Mirena The Product and Warnings

Each sterile intrauterine system contains levonorgestrel USP 52 mg in a cylindrical-shaped reservoir composed of a matrix of levonorgestrel and polydimethylsiloxane. The reservoir is mounted on the vertical arm of a T-shaped frame made of polyethylene and covered with a rate-controlling membrane of polydimethylsiloxane and silica. The T-frame is pigmented with barium sulphate. The polyethylene removal threads attached to the T-frame are pigmented with black iron oxide.

WARNINGS

 

1. Ectopic Pregnancy

 

 

Evaluate women who become pregnant while using Mirena for ectopic pregnancy. Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was about 1 ectopic pregnancy per 1000 users per year.

Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility. Teach them to recognize and report to their physician promptly any symptoms of ectopic pregnancy. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy.

The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Mirena is unknown. Clinical trials of Mirena excluded women with a history of ectopic pregnancy.

 

2. Intrauterine Pregnancy

 

 

In the event of an intrauterine pregnancy with Mirena, consider the following:

 

a. Septic abortion

 

 

In patients becoming pregnant with an IUD in place, septic abortion—with septicemia, septic shock, and death—may occur. If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation of Mirena may result in pregnancy loss.

 

b. Continuation of pregnancy

 

 

If a woman becomes pregnant with Mirena in place and if Mirena cannot be removed or the woman chooses not to have it removed, she should be warned that failure to remove Mirena increases the risk of miscarriage, sepsis, premature labor and premature delivery. She should be followed closely and advised to report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leakage of fluid.

 

c. Long-term effects and congenital anomalies

 

 

When pregnancy continues with Mirena in place, long-term effects on the offspring are unknown. As of September 2006, 390 live births out of an estimated 9.9 million Mirena users had been reported. Congenital anomalies in live births have occurred infrequently. No clear trend towards disorders of any kind has been observed. Because of the intrauterine administration of levonorgestrel and local exposure of the fetus to the hormone, the possibility of teratogenicity following exposure to Mirena cannot be completely excluded.

 

3. Sepsis

 

 

As of September 2006, 9 cases of Group A streptococcal sepsis (GAS) out of an estimated 9.9 million Mirena users had been reported. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion of Mirena is essential. GAS sepsis may also occur postpartum, after surgery, and from wounds.

 

4. Pelvic Inflammatory Disease (PID)

 

 

Mirena is contraindicated in the presence of known or suspected PID or in women with a history of PID unless there has been a subsequent intrauterine pregnancy. Use of IUDs has been associated with an increased risk of PID. The highest risk of PID occurs shortly after insertion (usually within the first 20 days thereafter) (see Insertion Precautions). A decision to use Mirena must include consideration of the risks of PID.

 

a. Women at increased risk for PID

 

 

PID is often associated with a sexually transmitted disease, and Mirena does not protect against sexually transmitted disease. The risk of PID is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners. Women who have had PID are at increased risk for a recurrence or re-infection.

 

b. PID warning to Mirena users

 

 

All women who choose Mirena must be informed prior to insertion about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or in infrequent cases can necessitate hysterectomy, or can cause death. Patients must be taught to recognize and report to their physician promptly any symptoms of pelvic inflammatory disease. These symptoms include development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever.

 

c. Asymptomatic PID

 

 

PID may be asymptomatic but still result in tubal damage and its sequelae.

 

d. Treatment of PID

 

 

Following a diagnosis of PID, or suspected PID, bacteriologic specimens should be obtained and antibiotic therapy should be initiated promptly. Removal of Mirena after initiation of antibiotic therapy is usually appropriate. Guidelines for PID treatment are available from the Center for Disease Control (CDC), Atlanta, Georgia. Adequate PID treatment requires the application of current standards of therapy prevailing at the time of occurrence of the infection with reference to prescription labeling.

Actinomycosis has been associated with IUDs. Symptomatic women with IUDs should have the IUD removed and should receive antibiotics. However, the management of the asymptomatic carrier is controversial because actinomycetes can be found normally in the genital tract cultures in healthy women without IUDs. False positive findings of actinomycosis on Pap smears can be a problem. When possible, confirm the Pap smear diagnosis with cultures.

