Xulane is a transdermal patch which contains a combination of hormones, ethinyl estradiol and norelgestromin, that are used to prevent pregnancy.
Indications for use
The drug is used for the purpose of contraception (prevention of unwanted pregnancy).
Xulane is a thin patch with a contact surface area which consists of three layers. The protective layer consists of a beige elastic film consisting of an outer layer of colored low-density polyethylene and a polyester inner layer. It provides structural support and protects the middle adhesive layer from external influences. The middle layer contains hormones, norelgestromin and ethinyl estradiol, which are the active substance of the patch. Polyisobutylene/polybutylene adhesive, crospovidone, non-woven polyester material, and lauryl acetate act as non-active components. The third layer is a removable film that protects the adhesive layer during storage and is removed immediately before attaching the patch. This transparent polyethylene terephthalate film has a polydimethylsiloxane coating on the side in contact with the middle adhesive layer.
The transdermal patch daily delivers 150 mcg of norelgestromin and 20 mcg of ethinylestradiol into the bloodstream.
Mechanism of action
Xulane depresses the gonadotropic function of the pituitary gland, suppresses the development of the follicle and prevents the process of ovulation. The contraceptive effect is enhanced by increasing the viscosity of cervical mucus and reducing the motility when passing through the fallopian tubes. The Pearl Index is 0.90.
The frequency of pregnancy increases in women with a body weight of more than 90 kg.
How to use a contraceptive patch?
The patch is easily controlled by a woman, the use and withdrawal of contraception do not require the participation of a doctor. To achieve the maximum contraceptive effect, it is necessary to strictly follow Xulane instructions for use.
The first patch should be glued on the first day of the period (the first day of the menstruation). Under this condition, you will not need additional contraception. If you glue it later, you’ll have to wait 7 days before the patch starts working.
You need to know the exact date and day of the week when the sticking occurred since the next patch will need to be stuck exactly seven days after it.
You should glue the patch to clean, dry skin and avoid using creams in this place.
In different life circumstances, the way of application and dose of Xulane drug can vary.
If you did not use hormonal contraceptives during the previous menstrual period:
- The patch is att6ached to the skin on the first day of the menstrual period. The transdermal system is held for a week. The day of the week when the first patch is glued will be basic, the subsequent patches will be changed on the same day (“change day”) but a week later (the days 8 and 15 of the period);
- Remove the patch on the day 22. Have a rest for a week (until the day 28).
If you used combined oral contraceptives during the previous menstrual period:
- The patch is attached on the first day of the menstrual period, which follows the completed course of oral intake of combined contraception;
- If five days have passed and the menstruation has not started, you’d better do a pregnancy test. Only after receiving a negative result, you can start using a transdermal Xulane system;
- If the patch was first attached after the first day of the period, it is necessary to use barrier methods of contraception for a week.
If you used progestogen-only medications during the previous menstrual period:
- In this case, a woman can switch to the transdermal system any day after the use of the previous contraceptive is completed;
- It is necessary to fulfill one condition: the patch should be attached immediately after the withdrawal of the previous drug. It is necessary to use additional barrier contraception for the next seven days.
Switching to Xulane after abortion or miscarriage:
- If an abortion or miscarriage occurred at a time when the pregnancy did not reach the week 20, the transdermal system can be started immediately after this unpleasant procedure. In this case, it is not necessary to use additional birth control methods. A new conception can occur only after the expiration of ten days after miscarriage or abortion;
- If the pregnancy was interrupted after the 20th week, the contraceptive patch may be used from the day 21 after the unpleasant procedure or on the first day of a new menstrual period.
Switching to Xulane after delivery:
- If a woman does not feed a newborn baby with breast milk, it is possible to begin using the transdermal system four weeks after the delivery;
- If you attach the patch later than the agreed period, you should use additional contraception (barrier method) for a week;
- If a woman had a sexual intercourse during this period, before using the patch it is necessary to exclude pregnancy or to wait for the next menstruation.
