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DROSPIRENONE AND ETHINYL ESTRADIOL is a brand name for Drospirenone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 ADVERSE REACTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Tablets must be taken in the order directed on the package every day at about the same time. The patient may begin using Drospirenone and Ethinyl Estradiol Tablets USP on day 1 of her menstrual cycle (ie, the first day of menstrual flow), or on the first Sunday after her period begins.
If the patient’s period begins on Sunday, she should start that same day. If Drospirenone and Ethinyl Estradiol Tablets USP is taken later than day 1 when first starting medication, an additional (barrier) method of birth control is recommended for the first 7 days of use.
One hormone-containing brown to reddish brown tablet is to be taken daily for 24 consecutive days, followed by 1 hormone-free white to off-white tablet daily for 4 consecutive days. Withdrawal bleeding usually occurs within 2 to 3 days following administration of the last hormone-containing brown to reddish brown tablet (ie, while the patient is taking the hormone- free white to off-white tablets).
The patient begins each subsequent course of Drospirenone and Ethinyl Estradiol Tablets USP on the same day of the week that she began her first course. She begins taking her next course immediately after completion of the last course, regardless of whether or not withdrawal bleeding is still in progress.
Management of missed tablets:
The patient should be instructed to use the following chart if she misses 1 or more of her birth control pills. She should be told to match the number of tablets missed with the appropriate starting time for her dosing regimen. The risk of pregnancy increases with each hormone-containing brown to reddish brown tablet missed.
Table 6 – Management of Missed Hormone-containing Brown to Reddish Brown Tablets Sunday Start Other Than Sunday Start Miss One Brown to Reddish Brown Tablet at Any Time Miss One Brown to Reddish Brown Tablet At Any Time Take it as soon as you remember, and take the next tablet at the usual time.
This means that you might take two tablets in one day Take it as soon as you remember, and take the next tablet at the usual time. This means that you might take two tablets in one day. Miss Two Brown to Reddish Brown Tablets in a Row Miss Two Brown to Reddish Brown Tablets in a Row First Two Weeks: 1.
Take two tablets the day you remember and two tablets the next day. 2. Then take one tablet a day until you finish the pack. 3. Use a back-up (barrier) method of birth control if you have sex in the seven days after you miss the tablets First Two Weeks: 1.
Serious Warnings and Precautions Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age, and with the number of cigarettes smoked.
For this reason, combination oral contraceptives, including Drospirenone and Ethinyl Estradiol Tablets USP, should not be used by women who are over 35 years of age and smoke. Women should not smoke. Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS.
For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH birth control pills. Drospirenone and Ethinyl Estradiol Tablets USP is a birth control pill containing estrogen and progestin. The progestin in Drospirenone and Ethinyl Estradiol Tablets USP is known as drospirenone and it may increase the levels of potassium in your blood.
Therefore, you should not take Drospirenone and Ethinyl Estradiol Tablets USP if you have kidney, liver, or adrenal disease (a disease that may alter the body’s fluid and mineral balance) because this could cause serious heart and health problems.
Other drugs may also increase potassium (see Before you use Drospirenone and Ethinyl Estradiol Tablets USP, talk to your doctor or pharmacist if you). During the first month that you take Drospirenone and Ethinyl Estradiol Tablets USP, you should have a blood test to check your potassium level.
Do not use Drospirenone and Ethinyl Estradiol Tablets USP if you are taking ombitasvir, paritaprevir, ritonavir, with or without dasabuvir for the treatment of Hepatitis C. Using these drugs at the same time as Drospirenone and Ethinyl Estradiol Tablets USP has the potential to cause liver problems, such as an increase in the ALT liver enzyme.
You can usually start Drospirenone and Ethinyl Estradiol Tablets USP about 2 weeks after finishing treatment with this combination of drugs used for Hepatitis C, but always consult with your doctor or pharmacist. It has been reported that drospirenone, the progestin in Drospirenone and Ethinyl Estradiol Tablets USP, may carry a higher risk of blood clots than some other progestins (including levonorgestrel).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Drospirenone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Take two tablets the day you remember and two tablets the next day. 2. Then take one tablet a day until you finish the pack. 3. Use a back-up (barrier) method of birth control if you have sex in the seven days after you miss the tablets.
Third and Fourth Weeks 1. Keep taking one tablet a day until Sunday. 2. On Sunday, safely discard the rest of the pack and start a new pack that day. 3. Use a back-up (barrier) method of birth control if you have sex in the seven days after you miss the tablets.
