Trust Pill

Trust Pill

Manufacturer:

DKT

Distributor:

DKT
Full Prescribing Info
Contents
Ethinylestradiol, levonorgestrel, ferrous fumarate.
Description
Each of the 21 ochreous tablets contains: Ethinylestradiol 30 mcg, Levonorgestrel 125 mcg.
Each of the seven brown tablets contains: Ferrous Fumarate 75 mg (equivalent to 24.75 mg of elemental iron).
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) is a safe and easy to use contraceptive pill. It is also used in the treatment of menstrual disorders such as painful menstruation, menstrual cycle symptoms, and excessive uterine bleeding. It contains Iron that helps improve the hemoglobin level of blood during menstruation.
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) does not delay the return of fertility after discontinuing its use. Generally, the patient's bleeding pattern before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) will return after the patient discontinue taking it. Some women, however, may have to wait a few months before their usual bleeding pattern returns.
Action
Pharmacotherapeutic group: Progestogen and Estrogens, fixed combinations. ATC code: G03AA07.
Pharmacology: Pharmacodynamics:
Overall Pearl Index (method failure + patient failure): 0.59 (upper tow-sided 95% confidence limit: 0.85).
The contraceptive effect of COCs is based on the interaction of various factors. The most important are the inhibition of ovulation and changes in cervical mucus.
Mechanism of action: Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) works primarily by preventing the release of eggs from the ovaries. Also, Ethinylestradiol acts synergistically with levonorgestrel to provide regular and consistent suppression of ovulation.
Pharmacokinetics: Absorption: Ethinylestradiol and Levonorgestrel are absorbed with maximum plasma concentrations occurring within 2 hours after Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) administration. Levonorgestrel reaches a bioavailability of nearly 100% after oral administration and is not subject to first-pass metabolism. Ethinylestradiol reaches a bioavailability of approximately 43% principally due to first pass metabolism.
The mean plasma pharmacokinetic parameters after daily exposure to Levonorgestrel & Ethinylestradiol remain statistically similar on day 21, 84, and 91.
The effect of food on the rate and the extent of Levonorgestrel and Ethinylestradiol absorption following oral administration Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) has not been evaluated.
Distribution: Levonorgestrel is about 97.5-99% bound principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Ethinylestradiol is about 95%-97% bound to serum albumin. Ethinylestradiol induces SHBG synthesis, which leads to decreased Levonorgestrel clearance.
Metabolism: Following absorption, Levonorgestrel is conjugated at the 17β-OH position to form sulfate and glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α,5β-tetrahydrolevonorgestrel are also present in plasma. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolism of Ethinylestradiol involves formation of Ethinylestradiol-3-sulfate in the gut wall, followed by 2-hydroxylation of a portion of the remaining untransformed Ethinylestradiol by hepatic cytochrome P-450 3A4 (CYP3A4). Hydroxylation at the 4-,6-, and 16- positions may occur. The various hydroxylated metabolites are subject to further methylation and/or conjugation.
Excretion: About 45% of Levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. The terminal elimination half-life for Levonorgestrel was about 34 hours. Ethinylestradiol is excreted in the urine and feces as glucuronide and sulfate conjugates, and it undergoes enterohepatic recirculation. The terminal elimination half-life of Ethinylestradiol was about 18 hours.
Race: The effect of race on the pharmacokinetics of Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) has not been evaluated.
Indications/Uses
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) is indicated for contraception and treatment of menstrual disorders such as dysmenorrhea, premenstrual syndrome, and menorrhagia.
Dosage/Direction for Use
Talk to a healthcare provider before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL).
Take one pill daily, beginning on the first day of menstrual bleeding. Patient can also start any day as long as patient is not pregnant and use a back-up method such as condom for the next seven days as a precaution to avoid pregnancy. Start with the pill marked number "1". Follow the arrows indicated on the pack.
The interval between two pills should be 24 hours. Incorporate it to patient's daily routine - after eating meals or before going to sleep so patient can easily remember to take it. A pack is good for 28 days.
Start a new pack the next day after taking the last brown pill regardless whether the patient's menstrual bleeding has stopped or not. Patient's menstrual period will return to normal two days after finishing the ochreous pills and while taking the brown pills.
Patient may continue taking the pill as long as the patient wants to avoid pregnancy. Do not skip taking the pill even if there is a brief pause from sexual activity.
Patient should only stop taking the pill after finishing a pack; otherwise, bleeding may start.
Vomiting and persistent severe diarrhea can interfere with the absorption of the pill. If vomiting occurs within two hours after taking a pill, another pill should be taken as soon as possible. If persistent vomiting and diarrhea last more than 24 hours, follow the instructions on Missed Pills.
If patient missed one ochreous pill, patient must take it within 12 hours after the 24-hour lapse to sustain its efficacy. Take the remaining pills as scheduled to avoid premature withdrawal bleeding. Follow the instructions on Missed Pills.
Missed Pills: The key to effective contraception is following the recommended dosage consistently.
If the patient missed taking one ochreous pill, take it as soon as remembered. Take the pill due for the day at the regular time even if it means taking two pills in one day. Keep taking one pill each day at the usual time. Patient will not need a back-up contraceptive method if only missed one pill.
Missing two or more ochreous pills consecutively increases the probability of getting pregnant. Take the most recently missed ochreous pill as soon as remembered and discard all remaining previously missed pills. Resume taking the next scheduled pill and either abstain from sex or use condoms for the next seven days. Count the ochreous pills left in the pack.
If one to six ochreous pills are left in the pack, finish the remaining ochreous pills and discard all brown pills. Use condoms for the next 7 days. Start a new pack immediately after finishing the ochreous pills. Bleeding may not come at a regular time.
If there are seven or more ochreous pills left in the pack, continue taking the contents of the pack including the brown pills. Start with a new pack after.
Diagram as follows will help patient to better understand. (See figure.)

