Overdose : מינון יתר

OVERDOSAGE
In case of overdosage, there is no specific antidote, and the treatment should be symptomatic.

Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur.
DESCRIPTION
DUAVIVE® (conjugated estrogens/bazedoxifene), contains conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist.

Conjugated estrogens are purified from pregnant mares' urine and consist of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. Conjugated estrogens are a mixture of sodium estrone sulfate and sodium equilin sulfate, and also contain as concomitant components, sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin.

Bazedoxifene is supplied as the acetate salt (bazedoxifene acetate) and has the chemical name 1H-Indol-5-ol, 1-[[4-[2-(hexahydro-1H-azepin-1-yl) ethoxy]phenyl]methyl]-2-(4- hydroxyphenyl)-3-methyl-, monoacetate. The empirical formula is C30H34N2O3 • C2H4O2, and the molecular weight is 530.65.

Bazedoxifene acetate is a white to tan powder. The aqueous solubility of bazedoxifene is pH- dependent. Solubility is higher at lower pH. The solubility of bazedoxifene acetate in unbuffered 
sterile water was measured to be 923 microgramsA/mL at pH 5.4. The following represents the chemical structure of bazedoxifene acetate:


CH3
HO
OH
N


. CH
3COOH


O
N


DUAVIVE® is available for oral administration as modified-release tablets containing 0.45 mg of conjugated estrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene. Each modified-release tablet of DUAVIVE® contains the following inactive ingredients: sucrose, hypromellose, lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, calcium phosphate tribasic, macrogol 400, ascorbic acid, sucrose palmitic acid ester, magnesium stearate, titanium dioxide (E171), red iron oxide (E172), hydroxyethylcellulose, povidone (E1201), polydextrose, maltitol liquid, poloxamer 188, black iron oxide (E172), isopropyl alcohol and propylene glycol (E1520).