Kariva Tablets 28s

Manufacturer TEVA Active Ingredient Ethinyl Estradiol and Desogestrel(ETH in il es tra DYE ole & des oh JES trel) Pronunciation Ka-REE-vah (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ol; Desogestrel: des-oh-JES-trel)
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
Combined Oral Contraceptive; Estrogen and Progestin Combination
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Pregnancy Category
Category X
FDA Approved
Jul 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Kariva is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (desogestrel). It works by preventing your body from releasing an egg (ovulation) and by making it harder for sperm to reach the egg. It also changes the lining of your uterus to prevent pregnancy. It is taken once a day to prevent 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 the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, taking it with food may help.

After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy. Be sure to follow your doctor's guidance on using non-hormonal birth control.

If you are also taking colesevelam, take it at least 4 hours before or after taking this medication. Do not skip doses, even if you do not have sex frequently. If you vomit or have diarrhea, this medication may not be as effective in preventing pregnancy. In this case, use an additional form of birth control, such as condoms, until you consult with your doctor.

If you miss two periods in a row, 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 place, avoiding the bathroom.

What to Do If You Miss a Dose

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

  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots and heart attack.
  • Take the pill at the same time every day to maximize effectiveness.
  • 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.
  • Kariva does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Take active tablets for 21 consecutive days, followed by 7 days of inactive (placebo) tablets. Begin a new pack on day 29.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered. If two or more active tablets are missed, refer to package insert for specific instructions, as backup contraception may be needed.
postpartum: May be started 4 weeks postpartum in non-breastfeeding women. Earlier initiation may increase risk of thromboembolism.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: One tablet orally daily, as per adult dosing, after menarche.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed

Hepatic Impairment:

Mild: Use with caution
Moderate: Contraindicated
Severe: Contraindicated

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) like Kariva primarily act by suppressing gonadotropins (FSH and LH), thereby inhibiting ovulation. They also cause changes in the cervical mucus, making it more viscous and less permeable to sperm, and alter the endometrium, making it less receptive to implantation. The progestin component (desogestrel) is responsible for the primary contraceptive effect, while the estrogen component (ethinyl estradiol) provides cycle control and potentiates the progestin's effects.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Desogestrel: ~80% (as etonogestrel)
Tmax: Ethinyl Estradiol: 1.5-2 hours; Etonogestrel (active metabolite of desogestrel): 1.5-12 hours
FoodEffect: Food does not significantly affect the rate or extent of absorption.

Distribution:

Vd: Ethinyl Estradiol: ~4.3 L/kg; Etonogestrel: ~1.5 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Etonogestrel: ~95-98% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: Biphasic, terminal half-life ~10-20 hours; Etonogestrel: ~25-30 hours
Clearance: Ethinyl Estradiol: ~5 mL/min/kg; Etonogestrel: ~3.5 mL/min/kg
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and Fecal (60%); Etonogestrel: Renal (40%) and Fecal (60%)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active tablet use.
PeakEffect: Not directly applicable for contraceptive effect; hormonal levels peak within hours of dosing.
DurationOfAction: Daily dosing maintains contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined 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, combined oral contraceptives, including Kariva, are contraindicated in women who are over 35 years of age and 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 or seek immediate 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, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach 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, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Difficulty sleeping.
Feeling extremely tired or weak.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
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.
Swelling or fluid retention in the body, which may cause weight gain or breathing difficulties.

If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of the signs of a blood clot, such as:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Difficulty 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 if they bother you or do not go away:

Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach pain or cramps
Bloating
Changes in menstrual periods, including spotting or bleeding between cycles
Enlarged breasts
Tender breasts
Decreased interest in sex
Hair loss
* Feeling nervous or excitable

This list is not exhaustive, and you may experience other 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:

  • ACHES: Abdominal pain (severe)
  • Chest pain (severe, shortness of breath, coughing blood)
  • Headaches (severe, sudden, or new onset, especially with vision changes)
  • Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
  • Severe leg pain (calf or thigh, redness, swelling, 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 conditions to ensure safe treatment:

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 or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or 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
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir)
A history of jaundice (turning yellow) during pregnancy or while using estrogen-containing products, such as hormonal birth control
Pregnancy or suspected pregnancy: Do not take this medication if you are pregnant
* Breastfeeding or plans to breastfeed

This is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor.
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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.

This medication may increase the risk of blood clots, stroke, or heart attack. Discuss these potential risks with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, consult with your doctor, as prolonged immobility may increase the risk of blood clots.

If you have diabetes (high blood sugar), inform your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor, and report any signs of high blood sugar, such as confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.

High blood pressure has been associated with medications like this one. Have your blood pressure checked regularly, as advised by your doctor. Additionally, undergo blood tests as recommended by your doctor, and discuss the results with them.

Regular breast exams and gynecological check-ups are crucial while taking this medication. Perform breast self-exams as instructed by your doctor. If you consume grapefruit juice or eat grapefruit frequently, inform your doctor, as it may interact with this medication.

This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug. It may also cause elevated cholesterol and triglyceride levels; discuss this with your doctor.

Prolonged use of this medication may lead to dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when outdoors.

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 need for additional non-hormonal birth control methods, such as condoms.

This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity, and consult with your doctor if you have questions.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.