4. You may not have a period this month. Third and Fourth Weeks 1. Safely dispose of the rest of the tablet pack and start a new pack that same day. 2. Use a back-up (barrier) method of birth control if you have sex in the seven days after you miss the tablets.
3. You may not have a period this month. 02 mg Page 26 of 67 If you miss two periods in a row, call your doctor or clinic. If you miss two periods in a row, call your doctor or clinic. Miss Three or More Brown to Reddish Brown Tablets in a Row Miss Three or More Brown to Reddish Brown Tablets in a Row Anytime in the cycle.
1. Keep taking one tablet a day until Sunday. 2. On Sunday, safely discard the rest of the pack and start a new pack that day. 3. Use a back-up (barrier) method of birth control if you have sex in the seven days after you miss the tablets.
4. You may not have a period this month. If you miss two periods in a row, call your doctor or clinic. Anytime in the cycle. 1. Safely dispose of the rest of the tablet pack and start a new pack that same day. 2. Use a back-up (barrier) method of birth control if you have sex in the seven days after you miss the tablets.
3. You may not have a period this month. If you miss two periods in a row, call your doctor or clinic. If the patient forgets any of the 4 hormone-free white to off-white tablets in week 4, she should be advised to safely dispose of the tablets she missed, and then to keep taking 1 tablet each day until the pack is empty.
A back-up method of birth control is not required. Special Notes on Administration Switching from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch): The patient should start Drospirenone and Ethinyl Estradiol Tablets USP on the day she would normally start her next pack of combined oral contraceptive.
In case a vaginal ring or transdermal patch has been used, the woman should start using Drospirenone and Ethinyl Estradiol Tablets USP preferably on the day of removal, but at the latest when the next application would have been due.
Switching from a progestin-only method (mini-pill, injection) or from a Progestin-releasing Intrauterine System (IUS): The patient may switch from the mini-pill to Drospirenone and Ethinyl Estradiol Tablets USP on any day of her cycle.
Patients using a progestin injection should start Drospirenone and Ethinyl Estradiol Tablets USP on the day the next injection is due. Patients using an IUS should start Drospirenone and Ethinyl Estradiol Tablets USP on the day the IUS is removed.
In all cases, the patient should be advised to use an additional (barrier) method for the first 7 days of Drospirenone and Ethinyl Estradiol Tablets USP use.
Following first trimester abortion:
The patient may start using Drospirenone and Ethinyl Estradiol Tablets USP immediately. When doing so, she […]
You should talk to your doctor about the available options. BEFORE you use Drospirenone and Ethinyl Estradiol Tablets USP, talk to your doctor or pharmacist if you: smoke are overweight have a history of breast disease (eg, breast lumps) or a family history of breast cancer have high blood pressure have high cholesterol have diabetes have heart or kidney disease have a history of seizures/epilepsy have a history of depression have a history of liver disease or jaundice wear contact lenses have uterine fibroids (benign tumors of the uterus) may be pregnant or are breast feeding have systemic lupus erythematosus have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis have haemolytic uremic syndrome have sickle cell disease have any problems with the valves in your heart and/or have an irregular heart rhythm have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages you are currently on daily, long-term treatment for a chronic condition with any of the medications listed below: Nonsteroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (eg, ibuprofen, naproxen or others) Potassium-sparing diuretics (spironolactone and others) Potassium supplements ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure (eg, captopril, enalapril, lisinopril, losartan, valsartan, irbesartan, or others) Heparin You should also inform your doctor about a family history of blood clots, heart attacks, or strokes.
02 mg Page 61 of 67 If you see a different doctor, inform him or her that you are using Drospirenone and Ethinyl Estradiol Tablets USP. Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.
Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of Drospirenone and Ethinyl Estradiol Tablets USP four weeks before surgery and not using Drospirenone and Ethinyl Estradiol Tablets USP for a time period after surgery or during bed rest.
Drospirenone and Ethinyl Estradiol Tablets USP should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear.
Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use Drospirenone and Ethinyl Estradiol Tablets USP only on the advice of your doctor and carefully follow all directions given to you.
You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant. If you and your doctor decide that, for you, the benefits of Drospirenone and Ethinyl Estradiol Tablets USP outweigh the risks, you should be aware of the following: THE RISKS OF USING DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP 1.
Circulatory disorders (including blood clot in legs, lungs, heart, eyes, or brain) Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills.
The risk of developing blood clots is especially high during the first year a woman ever uses a hormonal contraceptive or restarts the same or a different hormonal […]