BK-1

OTC

Indications

• For emergency contraceptive, BK-1 is taken within 72 hours of unprotected intercourse, or failure of contraceptive method.

Dosage

• One tablet is taken as soon as possible, within 12 hours and not over 72 hours of unprotected intercourse.
  If vomiting occurs within 3 hours after intaking the drug, additional administration should be started immediately.
• BK-1 is administered at any time during the menstrual cycle, but not at a delayed menses.
• After taking emergency contraception, a barrier method of contraception (such as condoms) should be used until the next menstrual period. BK-1 is not contraindicated while taking other common hormonal contraceptives.
• Women who have taken an enzyme inducer within the previous 4 weeks should use emergency contraception that is a non-hormonal method of contraception (eg, an IUD). Take a double dose of levonorgestrel (i.e. 3000 microgram within 72 hours after the unprotected intercourse) for those women unable or unwilling to use Cu-IUD.
• Use should not be recommended for children.

Usage

• Administered orally.

• Hypersensitivity to levonorgestrel or to any of the components of the drug.
• Severe hepatic impairment;
• Undiagnosed abnormal vaginal bleeding;
• Active thrombophlebitis or thromboembolic disorders;
• Acute liver disease, benign or malignant liver tumors;
• A history of breast cancer;
• Jaundice or persistent itching during a previous pregnancy;
• Disorders of acute porphyria;
• History of increased idiopathic intracranial pressure.
• Known or suspected pregnancy.

Very common

• Headache;
• Nausea, abdominal pain lower;
• Bleeding not related to menses;
• Fatigue.

Common

• Dizziness,
• Diarrhoea, vomiting,
• Delay of menses more than 7 days (if the next menstrual period is more than 5 days overdue, pregnancy should be excluded); menstruation irregular, breast tenderness.

• After using emergency contraception it is recommended to use a local barrier method (e.g. condom, diaphragm, spermicide, cervical cap) until the next menstrual period starts. The use of levonorgestrel does not contraindicate the continuation of regular hormonal contraception.
• There is no relevant use of levonorgestrel for children of prepubertal age in the indication emergency contraception.
• Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.
• Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with BK-1 following the second act of intercourse may therefore be ineffective in preventing pregnancy. If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded.
• If pregnancy occurs after treatment with BK-1, the possibility of an ectopic pregnancy should be considered, especially in people with abdominal/pelvic pain or depression, people with a history of ectopic pregnancy, tubal surgery, pelvic inflammation.
• After levonorgestrel intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. Women should be advised to make a medical appointment to initiate or adopt a method of regular contraception. If no withdrawal bleed occurs in the next pill-free period following the use of levonorgestrel after regular hormonal contraception, pregnancy should be ruled out.
• Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle.
• Levonorgestrel is not as effective as a conventional regular method of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception.
• Use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases.
• Levonorgestrel is not recommended in patients with severe hepatic dysfunction.
• Severe malabsorption syndromes, such as Crohn’s disease, might impair the efficacy of levonorgestrel.
• BK-1 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• BK-1 should not be given to pregnant women.
• The breast-feeding woman takes the tablet immediately after feeding and avoids nursing at least 8 hours following levonorgestrel administration.
• BK-1 increases the possibility of cycle disturbances.
• Do not drive or operate machinery if you feel tired or dizzy with levonorgestrel.