×
Components:
Desogestrel
Method of action:
Contraceptive, Gestagenic, Progestogen, Sex Hormones And Modulators Of The Genital System
Available in countries
Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.14

Name of the medicinal product

Lactinette

Qualitative and quantitative composition

Desogestrel

Pharmaceutical form

Film-coated tablet

Therapeutic indications

The information provided in Therapeutic indications of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

Contraception.

Oral contraception

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

Posology

To achieve contraceptive effectiveness, Lactinette must be used as directed (see 'How to take Lactinette' and 'How to start Lactinette').

Special populations

Renal impairment

No clinical studies have been performed in patients with renal impairment.

Hepatic impairment

No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Lactinette in these women is not indicated as long as liver function values have not returned to normal.

Paediatric population

The safety and efficacy of Lactinette in adolescents below 18 years has not been established. No data are available.

Method of administration

Oral use.

How to take Lactinette

Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one.

How to start Lactinette

No preceding hormonal contraceptive use [in the past month]

Tablet-taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following first-trimester abortion

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.

Following delivery or second-trimester abortion

The woman should be advised to start any day between day 21 to 28 after delivery or second-trimester abortion. When starting later, she should be advised to additionally use a barrier method until completion of the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Lactinette use or the woman has to wait for her first menstrual period.

How to start Lactinette when changing from other contraceptive methods

Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch).

The woman should start Lactinette preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries.

The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.

Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system [IUS]).

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due).

Management of 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 after initiation of Lactinette and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.

Advice in case of gastrointestinal disturbances

In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3-4 hours after tablet-taking, absorption may not be complete.

Treatment surveillance

Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease , the control examinations should be timed accordingly.

Despite the fact that Lactinette is taken regularly, bleeding disturbances may occur. If bleeding is 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 or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.

The treatment should be stopped if a pregnancy occurs.

Women should be advised that Lactinette does not protect against HIV (AIDS) and other sexually transmitted diseases.

Posology

How to take Lactinette

Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one.

How to start Lactinette

No preceding hormonal contraceptive use [in the past month]

Tablet taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding).

Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following first-trimester abortion:

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.

Following delivery or second-trimester abortion:

Contraceptive treatment with Lactinette after delivery can be initiated before the menstruations have returned.

How to start Lactinette when changing from other contraceptive methods

Changing from a combined oral contraceptive (combined hormonal contraceptive (COC), vaginal ring or transdermal patch)

The woman should start with Lactinette preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries.

The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.

Changing from a progestogen-only method (minipill, injection, implant or from a progestogen-releasing intrauterine system (IUS))

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due).

Management of 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 a pregnancy should be considered.

Advice in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3-4 hours after tablet taking absorption may not be complete. In such an event, the advice concerning missed tablets is applicable.

Treatment surveillance

Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease , the control examinations should be timed accordingly.

Despite the fact that Lactinette is taken regularly, bleeding disturbances may occur. If bleeding is 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 or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.

The treatment should be stopped if a pregnancy occurs.

Women should be advised that Lactinette does not protect against HIV (AIDS) and other sexually transmitted diseases.

Paediatric population

The safety and efficacy of Lactinette in children below 18 years has not yet been established. No data are available.

Method of administration

Oral use

Contraindications

The information provided in Contraindications of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

- Active venous thromboembolic disorder.

- Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

- Known or suspected sex-steroid sensitive malignancies.

- Undiagnosed vaginal bleeding.

-

- If you are allergic to peanut or soya.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Lactinette. In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Lactinette should be discontinued.

The risk for breast cancer increases in general with increasing age. During use of combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC. The expected number of cases diagnosed per 10,000 women who use COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

age group

expected cases COC-users

expected cases non-users

16-19 years

4.5

4

20-24 years

17.5

16

25-29 years

48.7

44

30-34 years

110

100

35-39 years

180

160

40-44 years

260

230

The risk in users of progestogen-only contraceptives (POCs), such as Lactinette, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive.

Compared to the risk of getting breast cancer ever in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.

When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Lactinette should be discontinued in the event of a thrombosis. Discontinuation of Lactinette should also be considered in case of long-term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use.

If a sustained hypertension develops during the use of Lactinette, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Lactinette should be considered.

Treatment with Lactinette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.

The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Despite the fact that Lactinette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Lactinette.

The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema.

), gastro-intestinal disturbances (Section 4.2), or concomitant medications that decrease the plasma concentration of etonogestrel, the active metabolite of desogestrel (Section 4.5).

Lactinette contains lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.

Laboratory tests

Data obtained with COCs have shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start taking Lactinette. In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Lactinette should be discontinued.

