Femoston 1mg/10mg Abbott treats estrogen deficiency (1 blister x 28 tablets)

Dosage form Box of 1 blister x 28 tablets
Specifications Estradiol, Didrogesterona

Ingredient

Composition information	Content
Estradiol	1mg
Didrogesterona	10mg

Uses

Indication

Femoston 1/10 mg is indicated in the following cases:

Treat the symptoms of estrogen deficiency in women who have passed the nearest menstrual period at least 6 months.

Prevention of osteoporosis in women after menopause people who are at high risk of fractures and those who are not tolerated, or contraindicated with other drugs used to prevent osteoporosis.The active ingredient of 17-Eltradiol has been chemically and biologically determined, endogenous esteriol in humans. It replaces the estrogen that has been reduced in menopausal women, and reduces menopausal symptoms. The estrogen helps avoid bone loss due to menopause or ovarian surgery.

dydrogesterone

Dydrogesterone is a oral progestogen that is active equivalent to progestogen uses an infusion. The estrogen stimulates the growth of endometrium, so the estrogen increases the risk of endometrial and endometrial cancer. Using more progestogen reduces the risk of endometrial hyperplasher caused by the estrogen in women without uterine surgery.

Pharmacokinetics

absorption

When used orally, Estradiol is absorbed by the digestive tract.

Dydrogesterone is quickly absorbed with TMAX from 0.5 to 2.5 hours. The complete bioavailability of dydrogesterone (oral at the dose of 20 mg compared to intravenously 7.8 mg) is 28%.

Distribution

The estrogen has been found both in the form of free and weak links with plasma albumin with non -specific bonds or strong affinity links with globulin global hormones (SHBG). The ratio attached to SHBG varies from 9 - 37% in premenopausal women and 23 - 53% in postmenopausal women using estrogen combined.

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

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, both directly and after turning the estradiol form. Estron Sulphat can participate in the intestinal circulation.

After being used orally, Dydrogesterone was quickly transformed into DHD. The concentration of main metabolites 20β-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.

Elimination

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

After taking Dydrogesterone, about 63% of the dose is excreted by urinary tract.

Before taking Femoston 1mg/10mg Abbott treats estrogen deficiency (1 blister x 28 tablets)

How to use

oral medication.

Dosage

Adults

The order of drug use must be specified on the blister.

Especially use 1 white tablet a day for the first 14 days and followed by 1 gray tablet per day for the next 14 days.

Continue to use Femoston 1/10 continuously without interrupting the medicine box.

Regardless of whether or not to connect the treatment of postmenopausal symptoms, the doctor will always prescribe the lowest possible dose in the shortest time.

If you are not using any HRT product or are moving from a combined preparation used sequential (for example, both estrogen and progesterone are combined in 1 tablet used every day), can use Femoston 1/10 on any convenient day.

If you are moving from HRT products "cycle" to "serial" (this is when using an estrogen or using a sticker in the first part of the cycle, followed by a daily tablet containing both the estrogen and progestogen up to 14 days), start using Femoston 1 October after you finish the previous medicine box (for example on the last day of the Progestogen period).

The doctor will adjust the dose depending on the response to the drug.

If you forget to take the medicine, you should take it as soon as possible. However, if the time to forget to drink is more than 12 hours, you should continue taking the next tablet without taking the capsules. If this happens, the possibility of uterine bleeding will increase.

Femoston 1/10 can be used or not used with food; However, tablets should be taken with water.

Children

Femoston 1/10 is not specified for children.

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 to do when overdose?

Both Estradiol and Dydrogesterone are low -toxic active ingredients. If you take too many Femoston tablets, it is not sure that it will cause any harm. However, overdose symptoms may include: nausea, vomiting, drowsiness and dizziness.

Not sure to treat overdose is necessary. However, if you (or anyone else) take too many medications, notify your doctor immediately. The above information has not applied for cases of overdose in children.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Common, ADR> 1/100

Nervous system: migraine.

Digestive: Nausea, abdominal pain, flatulence.

Muscle muscle: cramps.

Reproductive system: pain/breast tightness, bleeding, uterine hemorrhage, pelvic pain.

Uncommon, 1/1000

Genital system: Vaginal candidiasis.

Muscle system: Increased soft muscle tumor size.

Mental: depression, sexual change, stress.

Neurological: dizziness. cardiovascular: venous thrombosis. liver: gallbladder disease.

Skin and subcutaneous tissue: skin allergies.

Muscle muscle: back pain.

Reproductive system: uterine corrosion, menstruation.

Rare ADR

Blood and lymphatic system: Weakness of destruction of red blood cells (hemolytic anemia), pale blue skin, body fatigue, shortness of breath.

immune: allergic reactions (hypersensitivity).

Neuroscope: Mechanical incontinence (dancing).

Eyes: No contact lens tolerance.

cardiovascular: myocardial infarction, stroke. digestion: vomiting. liver: abnormalities of liver function, jaundice, eyes, weakness, difficulty in, abdominal pain.

Skin and subcutaneous tissue: External edema, Diverse Red Red Red Red Red Roses ...

Reproduction system: Big breasts, premenopause syndrome.

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

Contraindicated

Femoston medicine 1/10 contraindicated in the following cases:

Allergy (hypersensitivity) with estradiol, dydrogesterone or any other component of Femoston.

Ever or suspected breast cancer.

Suspected tumors that: depending on the estrogen (such as the membrane cancer in the uterus (endometrial cancer)), or a tumor dependent on progestogen (such as meningitis).

Vaginal hemorrhage is not diagnosed (for example, unexplained cause).

