Description overdue on 03/08/2014
- Latin name: Lactinette
- ATC code: G03AC09
- Active substance: Desogestrel (Desogestrelum)
- Manufacturer: GEDEON RICHTER Plc., Hungary
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions for use Laktineta: a method for receiving and dispensing the drug
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Analogs
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
One tablet of Laktinet contained 0, 075 mg desogestrel and a number of auxiliary components:
- colloidal silicon dioxide (Silicii dioxydum colloidale);
- D, L-α-tocopherol (dl-alfa-Tocopherol);
- stearic acid (Acidum stearicum);
- magnesium stearate (Magnesium stearate);
- povidone K30 (Povidonum K30);
- potato starch (Amylum solani);
- lactose monohydrate .
As part of the coating film, which is coated tablet contains:
- talc (Talcum);
- macrogol 3000 (Macrogolum 3000);
- Titanium Dioxide CI 77891 (Titanium Dioxide);
- Opadry II White (Opadry II White);
- polyvinyl alcohol (Spiritus polyvinylicus).
Product form
Laktinet The drug is available as biconvex, film-coated tablets of round shape, the color of which can vary from almost white to white. On one side of the tablet is present in the form of engraving letters "D", on the other engraved number "75".
The tablets are packaged in blisters of 28 pieces. In a cardboard box may be one or three blisters simultaneously.
Pharmacological action
Laktinet belong to the pharmacological group monophasic gestagensoderzhaschih contraceptives Intended for oral administration to prevent the onset of pregnancy .
Pharmacodynamics and pharmacokinetics
Film-coated birth control pills Laktinet are contraceptive, which is based on progestogen Third Generation desogestrel .
High affinity for the receptors of substance progesterone It provides reliable contraception even when used in low doses. As its main advantage is that it has almost no effect on lipid profile . Also, it has no effect on the exchange carbohydrates and indicators hemostasis .
These beneficial qualities desogestrel a guarantee of security (including contraindications to their use) of the modern low-dose oral contraceptives , Which include Laktinet.
Since, as the active substances are not used other hormonal components except progestogen Tablets Laktinet safe for women breast-feeding As well as for women who have contraindications or do not want to take estrogensoderzhaschie drugs.
Mechanism of action desogestrel It is due to braking Ovulation As evidenced by the lack of follicle during the procedure ultrasound diagnostics As well as a low content indicators in the body lyuteotropnogo (prolactin) hormone .
The effectiveness of the action desogestrel as confirmed by the low concentration progesterone in the middle menstrual cycle .
Another equally important property of the substance - the ability to increase the density and viscosity of the cervical mucus, which is produced cervical glands . This in turn creates a barrier to passage sperm and prevents fertilize the egg .
Pearl Index for the preparation of 0, 4. This figure reflects the number of pregnancies in a group of thousands of women throughout the year without contraceptives And the reliability of the method Contraception . The lower it is, the more effective is contraceptive .
With regard Laktineta Pearl Index similar to the targets set for contraceptives of the combined type .
These comparative studies have shown that when receiving tablets dropped after a maximum of three hours after the proper time in the group of women receiving the drug, the value Pearl Index It remained unchanged - 0, 4. Pearl Index to levonorgestrel index rose to 1, 6.
After receiving per os pills Laktinet desogestrel rapidly absorbed in stomach and intestine . The average maximum concentration of the substance in the circulating blood It is noted after 1, 8 and 2 hours. Indicator bioavailability is within 70%.
Under influence enzymes desogestrel subjected to processes hydroxylation and dehydrogenation , resulting in biotransformiroetsa before etonogestrel , Which is its main metabolite . Further metabolization etonogestrel completed education glucuronide and sulfate conjugates .
Etonogestrel Which is the most active metabolite of desogestrel It has the ability to bind to plasma proteins 95, 5-99%. To a large extent it concerns albumin To a lesser - globular proteins ( globulins ) Responsible for the binding hormones .
The average half-life metabolites of desogestrel is approximately 30 hours. Moreover, its duration is not changed depending on whether or not the reception of a single drug or course (repeated).
The equilibrium concentration observed after 4-5 days after you start taking the tablets.
Withdrawal metabolites as conjugates and free steroid hormone carried out mainly kidney urine. To a much lesser extent, they are derived from the content bowel .
In breast-feeding women etonogestrel misses in milk. The ratio of milk / blood plasma in this case is 0, 37/0, 55. This and the fact that the child receives on average for a day, about 150 ml breast milk per kg of its weight, it can get him or 0, 01 to 0, 05 mg etonogestrel .
Indications
Laktinet shown as contraceptive women who want to prevent an unplanned pregnancy .
Contraindications
Contraindications to the appointment of the drug are:
- thromboembolism (marked by a history of, or currently available);
- severe liver disease (contra-maintained as long as liver function tests are not normalized);
- dysfunction and liver failure ;
- the presence or the assumption on the existence of the patient hormone-dependent malignancy ;
- vaginal unclear nature of origin;
- pregnancy or suspected of it;
- intolerance to lactose;
- lactase deficiency ;
- glucose-galactose malabsorption ;
- forced immobilization for long periods of time;
- Hypersensitivity to the active substance or some of the auxiliary components.
Side effects
Research Laktinet preparation and active substance showed that the most frequent side effect of the drug is a violation of regularity menstrual cycle .
Approximately half of the women taking the drug observed Non-Cyclical bloody vaginal discharge . Every third to fifth woman on the background of pills menses become more rare (to the extent that eventually disappear completely), or - on the contrary - are increasing.
In some cases, can be observed and longer menstrual bleeding . However, as a rule, two months after receiving menses become less frequent.
To increase safety and reduce the risk of side effects, women taking Laktinet, it is recommended to regularly visit your gynecologist, to inform it of any changes of their condition, as well as keeping a diary Menstrual selections.
The category of the most frequently occurring in patients receiving gestagensoderzhaschih oral contraceptives Effects include:
- nausea;
- appearance acne ;
- lability of mood;
- decreased sex drive;
- tenderness in breast ;
- weight gain;
- headache.
Several less marked:
- increased fatigue;
- vomiting;
- hair loss ( alopecia );
- level increase intracranial pressure ;
- inflammatory processes vaginal mucosa ;
- cysts in the ovaries ;
- infections of the vagina ;
- increasing the severity of pain in the lower abdomen during menstrual bleeding .
Enough can rarely occur phenomena such as skin rash, erythema nodosa , Redness of the skin, hives . Some women may appear discharge from the breast . In rare cases registered ectopic pregnancy .
Admission Laktineta may be a precipitating factor for the development of or increase in severity angioedema As well as to its deterioration, if the latter is inherent.
There are cases when women taking oral contraceptives marked and more serious consequences. These include education hormone-dependent tumors and Development thromboembolism (venous or arterial) .
Instructions for use Laktineta: a method for receiving and dispensing the drug
If before using Laktineta woman did not drink any oral contraceptives , Pills start to the first day of the cycle. The daily dose - 1 tablet.
Thus it is recommended to take a clear one and the same time, maintaining the interval of 24 hours and follow the instructions on the package. When receiving Laktineta not required to make the intervals between each of the two courses.
If the woman has not been used previously hormonal contraception (at least in the preceding month), pills start to the first post menstrual bleeding day. Auxiliary barrier contraception is not needed.
If administration begin between 2 and 5 th days after closure menstrual bleeding , in this case birth control pills supplement barrier contraceptives .
To replace another combined contraceptive Laktinet to do so we recommend the next day after the failure of the previously used agent. The need for additional remedies available.
To replace another monocomponent formulation containing progestogen On Laktinet pills also begin immediately after the abolition of the previously used tools, whether minipill . progestagensoderzhaschie injection . intrauterine or Implants .
In each of the cases for the first week for greater reliability Contraception should resort to the use along with pills barrier contraceptives .
After the procedure abortion And after miscarriage during the first three months pregnancy , The drug is recommended to start immediately after abortion . The need for additional methods Contraception absent.
After abortion between 13 and 24 weeks, and after delivery , Reception Laktineta administered no earlier than 21-28 days. If the course is scheduled to begin later in the first seven days of a tablet combined with barrier contraceptives .
In situations where the course before taking the drug had unprotected sex, she will need to rule out the possibility pregnancy or proposed to shift the first day of use tablets on the first day of the following menstrual cycle .
If the previous reception of tablets has been passed, but it took less than twelve hours, contraceptive effect the drug remains unchanged, further reception continues in accordance with the usual scheme, without using additional methods of protection unwanted pregnancy .
If it passed from twelve hours to three days, the reliability Contraception reduced significantly. The drug continues to take on the familiar pattern, but complement it using other methods Contraception .
If a few hours after taking the pill begins vomiting It is an indication that the full absorption of the active drug substance has not happened. In this case, the instruction in Laktinet recommends resort to countermeasures similar to those resorted to if there was missing the next appointment. To make up for the missing pills taken from her next drug packaging.
If the intake of pills marked menstrual irregularities (eg too frequent, prolonged, painful or irregular bleeding), you should consider the option of replacing the drug. If symptoms do not disappear, and after that, you must pass a thorough examination to determine the exact cause of her appearance.
In some cases arising amenorrhea and others cycle disorders may be the result of improper dosing.
When pregnancy , Reception Laktineta immediately stopped.
Overdose
If you exceed the recommended dosage instructions may occur:
- vomiting;
- nausea;
- spotting or heavy bleeding from the vagina .
When any of these features assigned symptomatic treatment. There is no specific antidote drug.
Cooperation
Simultaneous treatment with drugs that induce microsomal liver enzymes It can cause breakthrough bleeding and reduce contraceptive effect Laktineta.
These drugs are derivatives hydantoin :
- phenytoin ;
- carbamazepine ;
- topiramate ;
- grizeofulfin ;
- rifabutin ;
- barbiturates ;
- primidone, oxcarbazepine .
In the case of having to go through a course of treatment with these drugs is recommended that women receiving supplement birth control pills the use of additional funds Contraception throughout the course of treatment and for seven days thereafter. After termination rifampicin use barrier contraceptives It recommended for a further 28 days.
The contraceptive effect Laktineta reduced by the simultaneous use of the background to it antibiotics As well as in the treatment of charcoal and similar to it in its action drugs.
Upon receiving Activated Carbon or an analogue thereof should be guided by the recommendations for dosage of the drug in the pass taking the pill.
Terms of sale
Laktinet belongs to the class of prescription drugs.
Storage conditions
The drug should be stored in its original packaging at a temperature not exceeding 25 ° C.
Shelf life
Usable for 3 years.
Analogs
Charozetta
Postinor
Analogs Laktineta - a drug Charozetta and Desogestrel .
Application Laktinet breastfeeding and pregnancy
Laktineta use by pregnant women is prohibited. This is due to the results of pre-clinical studies showing that high doses progestogens (one of which is the active ingredient of the drug) contribute to excessive masculinization female fetuses.
As for epidemiological studies , They found no increased risk of birth defects in the child and any disorders embryogenesis in newborn babies whose mothers took contraceptives before pregnancy, or - inadvertently - in the first week after its onset.
The received breastfeeding Laktinet no effect on the amount of breast milk in women, and its quality indicators. But desogestrel It has the ability in small quantities in milk.
Observations of lactating women using breastfeeding Laktinet to prevent pregnancy, confirmed that desogestrel It does not cause any disturbance of growth and development (both physical and mental).
However, for safety reasons we recommend careful observation of the child by a qualified pediatrician.
Reviews Laktinete
Reviews of doctors about the drug - positive. Most experts say that with proper selection, taking into account all of the recommendations in the instructions and contraindications to the appointment, it does not cause any serious side effects, even in the case of prolonged use.
Another strong argument in favor of the appointment - this is what the pill Laktinet fit lactating mothers, as well as those who are contraindicated combined oral contraceptives .
Reviews Laktinete at HS indicate that the drug does not affect the flavor and other qualities of milk and is considered safe for the health of the baby.
Reviews also left women taking it contraceptive More controversial. Many of them were satisfied with the pills, emphasizing ease of use and lack of side effects.
But along with this there are also negative comments, which says that after taking the drug changed menstrual cycle ( bleeding become more frequent and copious, or disappeared altogether), began more intensively fall hair , and increased weight .
Some refer to the shortcomings of the drug and its relatively high cost.
In the pharmaceutical market in Russia and Ukraine is a drug analogue Laktineta Charozetta Which is manufactured by ORGANON NV (Netherlands). Trying to decide which is better - Charozetta or Laktinet - should be borne in mind that in its properties, indications and composition, they are virtually identical, and the only significant difference is the price (a little bit cheaper Laktinet its equivalent).
Price Laktineta
Average price Laktineta in Russia is 750 rubles per pack of 28 tablets. In the Ukrainian pharmacies, it is sold in an average of 135 hryvnia.
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