Tri-Levlen (levonorgestrel + ethinyl estradiol) is a progestin/estrogen combined oral contraceptive indicated for use by females to prevent unwanted pregnancy.
It works by stopping ovulation and by altering cervical mucus and the lining of the womb to prevent sperm from entering. This helps prevent pregnancy.
Each cycle of Tri-Levlen 21 consists of three different drug phases as fol-lows:
- Phase 1: 6 brown tablets, each containing 0.050mg of levonorgestrel and 0.030 mg of ethinyl estradiol;
- Phase 2: 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol;
- Phase 3: 10 light-yellow tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol.
If you are using Tri-Levlen 28, then pack also contains 7 light-green film-coated inert tablets taken in Week 4.
Regardless of whether you are using Tri-Levlen 21 or Tri-Levlen 28, take 1 tablet daily exactly as directed at intervals not exceeding 24-hours, with or without food. Take tablets at the same time each day. If you pack contains 21 tablets, complete the pack and then discontinue for one week (7 days). Withdrawal bleeding usually occurs within 3 days following discontinuation of the tablets. After a 7-day break, start a new pack of Tri-Levlen 21, following the same schedule: 21 days on – 7 days off.
If you pack contains 28 tablets, take them according to the same sched-ule: one tablet daily. But in this case, you make no interruption as the pack contains 7 inert tablets that serve as reminders. As soon as you take the last tablet in the pack, start a new one.
In rare cases, Tri-Levlen can cause the following side effects:
- Gastrointestinal symptoms (abdominal cramps and bloating);
- Breakthrough bleeding;
- Change in menstrual flow;
- Rash (allergic);
- Temporary infertility after discontinuation of treatment;
- Melasma which may persist;
- Intolerance to contact lenses;
- Breast changes: tenderness, enlargement, secretion;
- Diminution in lactation when given immediately postpartum. Cholestatic jaundice;
- Mental depression;
- Reduced tolerance to carbohydrates;
- Vaginal candidiasis;
- Change in corneal curvature (steepening);
- Change in weight (increase or decrease);
- Change in cervical erosion and secretion.
In isolated cases, women taking Tri-Levlen experienced the following adverse conditions:
- Congenital anomalies;
- Retinal thrombosis;
- Optic neuritis;
- Changes in appetite;
- Cystitis-like syndrome;
- Pre-menstrual syndrome;
- Mesenteric thrombosis;
- Loss of scalp hair;
- Erythema multiforme;
- Erythema nodosum;
- Hemorrhagic eruption;
- Cerebral thrombosis.
- Impaired renal function;
- Hemolytic uremic syndrome;
- Budd-Chiari syndrome;
- Sickle-cell disease;
- Cerebral-vascular disease with mitral valve prolapse;
- Lupus-like syndromes;
- Changes in libido;
- Arterial thromboembolism;
- Cerebral hemorrhage;
- Gallbladder disease;
- Pulmonary embolism;
- Myocardial infarction;
- Hepatic adenomas or benign liver tumors.
But the connection of these side effects with the use of oral contraceptives have not been proved.
Do not use this product if you have any of the following conditions:
- Hypercalcemia in breast cancer;
- Abnormal vaginal bleeding;
- Hepatic neoplasms;
- Abnormal genital bleeding;
- Carcinomas (estrogenic);
- Intracranial HTN;
- Lver disease;
- Breast malignancy.
Certain drugs may interact with Tri-Levlen to make them less effective or cause an increase in breakthrough bleeding. Such drugs are certain antibiotics, rifampin, barbiturates (such as phenobarbital) and phenytoin (Dilantin), and phenylbutazone (Butazolidin). You may need to use an additional method of birth control during any cycle in which you take medicines that can make birth control pills less effective.
Use is contraindicated.
The risk of pregnancy increases with each active tablet missed (tablets 1-21).
- If you miss 1active pill: 1. Take it as soon as you realize your mistake. Take the next pill at your scheduled time. This means you may need to take 2 pills in 1 day. 2. You an additional non-hormonal method of birth control if you have sex;
- If you miss 2 active pills in a row in week 1 or week 2: 1. Take 2 pills on the day you realize your mistake and 2 pills the next day. 2. Then return to your usual schedule – 1 pill per day. 3. You MUST use an additional non-hormonal method of birth control if you have sex for those 7 days;
- If you miss 2 active pills in a row in week 3: 1. If you are a Day 1 Starter: Discard the rest of the pills and start a new pack that same day. If you are a Sunday Starter: Continue to take 1 pill each day until Sunday. On Sunday, discard the rest of the pills and start a new pack that same day. You may not have your period this month. If you get no period for 2 months in a row, get a pregnancy test and contact your doctor because you might be pregnant. 3. You MUST use an ad-ditional non-hormonal method of birth control if you have sex for those 7 days;
- If you miss 3 or more active pills in a row (during the first 3 weeks). 1. If you are a Day 1 Starter: Discard the rest of the pills and start a new pack that same day. If you are a Sunday Starter: Continue to take 1 pill each day until Sunday. On Sunday, discard the rest of the pills and start a new pack that same day. You may not have your period this month. If you get no period for 2 months in a row, get a pregnancy test and contact your doctor because you might be pregnant. 3. You MUST use an additional non-hormonal method of birth control if you have sex for those 7 days;
- If you forget any of the 7 inert pills in Week 4: Discard the pills you missed. Continue to take 1 pill each day until the pack is over. You do not need an additional non-hormonal method of birth control if you miss inert pills.
Tri-Levlen does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (such as gonorrhea, hepatitis B, Chlamydia, genital herpes, genital warts, and Syphilis).
Use the product with caution if you have any of the following conditions:
- weight gain;
- gallbladder disease;
- fluid retention;
- glucose intolerance;
- retinal thrombosis;
- liver disease;
- thyroid function tests/
If any of these adverse effects occur while you are taking birth control pills, contact your doctor right away: sharp chest pain, sudden shortness of breath, pain in the calf, sudden severe headache or vomiting, dizziness or fainting, sudden partial or complete loss of vision, disturbances of vision or speech, coughing of blood, weakness, or numbness in an arm or leg, breast lumps, severe pain or tenderness in the stomach area, weakness, lack of energy, fatigue, or change in mood, Jaundice or a yellowing of the skin or eyeballs accompanied by fever, difficulty in sleeping, fatigue, loss of appetite, light-colored bowel movements, dark-colored urine, crushing chest pain or heaviness in the chest.
Cigarette smoking increases the risk of serious cardiovascular side effects from birth control pills. This risk increases with age and with number of cigarettes smoked per day. Women over 35 years of age who use Tri-Levlen should not to smoke.
Taking large doses of this product can cause an overdose. Symptoms: nausea, withdrawal bleeding. Treatment should be symptomatic and supportive.