Mirena Intrauterine Delivery System 1'S

Contraception (69)Rx required

Key Information

Generic Name

Generic Name Levonorgestrel 52 mg

Manufacturer

Bayer Zydus Pharma Pvt Ltd

Country of Origin

India

Detailed Information

Introduction

INTRODUCTION ABOUT MIRENA INTRAUTERINE DELIVERY SYSTEMMIRENA INTRAUTERINE DELIVERY SYSTEM contains Levonorgestrel, which belongs to the group of medicines called Progestins. It is an intrauterine delivery system (IUS) that is placed in

Uses

OF MIRENA INTRAUTERINE DELIVERY SYSTEM As contraception and manages heavy menstrual bleeding (menorrhagia) Hormone replacement management (HRT) regimen to protect the lining of your womb

How It Works

MIRENA INTRAUTERINE DELIVERY SYSTEM acts as a contraceptive by thinning the lining of the uterus it manages pregnancy and manages sperm entry by thickening the lining of the uterus, thus it inhibits fertilization and it also blocks the release of eggs (ovulation). Reduces heavy menstrual bleeding by thinning the lining of the uterus. In menopause, it replaces hormones such as progesterone and manages cancer by protecting the lining of the womb.

Directions for Use

Only a doctor or a nurse with specialised training may fit the system. The device needs to be placed either during your period or within seven days after the start of your cycle. You don't have to wait until your period to replace the device if you currently have the device and it's time to get a new one. You should wait at least 6 weeks after giving birth before getting MIRENA INTRAUTERINE DELIVERY SYSTEM fitted. If you have no vaginal infections, you may be able to get MIRENA INTRAUTERINE DELIVERY SYSTEM installed right away after having an abortion.

Side Effects

using MIRENA INTRAUTERINE DELIVERY SYSTEM are irregular, mild or missing menstrual periods, spotting as well as vaginal bleeding, vaginal and external genital (vulva) infections caused by bacteria or fungi and acne. Consult your physician if any of the side effects worsen. USES OF MIRENA INTRAUTERINE DELIVERY SYSTEM As contraception and manages heavy menstrual bleeding (menorrhagia) Hormone replacement management (HRT) regimen to protect the lining of your womb HOW MIRENA INTRAUTERINE DELIVERY SYSTEM WORKSMIRENA INTRAUTERINE DELIVERY SYSTEM acts as a contraceptive by thinning the lining of the uterus it manages pregnancy and manages sperm entry by thickening the lining of the uterus, thus it inhibits fertilization and it also blocks the release of eggs (ovulation). Reduces heavy menstrual bleeding by thinning the lining of the uterus. In menopause, it replaces hormones such as progesterone and manages cancer by protecting the lining of the womb. DIRECTIONS FOR USEOnly a doctor or a nurse with specialised training may fit the system. The device needs to be placed either during your period or within seven days after the start of your cycle. You don't have to wait until your period to replace the device if you currently have the device and it's time to get a new one. You should wait at least 6 weeks after giving birth before getting MIRENA INTRAUTERINE DELIVERY SYSTEM fitted. If you have no vaginal infections, you may be able to get MIRENA INTRAUTERINE DELIVERY SYSTEM installed right away after having an abortion. SIDE EFFECTS OF MIRENA INTRAUTERINE DELIVERY SYSTEMCOMMON irregular, mild or missing menstrual periods spotting as well as vaginal bleeding vaginal and external genitalia (vulva) infections caused by bacteria or fungi acne anxiousness, depression or other mood swings less sexual drive headache, migraine, dizziness, presyncope (feeling faint) back pain nausea, vomiting, abdominal or pelvic pain, distended abdomen painful periods increased vaginal discharge tender and painful breasts spasm of the womb MIRENA INTRAUTERINE DELIVERY SYSTEM coming out by itself weight gain ovarian cysts UNCOMMON loss of consciousness eczema (swelling of the skin) cervicitis (swelling of the cervix (neck of the womb) swelling of legs or ankles increased facial and body hair growth hair loss itchy skin increased skin pigmentation or skin discoloration, particularly on the face (chloasma) uterine perforation genital infections causing vaginal itching, pain on passing urine, lower abdominal pain due to inflammation of the womb, ovaries or fallopian tubes a womb infection or womb lining inflammation that could result in a foul-smelling vaginal discharge (endometritis) RARE rashes, itching increased blood pressure Consult your physician immediately if you experience any of the following symptoms: signs of a blood clot in the lung include sharp pain in the chest, coughing blood or sudden shortness of breath swelling, pain, warmth and redness of arms and legs due to a blood clot in the leg. signs of a heart attack such as crushing chest pain or heaviness signs of strokes such as sudden severe headache, vomiting, dizziness, fainting, impaired speech, blurry vision, weakness, numbness or tingling of the face, arm or leg, particularly on one side of the body, vomiting, trouble understanding, trouble with walking and loss of balance signs of a blood clot in the eye such as sudden blurring of vision, eye pain or eye pressure allergic reactions such as itching, rashes, swelling of the face, lips, cheeks, tongue and/or throat if you develop mood swings and depression symptoms such as suicidal thoughts if you experience intense pain or fever soon after having a device inserted, you may have a severe infection that needs to be managed very away. sepsis, an extremely serious infection, can rarely happen severe pain and continuous bleeding, due to damage or a womb wall tear (perforation) signs and symptoms of perforation may include heavy bleeding upon insertion, significant pain, more pain than estimated and pain or bleeding that lasts for more than a few weeks, significant changes in your menstruation, pain experienced during sexual activity lower abdomen pain, fever or have missed a period or experiencing sudden bleeding may indicate an ectopic pregnancy (when the foetus develops outside the womb) if you have lower stomach pain or have painful or hard sex, you may have ovarian cysts or pelvic inflammatory disease. This is important because pelvic infections can lower your chances of becoming pregnant and raise your risk of an ectopic pregnancy

