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Daysee Levonorgestrel and Ethinyl Estradiol 015 Mg Reviews

Written By Wednesday, 20 April 2022 Add Comment Edit

Get an overview of AMETHYST (levonorgestrel and ethinyl estradiol tablet), including its generic name, conception (i.e. pill, oral solution, injection, inhaled medicine) and why it's used. The medication in Amethyst can exist sold under unlike names.

Refer to the "Also Known Every bit" section to reference different products that include the same medication every bit Amethyst.

Drug Basics

Make Name: Amethyst

Generic Proper noun: LEVONORGESTREL AND ETHINYL ESTRADIOL

Drug Type: Homo PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Information Electric current Every bit Of: 2019-08-26

Amethyst™

( Levonorgestrel and Ethinyl Estradiol Tablets , USP

ninety mcg / 20 mcg )

Revised: December 2017

Rx O nly

Patients should exist counseled that oral contraceptives do non protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such equally chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INFORMATION FOR THE PATIENT

Cursory Summary Patient Package Insert

Amethyst™
( Levonorgestrel and Ethinyl Estradiol Tablets , USP
90 mcg / 20 mcg )

Rx O nly

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against manual of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Oral contraceptives, also known as "birth-control pills" or "the pill," are taken to prevent pregnancy, and when taken correctly, accept a failure rate of approximately 1 to ii% per year (1 to two pregnancies per 100 women per year of utilize) when used without missing any pills. The average failure rate of big numbers of pill users is approximately 5% per year (five pregnancies per 100 women per year of employ) when women who miss pills are included. However, forgetting to accept pills considerably increases the chances of pregnancy.

Amethyst is a birth-control pill that is taken every day. When you take Amethyst, the lining of your uterus does non undergo the changes needed for flow, and therefore you practice not have regular menstrual periods. You are likely to accept unscheduled or unplanned haemorrhage or spotting when you start to use Amethyst. The number of days each month with unscheduled bleeding and spotting ordinarily decreases over time for the bulk of women. When using Amethyst, the convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding and spotting.

For the majority of women, oral contraceptives can be taken safely. Nevertheless, there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you:

  • smoke
  • accept high blood force per unit area, diabetes, high cholesterol, or a tendency to form blood clots, or are obese
  • have or take had clotting disorders, eye attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, malignant or benign liver tumors, or major surgery with prolonged immobilization
  • have headaches with neurological symptoms

You should non accept the pill if you doubtable y'all are meaning or have unexplained vaginal haemorrhage.

Although cardiovascular illness risks may be increased with oral contraceptive use in good for you, nonsmoking women over forty (even with the newer low-dose formulations), in that location are likewise greater potential health risks associated with pregnancy in older women.

Cigarette smoking increases the risk of serious adverse furnishings on the centre and claret vessels from oral contraceptive utilize. This run a risk increases with historic period and with the amount of smoking (15 or more cigarettes per twenty-four hour period has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not fume.

Most side effects of the pill are not serious. The most mutual such effects are nausea, airsickness, unscheduled bleeding, weight proceeds, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and airsickness, may subside inside the start three months of use.

The serious side furnishings of the pill occur very infrequently, especially if you are in adept health and do not smoke. However, you should know that the following medical conditions take been associated with or made worse by the pill:

  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a claret vessel in the brain (stroke), blockage of blood vessels in the heart (centre attack and angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Women with migraine also may be at increased take chances of stroke with pill use.
  • Liver tumors, which may rupture and cause severe haemorrhage. A possible, simply not definite, association has been institute with the pill and liver cancer. Notwithstanding, liver cancers are extremely rare. The adventure of developing liver cancer from using the pill is thus fifty-fifty rarer.
  • Loftier blood force per unit area, although claret force per unit area usually returns to normal when the pill is stopped.

The symptoms associated with these serious side furnishings are discussed in the detailed leaflet given to you with your supply of pills. Notify your health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, equally well equally some anticonvulsants and some antibiotics, herbal preparations containing St. John'southward Wort (Hypericum perforatum), and HIV/AIDS drugs may decrease oral contraceptive effectiveness.

Diverse studies give conflicting reports on the relationship between chest cancer and oral contraceptive employ.

Oral contraceptive use may slightly increase your chance of having chest cancer diagnosed, specially if you started using hormonal contraceptives at a younger age.

After you stop using hormonal contraceptives, the chances of having chest cancer diagnosed begin to go downwardly, and disappear x years after stopping utilise of the pill. It is not known whether this slightly increased risk of having breast cancer diagnosed is caused past the pill. Information technology may be that women taking the pill were examined more than often, so that breast cancer was more probable to be detected.

Yous should accept regular breast examinations by a wellness intendance professional person and examine your own breasts monthly. Tell your health intendance professional if you accept a family unit history of breast cancer or if y'all have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use oral contraceptives considering breast cancer is normally a hormone-sensitive tumor.

Some studies accept plant an increase in the incidence of cancer of the neck in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

Taking the pill provides some important noncontraceptive benefits. These include less painful menstruation, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to hash out whatsoever medical status you may have with your health care provider. Your health care provider will have a medical and family history before prescribing oral contraceptives and volition examine you. The physical exam may exist delayed to another time if you lot request it, and the health care provider believes that it is appropriate to postpone it. Y'all should be reexamined at least once a yr while taking oral contraceptives. The detailed patient data leaflet gives you lot further information which you should read and discuss with your health care provider.

