Crinone 8% Vaginal Gel
Progesterone
80mg/g
SERONO PHARMACEUTICALS LTD.
| Pack size | 15 Single-use Prefilled Applicators |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | ARABIAN ETHICALS CO. |
| Retail Price | 236.00 AED |
Indications
Crinone 8% Vaginal Gel is used for:
Premenstrual syndrome, Contraception, Menopausal HRT, Amenorrhoea, Recurrent miscarriage
Adult Dose
Oral
Progestogen component of menopausal hormonal replacement therapy. Adult: 200 mg daily as a single daily dose at night for 12-14 days of each mth.
Amenorrhoea
Adult: 400 mg daily for 10 days.
Dysfunctional uterine bleeding.
Adult: 400 mg daily for 10 days.
Prevention of Endometrial Hyperplasia.
Adult: 200 mg PO at night for 12 days sequentially per 28-day cycle
Vaginal Gel
Dysfunctional uterine bleeding.
Adult: 45 mg every other day from the 15th-25th day of the cycle. May increase dose to 90 mg in non-responders.
Amenorrhoea.
Adult: 45 mg every other day from the 15th-25th day of the cycle. May increase dose to 90 mg in non-responders.
Child Dose
Renal Dose
Administration
Contra Indications
Hypersensitivity; thrombophloebitis; cerebral apoplexy; severe hepatic impairment; undiagnosed vag bleeding, incomplete abortion, hormone-dependent carcinoma, as a diagnostic test for pregnancy; pregnancy. History or current high risk of arterial disease.
Precautions
Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy).
Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery.
Discontinue 4 week before major surgery or prolonged immobilization. Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted). Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk.
Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer. Evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk. Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use.
May cause dizziness; use caution when driving a motor vehicle or operating machinery
Increased risk of developing probable dementia in postmenopausal women >65 years of age reported
Use with caution in patients with history of depression
Use with caution in patients with diseases that could become exacerbated by fluid retention including epilepsy, migraine, renal dysfunction, diabetes, or asthma
Pregnancy-Lactation
Pregnancy Category: B
Lactation: Possibly safe; use caution
Interactions
Adverse Effects
Side effects of Progesterone :
>10%
Headache (10-31%), Breast tenderness (16-27%), Dizziness (15-24%), Abdominal pain (10-20%), Depression (19%), Breast pain (6-16%), Viral disease (7-12%)
1-10%
Vaginal discharge (10%), Fatigue (8-9%), Nausea (8%), Mood swings (6%)
Frequency Not Defined
Dementia, probable(postmenopausal women >65 years of age, possible association), Anorexia, Weakness, Weight change (less common than with synthetic progestins), Vomiting, Edema, DVT (postmenopausal women 50-79 years of age), Thrombophlebitis, Myocardial infarction (postmenopausal women 50-79 years of age), Stroke (postmenopausal women 50-79 years of age), Pulmonary emboli (postmenopausal women 50-79 years of age), Amenorrhea (less common than with synthetic progestins), Breakthrough bleeding (less common than with synthetic progestins), Change in menstrual flow(less common than with synthetic progestins), Spotting (less common than with synthetic progestins), Breast changes (less common than with synthetic progestins), Invasive breast cancer(postmenopausal women 50-79 years of age), Cholestatic jaundice, Vaginal candidiasis, General pruritus, Ectopic pregnancy
Mechanism of Action
Progesterone is the main hormone secreted by corpus luteum. It induces secretory changes in the endometrium, promotes mammary gland development, relaxes uterus, blocks follicular maturation and ovulation, and maintains pregnancy.
Note
Crinone 8% 80mg/g Vaginal Gel manufactured by SERONO PHARMACEUTICALS LTD.. Its generic name is Progesterone. Crinone 8% is availble in United Arab Emirates.
Farmaco UAE drug index information on Crinone 8% Vaginal Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.