Jaimiess Tablets 91s
Overview
What is this medicine?
How to Use This Medicine
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines.
Do not miss any doses, even if you do not have sexual intercourse frequently.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy. Follow your doctor's advice on using this additional form of birth control.
Administration
You can take this medication with or without food. If it causes stomach upset, take it with food. To maintain a consistent routine, take the medication at the same time every day.
If you are also taking colesevelam, take it at least 4 hours before or after taking this medication.
If you vomit or experience diarrhea, the medication may not be as effective in preventing pregnancy. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If the vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you are unsure about what to do, call your doctor for guidance.
Pregnancy Testing
If your menstrual cycle is 28 days and you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication. If your cycle is longer than 91 days and you miss one period, also take a pregnancy test before starting a new cycle.
Storage and Disposal
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missed Doses
If you miss a dose, refer to the package insert or consult your doctor for instructions on what to do. 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 certain period 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 one pill at the same time every day, without missing any doses, to ensure maximum effectiveness.
- Use a backup method of birth control (like condoms) for the first 7 days when starting the pill, or if you miss pills.
- Be aware of potential drug interactions with other medications, including herbal supplements like St. John's Wort.
- 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 or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, 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; change in stools; dark urine or yellow skin or eyes; or fever with chills
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, fast breathing, or breath that smells like fruit
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
New or worsening migraines
Depression or other mood changes
Breast changes: lump, pain, or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Fluid retention: swelling, weight gain, or trouble breathing
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Period changes, including spotting or bleeding between cycles
Back pain
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
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.
Seek Immediate Medical Attention If You Experience:
- A: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worst ever)
- E: Eye problems (sudden blurred vision, loss of vision)
- S: Severe leg pain (calf or thigh), swelling, redness, or warmth
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, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain medical 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 (turned yellow) during pregnancy or while using estrogen-containing products, such as hormonal birth control
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir)
Current use of glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant
Breast-feeding or plans to breast-feed
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust 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 levels as directed by your doctor. Additionally, this medication may cause high blood pressure, so have your blood pressure checked regularly as advised by your doctor.
Regular laboratory tests, including blood work, are crucial while taking this medication. Ensure that you undergo these tests as scheduled by your doctor. It is also essential to have regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor.
This medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug. Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Inform your doctor about all your medications and health issues, and discuss the potential need for additional non-hormone birth control methods, such as condoms.
If you are allergic to tartrazine (FD&C Yellow No. 5), consult with your doctor, as some products contain this ingredient. This medication may also cause high cholesterol and triglyceride levels, so discuss this potential risk with your doctor.
It is crucial to note that this medication does not protect against sexually transmitted diseases, such as HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity to reduce the risk of transmission. If you have questions or concerns, consult with your doctor.
The use of hormone-based birth control may be associated with an increased risk of cervical cancer, although this may be due to other factors. Additionally, some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while other studies have not found this association. If you have questions or concerns, discuss them with your doctor.
This medication is not intended for use in children who have not yet had their first menstrual period.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
What to Do:
There are no specific antidotes. Treatment is symptomatic. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT levels)
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Lamotrigine (reduced lamotrigine plasma concentrations, potentially leading to loss of seizure control).
Moderate Interactions
- CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Fluconazole, Grapefruit juice) - may increase plasma concentrations of ethinyl estradiol and levonorgestrel.
- Antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic circulation, though clinical evidence is limited for most. Backup method often recommended.
- Thyroid hormone replacement therapy (may require increased thyroid hormone dose due to increased thyroid binding globulin).
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels)
- Ascorbic acid (Vitamin C) (may increase ethinyl estradiol levels)
- Atorvastatin (may increase AUC of ethinyl estradiol)
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by COC use.
Timing: Prior to initiation
Rationale: To assess overall health and identify baseline cardiovascular status.
Timing: Prior to initiation
Rationale: As indicated by general health guidelines and patient age/risk factors.
Timing: Prior to initiation or as part of routine care
Routine Monitoring
Frequency: Annually or more frequently if clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraceptive method.
Frequency: Annually
Target: Not applicable
Action Threshold: Not applicable
Symptom Monitoring
- Severe abdominal pain (especially sudden, severe, or radiating)
- Chest pain, shortness of breath, or coughing up blood (possible pulmonary embolism)
- Severe headaches (especially sudden, worst ever, or associated with neurological symptoms)
- Eye problems (e.g., sudden partial or complete loss of vision, double vision, bulging eyes)
- Severe leg pain, swelling, warmth, or redness (possible deep vein thrombosis)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Unusual vaginal bleeding or spotting
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for COC use in pregnancy, and there is no evidence of harm to the fetus from inadvertent exposure during early pregnancy.
Trimester-Specific Risks:
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 may pass into breast milk.
Pediatric Use
Safety and efficacy are established for women of reproductive age. Use in pre-menarcheal females is not indicated. Adolescent use is similar to adult dosing for contraception or management of conditions like PCOS.
Geriatric Use
Not indicated for contraception in post-menopausal women. No data available for use in geriatric populations.
Clinical Information
Clinical Pearls
- Extended-cycle regimens like Jaimiess reduce the frequency of menstrual periods to approximately 4 per year.
- Breakthrough bleeding and spotting are common, especially during the first few cycles, and usually decrease over time. Counsel patients that this is normal and to continue taking pills.
- Missing pills, especially early in the cycle or at the end of the active pill phase, increases the risk of pregnancy. Advise patients on specific missed pill instructions.
- Counsel patients on the importance of using a backup method of contraception if they are taking medications that may reduce COC efficacy (e.g., certain antibiotics, anticonvulsants, St. John's Wort).
- Emphasize the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
Alternative Therapies
- Intrauterine devices (IUDs) - hormonal or copper
- Contraceptive implant (e.g., Nexplanon)
- Contraceptive patch (e.g., Xulane)
- Contraceptive vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive injection (e.g., Depo-Provera)
- Barrier methods (e.g., condoms, diaphragm)
- Spermicides
- Sterilization (tubal ligation, vasectomy)