Safety information

Indication and clinical use:

Estragyn Vaginal Cream is indicated for the treatment of the symptoms of vulvovaginal atrophy (VVA) due to estrogen deficiency.1

Estragyn Vaginal Cream should be prescribed with an appropriate dosage of a progestin for women with intact uteri to prevent endometrial hyperplasia/carcinoma.

Estragyn Vaginal Cream is intended for short term use and is not indicated for use in children (<16 years of age).

Contraindications:

  • Liver dysfunction or disease as long as liver function tests have failed to return to normal
  • Known or suspected estrogen-dependent or progestin-dependent malignant neoplasia (e.g. endometrial cancer )
  • Endometrial hyperplasia
  • Known, suspected, or past history of breast cancer
  • Undiagnosed abnormal genital bleeding
  • Known or suspected pregnancy
  • Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease)
  • Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis
  • Partial or complete loss of vision due to ophthalmic vascular disease
  • Classical migraine
  • Breastfeeding
  • The mineral oil found in Estragyn Vaginal Cream is not compatible with the latex rubber found in most condoms

Most serious warnings and precautions:

Risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis: The estrogen plus progestin arm of the WHI trial (mean age 63.3 years) indicated an increased risk in postmenopausal women receiving treatment with combined conjugated equine estrogens (CEE, 0.625 mg/day and medroxyprogesterone acetate(MPA, 2.5 mg/day) for 5.2 years compared to those receiving placebo.1

Risk of stroke and deep vein thrombosis: The estrogen-alone arm of the WHI trial (mean age 63.6 years) indicated an increased risk in hysterectomized women treated with CEE alone (0.625 mg/day) for 6.8 years compared to those receiving placebo1.

Therefore, the following should be given consideration at the time of prescribing:

  • Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases
  • Estrogens with or without progestins should be prescribed at the lowest effective dose for the approved indication
  • Estrogens with or without progestins should be prescribed for the shortest period possible for the approved indication

Xxx

Other relevant warnings and precautions

  • Invasive breast cancer
  • Endometrial hyperplasia & endometrial cancer
  • Ovarian cancer
  • Coronary heart disease
  • Increased blood pressure
  • Patients with otosclerosis
  • Glucose and lipid metabolism
  • Heme metabolism
  • Calcium and phosphorous metabolism
  • Hypothyroidism
  • Vaginal bleeding
  • Uterine leiomyomata
  • Endometriosis
  • Venous thromboembolism
  • Gallbladder diseases
  • Hepatic hemangioma
  • Jaundice
  • Liver function tests should be done periodically
  • Angioedema
  • Systemic lupus erythematosus
  • Cerebrovascular insufficiency
  • Dementia
  • Epilepsy
  • Fluid retention

Adverse events:

  • Altered coagulation tests
  • Palpitations; increase in blood pressure; coronary thrombosis
  • Increased blood sugar levels; decreased glucose tolerance
  • Neuro-ocular lesions (e.g. retinal thrombosis, optic neuritis); visual disturbances; steepening of the corneal curvature; intolerance to contact lenses
  • Nausea; vomiting, abdominal discomfort (cramps, pressure, pain, bloating)
  • Fatigue; changes in appetite; changes in body weight; change in libido
  • Gallbladder disorder; asymptomatic impaired liver function; cholestatic jaundice
  • Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur
  • Aggravation of migraine episodes; headaches; dizziness; neuritis
  • Mental depression; nervousness; irritability
  • Cystitis; dysuria; sodium retention; edema
  • Breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; vaginal itching/discharge; dyspareunia; endometrial hyperplasia; pre-menstrual-like syndrome; reactivation of endometriosis; changes in cervical erosion and amount of cervical secretion; breast swelling and tenderness.
  • Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; haemorrhagic eruption; loss of scalp hair; hirsutism and acne.
  • Isolated cases of: thrombophlebitis; thromboembolic disorders.

For more information:

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, dosing information and conditions of clinical use which have not been discussed in this piece. The Product Monograph is also available by calling our Medical Information Department at 1-855-331-0830.