What Y'all Should Know About Your Menstrual Bike When Y'all Utilize Amethyst
Y'all are likely to have unscheduled or unplanned bleeding or spotting when y'all start to use Amethyst. The number of days each month with bleeding or spotting unremarkably decreases over time in the majority of women. In a study of Amethyst, about 5 out of ten women had 7 or more days of bleeding or spotting while using their third 28-day pill pack of Amethyst. The number of women with 7 or more days of bleeding or spotting decreased to 3 out of 10 women during the use of their seventh pill pack. Among women who connected to employ Amethyst for i year, about half-dozen out of 10 women had no bleeding or spotting during their concluding calendar month of use.

Do non stop taking Amethyst because of bleeding or spotting every bit this will increase your adventure of getting pregnant. If the spotting or bleeding continues for more than vii sequent days or if the bleeding is heavy, telephone call your health intendance provider.

Can I Get Pregnant While Taking Amethyst ?
Y'all are not probable to become meaning if yous have Amethyst at the aforementioned time every day as directed past your health care provider. Because regular monthly haemorrhage does not occur on Amethyst, information technology may be difficult to recognize if yous get meaning. If you lot doubtable that yous may be meaning, or if you have symptoms of pregnancy such as nausea/vomiting or unusual chest tenderness, yous should have a pregnancy test and yous should contact your health care professional. Stop taking Amethyst if you are pregnant.

Instructions for the Patient

HOW TO Take AMETHYST
Important Points to Call back
Before You Outset Taking Amethyst:

i. BE Sure TO READ THESE DIRECTIONS:

Before you outset taking Amethyst.

And

Anytime you are not sure what to practice.

ii. THE TO Accept AMETHYST IS TO TakeEVERY AT THE Same Fourth dimension.

If you miss pills, yous could go significant. This includes starting the pack late. The more pills you miss, the more than likely you are to get significant. Meet "WHAT TO DO IF Yous MISS PILLS" below.

3. MANY WOMEN HAVE SPOTTING OR Light BLEEDING, OR MAY Experience SICK TO THEIR Breadbasket DURING THE FIRST 1 to iii PACKS OF PILLS.

If you experience ill to your stomach, do non stop taking Amethyst. This will usually get abroad.

If it doesn't go away, check with your health care professional person.

4. Nearly WOMEN HAVE SPOTTING OR BLEEDING DURING THE First FEW MONTHS OF TAKING AMETHYST. Do not stop taking your pills even if you are having bleeding or spotting. If the bleeding or spotting lasts for more than vii consecutive days, talk to your health intendance provider.

5. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT Bleeding, even when you brand up these missed pills.

On the days you have 2 pills to make upwardly for missed pills, you lot could also feel a picayune sick to your stomach.

six. IF You VOMIT (within iv hours after you take your pill), you should follow the instructions for WHAT TO Practice IF Y'all MISS PILLS. IF YOU HAVE DIARRHEA or IF You lot TAKE SOME MEDICINES, including some antibiotics, your pills may not work likewise.

Use a back-up nonhormonal method (such as condoms and/or spermicide) until yous cheque with your health care professional person.

7. IF YOU HAVE TROUBLE REMEMBERING TO TAKE Amethyst, talk to your health care professional about how to make pill-taking easier or about using another method of nascency command.

viii. IF YOU Have ANY QUESTIONS OR ARE UNSURE About THE INFORMATION IN THIS LEAFLET, phone call your health care professional person.

BEFORE You START TAKING AMETHYST

ane. Make up one's mind WHAT Fourth dimension OF DAY YOU Desire TO TAKE YOUR PILL. It is important to take your pill at the SAME TIME every day.

2. AT YOUR AMETHYST DISPENSER. The pill pack has 28 "active" white pills (with hormones).

3. Likewise Notice:

1) where on the pack to start taking pills, and

2) in what order to take the pills (follow the arrows).

image 7.jpg

* For use of day labels, come across WHEN TO Offset THE Outset OF AMETHYST below.

four. Exist Certain You HAVE Set up AT ALL TIMES:

Some other KIND OF NONHORMONAL BIRTH CONTROL (such as condoms and/or spermicide) to utilize every bit a back-up in case you miss pills.

AN Extra, FULL PILL PACK.

WHEN TO Starting time THE FIRST OF AMETHYST

24-hour interval one Start

1. On Day 1 of your menstruum, peel the day label from the sticker canvas which has the respective start day of your period printed on the left manus side; place the characterization on the dispenser in the designated location. Take your pill daily in the order indicated by the arrows on the dispenser carte du jour. Pick a time of day which will be easy to recall and take your pill at the same time every day.

2. Take the first "agile" white pill of the first pack during the first 24 hours of your catamenia.

3. You will non need to use a dorsum-upwards nonhormonal method of birth command, since yous are starting the pill at the beginning of your period.

WHAT TO Practise DURING THE MONTH

1. TAKE One PILL AT THE Aforementioned Fourth dimension EVERY Mean solar day UNTIL THE PACK IS EMPTY.

Practice not skip pills even if y'all are spotting or bleeding or feel sick to your stomach (nausea).

Exercise not skip pills even if you do non have sex very frequently.

2. WHEN YOU Finish A PACK

Start the next pack on the day after your last pill. Practise non wait any days betwixt packs.

IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS:

When switching from a 21 pill pack: First Amethyst on the first day of your period (withdrawal bleed). Be sure that no more than seven days laissez passer between the last day of your 21-twenty-four hour period pack and your first Amethyst pill.

