Active ingredients: Progesterone (Hydroxyprogesterone caproate)
LENTOGEST 341 mg / 2 ml solution for injection
Why is Lentogest used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Sex hormones and modulators of the genital system: progestogens
THERAPEUTIC INDICATIONS
Threat of abortion, habitual abortion, dysfunctional juvenile and climacteric metrorrhagia, primary and secondary amenorrhea, protection of pregnancy in case of surgery, luteal insufficiency.
Contraindications When Lentogest should not be used
Hypersensitivity to the active substance or to any of the excipients, blood loss from the external genitalia of a nature to be determined, thrombophlebitic and thromboembolic disorders, severe hepatic insufficiency, suspected or early stage breast cancer.
It should not be used in case of herpes gravidarum to the anamnesis.
Precautions for use What you need to know before taking Lentogest
Before starting therapy with Lentogest, in addition to performing a gynecological examination (including palpation of the breasts), the patient's personal and family medical history should be evaluated, in the light of contraindications and special and precautionary warnings for use. In addition, the presence of pregnancy must be excluded, except, of course, the case in which the drug is administered for indications of threatened abortion and habitual abortion.
The use of progestogens in the threat of abortion and in habitual abortion can be allowed in cases where it is absolutely essential in relation to the etiology of the specific pathological picture (infertility due to insufficiency of the second phase, threat of abortion due to insufficient activity of the corpus luteum gravidarum).
Caution should be taken in patients with epilepsy, asthma and heart or renal insufficiency and in diabetics since progestin hormones can determine or aggravate states of water retention and reduce glucose tolerance.
Interactions Which drugs or foods can modify the effect of Lentogest
The simultaneous intake of rifampicin, ampicillin, phenylbutazone, barbiturates, some anticonvulsants (hydantoins, etc.), can compromise the effectiveness of the treatment. It is also possible that the need for oral antidiabetic drugs or insulin is increased or decreased.
Warnings It is important to know that:
Like all oily solutions, Lentogest must be injected intramuscularly.
It is necessary to pay attention if during the treatment symptoms of partial or total loss of vision or diplopia appear and stop the treatment itself if papillary edema or lesions of the retinal vessels occur.
The same must be said of the first symptoms that may indicate thrombotic disorders affecting the peripheral, cerebral and pulmonary vessels. Particular attention must also be paid to subjects in whom there are alterations in endocrine tests and liver function; in such subjects the treatment should be stopped and the tests repeated after about two months.
Effects on driving and using machines
No effects on the ability to drive or use machines have been reported.
Pregnancy and breastfeeding
Lentogest is indicated in pregnancy in the cases indicated (see "Dose, method and time of administration") and under strict medical supervision.
Use while breastfeeding is not recommended.
Dosage and method of use How to use Lentogest: Dosage
- Threat of abortion: treatment should be started immediately by administering 1 vial of Lentogest. It is recommended to continue with 1 vial of Lentogest 2 times a week until the patient no longer presents the symptoms of the threat even after resuming her usual activity. L " further continuation of treatment with Lentogest will be decided in relation to individual clinical cases.
- Habitual abortion: Treatment should be started as soon as pregnancy has been safely ascertained. 1-2 ampoules of Lentogest will be injected intramuscularly per week until the 10th-12th week of pregnancy.
- Dysfunctional juvenile and climacteric bleeding: for the control of dysfunctional metrorrhagia it is advisable to administer 1 ampoule of Lentogest administered between the 18th and 20th day of the cycle. Withdrawal bleeding will appear 8-10 days after injection.
- Primary and secondary amenorrhea: treatment with Lentogest, in case of secondary amenorrhea, should not be started before pregnancy has been ruled out; moreover, in order to induce menstrual-like bleeding, an estrogen should be administered before, and for an adequate period, the administration, between the 18th and 20th day of the cycle, of 1 vial of Lentogest. from deprivation will appear 8-10 days after injection.
- Essential precautions: if the patient does not wish to become pregnant, other non-hormonal methods should be used for contraception (except for the Ogino-Knaus method and basal temperature). If during treatment no withdrawal period occurs, even if contraceptive measures are used, the possibility of pregnancy must be ruled out; it will therefore be necessary to suspend the treatment and carry out the appropriate tests in order to confirm or exclude the same. In the event that a pregnancy is actually established, the treatment with Lentogest (and not with estrogen) will be continued only in cases of actual need.
- Protection of pregnancy in case of surgery: it is advisable to start treatment with 1-2 ampoules of Lentogest at least one week before surgery. After surgery, treatment should be continued with 1-2 ampoules of Lentogest per week for 4 weeks .
- Luteal insufficiency: In cases where the luteal phase is shortened (increase in basal temperature in the second half of the cycle of short duration), the transformation of the endometrium is most likely incomplete. In such cases the administration of Lentogest favors the secretory transformation of the endometrium and therefore increases the likelihood of becoming pregnant. It is suggested to administer 1 ampoule of Lentogest three days after the rise in basal temperature, simultaneously with an estrogen (since, in general, there is a simultaneous estrogenic deficit).
