Prasterone vaginal
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaginal pessaries containing prasterone.
Drugs List
Therapeutic Indications
Uses
Atrophic vaginitis - post-menopausal
Dosage
Adults
1 pessary to be inserted once daily at bedtime.
Additional Dosage Information
If a dose is missed, it should be inserted as soon as the patient remembers unless the next dose is due in less than 8 hours, in which case the missed pessary should be inserted when the next dose is due. Do not insert 2 pessaries to make up for a missed dose.
Contraindications
Abnormal liver function test
Acute hepatic disorder
Angina
Breast cancer
Breastfeeding
Deep vein thrombosis
Endometrial cancer
History of breast cancer
History of venous thromboembolism
Myocardial infarction
Oestrogen dependent neoplasm
Porphyria
Pregnancy
Pulmonary embolism
Thromboembolic disorder
Thrombophilic disorder
Uncontrolled endometrial hyperplasia
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Family history of breast cancer
Major surgery
Predisposition to thromboembolic disease
Prolonged immobilisation
Severe headache
Asthma
Cardiac impairment
Cholelithiasis
Diabetes mellitus
Endometrial hyperplasia
Endometriosis
Epileptic disorder
Hepatic adenoma
Hepatic disorder
History of endometrial hyperplasia
Hypertension
Hypertriglyceridaemia
Migraine
Otosclerosis
Ovarian carcinoma
Renal impairment
Systemic lupus erythematosus
Uterine fibroids
Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Exclude oestrogen dependent neoplasm before treatment
Treat vaginal infections before initiation of therapy
Do breast & pelvic exam. before & during treatment if clinically indicated
Monitor blood pressure pre-treatment and periodically thereafter
Abnormal and/or irregular bleeding should be investigated
Advise patients of risks/benefits & review need for treatment regularly
Review treatment every 6 months
Advise patient of thromboembolic symptoms and to report them if they occur
Advise patient that changes in their breasts should be reported to Dr/nurse
Avoid immobilisation-treatment may cause increased risk of thromboembolism
Discontinue 4 - 6 weeks before major surgery
Discontinue at first signs of jaundice
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if liver function deteriorates
Discontinue if significant rise in blood pressure occurs
Discontinue if sudden pain in the chest occurs
Pregnancy confirmed: Discontinue this medication
Male & female: Damages latex condoms and diaphragms
Advise women to participate in breast/cervical cancer screening programmes
Pregnancy and Lactation
Pregnancy
Prasterone pessary is contraindicated during pregnancy.
The manufacturer notes that if pregnancy occurs during treatment with this medication, the treatment should be stopped immediately. The potential risk in humans is unknown.
There is little data on the use on this medication in pregnant women and no studies in animals were performed with regard to the reproductive toxicity.
Lactation
Prasterone pessary is contraindicated during breastfeeding.
The manufacturer notes that this medication is not indicated during breastfeeding.
Side Effects
Breast mass
Cervical changes
Cervical polyp
Endometrial polyps
Vaginal discharge
Weight changes
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Summary of Product Characteristics: Intrarosa 6.5mg pessary. Theramex UK Limited. Revised September 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.