When switching from a 28 pill pack (21 active and seven inactive pills, or 24 active and iv inactive pills): Outset Amethyst on the first day of your period (withdrawal bleed). Be sure that no more than 7 days pass afterwards the concluding active pill and your outset Amethyst pill.

IF Yous SWITCH FROM ANOTHER Blazon OF BIRTH CONTROL

When switching from other types of birth control such as pills containing only a progestin (progestin only pill or ), an injection, or an implant, your wellness care professional will provide you with instructions for when to start Amethyst.

WHAT TO DO IF YOU MISS PILLS

Combination oral contraceptives may not exist as effective if you lot miss pills. Instructions for what to practise if you miss pills are provided in the post-obit table.

# of pills missed in a row What to do when y'all miss a pill(s)
 one missed pill   Take the missed pill as shortly every bit you remember.
And then
  Have the adjacent pill at your regular time. This means you may have ii pills in 1 day.
  You COULD BECOME PREGNANT if yous have sexual activity during the seven days after you restart your pills. Yous MUST employ a nonhormonal nativity-control method (such as condoms and/or spermicide) every bit a redundancy for those 7 days.
 2 missed pills

 and remembered on the twenty-four hour period of the second missed pill

   Take 2 missed pills on the twenty-four hours yous remember. The following twenty-four hours you are back on schedule to take 1 pill a day.
 For example, you take your pills in the morning and you missed one pill on Monday and 1 on Tuesday. On Tuesday evening you remembered that you lot missed your Monday and Tuesday pills. You take the 2 missed pills on Tuesday evening and on Wed morning you're dorsum on schedule and yous take ane pill.
  You lot COULD Go Significant if you have sex during the seven days after you restart your pills. You MUST use a nonhormonal nativity-command method (such as condoms and/or spermicide) as a redundancy for those 7 days.
 2 missed pills

 and remembered on the mean solar day after the 2nd pill is missed

   Take 2 missed pills on the twenty-four hour period you lot remember. The side by side mean solar day you take two pills. The post-obit day you lot are back on schedule to take your pills.
 For example, you accept your pills in the morning and yous missed i pill on Monday and i on Tuesday. On Midweek morning you lot remembered that yous missed your Mon and Tuesday pills. You accept the 2 missed pills on Wednesday morning and 2 pills on Th morn. On Fri forenoon you're back on schedule and y'all have 1 pill.
  Y'all COULD Become PREGNANT if you accept sex during the 7 days afterwards you restart your pills. You lot MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a redundancy for those vii days.
 3 or more missed pills   Contact your health intendance professional for further communication. Keep taking one pill every day until you attain your wellness care professional. Do not take the missed pills.
  Y'all COULD Go PREGNANT if you have sex during the 7 days after you restart your pills. Y'all MUST employ a nonhormonal birth-control method (such every bit condoms and/or spermicide) as a back-up for those 7 days.

FINALLY, IF You ARE Nonetheless NOT Sure WHAT TO DO Almost THE PILLS YOU HAVE MISSED

Use a Back-UP NONHORMONAL Birth-CONTROL METHOD someday you take sex.

PREGNANCY Subsequently STOPPING THE PILL
If you do not desire pregnancy, you should use another method of birth-control immediately after stopping Amethyst . You can become meaning within days after stopping Amethyst.

For additional information run into "Detailed Patient Labeling."

Call your physician for medical communication about side effects. Y'all may report side effects to FDA at 1-800-FDA-1088.

Brands listed are the trademarks of their respective owners.

Distributed past:

Actavis Pharma, Inc.

Parsippany, NJ 07054 The states

Revised: December 2017

DETAILED PATIENT LABELING

This product (similar all oral contraceptives) is intended to foreclose pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INTRODUCTION

Any woman who considers using oral contraceptives (the "nativity-control pill" or "the pill") should understand the benefits and risks of using this grade of birth command. This leaflet volition give you much of the data you will need to make this conclusion and will too help yous decide if you are at risk of developing whatever of the serious side effects of the pill. It will tell you how to use the pill properly so that information technology will be as effective every bit possible. Withal, this leaflet is not a replacement for a careful discussion between you and your health intendance professional. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You lot should also follow your health care professional person's advice with regard to regular checkups while you are on the pill.

Amethyst is a birth-control pill that is taken every day. When yous take Amethyst, the lining of your uterus does not undergo the changes needed for menstruation, and therefore you do non accept regular menstrual periods. Y'all are probable to take unscheduled or unplanned bleeding or spotting when you first to use Amethyst. The number of days each month with unscheduled bleeding and spotting normally decreases over time for the majority of women. When using Amethyst, the convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned quantum bleeding and spotting.

EFFECTIVENESS OF CONTRACEPTIVES

Oral contraceptives or "birth-control pills" or "the pill" are used to preclude pregnancy and are more effective than other nonsurgical methods of nascency command. When they are taken correctly, without missing whatsoever pills the chance of becoming pregnant is approximately 1 to 2 % per year (ane to 2 pregnancies per 100 women per twelvemonth of utilize). Boilerplate failure rates are approximately 5% per year (5 pregnancies per 100 women per year of apply) when women who miss pills are included. The chance of condign pregnant increases with each missed pill.

