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- Lentogest (hydroxy progesterone caproate 341 mg) (unlicensed)
|How is this item sold e.g. single tablets or vials?||Per Vial|
The name of your medicine is Lentogest 341mg/2ml.The active ingredient of hydroxyprogesterone caproate (a hormone which acts on the lining of the uterus and is produced naturally by the body).
Each vial contains:
Active ingredient: 17 alpha hydroxyprogesterone caproate 341 mg
Solution for injection.
Threatened abortion, habitual abortion, dysfunctional youth and climacteric metrorrhagia, primary and secondary amenorrhea, protection of pregnancy in case of surgery, luteal insufficiency.
Posology and method of administration
Threatened abortion: treatment should be started immediately by administering 1 ampoule Lentogest. It is recommended to continue with 1 vial of Lentogest 2 times a week until the patient no longer has symptoms even after the threat resumes its normal activity. The further continuation of treatment with Lentogest will be decided in relation to individual clinical cases.
Recurrent miscarriage: Treatment should be started as soon as pregnancy has been established with certainty. It will inject intramuscularly 1-2 vials Lentogest week until the 10 th -12 th week of pregnancy.
Youth and dysfunctional metrorrhagia of menopause: the control of dysfunctional metrorrhagia is appropriate administration of 1 vial of Lentogest administered between 18 ° and 20 ° of the cycle. The withdrawal bleeding appear 8-10 days after injection.
Primary and secondary amenorrhea: treatment with Lentogest, in the case of secondary amenorrhea, should not be initiated before pregnancy has been excluded; addition, the purpose of inducing bleeding menstrual-like, an estrogen should be administered first, and for an appropriate time of administration, between 18 ° and 20 ° of the cycle, 1 vial of Lentogest. The withdrawal bleeding appear 8-10 days after injection.
In the event that the patient does not want a pregnancy, one must use other methods for contraception non-hormonal (to the exclusion of the method of Ogino-Knaus and the basal body temperature).
If during treatment appears to bleed deprivation, even if they are used contraceptive measures, we must exclude the possibility that this is a pregnancy, then you should stop treatment and make the appropriate tests to confirm or exclude the same. In the event that actually took a pregnancy, treatment with Lentogest (and not with estrogen) will only be continued in cases of real need.
Protection of the pregnancy in case of surgery: You should begin treatment with 1-2 ampoules Lentogest least one week before surgery. After surgery, the treatment should be continued with 1-2 ampoules Lentogest a week for 4 weeks.
Luteal insufficiency: in cases where the luteal phase is shortened (increase of the basal temperature in the second half of the cycle of short duration), the transformation of the endometrium is most probably incomplete. For these cases, the administration of Lentogest favors the transformation secretory endometrium and thus increases the probability of establishing pregnancy. It is suggested to administer 1 vial of Lentogest three days after the raising of the basal temperature, simultaneously to an estrogen (since, in general, it has a contemporary estrogen deficiency).
In the luteal phase support is inject 1 vial of Lentogest 2 times a week until the assessment of bHCG. In case of positive bHCG treatment should be continued until the 10 th -12 th week of pregnancy.
The different dosages of Lentogest can suitably be changed, according to medical prescription.
Hypersensitivity to the active substance or to any excipients, bleeding from external genitalia of nature to be determined, thrombophlebitis and thromboembolic disorders, liver failure, or suspected breast cancer at an early stage.
Should not be used in case of herpes gestationis anamnesis.
Special warnings and precautions for use - Top
Before initiating therapy with Lentogest and to perform a gynaecological examination (including palpation of the breasts), should be assessed the personal and family history of the patient, in light of contraindications and special warnings and precautions for use. You must also exclude the presence of a pregnancy, except of course for the signs of threatened abortion and habitual abortion.
Following the action exerted by the myometrium may occur Lentogest retention of a dead embryo. If therapy is continued for a long time it is therefore necessary to determine the persistence or not of a state gravidarum by appropriate supervision and pregnancy tests.