 

5. Irregular Bleeding and Amenorrhea

 

 

Mirena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea. During the first three to six months of Mirena use the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular. If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken to rule out endometrial pathology.

Amenorrhea develops in approximately 20% of Mirena users by one year. The possibility of pregnancy should be considered if menstruation does not occur within six weeks of the onset of previous menstruation. Once pregnancy has been excluded, repeated pregnancy tests are generally not necessary in amenorrheic subjects unless indicated, for example, by other signs of pregnancy or by pelvic pain.

 

6. Embedment

 

 

Embedment of Mirena in the myometrium may occur. Embedment may decrease contraceptive effectiveness and can result in difficult removal.

 

7. Perforation

 

 

Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later. If perforation occurs, Mirena must be removed and surgery may be required. Adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses and erosion of adjacent viscera have been reported with IUDs.

It is recommended that postpartum Mirena insertion be delayed until uterine involution is complete to decrease perforation risk. There is an increased risk of perforation in women who are lactating. Inserting Mirena immediately after first trimester abortion is not known to increase the risk of perforation, but insertion after second trimester abortion should be delayed until uterine involution is complete.

 

8. Ovarian Cysts

 

 

Since the contraceptive effect of Mirena is mainly due to its local effect, ovulatory cycles with follicular rupture usually occur in women of fertile age using Mirena. Sometimes atresia of the follicle is delayed and the follicle may continue to grow. Enlarged follicles have been diagnosed in about 12% of the subjects using Mirena. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases the enlarged follicles disappear spontaneously during two to three months observation. Surgical intervention is not usually required.

 

9. Breast Cancer

 

 

Women who currently have or have had breast cancer should not use hormonal contraception because breast cancer is a hormone-sensitive tumor.

Spontaneous reports of breast cancer have been received during postmarketing experience with Mirena. Because spontaneous reports are voluntary and from a population of uncertain size, it is not possible to use post-marketing data to reliably estimate the frequency or establish causal relationship to drug exposure. Two observational studies have not provided evidence of an increased risk of breast cancer during the use of Mirena .

 

 

        This is the UPDATED Mirena Product Imformation have a look,

   http://www.drugs.com/cdi/mirena-iud.html

 

 

 

  Below is another site well worth a look, official FDA Imformation site.        

                    

                                http://www.drugs.com/pro/mirena.html 

 

 

How does Mirena work?

It is not known exactly how Mirena works. Mirena may work in several ways. It may thicken your cervical mucus, thin the lining of your uterus, inhibit sperm movement and reduce sperm survival. Mirena may stop release of your egg from your ovary, but this is not the way it works in most cases. Most likely, these actions work together to prevent pregnancy.

 

          

 The Product:

 The Manufacturer of this product tells us as follows "Imagine a long-term birth control you don't have to think about every day, every month, or every year for up to five years. Birth control that's reversible* when you want it to be. That's Mirena®, a safe and 99.9% effective hormone-releasing intrauterine contraceptive that stays with you through different stages of your life. In addition, we are told that "In clinical studies, the most common side effects with Mirena included: Menstrual changes Lower abdominal pain (cramps) Acne or other skin problems Back pain Breast tenderness Headache Mood changes Nausea Ovarian cysts have been diagnosed in about 12% of Mirena users. In most cases, these cysts disappeared spontaneously during 2 to 3 months' observation. Women who have, or have had, breast cancer should not use hormonal therapy."   Not every woman experiences problems. Not every woman is miserable, but you should be aware that the possibility exists that this product will change your life in a very unpleasant way. Hundreds of women have reported severe side effects not reported by the manufacturer of this product. CHRONIC fatigue CONSTANT bleeding (up to 9 months) Heavy bleeding and clotting SEVERE Lower abdominal pain (cramps) SEVERE joint and pelvic pain SEVERE Acne or other skin problems DEBILITATING Back pain SEVERE bloating SEVERE weight gain SEVERE Headache SEVERE Mood changes and wood swings Constant Nausea Loss of hair Vaginal Dryness SEVERE depression and feeling of hopelessness Decreased Libido Increased body hair Dry skin Incontinence and constipation Many many more  