In comparison, average failure rates for other methods of nascence control during the first year of use are every bit follows:

 IUD: 0.ane to ii%  Female condom alone: 21%
 Depo-Provera® (injectable progestogen): 0.three%  Cervical cap
 Norplant® System (levonorgestrel implants): 0.05%       Never given birth: 20%
 Diaphragm with spermicides: xx%       Given birth: forty%
 Spermicides lonely: 26%  Periodic abstinence: 25%
 Male person prophylactic solitary: fourteen%  No methods: 85%

WHO SHOULD NOT TAKE CONTRACEPTIVES

Although cardiovascular disease risks may be increased with oral contraceptive utilise in healthy, nonsmoking women over forty (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

Cigarette smoking increases the risk of serious agin effects on the heart and blood vessels from oral contraceptive utilize. This take chances increases with age and with the amount of smoking (fifteen or more than cigarettes per day has been associated with a significantly increased gamble) and is quite marked in women over 35 years of age. Women who use oral contraceptives should non smoke.

Some women should not use the pill. For example, you should not take the pill if you have whatever of the following conditions:

  • History of eye set on or stroke.
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes.
  • History of claret clots in the deep veins of your legs.
  • Hereditary or acquired blood clotting disorders.
  • Chest pain (angina pectoris).
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina, or certain hormonally-sensitive cancers.
  • Unexplained vaginal haemorrhage (until a diagnosis is reached past your health care professional).
  • Liver tumor (benign or cancerous) or agile liver disease.
  • Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increment levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood.
  • Yellowing of the whites of the eyes or of the peel (jaundice) during pregnancy or during previous use of the pill.
  • Known or suspected pregnancy.
  • A need for surgery with prolonged bed rest.
  • Heart valve or middle rhythm disorders that may be associated with germination of blood clots.
  • Diabetes affecting your circulation.
  • Headaches with neurological symptoms such as aureola.
  • Uncontrolled high blood pressure.
  • Allergy or hypersensitivity to any of the components of Amethyst.

Tell your health care professional if you have had whatsoever of these conditions. Your health care professional tin recommend another method of birth command.

OTHER CONSIDERATIONS BEFORE TAKING CONTRACEPTIVES
Tell your health intendance professional person if you or whatever family member has ever had:

  • Breast nodules, fibrocystic disease of the breast, an aberrant breast X-ray or mammogram.
  • Diabetes.
  • Elevated cholesterol or triglycerides.
  • High claret pressure.
  • A trend to grade claret clots.
  • Migraine or other headaches or epilepsy.
  • Depression.
  • Gallbladder, liver, heart, or kidney disease.
  • History of scanty or irregular menstrual periods.

Women with any of these conditions should be checked ofttimes past their health care professional if they choose to use oral contraceptives. Also, be sure to inform your wellness intendance professional if you fume or are on any medications.

RISKS OF TAKING CONTRACEPTIVES
Amethyst is a non-cyclic oral contraceptive that provides a depression daily dose of estrogen and progestin; nonetheless, Amethyst provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per twelvemonth) than conventional cyclic oral contraceptives containing the same forcefulness of synthetic estrogens and similar strength of progestins.

1. Risk of Developing Claret Clots
Blood clots and blockage of blood vessels are the well-nigh serious side effects of taking oral contraceptives and can cause expiry or serious disability. In particular, a clot in the legs can cause thrombophlebitis and a jell that travels to the lungs tin can crusade a sudden blocking of the vessel carrying claret to the lungs. Rarely, clots occur in the blood vessels of the center and may cause blindness, double vision, or impaired vision.

Users of combination oral contraceptives have a higher risk of developing blood clots compared to non-users. This run a risk is highest during the get-go year of combination oral contraceptive use.

If you have oral contraceptives and need constituent surgery, demand to stay in bed for a prolonged illness or injury, or take recently delivered a infant, you lot may be at risk of developing blood clots. You should consult your wellness intendance professional person about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. Y'all should also non take oral contraceptives presently after delivery of a baby or after a midtrimester pregnancy termination. It is advisable to await for at least four weeks after commitment if y'all are non breastfeeding. If you are breastfeeding, yous should wait until y'all accept weaned your kid earlier using the pill. (Meet also the section While Breastfeeding in GENERAL PRECAUTIONS.)

The risk of blood clots is greater in users of combination oral contraceptives compared to nonusers. This risk may be higher in users of high-dose pills (those containing 0.05 mg or more of estrogen) and may as well be greater with longer use. In improver, some of these increased risks may continue for a number of years after stopping combination oral contraceptives. The gamble of abnormal blood clotting increases with historic period in both users and nonusers of combination oral contraceptives, but the increased hazard from the oral contraceptive appears to be present at all ages.

The excess risk of blood clots is highest during the kickoff year a woman ever uses a combined oral contraceptive. This increased risk is lower than blood clots associated with pregnancy. The apply of combination oral contraceptives also increases the risk of other clotting disorders, including eye attack and stroke. Blood clots in veins crusade death in i% to 2% of cases. The risk of clotting is further increased in women with other conditions. Examples include: smoking, high blood pressure level, abnormal lipid levels, sure inherited or acquired clotting disorders, obesity, surgery or injury, recent delivery or second trimester ballgame, prolonged inactivity or bed balance. If possible, combination oral contraceptives should be stopped earlier surgery and during prolonged inactivity or bed rest.

Cigarette smoking increases the risk of serious cardiovascular events. This risk increases with age and amount of smoking and is quite pronounced in women over 35. Women who use combination oral contraceptives should be strongly brash not to smoke. If y'all fume yous should talk to your health intendance professional before taking combination oral contraceptives.