The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be attributed to other factors. Discuss any concerns with your doctor. Some studies suggest a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while others have not found this link. If you have questions, consult with your doctor.

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

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Vaginal bleeding (withdrawal bleeding may occur in females)

What to Do:

Overdose is generally not life-threatening. Treatment is supportive. If you suspect an overdose, contact your doctor or poison control center immediately. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

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

  • Aromatase inhibitors (e.g., anastrozole, letrozole)
  • Ospemifene
  • Tamoxifen
  • Tizanidine (increased tizanidine levels)
  • Tranexamic acid (increased risk of thrombosis)
  • Certain anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital, topiramate, oxcarbazepine)
  • Rifampin
  • Griseofulvin
  • St. John's Wort
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Moderate Interactions

  • Antibiotics (e.g., ampicillin, tetracycline - theoretical risk of reduced efficacy due to altered enterohepatic circulation, though clinical significance is debated)
  • HIV protease inhibitors (e.g., ritonavir, nelfinavir)
  • NNRTIs (e.g., efavirenz, nevirapine)
  • Bosentan
  • Colesevelam
  • Lamotrigine (decreased lamotrigine levels)
  • Thyroid hormones (increased thyroid-binding globulin, requiring higher thyroid hormone dose)
  • Cyclosporine (increased cyclosporine levels)
  • Theophylline (increased theophylline levels)
  • Corticosteroids (increased corticosteroid levels)
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Minor Interactions

  • Acetaminophen (may increase ethinyl estradiol levels)
  • Ascorbic acid (may increase ethinyl estradiol levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To identify pre-existing hypertension and monitor for drug-induced hypertension.

Timing: Prior to initiation

Weight/BMI

Rationale: To assess for obesity, a risk factor for VTE, and monitor for weight changes.

Timing: Prior to initiation

Medical History (including family history of VTE, breast cancer)

Rationale: To identify contraindications and risk factors for adverse events.

Timing: Prior to initiation

Physical Exam (including breast and pelvic exam, Pap test)

Rationale: To screen for underlying conditions and ensure suitability for COC use.

Timing: Prior to initiation, as clinically indicated

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Routine Monitoring

Blood Pressure

Frequency: Annually

Target: <140/90 mmHg

Action Threshold: >140/90 mmHg or significant increase, consider discontinuation or alternative contraception.

Weight/BMI

Frequency: Annually

Target: Healthy BMI (18.5-24.9 kg/m²)

Action Threshold: Significant weight gain or obesity, reassess VTE risk.

Breast Exam

Frequency: Annually

Target: Normal

Action Threshold: New lumps or changes, further investigation.

Cervical Screening (Pap test)

Frequency: As per national guidelines (e.g., every 3-5 years)

Target: Normal

Action Threshold: Abnormal results, further investigation.

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Symptom Monitoring

  • Severe abdominal pain (pelvic mass, liver tumor, ectopic pregnancy)
  • Chest pain (pulmonary embolism, myocardial infarction)
  • Headaches (severe, sudden, or new onset; stroke, migraine with aura)
  • Eye problems (blurred vision, loss of vision; stroke, retinal thrombosis)
  • Severe leg pain (deep vein thrombosis)
  • Jaundice (liver dysfunction)
  • Mood changes, depression
  • Unusual vaginal bleeding

Special Patient Groups

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Pregnancy

Kariva is contraindicated in pregnancy. There is no indication for use in pregnancy, and studies have shown an association between in utero exposure to female sex hormones and congenital anomalies.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital anomalies (e.g., VACTERL association, limb reduction defects) if exposure occurs early in pregnancy, though data are conflicting and largely from older, higher-dose formulations.
Second Trimester: Not applicable, as contraception is not indicated.
Third Trimester: Not applicable, as contraception is not indicated.
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Lactation

Use is generally not recommended in breastfeeding women. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or their metabolites are excreted in breast milk.

Infant Risk: Potential for adverse effects on the infant, including jaundice and breast enlargement. Long-term effects on breastfed infants are unknown. Non-hormonal methods or progestin-only methods are preferred during lactation, especially in the first 6 weeks postpartum.
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Pediatric Use

Safety and efficacy have been established in females of reproductive age. Use is indicated only after menarche. Not for use in pre-pubertal girls.

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Geriatric Use

Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, and COCs are generally not recommended for women over 35 who smoke or for women over 40-50 due to increased cardiovascular risks.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of taking the pill at the same time every day for maximum effectiveness.
  • Counsel patients on the critical importance of not smoking while on COCs due to the increased risk of serious cardiovascular events.
  • Advise patients about potential drug interactions, especially with antibiotics, anticonvulsants, and St. John's Wort, and the need for backup contraception.
  • Educate patients on 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 STIs and that condoms should be used for this purpose.
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Alternative Therapies

  • Progestin-only pills (mini-pill)
  • Progestin implant (e.g., Nexplanon)
  • Progestin IUD (e.g., Mirena, Skyla, Kyleena, Liletta)
  • Copper IUD (e.g., Paragard)
  • Depot medroxyprogesterone acetate (DMPA) injection (e.g., Depo-Provera)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $30 - $100+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generics), Tier 3 or 4 (for brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the medication, including the amount taken and the time it happened.