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CRINONE is a brand name for Progesterone, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CRINONE (Progesterone gel) 8% is indicated for: luteal phase support in induced cycles such as In Vitro Fertilization (IVF) cycles including in oocyte donation recipient. 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada, safety and effectiveness in females before menarche have not…
Verbatim from this product's HC label. Tap a section to expand.
1 Adverse Reaction Overview Crinone is generally well tolerated. In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy.
Crinone (Progesterone 8%) Page 8 of 21 Common Adverse Events (≥ 1/100 to < 1/10): • Infections and Infestations: genital candidiasis, urinary tract infection • Immune System Disorders: hypersensitivity • Nervous System Disorders: headache, migraine, dizziness, somnolence- • Gastrointestinal Disorders: abdominal pain, constipation, diarrhoea, nausea, vomiting, abdominal distension • Psychiatric Disorders: depression, memory impairment, aggression, nervousness • Renal and Urinary Disorders: enuresis, cystitis • Reproductive System and Breast Disorders: libido decreased, breast tenderness, breast pain, dyspareunia, pruritus genital, vulvovaginal dryness, vaginal discharge • Musculoskeletal and Connective Tissue Disorders: muscle spasms, arthralgia • General Disorders and Administration Site Conditions: fatigue, pain • Skin and Subcutaneous Tissue Disorders: pruritis, rash, skin disorder, urticaria The adverse effects of Crinone are qualitatively identical to those described in the medical literature for natural progesterone, but their frequency appears to be lower.
Most adverse events are mild and transient in nature, frequently resolving during continued exposure to Crinone. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The adverse reactions data presented is based on the safety data that was gathered from 3 clinical trials, COL-1620/F01, COL1620-007US and EMR200113_001.
The exposure to progesterone / Crinone® in these 3 studies was 345 subjects. Reproductive System and Breast Disorders: breast tenderness. 5 Post-Market Adverse Reactions For adverse reactions identified during post-marketing surveillance, the frequency is not known, because it cannot be reliably estimated from the available data.
2 Clinical Trial Adverse Reactions 07/2023 TABLE OF CONTENTS • Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics.................................................................................................................. 2 Geriatrics ..................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 4. DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
5 5 OVERDOSAGE............................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 5 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations .................................................................................................. 1 Pregnant Women ...............................................................................................
CRINONE (Progesterone gel) should not be used in individuals with any of the following conditions: • Undiagnosed vaginal bleeding • Liver dysfunction or disease • Known or suspected malignancy of the breast or genital organs • Known or suspected progesterone-dependent neoplasia, • Known sensitivity to CRINONE (progesterone or any of the other ingredients) • Missed abortion • Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a history of these conditions • Acute porphyria CRINONE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 4. 1 Dosing Considerations One application of CRINONE 8% (90 mg of progesterone) every day, starting the day of the transfer. In some cases, the dose can be increased to two applications of CRINONE 8% daily.
If pregnancy occurs, treatment should be continued for up to 10 to 12 weeks. 125 g CRINONE 8% Vaginal Gel (90 mg progesterone) should be taken intravaginally once or twice daily. Most women will respond to 90 mg once daily. However, some women may need 90 mg twice daily.
If pregnancy occurs treatment may continue for up to 10-12 weeks. 4 Administration CRINONE is to be applied directly from the specially designed applicator into the vagina. CRINONE coats the vaginal mucosa to provide long-lasting release of progesterone.
Each applicator contains a slightly larger amount of gel than actually released, as the rest of the product tends to adhere to the inside of the applicator. It is therefore quite normal for a little gel to be left inside the applicator.
125 g) is delivered. Any content of gel remaining in the applicator after use must be discarded. Each applicator is intended for single use only. 5 Missed Dose If you forget to use CRINONE on a normal dosage day then use it the following day and then continue as before.
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.
