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Yasmin (drospirenone/ethinyl estradiol)

BOXED WARNING

Cigarette smoking increases the risk of serious cardiovascular (CV) events. Risk increases w/ age (>35 yrs of age) and w/ the number of cigarettes smoked. Should not be used by women who are >35 yrs of age and smoke.

OTHER BRAND NAMES

Ocella, Syeda

THERAPEUTIC CLASS

Estrogen/progestogen combination

DEA CLASS

RX

INDICATIONS

Prevention of pregnancy.

ADULT DOSAGE

Contraception

1 tab qd at the same time each day for 28 days, then repeat

Start either on 1st day of menses or on 1st Sunday after onset of menses

Conversions

Switching from a Different Birth Control Pill:
Start on the same day that a new pack of the previous oral contraceptive would have been started

Switching from a Method Other Than a Birth Control Pill:
Transdermal Patch/Vaginal Ring/Inj: Start when the next application or dose would have been due
Intrauterine Contraceptive/Implant: Start on day of removal

PEDIATRIC DOSAGE

Contraception

Not indicated for use premenarche; refer to adult dosing

DOSING CONSIDERATIONS

Adverse Reactions
GI Disturbances: In case of severe vomiting/diarrhea, absorption may not be complete and additional contraceptive measures should be taken; if vomiting occurs w/in 3-4 hrs after taking tab, may regard as missed dose

Other Important Considerations
Postpartum Women Who Elect Not to Breastfeed/After a 2nd Trimester Abortion:
Start therapy no earlier than 4 weeks postpartum. If patient initiates therapy postpartum and has not yet had a period, evaluate for possible pregnancy and instruct to use an additional method of contraception until patient has taken 7 consecutive days of therapy

ADMINISTRATION

Oral route

Take tabs in the order directed on the package, preferably after pm meal or at hs w/ some liquid, prn.
Take w/o regard to meals.
If 1st taken later than the 1st day of menstrual cycle, use a nonhormonal contraceptive as back-up during the first 7 days of therapy.
Take single missed pills as soon as remembered.

HOW SUPPLIED

Tab: (Drospirenone [DRSP]/Ethinyl Estradiol [EE]) 3mg/0.03mg

CONTRAINDICATIONS

Renal impairment, adrenal insufficiency, high risk of arterial/venous thrombotic diseases (eg, smoking if >35 yrs of age, presence/history of deep vein thrombosis/pulmonary embolism, cerebrovascular disease, coronary artery disease, thrombogenic valvular or thrombogenic rhythm diseases of the heart [eg, subacute bacterial endocarditis w/ valvular disease, or A-fib], inherited/acquired hypercoagulopathies, uncontrolled HTN, diabetes mellitus w/ vascular disease, headache w/ focal neurological symptoms or migraine w/ or w/o aura if >35 yrs of age), undiagnosed abnormal uterine bleeding, presence/history of breast cancer or other estrogen/progestin-sensitive cancer, benign/malignant liver tumors, liver disease, pregnancy.

WARNINGS/PRECAUTIONS

Increased risk of venous thromboembolism (VTE) and arterial thromboses (eg, stroke, MI). D/C if an arterial/venous thrombotic event occurs. If feasible, d/c at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. D/C if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions; evaluate for retinal vein thrombosis immediately. Potential for hyperkalemia in high-risk patients; contraindicated in patients predisposed to hyperkalemia. May increase risk of cervical cancer or intraepithelial neoplasia, and gallbladder disease. D/C if jaundice develops. May increase risk of hepatic adenomas and hepatocellular carcinoma. Cholestasis may occur w/ history of pregnancy-related cholestasis. Women w/ a history of combination oral contraceptive (COC)-related cholestasis may have the condition recur w/ subsequent COC use. Increased BP reported; d/c if BP rises significantly. May decrease glucose tolerance; monitor prediabetic and diabetic women. Consider alternative contraception w/ uncontrolled dyslipidemia. May increase risk of pancreatitis w/ hypertriglyceridemia or family history thereof. Evaluate the cause and d/c if indicated, if new headaches that are recurrent, persistent, or severe develop. Increase in frequency/severity of migraines may be a reason for immediate discontinuation of therapy. Unscheduled bleeding and spotting may occur; rule out pregnancy or malignancy. Post-pill amenorrhea or oligomenorrhea may occur. Caution w/ history of depression; d/c if depression recurs to a serious degree. May change results of some lab tests (eg, coagulation factors, binding proteins). Exogenous estrogens may induce/exacerbate angioedema in women w/ hereditary angioedema. Chloasma may occur, especially w/ a history of chloasma gravidarum; avoid sun or UV radiation exposure in women w/ a tendency to chloasma.

