Kelnor 1/50 Tablets 28s

Manufacturer TEVA Active Ingredient Ethinyl Estradiol and Ethynodiol Diacetate(ETH in il es tra DYE ole & e thye noe DYE ole dye AS e tate) Pronunciation Ethinyl Estradiol (ETH in il es tra DYE ole) & Ethynodiol Diacetate (e thye noe DYE ole dye AS e tate)
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy. If you have been given this drug for some other reason, talk with your doctor for more information.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Aug 1968
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Kelnor 1/50 is a birth control pill that contains two types of female hormones, an estrogen (ethinyl estradiol) and a progestin (ethynodiol diacetate). It works by preventing your body from releasing an egg (ovulation) and by changing your cervical mucus and the lining of your uterus to make it harder for sperm to reach an egg or for a fertilized egg to implant.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take your medication at the same time every day, with or without food. If you experience stomach upset, taking it with food may help alleviate this issue.

It's essential to take your medication as directed, even if you don't have sexual intercourse frequently. Do not skip any doses, as this may reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well, so use an additional form of birth control, such as condoms, until you consult with your doctor.

If you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding bathrooms.

Missing a Dose

If you miss a dose, refer to the package insert or contact your doctor for guidance on what to do next. If you're using this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a period to prevent pregnancy.
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Lifestyle & Tips

  • Take one tablet at the same time every day to maximize effectiveness.
  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Use a backup method of birth control (like condoms) if you miss pills, start a new pack late, or are taking medications that can reduce the effectiveness of your birth control.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain active drug, and the last 7 are inert (placebo).
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered and the next tablet at the usual time. If two consecutive active tablets are missed in Week 1 or 2, take two tablets on the day remembered and two tablets the next day, then continue with one tablet daily. Use backup contraception for 7 days. If two consecutive active tablets are missed in Week 3, or three or more consecutive active tablets are missed anytime, discard the rest of the pack and start a new pack on the same day (Sunday start) or Day 1 (Day 1 start). Use backup contraception for 7 days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
Prepubertal: Not indicated
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for fluid retention. No specific dose adjustment, but generally not recommended due to potential for fluid retention and electrolyte imbalance.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated due to impaired steroid metabolism.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), which in turn inhibits ovulation. Additional mechanisms include changes in the cervical mucus, increasing its viscosity and making it more difficult for sperm to penetrate, and alterations in the endometrium, making it less receptive to implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 40-60% (due to first-pass metabolism). Ethynodiol Diacetate: Rapidly and completely deacetylated to norethindrone, bioavailability of norethindrone is high.
Tmax: Ethinyl Estradiol: 1-2 hours. Ethynodiol Diacetate (as norethindrone): 1-2 hours.
FoodEffect: Food may slightly increase or decrease absorption, but generally not clinically significant.

Distribution:

Vd: Ethinyl Estradiol: Approximately 2-4 L/kg. Norethindrone: Approximately 4 L/kg.
ProteinBinding: Ethinyl Estradiol: Approximately 98% (primarily to albumin, also to sex hormone-binding globulin [SHBG]). Norethindrone: Approximately 96-97% (primarily to SHBG and albumin).
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: Biphasic, terminal half-life approximately 18-24 hours. Norethindrone: Approximately 5-14 hours.
Clearance: Ethinyl Estradiol: Approximately 5-13 mL/min/kg. Norethindrone: Approximately 0.4 L/hr/kg.
ExcretionRoute: Renal (approximately 40%) and fecal (approximately 60%) for both components and their metabolites.
Unchanged: Less than 10% for both components.
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically begins after 7 consecutive days of active pill use. Full protection after the first pack if started correctly.
PeakEffect: Peak hormone levels reached within 1-2 hours after administration.
DurationOfAction: Daily dosing maintains consistent hormone levels for contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

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.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Depression or other mood changes
Feeling extremely tired or weak
Swelling
Difficulty urinating or changes in urine output
Breast lump, breast pain or tenderness, or nipple discharge
Vaginal itching or discharge
Severe or persistent vaginal bleeding or spotting
Changes in vision, bulging eyes, or changes in contact lens comfort
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Changes in appetite
Dizziness or headache
Weight gain or loss
Stomach upset or vomiting
Stomach cramps
Bloating
Menstrual changes, including spotting or bleeding between cycles
Enlarged breasts
Breast tenderness
Hair loss
Changes in sex drive
Feeling nervous or excitable
* Acne (pimples)

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • **A**bdominal pain (severe)
  • **C**hest pain (severe), cough, shortness of breath
  • **H**eadaches (severe, sudden, or worse than usual)
  • **E**ye problems (blurred vision, flashing lights, partial or complete loss of vision)
  • **S**evere leg pain (calf or thigh), swelling, redness, or warmth
  • Yellowing of the skin or eyes (jaundice)
  • Unexplained vaginal bleeding or spotting that is heavy or lasts a long time
  • Lump in the breast
  • Mood changes or depression
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Vaginal bleeding with an unknown cause
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while taking estrogen-containing medications, such as hormonal birth control.
If you have taken a combination of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed.

Additionally, inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter medications
Natural products
Vitamins

It is crucial to ensure that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

Blood Clots, Stroke, and Heart Attack Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may further increase your risk of blood clots.

Blood Pressure Monitoring
Drugs like this one may cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks.

Blood Work and Diabetes Monitoring
Regular blood work is necessary while taking this medication. If you have diabetes, closely monitor your blood sugar levels as directed by your doctor. Be aware of signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath, and report them to your doctor.

