Kelnor 1/50 Tablets 28s
Overview
What is this medicine?
How to Use This Medicine
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.
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).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & 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.
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
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
- Glecaprevir/Pibrentasvir (increased ALT levels)
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)
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)
Minor Interactions
- Clofibrate (decreased ethinyl estradiol levels)
- Morphine (decreased morphine levels)
Monitoring
Baseline Monitoring
Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor for cardiovascular events.
Timing: Prior to initiation.
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.
Rationale: To assess overall health and rule out contraindications or conditions that may be exacerbated by COCs.
Timing: Prior to initiation (as clinically indicated).
Routine Monitoring
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: Sustained elevation above 140/90 mmHg may necessitate discontinuation or change in contraception.
Frequency: Annually
Target: N/A
Action Threshold: Identification of new risk factors or contraindications.
Frequency: Periodically, if risk factors for dyslipidemia exist.
Target: N/A
Action Threshold: Significant adverse changes may warrant re-evaluation of COC use.
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
Pregnancy
Contraindicated. Oral contraceptives should not be used during pregnancy. If pregnancy occurs during use, discontinue immediately.
Trimester-Specific Risks:
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.
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.
Geriatric Use
Not indicated for postmenopausal women. This medication is for contraception in women of reproductive age.
Clinical Information
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.
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)