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Mircette (desogestrel/ethinyl estradiol)

BOXED WARNING

Cigarette smoking increases the risk of serious cardiovascular (CV) side effects. Risk increases with age and with heavy smoking (≥15 cigarettes/day) and is quite marked in women >35 yrs. Women who use oral contraceptives should be strongly advised not to smoke.

OTHER BRAND NAMES

Kariva

THERAPEUTIC CLASS

Estrogen/progestogen combination

DEA CLASS

RX

INDICATIONS

Prevention of pregnancy.

ADULT DOSAGE

Contraception

1 tab qd for 28 days, then repeat

Start 1st Sunday after menses begins or 1st day of menses

Missed Dose

Miss 1 Active Tab: Take missed tab as soon as remembered
Miss 2 Consecutive Active Tabs in Week 1 or 2: Take 2 tabs the day remembered and 2 tabs the next day; thereafter, resume taking 1 tab qd until pack is finished. Use backup method of birth control if having intercourse in the 7 days after missing pills
Miss 2 Consecutive Active Tabs in Week 3 or Miss ≥3 Active Tabs in a Row at Any Time: (Sunday Start) Continue to take 1 tab qd until Sunday, then throw out the rest of the pack and start a new pack of pills that same day. (Day 1 Start) Throw out rest of the pack and start new pack the same day. (Sunday/Day 1 Start) Use backup method of birth control if having intercourse in the 7 days after missing pills

Conversions

Switching from a Sunday Start Oral Contraceptive:
Sunday Start:
Take 1st tab on the 2nd Sunday after last tab of a 21-day regimen or take on the 1st Sunday after last inactive tab of a 28-day regimen

Switching Directly from Another Oral Contraceptive:
Day 1 Start:
Take 1st tab on the 1st day of menstruation which begins after last active tab of previous product

PEDIATRIC DOSAGE

Contraception

Not indicated for use premenarche; refer to adult dosing

ADMINISTRATION

Oral route

Take exactly ud and at intervals not exceeding 24 hrs
Use another method of contraception until after the first 7 consecutive days of administration when initiating a Sunday Start regimen

HOW SUPPLIED

Tab: (Ethinyl Estradiol-Desogestrel) 0.02mg-0.15mg, (Ethinyl Estradiol) 0.01mg

CONTRAINDICATIONS

Thrombophlebitis or past history of deep vein thrombophlebitis, thromboembolic disorders (current or past history), suspected/known pregnancy, cerebral vascular or coronary artery disease, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, known/suspected breast carcinoma, carcinoma of the endometrium or other known/suspected estrogen-dependent neoplasia, hepatic adenomas or carcinomas.

WARNINGS/PRECAUTIONS

Increased risk of MI, vascular disease, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease. Increased risk of morbidity and mortality with HTN, hyperlipidemias, obesity, and diabetes mellitus (DM). D/C at least 4 weeks prior to and for 2 weeks after elective surgery associated with an increased risk of thromboembolism and during and following prolonged immobilization, if feasible. Start use no earlier than 4 weeks after delivery in women who elect not to breastfeed. Caution in women with CV disease risk factors. May develop visual changes or changes in lens tolerance in contact lens wearers. Retinal thrombosis reported; d/c if unexplained partial or complete loss of vision, onset of proptosis or diplopia, papilledema, or retinal vascular lesions develop. Should not be used to induce withdrawal bleeding as a test for pregnancy, or to treat threatened or habitual abortion during pregnancy. May decrease glucose tolerance; monitor prediabetic and diabetic patients. May elevate BP; monitor closely and d/c use if significant BP elevation occurs. New onset/exacerbation of migraine, or recurrent, persistent, severe headache may develop; d/c if these occur. Breakthrough bleeding and spotting reported; rule out malignancy or pregnancy. D/C if jaundice develops. May be poorly metabolized in patients with impaired liver function. May cause fluid retention; caution with conditions that aggravate fluid retention. Caution with history of depression; d/c if depression recurs to a serious degree. Does not protect against HIV infection (AIDS) and other STDs. Perform annual history/physical exam; monitor women with history of breast cancer. Not for use before menarche. May affect certain endocrine, LFTs, and blood components in laboratory tests.

ADVERSE REACTIONS

N/V, breakthrough bleeding, spotting, amenorrhea, migraine, mental depression, vaginal candidiasis, edema, weight changes, abdominal cramps/bloating, menstrual flow changes, pulmonary embolism, MI, HTN.

DRUG INTERACTIONS

Reduced efficacy and increased breakthrough bleeding and menstrual irregularities with rifampin, barbiturates, phenylbutazone, phenytoin sodium, carbamazepine, and possibly with griseofulvin, ampicillin, and tetracyclines. May decrease lamotrigine levels; dosage adjustment of lamotrigine may be necessary.

PREGNANCY AND LACTATION

Category X, not for use in nursing.

MECHANISM OF ACTION

Estrogen/progestogen combination; acts by suppressing gonadotropins, primarily inhibiting ovulation, and causing other alterations, including changes in cervical mucus (increases difficulty of sperm entry into uterus) and endometrium (reduces likelihood of implantation).

PHARMACOKINETICS

Absorption: Rapid and almost complete. Relative bioavailability 100% (Desogestrel), 93-99% (Ethinyl estradiol). Oral administration on various days during dosing led to altered parameters; refer to PI. Distribution: Found in breast milk. Etonogestrel: Plasma protein binding (99%), sex hormone-binding globulin (primary). Ethinyl estradiol: Plasma albumin binding (98.3%). Metabolism: Desogestrel: Etonogestrel (active metabolite). Liver and intestinal mucosa via hydroxylation, glucuronidation, and sulfate conjugation. Ethinyl estradiol: Conjugation. Elimination: Urine, bile, feces. Etonogestrel: T1/2=27.8 hrs. Ethinyl estradiol: T1/2=23.9 hrs (combination), 18.9 hrs (0.01mg).

ASSESSMENT

Assess for current or history of thrombophlebitis or thromboembolic disorders, history of HTN, hyperlipidemia, DM, obesity, breast cancer, nursing status, or any other conditions where treatment is contraindicated/cautioned, and possible drug interactions.

MONITORING

Monitor for MI, thromboembolism, stroke, hepatic neoplasia, and other adverse effects. Monitor BP with history of HTN, serum glucose levels in diabetic or prediabetic patients, lipid levels with hyperlipidemia, and for signs of worsening depression with previous history. Refer contact lens wearer to ophthalmologist if ocular changes develop. Perform annual history and physical exam. Monitor women with strong family history of breast cancer or who have breast nodules. Monitor LFTs, PT, thyroxine binding-globulin, T3 and T4, and serum folate levels.

PATIENT COUNSELING

Counsel about potential adverse effects, and to avoid smoking while on therapy. Inform that drug does not protect against HIV infection and other STDs. Inform about pregnancy risk if pills are missed. Instruct to take at the same time every day and that intervals between doses should not exceed 24 hrs. Instruct that when initiating a Sunday Start regimen, to use another method of contraception until after first 7 consecutive days of administration. Instruct if one "active" pill is missed to take as soon as remembered, and take next pill at regular time.

STORAGE

20-25°C (68-77°F).

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