Membrane in the uterus thickens abnormally (endometrial hyperplasia) without starting treatment.

is or has been caused by blood clots in the legs or lungs (venous thrombosis, such as deep vein thrombosis, pulmonary embolism).

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

Being or recently suffered from a disease caused by blood clots in arteries (arterial thrombosis), such as angina or infarction (myocardial infarction).

Being or having liver disease, and the liver function test indicators have not returned to normal.

Rare pigment disorders called "porphyria" that can be inherited or suffered.

Family history of gynecological cancer.

Be cautious when using

for postmenopausal symptomatic treatment, treatment with Femoston 1/I0 should only be started if symptoms seriously affect the quality of life. Consider risk factors and treatment benefits.

examination and monitoring

Before starting or reusing HRT, should notify the full medical history doctor of individuals and families. During the treatment process, periodic tests should be checked, including periodic breast x-rays at least 1 time per year.

Important note

Periodic breast test. If you have any abnormalities in the breast, immediately notify your doctor.

Cases of monitoring:

Endodical hyperplasia (uterine fibroids) or external tissues (endometriosis).

gallstones (gallstones).

migraine or severe headache.

Reasons to stop using Femoston immediately

jaundice and/or white eyes (jaundice).

Breast cancer

There is evidence that increases the risk of breast cancer progression in women who use the form of estrogen/progestogen and can only use the estrogen only, which depends on the treatment time.

Eliminating therapy of combining

The risk of breast cancer increases in women who use ITRR to combine the estrogen-Progestogen, clearly visible after about 3 years.

Oestrogen therapy

The risk of breast cancer does not increase in women who have surgery to remove the uterus only using the estrogen only to replace hormones. Observatory studies show that the rate of increased risk of breast cancer in the group only takes significantly lower by estrogen than the group using the estrogen-Progestogen mixture.

Hypermath of uterine mac and carcinoma

In women, the uterus is intact, the risk of increased endometrial and carcinoma increases when using the estrogen alone for a long time. Reports show that the risk of endometrial cancer in people who only use the estrogen only increases by 2 to 12 times compared to non -use people, depending on the duration of treatment and the dose of estrogen used.

Ovarian cancer

Ovarian cancer is rarer than breast cancer. Long -term use (at least 5 - 10 years) only estrogen is associated with slight increase in the risk of ovarian cancer.

Deep vein thrombosis

HRT is associated with increasing 1.3-3 times the risk of venous thrombosis (VTE), such as deep vein thrombosis or pulmonary embolism. This risk in the first year of using HRT is higher than in the following years.

It is necessary to consider the kidneys between benefits and risks when used, HRT. If VTE progresses after starting treatment with Femoston 1/10, it is advisable to stop the treatment.

Coronary artery disease (CAD)

There is no evidence from randomized tests that control the protection against muscle infarction in women with or without coronary artery disease (CAD) using HRT to coordinate the estrogen-Progestogen or only estrogen.

Oestrogen-Progestogen combination therapy: The risk of relative CAD increases slightly when using HRT in combination with estrogen and progestogen.

Therapy only used by estrogen: Random data controlled shows that the risk of CAD does not increase in women surgery surgery for uterine cutting only using estrogen only.

Brain stroke

HRT, including estrogen and progestogen combination therapy and only estrogen only increases the risk of brainstorming to 1.5 times.

Other cases

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

If there is an increase in blood lipid levels (hyperliglycerides), it is advisable to be monitored closely when treated with HRT (whether using only estrogen or combined preparations).

The estrogen can affect thyroid function.

Do not use this medication if you have rare genetic problems such as galactose intolerance, lactase lactase deficiency, or glucose-galactose. Femoston 1/10 is not a contraceptive and is not used for women who intend to get pregnant. In case of suspicion, use contraception without hormone

Femoston 1/10 contains lactose monohydrates. If you do not tolerate some lines, especially lactose, ask your doctor before taking this medication.

The ability to drive and operate machinery

Femoston 1/10 does not have or have negligible effects on the ability to drive and operate machinery.

Pregnancy

Do not use Femoston 1/10 if pregnant.

Breastfeeding period

Do not use Femoston 1/10 if breastfeeding.

Interaction

The following drugs can reduce the effect of Femoston and increase bleeding or hemorrhage:

Treatment drugs: epilepsy (phenobarbital, carbamazepin and phenytoin); HIV infection [AIDS] (such as ritonavir, nelfinavir).

Herbal drugs containing the enzyme of St John (the extract of the tree called the enzyme of St. John is found in herbal preparations used especially for menopausal symptoms).

estrogen can slow down other drugs, which can lead to increased concentration of those drugs in the blood. In addition, the drug control is careful and the ability to reduce the dose may be necessary, especially for the following drugs: tacrolimus, fentanyl, cyclosporin A, and theophylin.

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 (such as Phenobarbital, Carbamazepin, Phenytoin) Rifampicin, Rifabutin, Nevirapin, Efavirenz).

Ritonavir and Nelfinavir, although it has been known to inhibit the strong CYP450 3A4, A5, A7, but on the contrary, it increases the effects when used simultaneously with steroid hormones.

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

Clinically, increasing the metabolism of the estrogen and progestogen can lead to reduction and change in uterine bleeding properties of the user.

estrogen may affect other substances: tacrolimus and cyclosporin A (CYP450 3A4, 3A3); Fentanyl (CYP450 3A4); Theophylin (CYP450 1A2).

Estrogen can reduce the effectiveness of triple antidepressants and can enhance the coricoid effect by prolonging the half -life of the drug.

Storage

Store at a temperature not exceeding 30 ° C.

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