Desogestrel oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of desogestrel.
Drugs List
Therapeutic Indications
Uses
Oral contraception - progestogen only
Dosage
Adults
No preceding hormonal contraceptive use in the past month
One tablet to be taken daily at about the same time each day so that the interval between two tablets is always 24 hours.
The first tablet should be taken on the first day of menstrual bleeding and one tablet daily thereafter without taking any notice of possible bleeding.
A new pack should be started the day after the previous pack is finished.
Starting on days 2 to 5 is allowed, but during the first cycle, a barrier method is recommended for the first 7 days of tablet taking.
Transfer from another progestogen-only contraceptive (POP)
The patient may start on any day without a break between tablets. For an implant or progestogen-releasing IUD, tablet taking should start on the day of removal. If transferring from a depot progestogen injection, start tablet taking on the day the next injection would be due.
After first-trimester abortion
It is recommended to start taking desogestrel tablets immediately in which case there is no need for an additional method of contraception.
Contraception after delivery or second-trimester childbirth
Tablet taking can start 21 to 28 days after delivery or second-trimester abortion. If more than 28 days have elapsed since delivery, pregnancy should be ruled out and an additional method of contraception used for the first week. If unprotected intercourse has taken place during this period then pregnancy should be excluded or the woman should wait for her first menstrual period before tablet taking may commence.
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch)
Treatment with desogestrel should start preferably on the day after the last active tablet (the last tablet containing the active substances) of the previous COC, or on the day of removal of the vaginal ring or transdermal patch. The use of an additional contraceptive is not necessary in these cases.
Treatment may also start at the latest on the day following the usual tablet free, patch free, ring free or placebo tablet interval of the previous hormonal contraceptive, but during the first 7 days of tablet taking an additional barrier method is recommended.
Additional Dosage Information
Missed tablets
Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of pregnancy should be considered. If vomiting occurs within 3 to 4 hours after tablet-taking, the same advice is applicable as for a missed tablet.
Contraindications
Abnormal liver function test
Galactosaemia
History of severe hepatic disorder
Hormone dependent neoplasm
Porphyria
Pregnancy
Severe hepatic disorder
Undiagnosed gynaecological haemorrhage
Venous thromboembolism
Precautions and Warnings
History of ectopic pregnancy
Prolonged immobilisation
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic disorder
History of breast cancer
History of chloasma
History of cholestatic jaundice during pregnancy
History of severe depression
History of thromboembolic disorder
Lactose intolerance
Malabsorption syndrome
Ovarian cysts
Recent trophoblastic disorder
Recurrent cholestatic jaundice
Severe depression
Systemic lupus erythematosus
Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Contains lactose
Some formulations contain propylene glycol
Some products contain arachis (peanut) oil, soya or soya derivative
Exclude pregnancy prior to initiation of treatment
Monitor blood pressure before starting treatment
Perform a complete physical and gynaecological examination before therapy
Abnormal and/or irregular bleeding should be investigated
If intra-abdominal haemorrhage consider liver tumour
If pregnancy occurs possibility of ectopic pregnancy should be considered
If upper abdominal complaints/liver enlargement consider liver tumour
Investigate persistent or recurrent vaginal bleeding
Monitor patient for signs and symptoms of depression
Advise patient to report any new or worsening depression/suicidal ideation
Vomiting or severe diarrhoea may impair efficacy
May affect results of some laboratory tests
Advise patient to seek advice at first indications of pregnancy
Discontinue if persistent hypertension unresponsive to therapy occurs
Discontinue if thromboembolism occurs
Discontinue in the event of a prolonged period of immobilisation
Possibly discontinue treatment before surgery/immobilisation
Advise patient concurrent St John's wort may reduce contraceptive effect
All contraceptive pills slightly increase the risk of breast cancer
Changes in menstrual bleeding patterns should be expected
Treatment does not protect against risk of sexually transmitted disease
Women with a history of chloasma should avoid exposure to sun/UV light
Despite the fact that desogestrel tablets are taken regularly, bleeding disturbances may occur. If the bleedings are very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea during treatment depends on whether the tablets have been taken in accordance with instructions and may include a pregnancy test. Discontinue treatment if pregnancy occurs.
Monitor diabetic patients during the first month of use.
Pregnancy and Lactation
Pregnancy
Desogestrel is contraindicated during pregnancy.
The manufacturer does not recommend using desogestrel during pregnancy. Available reports indicate no increased risk of teratogenic or developmental effects when oral contraceptives are taken before and during early pregnancy. Animal studies indicate high doses of progestogenic substances may cause masculinisation of female foetuses.
Lactation
Desogestrel is considered safe for use during breastfeeding.
The manufacturer states desogestrel may be used safely when breastfeeding. Desogestrel does not appear to influence the production or quality of breast milk. However, infrequent cases of decrease in breast milk production have been reported. Small amounts of etonogestrel are excreted with the milk; the development and growth of the nursing infant should be carefully observed.
Side Effects
"Spotting" bleeds (early cycles)
Acne
Alopecia
Amenorrhoea
Anaphylaxis
Angioedema
Breast pain
Chloasma
Depressed mood
Depression
Dysmenorrhoea
Erythema nodosum
Fatigue
Headache
Increased risk of breast cancer
Increased risk of ectopic pregnancy
Intolerance to contact lenses
Menstrual disturbances
Mood changes
Nausea
Ovarian cysts
Rash
Reduced libido
Urticaria
Vaginitis
Vomiting
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2019
Reference Sources
Summary of Product Characteristics: Aizea 75 microgram film-coated tablets. Besins Healthcare Ltd. Revised February 2019.
Summary of Product Characteristics: Cerelle 75 microgram film-coated tablets. Consilient Health Ltd. Revised March 2019.
Summary of Product Characteristics: Cerazette 75mcg film-coated tablet. Merck Sharp and Dohme Ltd. Revised November 2020.
Summary of Product Characteristics: Desomono 75 microgram film-coated tablets. MedRx Licences Ltd. Revised February 2019.
Summary of Product Characteristics: Desorex 75 microgram film-coated tablets. Somex Pharma. Revised April 2013.
Summary of Product Characteristics: Feanolla 75 microgram film-coated tablets. Lupin Healthcare (UK) Ltd. Revised January 2019.
Summary of Product Characteristics: Moonia 75 microgram film-coated tablets. Stragen UK Ltd. Revised November 2020.
Summary of Product Characteristics: Zelleta 75 micrograms Tablets. Morningside healthcare Ltd. Revised February 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 August 2021
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last accessed: 06 August 2021
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