 

DRUG DESCRIPTION

 

Mirena Drug Interactions

The Latest update on Drug interactions here,

 

http://www.drugs.com/drug-interactions/mirena_d00557.html

 

 

 

Mirena (levonorgestrel) is known to interact with the following drugs: 

 Drug Interactions with Mirena (levonorgestrel).  Major Interactions acitretin , Agenerase , amprenavir , bexarotene , bosentan , etretinate , fosamprenavir , Fulvicin P/G , Fulvicin U/F , Grifulvin V , Gris-PEG , Grisactin 250 , Grisactin 500 , Grisactin Ultra , Griseofulicin , Griseofulvic , griseofulvin , griseofulvin microsize , griseofulvin ultramicrosize , Lexiva , Soriatane , Soriatane CK , Targretin , Tegison , Telzir , tizanidine , Tracleer , Zanaflex

Moderate Interactions acarbose , acetoHEXAMIDE , Aerolate III , Aerolate JR , Aerolate SR , Amaryl , aminoglutethimide , aminophylline , aminophylline extended release , amobarbital , Amytal Sodium , Anturane , Apidra , Apidra OptiClik Cartridge , aprepitant , Aquaphyllin , armodafinil , Asmalix , Atapryl , atazanavir , Bronkodyl , Busodium , butabarbital , butalbital , Butisol Sodium , carbamazepine , carbamazepine extended release , Carbatrol , Carbex , Cardizem , Cardizem CD , Cardizem LA , Cardizem Monovial , Cardizem SR , Cartia XT , CellCept , Cerebyx , chlorproPAMIDE , Choledyl , Choledyl SA , Clopine , clotrimazole , clozapine , Clozapine Synthon , Clozaril , colesevelam , conivaptan , cycloSPORINE , Cytadren , dasatinib , Denzapine , Depacon , Depakene , Depakote , Depakote ER , Depakote Sprinkles , Di-Phen , DiaBeta , Diabinese , Diflucan , Dilacor XR , Dilantin , Dilantin Infatabs , Dilantin Kapseals , Dilantin-125 , Diltia XT , diltiazem , diltiazem 24 hour extended release , diltiazem extended release , Diltiazem Hydrochloride CD , Diltiazem Hydrochloride SR , Diltiazem Hydrochloride XR , Diltiazem Hydrochloride XT , divalproex sodium , divalproex sodium extended release , Dymelor , efavirenz , Eldepryl , Elixophyllin , Emend , Emend 3-Day , Emend for Injection , Emsam , Epitol , Equetro , EXUBERA , EXUBERA Combination Pack 12 , EXUBERA Combination Pack 15 , EXUBERA Kit , FazaClo , felbamate , Felbatol , FK506 , fluconazole , fluvoxamine , fluvoxamine extended release , Fortamet , Fortovase , fosaprepitant , fosphenytoin , Gengraf , glimepiride , glipiZIDE , glipiZIDE extended release , GlipiZIDE XL , Glucophage , Glucophage XR , Glucotrol , Glucotrol XL , Glumetza , glyBURIDE , glyBURIDE micronized , Glynase PresTab , Glyset , Humalog , Humalog KwikPen , Humalog Pen , Humulin L , Humulin N , Humulin N Pen , Humulin R , Humulin R (Concentrated) , Humulin U , hypericum perforatum , Iletin II Lente Pork , Iletin II NPH Pork , Iletin II Regular Pork , Iletin Lente , Iletin NPH , Iletin Regular , insulin , insulin analog , insulin aspart , insulin aspart protamine , insulin detemir , insulin glargine , insulin glulisine , insulin inhalation, rapid acting , insulin isophane , Insulin Lente Pork , insulin lispro , insulin lispro protamine , Insulin Purified NPH Pork , Insulin Purified Regular Pork , insulin regular , insulin zinc , insulin zinc extended , insulin, lente , insulin, NPH , insulin, ultralente , Invirase , itraconazole , Januvia , Jumex , Ketek , Ketek Pak , ketoconazole , Lamictal , Lamictal Blue , Lamictal CD , Lamictal Green , Lamictal Orange , lamotrigine , Lantus , Lantus OptiClik Cartridge , Lantus Solostar Pen , lapatinib , Lente insulin , Levemir , Levemir FlexPen , Levemir InnoLet , Levemir PenFill , Luminal , Luvox , Luvox CR , Mebaral , mephobarbital , metformin , metformin extended release , miconazole , Micronase , Mifeprex , mifepristone , miglitol , modafinil , Monistat I.V. , Mycelex Troche , Mycobutin , mycophenolate mofetil , mycophenolic acid , Myfortic , Mysoline , nateglinide , nefazodone , nelfinavir , Nembutal , Nembutal Sodium , Neoral , nevirapine , nilotinib , Nizoral , Norvir , Norvir Soft Gelatin , Novolin L , Novolin N , Novolin N Innolet , Novolin N PenFill , Novolin R , Novolin R Innolet , Novolin R PenFill , NovoLog , NovoLog FlexPen , NovoLog PenFill , NPH insulin , Nuvigil , Orinase , oxcarbazepine , oxtriphylline , oxtriphylline extended release , pentobarbital , phenobarbital , phenylbutazone , Phenytek , phenytoin , phenytoin extended release , Phenytoin Sodium, Prompt , Prandin , Precose , Priftin , primidone , Prograf , protamine zinc insulin , Provigil , Quibron-T , Quibron-T/SR , Rapamune , regular insulin , ReliOn/Novolin N , ReliOn/Novolin R , repaglinide , Respbid , Reyataz , Rezulin , rifabutin , Rifadin , Rifadin IV , rifampin , rifapentine , Rimactane , Riomet , ritonavir , RU-486 , Sandimmune , saquinavir , saquinavir mesylate , secobarbital , Seconal Sodium , selegiline , Selgene , Serzone , sirolimus , sitagliptin , Slo-Bid Gyrocaps , Slo-Phyllin , Slo-Phyllin 125 , Slo-Phyllin 80 , sodium valproate , Solfoton , Sporanox , Sprycel , St. John's wort , Starlix , sulfinpyrazone , Sustiva , T-Phyl , tacrolimus , Tasigna , Taztia XT , Tegretol , Tegretol XR , telithromycin , Theo-24 , Theo-Dur , Theo-Dur Sprinkles , Theo-Time , Theo-X , Theobid , TheoCap , Theochron , Theoclear L.A.-130 , Theoclear L.A.-260 , Theoclear-80 , Theolair , Theolair-SR , theophylline , theophylline 24 hr extended release , theophylline extended release , Theovent , Tiazac , Tol-Tab , TOLAZamide , TOLBUTamide , Tolinase , Trileptal , troglitazone , Truphylline , Truxophyllin , Tykerb , Ultralente insulin , Uni-Dur , Uniphyl , valproic acid , Vaprisol , Velosulin BR , VFEND , Viracept , Viramune , voriconazole , Welchol , Zaponex , Zelapar

Minor Interactions acebutolol , Actos , alcohol , alcohol, ethyl , Amerge , atorvastatin , Blocadren , carvedilol , carvedilol extended release , Coreg , Coreg CR , Crestor , Crixivan , Dehydrated Alcohol , delavirdine , ethanol , Ethyl Alcohol , etravirine , Frova , frovatriptan , Inderal , Inderal LA , indinavir , InnoPran XL , Intelence , labetalol , Levatol , Lipitor , Lopressor , metoprolol , metoprolol extended release , metoprolol succinate , Metoprolol Succinate ER , metoprolol tartrate , naratriptan , Normodyne , penbutolol , pioglitazone , propranolol , propranolol extended release , Rescriptor , rosuvastatin , Sectral , timolol , Toprol-XL , Trandate , zolmitriptan , Zomig , Zomig-ZMT Back