Warnings & Precautions

& PRECAUTIONSPREGNANCYMIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use during pregnancy or suspect that you may be pregnant. Consult your doctor before using MIRENA INTRAUTERINE DELIVERY SYSTEM. BREASTFEEDINGSmall amount of active ingredient of this medicine is excreted into breast milk, there is no potential risk to babies or newborns and breastfeeding can be continued. Consult your doctor before placement MIRENA INTRAUTERINE DELIVERY SYSTEM. DRIVING AND USING MACHINESThere are no known effects of MIRENA INTRAUTERINE DELIVERY SYSTEM on the ability to drive or use machines. KIDNEYMIRENA INTRAUTERINE DELIVERY SYSTEM has not been studied in women with kidney impairment. Consult your doctor before placement MIRENA INTRAUTERINE DELIVERY SYSTEM. LIVERMIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in patients with liver problems or who have a liver tumour. Consult your doctor before placement MIRENA INTRAUTERINE DELIVERY SYSTEM. ALLERGYDo not fix MIRENA INTRAUTERINE DELIVERY SYSTEM if you are allergic (hypersensitive) to levonorgestrel or other ingredients of this medicine. HEART DISEASEMIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in patients with endocarditis (inflammation of the inner lining of the heart due to bacterial infection). Contact your doctor before placement MIRENA INTRAUTERINE DELIVERY SYSTEM and it should be used with caution in patients with high blood pressure or massive artery diseases, such as a heart attack, congenital heart disease or heart valve diseases or any heart problems. OTHERSMIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use if you: have or had the pelvic inflammatory disease (infection or inflammation of the female reproductive system) have an unexpected or painful vaginal discharge or vaginal itching, as these symptoms could be signs of an infection having or had womb lining inflammation after giving birth have or have recently had a uterus infection following delivery or an abortion during the past 3 months have or have ever had cervix (neck of your womb) inflammation have undergone or had an abnormal smear test (changes in the cervix) have uterus abnormalities, such as uterine fibroids, particularly those that enlarge the uterus cavity have an abnormal pattern of vaginal bleeding having a disease that makes you prone to infections. If you have this, a doctor will have informed you have or previously had, hormone-dependent cancer, such as breast cancer have or have ever had, any form of cancer, including blood (leukaemia), uterine or cervical cancer, unless in remission have or previously had trophoblastic diseases (development of a rare tumour group in early stages of pregnancy). If you have this, a doctor will have informed you about it have low immunity have lower genital tract infection have or develop migraine, feel dizzy, impaired vision, very severe headaches or if you get headaches more frequently than normal jaundice (yellowing of the skin or eyes) have abnormal blood lipid levels or have a family history of diabetes (high blood sugar levels) have had blood cancer (leukaemia) which now reoccurs are receiving long-term steroid therapy have a history of ovarian cysts or an ectopic pregnancy (foetus develops outside the womb), tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. if you have experienced a massive artery disease, such as a stroke have or family history history of thrombosis (blood clots) having irregular bleeding have epilepsy (fits) HIV or AIDS or any other sexually transmitted infections smoke as it increases the risk of developing a heart attack, stroke or blood clot genital infections are overweight had a history of heavy menstrual blood flow have systemic lupus erythematosus are immobilized have major surgery or trauma have varicose veins wear contact lens have a history of depression have to undergo any blood test are scheduled for surgery a tendency to develop chloasma (brown patches on your face or body) Use in paediatrics: MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in children and adolescents before the first menstrual bleeding (menarche). Consult your doctor for advice. Use in geriatrics: MIRENA INTRAUTERINE DELIVERY SYSTEM is not recommended for use in postmenopausal women. Consult your doctor for advice.

