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SRONYX Levonorgestrel and Ethinyl Estradiol Kit

by Mayne Pharma Inc. · 6 BLISTER PACK in 1 CARTON (51862-545-06) / 1 KIT in 1 BLISTER PACK (51862-545-01)
NDC 51862-0545-06
🏷️ FDA NDC (as labeled) 51862-545-06 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 51862-545-06
Product NDC 51862-545
11-digit billing NDC 51862054506
NCPDP billing unit EA — each (per item)
RxCUI 242297, 748797, 748868, 753544
Application # ANDA077681
SPL Set ID b0c1a495-4cd7-4664-8fe4-714812f53c71
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2016-08-03
Dosage form KIT
GPI-14 25990002400305
GPI class Sronyx
GCN Seq No 030986
GCN 11534
HICL code 001460
Ingredient (HICL) Levonorgestrel/Ethin.estradiol
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name SRONYX 0.10-0.02 MG TABLET
FDB brand name Sronyx
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB2 · RLD · RS
Why two NDCs? The FDA registers this code as 51862-545-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51862-0545-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Estrogen class.

Pharmacologic class Estrogen
Drug family (ATC) Progestogens and estrogens, sequential preparations, Natural and semisynthetic estrogens, plain, Estrogens
How it works Estrogen Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMayne Pharma Inc.
Application holderDR REDDYS LABORATORIES SA
FDA applicationANDA077681 (ANDA)
Labeler code51862
First marketedAug 2016
Product typeHuman Prescription Drug
Portfolio29 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SRONYX 0.10-0.02 MG TABLET Ingredient Levonorgestrel/Ethin.estradiol
📗 Our plain-language guide HelloPharmacist
  • It prevents pregnancy mainly by stopping your ovaries from releasing an egg. It also thickens the cervical mucus so sperm can't easily get through, and changes the uterine lining a...
  • What exactly does this medication do, and how well does it work?
  • The most common ones in the first few months are headaches, nausea, irregular bleeding or spotting, breast tenderness, and mood changes. Most of these tend to settle down after you...
  • Are there any side effects I should expect when I first start?
📖 Read our full Ethinyl Estradiol / Levonorgestrel guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.174 $1.04 / 6 kit
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 May 2022 Oct 2022 Jan 2026 $0.248 $0.173
▼ Down 14% over the last 17 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Altavera 70700-0116-85 Xiromed, 1 kit $0.113 AB Availability likely save 35%
Ayuna 65862-0848-88 Aurobindo 3 pouches $0.113 AB Availability likely save 35%
Levonorgestrel And Ethinyl Estradiol 00378-6550-53 Mylan 3 pouches $0.113 AB Discontinued save 35%
Chateal EQ 50102-0230-23 Afaxys 3 pouches $0.113 AB Availability likely save 35%
Marlissa 68462-0388-29 Glenmark 1 kit $0.113 AB Availability likely save 35%
Kurvelo 68180-0844-73 Lupin 63 tablets $0.113 AB Availability likely save 35%
Portia 00555-9020-58 Teva 6 pouches $0.113 — Availability likely save 35%
Daysee 68180-0846-13 Lupin 2 pouches $0.125 AB Availability likely save 28%
Levora 51862-0097-06 Mayne 1 kit $0.145 AB Discontinued save 17%
Lessina 00555-9014-67 Teva 3 pouches $0.151 — Availability likely save 13%
Aubra EQ 50102-0220-23 Afaxys 3 pouches $0.151 AB1 Availability likely save 13%
Levonorgestrel and Ethinyl Estradiol 68180-0854-73 Lupin 1 kit $0.151 AB1 Availability likely save 13%
Levonorgestrel And Ethinyl Estradiol 00378-7287-53 Mylan 3 pouches $0.151 AB1 Availability likely save 13%
Aviane 00555-9045-58 Teva 6 pouches $0.151 — Availability likely save 13%
Vienva 70700-0118-85 Xiromed, 1 kit $0.151 AB1 Availability likely save 13%
Falmina 16714-0359-01 Northstar 1 packet $0.151 AB1 Availability likely save 13%
Lutera 51862-0028-06 Mayne 1 kit $0.152 AB1 Discontinued save 13%
Sronyxthis 51862-0545-06 Mayne 1 kit $0.174 AB2 Discontinued —
Introvale 70700-0117-87 Xiromed, 1 kit $0.184 AB FDA listed +6%
Setlakin 16714-0366-03 Northstar 3 pouches $0.221 AB Availability likely +27%
Levonorgestrel and Ethinyl Estradiol 68180-0843-13 Lupin 1 kit $0.221 AB Availability likely +27%
levonorgestrel and ethinyl estradiol 68462-0672-95 Glenmark 3 pouches $0.221 AB Availability likely +27%
Afirmelle 65862-0849-88 Aurobindo 3 pouches $0.225 AB1 FDA listed +29%
Iclevia 65862-0865-83 Aurobindo 3 pouches $0.227 AB FDA listed +30%
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol 68180-0848-13 Lupin 2 pouches $0.239 AB Availability likely +38%
Levonest 16714-0340-01 Northstar 1 packet $0.339 AB Availability likely +95%
Levonorgestrel and Ethinyl Estradiol 68180-0857-73 Lupin 1 kit $0.339 AB Availability likely +95%
Tyblume 00642-7471-01 Exeltis 1 kit $0.828 — Availability likely +375%
levonorgestrel and ethinyl estradiol 42192-0623-03 Acella 1 kit $3.442 AB3 Availability likely +1877%
Levonest 50090-2505-00 A-S 1 kit — AB FDA listed —
Kurvelo 50090-6374-00 A-S 21 tablets — AB FDA listed —
Altavera 63629-2343-01 Bryant 1 kit — AB FDA listed —
Lutera 55741-0005-06 Dr. 1 kit — AB1 FDA listed —
Balcoltra 75854-0602-02 Avion 1 kit — AB3 FDA listed —
Vienva Tm 50090-5580-00 A-S 1 kit — AB1 FDA listed —
Levonorgestrel and Ethinyl Estradiol 79929-0003-07 Naari 1 kit — AB FDA listed —
Levonorgestrel and Ethinyl Estradiol 60505-4898-08 Apotex 1 kit — AB1 FDA listed —
Levonorgestrel and Ethinyl Estradiol 60505-4899-08 Apotex 1 kit — AB FDA listed —
Vienva TM 63629-2344-01 Bryant 1 kit — AB1 FDA listed —
Levonorgestrel and Ethinyl Estradiol 79929-0004-07 Naari 1 kit — AB1 FDA listed —
Aviane 63187-0889-28 Proficient 1 pouch — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Sronyx — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sronyx. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$6.8K
Claims incl. refills
212
Beneficiaries
148
Spend / beneficiary
$45.85
Spend / claim
$32.01
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51862-0545-06 You're viewing this 6 BLISTER PACK in 1 CARTON (51862-545-06) / 1 KIT in 1 BLISTER PACK (51862-545-01) 2016-08-03 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package No longer marketed (per FDA listing data)

