Lojaimiess Tablets

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
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Jan 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lojaimiess Tablets are a birth control pill that contains two female hormones, estrogen (Ethinyl Estradiol) and progestin (Levonorgestrel). It works by preventing ovulation (the release of an egg from the ovary) and by changing the lining of the uterus and cervical mucus to prevent pregnancy. It is taken daily.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Do not skip any doses, even if you don't have sex frequently.

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

You can take this medication with or without food. If it causes stomach upset, take it with food. To establish a routine, take your 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 have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If you experience vomiting or diarrhea 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 what to do, call your doctor for guidance.

Important Considerations for Women

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 menstrual cycle is longer than 91 days and you miss one period, take a pregnancy test before starting a new cycle of medication.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom.

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or call your doctor for instructions on what to do next. If you are taking this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as this significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
  • Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
  • Use a backup method of contraception (like condoms) for the first 7 days of your first pack, or if you miss pills.
  • Be aware of the 'ACHES' warning signs (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and seek immediate medical attention if they occur.
  • 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 orally once daily at the same time each day for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain active ingredients, and the last 7 are placebo.
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: Initiate no earlier than 4 weeks postpartum in non-lactating women due to increased risk of thromboembolism.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
Prepubertal: Not indicated
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific adjustment, but use with caution due to potential fluid retention.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated
Severe: Contraindicated

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (FSH and LH), thereby inhibiting ovulation. They also cause changes in the cervical mucus (making it thicker and less permeable to sperm) and the endometrium (making it less receptive to implantation). Ethinyl Estradiol provides the estrogenic component, and Levonorgestrel provides the progestational component.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: 40-60%; Levonorgestrel: ~100%
Tmax: Ethinyl Estradiol: 1-2 hours; Levonorgestrel: 1-2 hours
FoodEffect: Minimal effect on absorption, but may reduce gastrointestinal upset.

Distribution:

Vd: Ethinyl Estradiol: ~4.3 L/kg; Levonorgestrel: ~1.8 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Levonorgestrel: ~97% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~10-20 hours; Levonorgestrel: ~24-45 hours
Clearance: Ethinyl Estradiol: ~5-10 mL/min/kg; Levonorgestrel: ~1 mL/min/kg
ExcretionRoute: Ethinyl Estradiol: Renal (glucuronide and sulfate conjugates) and fecal; Levonorgestrel: Renal (glucuronide and sulfate conjugates) and fecal
Unchanged: Ethinyl Estradiol: <10%; Levonorgestrel: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use. Backup contraception is recommended for the first 7 days of the first cycle.
PeakEffect: Peak suppression of ovulation occurs after consistent use for several cycles.
DurationOfAction: Daily dosing maintains continuous contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
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Side Effects

Serious 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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ 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
+ Fever with chills
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ 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
Blurred eyesight
New or worsening migraines
Depression or other mood changes
Lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of eyesight
Bulging eyes
Changes in how contact lenses feel
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble 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 contact your doctor or seek medical help if you notice any of the following:

Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged breasts
Tender breasts
Period (menstrual) changes, including spotting or bleeding between cycles
Back pain
* Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)

Reporting 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:

  • Sudden severe headache or migraine
  • Sudden partial or complete loss of vision
  • Sudden severe pain or swelling in one leg
  • Chest pain, shortness of breath, or coughing up blood
  • Weakness or numbness in an arm or leg
  • Yellowing of the skin or eyes (jaundice)
  • Severe abdominal pain
  • Depressed mood
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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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Vaginal bleeding with an unknown cause
If you experienced jaundice during pregnancy or with estrogen use, such as hormonal birth control
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential 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 treatment. Do not initiate, stop, or adjust the dosage 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. 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 recommended by your doctor. It is also essential to have regular breast exams, gynecology check-ups, and perform breast self-exams as instructed by your doctor.

Certain medications, herbal products, or health conditions may interfere with the effectiveness of hormone-based birth control. Inform your doctor about all your medications and health issues, and discuss the potential need for 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; discuss this 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.

