Jaimiess Tablets 91s

Manufacturer XIROMED Active Ingredient Ethinyl Estradiol and Levonorgestrel Tablets(ETH in il es tra DYE ole & LEE voe nor jes trel) Pronunciation ETH in il es tra DYE ole & LEE voe nor 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, Hormonal
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Jul 2012
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Jaimiess is a birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and levonorgestrel (a progestin). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. This particular formulation is an extended-cycle pill, meaning you take active pills for 84 days and then a lower-dose estrogen pill for 7 days, resulting in fewer periods per year (typically 4).
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How to Use This Medicine

Taking Your Medication Correctly

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.
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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 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).
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet daily for 91 consecutive days. The regimen consists of 84 tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, followed by 7 tablets containing 0.01 mg ethinyl estradiol.

Condition-Specific Dosing:

first_time_use: Start on the first day of menstrual period or the first Sunday after the period begins. Use a backup method for the first 7 days.
missed_dose: Refer to package insert for specific instructions based on number of missed pills and week in cycle.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as for adults once menstruation has begun and contraception is desired.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: Use with caution; monitor for fluid retention
Dialysis: Use with caution; monitor for fluid retention

Hepatic Impairment:

Mild: Use with caution
Moderate: Contraindicated
Severe: Contraindicated

Pharmacology

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Mechanism of Action

Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins. Although the primary mechanism is inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Levonorgestrel: ~100%
Tmax: Ethinyl Estradiol: 1-2 hours; Levonorgestrel: 1-2 hours
FoodEffect: Food does not significantly affect the extent of absorption of levonorgestrel and ethinyl estradiol.

Distribution:

Vd: Ethinyl Estradiol: ~5 L/kg; Levonorgestrel: ~1.8 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Levonorgestrel: ~97-99% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: 13-27 hours; Levonorgestrel: 24-45 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Levonorgestrel: ~1 mL/min/kg
ExcretionRoute: Renal (Ethinyl Estradiol: ~40%, Levonorgestrel: ~40-50%); Fecal (Ethinyl Estradiol: ~60%, Levonorgestrel: ~30-40%)
Unchanged: Ethinyl Estradiol: <2%; Levonorgestrel: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use.
PeakEffect: Not applicable for contraceptive effect; refers to peak plasma concentrations.
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 combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Jaimiess, 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 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.
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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 worst ever)
  • E: Eye problems (sudden blurred vision, loss of vision)
  • S: Severe leg pain (calf or thigh), swelling, redness, or 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, 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.
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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 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.
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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

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT levels)
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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).
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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).
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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

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Baseline Monitoring

Complete medical history (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by COC use.

Timing: Prior to initiation

Physical examination (including blood pressure measurement)

Rationale: To assess overall health and identify baseline cardiovascular status.

Timing: Prior to initiation

Breast and pelvic examination, Pap test

Rationale: As indicated by general health guidelines and patient age/risk factors.

Timing: Prior to initiation or as part of routine care

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Routine Monitoring

Blood pressure

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.

Annual health check-up

Frequency: Annually

Target: Not applicable

Action Threshold: Not applicable

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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

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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:

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 may pass into breast milk.

Infant Risk: Potential for adverse effects on the infant (e.g., jaundice, breast enlargement). Consider alternative contraceptive methods or delay initiation until weaning.
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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.

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Geriatric Use

Not indicated for contraception in post-menopausal women. No data available for use in geriatric populations.

Clinical Information

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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.
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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)
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Cost & Coverage

Average Cost: $30 - $100 per 91-day supply
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered under Affordable Care Act as preventive care)
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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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.