Implanon NKST - Instructions For The Use Of A Contraceptive, Reviews, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Implanon NKST

Implanon NKST: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Implanon NXT

ATX code: G03AC08

Active ingredient: Etonogestrel (Etonogestrel)

Producer: NV ORGANON (Netherlands)

Description and photo update: 18.10.2018

Prices in pharmacies: from 11008 rubles.

Buy

Implanon NKST is a long-term contraceptive drug.

Release form and composition

Dosage form of Implanon NKST - implant: single-rod, from white with brownish or yellowish tinge to white, placed in the needle of a sterile disposable applicator, from which it should be easily removed; implant length - 3800–4200 mm, diameter - 1.95–2.05 mm, shell thickness - 0.054–0.066 mm (1 implant in a stainless steel needle of a ready-to-use sterile disposable applicator in blisters, in a cardboard box 1 applicator complete with 2 ambulatory card stickers and patient card).

Composition of 1 implant:

• active substance: etonogestrel - 68 mg;
• auxiliary components: barium sulfate - 15 mg; magnesium stearate - 0.1 mg; 14% and 28% vinyl acetate (copolymer of ethylene and vinyl acetate) - 15 and 43 mg (respectively).

Pharmacological properties

Pharmacodynamics

Implanon NKST is an implant for subcutaneous use containing etonogestrel, placed in a sterile disposable applicator, radiopaque, non-biodegradable.

Etonogestrel is a biologically active metabolite of desogestrel, a progestogen, which is widely used as an oral contraceptive hormonal agent.

Basically, the contraceptive effect is achieved by suppressing ovulation. During the first two years of use, ovulation is not observed, and only rarely does it occur during the third year. In addition, etonogestrel causes an increase in the viscosity of the cervical secretion, which interferes with the passage of sperm. Clinical effects are confirmed by studies in women aged 18–40 years.

The contraceptive effect of Implanon NKST is reversible, which is reflected in the rapid restoration of a normal ovulatory menstrual cycle after its removal. Despite the suppression of ovulation, the activity of the ovaries is not completely suppressed. Average plasma concentrations of estradiol in the blood remain above the value that is observed in the early phase of follicle formation.

Etonogestrel has no effect on lipid metabolism and changes in bone mineral density.

Pharmacokinetics

• absorption: etonogestrel is rapidly absorbed into the circulating blood. Ovulation-suppressing concentrations are usually achieved after 1 day, maximum (472-1270 pg / ml) - after 1-13 days. The rate of release of etonogestrel from the implant gradually decreases, with the result that its plasma concentration rapidly decreases during the first few months after administration. The average concentration by the end of the first year of use is approximately 200 pg / ml, and by the end of the third year it slowly decreases to 156 pg / ml;
• distribution: etonogestrel binds to plasma proteins by 95.5–99%; binding occurs mainly with albumin, to a lesser extent with globulin that binds sex hormones. The distribution volume of the total and in the central chamber is 220 l and 27 l, respectively;
• metabolism: etonogestrel undergoes hydroxylation and reduction; metabolites - glucuronides and sulfates;
• Elimination: the average elimination half-life for intravenous etonogestrel is approximately 25 hours, and plasma clearance is 7.5 l / h (these indicators do not change over time); etonogestrel and its metabolites in the form of free steroids and conjugates are excreted through the intestine and by the kidneys (ratio 1: 1.5).

Indications for use

Implanon NKST is prescribed for contraception (safety / efficacy has been confirmed in women 18–40 years of age).

Contraindications

Absolute:

• thrombosis (venous / arterial) and thromboembolism at the present time or the presence of a burdened history (including myocardial infarction, thrombosis, deep vein thrombophlebitis, pulmonary embolism, hemorrhagic / ischemic cerebrovascular disorders);
• the presence of antibodies to phospholipids;
• migraine, accompanied by focal neurological symptoms;
• breast cancer, including a burdened history;
• malignant hormone-dependent tumors (diagnosed / suspected);
• liver tumors (benign / malignant) at the present time or the presence of a burdened history;
• uncontrolled arterial hypertension;
• liver disease in severe course (while liver function tests are not normalized), including jaundice, congenital hyperbilirubinemia, including a burdened history;
• bleeding from the vagina of unknown etiology;
• pregnancy, including prospective;
• age up to 18 years;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in the presence of which the appointment of Implanon NKST requires caution):

• conditions preceding thrombosis, including transient ischemic attacks, angina pectoris, complicated lesions of the valvular apparatus of the heart, atrial fibrillation, extensive trauma;
• predisposition to arterial thrombosis (hereditary / acquired) including deficiency of antithrombin III, protein C and S;
• diabetes mellitus with / without diabetic angiopathy;
• combined use with anticoagulants;
• mild / moderate liver disease with normal liver function tests;
• chloasma, including a burdened history;
• severe depression.

