Kelnor 1/35 Tablets 28s

Manufacturer TEVA USA Active Ingredient Ethinyl Estradiol and Ethynodiol Diacetate(ETH in il es tra DYE ole & e thye noe DYE ole dye AS e tate) Pronunciation ETH-in-il es-tra-DYE-ole & eth-eye-NOE-dee-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
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Kelnor 1/35 is a birth control pill that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (ethynodiol diacetate). It works by preventing your body from releasing an egg (ovulation) and by making it harder for sperm to reach the egg or for a fertilized egg to implant in the womb. When taken correctly, it is a very effective method of preventing pregnancy.
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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 doses, as this can 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. 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

  • Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
  • Take the pill at the same time every day to maximize effectiveness and reduce the risk of breakthrough bleeding.
  • Use a backup method of birth control (like condoms) if you miss pills, have vomiting or severe diarrhea, or are taking certain medications that can reduce the pill's effectiveness.
  • 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 orally once daily at the same time each day for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: Refer to package insert for specific instructions based on number of missed pills and week of cycle.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as adult dosing for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but caution is advised due to potential fluid retention.
Dialysis: No specific dose adjustment recommended.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; consider alternative methods if liver function is significantly impaired.
Severe: Contraindicated in patients with severe liver disease or liver tumors.

Pharmacology

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Mechanism of Action

Kelnor 1/35 works primarily by suppressing gonadotropins, which in turn inhibits ovulation. Other mechanisms include changes in the cervical mucus (making it more difficult for sperm to penetrate the uterus) and changes in the endometrium (reducing the likelihood of implantation). Ethinyl estradiol provides the estrogenic component, and ethynodiol diacetate provides the progestational component.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 40-48%; Ethynodiol Diacetate: Rapidly absorbed, then deacetylated to norethindrone, which is the active progestin.
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone (from Ethynodiol Diacetate): 1-2 hours.
FoodEffect: Food may slightly decrease the rate but not the extent of absorption.

Distribution:

Vd: Ethinyl Estradiol: Approximately 2.8-8.6 L/kg; Norethindrone: Approximately 4 L/kg.
ProteinBinding: Ethinyl Estradiol: Approximately 98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: Approximately 97% (to albumin and SHBG).
CnssPenetration: Limited, but hormones can cross the blood-brain barrier.

Elimination:

HalfLife: Ethinyl Estradiol: Biphasic, terminal half-life approximately 10-20 hours; Norethindrone: Approximately 5-14 hours.
Clearance: Ethinyl Estradiol: Approximately 5-13 mL/min/kg.
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and fecal (60%); Norethindrone: Renal (50-80%) and fecal (20-50%).
Unchanged: Ethinyl Estradiol: Very little; Norethindrone: Very little.
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active pill taking when initiated on the first day of menstruation. Immediate if started on Day 1 of cycle.
PeakEffect: Steady-state concentrations are typically reached within 3-4 days of daily dosing.
DurationOfAction: Daily dosing is required to maintain contraceptive efficacy.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, oral contraceptives, including Kelnor 1/35, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Serious 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 or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin with or without fever
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Depression or other mood changes
Feeling very tired or weak
Swelling
Difficulty urinating or changes in urine output
Breast lump, pain, or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in color, or pain in a leg or arm
+ Trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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: Abdominal pain (severe)
  • C: Chest pain (severe), cough, shortness of breath
  • H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • E: Eye problems (sudden vision loss or blurring)
  • S: Severe leg pain (calf or thigh), swelling, redness, warmth
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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. Be sure to 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 specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using 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 breastfeeding or plan to breastfeed

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

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Your doctor needs to know about all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

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. 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. Discuss all your medications and health issues with your doctor to determine if you need to use a non-hormone form of birth control, 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 Birth Control

This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use latex or polyurethane condoms during sex to reduce the risk of transmission. If you have questions, consult your doctor.

Cancer Risks

Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use, while others have not. 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 suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (in females)

What to Do:

Seek medical attention if symptoms are severe or persistent. There is no specific antidote; treatment is supportive. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir, dasabuvir (used for Hepatitis C) - risk of ALT elevations.
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Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy.
  • Protease inhibitors (e.g., Ritonavir, Nelfinavir) - may alter hormone levels.
  • Certain antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic circulation (though clinical significance is debated).
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Moderate Interactions

  • Lamotrigine - oral contraceptives may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
  • Thyroid hormones (e.g., Levothyroxine) - oral contraceptives can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
  • Cyclosporine - oral contraceptives may increase cyclosporine plasma concentrations, increasing toxicity risk.
  • Theophylline - oral contraceptives may increase theophylline plasma concentrations.
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Minor Interactions

  • Acetaminophen - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Complete medical history and physical examination (including blood pressure, breast exam, pelvic exam, Pap test)

Rationale: To identify contraindications, risk factors for adverse events (e.g., cardiovascular disease, breast cancer), and establish baseline health status.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood pressure

Frequency: Annually, or more frequently if hypertension develops.

Target: <120/80 mmHg

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraceptive method.

Annual physical examination (including breast exam, pelvic exam, Pap test as per guidelines)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

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Symptom Monitoring

  • Severe abdominal pain (possible liver tumor, blood clot)
  • Severe chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, heart attack)
  • Severe headaches, dizziness, weakness, numbness, vision changes (possible stroke)
  • Eye problems (e.g., blurred vision, loss of vision, bulging eyes) (possible blood clot in eye)
  • Severe leg pain, swelling, warmth, redness (possible deep vein thrombosis)
  • Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (possible liver problems)
  • Depressed mood, changes in mood
  • New or worsening migraines

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy. There is no indication for oral contraceptive use in pregnancy, and there is no evidence of increased risk of birth defects with inadvertent use during early pregnancy.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended for use during lactation, especially in the immediate postpartum period. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids are excreted in breast milk.

Infant Risk: Potential for adverse effects on the infant (e.g., jaundice, breast enlargement). Consider progestin-only methods if contraception is needed during breastfeeding.
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Pediatric Use

Safety and efficacy have been established for post-menarcheal adolescents. Use before menarche is not indicated.

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Geriatric Use

Not indicated for use in postmenopausal women for contraception. Risk of cardiovascular events increases with age.

Clinical Information

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Clinical Pearls

  • Adherence is key: Missing pills significantly increases the risk of pregnancy. Advise patients on what to do if a pill is missed.
  • Smoking cessation is critical for women over 35 using oral contraceptives due to increased cardiovascular risk.
  • Be aware of potential drug interactions, especially with enzyme-inducing medications, which can reduce contraceptive efficacy.
  • Counsel patients on the ACHES warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
  • Oral contraceptives do not protect against STIs; advise on barrier methods for STI prevention.
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Contraceptive patch (e.g., Xulane)
  • Vaginal ring (e.g., NuvaRing, Annovera)
  • Contraceptive injection (e.g., Depo-Provera)
  • Contraceptive implant (e.g., Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $20 - $50 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered under ACA as preventive care)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.