Binodian Depot (Prasterona-Estradiol) Injection Sol 1 ml
This is a Brand Medication
THERAPEUTIC INDICATIONS: Manifestations typical female climacteric deficiency or after ovariectomy, as hot flashes, sweating, sleep disturbances, depression, irritability, headache and dizziness.
Furthermore, BINODIAN DEPOT might favorably influence irritable bladder, frequent in the climacteric, as well as regressive manifestations of the skin and mucous membranes (particularly in the genital region) that usually appear in older age and on osteoporotic disorders.
Contraindications: Pregnancy, hormone dependent tumors of the uterus or breast, or suspected of such, liver tumors (current or history of), endometriosis, congenital disorders of lipid metabolism, a history of aggravation of otosclerosis during a pregnancy, thromboembolism acute arterial (eg, myocardial infarction, stroke), deep vein thrombosis active thromboembolic disorders or documented history of these conditions. Hypersensitivity to the active substance or any excipients.
CAUTIONS: Women who suffer from diabetes, hypertension, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany or chorea minor, require careful medical supervision.
If you have uterine bleeding in perimenopausal women, and, above all in post-menopausal women should be clarified the cause of them.
Avoid pregnancy during treatment. Therefore, depending on the individual situation, patients retain their menstrual function and be exposed to a pregnancy, should use hormonal contraceptive methods. If during treatment with DEPOT BINODIAN not present menstrual bleeding at intervals used, we must have the possibility of pregnancy despite the use of contraceptive measures. In such a case be discontinued until it has made a differential diagnosis.
If during treatment with BINODIAN DEPOT manifestations of hirsutism appeared on the face and legs or voice changes, it is very unlikely to be due to the use of the preparation for, as we know, this kind of events occur spontaneously with some frequency during menopause. However, it is advisable to keep under close medical observation for those patients who make professional use of his voice.
To the smallest change in the timbre or tone (voice tiring easily, harshness, hoarseness) is appropriate to stop treatment, because if the condition is irreversible can not be determined in each case whether it was a spontaneous virilization or not.
Venous thromboembolism: Both randomized controlled studies and epidemiological studies have suggested an increased relative risk of developing venous thromboembolism (VTE), ie deep vein thrombosis or pulmonary embolism. Therefore, it should carefully weigh the benefits / risks with the patient when prescribing HRT to women with a risk factor for VTE.
Generally, VTE risk factors recognized include personal history, family history (the occurrence of VTE in a direct relative relatively early age may indicate genetic disposition) and severe obesity. The risk of VTE also increases with age. There is no consensus about the possible role of varicose veins in VTE.
The risk of VTE may be temporarily increased with prolonged immobilisation, major elective surgery or trauma, or major trauma. Depending on the nature of the event and the duration of detention should be considered a temporary interruption of HRT.
Arterial thromboembolism: In two large clinical trials which used conjugated equine estrogens (CEE) with medroxyprogesterone acetate (MPA) continuously and combined, there was a possible increased risk of ischemic heart disease during the first year of use and then no benefit. A large clinical trial with CEE alone showed a potential reduction in rates of ischemic heart disease in women aged between 50 and 59 years and no overall benefit in the entire study population. As a secondary outcome, in two large clinical trials which used CEE alone or combined with MPA showed a 30-40% increase in risk of stroke. It is uncertain whether these findings also extend to other HRT or routes of administration other than oral.
Breast cancer: clinical and observational studies have shown an increased risk of breast cancer diagnosed in women using HRT for several years. These findings may be due to a diagnosis made early, a growth promoting effects on pre-existing tumor or a combination of both.
Estimates for the overall relative risk of breast cancer diagnosis reported in more than 50 epidemiological studies range in most of them between 1 and 2.
The relative risk increases with duration of treatment and may be lower or possibly neutral with estrogen-only products.
Two large clinical trials of CEE alone or in combination with AMP showed continuing risk estimates of 0.77 (95% CI 0.59 - 1.01) or 1.24 (95% CI 1.01-1.54) after 6 years of use of HRT. It is unknown whether this increased risk also extends to other HRT.
Similar increases were observed for breast cancer diagnosis for example, with the delay of natural menopause, alcohol intake or the presence of fat.
The excess risk disappears at the end of a few years after stopping HRT.
In most studies have reported that tumors are diagnosed in current or recent users of HRT tend to be better differentiated than those found in women nonusers. The information available about the extension beyond the breast is not conclusive.
HRT increases the density of mammographic images, which can adversely affect the radiological detection of breast cancer in some cases.
Endometrial cancer in women with intact uterus, estrogen administration in the long term without the addition of a progestin, increases the risk of endometrial hyperplasia and therefore the endometrial carcinoma. Because no DEPOT BINODIAN progestational activity, avoid the increased risk by additional administration of an appropriate dose of a progestin to the appropriate duration of treatment per cycle.
Ovarian cancer: In an epidemiological study found a slight increased risk of ovarian cancer for women receiving estrogen replacement therapy (ERT) in the long term (more than 10 years), while in a meta-analysis of 15 studies found no increased risk for women taking ERT. Therefore, it is unclear the effect of ERT on ovarian cancer.
Hepatic tumors during treatment with hormonal substances such as those containing BINODIAN DEPOT, there have been sometimes benign liver tumors, and even more rarely, malignant in rare cases can cause bleeding in the abdominal cavity with danger to the patient. If there is severe epigastric pain, enlarged liver or signs of intraabdominal bleeding, one must consider the possibility of a liver tumor in the differential diagnosis.
Dementia: Limited evidence obtained from clinical trials with preparations containing CEE states that hormone therapy may increase the risk of probable dementia if initiated in women aged greater than or equal to 65 years. The risk may be reduced if treatment is initiated early in menopause, as observed in other studies. It is unknown whether these findings also extend to other HRT.
Other conditions: In women with hereditary angioedema, management of endogenous estrogens may induce or exacerbate symptoms of angioedema.
Medical Examination / Consultation: Before starting or restarting treatment with HRT, it is necessary to obtain a medical history and complete physical examination, guided by the contraindications and warnings and they must be repeated periodically. The frequency and nature of these assessments should be based on established practices and standards tailored to the individual woman but should generally include special attention to blood pressure, breasts, abdomen and pelvic organs, including routine cervical cytology.
RESTRICTIONS OF USE DURING PREGNANCY AND BREAST FEEDING: Contraindicated DEPOT BINODIAN employment during pregnancy.
Only a small fraction of estradiol and its metabolites pass into breast milk.
No information is available about the passage of prasterone enanthate (DHEA enanthate) into breast milk.
DOSAGE AND ADMINISTRATION:
Before starting treatment with BINODIAN-DEPOT should be a thorough general medical examination and gynecological (including breast and cervical cytology).
It is convenient to carry out examinations every 6 months for disease control.
Like all BINODIAN-DEPOT oil solutions should be administered intramuscularly. Short-termreactions (urge to cough coughing breathing difficulty) occurring in isolated cases during or immediately after the injection of oil solutions can be avoided as it has proven very slowlyinjecting the solution.
In general, given a vial or syringe intramuscularly every 4 weeks.
The interval between injections can be spaced according to the improvement obtained.
- Name of medicine: Binodian Depot
- Comparable patent medicine: Binodian Depot
- Active ingredient: Prasterone-Estradiol
- Presentation: Injectable Sun
- Concentration: 200 MG/4MG
- Extended-release tablets: No
- Lab: Bayer Dr Mexico, S. A. DE CV
- Box of 1 prefilled syringe
- Made in: Mexico