Femoston Conti 1mg/5mg Abbott Treatment of Estrogen deficiency (1 blister x 28 tablets)

Dosage form Box of 1 blister x 28 tablets
Specifications Dydrogesterone, estradiol

Ingredient

Composition information	Content
Dydrogesterone	5mg
Estradiol	1mg

Uses

indications

Femoston® Conti is indicated in the following cases:

Treatment of estrogen deficiency symptoms in women who have passed the nearest menstrual period at least 12 months.

Prevent osteoporosis in postmenopausal women with high risk of fractures without tolerance, or contraindicated with other drugs that prevent osteoporosis.

Pharmacokology

Pharmaceutical groups: Genital urinary system and sex hormones, progestogen and estrogen, fixed combination. ATC code: G03FA14.

estradiol

The active ingredient of 17p-Eltradiol has been chemically defined and biological is endogenous estradiol in humans.

It replaces the estrogen that has been reduced in menopausal women, and reduces menopausal symptoms.

estrogen helps avoid bone loss caused by menopause or ovarian surgery.

dydrogesterone

dydrogesterone is a oral progestogen that is active in the same activity as the progestogen uses the infusion.

Because the estrogen stimulates the growth of endometrium, the estrogen increases the risk of endometrial hysterectomy and endometrial cancer. Using more progestogen reduces the risk of endometrial hyperplasher caused by the estrogen in women without uterine surgery.

pharmacokinetics

estradiol:

absorption

Estradiol's absorption capacity depends on the size of the urinary sub -size, Estradiol The micro -fertilizer form absorbed immediately through the digestive tract.

Distribution

estrogen has been found both in the form of free and linked. About 98-99% estradiol binds with plasma proteins including about 30-52% linked to albumin and 46-69% weak linking globulin associated with sex hormones (SHBG).

Metabolism

After drinking, Estradiol is very strongly metabolized. The non -linked and linked metabolites are mainly estron and estron sulphat. These metabolites can contribute to the activity of the estrogen, or directly or after turning the esteriol. Estron Sulphat can participate in the periodic period.

Elimination

In the urine, the main compounds are Glucorunide of Estron and Estradiol. Selling time is from 10-16 hours. The estrogen is secreted into breast milk.

Dependence on the dose and time: After taking Femoston every day, estradiol concentration reaches a stable state after about 5 days. In general, the stable concentration is achieved within 8 to 11 days of medication.

dydrogesterone:

absorption

After drinking, Dydrogesterone is quickly absorbed with TMAX from 0.5 to 2.5 hours. The complete bioavailability of dydrogesterone (orally the dose of 20 mg compared to intravenous infusion 7.8 mg) is 28 %.

Distribution

After the intravenous injection Dydrogesterone, the static distribution of the drug is about 1400 liters. More than 90% Dydrogesterone and DHD are linked to plasma proteins

Metabolism

After being used orally, Dydrogesterone was quickly transformed into DHD. The concentration of main metabolites 20α-dihydrodydrogesterone (DHD) peaks at about 1.5 hours after drinking. DHD concentration in plasma is significantly higher than the mother medicine. The AUC and CMAX ratio of DHD and the mother substance are about 40 and 25 respectively. Half of the average semi -discharged of Dydrogesterone and DHD changes between 5 to 7 and 14 to 17 hours respectively. A common feature of all metabolites is the configuration of the 4.6-on Dien 3-on configuration of the mother and the loss of 17p-hydroxy. This explains the lack of the effects of estrogen and androgen of dydrogesterone.

Elimination

After taking Dydrogesterone above, about 63% of the dose is eliminated by the urinary tract. The coefficient of plasma clearance is 6.4 liters/minute. Within 72 hours the drug is completely eliminated. DHD is present in urine in the form of an associated with glucuronic acid.

Depends on the dose and time: pharmacokinetics of single dose (1 most used) and many times are straight lines in the oral range of 2.5 to 10 mg. Compare the dynamic between 1 single and repeated use shows that the pharmacokinetics of dydrogesterone and DHD does not change as the result of the reminders. Stability achieved after 3 days of treatment.

Before taking Femoston Conti 1mg/5mg Abbott Treatment of Estrogen deficiency (1 blister x 28 tablets)

How to use

oral medication.

This

estrogen and progestogen are used every day without interruption.

Use Femoston® Conti continuously without interrupting the boxes.