In support of the luteal phase, 1 vial of Lentogest will be injected twice a week until the βHCG is evaluated. In case of positive βHCG, the treatment will be continued until the 10th-12th week of pregnancy.
The different dosages of Lentogest can be suitably varied, according to medical prescription.
Overdose What to do if you have taken too much Lentogest
No cases of overdose have been reported. In case of accidental intake of an excessive dose of Lentogest, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Lentogest
Manifestations related to thromboembolic accidents (peripheral, pulmonary, cerebral, retinal) and to neuroocular lesions; nausea, headache, dizziness; abdominal cramps; phenomena of nervous irritation, depression, changes in libido, premenstrual syndrome, spotting (slight bleeding from the external genitalia between one menstruation and the next); acne, hypertrichosis; hemorrhagic and erythematous skin rashes; pain at the injection site; water retention; weight gain; increased pressure in predisposed individuals. Cholestatic jaundice, abnormal liver function tests and blood coagulation tests have been reported rarely. Any side effects not described in the package leaflet should be reported to your doctor or pharmacist.
Expiry and Retention
Check the expiration date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package
Keep out of reach of children.
Do not store above 25 ° C
Deadline "> Other information
COMPOSITION
Each vial contains:
Active ingredient: 17α-hydroxyprogesterone caproate 341 mg
Excipients: Benzyl alcohol, Ethyl oleate.
PHARMACEUTICAL FORM AND CONTENT
Injectable solution. 2 ml vial.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
LENTOGEST
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each vial contains:
Active principle: 17 alpha hydroxyprogesterone caproate 341 mg
For excipients, see p. 6.1
03.0 PHARMACEUTICAL FORM -
Injectable solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Threat of abortion, habitual abortion, dysfunctional juvenile and climacteric metrorrhagia, primary and secondary amenorrhea, protection of pregnancy in case of surgery, luteal insufficiency.
04.2 Posology and method of administration -
Threat of abortion: treatment should be started immediately by administering 1 ampoule of Lentogest. It is advisable to continue with 1 vial of Lentogest 2 times a week until the patient no longer presents the symptoms of the threat even after resuming her usual activity. The further continuation of treatment with Lentogest will be decided in relation to the individual clinical cases.
Habitual abortion: treatment should be started as soon as pregnancy has been safely ascertained. 1-2 ampoules of Lentogest will be injected intramuscularly per week until the 10th-12th week of pregnancy.
Dysfunctional juvenile and climacteric bleeding: for the control of dysfunctional metrorrhagia it is advisable to administer 1 ampoule of Lentogest administered between the 18th and 20th day of the cycle. Withdrawal bleeding will appear 8-10 days after injection.
Primary and secondary amenorrhea: treatment with Lentogest, in case of secondary amenorrhea, should not be started before pregnancy has been ruled out; moreover, in order to induce menstrual-like bleeding, an estrogen should be administered before, and for an adequate period, the administration, between the 18th and 20th day of the cycle, of 1 vial of Lentogest. from deprivation will appear 8-10 days after injection.
Essential precautions
If the patient does not wish to become pregnant, other non-hormonal methods should be used for contraception (except for the Ogino-Knaus method and basal temperature).
If during treatment no withdrawal period occurs, even if contraceptive measures are used, the possibility of pregnancy must be ruled out; it will therefore be necessary to suspend the treatment and carry out the appropriate tests in order to confirm or exclude the same. In the event that a pregnancy is actually established, the treatment with Lentogest (and not with estrogen) will be continued only in cases of actual need.
Protection of pregnancy in case of surgery: it is advisable to start treatment with 1-2 ampoules of Lentogest at least one week before surgery. After surgery, treatment should be continued with 1-2 ampoules of Lentogest per week for 4 weeks.
Luteal insufficiency: in cases where the luteal phase is shortened (increase in basal temperature in the second half of the cycle of short duration), the transformation of the endometrium is most likely incomplete. In such cases, the administration of Lentogest favors the secretory transformation of the endometrium and therefore the likelihood of becoming pregnant increases. It is suggested to administer 1 ampoule of Lentogest three days after the rise in basal temperature, simultaneously with an estrogen (since, in general, there is a simultaneous estrogenic deficit).
In support of the luteal phase, 1 vial of Lentogest will be injected twice a week until bHCG is evaluated. In case of positive bHCG, the treatment will be continued until the 10th-12th week of pregnancy.
The different dosages of Lentogest can be suitably varied, according to medical prescription.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients, blood loss from the external genitalia of a nature to be determined, thrombophlebitic and thromboembolic disorders, severe hepatic insufficiency, suspected or early stage breast cancer.
It should not be used in case of herpes gravidarum to the anamnesis.
