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PROMETRIUM is a brand name for Progesterone, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics, 1.2 Geriatrics 07/2025
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 07/2025 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................................
4 1 INDICATIONS ......................................................................................................................... 1 Pediatrics....................................................................................................................................
2 Geriatrics .................................................................................................................................... 4 2 CONTRAINDICATIONS ............................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 4 4 DOSAGE AND ADMINISTRATION ............................................................................................
1 Dosing Considerations ............................................................................................................... 2 Recommended Dose and Dosage Adjustment ..........................................................................
4 Administration ........................................................................................................................... 5 Missed Dose ...............................................................................................................................
6 5 OVERDOSAGE ........................................................................................................................ 6
Some of the information presented in the Warnings and Precautions section is provided in light of the fact that progestin medication is often prescribed concomitantly with an estrogen medication. Information in this section pertaining to combined estrogen-progestin therapy may therefore not apply to progestin-only therapy.
Health Care Professional discretion is advised. 1 Dosing Considerations Pregnancy should be excluded before initiating HRT. 2 Recommended Dose and Dosage Adjustment Hormone Replacement Therapy: For initiation and continuation of hormone replacement therapy (estrogens and progesterone) in postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see also Section 7 WARNINGS AND PRECAUTIONS).
e. from day 8 to day 21 for a 28-day cycle, and from day 12 to day 25 for a 30-day cycle). 25 mg conjugated estrogens or higher) should be administered 300 mg daily for the last 12-14 days of estrogen treatment. The dosage of PROMETRIUM® should be proportional to the dosage of estrogen.
With adequate adjustment of the dosage of PROMETRIUM®, patients should experience either regular withdrawal uterine bleeding or cessation of bleeding (amenorrhea). Prometrium is not indicated for paediatric use. 4 Administration Prometrium is formulated for oral administration and must be swallowed whole.
Capsules should not be chewed, crushed nor pierced. The 200 mg daily dosage of PROMETRIUM® should be taken at bedtime. Patients receiving 300 mg PROMETRIUM® daily should take one capsule (100 mg) in the morning and two capsules (200 mg) at bedtime.
The morning dose should be taken 2 hours after breakfast. Concomitant food ingestion significantly increases the bioavailability of micronised progesterone. 5 DRUG-FOOD INTERACTIONS. 5 Missed Dose If a patient is treated with 200 mg daily (total dose at bedtime) and she forgets to take this dose, she should take a dose of one capsule (100 mg) the following morning and continue taking the rest of the capsules as prescribed.
4 Geriatrics 07/2025 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................................
4 1 INDICATIONS ......................................................................................................................... 1 Pediatrics....................................................................................................................................
2 Geriatrics .................................................................................................................................... 4 2 CONTRAINDICATIONS ............................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 4 4 DOSAGE AND ADMINISTRATION ............................................................................................
1 Dosing Considerations ............................................................................................................... 2 Recommended Dose and Dosage Adjustment ..........................................................................
4 Administration ........................................................................................................................... 5 Missed Dose ...............................................................................................................................
6 5 OVERDOSAGE ........................................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..............................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Progesterone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If a patient is treated with 300 mg daily, and she forgets to take a morning or evening dose, she should not take the missed dose. 5 OVERDOSAGE The toxicity of progesterone is very low. Symptoms that may occur are: nausea, vomiting, somnolence and dizziness.
Progestin (norethindrone acetate) overdosage has been characterized by depressed mood, tiredness, acne and hirsutism. For management of a suspected drug overdose, contact your regional Poison Control Centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition PROMETRIUM® (progesterone capsules, Organon Std) Page 7 of 41 [Organon] Proprietary Route of Administration Dosage Form / Strength Non-medicinal Ingredients Oral Capsule, 100 mg progesterone gelatin, glycerin, soya lecithin (may contain traces of medium chain triglycerides), sunflower oil, titanium dioxide.
