Generic Aygestin (Norethindrone Acetate)

Aygestin
Aygestin is a hormone used in treatment of endometriosis, amenorrhea, and abnormal uterine bleeding caused by hormonal imbalance.
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Introduction

Aygestin is a oral progestin tablet that contains the synthetic hormone norethindrone acetate. It is classified as a progestogen and is approved for specific gynecologic and obstetric indications. The medication is supplied in a 5 mg tablet and is manufactured by TherapeuticsMD (formerly Jenapharm). In addition to its FDA-approved uses, clinicians sometimes consider Aygestin for other hormonal conditions, but such applications remain off-label and must be supervised by a qualified health professional.


What is Aygestin?

Aygestin is a prescription-only medication that delivers the active compound norethindrone acetate. It belongs to the class of synthetic progestins derived from testosterone. The drug was first introduced in the United States in the early s and is marketed under the brand name Aygestin; the same active ingredient is also available as generic norethindrone acetate and is marketed under brand names such as Camila, Noretide, and Ortho-Novum.

Aygestin is the generic version of well-known medications, containing the active compound norethindrone acetate. Our online pharmacy provides this generic alternative as a cost-effective treatment option.

The tablet is supplied in a fixed 5 mg dose, which simplifies prescribing and reduces dosing errors.


How Aygestin Works

Norethindrone acetate is a progestogenic agonist that binds to progesterone receptors in target tissues (endometrium, breast, hypothalamus, and pituitary). By activating these receptors, the drug mimics the natural hormone progesterone, producing several therapeutic effects:

  1. Endometrial transformation - The drug thins the uterine lining, making it unsuitable for implantation and reducing menstrual bleeding.
  2. Hypothalamic-pituitary suppression - It decreases the frequency of gonadotropin-releasing hormone (GnRH) pulses, leading to lower luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, which in turn limits ovarian estrogen production.
  3. Anti-estrogenic activity - In certain tissues, norethindrone acetate opposes estrogen-driven proliferation, contributing to the management of hormone-sensitive conditions.

After oral ingestion, norethindrone acetate is rapidly hydrolyzed to norethindrone, the active moiety. Peak plasma concentrations occur within 1-2 hours, and the drug’s half-life ranges from 8 to 10 hours, allowing once-daily dosing. The medication is metabolized primarily by the cytochrome P450 3A4 (CYP3A4) pathway and excreted in the urine as conjugated metabolites.


Conditions Treated with Aygestin

Approved indications (United States)

  • Endometriosis - Aygestin reduces ectopic endometrial tissue growth and alleviates associated pelvic pain.
  • Abnormal uterine bleeding (AUB) due to hormonal imbalance - The progestin stabilizes the endometrium, decreasing irregular bleeding episodes.
  • Hormone-replacement therapy (HRT) for menopausal symptoms - Used in combination with estrogen to protect the endometrium and reduce menopausal hot flashes.

Why the drug is effective

  • In endometriosis, the progestogenic effect induces decidualization and atrophy of endometrial implants, mitigating pain.
  • For AUB, the tablet suppresses the proliferative phase of the menstrual cycle, leading to a more predictable and lighter bleed.
  • In HRT, progesterone antagonizes estrogen-induced endometrial hyperplasia, lowering the risk of endometrial carcinoma while providing systemic hormonal balance.

Off-Label and Investigational Uses of Aygestin

Off-label use Evidence basis Comments
Management of heavy menstrual bleeding (HMB) when oral contraceptives are unsuitable Small randomized trials (e.g., Brufsky 2015) show reduced menstrual blood loss with norethindrone acetate compared with placebo. Not FDA-approved for HMB alone; patients should be monitored for anemia.
Adjunctive therapy for breast cancer in pre-menopausal women Observational studies suggest that progestins may modulate estrogen receptors, but data are limited and contradictory. Use remains experimental; only under specialist oncology supervision.
Treatment of amenorrhea related to hypothalamic dysfunction Case series indicate that progestin-only regimens can restore cyclic bleeding. Requires careful endocrine assessment.
Prevention of ovarian cyst recurrence after surgical removal A 2018 pilot study reported lower recurrence rates with continuous norethindrone acetate. Evidence is preliminary; not part of standard guidelines.

