Valena Cream

Valena Cream is used for: Vulvular and vaginal atrophy, Atrophic vaginitis

Vaginal Prep (Vaginal Cream 0.01%) Vulvular and vaginal atrophy due to menopause Adult The usual dosage range is 2 to 4 g (marked on the applicator) daily for one or two weeks, then gradually reduced to one-half initial dosage for a similar period. A maintenance dosage of 1g, one to three times a week, may be used after restoration of the vaginal mucosa has been achieved. Vaginal Prep (Vaginal Tab) Atrophic vaginitis Adult: Initial: Insert 1 tab (20 mcg) once daily for 2 wk. Maintenance: Insert 1 tab twice wkly. Attempt to discontinue or taper medication at 3-6 mthly intervals.

Intravaginal Administration Instructions for Applicator Use: Step 1. Open the sealed wrapper and remove the applicator. Step 2. Insert the tip of the applicator into the tube. Step 3. Press down the tube and squeeze the specified amount of gel into the applicator tube. Step 4. Remove the applicator from the tube. Step 5. Gently insert the rounded tip of the applicator. Step 6. Push the plunger to release the cream. Step 7. Remove the applicator. (It is normal for a small amount of gel to be left in the applicator. You will still get the right dose of medicine.) Keep the applicator clean and germ free for later use. Vaginal cream or tablet Use the applicator provided with drug to insert vaginal tablet or measure dose of vaginal cream Lay on back with pelvis slightly tilted upward, or stand with one knee bent (ie, foot on seat of chair or toilet), insert the prescribed dose with the applicator The applicator should be inserted (without forcing) as far as comfortably possible, or until half of the applicator is inside vagina Note: The vaginal tablet dissolves gradually over several hours, so bedtime application may be desired

Undiagnosed abnormal genital bleeding Known, suspected, or history of breast cancer Known or suspected estrogen-dependent neoplasia Active DVT, PE, or history of these conditions Active arterial thromboembolic disease (eg, stroke, MI), or a history of these conditions Known anaphylactic reaction or angioedema to estrogen Known liver impairment or disease Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Known or suspected pregnancy

Increased risk of endometrial cancer Close clinical surveillance of all women taking estrogens is important Risk of endometrial cancer in women with a uterus increases with use of unopposed estrogens; adding progestin to estrogen therapy may reduce risk of endometrial hyperplasia, a precursor to endometrial cancer Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding Breast cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer; prescribe estrogens with or without progestins at the lowest doses and for the shortest duration System absorption occurs with intravaginal administration; consider warnings, precautions, and adverse effects associated with systemic estrogen-alone therapy Increased risk of stroke and DVT reported with estrogen-alone therapy; increased risk of PE, DVT, stroke, and MI reported with estrogen plus progestin therapy; discontinue drug immediately if these conditions occur or are suspected The WHI estrogen plus progestin substudy reported a statistically nonsignificant increased risk of ovarian cancer (4 vs 3 cases per 10,000 women-years) Estrogen with or without progesterone may increase risk of dementia Increased risk of gallbladder disease (2- to 4-fold) requiring surgery in postmenopausal women receiving estrogen has been reported Severe hypercalcemia in women with breast cancer and bone metastases reported with estrogen use; if hypercalcemia occurs, discontinue estrogen and initiate appropriate treatment to reduce serum calcium level Retinal vascular thrombosis reported; discontinue estrogen pending examination if there is a sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if papilledema or retinal vascular lesions diagnosed, permanently discontinue estrogens Rare occurrences reported of substantial blood pressure increases that were attributed to idiosyncratic reactions to estrogens May cause elevated triglycerides that lead to pancreatitis in women with preexisting hypertriglyceridemia; discontinue estrogens if pancreatitis occurs Estrogens may be poorly metabolized with hepatic impairment; if cholestatic jaundice occurs, discontinue estrogens; exercise caution in any woman with a history of cholestatic jaundice associated with past estrogen use or with pregnancy Estrogen administration leads to increased thyroid-binding globulin (TBG) levels; women with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range, however, women dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy; monitor thyroid function in these women during treatment to maintain their free thyroid hormone levels in an acceptable range Estrogens may cause some degree of fluid retention; women with conditions that might be influenced by this factor (eg, cardiac or renal impairment) warrant careful observation; monitor any woman with a condition(s) that might predispose her to fluid retention, such as cardiac or renal impairment; discontinue estrogen-alone therapy with evidence of medically concerning fluid retention Malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy; if residual endometriosis post-hysterectomy exists, the addition of progestin should be considered Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema; consider whether benefits of estrogen therapy outweigh risks in such women Estrogen therapy may exacerbate asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; consider whether benefits of estrogen therapy outweigh risks in women with these conditions Local abrasion induced by vaginal tablet applicator reported Serum follicle stimulating hormone (FSH) and estradiol levels not shown for the management of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity Estrogen-induced hypocalcemia may occur in women with hypoparathyroidism; consider whether benefits of estrogen therapy outweigh risks in such women

Pregnancy Not indicated for use in pregnancy; there are no data with use in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy Lactation Estrogens are present in human milk and can reduce milk production in breast-feeding females; this reduction can occur at any time but is less likely to occur once breastfeeding is well-established; the clinical need for therapy and any potential adverse effects on breastfed child or from underlying maternal condition. developmental and health benefits of breastfeeding should be considered along with the mother’s

CYP3A4 inducers or inhibitors may affect estrogen drug metabolism CYP3A4 inducers (eg, St. John's wort [Hypericum perforatum] preparations, phenobarbital, carbamazepine, and rifampin) may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice) may increase plasma concentrations of estrogens and may result in side effects

Side effects of Estradiol vag prep : >10% Headache (5-16%) 1-10% Vulvovaginal mycotic infection (5-8%) Vulvovaginal pruritus (8%) Back pain (7%) Abdominal pain (7%) Diarrhea (5%) Breast pain, Irregular vaginal bleeding or spotting, Abdominal bloating, Nausea and vomiting, Hair loss, Fluid retention, Vaginal yeast infection, Reactions from inserting Vaginal Cream, such as vaginal burning, irritation, itching etc.

Estradiol is a naturally occurring oestrogen. Oestrogens are responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. They modulate the pituitary secretion of gonadotrophins, LH and FSH through a negative feedback system.

Valena 0.01% Cream manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Estradiol vag prep. Valena is availble in Bangladesh. Farmaco BD drug index information on Valena Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.