Briellyn (ethinyl estradiol, norethisterone) is an oral drug which is used for hormonal contraception.
Contents:
Indications for use
- Prevention of pregnancy;
- Treatment of acne.
Mechanism of action
The active substances of the drug inhibit ovulation, cause changes in the cervical mucus, which prevents the penetration of spermatozoa into the uterus.
Dosage and mode of application
Each pack of Briellyn contains 21 light peach tablets (ethinyl estradiol and norethisterone) and 7 white inert tablets that do not have any therapeutic effect. These 7 tablets act as “reminders”.
Take 1 tablet per day, for 28 days in a row, at the same time of a day (preferably in the evening or in the morning after meals). Intervals between doses should not exceed 24 hours.
You can either start taking birth control pills on the first day of your period (the first day of your menstrual bleeding) or on Sunday following the onset of your period. Once you’ve finished the first pack of Briellyn, begin the next pack without breaks. Use the same dosing regimen for all the next cycles of contraception.
Try not to miss pills (especially those with hormones) since this reduces the contraceptive effectiveness of the drug.
Overdose
Cases of overdosage have not been reported. Potential negative effects include vomiting, nausea, spotting/bleeding.
Side effects
In some cases, Briellyn tablets can cause adverse effects, including: breast tenderness/pain, bacterial vaginitis, abnormal vaginal bleeding, menorrhagia, metrorrhagia, vaginal hemorrhage, dysmenorrhea, dysfunctional uterine bleeding, ovarian vein, thrombosis, amenorrhea, breakthrough bleeding, breast enlargement, vaginitis, breast secretion,, cervical secretion, diminution in lactation, spotting, cervical erosion changed, premenstrual syndrome, uterine fibroid disease exacerbated, vaginal infection, pollakiuria, dysuria, pelvic pain, ovarian cyst, pelvic fluid collection, nipple pain, nipple discharge, galactorrhea, fibrocystic breast change, breast disorder, breast mass, uterine leiomyomata size increased, cervical ectropion changed, endometrial hyperplasia, ovarian cyst, uterine enlargement, high blood pressure, vein thrombosis, myocardial infarction, hypertension, coronary artery thrombosis, palpitation, tachycardia, angina pectoris, hot flush, irregular heart rate, headache, migraine, dizziness, cerebral hemorrhage, cerebral thrombosis, fainting, hyperesthesia, paresthesia, vaginal candidiasis, painful menstruations, hypoesthesia, somnolence, sensory disturbance, transient ischemic attack, ischemic stroke, chorea, hemiparesis, hepatic adenoma, hepatic carcinoma, benign liver tumor, hemangioma of liver, breast cancer, ovarian cancer, endometrial cancer, uterine cancer, hypothyroidism, hyperthyroidism, nausea, vomiting, abdominal pain/cramps, bloating, colitis, dyspepsia, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, mesenteric thrombosis, constipation, pancreatitis, liver disease, gallbladder disease, cholestatic jaundice, Budd-Chiari syndrome, cholelithiasis, cholecystitis, changes in mood, depression, anxiety, nervousness, sleeping disorders, suicidal ideation, panic attack, libido changed, homicidal ideation, dissociation, bipolar disorder, mood disturbed, irritability, acne, hirsutism, loss of scalp hair, epilepsy exacerbated, dementia, melasma, chloasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, photosensitivity, pruritus, alopecia, generalized rash, allergic rash, skin discoloration, urticaria, angioedema, night sweats, angioedema, hirsutism, skin burning sensation, generalized erythema, pulmonary embolism, asthma, dyspnea, hemolytic uremic syndrome, anemia, hypersensitivity reaction, anaphylactic/anaphylactoid reaction, corneal curvature change/steepening, contact lens intolerance, cataracts, retinal thrombosis, vision disorders, corneal thinning, fungal infection, leg cramp, backache, myalgia, arthralgia, back pain, impared renal function, cystitis, weight fluctuation, poor tolerance to carbohydrates, increased/decreased appetite, increased triglycerides, cervical smear abnormal, weight gain, edema, fatigue, weakness, porphyria, Vitamin B6 deficiency, decreased weight, peripheral edema, malaise, diabetes mellitus, hypoglycemia, abnormal blood glucose, hypocalcemia, chest pain.
Contraindications
Do not take Briellyn for birth control if you have any of the following diseases/conditions:
- hypersensitivity to norethisterone, ethinyl estradiol, or other ingredients of the contraceptive;
- blood clots, diseased blood vessels, heart disease, heart attack, stroke, angina, liver disease, liver tumor, severe headacheб hypertension, diabetes (including in the anamnesis);
- hypersensitivity to any other combination oral contraceptives, drugs, foods;
- rash, hives, itching, wheezing, cough, shortness of breath, swelling of face or throat (including in the anamnesis);
- endometrial cancer, cancer of the cervix or vagina (including in the anamnesis);
- vaginal bleeding of unknown origin (including in the anamnesis);
- pregnancy;
- breastfeeding period;
- if you currently taking drugs such as ombitasvir, paritaprevir, ritonavir, and some others (See Interactions);
- jaundice caused by pregnancy or hormonal contraceptives in the anamnesis;
- you are planning to undergo a surgery (6 weeks before it);
- if you do not have menstrual periods yet.
