Norethindrone 5mg Tablets

Norethindrone is a synthetic progestin that transforms proliferative endometrium into secretory endometrium. It inhibits the secretion of pituitary gonadotropins (LH and FSH), thereby inhibiting follicular maturation and ovulation. It also increases the viscosity of cervical mucus, making it more difficult for sperm to penetrate, and alters the endometrium to make it less receptive to implantation.

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 immediately or seek emergency medical attention:

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
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Stomach pain
Severe dizziness or fainting
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, such as:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Mood changes, such as depression or other emotional changes
Swelling
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

Most people experience few or no side effects while taking this medication. However, some individuals may encounter mild side effects. If you experience any of the following symptoms and they bother you or persist, contact your doctor:

Dizziness or headache
Upset stomach or vomiting
Cramps
Bloating
Tender breasts
Trouble sleeping
Pimples (acne)
Weight gain
Vaginal bleeding or spotting
* 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.

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. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you have a history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver disease or liver tumors
+ Recent heart attack
+ Recent stroke
If you have a history of other specific health conditions, such as:
+ Cancer of the uterus, ovary, cervix, or vagina
+ Vaginal bleeding with an unknown cause

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. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

This drug may increase your risk of developing blood clots, having a stroke, or experiencing a heart attack. It is crucial to discuss these potential risks with your doctor.

If you have diabetes (high blood sugar), it is vital to closely monitor your blood sugar levels while taking this medication.

Regular breast exams and gynecology check-ups are necessary, and you should also perform breast self-exams as instructed by your healthcare provider.

As this drug may interfere with certain laboratory tests, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication.

If you suspect you are pregnant, have a positive pregnancy test, or experience any signs of pregnancy, contact your doctor immediately.

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby associated with this medication.

• Strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort): May significantly decrease norethindrone levels, leading to reduced efficacy (e.g., breakthrough bleeding, treatment failure).
• Tranexamic acid: Increased risk of thromboembolism when used with hormonal contraceptives/progestins.

• Moderate CYP3A4 inducers (e.g., bosentan, griseofulvin, modafinil, topiramate): May decrease norethindrone levels.
• CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; protease inhibitors like ritonavir, indinavir): May increase norethindrone levels, potentially increasing adverse effects.
• Thyroid hormones: Norethindrone may increase thyroid-binding globulin, leading to increased total thyroid hormone levels but unchanged free thyroid hormone levels. Patients on thyroid replacement therapy may require an increase in their thyroid hormone dose.

• Ascorbic acid (Vitamin C): May increase norethindrone levels slightly.
• Acetaminophen: May increase norethindrone levels slightly.

• Abnormal vaginal bleeding (spotting, breakthrough bleeding, heavy bleeding)
• Signs of thromboembolic events (e.g., sudden severe headache, vision changes, chest pain, shortness of breath, leg pain/swelling)
• Signs of liver dysfunction (e.g., jaundice, severe abdominal pain)
• Mood changes, depression
• Breast changes (lumps, tenderness)
• Weight changes
• Fluid retention/edema

Contraindicated in pregnancy. There is evidence of fetal risk based on human experience, and the risks of use in pregnant women clearly outweigh any possible benefits. Exposure during the first trimester has been associated with virilization of female fetuses.

Norethindrone is excreted in breast milk. While generally considered compatible with breastfeeding, caution is advised. Observe the infant for any potential effects.

Safety and efficacy have not been established in pediatric patients. Use in adolescents should be carefully considered and is generally off-label for the 5mg dose, unless for specific gynecological conditions under specialist guidance.

Use with caution in elderly patients, as they may have age-related decreases in hepatic function or increased risk of cardiovascular events. Consider lower starting doses and monitor closely.

• Norethindrone 5mg is primarily used for gynecological conditions like endometriosis, amenorrhea, and abnormal uterine bleeding, not typically as a standalone contraceptive (though lower doses are used for progestin-only pills).
• Patients should be advised to take the medication at the same time each day to maintain consistent hormone levels.
• Breakthrough bleeding or spotting is common, especially during the initial months of therapy, and usually decreases over time. Patients should be counseled on this expected side effect.
• Advise patients to report any signs of blood clots (e.g., sudden severe headache, chest pain, leg pain/swelling) immediately.
• For endometriosis, the dose may be gradually titrated upwards to manage symptoms and minimize side effects.
• Ensure a negative pregnancy test before initiating therapy in women of childbearing potential.

• For Endometriosis: GnRH agonists/antagonists (e.g., leuprolide, elagolix), combined oral contraceptives, NSAIDs, surgery.
• For Abnormal Uterine Bleeding: Combined oral contraceptives, IUDs (e.g., levonorgestrel-releasing IUD), NSAIDs, tranexamic acid, endometrial ablation, hysterectomy.
• For Amenorrhea: Estrogen-progestin therapy (if estrogen deficiency is the cause), treatment of underlying cause.

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 happened.