Actions of Cerciora-T in details
Pharmacology: Pharmacodynamics: Emergency contraceptive pills are not effective if a woman is already pregnant. Cerciora-T is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, Cerciora-T may inhibit implantation (by altering the endometrium). Cerciora-T is not effective once the process of implantation has begun.
Pharmacokinetics: Absorption: Cerciora-T is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism.
Distribution: The apparent volume of distribution of Cerciora-T is reported to be approximately 1.8 L/kg. It is about 97.5-99% protein-bound, principally to sex hormone binding globulin (SHBG) and to a lesser extent, serum albumin.
Metabolism: Following absorption, Cerciora-T is conjugated at the 17β-OH position to form sulfate conjugates and to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16β-hydroxylevonorgestrel. Cerciora-T and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold and this may account in part for the wide variation observed in Cerciora-T concentrations among users.
Excretion: About 45% of Cerciora-T and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.
How should I take Cerciora-T?
Use Cerciora-T exactly as directed by your doctor or follow the instructions on the package. Cerciora-T is for occasional use as emergency birth control. It should not replace your regular birth control method. You may use Cerciora-T at any time during your monthly period.
Cerciora-T comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Plan B® is available as an over-the-counter medicine for women 17 years of age and older, and is available only with a doctor's prescription for women younger than 17 years of age. Plan B One-Step® is available as an over-the-counter medicine for any woman of childbearing potential.
If you vomit within 2 hours after taking Cerciora-T, call your doctor right away. Your doctor may prescribe another tablet for you.
Dosing
The dose of Cerciora-T will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Cerciora-T. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For emergency contraception:
- For oral dosage form (Plan B One-Step® tablets):
- Adults and teenagers—One tablet taken as soon as possible and not more than 72 hours (3 days) after unprotected sex or after failure of another birth control method.
- For oral dosage form (Plan B® tablets):
- Adults and teenagers 17 years of age and older—One tablet taken as soon as possible and not more than 72 hours (3 days) after unprotected sex or after failure of another birth control method. A second tablet should be taken 12 hours after the first dose.
- Children younger than 17 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (Plan B One-Step® tablets):
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Cerciora-T administration
Cerciora-T is a T-shaped plastic device that is inserted through the vagina and placed into the uterus. You will receive the device in a clinic setting. Your doctor will place the device into your uterus using a thin plastic tube. The device is usually inserted within 7 days after the start of a menstrual period.
You may feel pain or dizziness during insertion of the intrauterine device. You may also have some vaginal bleeding. These symptoms should last only 30 minutes or less after the device is inserted, especially if you stay in a sitting or lying position during that time. Tell your doctor if you still have these symptoms after 30 minutes have passed.
A pair of strings is attached to the device for removal when you decide to discontinue using it. Your doctor will cut these strings short enough so they do not protrude from your vagina. Do not pull on the strings or attempt to remove the device.
After each menstrual period you should check to make sure you can still feel the removal strings. Wash your hands with soap and water, and insert your clean fingers into the vagina. You should be able to feel the strings deep inside the vagina, at the opening of your cervix. Call your doctor at once if you cannot feel the strings, or if you think the device has slipped lower in your uterus or out of your uterus. A sudden increase in menstrual flow may be a sign that the device has slipped out of place.
If you think the device is not properly in place, use a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy until your doctor is able to replace the Cerciora-T device.
Your doctor will need to see you within 4 and 12 weeks after insertion of the device to make sure it is still in place correctly. Be sure to also have regular annual pelvic exams and Pap smears while you are using the Cerciora-T intrauterine system.
The Cerciora-T intrauterine system should not interfere with sexual intercourse, wearing tampons, or using other vaginal medications recommended by your doctor.
You may have irregular periods during the first 3 to 6 months of using the intrauterine system. Your flow may be lighter or heavier, and you may eventually stop having periods after several months. Contact your doctor if you think you might be pregnant, or if you do not have a menstrual period for 6 weeks in a row.
The Cerciora-T intrauterine system must be removed at the end of the 5-year wearing time. Your doctor can insert a new device at that time if you wish to continue using this form of contraception. Only your doctor should remove the intrauterine system. Do not attempt to remove the device yourself.
Following removal of the Cerciora-T intrauterine device, you may become pregnant right away. Most women who choose to discontinue using the device in order to have a baby will become pregnant within the first year after removal.
Cerciora-T pharmacology
Mechanism of Action
Emergency contraceptive pills are not effective if a woman is already pregnant. Cerciora-T tablets, 0.75 mg is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.
Pharmacokinetics
Absorption
No specific investigation of the absolute bioavailability of Cerciora-T tablets, 0.75 mg in humans has been conducted. However, literature indicates that Cerciora-T is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism.
After a single dose of Cerciora-T tablets, 0.75 mg administered to 16 women under fasting conditions, the mean maximum serum concentration of Cerciora-T was 14.1 ng/mL at an average of 1.6 hours. See Table 2.
Effect of Food: The effect of food on the rate and the extent of Cerciora-T absorption following single oral administration of Cerciora-T tablets, 0.75 mg has not been evaluated.
Distribution
The apparent volume of distribution of Cerciora-T is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.
Metabolism
Following absorption, Cerciora-T is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Cerciora-T and its phase ׀ metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in Cerciora-T concentrations among users.
Excretion
About 45% of Cerciora-T and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.
Specific Populations
Pediatric: This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.
Geriatric: This product is not intended for use in postmenopausal women, and pharmacokinetic data are not available for this population.
Race: No formal studies have evaluated the effect of race on pharmacokinetics of Cerciora-T tablets, 0.75 mg. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Cerciora-T tablets, 0.75 mg and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.
Hepatic Impairment: No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Cerciora-T tablets, 0.75 mg.
Renal Impairment: No formal studies were conducted to evaluate the effect of renal disease on the disposition of Cerciora-T tablets, 0.75 mg.
Drug-Drug Interactions
No formal drug-drug interaction studies were conducted with Cerciora-T tablets, 0.75 mg.
References
- 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).
- NCIt. "Levonorgestrel: 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).
- EPA DSStox. "Norgestrel: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Cerciora-T 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 Cerciora-T. 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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