2. Heart Attacks and Strokes
Oral contraceptives may increase the trend to develop strokes or transient ischemic attacks (blockage or rupture of blood vessels in the brain), and angina pectoris and eye attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability.

Smoking greatly increases the possibility of suffering eye attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of centre disease.

Women with migraine (especially migraine/headache with neurological symptoms such as aureola) who accept oral contraceptives also may be at higher run a risk of stroke and must not use combination oral contraceptives (see section WHO SHOULD NOT Take ORAL CONTRACEPTIVES).

3. Gallbladder Disease
Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this chance may be related to pills containing high doses of estrogens. Oral contraceptives may worsen existing gallbladder disease or accelerate the evolution of gallbladder disease in women previously without symptoms.

4. Liver Tumor
In rare cases, oral contraceptives can cause benign but unsafe liver tumors. These benign liver tumors tin can rupture and cause fatal internal bleeding. In add-on, a possible but non definite association has been establish with the pill and liver cancers in ii studies in which a few women who developed these very rare cancers were institute to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The run a risk of developing liver cancer from using the pill is thus even rarer.

5. Cancer of the Reproductive Organs and Breasts
Various studies requite conflicting reports on the human relationship betwixt breast cancer and oral contraceptive use.

Oral contraceptive employ may slightly increase your risk of having chest cancer diagnosed, particularly if you started using hormonal contraceptives at a younger age.

After y'all terminate using hormonal contraceptives, the chances of having chest cancer diagnosed begin to go down, and disappear 10 years afterwards stopping use of the pill. It is not known whether this slightly increased risk of having breast cancer diagnosed is caused by the pill. It may be that women taking the pill were examined more oftentimes, then that breast cancer was more than probable to be detected.

You should have regular chest examinations by a health care professional and examine your own breasts monthly. Tell your health care professional if you have a family history of chest cancer or if you have had breast nodules or an abnormal mammogram. Women who currently take or have had chest cancer should not employ oral contraceptives because breast cancer is usually a hormone-sensitive tumor.

Some studies have establish an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may exist related to factors other than the use of oral contraceptives.

6. Lipid Metabolism and Pancreatitis
In that location have been reports of increases of claret cholesterol and triglycerides in users of combination oral contraceptives. Increases in triglycerides take led to inflammation of the pancreas (pancreatitis) in some cases.

Estimated Risk of Death from a Birth-Control Method or Pregnancy
All methods of nativity command and pregnancy are associated with a risk of developing certain diseases which may pb to inability or death. An guess of the number of deaths associated with different methods of nascence control and pregnancy has been calculated and is shown in the following table.

Almanac Number of Nascency-Related or Method-Related Deaths Associated with Command of Fertility per 100,000 Nonsterile Women, by Fertility-Control Method and According to Historic period

Method of command and effect 15 to xix xx to 24 25 to 29 xxx to 34 35 to 39 forty to 44
 No fertility-control methods*  7.0  7.4  9.1  14.viii  25.7  28.ii
 Oral contraceptives
       nonsmoker**  0.three  0.5  0.9  one.9  13.8  31.6
 Oral contraceptives
       smoker**  2.2  3.four  vi.six  13.5  51.one  117.2
 IUD**  0.8  0.8  ane.0  i.0  ane.4  1.4
 Safe*  1.1  ane.half dozen  0.vii  0.2  0.three  0.4
 Diaphragm/spermicide*  1.9  1.2  1.ii  1.3  2.2  two.eight
 Periodic abstinence*  2.v  1.6  1.6  ane.7  two.9  3.6

* Deaths are birth-related

**Deaths are method-related

In the higher up table, the run a risk of death from any birth-control method is less than the gamble of childbirth, except for oral contraceptive users over the historic period of 35 who smoke and pill users over the age of forty even if they do not fume. Information technology can exist seen in the tabular array that for women anile 15 to 39, the gamble of death was highest with pregnancy (seven to 26 deaths per 100,000 women, depending on age). Amidst pill users who do non fume, the take chances of death was e'er lower than that associated with pregnancy for whatsoever age group, except for those women over the age of forty, when the run a risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the historic period of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of twoscore and smokes, her estimated risk of death is iv times college (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.

The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older high-dose pills. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use past healthy, nonsmoking women over twoscore years of historic period may outweigh the possible risks. Older women, as all women, who accept oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with the individual patient needs.

Warning SIGNALS
If whatsoever of these adverse effects occur while you lot are taking oral contraceptives, call your health care professional immediately:

  • Sharp chest pain, coughing of blood, or sudden shortness of jiff (indicating a possible jell in the lung).
  • Pain in the calf (indicating a possible jell in the leg).
  • Crushing chest pain or heaviness in the chest (indicating a possible heart attack).
  • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke).
  • Sudden fractional or complete loss of vision (indicating a possible clot in the eye).
  • Chest lumps (indicating possible chest cancer or fibrocystic illness of the chest; inquire your health care professional person to show you lot how to examine your breasts).
  • Severe pain or tenderness in the tum surface area (indicating a possibly ruptured liver tumor).
  • Difficulty in sleeping, weakness, lack of energy, fatigue, or alter in mood (possibly indicating severe low).
  • Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of ambition, dark-colored urine, or light-colored bowel movements (indicating possible liver problems).

