Tri-VyLibra is a triphasic hormonal contraceptive which contains ethinyl estradiol and norgestimate.
Contents:
Indications for use
- Pregnancy prevention.
Mechanism of action
The drug prevents the release of an egg during your menstrual cycle. It also makes vaginal fluid thicker to help prevent fertilization and changes the lining of the womb to prevent attachment of a fertilized egg.
Dosage and mode of application
Each pack of Tri-VyLibra contains 28 pills:
- 7 white tablets each containing 0.18 mg norgestimate/0.035 mg ethinyl estradiol;
- 7 light blue tablets each containing 0.215 mg norgestimate/0.035 mg ethinyl estradiol;
- 7 dark blue tablets each containing 0.25 mg norgestimate/0.035 mg ethinyl estradiol;
- 7 green inert tablets to help ease administration.
Take the first tablet on the first day your menstrual bleeding. Keep taking 1 tablet per day for 28 consecutive days, preferably in the evening. Menstrual-like bleeding usually begins a few days after taking the last dark blue tablet. Begin taking tablets from a new pack without interruption. Do not miss tablets (especially those containing hormones). All tablets should be taken at about the same hour.
Overdose
Do not take more tablets per day than indicated in the instructions for use. Overdosage can cause a headache, vomiting, nausea, vaginal bleeding (in girls). There is no specific antidote for ethinyl estradiol and norgestimate. Treatment should be symptomatic. If you experience any severe/lasting adverse reactions, seek medical care.
Side effects
Tri-VyLibra side effects are rare. Potential adverse reactions include:
- nausea/vomiting;
- diarrhea;
- abdominal/gastrointestinal pain;
- paresthesia;
- cerebrovascular accident;
- flatulence;
- abnormal withdrawal bleeding;
- vaginal infection;
- abdominal distention;
- constipation;
- pancreatitis;
- headache/migraine;
- dizziness;
- dyspnea;
- pulmonary embolism;
- dysmenorrhea;
- metrorrhagia;
- vaginal discharge;
- suppressed lactation;
- oligomenorrhea;
- amenorrhea;
- genital discharge;
- breast tenderness/pain/enlargement/swelling/discharge/discomfort;
- nipple pain;
- menstrual disorder;
- vulvovaginal infection;
- urinary tract infection;
- amenorrhea;
- PMS;
- ovarian cyst;
- vulvovaginal dryness;
- rash;
- acne;
- hirsutism;
- urticaria;
- angioedema;
- excessive sweating;
- pruritus;
- erythema;
- changes in skin color;
- hyperhidrosis;
- photosensitivity reaction;
- weight fluctuation;
- fluid retention;
- cervical dysplasia;
- breast cyst;
- breast cancer;
- palpitation;
- thrombosis;
- hypertension;
- carcinoma of the cervix;
- benign breast neoplasm;
- focal nodular hyperplasia;
- fibroadenoma of the breast;
- hepatitis;
- vision disorders;
- dry eye;
- deep vein thrombosis;
- appetite changes;
- dyslipidemia;
- depression;
- contact lens intolerance;
- retinal vascular thrombosis;
- hot flush;
- tachycardia;
- arterial thromboembolism;
- myocardial infarction;
- venous thromboembolic event;
- mood swings;
- asthenic conditions;
- edema;
- nervousness;
- insomnia anxiety;
- libido disorder;
- hypersensitivity;
- muscle spasms;
- pain in extremity;
- back pain;
- myalgia;
- weight changes;
- fatigue;
- hepatic adenoma;
- breast cancer;
- chest pain.
Contraindications
Do not use Tri-VyLibra if you have any of the following conditions:
- if you are smoking and are over 35 years of age;
- pregnancy;
- headaches with focal neurological symptoms or migraine headaches with aura;
- cerebrovascular disease;
- coronary artery disease;
- uncontrolled hypertension;
- diabetes mellitus with vascular disease;
- thrombogenic valvular or thrombogenic rhythm diseases of the heart;
- use of Hepatitis C drugs such as ombitasvir/paritaprevir/ritonavir/dasabuvir;
- liver tumors;
- liver disease;
- undiagnosed uterine bleeding;
- deep vein thrombosis or pulmonary embolism (including a history);
- breast cancer or other estrogen- or progestin-sensitive cancer (including a history).
With caution:
- irregular periods;
- depression;
- thrombotic and other vascular events;
- carcinoma of the breast and cervix, including a history;
- liver disease;
- gallbladder disease;
- headache;
- uncontrolled hypertension;
- carbohydrate and lipid metabolic effects.
Interactions
Drug interactions may reduce the contraceptive effect of Tri-VyLibra or increase your risk for adverse reactions. Before using birth control pills, always tell your doctor or pharmacist that you are currently taking or going to take other medicines.
When using Tri-VyLibra, avoid taking the following medications:
- aromatase inhibitors (anastrozole, exemestane);
- ospemifene;
- tizanidine;
- tranexamic acid;
- tamoxifen;
- drugs used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir);
- griseofulvin;
- modafinil;
- drugs used to treat seizures (barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate);
- HIV drugs (nelfinavir, nevirapine, ritonavir);
- rifamycins (rifampin, rifabutin);
- St. John’s Wort.
This contraceptive may affect certain laboratory tests (blood clotting, thyroid). Make sure all your doctors know that you use this drug.
Pregnancy and breastfeeding
There is no reason to use Tri-VyLibra if you are pregnant. Moreover, use of this drug is contraindicated during pregnancy because there is little data about how ethinyl estradiol and norgestimate can affect the fetus.
Do not use these tablets if you are breastfeeding since they can change milk composition and production. Besides, there is little data about how ethinyl estradiol and norgestimate can affect the baby.
What if I miss a pill?
Try to take this drug without missing doses. Missing each active tablet increases your risk of becoming pregnant. If you missed one or more active tablet, follow the instructions given below:
One tablet is missed in Weeks 1, 2, or 3:
- The tablet is taken as soon as possible, then take one tablet each day until the pack is empty.
Two active tablets are missed in Week 1 or Week 2:
- Take the two missed tablets the day you remember and two more tablets the next day. Then take one tablet each day until the pack is empty. Additional non-hormonal methods of contraception are not needed.
Two active tablets are missed in Week 3 or more active tablets are missed in a row in Weeks 1, 2, or 3:
- Day 1 start: Discard the rest of the pack and start a new pack that same day;
- Sunday start: Take one tablet each day until Sunday, then discard the rest of the pack and start a new pack immediately (Sunday). Additional non-hormonal methods of contraception are needed if you have sex within 7 days after missing tablets.
If you missed any of the 7 green inert tablets, throw them away since they do not contain any hormones and serve as “reminders”.
Precautions
Discontinue using Tri-VyLibra tablets if you become pregnant, if you notice first-time abnormal migraine headaches, vision problems (including temporary blindness), hearing loss, first-time epileptic seizures, jaundice, symptoms of thrombophlebitis or thromboembolic complications, itching, an increase in blood pressure, fibroids growth, signs of an increased liver.
Stop taking tablets 6 weeks prior to the scheduled major surgery.
If you have vomiting or diarrhea 1-4 hours after taking a tablet containing hormones, you should not stop taking tablets. At the same time, you should use a non-hormonal method of preventing pregnancy for 7 days.
This drug will not protect you from sexually transmitted diseases, including HIV and AIDS.
Store at room temperature, away from direct sunlight, moisture and heat.
Do not use the drug after the expiration date.
Keep out of reach of children.