Lady

Lady

ethinylestradiol + levonorgestrel

Manufacturer:

DKT

Distributor:

DKT
Full Prescribing Info
Contents
Levonorgestrel, ethinyl estradiol.
Description
Each of the 21 beige tablets contain: Ethinyl Estradiol 30 mcg and Levonorgestrel 150 mcg.
Each of the 7 white tablets contain: Lactose 40 mg.
Ethiny Estradiol + Levonorgestrel (LADY) is a low-dose monophasic and simple-to-use contraceptive pill. It is also used in the treatment of menstrual disorders such as painful menstruation, premenstrual syndrome (PMS), and excessive uterine bleeding.
Ethinyl Estradiol + Levonorgestrel (LADY) does not delay the return of fertility after discontinuing its use. Generally, the patient's bleeding pattern before taking Ethinyl Estradiol + Levonorgestrel (LADY) will return after the patient discontinued taking it. Some women, however, may have to wait a few months before their usual bleeding pattern returns.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Ethinyl Estradiol + Levonorgestrel (LADY) works primarily by preventing the release of eggs from the ovaries. Also, ethinyl estradiol acts synergistically with levonorgestrel to provide regular and consistent suppression of ovulation.
Pharmacokinetics: Ethinyl Estradiol is absorbed well and rapidly by the gastrointestinal tract. The presence of an Ethinyl group at the 17-position greatly reduces hepatic first-pass metabolism compared with Estradiol, enabling the compound to be much more active if taken orally. There is some initial conjugation at the gut wall, and the systemic bioavailability is only 40%. Ethinyl Estradiol is highly protein bound, unlike naturally occurring estrogens, which are mainly bound to sex hormone-binding globulin; it is principally bound to albumin. It is metabolized in the liver, and excreted in urine and feces. Metabolites undergo enterohepatic recycling.
Levonorgestrel is rapidly and almost completely absorbed after being taken orally and undergoes little first-pass hepatic metabolism. It is highly bound to plasma proteins; 42% to 68% to sex hormone-binding globulin and 30% to 56% to albumin. The proportion bound to sex hormone-binding globulin is higher when it is given with an estrogen. Levonorgestrel is metabolized in the liver to sulfate and glucuronide conjugates, which are excreted in the urine and to a lesser extent in the feces.
Indications/Uses
Ethinyl Estradiol + Levonorgestrel (LADY) 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 Ethinyl Estradiol + Levonorgestrel (LADY).
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 hour. 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 white pill. Patient's menstrual period will most likely return two days after finishing the beige pills and while taking the white 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 lasts more than 24 hours, follow the instructions on Missed Pills.
If patient missed a beige 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 one beige 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 one pill is missed.
Missing two or more beige pills consecutively increases the probability of getting pregnant. Take the most recently missed beige 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 beige pills left in the pack.
If one to six beige pills are left in the pack, finish the remaining beige pills and discard all white pills. Use condoms for the next seven days. Start a new pack immediately after finishing the remaining beige pills. Bleeding may not come at a regular time.
If there are seven or more beige pills left in the pack, continue taking the contents of the pack including the white pills. Start with a new pack after. (See figure.)

Click on icon to see table/diagram/image

What to do if patient missed taking one or more white pills: Discard the missed white pills. Take the remaining white pills as scheduled until the patient finished the pack. Start with a new pack.
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 the 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 the healthcare provider for further instructions.
Contraindications
Make sure the patient is not pregnant before taking Ethinyl Estradiol + Levonorgestrel (LADY). Patient should inform the healthcare provider immediately if patient has the following conditions before she start taking Ethinyl Estradiol + Levonorgestrel (LADY): 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.
Ethinyl Estradiol + Levonorgestrel (LADY) is not recommended for pregnant women.
Breastfeeding mothers should not use Ethinyl Estradiol + Levonorgestrel (LADY). This may reduce the volume of the breastmilk. Breastfeeding mothers can use progestin-only pills.
Special Precautions
Regular consultation with a healthcare provider is recommended while taking Ethinyl Estradiol + Levonorgestrel (LADY). If patient suffers from diarrhea and/or vomiting, its efficacy may be reduced. Inform the healthcare provider if patient is suffering from the following conditions: diabetes mellitus, high blood pressure, varicose veins, multiple sclerosis, epilepsy, migraine, ophthalmological problems, tetany.
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 (analgesic, anti-migraine and tranquilizer) with contraceptive pill may decrease the contraceptive's efficacy. If patient is advised to take the drugs mentioned previously, consult a healthcare provider for proper intake and dosage schedule of the contraceptive pill.
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 after taking these drugs.
Taking oral contraceptive pills and drugs that induce hepatic enzyme production such as anti-epileptic drugs (carbamazepine, oxcarbazepine, felbamate, topiramate, phenytoin), antifungal (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 a 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
Tab (21 beige-colored and 7 white-colored) 28's.
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