Furnishings OF CONTRACEPTIVES
1. Unscheduled Bleeding and Spotting
Unscheduled bleeding or spotting is likely to occur while you are taking Amethyst. Unscheduled bleeding or spotting occurs most often during the first seven pill packs of Amethyst use. It tends to decrease with subsequent pill packs of use, but may occur later on you accept been taking Amethyst for some fourth dimension. In a report of Amethyst, 60% of women had bleeding and/or spotting during the sixth pill pack of use. Bleeding and/or spotting decreased to 48% during pill pack nine, and to 41% during pill pack xiii. In this study, the percent of women who discontinued handling, at to the lowest degree in part, due to unscheduled bleeding or spotting was 18%.

The post-obit figure shows by pill pack, the pct of women using Amethyst in a North American study, who experienced unscheduled bleeding or spotting only.

Percentage of Subjects Reporting Bleeding or Spotting Only per Pill Pack

image 8.jpg

*: The Due north for each pill pack is the number of subjects with 28 days of data.

Haemorrhage required sanitary protection; spotting but did not require germ-free protection.

The following figure shows the percentage of women using Amethyst in a North American study who had iv or more than and 7 or more days of bleeding or spotting during each pill pack. During pill pack 2, 67% of women experienced 4 or more than days of haemorrhage or spotting and 54% of these women experienced 7 or more days bleeding or spotting. During the final pill pack of use of Amethyst (pill pack 13), these percentages were 31% and 20%, respectively.

Per centum of Subjects Reporting Greater Than or Equal to 4 or vii Days of Bleeding and/or Spotting per Pill (Report 313-NA)

image 9.jpg

*: The Northward for each pill pack is the number of subjects with 28 days of data.

It is important to go on taking your pills at the aforementioned time each solar day co-ordinate to your daily routine, even if you are having unscheduled bleeding or spotting. If the unscheduled bleeding and/or spotting go along for an extended flow of time (for instance, 7 consecutive days) or if the bleeding is heavy, contact your wellness care professional person.

2. Contact Lenses
If you clothing contact lenses and notice a modify in vision or an disability to wear your lenses, contact your wellness care professional.

3. Fluid Retentiveness
Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your claret pressure. If you lot experience fluid retentiveness, contact your wellness intendance professional.

4. Melasma
A spotty concealment of the skin is possible, particularly of the face.

5. Other Side Effects
Other side furnishings may include nausea, breast tenderness, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, inflammation of the pancreas, and allergic reactions.

If these or whatever other side effects bother yous, contact your health intendance professional person.

Full general PRECAUTIONS
1. Apply of Oral Contraceptives Earlier or During Early on Pregnancy
Because regular monthly bleeding does not occur on Amethyst, an unexpected pregnancy may be hard to recognize. If you lot suspect you may be meaning, or if yous have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, a pregnancy test should be performed and you should contact your health care professional. Stop taking Amethyst if yous are meaning. Pregnancy is unlikely if the pill is taken equally directed.

At that place is no conclusive evidence that oral contraceptive use is associated with an increment in nascence defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, only these studies accept not been confirmed. Nevertheless, oral contraceptives should not be used during pregnancy. You should check with your health care professional virtually risks to your unborn child of whatever medication taken during pregnancy.

2. While Breastfeeding
If you lot are breastfeeding, consult your health intendance professional before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child accept been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the corporeality and quality of your milk. If possible, practice not apply oral contraceptives while breastfeeding. You should apply another method of contraception since breastfeeding provides only fractional protection from becoming pregnant and this partial protection decreases significantly as you breastfeed for longer periods of time. You should consider starting oral contraceptives but after you lot take weaned your kid completely.

3. Laboratory Tests
If you are scheduled for any laboratory tests, tell your health care professional yous are taking birth-control pills. Sure claret tests may be affected by nativity-control pills.

4. Drug Interactions
Certain drugs may interact with birth-command pills to brand them less effective in preventing pregnancy or cause an increment in unscheduled haemorrhage. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for case, phenobarbital) and phenytoin (Dilantin® is i brand of this drug), primidone (Mysoline®), topiramate (Topamax®), carbamazepine (Tegretol® is one brand of this drug), phenylbutazone (Butazolidin® is ane brand), some drugs used for HIV or AIDS such as ritonavir (Norvir®), modafinil (Provigil®) and perhaps certain antibiotics (such as ampicillin and other penicillins, and tetracyclines), and herbal products containing St. John'south Wort (Hypericum perforatum). You may also demand to utilise a nonhormonal method of contraception during whatever pill pack in which you take drugs that can make oral contraceptives less effective.

You lot may be at higher risk for a specific type of liver dysfunction if you take troleandomycin and oral contraceptives at the same fourth dimension.

Y'all should inform your health intendance professional about all medicines you are taking, including nonprescription products.

5. Sexually Transmitted Diseases
This production (similar all oral contraceptives) is intended to prevent pregnancy. Information technology does non protect against manual of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

What You Should Know About Your Menstrual Cycle When You Use Amethyst
Yous are likely to have unscheduled or unplanned bleeding or spotting when you first to use Amethyst. The number of days each month with bleeding or spotting usually decreases over time in the bulk of women. In a report of Amethyst, about 5 out of 10 women had 7 or more days of bleeding or spotting while using their third 28-day pill pack of Amethyst. The number of women with seven or more days of bleeding or spotting decreased to iii out of 10 women during the use of their seventh pill pack. Amidst women who continued to utilize Amethyst for one twelvemonth, virtually 6 out of 10 women had no bleeding or spotting during their last month of use.