Femoston® Conti can be used or not used with food.

Dosage

Dosage is a tablet daily in the 28 -day cycle.

Regardless of whether to start or continue treating postmenopausal symptoms, the lowest dose is effective and effective in the shortest time. Continuous combination treatment can start with Femoston® Conti depending on the time from menopause and the severity of symptoms.

Based on clinical response, the dose can be adjusted later.

Patients who move from products are continuously used in order or cycle should complete the 28 -day cycle then switch to Femoston® Conti.

Patients who transfer from combined preparations can start treatment at any time.

Children:

Femoston® Conti is not indicated for children.

Old people:

Experience in treatment in women over 65 years old is limited.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when overdose? However, overdose symptoms may include: nausea, vomiting, breast tightness, dizziness, abdominal pain, drowsiness/fatigue and menstruation. Not sure that overdose symptom treatment is necessary. The above information is also applied to cases of overdose in children.

What to do when you forget 1 dose? If more than 12 hours have passed, the treatment should be continued with the next tablet without using the forgotten tablet. Abnormal possibility of bleeding or increased blood stains.

Side Effects

When using Femoston® Conti, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Infections and parasites: Vaginal candidiasis.

Mental: depression, stress.

nerve: headache, migraine, dizziness.

Digestive system: abdominal pain, nausea, vomiting, flatulence.

Skin and subcutaneous tissue system: skin allergic reaction (e.g. rash, itching).

Muscle and connective tissue: back pain.

Reproductive and breast pain system: pain/breast stretch, menstrual disorders (postmenopausal blood stains, uterine bleeding, menorrhagia, amenorrhea, abnormal menstrual periods, dysmenorrhea), pelvic pain, cervical corrosion.

Body: The state of weakness (weakness, fatigue, instability), peripheral edema, weight gain.

Uncommon, 1/1000

benign, malignant and unknown tumor: Increasing soft muscle tumor size.

The immune system: allergens (hypersensitivity). Mental: Sexual influence. blood vessels: venous thrombosis. liver: abnormal liver function, occasionally accompanied by jaundice or weakness, and abdominal pain, gallbladder disorders.

Breeding and breast system: Big breasts, Premenstrual syndrome.

Body: Losing weight.

Rare, ADR

Heart: myocardial infarction.

Skin and subcutaneous tissue system: angioedema, vascular hemorrhage.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated:

Femoston® Conti drugs contraindicated in the following cases:

Breast cancer is available or still suspicious.

Malignant malignant tumors are known or suspicious (for example: membrane cancer in the uterus).

Progestogen dependent tumors already know or still doubt (for example, meninges).

Genital bleeding has not been diagnosed.

Endometrial hyperplasia that has not been treated.

Previous spontaneous venous thrombosis or being encountered (deep vein thrombosis, pulmonary embolism).

Known bleeding disorders (eg protein C, protein S or deficiency of anticoagulants).

Acute or recent arterial thrombosis (for example: angina, myocardial infarction).

Acute liver disease or a history of liver disease, as long as the liver function tests have not returned to normal.

Rare pigment disorders "Porphyria".

Hypersensitivity to active ingredients or any excipients.

Be cautious when using

for postmenopausal symptomatic treatment, should only start using replacement hormones (HRT) when symptoms adversely affect the quality of life. In any case, it is necessary to be carefully evaluated, at least every year on the benefits and risks. Only continue to use HRT when the benefits are superior to the risk.

Evidence of HRT -related risks in early menopausal treatment is quite limited. However, due to the low level of absolute risk in young women, the balance between benefits and risks in these women can be more convenient in older women.

Exam / monitor:

Before starting to use or start using HRT, it is necessary to fully learn the medical history of the individual and the whole family. Based on medical history and contraindications, warnings when taking drugs, it is necessary to examine the entity (including pelvic and breast areas). During treatment, it is necessary to regularly examine the frequency and properties suitable for each woman. It is necessary to ask the woman to notify the doctor or nursing any change in the breast. Must check, including the appropriate visual methods such as mammography, in accordance with existing screening instructions and are changed according to the clinical requirements of each individual.

The cases need to be monitored:

For any of the following cases, it has happened before, and/or worse during pregnancy or before hormone treatment, patients need to be closely monitored, need to take into account these cases may appear or worse during Femoston® Conti treatment, especially:

Smooth muscle tumor (uterine fibroids) or endometriosis.

