Duoluton-L Actions

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Actions of Duoluton-L in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: The hormonal components of Duoluton-L inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms which may contribute to the effectiveness of Duoluton-L as a contraceptive include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Pharmacokinetics: Ethinyl Estradiol (Duoluton-L) is subject to considerate first-pass metabolism with a mean bioavailability of 40-45%. Levonorgestrel (Duoluton-L) does not undergo first-pass metabolism and is therefore completely bioavailable.

Levonorgestrel (Duoluton-L) is extensively plasma protein-bound both to sex hormone-binding globulin (SHBG) and albumin. Ethinyl Estradiol (Duoluton-L) however, is bound in plasma only to albumin and enhances the binding capacity of SHBG. Following oral administration, peak plasma levels of each drug occur within 1 to 4 hours. The elimination half-life for Ethinyl Estradiol (Duoluton-L) is approximately 25 hours. It is primarily metabolized by aromatic hydroxylation but a wide variety of hydroxylated and methylated metabolites are formed, and these are present both free and as conjugates with glucuronide and sulfate. Conjugated Ethinyl Estradiol (Duoluton-L) is excreted in bile and subject to enterohepatic recirculation. About 40% of the drug is excreted in the urine and 60% is eliminated in the feces.

Elimination half-life for Levonorgestrel (Duoluton-L) is approximately 24 hours. The drug is primarily metabolized by reduction of the A ring followed by glucuronidation. About 60% of Levonorgestrel (Duoluton-L) is excreted in the urine and 40% is eliminated in the feces.

How should I take Duoluton-L?

Take Duoluton-L exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Read the entire patient information book before using the Ethinyl Estradiol (Duoluton-L) and Levonorgestrel (Duoluton-L) emergency contraceptive kit.

Use the pregnancy test provided to determine if you are already pregnant from sex earlier in the month or in a previous month. Duoluton-L will not be effective if you are already pregnant.

To use the pregnancy test:

If a pink/purple line appears in the round window, you are pregnant. Do not take Duoluton-L, it will not work. Contact your doctor immediately. The test may show that you are pregnant when you are not if you have had a miscarriage or have given birth within the past 8 weeks. Ask your doctor for help in interpreting the test if you have recently been pregnant.

If no pink/purple line appears in the round window, the test is negative and you are not pregnant. Take two Duoluton-L tablets as soon as possible and within 72 hours of having unprotected sex. Take the second dose of two tablets 12 hours after the first dose.

The first dose of Duoluton-L must be taken as soon as possible and within 72 hours of having unprotected sex, and the second dose 12 hours following the first, to be effective.

If you vomit within one hour of taking either dose of Duoluton-L, contact your doctor.

Schedule a follow-up visit with your doctor for three weeks after taking Duoluton-L.

Contact your doctor as soon as possible if you miss your period following the use of Duoluton-L.

Duoluton-L is not intended for use as ongoing pregnancy protection and should not be used as a routine form of contraception.

Store Duoluton-L at room temperature away from moisture and heat.

Duoluton-L administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.

The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store this medication at room temperature away from moisture and heat.

Duoluton-L pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Mode of Action

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Pharmacokinetics

Absorption

No specific investigation of the absolute bioavailability of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) in humans has been conducted. However, literature indicates that Levonorgestrel (Duoluton-L) is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism. Ethinyl Estradiol (Duoluton-L) is rapidly and almost completely absorbed from the gastrointestinal tract but, due to first-pass metabolism in gut mucosa and liver, the bioavailability of Ethinyl Estradiol (Duoluton-L) is between 38% and 48%.

A summary of the single dose and multiple dose Levonorgestrel (Duoluton-L) and Ethinyl Estradiol (Duoluton-L) pharmacokinetic parameters for 18 women under fasting conditions is provided in Table 1. The plasma concentrations of Levonorgestrel (Duoluton-L) and Ethinyl Estradiol (Duoluton-L) reached steady-state by approximately day 14. Levonorgestrel (Duoluton-L) and Ethinyl Estradiol (Duoluton-L) concentrations did not increase from days 14 to 28, but did increase from days 1 to 28.

Table 1: Mean (SD) Pharmacokinetic Parameters of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) Over a 28-Day Dosing Period

The effect of food on the rate and the extent of Levonorgestrel (Duoluton-L) and Ethinyl Estradiol (Duoluton-L) absorption following oral administration of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) has not been evaluated.

Distribution

Levonorgestrel (Duoluton-L) in serum is primarily bound to sex hormone-binding globulin (SHBG). Ethinyl Estradiol (Duoluton-L) is about 97% bound to serum albumin. Ethinyl Estradiol (Duoluton-L) does not bind to SHBG, but induces SHBG synthesis.

Metabolism

Levonorgestrel (Duoluton-L): The most important metabolic pathways are reduction of the Δ4-3-oxo group and hydroxylation at positions 2α, 1β, followed by conjugation. Most of the circulating metabolites are sulfates of 3α, 5β-tetrahydro-Levonorgestrel (Duoluton-L), while excretion occurs predominantly in the form of glucuronides. Some of the parent Levonorgestrel (Duoluton-L) also circulates as 17β-sulfate. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in Levonorgestrel (Duoluton-L) concentrations among users.

Ethinyl Estradiol (Duoluton-L): Cytochrome P450 enzymes (CYP3A4) in the liver are responsible for the 2-hydroxylation that is the major oxidative reaction. The 2-hydroxy metabolite is further transformed by methylation, sulfation, and glucuronidation prior to urinary and fecal excretion. Levels of CYP3A4 vary widely among individuals and can explain the variation in rates of Ethinyl Estradiol (Duoluton-L) 2-hydroxylation.

Excretion

The terminal elimination half-life for Levonorgestrel (Duoluton-L) in Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) is about 36 hours. Levonorgestrel (Duoluton-L) and its metabolites are excreted in the urine (40% to 68%) and in feces (16% to 48%). The terminal elimination half-life of Ethinyl Estradiol (Duoluton-L) in Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) is about 21 hours.

Ethinyl Estradiol (Duoluton-L) is excreted in the urine and feces as glucuronide and sulfate conjugates and undergoes enterohepatic recirculation.

Special Populations

Race

No formal studies on the effect of race on the pharmacokinetic parameters of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) were conducted.

Hepatic Insufficiency

No formal studies have evaluated the effect of hepatic disease on the disposition of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets). However, steroid hormones may be poorly metabolized in patients with impaired liver function.

Renal Insufficiency

No formal studies have evaluated the effect of renal disease on the disposition of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets).

Drug-Drug Interactions

Clinical Studies

The efficacy and safety of Duoluton-L (Levonorgestrel (Duoluton-L) and ethinyl estradol tablets) were studied in 2 one-year clinical trials of subjects age 18



References

  1. DailyMed. "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "ESTRADIOL; LEVONORGESTREL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. NCIt. "Ethinyl Estradiol: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Duoluton-L are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Duoluton-L. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

5 consumers reported administration

When best can I take Duoluton-L, on an empty stomach, before or after food?
ndrugs.com website users have also released a report stating that Duoluton-L should be taken After food. In any case, this may not be the right description on how you ought to take this Duoluton-L. Kindly visit your doctor for more medical advice in this regard. Click here to see other users view on when best the Duoluton-L can be taken.
Users%
After food5
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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