Do non stop taking Amethyst because of haemorrhage or spotting as this will increase your chance of getting meaning. If the spotting or bleeding continues for more than than 7 consecutive days or if the bleeding is heavy, call your health intendance provider.

Can I Become Pregnant While Taking Amethyst ?
Y'all are not likely to get significant if you accept Amethyst at the same time every day every bit directed by your health care provider. Because regular monthly bleeding does not occur on Amethyst, it may exist difficult to recognize if y'all get pregnant. If you suspect that you may exist significant, or if y'all accept symptoms of pregnancy such equally nausea/vomiting or unusual breast tenderness, you should have a pregnancy test and you should contact your health care professional. Terminate taking Amethyst if you are significant.

HOW TO Accept AMETHYST

Important Points to Retrieve
Before Y'all Starting time Taking Amethyst:

1. BE Certain TO READ THESE DIRECTIONS:

Before you start taking Amethyst.

And

Anytime yous are not certain what to practice.

2. THE TO TAKE AMETHYST IS TO TAKEEVERY AT THE Same TIME.

If you lot miss pills, yous could get significant. This includes starting the pack belatedly. The more pills you miss, the more likely y'all are to get meaning. See "WHAT TO DO IF YOU MISS PILLS" below.

3. MANY WOMEN Accept SPOTTING OR LIGHT Bleeding, OR Experience SICK TO THEIR Tum DURING THE FIRST one to three PACKS OF PILLS.

If you experience sick to your stomach, do not end taking Amethyst. This will unremarkably become abroad.

If information technology doesn't go away, check with your health care professional.

4. MOST WOMEN Accept SPOTTING OR Haemorrhage DURING THE FIRST FEW MONTHS OF TAKING AMETHYST. Do not cease taking your pills even if you are having bleeding or spotting. If the bleeding or spotting lasts for more than than seven consecutive days, talk to your wellness care provider.

v. MISSING PILLS CAN Also CAUSE SPOTTING OR LIGHT BLEEDING, fifty-fifty when you brand up these missed pills.

On the days you take 2 pills to make up for missed pills, y'all could besides experience a little sick to your stomach.

6. IF Yous VOMIT (within four hours after yous take your pill), you lot should follow the instructions for WHAT TO Do IF YOU MISS PILLS. IF YOU Take DIARRHEA or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may non work every bit well.

Use a back-up nonhormonal method (such as condoms and/or spermicide) until you check with your health care professional person.

vii. IF You lot HAVE TROUBLE REMEMBERING TO TAKE Amethyst, talk to your health care professional person nearly how to make pill-taking easier or nearly using another method of birth control.

viii. IF Y'all HAVE Any QUESTIONS OR UNSURE About THE INFORMATION IN THIS LEAFLET, call your health care professional person.

Before YOU START TAKING AMETHYST
ane. DECIDE WHAT Time OF Yous WANT TO TAKE YOUR . It is important to take your pill at the Same TIME every solar day.

2. AT YOUR AMETHYST DISPENSER. The pill pack has 28 "active" white pills (with hormones).

iii. ALSO Notice:

i) where on the pack to start taking pills, and

2) in what guild to take the pills (follow the arrows).

image 10.jpg

* For employ of 24-hour interval labels, run across WHEN TO START THE Start OF AMETHYST below.

four. Be SURE You lot HAVE Gear up AT TIMES:

ANOTHER KIND OF NONHORMONAL Nascence CONTROL (such as condoms and/or spermicide) to utilize every bit a back-up in case you miss pills.

AN Extra, .

WHEN TO Beginning THE First OF AMETHYST
Twenty-four hours ane Kickoff
1. On Day 1 of your period, peel the day label from the sticker sheet which has the corresponding start day of your period printed on the left hand side; place the label on the dispenser in the designated location. Take your pill daily in the order indicated by the arrows on the dispenser card. Pick a time of 24-hour interval which will be easy to remember and take your pill at the same time every day.

ii. Take the first "active" white pill of the first pack during the first 24 hours of your menstruation.

iii. You volition not need to use a redundancy nonhormonal method of birth control, since y'all are starting the pill at the start of your menses.

WHAT TO DO DURING THE MONTH
one. TAKE   AT THE Same Fourth dimension EVERY UNTIL THE IS EMPTY.

Do not skip pills even if you are spotting or haemorrhage or feel ill to your tummy (nausea).

Do not skip pills fifty-fifty if you do non have sex very frequently.

two. WHEN YOU Cease A

Start the next pack on the day after your last pill. Practise not expect any days between packs.

IF YOU SWITCH FROM ANOTHER Make OF COMBINATION PILLS:
When switching from a 21 pill pack: Commencement Amethyst on the outset mean solar day of your menstruum (withdrawal bleed). Be certain that no more vii days pass between the last day of your 21-day pack and your first Amethyst pill.

When switching from a 28 pill pack (21 active and vii inactive pills, or 24 agile and four inactive pills): Start Amethyst on the commencement day of your period (withdrawal bleed). Be sure that no more than than 7 days pass after the last agile pill and your start Amethyst pill.

IF YOU SWITCH FROM ANOTHER Blazon OF Nascency CONTROL
When switching from other types of birth command such as pills containing only a progestin (progestin but pill or ), an injection, or an implant, your health care professional volition provide you with instructions for when to get-go Amethyst.

WHAT TO Practice IF You MISS PILLS

Combination oral contraceptives may not be as constructive if you miss pills. Instructions for what to practice if you miss pills are provided in the following tabular array.