04.4 Special warnings and appropriate precautions for use -
Before starting therapy with Lentogest, in addition to performing a gynecological examination (including palpation of the breasts), the patient's personal and family medical history should be evaluated, in the light of contraindications and special and precautionary warnings for use. Furthermore, the presence of a pregnancy must be excluded, except, of course, for the indications of threatened abortion and habitual abortion.
Following the action carried out by Lentogest on the myometrium, retention of an embryo that is already dead could occur. In the event that the therapy is continued for a long time, it is therefore necessary to ascertain the persistence or otherwise of a state of pregnancy by means of adequate checks and pregnancy tests.
The use of progestogens in the threat of abortion and in habitual abortion can be allowed in cases where it is absolutely essential in relation to the etiology of the specific pathological picture (infertility due to insufficiency of the second phase, threat of abortion due to insufficient activity of the corpus luteum gravidarum).
Like all oily solutions, Lentogest must be injected intramuscularly. A possible intravascular injection could give rise to an oily embolism.
It is necessary to pay attention if during the treatment symptoms of partial or total loss of vision or diplopia appear and stop the treatment itself if papillary edema or lesions of the retinal vessels occur. The same must be said of the first symptoms that may indicate thrombotic disorders affecting the peripheral, cerebral and pulmonary vessels. Particular attention must also be paid to subjects in whom there are alterations in endocrine tests and liver function; in such subjects the treatment should be stopped and the tests repeated after about two months.
Caution should be taken in patients with epilepsy, asthma and heart or renal insufficiency and in diabetics since progestin hormones can determine or aggravate states of water retention and reduce glucose tolerance.
04.5 Interactions with other medicinal products and other forms of interaction -
The simultaneous intake of rifampicin, ampicillin, phenylbutazone, barbiturates, some anticonvulsants (hydantoins, etc.), can compromise, by enzymatic induction and acceleration of hepatic degradation, the efficacy of the treatment. It is also possible that the need for oral antidiabetic drugs or insulin is increased or decreased.
04.6 Pregnancy and breastfeeding -
Lentogest is indicated in pregnancy in the cases indicated (see "Dose, method and period of administration") and under strict medical supervision.
Use while breastfeeding is not recommended.
04.7 Effects on ability to drive and use machines -
Lentogest does not affect the ability to drive or use machines.
04.8 Undesirable effects -
A statistically significant incidence of peripheral, pulmonary, cerebral, retinal thromboembolic accidents and neuro-ocular lesions has been described following the use of estrogen-associated progestogens. Other secondary reactions reported following the use of progestogens in different combinations were: increased blood pressure in predisposed individuals, weight gain, premenstrual syndrome, spotting; changes in libido; abdominal cramps, fluid retention; acne, headache, dizziness, nausea; phenomena of nerve irritation, depression, hypertrichosis, hemorrhagic and erythematous skin rashes, pain at the injection site.
Cholestatic jaundice, abnormal liver function tests such as BSF retention, alkaline phosphatase, transaminase, and blood coagulation tests have been reported rarely.
04.9 Overdose -
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: sex hormones and modulators of the genital system: progestogens derived from pregnene. ATC: G03DA03
Lentogest is a long-acting progestin made by esterification of 17α-hydroxyprogesterone which favors the physiological phenomena associated with the sexual apparatus and with pregnancy.
05.2 "Pharmacokinetic properties -
Administered intramuscularly, 17α-hydroxyprogesterone caproate is released slowly from the deposit in a biphasic manner and with half-lives of approximately 5 and 11 days respectively; it does not accumulate in the organism and does not indicate specific deposits in organs or tissues.
Once released from the deposit, 17α-hydroxyprogesterone caproate is rapidly excreted unchanged or in the form of metabolites. Elimination is mainly biliary (urine / faecal elimination ratio = 0.05-0.02) and takes place constantly and at a high rate (half-life: about 10 hours). An entero-biliary circulation is unlikely.
The prolonged biological activity of the product is due to the slower reabsorption from the injection site rather than to storage and slow release from the adipose tissue: in this tissue, less than 10% was found from the injected dose of 17α-hydroxyprogesterone caproate, in contrast to the behavior of progesterone which, despite having a shorter half-life, is concentrated in greater quantities in the adipose tissue.
05.3 Preclinical safety data -
The toxicity of 17α-hydroxyprogesterone caproate is low. It is practically devoid of acute toxicity: in rats the LD50 is 200 mg / 100 g.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Benzyl alcohol, ethyl oleate.
06.2 Incompatibility "-
There are no known incompatibilities.
06.3 Period of validity "-
In intact packaging: 5 years.
06.4 Special precautions for storage -
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Glass vials packed in boxes of a 2ml vial.
06.6 Instructions for use and handling -
No special instructions.
The unused product and the waste derived from this medicine must be disposed of in accordance with the legal requirements.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi
08.0 MARKETING AUTHORIZATION NUMBER -
AIC n. 024542019
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
1983/2005
10.0 DATE OF REVISION OF THE TEXT -
May 2010