If the contraceptive patch partially or completely detached:
- This situation indicates that fewer necessary hormones were released to the woman’s body;
- Even a partial detachment of the drug for 24 hours can significantly spoil the expected result. Therefore, you need to change the patch as early as possible by gluing a new one (to this same place). There are no other supporting methods required;
- The subsequent change of Xulane is carried out in the “change day” which was determined earlier;
- If a complete or partial detachment of the transdermal system was observed for more than 24 hours, then the probability of pregnancy is high;
- In this situation, it is necessary to do a pregnancy test. If the result is negative, start using the drug from scratch, considering this application as the first day of the contraceptive period and, accordingly, there is a change in the “change day”;
- You should use additional contraceptive methods for a week;
- If the patch has lost its stickiness, do not try to attach it again to the skin. Do not use an ordinary sticky tape or a bandage to improve the fixation.
Correction of the “change day”:
If you need to shift menstrual bleeding for one period, it is necessary to use a new patch, which is attached on the day 22. This will delay the breakthrough bleeding. In this situation, a woman may have spotting in the intervals between menstruations.
It is not recommended to use the patch for more than six weeks in a row. You should have a break in the application of the drug for a week. After seven days, you can start using Xulane again.
You can change the “change day” in a hormone-free period by attaching the first patch on the skin. At the same time, you should not forget that the period between the removal of the third patch of the previous period and the attachment of a new one (with a “change day” correction) should not exceed seven days.
What if you forget to change your birth control patch?
If you forgot to change the transdermal system after the first week of use and have detained him for more than a day, you should change it and start counting from the new “change day”. In this case, you need to use additional birth control methods for 7 days.
If you forgot to change the contraceptive patch in the second or third week and the delay did not exceed two days, simply attach a new one. A new patch is attached according to your usual schedule.
Xulane transdermal patch is considered a strong systemic drug which can cause side effects:
Peripheral and central nervous system:
- partial loss of sensitivity of the upper or lower extremities;
- tremor and convulsions;
- emotional stress: depressive states, irritability;
- problems with sleep.
- urinary tract infection;
- dyspareunia is a painful coitus;
- vaginitis – inflammation of the vaginal mucosa, provoked by pathogenic microorganisms;
- mastitis – an inflammation of the tissues of the mammary glands;
- decreased sexual desire;
- dysmenorrhea – a pain symptomatology in the abdominal area associated with uterine spasms during menstruation;
- breast enlargement;
- disorders of menstrual periods, bloody discharge between menstruations, hypermenorrhoea;
- fibroadenoma of the mammary glands;
- violation of the production of cervical mucus and breast milk, not associated with obstetric care;
- ovarian failure, polycystosis.
- gingivitis – inflammation of the mucous membrane of the gums;
- increased appetite or lack of appetite;
- pain in the abdomen;
- gastritis and gastroenteritis (acute or chronic inflammation in the wall of the stomach and small intestine);
- dyspepsia (flatulence, diarrhea, or, conversely, constipation and vomiting);
- hemorrhoids – inflammation and enlargement of internal venous nodes of the rectum plexus.
- attacks of asthma;
- shortness of breath;
- infection with ENT organs.
- varicose veins;
- increased blood pressure;
- allergic reactions: itching, rashes, hives;
- increased skin dryness;
- contact dermatitis;
- photosensitivity – an increase in the sensitivity of the body to ultraviolet radiation;
- change in the shade of the epidermis;
- increased sweating;
- alopecia – a pathological hair loss.
- tendonosis – changes in the parameters of tendons;
- arthralgia – pain in the affected joint;
- muscle cramps and a decrease in their tone;
- ostalgia – a pain in the spine and legs;
- myalgia – pain in the muscles.
- weight gain;
- hypercholesterolemia – increased cholesterol levels in the blood;
- hypertriglyceridemia – increased triglycerides in the blood plasma on an empty stomach.
- decreased general tone, a constant sense of fatigue;
- thrombophlebitis of superficial veins;
- pain symptomatology in the chest;
- flu-analgesic manifestations;
- asthenic syndrome;
- conjunctivitis, eyesight problems;
- lymphadenopathy -an increase in the lymph nodes of the lymphatic system;
- alcohol intolerance;
- embolism of the pulmonary artery.