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51862-545-06, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51862-0545-06, written without dashes as 51862054506. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51862-0545-06, the first segment (51862) is the labeler code FDA assigned to Mayne Pharma Inc.; the middle segment (0545) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Mayne Pharma Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 52 words ▾

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table III lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.

The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table III Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year.

United States. % of Women Experiencing an Accidental Pregnancy within the First Year of Use % of Women Continuing Use at One Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method (1) Typical Use Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. (2) Perfect Use Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

(3) (4) Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.

4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.

Chance 85 85 Spermicides Foams, creams, gels, vaginal suppositories, vaginal film. 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation method 3 Sympto-thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post Ovulation 1 Withdrawal 19 4 Cap With spermicidal cream or jelly.

Parous women 40 26 42 Nulliparous women 20 9 56 Sponge Parous women 40 20 42 Nulliparous women 20 9 56 Diaphragm 20 6 56 Condom Without spermicides. Female (Reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only

0.5 Combined

0.1IUD Progesterone T 2 1.5 81 Copper T380A 0.8 0.6 78 Lng 20 0.1 0.1 81 Depo Provera 0.3 0.3 70 Norplant and Norplant-2 0.05 0.05 88 Female sterilization 0.5 0.5 100 Male sterilization 0.15 0.10 100

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Sronyx ® (Levonorgestrel and Ethinyl Estradiol Tablets USP) To achieve maximum contraceptive effectiveness, Sronyx must be taken exactly as directed at intervals not exceeding 24-hours. Sronyx is a monophasic preparation plus 7 inert tablets. The dosage of Sronyx is one tablet daily for 21 consecutive days per menstrual cycle plus 7 peach inert tablets according to the prescribed schedule.

It is recommended that Sronyx be taken at the same time each day, preferably after the evening meal or at bedtime. During the first cycle of medication, the patient should be instructed to take one white Sronyx tablet daily and then 7 peach inert tablets for twenty-eight (28) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) Withdrawal bleeding usually occurs within 3 days following the last white tablet.

(If Sronyx is first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on Sronyx until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.) When switching from another oral contraceptive, Sronyx should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive. The patient begins her next and all subsequent 28-day courses of Sronyx on the same day of the week that she began her first course, following the same schedule.