The use of progestogens in threatened abortion and habitual in abortion may be permitted in cases where it is absolutely essential in relation to the etiology of the specific clinical picture (failure of the second phase of infertility, threatened miscarriage by insufficient activity of corpus luteum gravidarum).
Like all oily solutions, the Lentogest must be injected intramuscularly. A possible intravascular injection may lead to oily embolism.
Should pay attention if symptoms occur during treatment of partial or complete loss of vision or diplopia and stop treatment if it is found that papilledema or retinal vessel injury. The same must be said of the early symptoms that may indicate thrombotic disorders dependent peripheral vessels, brain, lung. Particular attention should be directed to subjects in which you detect alterations of endocrine tests and liver function in these subjects, treatment should be discontinued and the test repeated after two months.
Precautions must be taken in patients with epilepsy, asthma and heart failure or renal and diabetic since the hormones progestin can cause or aggravate states of water retention and reduce glucose tolerance.
The intake of rifampicin, ampicillin, phenylbutazone, barbiturates, some anticonvulsants (hydantoins, etc..), May compromise, due to enzyme induction and acceleration of degradation of the liver, the effectiveness of treatment. It is also possible that the need for oral antidiabetic agents or insulin is increased or reduced.
Pregnancy and lactation - Home Page
The Lentogest is indicated during pregnancy in the cases above (see "Dosage and administration period") and under strict medical supervision.
Use during lactation is not recommended.
Effects on ability to drive and use machines
Lentogest not affect your ability to drive or operate machinery.
Following the use of estrogen combined with progestin has been reported statistically significant incidence of peripheral thromboembolic accidents, lung, brain, retina and neuro-ocular lesions. Other reactions reported following use of progestins in different groups were: pressure in susceptible individuals, weight gain, premenstrual syndrome, spotting, changes in libido, abdominal cramps, water retention, acne, headache, dizziness, nausea; phenomena of nervous irritation, depression, hirsutism, rash erythematous and hemorrhagic type, pain at the injection site.
Have been reported rarely cholestatic jaundice, alterations in liver function tests such as retention of BSF, alkaline phosphatase, transaminases, and tests of blood coagulation.
There have been no reported cases of overdose.
Pharmacotherapeutic group: sex hormones and modulators of the genital system: progestins pregnene derivatives.
The Lentogest is a long-acting progestin produced by esterification of the 17α-hydroxyprogesterone, which promotes the physiological phenomena associated with the sexual organs and pregnancy.
Intramuscular 17α-hydroxyprogesterone caproate on it slowly releases from the storage and biphasic manner with half-lives respectively about 5 and 11 days, does not accumulate in the body and does not report deposits in specific organs or tissues.
Once released from storage on 17α-hydroxyprogesterone caproate is rapidly excreted unchanged or as metabolites. Elimination is primarily biliary (ratio of urine elimination / I = 0:05 to 0:02) and is implemented consistently and with high speed (half life: about 10 hours). Enterohepatic bile circulation is unlikely.
The prolonged biological activity of the product is attributable to the slower resorption from the place of injection rather than to a storage and a slow release from adipose tissue: in this tissue, the injected dose of 17α-hydroxyprogesterone caproate was found less than 10%, in contrast with the behavior of progesterone which, while having a duration shorter half-life, is concentrated in quantities greater than in adipose tissue.
The toxicity of 17α-hydroxyprogesterone caproate is low. It is virtually devoid of acute toxicity: LD 50 in rat is 200 mg/100 g.
Benzyl alcohol, ethyl oleate.
There are no known incompatibilities.
Period of validity
A Unopened: 5 years.
Special precautions for storage - Top
Do not store above 25 ° C.
Nature and contents of the pack
Glass vials packed in a box of one vial of 2 ml.
Instructions for use and handling
Any unused product or waste materials derived from such medicinal product must be disposed of in accordance with legal requirements.