ADVERSE REACTIONS

Premenstrual syndrome, headache/migraine, breast pain/tenderness/discomfort, N/V, irregular uterine bleeding.

DRUG INTERACTIONS

Potential for an increase in serum K+ concentration w/ other drugs that may increase serum K+ concentration (eg, ACE inhibitors, heparin, aldosterone antagonists, NSAIDs); monitor serum K+ concentrations during 1st treatment cycle in women receiving daily, long-term treatment for chronic conditions or diseases w/ medications that may increase serum K+ concentration. Consider monitoring serum K+ concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly. Drugs or herbal products that induce certain enzymes, including CYP3A4 (eg, phenytoin, bosentan, products containing St. John's wort) may decrease effectiveness or increase breakthrough bleeding; use an alternative method of contraception or a back-up method when enzyme inducers are used, and continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Atorvastatin may increase EE exposure; ascorbic acid and acetaminophen may increase EE levels. Moderate or strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, diltiazem, grapefruit juice) may increase plasma concentrations of estrogen or progestin or both. Significant changes (increase/decrease) in plasma estrogen and progestin levels noted in some cases w/ HIV/hepatitis C virus protease inhibitors or non-nucleoside reverse transcriptase inhibitors. Pregnancy reported w/ antibiotics. May decrease levels of lamotrigine and reduce seizure control; dosage adjustments of lamotrigine may be necessary. May need to increase dose of thyroid hormone in patients on thyroid hormone replacement therapy due to increased levels of thyroid-binding globulin. May increase plasma levels of CYP3A4 substrates (eg, midazolam), CYP2C19 substrates (eg, omeprazole, voriconazole), and CYP1A2 substrates (eg, theophylline, tizanidine). 

PREGNANCY AND LACTATION

Contraindicated in pregnancy, not for use in nursing.

MECHANISM OF ACTION

Estrogen/progestogen oral contraceptive; acts primarily by suppressing ovulation. Also causes cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

PHARMACOKINETICS

Absorption: DRSP: Absolute bioavailability (76%); (Cycle 13/Day 21) Cmax=78.7ng/mL; Tmax=1.6 hrs; AUC=968ng•h/mL. EE: Absolute bioavailability (40%); (Cycle 13/Day 21) Cmax=90.5pg/mL; Tmax=1.6 hrs; AUC=469pg•h/mL. Distribution: Found in breast milk. DRSP: Vd=4L/kg, plasma protein binding (97%). EE: Vd=4-5L/kg; plasma protein binding (98.5%). Metabolism: DRSP: Reduction, subsequent sulfation, oxidation catalyzed by CYP3A4. EE: Gut and liver (1st-pass), conjugation w/ glucuronide or sulfate, hydroxylation (via CYP3A4). Elimination: DRSP: Urine, feces; T1/2=30 hrs. EE: Urine, feces; T1/2=24 hrs.

Refer to PI for additional parameters.

ASSESSMENT

Assess for renal impairment, abnormal uterine bleeding, adrenal insufficiency, pregnancy/nursing status, any other conditions where treatment is contraindicated or cautioned, and possible drug interactions.

MONITORING

Monitor for bleeding irregularities, venous/arterial thrombotic events, cervical cancer or intraepithelial neoplasia, retinal vein thrombosis or any other ophthalmic changes, jaundice, new/worsening headaches or migraines, depression, cholestasis w/ history of pregnancy-related cholestasis, pancreatitis, and other adverse reactions. Monitor thyroid function if receiving thyroid replacement therapy, glucose levels in diabetic or prediabetic patients, lipid levels w/ dyslipidemia, and BP in patients w/ HTN. Monitor serum K+ levels during the 1st treatment cycle in women receiving daily, long-term treatment for chronic conditions or diseases w/ medications that may increase serum K+ concentration. Conduct a yearly visit in all patients for a BP check and for other indicated healthcare.

PATIENT COUNSELING

Inform of risk/benefits of therapy. Counsel that cigarette smoking increases the risk of serious CV events. Inform of the risk of VTE. Advise that drug does not protect against HIV infection and other STDs. Instruct to take ud. Counsel on what to do if pills are missed or if vomiting occurs w/in 3-4 hrs after taking tab. Advise to inform physician of all concomitant medications and herbal supplements currently being taken. Inform that amenorrhea may occur and pregnancy should be ruled out if amenorrhea occurs in ≥2 consecutive cycles. Counsel to use a back-up or alternative method of contraception when enzyme inducers are used w/ therapy. Inform that therapy may reduce breast milk production. Counsel women who start therapy postpartum and have not yet had a period to use an additional method of contraception until drug is taken for 7 consecutive days. Instruct to d/c if pregnancy occurs during treatment.

STORAGE

(Syeda) 20-25°C (68-77°F). (Yasmin, Ocella) 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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