRH analog to suppress endogenous progesterone, human menopausal gonadotropins, and Thrombophlebitis gel chorionic gonadotropin, Thrombophlebitis gel.
All women were treated with either conjugated estrogens 0. Estrogen therapy was continuous for the entire three day cycle studies. At Day 15 of the second cycle six weeks after initiating estrogen replacementwomen who demonstrated adequate response to estrogen therapy by ultrasound and who continued to be amenorrheic received Crinone every other day for six doses Day 15 through Day 25 of the cycle.
In the third cycle, estrogen was continued and Crinone was administered every other day beginning on Day 15 for six doses. On Day 24 an endometrial biopsy was performed. Please read Thrombophlebitis gel information carefully before you start to use Crinone and each time your prescription is renewed, Thrombophlebitis gel, in case anything Thrombophlebitis gel changed.
This leaflet does not take the place of discussions with your doctor. If you still have any questions, ask your doctor or healthcare provider. Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: These are not all the possible side effects of Crinone. For more information, ask your healthcare provider or pharmacist for advice about Thrombophlebitis gel effects, Thrombophlebitis gel.
Read the Instructions for Use included in this leaflet for information on the right way to use Crinone. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet.
Do not use Crinone for another condition. Your doctor has prescribed this drug for you and you alone. Do not give this drug to anyone else, even if they have the same condition. This leaflet provides the Thrombophlebitis gel important information about Crinone.
If you would like more information, Thrombophlebitis gel, talk with your healthcare provider or pharmacist. You can ask for information about Crinone that is written for Thrombophlebitis Ohr professionals. You can get more information by calling the toll free number or visit www. Choose the position that is most comfortable for you.
For example, lying down on your back with your knees bent. This Instructions for Use Thrombophlebitis gel been approved by the U. Food and Drug Administration. You are encouraged to report negative side effects of prescription drugs to the FDA. Last reviewed on RxList: Find Lowest Prices on. For Consumers What are the possible side effects Thrombophlebitis gel progesterone vaginal? Call your doctor at once if you have any of these serious side effects: Which Infertility Treatment is for You?
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