Utrogestan

Utrogestan

progesterone

Manufacturer:

Besins

Distributor:

Metro Drug
Full Prescribing Info
Contents
Progesterone.
Description
Oral route: Each soft-gel capsule contains: Progesterone 100 mg or 200 mg.
Vaginal route: Each soft-gel capsule contains: Progesterone 200 mg.
Action
Progesterone (Utrogestan), which contains progesterone in micronised form, significantly increases plasma progesterone levels following oral, thus making it possible to correct any deli tits in progesterone.
Elevation of blood progesterone levels starts from the first hour onwards, with peak plasma levels reached within 1-3 hours following administration.
Metabolisation: plasma and urinary metabolites are identical to those found during physiological corpus luteum secretion. Its main plasma metabolites include 20-alpha-hydroxy-delta-4-pregnenolone and 5-alpha-dihydroprogesterone. Urinary elimination occurs at a rate of 95% in the form of glucuronide-conjugated metabolites. Its main urinary metabolite is 3-alpha-5-beta pregnanediol (pregnandiol).
Oral route: Owing to the tissue retention time of the hormone, it might be prudent to divide the dosage into two doses, to be taken at 12-hourly intervals approx., in order to ensure that impregnation is obtained throughout the entire 24-hour period.
Vaginal route: At the standard recommended dose, stable physiological levels of plasma progesterone, similar to those obtained during the luteal phase of a normal, ovulatory menstrual cycle, can be reached and maintained.
Progesterone (Utrogestan) Vaginal soft capsules, induce adequate endometrial maturity, thus promoting embryo implantation.
At higher doses, reached via gradual upward titration, this route of administration makes it possible to achieve blood progesterone levels similar to those observed during the first trimester of pregnancy.
Indications/Uses
Oral route: Disorders associated with a progesterone deficit: pre-menstrual syndrome, menstrual irregularity, benign breast disease, pre-menopause.
Treatment of the menopause (as an adjuvant to oestrogen therapy).
Infertility caused by luteal phase defect.
Menace of abortion or prevention of recurrent spontaneous abortions due to diagnosed luteal phase defect.
Menace of preterm delivery.
Vaginal route: During In Vitro Fertilization cycles (IVF).
Menace of abortion or prevention of recurrent spontaneous abortions due to luteal phase defect.
Menace of preterm delivery.
Dosage/Direction for Use
Oral route: The standard daily dosage regimen is 200 to 300 mg of progesterone taken in one or two doses, i.e. 200 mg in the evening at bedtime and another 100 mg in the morning, if needed.
In the case of luteal phase defect (pre-menstrual syndrome, menstrual irregularity, pre-menopause, benign breast disease): the treatment is administered over 10 days per menstrual cycle, usually from cycle days 17 to 26 inclusive.
In the treatment of the menopause: given that stand-alone oestrogen therapy is not recommended, progesterone may be used as an adjuvant, to be given during the last two weeks of the treatment sequence, followed by a one-week suspension of all replacement therapy, during which withdrawal bleeding may be observed.
In the case of threatened abortion or in the prevention of LPD-related recurrent spontaneous abortions: the usual daily dosage is 200 mg to 400 mg progesterone, spread over two doses, to be taken up until gestation week 12.
In the case of threatened preterm delivery: 400 mg of progesterone every 6 to 8 hours, depending on the clinical results obtained during the acute phase, followed by a maintenance dose (e.g. 3 x 200 mg a day) to be taken up until gestational week 36.
Vaginal route: The usual daily dosage is 200 mg of progesterone (i.e. one 200 mg capsule or two 100 mg capsules taken in two doses, one in the morning and one in the evening), to be inserted deep into the vagina, with or without the help of an applicator. This dosage may be increased depending on the individual patient response.
In the case of partial luteal phase defect (dysovulation, irregular menstrual cycles): the daily dose is 200 mg progesterone, administered over 10 days per menstrual cycle, usually from cycle days 17 to 26.
In the case of infertility associated with total luteal phase defect (oocyte donation): the initial progesterone dose is 100 mg, administered on days 13 and 14 of the transfer cycle, followed by 100 mg of progesterone given in the morning and evening of cycle days 15 to 25. From day 26 onwards, in the event of conception, dosage is increased in weekly increments of 100 mg progesterone per day, to reach a maximum daily dose of 600 mg progesterone, spread over three doses. This dosage is maintained up until day 60.
In the case of luteal phase supplementation during IVF: treatment is initiated in the evening of the transfer, at a rate of 600 mg progesterone spread over three doses (morning, noon and evening).
In the case of threatened abortion or in the prevention of LPD-related recurrent spontaneous abortions: the usual daily dosage is 200 mg to 400 mg progesterone, spread over two doses, to be taken up until gestation week 12.
