EVRA TRANSDERMAL 3 PATCHES

Indications

Approved Uses

Prevention of pregnancy (contraception) in women of reproductive age

Dosage & Administration

Dosing by Condition

Contraception: Apply 1 patch once weekly for 3 consecutive weeks (21 days), then have a 7-day patch-free interval; start the next cycle with a new patch on the same weekday (patch change day).

Initial Dose

Apply one patch on the first day of the menstrual cycle or the first Sunday after the menstrual period begins. If starting after day 1 of the cycle, use non-hormonal backup contraception for the first 7 days.

Maintenance Dose

One patch per week for 3 consecutive weeks, followed by one patch-free week; cycle repeated continuously

Maximum Dose

Maximum: apply only ONE patch at a time; each patch is worn for 7 days (weekly), followed by a patch-free week after 3 consecutive weeks.

Children's Dosage

Safety and efficacy are established in post-pubertal adolescents aged 18 and above; the same dosage is recommended. Use before menarche is not indicated.

How to Take

Apply to clean, dry, intact skin on the buttock, abdomen, upper outer arm, or upper torso (avoid breasts). Press firmly with the palm for ~10 seconds to ensure full contact, especially at the edges. Do not apply to red/irritated/cut skin, do not use creams/lotions/powders at the site, rotate sites, and do not cut/alter the patch; it may be worn during bathing, swimming, and exercise-check daily that it remains fully adhered.

Side Effects

Common Side Effects

Common: application-site reactions (irritation/erythema/pruritus), breast tenderness, headache, nausea, abdominal pain/cramps, mood changes, and breakthrough bleeding/spotting.

Side Effect Frequency

Very common (≥10%): application-site reactions, breast symptoms (tenderness/discomfort), headache, nausea. Common (1-10%): menstrual irregularities/breakthrough bleeding, abdominal pain, mood changes, dizziness, weight gain; acne and GI upset (vomiting/diarrhea) may occur. Serious events such as venous thromboembolism are rare/uncommon but clinically important.

Safety & Warnings

Contraindications

Contraindications include: current/history of VTE or ATE (e.g., DVT/PE, stroke, MI) or high-risk thrombophilia; migraine with aura; breast cancer or other estrogen/progestin-sensitive malignancy; severe hepatic disease or liver tumors; uncontrolled hypertension; diabetes with vascular disease; undiagnosed abnormal uterine bleeding; pregnancy; hypersensitivity to components; women >35 years who smoke; and concomitant use with hepatitis C regimens containing ombitasvir/paritaprevir/ritonavir (± dasabuvir) due to ALT elevations.

Warnings & Precautions

Key warnings/precautions: increased risk of VTE/ATE (higher in smokers; contraindicated if >35 and smoking); monitor blood pressure and discontinue if significant hypertension; stop before major surgery with prolonged immobilization; does not protect against STIs; possible reduced efficacy in higher body weight (e.g., >90 kg); monitor for depression/mood changes; risk of chloasma; and counsel on patch adhesion/detachment management.

Drug Interactions

Drug Interactions

Clinically important interactions: enzyme/CYP3A inducers (e.g., rifampin/rifabutin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate, St. John’s wort) can reduce efficacy; certain antiretrovirals may alter hormone exposure; lamotrigine levels can be reduced (loss of seizure control); and ombitasvir/paritaprevir/ritonavir (± dasabuvir) is contraindicated due to ALT elevations.

Food Interaction

No clinically meaningful food restrictions; grapefruit/grapefruit juice is not a standard clinically significant interaction for the transdermal ethinylestradiol/norelgestromin patch.

Special Populations

Pregnancy

Contraindicated

Children

Safety and efficacy are established in post-pubertal adolescents aged 18 and above; the same dosage is recommended. Use before menarche is not indicated.

Elderly

Not applicable - indicated for women of reproductive age only; not used post-menopause

Kidney Impairment

No renal dose adjustment recommended.

Liver Impairment

Contraindicated in active/severe hepatic disease or hepatic tumors; no dose adjustment is provided-discontinue if jaundice or clinically significant LFT abnormalities develop.

Storage & Patient Advice

Missed Dose

If the patch is off/forgotten for <24 hours: reapply or replace immediately; no backup needed; keep the same patch change day. If off/forgotten for ≥24 hours or unknown: apply a new patch immediately, start a new 4-week cycle (new patch change day), and use backup non-hormonal contraception for 7 days. If the patch-free interval exceeds 7 days: apply a new patch immediately, start a new cycle, and use backup for 7 days.

Stopping the Medicine

Can be stopped at any time; fertility typically returns quickly after discontinuation-if stopping and pregnancy is not desired, start an alternative contraceptive method immediately.

Overdose

Overdose is unlikely but may cause nausea/vomiting, breast tenderness, dizziness/abdominal pain, and withdrawal bleeding; remove any patches and provide symptomatic/supportive care and seek medical attention as needed.

Patient Counseling

Use 1 patch weekly for 3 weeks then 1 patch-free week; change on the same weekday each week. Apply to clean, dry intact skin on buttock/abdomen/upper outer arm/upper torso (not breasts), press firmly ~10 seconds, rotate sites, avoid lotions at the site, and check daily adhesion. Not protective against STIs. Counsel on VTE warning signs and to avoid smoking (especially age >35). Dispose by folding sticky sides together and keep in pouch; store below 25°C (SFDA).

Pharmacology

Mechanism of Action

Transdermal delivery of ethinylestradiol and norelgestromin suppresses ovulation via inhibition of gonadotropins (FSH/LH), thickens cervical mucus, and induces endometrial changes that reduce the likelihood of implantation.

Onset of Action

If started on Day 1 of menses, contraception is immediate; if started at any other time, use backup contraception for 7 days.

Duration of Effect

Each patch provides contraceptive hormone delivery for 7 days when properly adhered; protection is maintained across the 3 consecutive weekly patches when used as directed.

Bioavailability

Absolute bioavailability values are not reliably standardized for this patch in routine references; clinically, transdermal delivery avoids first-pass metabolism and provides sustained systemic exposure comparable to oral CHCs-do not quote fixed % bioavailability without product-specific data.

Excretion

Elimination occurs via both renal and fecal/biliary routes, mainly as metabolites/conjugates (ethinylestradiol via urine and bile; norelgestromin metabolites via urine and feces).

Product Information

Available Dosage Forms

Transdermal patch

Composition per Dose

Each transdermal patch: Ethinylestradiol 0.6mg + Norelgestromin 6mg (delivers approximately 20 mcg ethinylestradiol and 150 mcg norelgestromin per 24 hours over 7 days)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Hormone Type

Combined

Method

Patch

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