Tri-Mili is a combination birth control pill which contains 2 hormones, ethinyl estradiol and norgestimate.
Contents:
Indications for use
- Pregnancy prevention.
Mechanism of action
The drug works by suppressing ovulation, changing the implantation ability of the endometrium.
Dosage and mode of application
Each pack of Tri-Mili contains 28 pills:
- 7 pills each containing norgestimate 0.180mg, ethinyl estradiol 0.035mg;
- 7 pills each containing norgestimate 0.215mg, ethinyl estradiol 0.035mg;
- 7 pills each containing norgestimate 0.250mg, ethinyl estradiol 0.035mg;
- 7 inactive pills.
Begin the pack on the first day your period (Day 1 of your menstrual bleeding). Take 1 tablet daily for 28 days in a row. Menstrual-like bleeding typically occurs a few days after taking the last tablet containing hormones. Begin a new pack without any breaks. It’s important that you take the drug each day without missing tablets. You can take the first dose at any time of a day, however, all next doses should be taken at about the same hour, preferably in the evening.
Overdose
Do not take excessive doses of the drug as it will not increase the contraceptive reliability but can only lead to adverse reactions such as a headache, vomiting, nausea, and spotting/vaginal bleeding. There is no specific antidote. Treatment is symptomatic.
Side effects
Tri-Mili is usually tolerated well but in some cases, women may experience the following adverse side effects (usually temporary and mild):
- Gastrointestinal: nausea/vomiting, gastrointestinal disorder, diarrhea, abdominal/gastrointestinal pain, flatulence, abdominal distention, constipation, pancreatitis;
- Nervous system: headache/migraine, dizziness, syncope, paresthesia, convulsion, cerebrovascular accident;
- Respiratory: dyspnea, pulmonary embolism;
- Genitourinary: breast issues, dysmenorrhea, metrorrhagia, abnormal withdrawal bleeding, vaginal infection, genital discharge, breast tenderness, breast pain, breast enlargement, breast swelling, breast discharge, breast discomfort, nipple pain, menstrual discomfort, menstrual disorder, vulvovaginal infection, urinary tract infection, amenorrhea, premenstrual syndrome, ovarian cyst, vulvovaginal dryness, vaginal discharge, suppressed lactation, oligomenorrhea and amenorrhea;
- Dermatologic: rash, acne, plopecia, hirsutism, urticaria, pruritus, erythema, skin discoloration, hyperhidrosis, photosensitivity reaction, angioedema, erythema nodosum, night sweats;
- Metabolic: weight fluctuation, fluid retention, appetite disorder, dyslipidemia;
- Oncologic: cervical dysplasia, breast cyst, breast cancer, carcinoma of the cervix in situ, hepatic adenoma, breast cancer, benign breast neoplasm, focal nodular hyperplasia, fibroadenoma of the breast;
- Hepatic: hepatitis;
- Ocular: vision impaired, dry eye, contact lens intolerance, retinal vascular thrombosis;
- Cardiovascular: palpitation, thrombosis, hypertension, hot flush, tachycardia, arterial thromboembolism, myocardial infarction, venous thromboembolic event, deep vein thrombosis;
- Psychiatric: depression, mood altered, mood disorder, nervousness, insomnia, anxiety, libido disorder, irritability, mood swing;
- Immunologic: hypersensitivity;
- Musculoskeletal: muscle spasms, pain in extremity, back pain, myalgia;
- Other: weight increased, weight decreased, fatigue, chest pain, asthenic conditions, edema.
