Ethinyl estradiol / norgestrel

Prevention of pregnancy in females who choose an oral contraceptive. Safety/efficacy extend to postpubertal adolescents; not indicated before menarche or after menopause. It does not prevent HIV or other sexually transmitted infections. Norgestrel is not norethindrone, and this estrogen-containing product is not the OTC progestin-only norgestrel pill.

One white active tablet daily for 21 days, then one light-green inert tablet daily for 7 days, at the same time; begin the next pack immediately after the last placebo. PI Sunday start: first Sunday after menstruation begins, or that day if Sunday; use nonhormonal backup during the first 7 active-pill days. Patient Instructions also permit Day 1 start within 24 hours of period onset without backup. CDC permits clinician-directed initiation when reasonably certain not pregnant; if > 5 days after bleeding began, backup 7 days. Agree which initiation plan applies.

One active missed: take promptly, next at usual time, backup 7 days. Two consecutive active pills missed in weeks 1–2: two pills on the remembered day and two next day, then one daily; backup 7 days. Two in week 3 or ≥ 3 active pills missed: the selected Instructions say continue one daily until Sunday, then discard/start a new pack that Sunday; backup 7 days. Missed placebo: discard it and stay on schedule, no backup if next pack starts on time. Within 3–4 hours of vomiting/diarrhea, patient Instructions advise another same-color pill; if GI illness lasts > 1 day use extra contraception and consult. These are exact selected-pack instructions, distinct from CDC guidance below.

One active pill late or missed with < 48 hours since due: take promptly and continue; usually no backup. ≥ 2 consecutive missed with ≥ 48 hours since due: take only the most recent missed, discard earlier missed pills, continue and use backup until 7 consecutive active-pill days. If in the last active week, omit the hormone-free interval and start the next pack immediately. Consider emergency contraception for first-week misses plus unprotected sex in the preceding 5 days; ulipristal requires a separate restart plan. For vomiting/diarrhea < 48 hours, CDC generally advises no redose/backup; ≥ 48 hours requires backup until 7 active-pill days after recovery, with final-week interval omission and emergency-contraception assessment when relevant. Follow one clinician-agreed pathway rather than blend it with the product’s different algorithm.

Label: transition from a 21-day pill course after 7 pill-free days; from a 28-day course the next day without a gap. Other-method timing and 7-day backup depend on the method; use the exact Instructions and clinician plan. CDC adds residual-sperm protection when removing an IUD, such as retaining it 7 days after starting COCs or appropriate prior barrier/abstinence/emergency contraception. Label nonlactating postpartum or after second-trimester abortion: no earlier than day 28, backup 7 days; first-trimester abortion/miscarriage can start immediately without backup. CDC postpartum eligibility further depends on breastfeeding and VTE risk; day 28 alone is not universal clearance.

Current Cryselle PI provides no renal dose formula. Liver disease/tumors can contraindicate use; do not reduce tablets to bypass that restriction. Continuous-cycle, high-estrogen Ogestrel or emergency-contraception dosing is not inferred from this 21-plus 7 pack. Persistent bleeding needs assessment rather than dose escalation.

High arterial/venous thrombotic risk, including smoking over 35, current/past DVT/PE, thrombophilia, cerebrovascular/coronary disease, thrombogenic cardiac disease, uncontrolled hypertension or vascular-disease diabetes. Migraine aura/focal neurologic headache at any age and any migraine over 35; liver disease or benign/malignant liver tumors; unexplained abnormal uterine bleeding; pregnancy; current/past breast cancer; ingredient hypersensitivity; ombitasvir/paritaprevir/ritonavir HCV combinations with/without dasabuvir. Warning text also prohibits hypertension with vascular disease. Eligibility requires full clinical assessment.

Cigarette smoking increases serious cardiovascular-event risk; risk rises with age and number smoked. Cryselle is contraindicated in women over 35 who smoke. CDC’s general smoking categories do not negate this exact product prohibition.

Common COC effects include irregular bleeding, nausea, breast tenderness and headache; Cryselle studies also report weight changes, acne, cramps/bloating, discharge and mood symptoms. Serious vascular/hepatic events and rare severe allergy are described; spontaneous reports cannot establish incidence or causality. Overdose can cause nausea/withdrawal bleeding; obtain medical or Poison Help advice, especially after a child’s exposure.

