Bula do remedy Sandrena

the package insert of the medicine Sandrena. Active principles Estradiol.

what For?

SANDRENA is indicated for treatment of the syndrome of the climacteric, associated with deficiency estrogen (ex.: hot flashes, night sweats, tissue atrophy urogenital and depressed mood), the result of natural menopause or surgical. Prevention of osteoporosis post-menopause.

Pharmacokinetics

How it works?

SANDRENA is a gel alcohol based. When applied on the skin the alcohol evaporates rapidly and estradiol is then absorbed and stored in subcutaneous tissue from where it is gradually released into the circulation. The administration percutaneous avoid the effect of the first pass through the liver. For these reasons, the fluctuations in the plasma concentration with SANDRENA are less pronounced that the oestrogen oral. A dose percutaneous estradiol 1.5 mg (1.5 g of gel) results in a plasma concentration of approximately 340 pmol/l, which corresponds to the beginning of the follicular phase of women in pre-menopause. During treatment with SANDRENA, the ratio estradiol/estrone is 0.7, while during the oral treatment, this ratio drops to less than 0.2. The bioavailability of SANDRENA is 82%, compared with the oral dose equivalent, valerato de estradiol. On the other hand, the metabolism and the excretion of estradiol transdermal is the same as the estrogens natural.

Contraindications

When should I not use?

Hypersensitivity to the components of the formula; during pregnancy and lactation; vaginal bleeding not diagnosed; disorders, cardio-or cerebrovascular as tromboflebites, processes, thromboembolic, or a past history of these conditions; liver disorders severe (including syndrome, Dubin-Johnson syndrome, Rotor); cases confirmed or suspected tumors estrogen-dependent (ex.: cancer of breast, endometrial or ovarian cancer).

Dosage

How to use?

SANDRENA is indicated for continuous use, but can be used cyclically. The dose should be adjusted individually from 0.5 g to 1.5 g per day, corresponding to 0.5 mg to 1.5 mg of estradiol per day. The initial dose is 1.0 mg estradiol (1.0 g gel) daily. In patients with uterus intact, is recommended to combine the treatment of SANDRENA with a progestogen, for example, acetate medroxyprogesterone, norethindrone, norethisterone acetate or diidrogesterona for 10-12 days per cycle. In patients in post-menopause is established, the treatment cycles may be increased to 3 months. SANDRENA is administered in a single daily dose, and applied on the skin of the abdomen or thigh (right or left), on alternate days. The surface of application must be in an area of 1-2 feet, or to be, SANDRENA should be well spread and should not be concentrated in an area less than 1 inch. SANDRENA should not be applied on the chest (in the region of the breasts), on the face, skin irritations or in the vaginal area. After the application, you should let the gel dry for a few minutes. Wash your hands well after application to avoid accidental contact of the gel with the eyes. If the patient forgets to apply a dose, this should be applied as soon as possible, within 12 hours after the usual time. If you exceed the 12 hours that dose should be disregarded. The neglect of the doses it can induce bleeding irregular.

Side Effects

What are the evils that can cause me?

The adverse reactions are usually mild and rarely lead to discontinuation of treatment. If you are experiencing adverse reactions, these will occur during the first months of treatment. Occasional: headache, edema, weight gain, tension, tenderness, bleeding vaginal unforeseen or spotting. Rare: Migraine, changes in libido and mood, gastrointestinal disorders (vomiting, stomach cramps), high blood pressure, irritation in the skin.

Warnings and Precautions

what should I know before using?

A full gynecological examination should be performed and repeated at least once a year during treatment. The prolonged use of SANDRENA, without the combined use of a progestogen, can cause endometrial hyperplasia. For this reason, women who have the uterus intact, is recommended the combined use of a progestogen cyclical during treatment with SANDRENA. Withdrawal bleeding similar to menstruation generally occurs after the completion of each cycle of progestogen. In case of a uterine bleeding is unexpected, or prolonged during treatment with SANDRENA, the cause must be researched and clarified. You must take into account the discontinuation of the treatment before a surgery or prolonged immobilisation. The risks and benefits of treatment should be evaluated and monitored strictly in patients who are experiencing: endometriosis; endometrial hyperplasia; cardiovascular diseases, including vascular disorders of the brain; history of thromboembolic disease; hypertension, severe; history (or family history next) of cancer of the breast; disorders of the metabolism of lipids; renal dysfunction. Women in treatment with SANDRENA who presented during pregnancy or hormonal treatment prior) the following situations should be carefully monitored: mild hypertension; migraine or severe headaches; disturbances in liver function; disorders benign breast; cholestasis/cholelithiasis; porphyria; leiomyoma uterine; Diabetes mellitus; epilepsy; asthma; otosclerosis; multiple sclerosis.

Overdose

what to do if someone use a larger amount than is recommended?

Generally, estrogens are well tolerated in overdose. The possible symptoms of an overdose are the same cited for adverse reactions. The treatment is symptomatic.

Introduction

SANDRENA, in the pharmaceutical form of a gel, is packed in sticks of dose unit in packs containing 28 sachets of 0.5 mg, 91 sachets of 0.5 mg, 28 sachets of 1.0 mg, 91 sachets of 1.0 mg.

AKZO NOBEL Ltda Division Organon.

Drug Interactions

There are indications that estrogens reduce the effects of anti-hypertensive drugs, anticoagulants, and antidiabetic agents. The simultaneous treatment with potent inducers enzymatic liver (for example: barbiturates, carbamazepine, griseofulvin, and rifampin) may reduce plasma levels of estradiol. The significance of these interactions in applications transdérmicas has not been well clarified. No interaction between SANDRENA and other medications has been reported.

Introduction

Sandrena
Estradiol

Compositions

Each sachet with 0.5 g of gel contains: Estradiol 0.5 mg. Each sachet with 1.0 g of gel contains: Estradiol 1.0 mg.

Pharmacodynamics

The pharmacodynamics of SANDRENA is similar to that of estrogens in oral, with the greatest difference in relation to oral administration, is found on the pharmacokinetics. The clinical efficacy of SANDRENA, in the treatment of the symptoms of menopause is comparable to that of estrogen administered by the oral route. Combined with the acetate of the medroxyprogesterone, the treatment of percutaneous, with estradiol lowers the total cholesterol without reducing the level of HDL-cholesterol. The treatment with SANDRENA is as efficient as oestrogen oral in the reduction of bone loss in post-menopause.

Administration

SANDRENA is administered in a single daily dose, and applied on the skin of the abdomen or thigh (right or left), on alternate days. The surface of application must be in an area of 1-2 feet, or to be, you should be well spread and should not be concentrated in an area less than 1 inch. SANDRENA should not be applied on the chest (in the region of the breasts), on the face, skin irritations or in the vaginal area. After the application, you should let the gel dry for a few minutes. Wash your hands well after application to avoid accidental contact of the gel with the eyes.

Laboratory

Akzo Nobel Ltda.

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