Instructions for the use of Implanon NKST: method and dosage

Before using Implanon NKST, pregnancy must be ruled out.

Before inserting an implant, the recommendations for insertion and removal of the implant should be carefully reviewed.

Implanon NKST is a long-acting hormonal contraceptive. You can remove it at any time, but no later than 3 years from the date of introduction. Earlier removal is possible in overweight women. If a new one is introduced immediately after removal of the drug, contraceptive protection will not decrease.

Implanon NKST is injected subcutaneously, directly under the skin on the inner side of the shoulder, thus avoiding injury to the nerves and large blood vessels.

Immediately after insertion, it is necessary to palpate the presence of the implant under the skin. If you cannot find the implant, or there are doubts about its presence under the skin, other diagnostic methods should be used to confirm its presence. Until this point, the woman is recommended to use a non-hormonal (barrier) method of contraception.

Features of the beginning of the use of Implanon NKST:

• no use of contraceptive hormonal drugs in the previous month: the drug can be administered within 1–5 days of the menstrual cycle, even if menstrual bleeding has not yet ended, the use of additional methods of contraception is not required;
• switching from a combined hormonal method of contraception: Implanon NKST is preferably administered on the day following the day of taking the last active pill, but not later than the day that follows the usual interval for taking pills, or the period during which placebo pills were taken. In cases where a transdermal patch or vaginal ring was previously used, it is advisable to insert the implant on the day of removal, but not later than the day of the next application of the previous drug;
• switching from a progestogenic method of contraception: injectable hormonal contraceptives - Implanon NKST must be administered on the day when the next injection is to be given; progestogen-only tablets - the transition can be made any day, provided that the implant is inserted within 24 hours after taking the last tablet; implant / intrauterine device - the implant must be inserted on the day of removal of the previous implant / intrauterine device;
• use after miscarriage or abortion: in the first trimester - Implanon NKST is administered within 5 days after an abortion / miscarriage, in the second trimester - between 21 and 28 days;
• application after childbirth: for breastfeeding - the implant is inserted at the end of the fourth week after childbirth; in the absence of breastfeeding - between 21 and 28 days after birth.

If the recommendations are followed, additional methods of contraception are not required; if deviating from them, the woman must observe barrier methods of contraception for 7 days. In cases where during this period there was sexual contact, pregnancy must be excluded.

Implanon NKST should be injected directly under the skin. Incorrect or too deep implant insertion can be complicated by paresthesia, implant migration, and in rare cases, intravascular insertion. If inserted too deep, the implant may not be palpable, which can lead to difficulties in determining its location and removal.

It is necessary to inject Implanon NKST under aseptic conditions using a special applicator. The introduction should only be carried out by a qualified gynecologist. It is recommended that during the entire procedure the doctor is in a sitting position so that he can clearly see the injection site and movement under the skin of the needle.

The exact location of the implant must be determined by the gynecologist prior to the procedure for removing the implant. In cases where the implant is not palpable, it may need to be surgically removed under ultrasound guidance. Removal of deeply inserted implants must be carried out with care to avoid damage to the deep vascular or nerve structures of the shoulder.

Implanon NKST can be replaced immediately after removal of the previous implant. A new implant can be inserted at the same site and through the same incision from which the previous one was removed.

Side effects

During the period of use of the contraceptive Implanon NKST, the nature of menstrual bleeding may change, which manifests itself as a change in their frequency (absence, more / less frequent), intensity (increase / decrease) or duration of bleeding. In 20% of cases, there was an absence of menstrual bleeding, with the same frequency - more frequent and / or prolonged bleeding. Severe bleeding has been reported occasionally. Changes in the nature of vaginal bleeding is the most common reason for discontinuing the use of Implanon NKST (approximately 11%). Painful menstrual spotting tends to improve during therapy. The nature of the bleeding that occurs during the first 3 months of use,in most cases allows predicting the future pattern of bleeding.

