Kariva 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 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.
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.
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 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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT levels)
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
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)
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels)
- Ascorbic acid (may increase ethinyl estradiol levels)
Monitoring
Baseline Monitoring
Rationale: To identify pre-existing hypertension and monitor for drug-induced hypertension.
Timing: Prior to initiation
Rationale: To assess for obesity, a risk factor for VTE, and monitor for weight changes.
Timing: Prior to initiation
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation
Rationale: To screen for underlying conditions and ensure suitability for COC use.
Timing: Prior to initiation, as clinically indicated
Routine Monitoring
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: >140/90 mmHg or significant increase, consider discontinuation or alternative contraception.
Frequency: Annually
Target: Healthy BMI (18.5-24.9 kg/m²)
Action Threshold: Significant weight gain or obesity, reassess VTE risk.
Frequency: Annually
Target: Normal
Action Threshold: New lumps or changes, further investigation.
Frequency: As per national guidelines (e.g., every 3-5 years)
Target: Normal
Action Threshold: Abnormal results, further investigation.
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
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:
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.
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.
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
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.
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)