Xulane patch is contraindicated for use in the following cases:
- thrombosis and thromboembolism (arterial thrombosis, venous thrombosis, deep vein thrombosis, pulmonary thromboembolism, including in the anamnesis);
- coagulopathy with a tendency to thrombosis;
- hereditary predisposition to thrombosis;
- severe cardiovascular diseases: angina, severe hypertension, myocardial infarction (including in the anamnesis);
- cerebrovascular diseases;
- disorders of cerebral circulation (ischemic stroke, hemorrhagic stroke, thrombosis of the retinal arteries, including in the anamnesis);
- hereditary dyslipoproteinemia, hyperlipidemia, severe obesity;
- hormone-dependent tumors (including in the anamnesis), adenoma and carcinoma of the liver; endometrial hyperplasia;
- diabetes mellitus, complicated by vascular lesions: microangiopathy, retinopathy;
- migraine with aura;
- uterine bleeding of unclear etiology;
- age under 18 years;
- pregnancy, breastfeeding;
- postpartum period (4 weeks);
- postmenopausal period;
- hypersensitivity to ethinyl estradiol and norelgestromin.
Do not attach the drug on the area of the mammary glands, as well as on hyperemic, irritated or damaged skin areas.
With caution: in smoking women over 35 years of age, with prolonged immobilization, obesity, thrombophlebitis of superficial veins and varicose veins, arterial hypertension, cardiac valve disorders, atrial fibrillation, diabetes mellitus, systemic lupus erythematosus, Crohn’s disease and ulcerative colitis, violations of liver function (including during previous pregnancy or previous use of sex hormones), impaired renal function, menstrual period disorders.
If you deviate from the recommendations in the use of the transdermal system, an overdose is possible. A woman may have nausea, vomiting, bleeding from the vagina. If you have such symptoms, you should remove the patch immediately and seek help and advice from a gynecologist.
Women who take drugs that induce microsomal enzymes (hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil, phenylbutazone, St. John’s wort preparations and antibiotics (ampicillin), should use an additional method of contraception or choose a different birth control method. Joint use of Xulane with these drugs can cause an acceleration of the metabolism of sex hormones, which can be the cause of intermenstrual bleeding or ineffectiveness of hormonal contraception.
Pregnancy and breastfeeding
Xulane is contraindicated for use in pregnancy.
According to epidemiological studies, there was no increase in the likelihood of developmental defects in children born to women using a hormonal transdermal system before pregnancy. Most recent studies have not revealed a teratogenic effect in hormonal contraceptives taken in the early stages of pregnancy.
Contraceptive steroids and their metabolites in small amounts are excreted in breast milk. If a woman continues breastfeeding a baby, side effects may occur: jaundice and enlargement of the mammary glands. In addition, using combined hormonal contraceptives after delivery reduces the amount of breast milk and impairs its quality. This is why breastfeeding women are recommended to refrain from attaching the contraceptive patch. Instead, they should use other methods of contraception before the complete cessation of breastfeeding.
Combined hormonal contraceptives can affect the resistance of peripheral tissues to insulin and glucose tolerance but there is no evidence of a need to change the regimen of diabetes therapy during the use of Xulane. At the same time, the health status of women with diabetes should be carefully monitored, especially at an early stage of using the drug.
A birth control patch does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
When using combined hormonal contraceptives, the menstrual period (spotting or intermenstrual bleeding) can be disturbed, especially in the first 3 months of contraception.
If you have persistent intermenstrual bleeding during the long-term use of the transdermal system, or if such bleeding occurs after previous regular periods, it is necessary to exclude organic disease or pregnancy.
Withdrawal of Xulane contraceptive can trigger amenorrhea or oligomenorrhea, especially if these conditions were present before the use of hormonal contraception.
If Xulane transdermal system causes irritation of the skin, it is possible to glue a new patch onto another area of the skin. At the same time, only one patch can be used.
In women with a body weight of 90 kg or more, the effectiveness of birth control can be reduced.
Women who use Xulane are advised to refrain from smoking.
The safety and effectiveness of the drug were only studied in women aged 18 to 45 years.
Retinal thrombosis associated with the use of a transdermal system:
use of oral contraceptives should be discontinued in the event of an unexpected transient, partial or complete loss of vision; seizures of vision or diplopia; edema of the papilla or disruption of the integrity of the vessels of the retina. Appropriate diagnostic and therapeutic measures should be taken immediately.
Women who have experienced hyperpigmentation of the facial skin during pregnancy should avoid exposure to sunlight or artificial ultraviolet light while using the contraceptive patch. Often hyperpigmentation is not completely reversible.