All off-label applications listed above have not received formal approval from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Patients should discuss potential benefits and risks with a qualified healthcare provider before initiating such therapy.


Is Aygestin the Right Medication for You?

Suitable patient populations

  • Women of reproductive age diagnosed with endometriosis or hormonal AUB who prefer a progestin-only approach.
  • Perimenopausal or early-postmenopausal women requiring estrogen-progestin HRT, particularly those with an intact uterus.
  • Patients who cannot tolerate combined oral contraceptives due to estrogen-related side effects (e.g., migraine with aura).

Clinical scenarios where Aygestin is often recommended

  • When surgical intervention for endometriosis is not feasible or as an adjunct to surgery.
  • In individuals with contraindications to estrogen (e.g., history of thromboembolism) who still need endometrial protection.
  • For women seeking a short-term hormonal regimen to regulate irregular bleeding before definitive fertility planning.

Contraindications

  • Known or suspected pregnancy.
  • Active or history of thromboembolic disorders (deep-vein thrombosis, pulmonary embolism).
  • Uncontrolled hypertension, liver disease, or estrogen-dependent neoplasia.
  • Known hypersensitivity to norethindrone acetate or any tablet excipient.

Patients with any of the above conditions should avoid Aygestin unless a specialist determines that benefits outweigh risks.


Risks, Side Effects, and Interactions

Common

  • Nausea or vomiting
  • Breast tenderness or enlargement
  • Headache
  • Mood changes (e.g., irritability)
  • Spotting or breakthrough bleeding

Rare

  • Weight gain or fluid retention
  • Decreased libido
  • Hirsutism (excess hair growth)
  • Dysmenorrhea (painful periods)

Serious

  • Thromboembolic events - Deep-vein thrombosis, pulmonary embolism (particularly in patients with pre-existing risk factors).
  • Liver dysfunction - Elevated transaminases or cholestatic hepatitis.
  • Severe allergic reaction - Anaphylaxis, angioedema, or urticaria.
  • Melasma or other pigmentary changes - May persist after discontinuation.

Drug-drug interactions

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort) can lower norethindrone plasma levels, reducing efficacy.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, grapefruit juice) may increase drug exposure and heighten side-effect risk.
  • Anticoagulants - Progestins may modestly increase clotting risk; monitor INR or anti-Xa levels closely.
  • Antiepileptic drugs - Some may reduce hormonal contraceptive effectiveness; consider alternative contraception.

Drug-food interactions

  • Grapefruit juice should be avoided because it can inhibit CYP3A4 and raise norethindrone concentrations.

Patients should inform their health-care team of all medications, supplements, and herbal products before beginning Aygestin.


Use: Dosing, Missed Dose, Overdose

Standard dosing

  • Endometriosis - 5 mg taken orally once daily for 10 consecutive days each month, repeated for 6-12 months.
  • Abnormal uterine bleeding - 5 mg taken orally once daily for 10 days each month, continued as needed for bleeding control.
  • Hormone-replacement therapy - 5 mg taken orally once daily, typically combined with daily estrogen (e.g., estradiol) for 12-24 months.

Dosage adjustments are rarely required; however, clinicians may tailor the duration based on therapeutic response and side-effect profile.

Missed dose

  • If a dose is missed by less than 12 hours, take it as soon as remembered and continue with the next scheduled dose.
  • If more than 12 hours have passed, skip the missed tablet and resume the regular schedule; do not double-dose.

Overdose

  • Symptoms may include severe nausea, vomiting, dizziness, or fainting.
  • Seek immediate medical attention or call a poison-control center. No specific antidote exists; treatment is supportive and symptomatic.

Practical precautions

  • Aygestin may be taken with or without food; however, taking it with a small meal can reduce stomach upset.
  • Alcohol does not interact directly but can exacerbate dizziness and nausea.
  • Patients should avoid operating heavy machinery until they know how the medication affects them.

