Primogyn Side effects

• Side effects of Primogyn in details
• Primogyn contraindications
• Primogyn reviews

What are the possible side effects of Primogyn?

Primogyn increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using Primogyn lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using Primogyn. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Treatment with Primogyn long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Primogyn long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

If you experience any of the following serious side effects, stop using Primogyn and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• shortness or breath or pain in the chest;

• a painful, red, swollen leg;

• abnormal vaginal bleeding;

• pain, swelling, or tenderness in the abdomen;

• severe headache or vomiting, dizziness, faintness or changes in vision or speech;

• yellowing of the skin or eyes; or

• a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to use Primogyn and talk to your doctor if you experience

• decreased appetite, nausea, or vomiting;

• swollen breasts;

• acne or skin color changes;

• decreased sex drive;

• migraine headaches or dizziness;

• vaginal pain, dryness, or discomfort;

• water retention (swollen hands, feet, or ankles);

• depression; or

• changes in your menstrual cycle or break-through bleeding.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Side effects of Primogyn in details

See WARNINGS and Boxed Warning regarding the potential adverse effects on the fetus, the induction of malignant neoplasms, gallbladder disease, cardiovascular disease, elevated blood pressure, and hypercalcemia.

Skin irritation: In controlled clinical studies with Primogyn (Primogyn transdermal), the most commonly reported adverse events were topical reactions of erythema and/or pruritus at the application site. In general these reactions caused patients little or no discomfort, and led to premature discontinuation of treatment in 0.9% (3/317) of patients in these trials. The rate of application site reactions, based on 8,135 applications of the 0.025, 0.05, and 0.1 Primogyn (Primogyn transdermal) systems in these trials was 6.1 per 100 applications (4.9, 5.4, 10.7 for the 3 Primogyn (Primogyn transdermal) doses respectively) compared to 6.2 in the placebo treated patients (2,014 applications).

In a placebo-controlled trial of Primogyn (Primogyn transdermal) 0.025, 0.05, and 0.1 conducted in 196 patients in the US, the adverse events reported by at least 5% of patients in 1 or more of the treatment groups are shown in Table 5.

Urogenital Adverse Events : In the US placebo-controlled study, 72 patients were included who had intact uteri. As expected, after 12-13 weeks of continuous unopposed therapy, findings of endometrial hyperplasia (diagnosed either by endometrial biopsy and/or ultrasonography) were increased with increasing doses of Primogyn (placebo: 0/18 patients; Primogyn (Primogyn transdermal) 0.025: 1/14 (7.1%); Primogyn (Primogyn transdermal) 0.05: 12/22 (54.5%); Primogyn (Primogyn transdermal) 0.1: 10/18 (55.6%). In the 86 patients who had not previously undergone a total hysterectomy, vaginal bleeding was also increased with increasing doses of Primogyn [placebo: 2/21 patients (9.5%); Primogyn (Primogyn transdermal) 0.025: 6/19 (31.6%); Primogyn (Primogyn transdermal) 0.05: 14/25 (56.0%); Primogyn (Primogyn transdermal) 0.1: 12/21 (57.1%)].

In 2 long-term studies involving a total of 488 patients treated for a mean duration of 618 days and up to 3.5 years, the nature and incidence of adverse events did not change with prolonged duration of treatment.

The following additional adverse reactions have been reported with estrogen therapy:

1. Genitourinary System. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; increase in size of uterine leiomyomata; vaginal candidiasis; change in amount of cervical secretion.

2. Breasts. Tenderness, enlargement.

3. Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; gallbladder disease.

4. Skin. Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism.

5. Eyes. Steepening of corneal curvature: intolerance to contact lenses.

6. Central Nervous System. Headache, migraine, dizziness; mental depression; chorea.

7. Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido.

What is the most important information I should know about Primogyn?

• Primogyn spray may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Primogyn spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Primogyn spray is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse right away with warm clean water.
• Check with your doctor before you apply sunscreen to the application site while you are using Primogyn spray.
• Primogyn spray is flammable. Avoid fire, flame, or smoking until the medicine has dried on your skin.
• Eating grapefruit or drinking grapefruit juice may increase the risk of Primogyn spray's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Primogyn spray.
• Tell your doctor or dentist that you take Primogyn spray before you receive any medical or dental care, emergency care, or surgery. If possible, Primogyn spray should be stopped at least 4 to 6 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, car ride, bedrest, or illness).
• Primogyn spray may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.
• If you wear contact lenses and you develop problems with them, contact your doctor.
• Diabetes patients - Primogyn spray may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Primogyn spray may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Primogyn spray.
• Talk with your doctor regularly (eg, every 3 to 6 months) about whether you need to continue taking Primogyn spray.
• Lab tests and medical exams, including physicals and blood pressure, may be performed while you use Primogyn spray. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Examine your breasts monthly as directed by your doctor. Report any lumps right away.
• Use Primogyn spray with caution in the ELDERLY; they may be more sensitive to its effects.
• Primogyn spray should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Primogyn spray if you are pregnant. If you think you may be pregnant, contact your doctor right away. Primogyn spray is found in breast milk. Do not breast-feed while you are taking Primogyn spray.

Primogyn contraindications

Primogyn can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Primogyn may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin while you are using Primogyn, to help lower this risk. Report any unusual vaginal bleeding right away.

Long-term use of Primogyn may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using Primogyn transdermal long term.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Primogyn transdermal.

Primogyn transdermal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

References

1. DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. DTP/NCI. "estradiol: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology