Postinor tablets 0.75mg №2×1

Name:
Postinor tabl 0.75mg in bl. in pack. No. 2×1 Main active ingredient Levonorgestrel Release form tablets Composition Each tablet contains: Active ingredient: levonorgestrel – 0.75 mg Excipients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate (71.25 mg).
Description:
Round, flat, off-white, bevelled tablets, marked “INOR?” on one side. Dosage 0.75 mg Pharmacological properties Pharmacodynamics The exact mechanism of action of POSTINOR is unknown. When used at recommended doses, the effect of levonorgestrel is presumably mediated by preventing ovulation and fertilization if intercourse occurs in the preovulatory phase, when the likelihood of fertilization is highest. In addition, it can cause changes in the endometrium that prevent the implantation of a fertilized egg. The drug is ineffective if the implantation process has already begun. Efficacy: In a previous clinical study, levonorgestrel 750 mcg (as two doses of 750 mcg taken 12 hours apart) prevented 85% of expected pregnancies. Apparently, the effectiveness of the drug decreases over time after sexual contact (95% within 24 hours, 85% – when used from 24 to 48 hours, 58% – when used in the interval from 48 to 72 hours). Two levonorgestrel 750 mcg tablets taken at the same time (within 72 hours of unprotected intercourse) prevented 84% of expected pregnancies in a previous clinical study. There are no differences in the frequency of pregnancy in women who took the drug on the third or fourth day after unprotected intercourse (p> 0.2). There are limited data, requiring further confirmation, on the effect of overweight/high body mass index (BMI) on contraceptive efficacy. Three studies from the World Health Organization (WHO) showed no trend towards decreasing efficacy with increasing body weight/BMI (see Table 1), while 2 others (Creinin et al., 2006 and Glasier et al., 2010 ) there was a decrease in efficacy with increasing body weight/BMI (see Table 2). Both meta-analyses were conducted excluding cases of taking the drug later than 72 hours after unprotected intercourse (off-label use) and women who had unprotected intercourse after taking the drug. Table 1 Meta-analysis of three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) BMI (kg/m2) Low weight women 0-18.5 Normal weight women 18.5- 25 Overweight women 25-30 Obese women ? 30 Total number 600 3952 1051 256 Number of pregnancies 11 39 6 3 Pregnancy rate 1.83% 0.99% 0.57% 1.17% Confidence interval 0.92 – 3.26 0.70-1.35 0.21 – 1.24 0.24 – 3.39 Table 2. Meta-analysis of studies Creinin et al., 2006, and Glasier et al., 2010 BMI (kg/m2) Women with low weight 0-18.5 Women with normal weight 18.5-25 Overweight women 25-30 Obese women ? 30 Total number 64,933 339,212 Number of pregnancies 1 9 8 11 Pregnancy rate 1.56% 0.96% 2.36% 5.19% Confidence interval 0.04 – 8.40 0.44-1.82 1.02 -4.60 2.62 – 9.09 With the recommended dosing regimen, levonorgestrel does not have a significant effect on blood coagulation factors, lipid and carbohydrate metabolism. Pediatric Population A prospective observational study showed that of 305 cases of emergency contraceptive use of levonorgestrel tablets, seven women became pregnant. Thus, the overall failure rate was 2.3%. The failure rate for women under 18 (2.6% or 4/153) was comparable to the failure rate for women 18 and older (2.0% or 3/152). Pharmacokinetics After oral administration, levonorgestrel is rapidly and almost completely absorbed. After taking 1.5 mg of levonorgestrel, the maximum serum concentration is 18.5 ng / ml and is reached after 2 hours. After reaching the maximum concentration of levonorgestrel decreases, and the average elimination half-life is about 26 hours. Levonorgestrel is excreted as metabolites and is not excreted unchanged. Metabolites of levonorgestrel are excreted in the urine and feces in approximately the same proportions. Biotransformation occurs in accordance with the known mechanisms of steroid metabolism: levonorgestrel is hydroxylated in the liver, and its metabolites are excreted in the form of glucuronide conjugates. Pharmacologically active metabolites of the drug are unknown. Levonorgestrel binds to serum albumin and sex hormone-binding globulin (SHBG). Only about 1.5% of the total serum concentration is present as a free steroid, 65% specifically binds to SHBG. The absolute bioavailability of levonorgestrel is almost 100% of the administered dose. About 0.1% of the dose of the drug administered to the mother, can come with breast milk to the child. Indications for use Emergency contraception within 72 hours after unprotected intercourse or if the contraceptive method used was unreliable. Contraindications Hypersensitivity to the active substance (levonorgestrel) or any of the auxiliary ingredients listed in the “Composition” section. Use during pregnancy and lactation Pregnancy Pregnant women should not use POSTINOR. It will not cause an abortion. According to limited epidemiological data, in the case of a developing pregnancy, the drug does not have an undesirable effect on the fetus. At the same time, there are no clinical data on the possible consequences of taking levonorgestrel in doses above 1.5 mg. Breastfeeding Levonorgestrel is excreted in breast milk. The potential exposure of the nursing infant to levonorgestrel can be reduced if a nursing woman takes the tablets immediately after feeding, avoiding feeding after each dose of POSTINOR. Fertility Levonorgestrel increases the possibility of menstrual irregularities, which in some cases leads to earlier or later ovulation. These changes may affect the dates of the fertile period, but there are no long-term fertility data on long-term follow-up. Dosing and Administration Dosing Two tablets should be taken. Both tablets should be taken as soon as possible, preferably within the first 12 hours and no later than 72 hours after unprotected intercourse (see Pharmacodynamics section). If vomiting occurs within three hours after taking any of the tablets, another 2 tablets should be taken immediately. For women who have been taking microsomal liver enzyme inducers for the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraceptives, such as a copper-containing intrauterine device (IUD) or a double dose of levonorgestrel (for example, 4 tablets once) is recommended. women who are unable or unwilling to use a copper-containing IUD (see section Interaction with other medicinal products). POSTINOR can be used in any phase of the menstrual cycle, provided there is no delay in menstrual bleeding. After using emergency contraception, it is recommended to use a local barrier method (condoms, cervical cap) until the next menstruation. The use of POSTINOR is not a contraindication for continuing regular hormonal contraception. Use in children Levonorgestrel is not recommended for use in children. Very limited data are available for use in young women under 16 years of age. POSTINOR is not intended for use in adolescents for emergency contraception. Method of application For oral administration. Side effects Side effects The most common side effect was nausea. Organ system class according to MedDRA 16.0 Frequency of adverse reactions Very common (? 10%) Common (? 1% to < 10%) Nervous system disorders Headache Dizziness Gastrointestinal disorders Nausea Pain in the lower abdomen Diarrhea Vomiting Reproductive system and breast disorders Non-menstrual bleeding Delayed menses more than 7 days Irregular menstruation Breast engorgement Systemic disorders and injection site complications Fatigue 5-7 days from the expected date. If the onset of the next menstruation is more than 5 days late, pregnancy should be excluded. The following adverse reactions have been reported in post-marketing surveillance: Gastrointestinal disorders Very rare (<1/10,000): abdominal pain. Skin and subcutaneous tissue disorders Very rare (<1/10,000): skin rash, urticaria. Reproductive system and breast disorders Very rare (<1/10,000): pelvic pain, dysmenorrhea. Systemic disorders and complications at the injection site Very rare (<1/10000): swelling of the face. Overdose No serious adverse effects have been reported following acute overdose with large doses of oral contraceptives. Overdose may cause nausea and breakthrough bleeding. There are no specific antidotes, treatment should be symptomatic. Interaction with other drugs The metabolism of levonorgestrel is activated with the simultaneous use of drugs that are inducers of hepatic enzymes, mainly inducers of the CYP3A4 enzyme system. With simultaneous use with efavirenz, a decrease in plasma levels of levonorgestrel (AUC) by approximately 50% was found. Medicinal products that appear to have a similar ability to lower plasma levels of levonorgestrel include barbiturates (including primidone), phenytoin, carbamazepine, herbal preparations containing St. John's wort (Hypericum perforatum), rifampicin, ritonavir, rifabutin, and griseofulvin. Women receiving these drugs should seek advice from their doctor. In women who have been taking microsomal liver enzyme inducers within the past 4 weeks and require emergency contraception, the use of non-hormonal emergency contraceptives (eg, a copper-containing IUD) should be considered. Taking a double dose of levonorgestrel (eg, levonorgestrel 3000 mcg within 72 hours of unprotected intercourse) is an option for those women who are unable or unwilling to use a copper-containing IUD, although this specific combination (double dose of levonorgestrel during use of microsomal inducers liver enzymes) has not been studied. Medicinal products containing levonorgestrel may cause an increase in the toxicity of cyclosporine due to the possible inhibition of the metabolism of cyclosporine. Precautions Emergency contraception is a method that can be used occasionally. It should not replace a regular contraceptive method. Emergency contraception does not prevent pregnancy in all cases. If there is doubt about the timing of unprotected intercourse, or if unprotected intercourse occurred earlier than 72 hours ago during the same menstrual cycle, there is a possibility that conception has already occurred. In this regard, the use of POSTINOR during the second sexual intercourse may be ineffective in preventing pregnancy. If the menstrual cycle is delayed by more than 5 days, or if there is unusual bleeding on the day of the expected period, or if there is other reason to suspect pregnancy, pregnancy should be excluded. If pregnancy occurs after the use of POSTINOR, the possibility of an ectopic pregnancy should be considered. The absolute risk of ectopic pregnancy appears to be low because levonorgestrel prevents ovulation and fertilization. Ectopic pregnancy can develop despite the appearance of uterine bleeding. In this regard, levonorgestrel should be used with increased caution in the presence of risk factors for ectopic pregnancy (salpingitis or history of ectopic pregnancy). The use of POSTINOR is not recommended in patients with severe hepatic impairment. The effectiveness of POSTINOR may be adversely affected by severe malabsorption syndromes, such as Crohn's disease. Women suffering from these conditions should consult a doctor if emergency contraception is needed. After taking the drug POSTINOR, menstruation usually passes normally and comes on time. Sometimes menstruation can start a few days earlier or later. Women should be advised to visit a doctor in order to select and start using one of the methods of regular contraception. If withdrawal bleeding does not occur in the next period without pills after using POSTINOR and after using regular hormonal contraception, pregnancy should be excluded. Repeated use of the drug during one menstrual cycle is not recommended due to the possibility of a violation of the cycle. There are limited data requiring further confirmation that the contraceptive efficacy of POSTINOR may decrease with an increase in body weight or body mass index (BMI) (see Pharmacodynamics section). For all women, regardless of their body weight and BMI, emergency contraception should be taken as soon as possible after unprotected intercourse. POSTINOR is not effective as a standard regular method of contraception and can only be used as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to use long-term methods of contraception. The use of emergency contraception does not replace the necessary precautions related to protection against sexually transmitted diseases. This medicine contains lactose monohydrate. Patients with congenital intolerance to galactose or lactose or malabsorption syndrome of glucose and galactose are not recommended to take the drug. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. Buy Postinor tablets 0.75 mg No. 2x1 Price for Postinor tablets 0.75 mg No. 2x1