Presentation and Status in Health Basket
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Solution for Injection 1 x 25 mg |
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Solution for Injection 4 x 25 mg |
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Solution for Injection 7 x 25 mg |
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Dosage
Adults
Once daily injection of 25 mg from day of oocyte retrieval, usually until 12 weeks of confirmed pregnancy.
Indications
For luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations in adults.
Contra-Indications
* Hypersensitivity to the active substance or to any of the excipients
* Undiagnosed vaginal bleeding
* Known missed abortion or ectopic pregnancy
* Severe hepatic dysfunction or disease
* Known or suspected breast or genital tract cancer
* Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events
* Porphyria
* A history of idiopathic jaundice severe pruritus or pemphigoid gestationis during pregnancy
Special Precautions
* Progesterone should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis.
* Caution is indicated in patients with mild to moderate hepatic dysfunction.
* Caution is indicated in patients with moderate to severe renal dysfunction, because accumulation of cyclodextrins may occur.
* History of depression need to be closely observed. Consider discontinuation if symptoms worsen.
* Progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.
* A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a small number of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy.
* Sex steroid use may also increase the risk of retinal vascular lesions. To prevent these latter complications, caution is to be taken in users >35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary oedema or retinal haemorrhage.
* Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.
Side Effects
Very common: Uterine spasm Vaginal haemorrhage, Administration site reactions
Common: headache, abdominal distension, abdominal pain, nausea, vomiting, constipation, breast tenderness, breast pain, vaginal discharge, vulvo-vaginal pruritus vulvo-vaginal discomfort, vulvo-vaginal inflammation, OHSS, injection site haematoma, injection site induration Fatigue
See prescribing information for full details.
Drug interactions
The effect of concomitant injectable products on the exposure of this medical product has not been assessed. Concomitant use with other drugs is not recommended.
Pregnancy and Lactation
Pregnancy: There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. The rates of congenital anomalies, spontaneous abortion and ectopic pregnancies observed during the clinical trial were comparable with the event rate described in the general population although the total exposure is too low to allow conclusions to be drawn.
Lactation: Progesterone is excreted in human milk and Prolutex should not be used during breast-feeding.
Overdose
High doses of progesterone may cause drowsiness.
Treatment of overdose consists of discontinuation of Prolutex together with initiation of appropriate symptomatic and supportive care.
