Sandrena
PRESCRIBING INFORMATION CAN BE FOUND HERE
Adverse event reporting can be found at the bottom of this page
See SmPC for full information before prescribing
SANDRENA GEL OVERVIEW:
Smooth, opalescent transdermal gel: Sandrena is an alcohol-based gel containing either 0.5mg or 1.0mg estradiol, a naturally occurring form of oestrogen derived from plants. Sandrena can be used for continuous or cyclical treatment.
The usual starting does is 1.0mg estradiol (1.0 g gel) daily but the selection of the initial dose can be based on the severity of the patient's symptoms.
Depending on the clinical response, the dosage can be readjusted after 2-3 cycles individually from 0.5g to 1.5g per day, corresponding to 0.5 to 1.5 mg estradiol per day. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
In patients with an intact uterus, it is recommended to be combined with a suitable dose of progestogen for an adequate duration for at least 12-14 consecutive days per month/28 day cycle or to oppose oestrogen-stimulated hyperplasia of the endometrium. Unless there is a previous diagnosis of endometriosis, it it not recommended to add a progestogen in hysterectomised women.
The experience of treating women older than 65 years old is limited.
Sandrena is indicated for oestrogen deficiency symptoms in postmenopausal women and provides effective relief of menopausal symptoms.2,3
ADVANTAGES OF GEL FORMULATION:
- Cosmetically appealing and easy to use
- Low volume gel is non-greasy and non-smelling
SANDRENA CAN BE USED FOR POSTMENOPAUSAL WOMEN WHO:
- Do not want to take tablets
- Do not want to wear a patch
SAFETY PROFILE:
Contraindications
- Known, past or suspected breast cancer
- Known or suspected oestrogen-dependent malignant tumours
- Undiagnosed genital bleeding
- Untreated endometrial hyperplasia
- Previous or current venous thromboembolism
- Known thrombophilic disorders
- Active or recent arterial thromboembolic disease
- Acute liver disease, or a history of liver disease as long as liver functions have failed to return to normal
- Hypersensitivity to active ingredient or excipients
- Porphyria
SIDE EFFECTS:
During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment.
The common side effects include:
- Weight increase or decrease
- Depression, nervousness and lethargy
- Headache, dizziness
- Hot flushes
- Nausea, vomiting, stomach cramps, flatulence, abdominal pain, rash, pruritis
- Unscheduled vaginal bleeding or spotting, vaginal discharge, disorder of vulva/vagina, menstrual disorder, breast pain/tension
- Skin irritation, application site pain, increased sweating, edema
July 2024/HRT-2bab(4)
ADVERSE EVENTS SHOULD BE REPORTED. REPORTING FORMS AND INFORMATION CAN BE FOUND AT WWW.MHRA.GOV.UK/YELLOWCARD. ADVERSE EVENTS SHOULD ALSO BE REPORTED TO ORION PHARMA (UK) LTD ON 01635 520300. |
Reference:
- MIMS Online. Sandrena (estradiol hemihydrate). Date accessed: 22nd July 2024. https://www.mims.co.uk/drugs/obstetrics-and-gynaecology/menopausal-disorders/sandrena
- Sandrena Summary of Product Characteristcs
- Hirvonen E etal. BJOG 1997;104 Suppl 16: 19-25, Transdermal oestradiol gel in the treatment of the climacterium: a comparison with oral therapy. https://pubmed.ncbi.nlm.nih.gov/9389779/