LOGYNON TAB 21/TAB

Indications

Approved Uses

Oral contraception (prevention of pregnancy).

Dosage & Administration

Dosing by Condition

Contraception: 1 tablet orally daily for 21 consecutive days in the blister-pack order, followed by a 7-day tablet-free interval, then repeat with the next pack.

Initial Dose

One tablet daily starting on Day 1 of menstrual cycle, taken in the correct phase order

Maintenance Dose

One tablet daily for 21 days followed by 7 tablet-free days

Maximum Dose

1 tablet orally once daily (do not exceed 1 tablet per 24 hours for routine use).

Children's Dosage

Not approved for pre-menarchal children; approved for post-menarchal adolescents at the same adult dose

Dose Adjustment Notes

No routine dose adjustment is recommended; combined oral contraceptives are contraindicated in severe hepatic disease and should be avoided with active serious liver disease/cholestasis.

How to Take

Take 1 tablet orally once daily at the same time each day, following the order indicated on the 21-tablet blister (arrows/sequence); take tablets for 21 consecutive days, then have a 7-day tablet-free interval, then start the next pack.

Side Effects

Common Side Effects

Nausea (± vomiting), headache, breast tenderness, breakthrough bleeding/spotting, mood changes, and weight change/bloating.

Side Effect Frequency

Very common/common: nausea, headache, breast tenderness, breakthrough bleeding/spotting; Common: mood changes, changes in libido, fluid retention/bloating, weight change, acne; Uncommon/Rare but serious: venous thromboembolism (DVT/PE), arterial thrombosis (MI/stroke), hypertension, migraine worsening, cholestasis/gallbladder disease, and very rare hepatic tumors (e.g., hepatic adenoma).

Safety & Warnings

Contraindications

Contraindicated in: current/history of venous thromboembolism or arterial thromboembolism (e.g., DVT/PE, stroke, MI); known thrombophilia; migraine with aura; uncontrolled hypertension or multiple major cardiovascular risk factors; current/history of breast cancer or other estrogen/progestin‑sensitive malignancy; liver tumors or severe/active hepatic disease; undiagnosed abnormal genital bleeding; pregnancy; hypersensitivity to components; and women >35 years who smoke. Also contraindicated with ombitasvir/paritaprevir/ritonavir ± dasabuvir (HCV regimen) due to ALT elevations.

Warnings & Precautions

Warn about thromboembolism risk (higher with smoking and age >35) and to stop/seek care for symptoms of clot or stroke; monitor blood pressure; discontinue prior to major surgery with prolonged immobilization and during prolonged immobilization; does not protect against HIV/STIs; use caution in hypertriglyceridemia, diabetes, depression, and gallbladder/liver disease; evaluate significant headaches/visual changes and abnormal bleeding.

Age Restriction

Not indicated before menarche; may be used in adolescents after menarche when contraception is needed (no specific minimum age otherwise).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: strong enzyme inducers reduce efficacy (rifampin/rifabutin; certain anticonvulsants such as carbamazepine, phenytoin, phenobarbital, primidone, topiramate, oxcarbazepine; St. John’s wort; some antiretrovirals); HCV regimen ombitasvir/paritaprevir/ritonavir ± dasabuvir is contraindicated; lamotrigine levels can decrease; ethinylestradiol may increase ciclosporin exposure; thyroid hormone dose may need adjustment; broad-spectrum antibiotics generally do not reduce efficacy except rifamycins (routine backup not required unless vomiting/diarrhea).

Interaction Severity

MAJOR: Strong enzyme inducers (e.g., rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital/primidone, topiramate at higher doses, St. John’s wort) reduce contraceptive efficacy; MODERATE: some antiretrovirals and certain antibiotics/antifungals may alter hormone exposure-use backup if clinically indicated; SPECIAL/CONTRAINDICATED: ethinylestradiol-containing COCs should not be used with ombitasvir/paritaprevir/ritonavir ± dasabuvir due to ALT elevations.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Children

Not approved for pre-menarchal children; approved for post-menarchal adolescents at the same adult dose

Elderly

Not applicable - combined oral contraceptives are not indicated post-menopause

Liver Impairment

No dose adjustment is recommended; use is contraindicated in active/severe hepatic disease or hepatic tumors and should be stopped if significant liver dysfunction develops.