In the case of threatened preterm delivery: Active treatment: 200 mg-300 mg x 2-3 times/day in 3 days. Maintain dosage: 100 mg-200 mg/day till suppression of contraction.
Overdosage
Oral route: With oral administration, the undesirable effects described in Adverse Reactions are mostly symptomatic of overdosage.
A reduction in dosage will cause such signs to regress spontaneously.
In some users, the usual dosage may prove to be too high, as evidenced by the persistence or recurrence of uncontrolled endogenous progesterone secretion, marked sensitivity to the product itself or concomitantly low levels of blood oestradiol. The following measures should be taken: Progesterone should be administered in the evening AT BEDTIME, over a 10-day period per cycle.
In the event of breakthrough bleeding (spotting)/shortening of the menstrual cycle, initiation of treatment should be deferred until later into the cycle (e.g. day 19 instead of day 17).
Perimenopausal women/women receiving HRT should be tested to ensure that blood oestradiol levels are sufficient.
Vaginal route: With vaginal administration, no case of overdose has so far been reported.
Contraindications
Known hypersensitivity to the active substance or any of the excipients.
Severe changes in hepatic function.
Special Precautions
The treatment, when administered in accordance with the recommended schedules, is not contraceptive.
The menstrual cycle may be shortened and/or bleeding may occur if the treatment sequence is initiated too early, particularly before cycle day 15.
In the presence of uterine bleeding, Utrogestan must not be prescribed until a definite cause has been established, preferably via endometrial investigation.
Treatment should be suspended at the onset of any: Eye disorders, such as loss of vision, diplopia, vascular lesions of the retina.
Venous thromboembolisms or thrombotic events, regardless of the territory.
Severe headaches.
Patients with a history of thrombophlebitis should be closely monitored.
More than half of early spontaneous abortions (miscarriages) are caused by genetic disorders. Furthermore, they may also be caused by infectious manifestations and mechanical disorders; in which case, the sole result of administrating progesterone would be to delay expulsion of a dead ovum. Progesterone administration must therefore only be reserved for cases where corpus luteum secretion is inadequate.
During HILT involving oestrogens, administration of progesterone over a minimum of 12 days per cycle is strongly recommended.
Effects on Ability to Drive and Use Machines: Attention should be drawn to the risks of drowsiness and/or dizziness associated with the oral use of this product, particularly in the case of patients intending to drive or operate machinery. Intake of capsules at bedtime will avoid such problems.
Use In Pregnancy & Lactation
The use of Utrogestan soft capsules is not contraindicated during pregnancy including the first few weeks.
It should not be prescribed to nursing mothers.
Adverse Reactions
Drowsiness and/or transient dizziness are particularly observed in patients with concomitantly low levels of oestrogen. These effects are immediately reversible upon reduction of the Utrogestan dosage or escalation of the oestrogen dose, without compromising the therapeutic benefit.
The menstrual cycle may be shortened and/or intermenstrual bleeding may occur, if the treatment sequence is initiated too early, particularly before cycle day 15.
Altered menstrual cycles, amenorrhoea and intermenstrual bleeding have been observed and reported in association with general progestin use.
Oral route: The following effects have been reported in association with soft capsules administered via the oral route: Common undesirable effects: altered menstrual cycles, amenorrhoea, intermenstrual bleeding, headaches.
Uncommon undesirable effects: drowsiness, transient dizziness, cholestatic jaundice, pruritus, gastrointestinal disorders.
If the patient has notice any side effects not mentioned in this leaflet, please inform the doctor.
Vaginal route: After vaginal administration, local irritation may occur (due to the presence of soya lecithin, peanut oil).
Side Effects
For possible side effects see Overdosage.
Due to arachis oil and soya-bean lecithin, there is a risk of allergic reactions (rash, generalized allergic reaction).
Drug Interactions
Powerful enzyme inducers such as barbiturates, antiepileptic agents (phenytoin), rifampicin, phenylbutazone, spironolactone and griseofulvin. These drugs enhance metabolisation in the liver.
Certain antibiotics (ampicillin, tetracyclines): variations in the intestinal flora, which lead to a change in the enterohepatic circulation of steroids.
Progestins may cause a reduction in glucose tolerance, which increases the need for insulin and other anti-diabetic agents in diabetic patients.
Storage
Store at temperature below 25°C.
Shelf-Life: 36 months from manufacturing date. This is a prescription drug.
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Soft-gelatin cap (oral/vag) 100 mg x 30's. 200 mg x 15's.
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