Immune System Disorders:
Hypersensitivity reactions usually manifesting as skin rash Reproductive System and Breast Disorders: Metrorrhagia (spotting) Vaginal irritation and other mild application site reactions
2 Breast-feeding .................................................................................................... 3 Pediatrics............................................................................................................
4 Geriatrics ............................................................................................................ 7 8 ADVERSE REACTIONS.................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 5 Post-Market Adverse Reactions...............................................................................
8 9 DRUG INTERACTIONS ................................................................................................ 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions ............................................................................................ 6 Drug-Herb Interactions ............................................................................................
7 Drug-Laboratory Test Interactions........................................................................... 9 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action .........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 9 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
11 PART II: SCIENTIFIC INFORMATION ..................................................................................... 12 13 PHARMACEUTICAL INFORMATION .......................................................................... 12 14 CLINICAL TRIALS ......................................................................................................
13 15 MICROBIOLOGY ...................................................................................................... 14 16 NON-CLINICAL TOXICOLOGY ....................................................................................
14 PATIENT MEDICATION INFORMATION ................................................................................ 16 Crinone (Progesterone 8%) Page 4 of 21 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS CRINONE (Progesterone gel) 8% is indicated for: luteal phase support in induced cycles such as In Vitro Fertilization (IVF) cycles including in oocyte donation recipient.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada, safety and effectiveness in females before menarche have not been established. As CRINONE is indicated for use in women who are post- menarcheal, pediatric use is not applicable.
2 Geriatrics Geriatrics (≥65 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. 2 CONTRAINDICATIONS CRINONE (Progesterone gel) should not be used in individuals with any of the following conditions: • Undiagnosed vaginal bleeding • Liver dysfunction or disease • Known or suspected malignancy of the breast or genital organs • Known or suspected progesterone-dependent neoplasia, • Known sensitivity to CRINONE (progesterone or any of the other ingredients) • Missed abortion • Thrombophlebitis, thromboembolic disorders, cerebral […]
Do not administer double doses to make up for a forgotten single dose. 5 OVERDOSAGE There have been no reports of overdosage with CRINONE (Progesterone gel). Acute overdosage is unlikely with this product due to the concentration-dependent, rate-limited absorption of progesterone by the vaginal epithelium and the controlled release characteristics of the formulation.
In the case of overdosage, however, discontinue CRINONE, treat the patient symptomatically, and institute supportive measures. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING CRINONE (Progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone in a diluted emulsion system.
The carrier vehicle is a oil-in-water emulsion containing the water swellable, but insoluble polymer, polycarbophil. Physically, CRINONE has the appearance of a soft, white to off-white gel packed in single-use applicators designed for vaginal administration CRINONE (Progesterone gel) is available in the following strength: 90 mg (8% gel) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist- off top.
125g of gel. Applicators are packaged in cartons of 6 and 18 per box. For management of a suspected drug overdose, contact your regional poison control centre. Crinone (Progesterone 8%) Page 6 of 21 Table – Dosage Forms, Strengths, Composition and Packaging 7 WARNINGS AND PRECAUTIONS The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis).
Should any of these occur or be suspected, the drug should be discontinued immediately. Patients who have risk factors for thrombotic disorders should be kept under careful observation. Treatment should be discontinued if the results of liver function tests become abnormal or if cholestatic jaundice appears.
Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose. As with all prescription drugs, this medicine should be kept out of the reach of children.
General The pre-treatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. , epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. The pathologist should be advised of progesterone therapy when relevant specimens are submitted.
In cases of breakthrough bleeding, as in all cases of irregular bleeding per vagina, non-functional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken. Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
A decrease in glucose tolerance has been observed in a small number of patients on oestrogen-progestin combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progestin therapy.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients vaginal Progesterone gel 90 mg (8%) Carbomer 974P, glycerine, hydrogenated palm oil glycerides, light liquid paraffin, polycarbophil, purified water, sodium hydroxide, sorbic acid.
Crinone (Progesterone 8%) Page 7 of 21 Reproductive Health: Female and Male […]