Storage & Patient Advice

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.

Missed Dose

If 1 active tablet is missed (<48 hours since a pill should have been taken): take it as soon as remembered and continue the rest as scheduled (may take 2 in one day); no backup needed. If ≥2 active tablets are missed (≥48 hours): take the most recent missed tablet ASAP, continue daily, and use backup contraception for 7 days; if misses occur in the last week of active tablets, omit the 7-day break and start the next pack immediately.

Overdose

Overdose is usually not life-threatening; possible symptoms include nausea, vomiting, breast tenderness, dizziness, and withdrawal/vaginal bleeding-manage with supportive care and seek medical attention/poison center advice for large ingestions.

Patient Counseling

Take 1 tablet by mouth once daily at the same time each day for 21 consecutive days, then have a 7‑day tablet‑free interval and start the next pack on day 8 (withdrawal bleeding usually occurs during the break). If a tablet is missed, follow the package leaflet; as a practical rule, if >12 hours late, take the missed tablet as soon as remembered, continue the pack, and use backup contraception (e.g., condoms) for the next 7 days (and consider emergency contraception if unprotected sex occurred in the first week). This product does not protect against STIs/HIV. Avoid smoking (especially age >35) due to increased thrombotic/cardiovascular risk. Seek urgent care for symptoms of thrombosis or stroke (e.g., unilateral leg swelling/pain, chest pain, shortness of breath, sudden severe headache, vision/speech changes). Check for drug interactions that reduce efficacy (enzyme inducers such as rifampicin/rifabutin, certain antiepileptics, some antiretrovirals, and St John’s wort).

Monitoring Requirements

Check blood pressure before initiation and periodically (at least annually); assess VTE/cardiovascular risk factors and smoking status; routine cervical screening and breast screening per national programs; evaluate for new severe headaches, visual symptoms, or signs of thrombosis/liver dysfunction.

Pharmacology

Mechanism of Action

Suppresses ovulation by inhibiting 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, contraceptive protection is immediate. If started on days 2-5 of menses, use backup contraception for the first 7 days. If started at any other time in the cycle, use backup contraception for the first 7 days and ensure the patient is not pregnant.

Duration of Effect

Contraceptive effect is maintained continuously with correct daily dosing (one tablet every 24 hours) and across the standard 7-day hormone-free interval; the hormone-free interval should not exceed 7 days. If active tablets are missed, protection may be reduced.

Half-Life

Ethinylestradiol: ~12-23 hours; Levonorgestrel: ~20-24 hours (some references report a wider range up to ~49 hours depending on assay/population).

Metabolism

Both are extensively metabolized in the liver: ethinylestradiol mainly via CYP3A4-mediated oxidation plus conjugation (sulfation/glucuronidation) with enterohepatic recirculation; levonorgestrel mainly via reduction/oxidation (including CYP3A4 involvement) followed by conjugation (glucuronide/sulfate).

Protein Binding

Levonorgestrel: 97.5-99% (mainly to SHBG). Ethinylestradiol: >95% (mainly to albumin).

Product Information

Available Dosage Forms

Tablet (oral use), 21-tablet blister pack.

Composition per Dose

Each tablet (Phase 3 / this SKU): Ethinylestradiol 30µg + Levonorgestrel 125µg. Note: Logynon is a triphasic product - Phase 1 (6 tablets): Ethinylestradiol 30µg + Levonorgestrel 50µg; Phase 2 (5 tablets): Ethinylestradiol 40µg + Levonorgestrel 75µg; Phase 3 (10 tablets): Ethinylestradiol 30µg + Levonorgestrel 125µg

Generic Availability

Yes

OTC Alternatives

No OTC alternative for prescription hormonal contraception; barrier methods (condoms) available OTC

Hormone Type

Combined

Method

Oral

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