Contraindications
Tri-Mili absolute contraindications:
- hypersensitivity to ethinyl estradiol and norgestimate;
- estrogen- or progestin-dependent cancer, including a history;
- breast cancer, including a history;
- endometrial cancer;
- hepatic tumors;
- hypertension;
- diabetes mellitus;
- active hepatic disease;
- cholestatic jaundice, including a history;
- thrombophlebitis, including a history;
- thromboembolism, including a history;
- thrombogenic valvular or rhythm heart disease;
- CAD;
- SLE;
- pregnancy;
- 21 days postpartum;
- 6 weeks postpartum if breastfeeding;
- cerebrovascular disease;
- thrombophilias;
- migraine headaches;
- planned major surgery with prolonged immobilization;
- smoking over the age of 35 or heavy smoking;
- undiagnosed vaginal bleeding.
With caution:
- HTN;
- hyperlipidemia;
- diabetes mellitus;
- vomiting or diarrhea;
- obesity;
- inflammatory bowel disease;
- gallbladder disease;
- sensitivity to fluid retention;
- a history of depression;
- hepatic impairment;
- renal disease;
- hereditary angioedema.
Interactions
Use of Tri-Mili tablets is contraindicated if you are currently taking cisapride, dasabuvir, paritaprevir, ritonavir, thioridazine, fosamprenavir, ombitasvir, or tranexamic acid.
Avoid use with acitretin, albendazole, alosetron, anastrozole, aprepitant, armodafinil, artemether/lumefantrine, atazanavir, bendamustine, bexarotene, bosentan, brigatinib, butabarbital, butalbital, cannabidiol, carbamazepine, carfilzomib, clobazam, codeine, dabrafenib, darunavir, dexamethasone, dihydrocodeine, efavirenz, elagolix, eliglustat, elvitegravir, enasidenib, encorafenib, eslicarbazepine acetate, etravirine, exemestane, felbamate, fenofibrate, fenofibric acid, fosaprepitant, fosphenytoin, garlic, gemfibrozil, glecaprevir, glycerol phenylbutyrate, griseofulvin, hydrocodone, ivosidenib, lesinurad, letrozole, lopinavir/ritonavir, lumacaftor, meperidine, methadone, mifepristone, minocycline, mitotane, modafinil, nelfinavir, nevirapine, oxcarbazepine, oxycodone, pentobarbital, perampanel, phenobarbital, phenytoin, pibrentasvir, pioglitazone, prednisone, primidone, procarbazine, rifabutin, rifampin, rifapentine, rufinamide, sarilumab, secobarbital, somatropin, St. John’s wort, sugammadex, tesamorelin, tipranavir, tizanidine, tocilizumab, topiramate, tramadol, ulipristal, ursodiol, valproic acid, vemurafenib, vinblastine, abemaciclib, acalabrutinib, acarbose, ado-trastuzumab emtansine, alfentanil, amiodarone, amitriptyline, amoxapine, angiotensin II, atomoxetine, cabozantinib, caffeine citrate, chlorpropamide, cholestyramine, clozapine, cocaine, colesevelam, colestipol, copanlisib, cyclosporine, dasatinib, desipramine, desmopressin, desvenlafaxine, dextroamphetamine, diazoxide, disopyramide, docetaxel, droxidopa, ephedrine, epinephrine, erythromycin, everolimus, exenatide, fentanyl, flecainide, flibanserin, fostamatinib, glimepiride, glipizide, glyburide, ibrutinib, imipramine, indomethacin, insulin, iobenguane I 131, ixabepilone, lamotrigine, levomilnacipran, levothyroxine, linagliptin, liothyronine, liotrix, liraglutide, lisdexamfetamine, lixisenatide, metformin, methylphenidate, miglitol, nateglinide, nilotinib, nortriptyline, pazopanib, pimozide, pirfenidone, propranolol, protriptyline, quinidine (antiarrhythmic), rasagiline, repaglinide, ropinirole, rosiglitazone, saxagliptin, sirolimus, sitagliptin, sorafenib, sunitinib, tacrolimus, testosterone, theophylline, thyroid, tolazamide, tolbutamide, tolvaptan, triamcinolone, vandetanib, vardenafil, venetoclax, vincristine, vinorelbine, alprazolam, aminocaproic acid, amoxicillin, ampicillin, anti-inhibitor coagulant complex, ascorbic