What is Crinone used for?

Continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses. The experience in treating women older than 65 years is limited.

What pharmaceutical form is Crinone available in?

Crinone: Żel dopochwowy 80 mg/g

What are the side effects of Crinone?

a. Summary of the safety profile The most commonly reported related adverse drug reactions for Bijuve in clinical trials were breast tenderness (10.4%), headache (3.4%), nausea (2.2%), pelvic pain (3.1%), vaginal hemorrhage (3.4%), and vaginal discharge (3.4%). Incidence of Related Treatment Emergent Adverse Events Occurring in ≥ 3% in 1 mg E2/100 mg P Treatment Arm and More Commonly than Placebo (Study TXC12‑05) 1 mg E2/ 100 mg P (N=415) Placebo (N=151) Breast tenderness 43 (10.4) 1 (0.7) Heada

Who should NOT take Crinone?

- Known, past or suspected breast cancer; - Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer); - Undiagnosed genital bleeding; - Untreated endometrial hyperplasia; - Previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism); - Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4.); - Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);

Does Crinone interact with other medications?

No drug-drug interaction studies have been conducted with Bijuve The drug-drug interactions of estradiol and progesterone have been extensively studied and are well established. Both estrogens and progesterone are metabolized via cytochrome P450 Effects of other medicinal products on Bijuve The metabolism of estrogens and progestogens may be increased by concomitant use of substances known to induce drug-metabolizing enzymes, specifically cytochrome P450 enzymes, such as antico

Can Crinone be used during pregnancy?

Pregnancy Bijuve is not indicated during pregnancy. If pregnancy occurs during medication with Bijuve treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of oestrogens and progestogens indicate no teratogenic or foetotoxic effect. There are no adequate data from the use of estradiol/progesterone in pregnant women. Lactation Bijuve is not indicated during lactation. Fertility Bijuv

What precautions should be taken with Crinone?

Bijuve capsules no longer required should not be disposed via wastewater or the municipal sewage system. The hormonal active compounds in the capsule may have harmful effects if reaching the aquatic environment. The capsules should be returned to a pharmacy or disposed of in another safe way according to local requirements. These measures will help to protect the environment.

What ATC class does Crinone belong to?

Crinone: ATC G03DA04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Crinone

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

The ATC code is G03FA04 progesterone and oestrogen Estradiol The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.‍‍‍‍‍‍‍ It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Progesterone The active ingredient, progesterone is a natural progestogen, that is chemically and biologically identical to endogenous human progesterone. As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestogen greatly reduces the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women. Clinical efficacy and safety Bijuve (1 mg estradiol/100 mg progesterone) was evaluated in 726 postmenopausal women who participated in 1 phase 3 trial. Among these, 141 women were treated with 1 mg estradiol/100 mg progesterone and 135 received placebo. Endometrial safety was evaluated in 268 women for a period of 1 year. Relief of oestrogen-deficiency symptoms and bleeding patterns. Relief of menopausal symptoms was achieved during the first few weeks of treatment. In a 12-week study, 1mg estradiol/100 mg progesterone significantly reduced the number and severity of hot flushes compared to placebo at weeks 4 and 12. In this study, amenorrhea was reported in 82.6% of the women who received 1mg estradiol/ 100 mg progesterone during months 10 to 12. Bleeding and/or spotting was reported in the 1mg estradiol/100 mg progesterone group by 30.1% of women during the first 3 months of treatment and by 17.4% of women during months 10 to 12. Endometrial safety The effects of 1mg estradiol/100 mg progesterone (Bijuve) on the endometrium was assessed in the 52-week safety trial. During the trial, assessments of endometrial biopsies taken at 12 months or at early trial discontinuation revealed 1 case of simple endometrial hyperplasia without atypia and no endometrial cancer in women who received Bijuve (1 mg estradiol/ 100 mg progesterone capsules (N=1/268, 0.37%; 2-sided 95% CI:1.83%). Four (4) cases of disordered proliferative endometrium were also reported for BIJUVE 1 mg estradiol/ 100 mg progesterone) capsules.

Crinone

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