Research suggests that the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be attributed to other factors. Additionally, some studies have shown a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while others have not. 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 is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or seek medical attention. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir, dasabuvir (increased ALT elevation)
  • Glecaprevir/pibrentasvir (increased ALT elevation)
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Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Certain HIV protease inhibitors (e.g., Nelfinavir, Ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine, Efavirenz) - may alter COC levels.
  • Lamotrigine - COCs may decrease lamotrigine levels, leading to loss of seizure control.
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Moderate Interactions

  • Broad-spectrum antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic recirculation, though clinical significance is debated.
  • CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Grapefruit juice) - may increase COC levels, potentially increasing adverse effects.
  • Thyroid hormone replacement (e.g., Levothyroxine) - COCs may increase thyroid-binding globulin, requiring increased thyroid hormone dose.
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Minor Interactions

  • Acetaminophen - may increase Ethinyl Estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase Ethinyl Estradiol levels.

Monitoring

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Baseline Monitoring

Complete medical history (including family history of VTE, breast cancer)

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

Timing: Prior to initiation

Blood pressure

Rationale: To identify hypertension, a risk factor for cardiovascular events.

Timing: Prior to initiation

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

Rationale: To rule out contraindications and establish baseline health status.

Timing: Prior to initiation (as clinically indicated)

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Routine Monitoring

Blood pressure

Frequency: Annually or more frequently if clinically indicated

Target: <140/90 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraceptive method.

Annual physical examination (including breast and pelvic exam, Pap test)

Frequency: Annually (as per general health guidelines)

Target: Normal findings

Action Threshold: Abnormal findings require further investigation and potential discontinuation.

Weight/BMI

Frequency: Annually

Target: Healthy range

Action Threshold: Significant weight gain may increase cardiovascular risk.

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Symptom Monitoring

  • Severe abdominal pain (A)
  • Severe chest pain, shortness of breath, or coughing up blood (C)
  • Severe headaches (H)
  • Eye problems (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, light-colored stools
  • Mood changes, depression
  • New or worsening migraines

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for use of COCs in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure during early pregnancy.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects observed.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended during lactation, especially in the first 6 weeks postpartum. Estrogen-containing contraceptives can decrease the quantity and quality of breast milk and may be excreted in small amounts into breast milk. Progestin-only methods are generally preferred for lactating women.

Infant Risk: Small amounts of hormones may pass into breast milk, but no adverse effects on infant health or development have been consistently demonstrated. However, potential for reduced milk supply is a concern.
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Pediatric Use

Indicated for post-menarcheal adolescents for contraception. Safety and efficacy are expected to be similar to adults. Not indicated for prepubertal children.

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Geriatric Use

Not indicated for postmenopausal women. Risk of cardiovascular events increases with age, making COCs generally unsuitable for women over 50.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of consistent daily dosing at the same time to maintain efficacy and minimize breakthrough bleeding.
  • Counsel patients on the 'ACHES' warning signs for serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and when to seek immediate medical attention.
  • Strongly advise against smoking, especially for women over 35, due to significantly increased cardiovascular risk.
  • Discuss potential drug interactions, particularly with enzyme-inducing medications, and advise on the need for backup contraception.
  • Remind patients that COCs do not protect against STIs and that condoms should be used for STI prevention.
  • Consider progestin-only methods or non-hormonal options for women with contraindications to estrogen (e.g., history of VTE, uncontrolled hypertension, migraine with aura).
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Alternative Therapies

  • Progestin-only pills (POPs)
  • Progestin implants (e.g., Nexplanon)
  • Progestin IUDs (e.g., Mirena, Skyla, Kyleena, Liletta)
  • Copper IUD (Paragard)
  • Contraceptive patch (e.g., Xulane)
  • Vaginal ring (e.g., NuvaRing, Annovera)
  • Contraceptive injection (e.g., Depo-Provera)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $15 - $50 per 28 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered at no cost under ACA)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.