FAQ

  • What should I do if I travel internationally with Aygestin?

    • Keep the tablets in their original packaging with a copy of the prescription. Store them in a carry-on bag to avoid temperature extremes in checked luggage.
  • Can I take Aygestin while breastfeeding?

    • Norethindrone acetate is excreted in breast milk in small amounts. Most guidelines advise caution; discuss risks and benefits with your health-care provider before use.
  • Does Aygestin contain any allergens such as gluten or lactose?

    • In the United States, the tablet excipients are typically microcrystalline cellulose, magnesium stearate, and lactose. Patients with severe lactose intolerance should verify the specific formulation.
  • How does Aygestin differ from combined oral contraceptives?

    • Aygestin contains only a progestin, whereas combined pills include both estrogen and progestin. This difference influences side-effect profiles, clotting risk, and suitability for certain medical conditions.
  • Is it safe to use Aygestin for more than one year?

    • Long-term use is permissible when indicated (e.g., HRT). Routine monitoring of blood pressure, lipid profile, and liver enzymes is recommended.
  • Will Aygestin affect my laboratory hormone tests?

    • Yes, synthetic progestins can suppress endogenous LH and FSH, potentially altering pituitary hormone panels. Inform the laboratory of your medication.
  • Can I take Aygestin with herbal supplements like black cohosh?

    • Black cohosh may have estrogen-modulating effects; combined use has not been systematically studied. Discuss any supplements with your provider to avoid unpredictable hormonal interactions.
  • What is the appearance of a 5 mg Aygestin tablet?

    • The tablet is round, white, and bears the imprint “AYG 5 MG”. This helps differentiate it from other progestin products.
  • Does Aygestin require refrigeration?

    • No. Store at controlled room temperature (15-30 °C) away from excess heat, moisture, and direct sunlight.
  • Are there any special considerations for patients with a history of depression?

    • Progestins can influence mood; monitor for worsening depressive symptoms, especially during the initial weeks of therapy.

Glossary

Progestogen
A class of hormones that mimic the effects of progesterone, a natural hormone involved in the menstrual cycle and pregnancy.
Endometrium
The inner lining of the uterus that thickens each month in preparation for potential embryo implantation.
CYP3A4
An enzyme in the liver that metabolizes many drugs; substances that induce or inhibit CYP3A4 can alter medication levels.
Hypothalamic-pituitary-ovarian axis
The hormonal feedback loop among the hypothalamus, pituitary gland, and ovaries that regulates reproduction.

Buying Aygestin from Our Online pharmacy

Patients who encounter cost barriers, limited local availability, or insurance restrictions can obtain Aygestin through our online pharmacy. We partner with licensed overseas pharmaceutical distributors that adhere to Good Manufacturing Practice (GMP) standards, ensuring each batch meets stringent quality controls.

  • Affordable pricing - Because we source directly from manufacturers, the price is close to the wholesale cost, offering a significant reduction compared with typical retail pharmacies.
  • Verified quality - Every shipment is accompanied by a certificate of analysis confirming identity, potency, and purity of norethindrone acetate.
  • Discrete delivery - Orders are packaged in unmarked, tamper-evident parcels and shipped via express or regular airmail (approximately 7 days for express, 3 weeks for standard).
  • Privacy-focused service - As a pharmacy broker, we never share personal information with third parties; all communications are encrypted and stored securely.

Our platform provides a reliable, cost-effective pathway for patients who need consistent access to Aygestin while maintaining confidentiality and peace of mind.


Disclaimer

The information presented about Aygestin is intended for general educational purposes only and should not replace professional medical advice. All therapeutic decisions, including any off-label applications, must be made under the supervision of a qualified health-care provider. Readers are assumed to be responsible adults capable of evaluating health information. Our online pharmacy offers access to Aygestin for individuals who may experience limited availability through conventional pharmacies or who seek affordable generic alternatives. Always consult a qualified medical professional before starting, adjusting, or discontinuing any medication.

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