Risk factors for thromosomy disorders.

Risk factors for tumor dependent on estrogen, such as the 1 -level genetics for breast cancer.

Hypertension.

Liver dysfunction (such as liver gland).

Diabetes with or without vascular complications.

gallstones.

Migraine or headache (severe).

Systemic Red Reds.

History of endometrial hyperplasia.

epilepsy.

hen.

Ear sclerosis.

Reasons to stop using Femoston® Conti immediately:

Need to stop treating immediately in cases of contraindications and in the following cases:

jaundice or impaired liver function.

significant hypertension.

New start of migraine headache.

pregnancy.

Other cases:

estrogen can cause water retention, so patients with heart or kidney dysfunction should be carefully monitored.

If you have increased blood lipid level (hyper triglyceride), you should be closely monitored when treated with HRT (whether it is only for estrogen or combined or combined preparations). In cases of rare rare lipid (triglyceride), it increases too high, leading to pancreatitis when treated with estrogen for these cases.

estrogens increases the globulin gland (TBG), resulting in an increase in the total amount of thyroid hormones during the circulation. The thyroid hormone in the circulation is determined by iodine associated with protein (PBI), the content of T4 (measured by column or by fluorescent immunity) or T3 (measured by fluorescent immunity). The reduction of T3 absorption reflects high TBG. Free T3 and T4 concentrations are not. Other conjugate proteins may also increase in plasma, ie globulin binding to corticosteroids (CBG), globulin associated with sex hormones (SHBG) leading to an increase in the amount of corticosteroids and sex steroids in the common circulation. Free or biological hormone concentration is unchanged. The concentration of other proteins in plasma can also increase (Angiotensin/Renin precursor, Alpha-i Antitrypsin, Ceruloplasmin).

Using HRT does not improve cognitive function clearly. There are a few evidence of an increase in the risk of a neurological crisis in women in addition to 65 -year -old women starting to use HRT both continuously combined preparations or only using estrogen.

Do not use this drug if you have rare genetic problems such as galactose intolerance, lactase lactase deficiency or Glucose-Galactose.

This combination and progestogen combination therapy is not contraceptive.

The ability to drive and operate machinery

Femoston® Conti does not have or have negligible effects on the ability to drive and operate machinery.

pregnancy

Do not use Femoston® Conti during pregnancy. If you are pregnant while being treated with this Femoston® Conti, you need to stop the drug immediately.

The results of most epidemiological studies have ever been related to unintentional contact between the fetus and the estrogen and progestogen mixture showing that it does not work to be teratogenic or toxic to the fetus. There is no adequate data on the use of dydrogesterone/estradiol in pregnant women.

Breastfeeding period

Do not use Femoston® Conti while breastfeeding.

Drug interaction

There is no research conducted to survey the interaction of Femoston® Conti and other drugs.

Efficiency of estrogen and progestogen may be impaired:

estrogen and progestogen may be metabolized when used simultaneously with enamel metabolic substances, especially P450 2B6, 3A4, 3A5, 3A7, such as anti -epileptic drugs (for example, Phenobarbital, Carbamazepine and Phenytoin) and anti -infection drugs (for example: Rifampicin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutin, Rifabutine nevirapin, efavirenz).

ritonavir and nelfinavir, although it is known to be strong inhibition CYP450 3A4, A5, A7, but on the contrary, it increases effects when used simultaneously with steroid hormones.

Herbal preparations contain St. John’s World (Hypericum Perfloratum) can cause metabolism of estrogen and progestogen through CYP450 3A4.

Clinically, increasing the metabolism of estrogen and progestogen can lead to reduced efficiency and changes in uterine bleeding properties of users.

estrogen can affect the transformation of other drugs:

estrogen can inhibit the metabolic enzyme CYP450 due to competitive inhibition. This effect is particularly significant with substances that have narrow treatment indicators, such as:

tacrolimus and cyclosporine A (CYP450 3A4, 3A3).

fentanyl (CYP450 3A4).

Theophyllin (CYP450 1A2). Clinically

, which leads to an increase in the concentration of drugs affected in plasma to toxicity. Therefore, it may be necessary to tighten the concentration of drug concentration for a long time and reduce the dose of Tacrolimus, Fentanyl, Cyclosporine A and theophyllline may be necessary.

Storage

No storage at temperatures above 30 ° C.

Store in the original packaging and in a dry place.

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