# of pills missed in a row What to exercise when you miss a pill(southward)
 i missed pill   Take the missed pill every bit presently as you remember.
Then
  Take the next pill at your regular time. This ways y'all may take ii pills in 1 24-hour interval.
  You COULD BECOME PREGNANT if you take sex during the 7 days after you restart your pills. Y'all MUST use a nonhormonal nascence-control method (such as condoms and/or spermicide) equally a redundancy for those vii days.
 two missed pills

 and remembered on the day of the second missed pill

   Accept two missed pills on the twenty-four hour period you recollect. The following solar day y'all are back on schedule to take i pill a day.
 For example, yous take your pills in the morning and you missed 1 pill on Monday and 1 on Tuesday. On Tuesday evening you remembered that you missed your Monday and Tuesday pills. You have the 2 missed pills on Tuesday evening and on Wed morning you're back on schedule and yous take 1 pill.
  You COULD BECOME PREGNANT if you accept sexual activity during the 7 days after you restart your pills. You MUST apply a nonhormonal birth-control method (such as condoms and/or spermicide) every bit a back-upwardly for those vii days.
 two missed pills

 and remembered on the 24-hour interval after the second pill is missed

   Take ii missed pills on the twenty-four hours you lot think. The next day you take 2 pills. The following day you are back on schedule to take your pills.
 For example, you take your pills in the morning and you lot missed 1 pill on Monday and i on Tuesday. On Wednesday morning you remembered that you lot missed your Monday and Tuesday pills. You take the 2 missed pills on Wednesday morning and 2 pills on Thursday morning. On Friday morning you're dorsum on schedule and yous have one pill.
  You COULD BECOME PREGNANT if y'all have sex during the seven days after you restart your pills. You lot MUST use a nonhormonal birth-control method (such equally condoms and/or spermicide) as a back-up for those 7 days.
 three or more than missed pills   Contact your health intendance professional for further advice. Keep taking one pill every day until yous reach your health care professional person. Do not have the missed pills.
  You COULD Become Meaning if you have sex during the 7 days after you restart your pills. You lot MUST apply a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-upwards for those vii days.

FINALLY, IF YOU Even so NOT SURE WHAT TO Do ABOUT THE PILLS YOU HAVE MISSED

Utilize a Back-Up NONHORMONAL BIRTH-Command METHOD anytime you lot have sexual activity.

KEEP TAKING   EACH until you tin can attain your health care professional.

PREGNANCY DUE TO FAILURE
The incidence of pill failure resulting in pregnancy is approximately 1 to 2% per year (one to two pregnancies per 100 women per twelvemonth of use) if taken every 24-hour interval as directed, but the average failure rate is approximately 5% per twelvemonth (five pregnancies per 100 women per year of utilise) including women who practice not e'er take the pill exactly as directed without missing any pills. If y'all practise get significant, the gamble to the fetus is minimal, but you lot should stop taking your pills and discuss the pregnancy with your wellness care professional.

PREGNANCY AFTER STOPPING THE PILL
If yous do not desire pregnancy, y'all should use some other method of nascence-control immediately after stopping Amethyst . A pregnancy tin occur within days after stopping Amethyst.

At that place does not appear to be any increase in nascence defects in newborn babies when pregnancy occurs soon afterwards stopping the pill.

There may be some delay in condign pregnant after you terminate using oral contraceptives, specially if you had irregular menstrual cycles before you lot used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once y'all take stopped taking the pill and desire pregnancy.

OVERDOSAGE
Overdosage may cause nausea, airsickness, chest tenderness, dizziness, abdominal hurting, and fatigue/drowsiness. Withdrawal bleeding may occur in females. In case of overdosage, contact your wellness care professional person or pharmacist.

OTHER Data
Your health intendance professional will have a medical and family history earlier prescribing oral contraceptives and will examine you. The physical exam may be delayed to another time if you request it and the wellness care professional believes that it is appropriate to postpone it. You lot should be reexamined at least in one case a twelvemonth. Be sure to inform your health care professional person if there is a family history of whatsoever of the conditions listed previously in this leaflet. Be certain to go along all appointments with your health intendance professional, because this is a time to determine if there are early on signs of side furnishings of oral contraceptive employ.

Do not use the drug for any status other than the one for which it was prescribed. This drug has been prescribed specifically for yous; do not give it to others who may desire nascency-control pills.

HEALTH BENEFITS FROM CONTRACEPTIVES
In improver to preventing pregnancy, some information suggests that the use of oral contraceptives provide certain other benefits. The benefits are:

  • Decreased blood loss, and less atomic number 26 may exist lost. Therefore, anemia due to iron deficiency is less likely to occur.
  • Pain or other wheel-related symptoms may occur less often.
  • Ovarian cysts may occur less oft.
  • Ectopic (tubal) pregnancy may occur less oftentimes.
  • Noncancerous cysts or lumps in the breast may occur less frequently.
  • Acute pelvic inflammatory illness may occur less ofttimes.
  • Oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.

If yous desire more than information about birth-control pills, ask your wellness care professional or pharmacist. They have a more than technical leaflet called the Professional person Labeling which you may wish to read.

Phone call your doctor for medical communication most side effects. You may written report side furnishings to FDA at one-800-FDA-1088.

Brands listed are the trademarks of their respective owners.

Distributed past:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised: December 2017

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Source: https://www.healthgrades.com/drugs/feed/amethyst

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