Breast and Gynecologic Health
Regular breast exams and gynecology check-ups are crucial while taking this medication. Additionally, perform breast self-exams as instructed by your doctor.

Lab Tests and Interactions
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this drug. Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the potential need for non-hormone birth control methods, such as condoms.

Skin and Sun Protection
This medication may cause dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when outdoors.

Sexually Transmitted Diseases and Pregnancy
This medication does not protect against diseases like HIV or hepatitis that can be transmitted through sexual contact. Use latex or polyurethane condoms during sex to reduce the risk of transmission. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.

Cancer Risks
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical and breast cancer, although the evidence is not conclusive. Discuss any concerns with your doctor.

Pediatric Use and Pregnancy
This medication is not intended for use in children who have not had their first menstrual period. If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor right away.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (in females)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
  • Glecaprevir/Pibrentasvir (increased ALT levels)
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Major Interactions

  • Rifampin (decreased contraceptive efficacy)
  • Phenytoin (decreased contraceptive efficacy)
  • Carbamazepine (decreased contraceptive efficacy)
  • Barbiturates (e.g., Phenobarbital) (decreased contraceptive efficacy)
  • Topiramate (decreased contraceptive efficacy)
  • Griseofulvin (decreased contraceptive efficacy)
  • St. John's Wort (decreased contraceptive efficacy)
  • Ritonavir-boosted protease inhibitors (variable effects on COC levels, potential for decreased efficacy or increased adverse effects)
  • Lamotrigine (decreased lamotrigine levels, loss of seizure control)
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Moderate Interactions

  • Antibiotics (e.g., ampicillin, tetracycline) (potential, though often minor, decrease in efficacy due to gut flora alteration)
  • Acetaminophen (increased ethinyl estradiol levels)
  • Ascorbic Acid (increased ethinyl estradiol levels)
  • Atorvastatin (increased ethinyl estradiol levels)
  • Thyroid hormones (e.g., Levothyroxine) (decreased thyroid hormone levels due to increased SHBG)
  • Cyclosporine (increased cyclosporine levels)
  • Theophylline (increased theophylline levels)
  • Corticosteroids (e.g., Prednisolone) (increased corticosteroid levels)
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Minor Interactions

  • Clofibrate (decreased ethinyl estradiol levels)
  • Morphine (decreased morphine levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor for cardiovascular events.

Timing: Prior to initiation.

Medical History (including family history)

Rationale: To identify risk factors for venous thromboembolism (VTE), arterial thrombotic events (e.g., stroke, MI), breast cancer, liver disease, and migraines.

Timing: Prior to initiation.

Physical Examination (including breast and pelvic exam)

Rationale: To assess overall health and rule out contraindications or conditions that may be exacerbated by COCs.

Timing: Prior to initiation (as clinically indicated).

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Routine Monitoring

Blood Pressure

Frequency: Annually

Target: <140/90 mmHg

Action Threshold: Sustained elevation above 140/90 mmHg may necessitate discontinuation or change in contraception.

Annual Physical Examination

Frequency: Annually

Target: N/A

Action Threshold: Identification of new risk factors or contraindications.

Lipid Profile (if indicated)

Frequency: Periodically, if risk factors for dyslipidemia exist.

Target: N/A

Action Threshold: Significant adverse changes may warrant re-evaluation of COC use.

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Symptom Monitoring

  • Severe abdominal pain (A)
  • Severe chest pain, shortness of breath, or coughing up blood (C)
  • Severe headaches (H)
  • Eye problems (e.g., blurred vision, loss of vision) (E)
  • Severe leg pain (calf or thigh), swelling, warmth, or redness (S)
  • Jaundice (yellowing of skin or eyes)
  • Dark urine or light-colored stools
  • Unexplained vaginal bleeding or spotting
  • Lump in the breast
  • Mood changes, depression

Special Patient Groups

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Pregnancy

Contraindicated. Oral contraceptives should not be used during pregnancy. If pregnancy occurs during use, discontinue immediately.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects from inadvertent exposure during early pregnancy.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not generally recommended. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Consider progestin-only methods if contraception is needed during lactation.

Infant Risk: L4 (Possibly Hazardous): Small amounts of steroids are excreted in breast milk. Potential for adverse effects on the infant (e.g., jaundice, breast enlargement) and reduction in milk supply. Weigh benefits vs. risks.
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Pediatric Use

Not indicated for prepubertal females. For post-menarcheal adolescents, the adult dosing regimen applies. Safety and efficacy are expected to be similar to adults.

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Geriatric Use

Not indicated for postmenopausal women. This medication is for contraception in women of reproductive age.

Clinical Information

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Clinical Pearls

  • Emphasize strict adherence to the daily dosing schedule at the same time each day for optimal contraceptive efficacy.
  • Counsel patients on the critical importance of not smoking while using COCs due to the significantly increased risk of serious cardiovascular events.
  • Educate patients about the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and when to seek immediate medical attention.
  • Remind patients that COCs do not protect against sexually transmitted infections (STIs) and that condoms should be used for STI prevention.
  • Discuss potential drug interactions, especially with antibiotics, anticonvulsants, and St. John's Wort, and advise on the need for backup contraception if such interactions occur.
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Alternative Therapies

  • Progestin-only pills (mini-pills)
  • Progestin injection (e.g., Depo-Provera)
  • Progestin implant (e.g., Nexplanon)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $15 - $50 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered without cost-sharing under ACA for contraception)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for proper treatment and care.