Drug Interactions

SA. Drug-Drug interactions: Before placement MIRENA INTRAUTERINE DELIVERY SYSTEM, inform your doctor if you are taking or have recently taken any other medicines, including medicines: medicines used to manage epilepsy (Ex. phenobarbital, phenytoin, carbamazepine, oxcarbazepine, topiramate, primidone) medicines used to manage tuberculosis (Ex. rifabutin, rifampicin) medicines used to manage HIV and hepatitis C virus infection (Ex. nevirapine, efavirenz, simeprevir) medicine used to manage fungal infections (Ex. griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole) hormonal contraceptive method (a medicine used to manage pregnancy) medicines used to manage bacterial infections Ex. clarithromycin, erythromycin sedatives Ex. pentobarbital (used to induce sleep) medicines used to manage chest pain and high blood pressure Ex. diltiazem St John’s Wort (a herbal medicine used to manage depression) anticoagulants Ex. warfarin (a medicine used to manage blood clots) SYNOPSIS Drug : Levonorgestrel Pharmacological Category : Progestins Therapeutic Indication : Prevents pregnancy, Manages heavy menstrual bleeding (menorrhagia) and in menopause Dosage Forms : Tablet, Kit, Intra Uterine Delivery System MORE INFORMATION Keep MIRENA INTRAUTERINE DELIVERY SYSTEM out of the sight and reach from children Store MIRENA INTRAUTERINE DELIVERY SYSTEM below 30°C Protect from moisture and direct sunlight

Article Information

I(

Written By

ity (HPRA). [Revised in December 2019] [Accessed on 11th August 2022] https://www.hpra.ie/img/uploaded/swedocuments/e2d46b10-9199-490b-9323-f2c95bc026c0.pdf 6. Odyssea Pharma. U.S. Food & Drug Administration. [Revised in October 2019] [Accessed on 11th August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206229s008lbl.pdf 7. Bayer Inc. Levonorgestrel. [Revised in September 2021] [Accessed on 11th August 2022] https://www.bayer.com/sites/default/files/mirena-pm-en.pdf 8. Bayer (Pty) Ltd. Levonorgestrel. [Revised in June 2019] [Accessed on 11th August 2022] https://www.bayer.com/sites/default/files/MIRENA_EN_PIL.pdf 9. Bayer HealthCare Pharmaceuticals Inc. Levonorgestrel. [Revised in August 2021] [Accessed on 11th August 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dcbd6aa2-b3fa-479a-a676-56ea742962fc&## USEFUL DIAGNOSTIC TESTS Complete blood count Blood glucose levels Liver function test AUTHOR DETAILS Written By Dr. Dhivakaran R

Medical Content Writer

DS

Reviewed By

Dr. Sankara Babu Gorle

Medical Expert

Last Updated

29 Nov 2022

Tags

#contraception (69)#generic name levonorgestrel 52 mg