She begins taking her white tablets on the next day after ingestion of the last peach tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Sronyx is started later than the next day, the patient should be protected by another means of contraception until she has taken a tablet daily for seven consecutive days. If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen.

This type of bleeding is usually transient and without significance, however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Sronyx is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more active tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed.

If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. The risk of pregnancy increases with each active (white) tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below.

If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more peach tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. In the nonlactating mother, Sronyx may be initiated postpartum, for contraception.

When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See " CONTRAINDICATIONS , " " WARNINGS , " and PRECAUTIONS " concerning thromboembolic disease.) It is to be noted that early resumption of ovulation may occur if bromocriptine mesylate has been used for the prevention of lactation.

⛔ Contraindications 116 words ▾

CONTRAINDICATIONS Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: Thrombophlebitis or thromboembolic disorders A past history of deep-vein thrombophlebitis or thromboembolic disorders Cerebral-vascular or coronary-artery disease Current diagnosis of, or history of, breast cancer, which may be hormone sensitive Carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia Undiagnosed abnormal genital bleeding Cholestatic jaundice of pregnancy or jaundice with prior pill use Hepatic adenomas or carcinomas Known or suspected pregnancy Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

⚠️ Warnings ~3 min read ▾

WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies.

Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers.

The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiologic methods. 1.

THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS a. Myocardial infarction An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary-artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.

The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30. Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases.

Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and nonsmokers over the age of 40 (Table IV) among women who use oral contraceptives. TABLE IV. (Adapted from P.M.

Layde and V. Beral) CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN-YEARS BY AGE, SMOKING STATUS, AND ORAL CONTRACEPTIVE USE AGE EVER-USERS NON-SMOKERS EVER-USERS SMOKERS CONTROLS NON-SMOKERS CONTROL SMOKERS 15-24 0.0 10.5 0.0 0.0 25-34 4.4 14.2 2.7 4.2 35-44 21.5 63.4 6.4 15.2 45+ 52.4 206.7 11.4

27.9Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. Oral contraceptives have been shown to increase blood pressure among users (see section 10 in "WARNINGS" ).

Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. b. Thromboembolism An increased risk of thromboemboli…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 – 1.12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (,6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use.

The other two studies found an increased relative risk of 1.19 – 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximate 1.4 with more than 8-10 years of COC use. Figure 2: Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. "ever COC" are females with current or past COC use; "never COC use" are females that never used COCs.

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see " WARNINGS " section). Thrombophlebitis Arterial thromboembolism Pulmonary embolism Myocardial infarction Cerebral hemorrhage Cerebral thrombosis Hypertension Gallbladder disease Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: Mesenteric thrombosis Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related: Nausea Vomiting Gastrointestinal symptoms, (such as abdominal cramps and bloating) Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Temporary infertility after discontinuation of treatment Edema Melasma which may persist Breast changes: tenderness, enlargement, secretion Change in weight (increase or decrease) Change in cervical erosion and secretion Diminution in lactation when given immediately postpartum Cholestatic jaundice Migraine Rash (allergic) Mental depression Reduced tolerance to carbohydrates Vaginal candidiasis Change in corneal curvature (steepening) Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: Pre-menstrual syndrome Cataracts Optic neuritis Changes in appetite Cystitis-like syndrome Headache Nervousness Dizziness Hirsutism Loss of scalp hair Erythema multiforme Erythema nodosum Hemorrhagic eruption Vaginitis Porphyria Impaired renal function Hemolytic uremic syndrome Budd-Chiari syndrome Acne Changes in libido Colitis Figure 2

🔄 Drug Interactions 86 words ▾

8. DRUG INTERACTIONS Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin and tetracyclines.

Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Sronyx with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

🔄 Drug / Laboratory Test Interactions 140 words ▾

9. INTERACTIONS WITH LABORATORY TESTS Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives: Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay.

Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered. Other binding proteins may be elevated in serum. Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.

Triglycerides may be increased. Glucose tolerance may be decreased. Serum folate levels may be depressed by oral contraceptive therapy.

This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

🤰 Pregnancy 11 words ▾

11. PREGNANCY See " CONTRAINDICATIONS " and " WARNINGS " sections.

🧒 Pediatric Use 54 words ▾

13. PEDIATRIC USE Safety and efficacy of Levonorgestrel and Ethinyl Estradiol Tablets USP have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

🆘 Overdosage 31 words ▾

OVERDOSAGE Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). PHARMACOKINETICS Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol of Levonorgestrel and Ethinyl Estradiol Tablets USP in humans has been conducted.