Click on icon to see table/diagram/image

What to do if patient missed taking the brown pill: Discard the missed brown pills. Take the remaining brown pills as scheduled until patient finishes the pack. Start with a new pack after. The brown pills contain Ferrous Fumarate, an Iron supplement, that helps improve the hemoglobin content of blood during menstruation.
If patient continually forgets to take the pills, ask the healthcare provider for ways to become compliant, or for another method of contraception which will suit patient better.
Overdosage
No serious ill effects have been reported after ingestion of large doses of oral contraceptives, although it may cause nausea and withdrawal bleeding in females. Treatment is unnecessary because the overdose is unlikely to be life-threatening. Ask a healthcare provider for further instructions.
Contraindications
Patient should inform the healthcare provider if she has the following conditions before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL): liver disorders, clotting disorders, breast and cervical cancer, sickle-cell anemia, hormone-active tumors, hyperlipidemia, severe cardiovascular diseases, previous or existing thromboembolic diseases, idiopathic jaundice.
(See Use in Pregnancy & Lactation section for further information.)
Special Precautions
Regular consultation with a healthcare provider is recommended while taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL). If patient suffers from diarrhea and/or vomiting, its efficacy may be reduced. Inform the healthcare provider if the patient is suffering from the following conditions: diabetes mellitus, high blood pressure, varicose veins, multiple sclerosis, epilepsy, migraine, ophthalmological problems, tetany.
Use In Pregnancy & Lactation
Make sure the patient is not pregnant before taking Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL).
Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL) is not recommended for pregnant women.
Breastfeeding mothers should not use Ethinylestradiol + Levonorgestrel + Ferrous Fumarate (TRUST PILL). This may reduce the volume of the breast milk. Breastfeeding mothers can use progestin-only pills.
Adverse Reactions
The oral contraceptive pill is one of the most researched product in the history of modern medicine, and its safety has long been established. Some women may experience side effects such as headache, gastric upsets, nausea, vomiting, abdominal cramps, changes in appetite, breast tenderness, change in body weight and libido, depressive moods, or interference with liver functions.
Drug Interactions
Taking drugs for infection (such as ampicillin, chloramphenicol, neomycin, penicillin V, nitrofurantoin, sulfonamides, tetracycline and isoniazid) and pain (analgesics, anti-migraine and tranquilizer) with contraceptive pill may decrease the contraceptive's efficacy. If the patient is advised to take the previously mentioned drugs, consult a healthcare provider for proper intake and dosage schedule of the contraceptive pills.
Taking contraceptive pills and anti-infective drugs (such as clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir) or grapefruit juice may inhibit cytochrome P-450 isoenzyme 3A4. Adverse effects may be seen upon taking these drugs.
Taking oral contraceptive pills and drugs that induce hepatic enzyme production such as anti-epileptic drugs (carbamazepine, oxcarbazepine, felbamate, topiramate, phenytoin), anti-fungal (griseofulvin), anti-diabetic (troglitazone), musculoskeletal (phenylbutazone), and anti-tuberculosis (rifampicin) drugs can considerably reduce the contraceptive's efficacy.
Taking contraceptives and troleandomycin may increase the risk of cholestatic jaundice.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs / Oral Contraceptives
ATC Classification
G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Trust Pill tab
Packing/Price
28's
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