PROMETRIUM® (progesterone) 100 mg capsules to be taken orally; contain 100 mg progesterone as the active ingredient. PROMETRIUM® 100 mg capsule is a round, slightly yellow soft capsule, containing whitish oily suspension. Packaging PROMETRIUM 100 mg progesterone capsules are available in unit dose blister packages, with 30 capsules per package.
PROMETRIUM 100 mg progesterone capsules are also approved in unit dose blister packages, with 15 capsules per package (sample size, not available for sale). 7 WARNINGS AND PRECAUTIONS See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General PROMETRIUM is NOT a contraceptive and must only be used in accordance with the indications in Section 1 INDICATIONS Each Progesterone Soft Capsule 100 mg contains 1 mg soya lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients).
As there is a possible relationship between allergy to soya and allergy to peanut, patients with peanut allergy should avoid using Progesterone Soft Capsules. Progesterone Soft Capsules contain highly refined oil, for which the incidence of hypersensitivity is very rare in adults.
Carcinogenesis and Mutagenesis Breast Cancer Available epidemiological data indicate that the use of combined estrogen plus progestin by postmenopausal women is associated with an increased risk of invasive breast cancer. 5 mg/day), among 10,000 women over a one-year period, there were: • 8 more cases of invasive breast cancer (38 on combined HRT versus 30 on placebo).
1] vs. 04) and were at a more advanced stage compared with those diagnosed in the placebo group. The percentage of women with abnormal mammograms (recommendations for short-interval follow-up, a suspicious abnormality, or highly suggestive of malignancy) was significantly higher in the estrogen plus progestin group versus the placebo group.
This difference appeared at year one and persisted in each year thereafter. 625 mg/day), there was no statistically significant difference in the rate of invasive breast cancer in hysterectomized women treated with conjugated equine estrogens versus women treated with placebo.
It is recommended that estrogens with or without progestins not be given to women with existing breast cancer or those with a previous history […]
6 7 WARNINGS AND PRECAUTIONS .............................................................................................. 1 Special Populations ..................................................................................................................
1 Pregnant Women ......................................................................................................... 2 Breast-feeding ..............................................................................................................
3 Pediatrics ...................................................................................................................... 4 Geriatrics ......................................................................................................................
15 8 ADVERSE REACTIONS ........................................................................................................... 1 Adverse Reaction Overview .....................................................................................................
2 Clinical Trial Adverse Reactions ............................................................................................... 5 Post-Market Adverse Reactions ...............................................................................................
18 9 DRUG INTERACTIONS ........................................................................................................... 2 Drug Interactions Overview .....................................................................................................
4 Drug-Drug Interactions ............................................................................................................ 5 Drug-Food Interactions ............................................................................................................
6 Drug-Herb Interactions ............................................................................................................ 7 Drug-Laboratory Test Interactions ...........................................................................................
20 10 CLINICAL PHARMACOLOGY .................................................................................................. 1 Mechanism of Action .............................................................................................................
2 Pharmacodynamics ................................................................................................................ 3 Pharmacokinetics ...................................................................................................................
22 11 STORAGE, STABILITY AND DISPOSAL ..................................................................................... 23 PART II: SCIENTIFIC INFORMATION ...................................................................................................
24 13 PHARMACEUTICAL INFORMATION ....................................................................................... 24 14 CLINICAL TRIALS ...................................................................................................................
1 Clinical Trial by Indication ...................................................................................................... 25 16 NON-CLINICAL TOXICOLOGY ........................................................................................................
31 PROMETRIUM® (progesterone capsules, Organon Std) Page 4 of 41 [Organon] Proprietary PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PROMETRIUM® (progesterone) is indicated for: women with an intact uterus as an adjunct to postmenopausal estrogen replacement therapy to significantly reduce the risk of endometrial hyperplasia and carcinoma.
1 Pediatrics Prometrium is not indicated for pediatric use. 2 Geriatrics The […]