However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration and is not subject to first-pass metabolism. Ethinyl estradiol is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the absolute bioavailability of ethinyl estradiol is about 40%. After a single dose of three Levonorgestrel and Ethinyl Estradiol Tablets USP to 17 women under fasting conditions, the extents of absorption of levonorgestrel and ethinyl estradiol were 98.6% and 99.0%, respectively, relative to the same dose of the 2 drugs when given as a microcrystalline suspension in water.

The effect of food on the bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets USP following oral administration has not been evaluated. The pharmacokinetics of levonorgestrel and ethinyl estradiol following daily administration of Levonorgestrel and Ethinyl Estradiol Tablets USP for 21 days per cycle for three cycles, were determined in 18 women. Estimates of the pharmacokinetic parameters of levonorgestrel and ethinyl estradiol following single and multiple dose administration of Levonorgestrel and Ethinyl Estradiol Tablets USP are summarized in Table I.

Mean levonorgestrel and ethinyl estradiol levels after a single dose and on day 21 at steady state are shown in Figure 1. The pharmacokinetics of total levonorgestrel are non-linear due to an increase in binding to SHBG, which is attributed to increased SHBG levels that are induced by the daily administration of ethinyl estradiol. Increased binding of levonorgestrel to SHBG leads to decreased clearance of levonorgestrel.

Observed maximum levonorgestrel concentrations increased from day 1 to day 21 of the 1st and 3rd cycles by 66% and 83%, respectively. In calculating the mean concentration for ethinyl estradiol, any individual subject value below the quantifiable limit (i.e., 20 pg/mL) was converted to 0; and the 0 values were included for calculation of the mean concentration. Table I provides a summary of Levonorgestrel and Ethinyl Estradiol pharmacokinetic parameters.

TABLE I MEAN (SD) PHARMACOKINETIC PARAMETERS OF LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP AFTER SINGLE DOSE AND AFTER MULTIPLE DOSING FOR 3 CYCLES C max = maximum concentration t max = time to maximum concentration AUC = area under the drug concentration curve from time 0 to infinity CL/f = oral clearance Vz = volume of distribution SHBG = sex hormone-binding globulin AUC (0-24) = area under the drug concentration time curve from time 0 to 24 hours; this represents the area for one dosing interval at steady state.

Levonorgestrel Day (cycle) Cmax ng/mL tmax h AUC ng∙h/mL CL/F mL/min/kg Vz L SHBG nmol/L 1 2.36 (0.79) 1.3 (0.4) 29.2 (10.0) 1.0 (0.3) 129 (46) 64.5 (22.0) AUC (0-24h) ng∙h/mL 21 (1) 4.04 (2.08) 1.0 (0.3) 43.8 (22.4) 0.73 (0.34) 106 (42) 94.7 (37.4) 21 (3) 4.53 (1.94) 1.0 (0.3) 49.5 (24.5) 0.65 (0.33) 96 (35) 107.4 (45.8) Ethinyl Estradiol Day (cycle) Cmax pg/mL tmax h AUC (0-24) pg∙h/mL 1 49.5 (13.4) 1.5 (0.4) 298 (215) 21(1) 66.2 (29.5) 1.4 (0.4) 596 (494) 21(3) 58.1 (19.3) 1.4 (0.3) 417 (289) Figure 1 Distribution Levonorgestrel in serum is primarily bound to SHBG.

Protein binding values for levonorgestrel are provided in Table II. Ethinyl estradiol is about 97% bound to plasma albumin. Ethinyl estradiol does not bind to SHBG, but induces SHBG synthesis.

TABL…

📦 How Supplied / Storage and Handling 76 words ▾

HOW SUPPLIED Sronyx ® is available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows: 21 active tablets: white, round tablet debossed with "WATSON" on one side and "967" on the other side. 7 inert tablets: peach, round tablet debossed with "WATSON" on one side and "P1" on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

📦 Storage and Handling 13 words ▾

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

📋 Description 135 words ▾

DESCRIPTION Each cycle of Sronyx ® (Levonorgestrel and Ethinyl Estradiol Tablets USP) consists of 21 white active tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol; and seven peach tablets – inert. The inactive ingredients are Croscarmellose Sodium NF, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose (PH 102) NF, and Povidone (K29/32) NF. Each inactive, placebo tablet contains the following inactive ingredients: FD & C Yellow #6 Lake 35-42%, Lactose Anhydrous (DT Micro) NF, Lactose Monohydrate (200M) NF, Magnesium Stearate NF and Microcrystalline Cellulose NF.

Levonorgestrel has a molecular weight of 312.4 and a molecular formula of C 21 H 28 O 2 . Ethinyl estradiol has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: Chemical Structure

💬 Information for Patients 11 words ▾

INFORMATION FOR THE PATIENT See " Patient Labeling " printed below.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.