acid (vitamin C), asparaginase, axitinib, azithromycin, bevacizumab, C1 esterase inhibitor, caffeine, cefaclor, cefadroxil, cefazolin, cefdinir, cefditoren pivoxil, cefepime, cefixime, cefotaxime, cefotetan, cefoxitin, cefpodoxime proxetil, cefprozil, ceftaroline fosamil, ceftazidime, ceftibuten, ceftriaxone, cefuroxime axetil, cefuroxime sodium, cephalexin, chasteberry, ciprofloxacin, clarithromycin, clindamycin, coagulation factor IX, coagulation factor VIIa, cobimetinib, dantrolene, darbepoetin alfa, deferasirox, delafloxacin, dicloxacillin, duloxetine, eltrombopag, eplerenone, epoetin alfa, etanercept, factor XIII concentrate, gemifloxacin, ginseng, grapefruit, green tea, guarana, lenalidomide, lenvatinib, levofloxacin, licorice, lincomycin, lurasidone, marijuana, melatonin, methoxy polyethylene glycol-epoetin beta, metoprolol, metronidazole, metyrapone, midazolam, milk thistle, moxifloxacin, nafcillin, neomycin, nintedanib, nitrofurantoin, ofloxacin, paromomycin, pegaspargase, penicillin V, perphenazine, pomalidomide, ponatinib, prothrombin complex concentrate (human), ramelteon, ramucirumab, red clover, riluzole, romidepsin, saw palmetto, sulfadiazine, sulfadoxine, sulfamethoxazole, sulfasalazine, sulfisoxazole, tadalafil, telotristat ethyl, temsirolimus, tetracycline, thalidomide, tigecycline, tinidazole, tretinoin, triazolam, trimethoprim, vorinostat, ziv-aflibercept, zolmitriptan.
Pregnancy and breastfeeding
Pregnancy
Use of Tri-Mili pills is contraindicated during pregnancy since there is no reason for that. Besides, there is little data on how sex hormones can affect the fetus.
Lactation
Do not use this drug while breastfeeding since the active substances of the drug can decrease milk production. Besides, there is little data on how sex hormones can affect the baby.
What if I miss a pill?
If you miss one active tablet in Weeks 1, 2, or 3:
- Take the missed tablet as soon as you remember, then take one tablet per day until you finish the pack.
If you miss two active tablets in Week 1 or Week 2:
- Take the two missed tablets as soon as you remember and two more tablets the next day. Then take one tablet per day until you finish the pack. There is no need to use additional backup methods of birth control if you have sex within 7 days after missing tablets.
If you miss two active tablets in Week 3 or you miss more active tablets in a row in Weeks 1, 2, or 3:
- Day 1 start: Throw out the remaining tablets and start a new pack immediately;
- Sunday start: Keep taking one tablet per day until Sunday, then discard the remaining tablets and start a new pack that same day. You also need to use additional backup methods of birth control if you have sex within 7 days after missing tablets.
Precautions
Stop using Tri-Mili drug if pregnancy occurs, if you have abnormal migraine headaches, vision disorders, hearing loss, symptoms of thrombophlebitis or thromboembolic complications, first-time epileptic seizures or an increased frequency of seizures, jaundice, body itching, high blood pressure, fibroids growth, an increased liver.
If you have gastrointestinal disorders (vomiting/diarrhea) 1-4 hours after taking the tablet, the contraceptive may lose its effectiveness since it takes 4 hours for the body to fully absorb the medication. In this case, you should keep taking tablets at your usual time and use an additional backup method of birth control for at least 7 days.
Discontinue hormonal contraception 6 weeks prior to the planned major surgery.
Tri-Mili does not prevent sexually-transmitted diseases.
Store the drug at room temperature, away from heat, direct sunlight, moisture. Keep out of reach of children and pets.