Possible side effects (> 10% - very common;> 1% and 0.1% and <1% - infrequently):

• immune system: infrequently - hypersensitivity to any component of the drug;
• digestive system: often - nausea, abdominal pain, bloating; infrequently - constipation, vomiting, diarrhea;
• nervous system: very often - headache; often - dizziness; infrequently - drowsiness, migraine;
• musculoskeletal and connective tissue: infrequently - back pain, myalgia, arthralgia, musculoskeletal pain;
• parasitic / infectious diseases: very often - vaginal infections; infrequently - rhinitis, pharyngitis, urinary tract infections (cystitis, urethritis);
• nutrition and metabolism: often - increased appetite;
• vessels: often - hot flashes;
• psyche: often - nervousness, depression, emotional lability, decreased libido, insomnia, anxiety;
• skin and subcutaneous tissue: very often - acne; often - alopecia; infrequently - rash, hypertrichosis, itching;
• genitals and mammary gland: very often - chest pain, soreness in the mammary glands, irregular menstruation; often - ovarian cyst, dysmenorrhea; infrequently - an increase in the mammary glands, discomfort / itching in the vagina and vulva, vaginal discharge, galactorrhea;
• kidneys and urinary tract: infrequently - dysuria;
• instrumental / laboratory data: very often - an increase in body weight; often - a decrease in body weight;
• general disorders: often - pain / reaction at the location of the implant, flu-like condition, fatigue; infrequently - edema, hyperthermia.

Additionally, local reactions were studied, which were noted in 8.6% of cases. The most common are erythema, local edema, hematomas, pain, and bruising.

During post-registration observations, such adverse reactions were noted as a clinically significant increase in blood pressure, seborrhea, anaphylactic reactions, angioedema and urticaria; when inserting / removing an implant - bruising, minor local irritation, itching or pain; at the site of the incision - fibrosis, scar formation or the development of an abscess; possibly - paresthesia or similar phenomena, migration or loss of the implant, surgery when removing the implant.

There are rare reports of the development of an ectopic pregnancy.

Women using contraceptive hormonal drugs had the following serious violations:

• arterial thromboembolism;
• venous thromboembolism;
• chloasma;
• hormone-dependent tumors;
• pruritus / jaundice associated with cholestasis;
• porphyria;
• cholelithiasis;
• hemolytic uremic syndrome;
• systemic lupus erythematosus;
• chorea;
• hearing loss associated with otosclerosis;
• herpes during pregnancy.

Overdose

Before inserting a new implant, the previous one must always be removed. There is no evidence of an overdose of etonogestrel. In general, there are no data on serious side effects as a result of an overdose of Implanon NKST.

special instructions

Generally, the risk of developing breast cancer increases with age. The diagnosed cases in women using Implanon NKST tend to be less clinically apparent than in women who have never used hormonal contraceptives. The increased risk may be due to earlier diagnosis, the biological effects of the drug, or a combination of these factors.

When acute or exacerbation of chronic liver disease occurs, medical advice is required.

In the course of conducting epidemiological studies, it was found that there is a relationship between the use of Implanon NKST and an increase in the incidence of venous thromboembolism. In cases of thrombosis, the implant is removed. Another reason that may require removal of the drug is prolonged immobilization associated with surgery or illness. For women with a history of thromboembolic diseases, before starting the use of the drug, it is necessary to correlate the expected benefit with the possible risk of relapse.

If during the use of Implanon NKST persistent hypertension occurs, or significantly increased blood pressure in response to antihypertensive therapy is not adequately reduced, the implant is removed.

Despite the fact that progestogens can affect glucose tolerance and insulin resistance of peripheral tissues, there is no confirmation that it is necessary to adjust the regimen in patients with diabetes mellitus who use hormonal contraceptives containing only progestogen. Nevertheless, the condition of women with diabetes mellitus requires careful monitoring throughout the entire period of therapy.

Periodic examinations should be carried out for women who are being treated for hyperlipidemia (associated with the likelihood of an increase in low-density lipoprotein levels and worsening control of hyperlipidemia).

Chloasma can sometimes develop, especially in women with a history of aggravated disease. If you have a predisposition to chloasma, it is recommended to avoid exposure to sunlight or UV radiation.

It cannot be ruled out that in overweight women, the contraceptive effect during the third year of using Implanon NKST may be reduced, which may require an earlier replacement of the implant.

If the drug is injected incorrectly, expulsion of the implant is possible.

During the period of application of Implanon NKST, follicle growth can be observed, in some cases the follicle can reach a larger size than in the normal cycle. These follicles tend to disappear spontaneously and are often asymptomatic; in some cases, there may be mild lower abdominal pain. In rare cases, surgery is required.

