Utrogestan
Cheaper & Alternative Brands
Same generic (Progesterone Micronised), same form (Capsule)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Aquagest SC injection is indicated for progesterone supplementation in women up to and including 34 years of age who are unable to use or tolerate vaginal preparations and undergoing In Vitro Fertilization (IVF) with or without Intracytoplasmic Sperm Injection (ICSI).
Dosage & Administration
Route of Administration: SC injection only.
Adult
: Once daily injection of 25 mg from day of oocyte retrieval for up to 10 weeks of total duration, usually until 12 weeks of confirmed pregnancy.
Pediatrics
(0 to 18 years): The safety and efficacy of Progesterone in pediatric patients has not been established.
Geriatrics
(>65 years of age): No clinical data have been established in patients over the age of 65.
Contraindications
Progesterone should not be used in individuals with any of the following conditions:
Hypersensitivity to progesterone 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 thrombo- phlebitis, or a history of these events
Porphyria
A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy.
Side Effects & Adverse Reactions
Headache, Abdominal distension, Abdominal pain, Nausea, Vomiting, Constipation, Uterine spasm, Vaginal haemorrhage, Breast tenderness, Breast pain, Vaginal discharge, Vulvo-vaginal pruritus, Vulvo-vaginal discomfort, Vulvo-vaginal inflammation, OHSS, Administration site reactions, such as irritation, pain, pruritus and swelling, Injection site haematoma, Injection site induration, Fatigue.
Warnings & Precautions
Aquagest 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.
Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
Because 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.
Pharmacology & Mechanism of Action
Progesterone is a hormone that occurs naturally in females, and is essential for endometrial receptivity, embryo implantation, and the successful establishment of pregnancy. A low progesterone concentration or an insufficient response to progesterone can cause infertility and pregnancy loss. Progesterone binds and activates its nuclear receptor, PR, which plays an important part in the signaling of stimuli that maintain the endometrium during its preparation for pregnancy.