The risk for breast cancer increases in general with increasing age. During the use of combined oral contraceptives (COCs) the risk for having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC. The expected number of cases diagnosed per 10 000 women who use combined COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

Age group

Expected cases COC-users

Expected cases non-users

16-19 years

4.5

4

20-24 years

17.5

16

25-29 years

48.7

44

30-34 years

110

100

35-39 years

180

160

40-44 years

260

230

The risk in users of progestogen-only contraceptives (POCs), such as Lactinette, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive. Compared to the risk of getting breast cancer even in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.

When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for Lactinette used as a contraceptive in the absence of an oestrogenic component is unknown, Lactinette should be discontinued in the event of a thrombosis. Discontinuation of Lactinette should also be considered in case of long-term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use.

If sustained hypertension develops during the use of Lactinette, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Lactinette should be considered.

Treatment with Lactinette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.

The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Despite the fact that Lactinette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Lactinette.

The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestations; otosclerosis-related hearing loss; (hereditary) angioedema.

Each tablet of this medicinal product contains 55.07 mg of lactose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Substance-powder

Lactinette has no or negligible influence on the ability to drive and use machines.

Lactinette has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Lactinette. Since Lactinette causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent. Information, counselling, and a bleeding diary can improve the woman's acceptance of the bleeding pattern.

The most commonly reported other undesirable effects in the clinical trials with Lactinette (> 2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.

All undesirable effects are listed by system organ class and frequency; common (>1/100), uncommon (1/1,000 to <1/100) and rare (<1/1,000).

System Organ Class

(MedDRA)*

Frequency of adverse reactions

Common

Uncommon

Rare

Infections and infestations

Vaginal infection

Psychiatric disorders

Mood altered, Depressed mood, Libido decreased

Nervous system disorders

Headache

Eye disorders

Contact lens intolerance

Gastrointestinal disorders

Nausea

Vomiting

Skin and subcutaneous tissue disorders

Acne

Alopecia

Rash, Urticaria, Erythema nodosum

Reproductive system and breast disorders

Breast pain, Menstruation irregular, Amenorrhoea

Dysmenorrhoea, Ovarian cyst

General disorders and administration site condition

Fatigue

Investigations

Weight increased

* MedDRA version 9.0

Breast discharge may occur during use of Lactinette. On rare occasions, ectopic pregnancies have been reported. In addition, (aggravation of) angioedema and/or aggravation of hereditary angioedema may occur.

In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported.

Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with hormonal contraceptives.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Lactinette. Since Lactinette causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent. Information, counselling and a bleeding diary can improve the woman's acceptance of the bleeding pattern.

The most commonly reported other undesirable effects in the clinical trials with Lactinette (>2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.

All undesirable effects are listed by system organ class and frequency; common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100) and rare (>1/10,000 to <1/1,000).

System Organ Class

(MedDRA)*

Frequency of adverse reactions

Common

Uncommon

Rare

Infections and infestations

Vaginal infection

Psychiatric disorders

Mood altered, Depressed mood, Libido decreased

Nervous system disorders

Headache

Eye disorders

Contact lens intolerance

Gastrointestinal disorders

Nausea

Vomiting

Skin and subcutaneous tissue disorders

Acne

Alopecia

Rash, Urticaria, Erythema nodosum

Reproductive system and breast disorders

Breast pain, Menstruation irregular, Amenorrhoea

Dysmenorrhoea, Ovarian cyst

General disorders and administration site condition

Fatigue

Investigations

Weight increased

* MedDRA version 9.0

Breast discharge may occur during use of Lactinette.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
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There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.

There have been no reports of serious adverse effects from overdose. Symptoms that may occur in these case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and the treatment should be symptomatic.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

Pharmacotherapeutic group: hormonal contraceptives for systemic use, ATC code: G03AC09.

Mechanism of action

Lactinette is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only pills, Lactinette is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of Lactinette is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

Clinical efficacy and safety

When studied for 2 cycles, using a definition of ovulation as a progesterone level greater than 16 nmol/L for 5 consecutive days, the ovulation incidence was found to be 1% (1/103) with a 95% confidence interval of 0.02% - 5.29% in the ITT group (user and method failures). Ovulation inhibition was achieved from the first cycle of use. In this study, when Lactinette was discontinued after 2 cycles (56 continuous days), ovulation occurred on average after 17 days (range 7-30 days).

In a comparative efficacy trial (which allowed a maximum time of 3 hours for missed pills) the overall ITT Pearl-Index found for Lactinette was 0.4 (95% confidence interval 0.09 - 1.20), compared to 1.6 (95% confidence interval 0.42 - 3.96) for 30 μg levonorgestrel.