Interactions
Do not combine Briellyn with the following drugs:
- dasabuvir;
- ombitasvir;
- paritaprevir;
- ritonavir.
If possible, avoid the following interactions:
- acetaminophen;
- rifampin;
- temazepam;
- pioglitazone;
- mineral oil;
- modafinil;
- mycophenolate;
- rifabutin;
- rifapentine;
- griseofulvin;
- penicillins;
- phenytoin;
- tamoxifen;
- aloxifene;
- theophylline;
- tetracyclines;
- aprepitant;
- thyroid hormones;
- topiramate;
- warfarin;
- ascorbic acid;
- prednisolone;
- ritonavir or other drugs for HIV infection or AIDS;
- rosuvastatin;
- selegiline;
- St. John’s Wort;
- atorvastatin;
- barbiturates;
- diazepam;
- bosentan;
- carbamazepine;
- caffeine;
- clofibrate;
- cyclosporine;
- dantrolene;
- doxercalciferol;
- felbamate;
- grapefruit juice;
- hydrocortisone;
- nefazodone;
- oxcarbazepine.
Pregnancy and breastfeeding
Briellyn is not indicated for use during pregnancy and lactation. Moreover, a patient needs to exclude pregnancy before using hormonal contraceptives. Discontinue using the drug if you become pregnant when on the pills. Ethinyl estradiol and norethisterone are excreted into breast milk and may affect the baby.
What if I miss a pill?
You miss 1 light peach pill:
Take the missed pill as soon as you remember, take the next pill at your regular time
You missed 2 light peach pills in a row (week 1 or week 2):
Take the missed 2 pills as soon as you remember, take 2 pills the next day, then return to your regular dosing schedule. In addition, you should use backup birth control methods for 7 days following the missed pills.
You missed 2 light peach pills in a row (week 3):
- Sunday-Start: take 1 pill per day until Sunday, then discard the remaining pills and start a new pack immediately, In addition, you should use backup birth control methods for 7 days following the missed pills;
- Day-1 Start: discard the remaining pills, start a new pack immediately. In addition, you should use backup birth control methods for 7 days following the missed pills.
You missed 3 or more light peach pills in a row:
- Sunday-Start: take 1 pill daily until Sunday, then throw out the remaining pills and a start a new pack immediately. In addition, you should use backup birth control methods for 7 days following the missed pills;
- Day-1 Start: discard the rest of the pills, start a new pack immediately. In addition, you should use backup birth control methods for 7 days following the missed pills.
If you missed any of the light peach pills, you may have spotting/vaginal bleeding or you may even become pregnant. The risk is especially high if you miss 2 light peach pills in a row.
You missed any of the 7 white pills (week 4):
Throw out the missed pills and continue taking 1 pill per day until the pack is empty. Backup birth control methods are not needed during this time since these tablets do not contain any hormones. Begin a new pack the next day after taking the last white pill from the blister.
If you are still not sure what to do after missing pills of Briellyn, consult a doctor.
Precautions
Before starting hormonal contraception and every 6 months, a woman should visit a gynecologist and undergo a thorough general medical and gynecological examination.
Briellyn tablets may change the usual course of the menstrual periods, rectal temperature and properties of cervical mucus.
Vomiting and diarrhea within 3-4 hours after taking a light peach pill can reduce its contraceptive effectiveness. In this case, you should continue taking pills at your regular time and use additional backup birth control methods.
If you have intermenstrual vaginal bleeding in the first few months of taking the drug, do not interrupt the course since light spotting usually disappears on its own after the body adapts to ethinyl estradiol and norethisterone (the adaptation period is usually 3 months). If spotting recurs or becomes heavier, consult a doctor as soon as possible. Doctor’s consultation is also required if you miss a menstrual-like reaction during the 7 no-hormone days.
Smoking women taking Briellyn for birth control have an increased risk of developing vascular diseases (myocardial infarction, or stroke). The risk increases with age and depends on the number of cigarettes smoked daily (especially in patients over 30). The risk of thrombosis increases with hypertension.
The drug must be canceled 6 weeks before the scheduled surgical intervention or long-term immobilization. In these cases, you can resume hormonal contraception 2 weeks after the end of immobilization.
Stop taking the tablets and consult a doctor if you have:
- early signs of phlebitis, thrombosis or embolism;
- pain in the lower limbs, veins bloating;
- pain/a feeling of pressure/heaviness in the chest;
- a significant increase in blood pressure;
- increased seizures;
- sudden shortness of breath;
- skin itching;
- severe pain in the lower abdomen;
- abnormal headaches and migraines;
- depression;
- hepatitis;
- jaundice;
- cholestasis;
- porphyria;
- vision disorders (blurred vision, temporary blindness);
- speech problems;
- unusual motor disorders;
- pregnancy.
Patients who have a predisposition to chloasma should avoid exposure to the sun when using Briellyn drug.