Rarely, the implant may migrate from the insertion site. In such a situation, it can be difficult to locate and remove it.

In cases where a woman has amenorrhea or abdominal pain, an ectopic pregnancy should be taken into account when conducting differential diagnosis.

There are reports of the following conditions, which occurred both with the use of sex steroid hormones (the connection with the use of progestogens has not been established), and during pregnancy: the formation of gallstones, associated with otosclerosis, hearing loss, herpes during pregnancy, associated with cholestasis itching / jaundice, porphyria, hemolytic uremic syndrome, systemic lupus erythematosus, Sydenham's chorea, (hereditary) angioedema.

Before using / before replacing Implanon NKST, you must carefully study the patient's history (including family) and exclude pregnancy. Blood pressure should be measured and a physical examination performed.

After 3 months of therapy, the woman is recommended to undergo a medical examination, including the study of the undesirable effects, questions and complaints that have appeared. Based on the tolerability of the drug, the doctor will determine the nature and frequency of further periodic medical examinations (but at least once every six months).

It must be taken into account that Implanon NKST does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

The effectiveness of therapy in combination with other drugs may be reduced.

During the use of the drug, a change in the nature of menstrual bleeding is possible. Evaluation of vaginal bleeding should be done individually. It may include examination to rule out pregnancy or gynecological pathologies.

The use of the contraceptive Implanon NKST can affect some laboratory parameters, including biochemical parameters of thyroid, liver, kidney and adrenal gland function, concentration of (transport) proteins in plasma, including parameters of carbohydrate metabolism, corticosteroid-binding globulin and lipid / lipoprotein fractions, blood clotting and fibrinolysis. Typically, these changes do not exceed the normal range.

Influence on the ability to drive vehicles and complex mechanisms

The effect of Implanon NKST on the ability to drive vehicles has not been studied. Patients should take into account the likelihood of dizziness occurring.

Application during pregnancy and lactation

Pregnancy is a contraindication to the use of Implanon NKST. If pregnancy is suspected / confirmed, the implant should be removed. When conducting preclinical studies, it was found that very high doses of progestogenic compounds can lead to masculinization of female fetuses. The available data on the effect of Implanon NKST on the fetus and pregnant woman is insufficient.

Implanon NKST can be used during breastfeeding under the supervision of a doctor for the growth and development of the child. You can start therapy from the fifth week after childbirth.

Pediatric use

According to the instructions, Implanon NKST should not be prescribed to patients under 18 years of age, which is due to the lack of data confirming the efficacy / safety of the drug in this group of patients.

Drug interactions

The interaction of Implanon NKST is possible with drugs - inducers of liver microsomal enzymes, including the following drugs: cytochrome P ₄₅₀ isoenzymes(eg phenobarbital, phenytoin, primidone, carbamazepine, bosentan, rifampicin) and possibly oxcarbazepine, topiramate, felbamate, griseofulvin, herbal preparations containing St. reverse transcriptase inhibitors (eg efavirenz, nevirapine); and combinations of the latter. As a result of combined use, an increase in the clearance of sex hormones is possible. If it is necessary to carry out combined therapy during their use and within 28 days after the termination of their intake, it is necessary to additionally apply a barrier method of contraception.

Women who receive long-term treatment with drugs that induce liver microsomal enzymes are advised to remove the implant and use a non-hormonal method of contraception.

Certain drugs (such as ketoconazole) that inhibit liver microsomal enzymes (such as CYP3A4) can increase plasma hormone concentrations.

With the simultaneous appointment of Implanon NKST with other drugs, it is necessary to take into account the likelihood of their interaction, including a decrease / increase in their plasma concentrations. There have been no specific studies examining interactions.

Analogs

Implanon NKST analogs are: Evadir 2, Protinor, Depo-Provera, Charosetta, Laktinet, Eskapel.

Terms and conditions of storage

Store in a place protected from light and moisture at a temperature of 2-30 ° C. Keep out of the reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Implanon NKST

Reviews of Implanon NKST, as a rule, characterize the drug as effective and convenient to use. The possibility of using it during breastfeeding is also emphasized. Of the side effects, a change in the nature of vaginal discharge is most often noted.

Price for Implanon NKST in pharmacies

The price of Implanon NKST (1 implant) can vary from 10,500 to 11,900 rubles.

Implanon NKST: prices in online pharmacies

Drug name Price Pharmacy

Implanon NKST 68 mg 1 pc. RUB 11008 Buy

Implanon NKST implant 68mg RUB 11,623 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!