|fdaLIADAdult=Progesterone intrauterine insert (Progestasert(R)) was discontinued on 06/01/2001.View additional information.
|fdaLIADAdult=Progesterone intrauterine insert (Progestasert(R)) was discontinued on 06/01/2001.View additional information.
a) Important Notes
1) Before insertion of the intrauterine device containing progesterone, the patient must read and initial each section of the Patient Information Leaflet supplied with the system [5]. The intrauterine system should be inserted only by physicians familiar with the instructions. Prior to insertion, a cervical Pap smear, tests for Neisseria gonorrhoeae and Chlamydia, and a pelvic exam should be conducted.
b) One system containing 38 mg of progesterone should be inserted into the uterus using the inserter provided [5]. The system should be removed and replaced every 12 months for continued effectiveness.
c) Patients should be advised that this product will not protect them from HIV infection or other sexually transmitted diseases.
d) The patient should return for a check up 3 months after insertion and at 12 months for removal and replacement of the system.
e) Should not be inserted until involution of the uterus is complete following abortion or child birth.
Abnormal uterine bleeding unrelated to menstrual cycleView additional information.
Abnormal uterine bleeding unrelated to menstrual cycleView additional information.
a) Progesterone 5 to 10 mg is injected IM daily for 6 doses. The bleeding should be expected to stop within 6 days. If the menstrual flow begins during the course of progesterone injections, therapy should be stopped. If estrogen therapy is to be used, progesterone should be initiated after 2 weeks of estrogen therapy [9].
1) Progesterone gel (Crinone(R) 8%) 90 mg once daily is administered vaginally in women who require progesterone supplementation. In women with partial or complete ovarian failure who require progesterone replacement, a dose of 90 mg twice daily is administered [8].
2) A desired dosage increase from the 4% gel can only be achieved by using the 8% gel rather than increasing the volume of the 4% gel [8].
b) Vaginal Insert
1) Administer 100 mg vaginal insert vaginally 2 to 3 times a day starting the day after oocyte retrieval and continuing for up to 10 weeks total duration for women undergoing Assisted Reproductive Technology treatment for infertility [19].
a) Oral micronized progesterone should be given as a single daily dose in the evening, 200 mg for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogen tablets [10].
a) In the treatment of amenorrhea, progesterone 5 to 10 mg in oil should be administered IM daily for 6 to 8 days (Prod Info Progesterone USP, 2000). If a proliferative endometrium is produced, withdrawal bleeding should occur within 48 to 72 hours after discontinuing the progesterone. This may be followed by spontaneous normal cycles.
a) Oral progesterone may be given as a single daily dose of 400 mg in the evening for 10 days [10].
a) For secondary amenorrhea, vaginal progesterone gel 4% is administered every other day up to a total of 6 doses. For those who fail to respond, a trial of 8% (90 mg) every other day up to a total of 6 doses may be used (Prod Info Crinone(R), 2000).
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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Progesterone (oral) is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Progesterone intrauterine insert (Progestasert(R)) was discontinued on 06/01/2001.View additional information.
a) Important Notes
1) Before insertion of the intrauterine device containing progesterone, the patient must read and initial each section of the Patient Information Leaflet supplied with the system [5]. The intrauterine system should be inserted only by physicians familiar with the instructions. Prior to insertion, a cervical Pap smear, tests for Neisseria gonorrhoeae and Chlamydia, and a pelvic exam should be conducted.
b) One system containing 38 mg of progesterone should be inserted into the uterus using the inserter provided [5]. The system should be removed and replaced every 12 months for continued effectiveness.
c) Patients should be advised that this product will not protect them from HIV infection or other sexually transmitted diseases.
d) The patient should return for a check up 3 months after insertion and at 12 months for removal and replacement of the system.
e) Should not be inserted until involution of the uterus is complete following abortion or child birth.
Abnormal uterine bleeding unrelated to menstrual cycleView additional information.
a) Progesterone 5 to 10 mg is injected IM daily for 6 doses. The bleeding should be expected to stop within 6 days. If the menstrual flow begins during the course of progesterone injections, therapy should be stopped. If estrogen therapy is to be used, progesterone should be initiated after 2 weeks of estrogen therapy [9].
a) Vaginal Gel
1) Progesterone gel (Crinone(R) 8%) 90 mg once daily is administered vaginally in women who require progesterone supplementation. In women with partial or complete ovarian failure who require progesterone replacement, a dose of 90 mg twice daily is administered [8].
2) A desired dosage increase from the 4% gel can only be achieved by using the 8% gel rather than increasing the volume of the 4% gel [8].
b) Vaginal Insert
1) Administer 100 mg vaginal insert vaginally 2 to 3 times a day starting the day after oocyte retrieval and continuing for up to 10 weeks total duration for women undergoing Assisted Reproductive Technology treatment for infertility [19].
a) Oral micronized progesterone should be given as a single daily dose in the evening, 200 mg for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogen tablets [10].
a) In the treatment of amenorrhea, progesterone 5 to 10 mg in oil should be administered IM daily for 6 to 8 days (Prod Info Progesterone USP, 2000). If a proliferative endometrium is produced, withdrawal bleeding should occur within 48 to 72 hours after discontinuing the progesterone. This may be followed by spontaneous normal cycles.
a) Oral progesterone may be given as a single daily dose of 400 mg in the evening for 10 days [10].
a) For secondary amenorrhea, vaginal progesterone gel 4% is administered every other day up to a total of 6 doses. For those who fail to respond, a trial of 8% (90 mg) every other day up to a total of 6 doses may be used (Prod Info Crinone(R), 2000).
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Progesterone (oral) in adult patients.
Non–Guideline-Supported Use
Premature birth of newborn, Short cervix; Prophylaxis
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (oral) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Progesterone (oral) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Progesterone (oral) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Progesterone (oral) in pediatric patients.
Contraindications
Condition1
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Progesterone (oral) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Progesterone (oral) in the drug label.
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