The Pearl-Index for Lactinette is comparable to the one historically found for COCs in the general COC-using population.

Treatment with Lactinette leads to decreased estradiol levels, to a level corresponding to the early follicular phase. No clinically relevant effects on carbohydrate metabolism, lipid metabolism, and haemostasis have been observed.

Paediatric population

No clinical data on efficacy and safety are available in adolescents below 18 years.

Pharmacotherapeutic group: hormonal contraceptives for systemic use, ATC code: G03AC09.

Lactinette is a progestogen-only pill, which contains the progestogen Lactinette. Like other progestogen-only pills, Lactinette is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of Lactinette is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

When studied for 2 cycles, using a definition of ovulation as a progesterone level greater than 16 nmol/L for 5 consecutive days, the ovulation incidence was found to be 1% (1/103) with a 95% confidence interval of 0.02% -5.29% in the ITT group (user and method failures). Ovulation inhibition was achieved from the first cycle of use. In this study, when Lactinette was discontinued after 2 cycles (56 continuous days) ovulation occurred on average after 17 days (range 7-30 days).

In a comparative efficacy trial (which allowed a maximum time of 3 hours for missed pills), the overall ITT Pearl-Index found for Lactinette was 0.4 (95% confidence interval 0.09% - 1.20%), compared to 1.6 (95% confidence interval 0.42% - 3.96%) for 30 μg levonorgestrel.

The Pearl-Index for Lactinette is comparable to the one historically found for COCs in the general COC-using population.

Treatment with Lactinette leads to decreased estradiol levels, to a level corresponding to the early follicular phase. No clinically relevant effects on carbohydrate metabolism, lipid metabolism and haemostasis have been observed.

Paediatric population

No clinical data on efficacy and safety are available in adolescents below 18 years.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Absorption

After oral dosing of Lactinette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.

Distribution

ENG is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to SHBG.

Biotransformation

DSG is metabolised via hydroxylation and dehydrogenation to the active metabolite ENG. ENG is primarily metabolised by the cytochrome P450 3A (CYP3A) isoenzyme and subsequently conjugated with sulphate and glucuronide.

Elimination

ENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing. Steady-state levels in plasma are reached after 4-5 days. The serum clearance after i.v. administration of ENG is approximately 10 l per hour. Excretion of ENG and its metabolites either as free steroid or as conjugates, is with urine and faeces (ratio 1.5:1). In lactating women, ENG is excreted in breast milk with a milk/serum ratio of 0.37-0.55. Based on these data and an estimated milk intake of 150 ml/kg/day, 0.01 - 0.05 microgram etonogestrel maybe ingested by the infant.

Special populations

Effect of renal impairment

No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of DSG.

Effect of hepatic impairment

No studies were conducted to evaluate the effect of hepatic disease on the pharmacokinetics of DSG. However, steroid hormones may be poorly metabolized in women with impaired liver function.

Ethnic groups

No studies were performed to assess pharmacokinetics in ethnic groups.

Absorption

After oral dosing of Lactinette, Lactinette (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.

Distribution

ENG is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to SHBG.

BiotransformationDSG is metabolised via hydroxylation and dehydrogenation to the active metabolite ENG. ENG is metabolised via sulphate and glucuronide conjugation.

Elimination

ENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing. Steady-state levels in plasma are reached after 4-5 days. The serum clearance after IV administration of ENG is approximately 10 l per hour. Excretion of ENG and its metabolites either as free steroid or as conjugates, is with urine and faeces (ratio 1.5:1). In lactating women, ENG is excreted in breast milk with a milk/serum ratio of 0.37-0.55. Based on these data and an estimated milk intake of 150 ml/kg/day, 0.01 - 0.05 microgram etonogestrel may be ingested by the infant.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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hormonal contraceptives for systemic use, ATC code: G03AC09.

Preclinical safety data

The information provided in Preclinical safety data of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of desogestrel.

Environmental Risk Assessment (ERA)

The active substance etonogestrel shows an environmental risk to fish.

Toxicological studies did not reveal any effects other than those, that can be explained from the hormonal properties of Lactinette.

Incompatibilities

The information provided in Incompatibilities of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

Not applicable.

Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Lactinette is based on data of another medicine with exactly the same composition as the Lactinette of the medicine (Desogestrel). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Lactinette directly from the package or from the pharmacist at the pharmacy.
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Coated tablet; Intramammary Ointment
Substance-powder

The active substance etonogestrel shows an environmental risk to fish.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

No special requirements.

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