CYP-inducing drugs/herbals such as rifampin/rifabutin, selected antiseizure drugs, bosentan, griseofulvin, aprepitant or St John’s wort can reduce hormone exposure; use alternative or backup contraception during exposure and 28 days afterward. Separate colesevelam by 4 hours. CYP inhibitors and some HIV/HCV therapies can raise or lower hormone levels; verify the exact regimen. Contraindicated HCV combinations require stopping before treatment; PI allows restart approximately 2 weeks after completion. COCs can lower lamotrigine exposure and seizure control; review supervised dose adjustments, including when estrogen stops. Other affected drugs include cyclosporine, tizanidine, theophylline, prednisolone and voriconazole. Thyroid replacement may need reassessment because binding proteins rise; labs for lipids, coagulation or glucose can change.

Stop if pregnancy is confirmed; COCs are not a pregnancy test or treatment for threatened abortion. Inadvertent early exposure data do not show a clear major-birth-defect increase, but there is no indication to continue. Cryselle advises alternative contraception during breastfeeding when possible until weaning; estrogen can reduce milk production and small amounts reach milk. CDC postpartum categories consider VTE risk and lactation separately; do not assume every postpartum patient is eligible at 4 weeks.

Expected contraceptive efficacy after puberty is comparable below 16 and in older reproductive-age users; not indicated before menarche or in postmenopausal patients. Age> 35 with smoking or migraine changes suitability; age alone is not a numeric dose-reduction instruction.

CDC: migraine aura is category 4; adequately controlled hypertension generally category 3, severe hypertension/vascular disease category 4. Obesity alone is generally category 2, but combined thrombotic risks matter. CHCs are category 4 < 21 days postpartum; subsequent eligibility depends on breastfeeding and VTE risk, not a universal day threshold. These general categories complement the selected label. Cryselle liver disease/tumors remain contraindications; no renal adjustment algorithm is supplied.

The current selected PI states that COCs prevent pregnancy primarily by suppressing ovulation. It supplies no detailed product-specific absorption, protein-binding, elimination half-life or renal/hepatic PK table. Its documented interaction findings do not justify copying levonorgestrel/norethindrone numerical PK or a dose-equivalence calculation into this norgestrel profile.

Measure BP before initiation; assess thrombotic/migraine/smoking history, postpartum/lactation stage and interactions. Follow BP, mood, bleeding and glucose/lipids when clinically indicated. CDC does not require a pelvic exam or routine universal laboratory panel simply to start CHCs in a healthy patient. Assess pregnancy after missed withdrawal bleeding when adherence was poor or after two missed periods despite adherence.

Take the correct pack in sequence without extending the placebo interval; keep a spare pack and the agreed missed-pill/illness plan. Use backup with relevant interactions; seek advice promptly after missed pills/unprotected sex. Avoid smoking and report chest pain, dyspnea, unilateral leg swelling, severe headache/weakness, visual changes or jaundice urgently. This pill does not prevent STIs; condoms provide additional protection. Discuss surgery, pregnancy or breastfeeding before continuing.

Current Teva Cryselle: 21 white active round tablets, C33 / TV, each norgestrel 0.3 mg + EE0.03 mg; 7 light-green inert tablets, T / PL2. NDC0480-3493-16 carton of 6 blister-card dispensers. Verify the actual card and current patient Instructions.

Current selected Cryselle and Low-Ogestrel 28 active strength is norgestrel 0.3 mg + EE0.03 mg (30 mcg), with 21 active/7 inert tablets. Low-Ogestrel uses white WATSON847 actives and peach WATSONP1 placebos, not Cryselle’s colors. FDA currently lists Cryselle 21/28 Prescription, Low-Ogestrel 21 Discontinued/28 Prescription; Ogestrel 0.5 mg/50 mcg 21/28 Discontinued. No executable regimen for discontinued higher-strength products or progestin-only OTC norgestrel is supplied.

Store selected Cryselle at 20–25°C and keep in its ordered blister card, away from children. Do not rearrange actives/placebos or transfer another brand’s tablet colors/imprints as this pack’s directions. Follow the exact dispensed product’s labeling.