Premarin Vaginal Cream

Premarin Vaginal Cream

estrogens

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Conjugated estrogens
Indications/Uses
Atrophic vaginitis, dyspareunia & kraurosis vulvae.
Dosage/Direction for Use
Intravag Atrophic vaginitis & kraurosis vulvae Initially 0.5 g in cyclic regimen (daily for 21 days & then off for 7 days), may be adjusted to 2 g. Dyspareunia 0.5 g twice wkly administered in continuous regimen or in cyclic regimen (daily for 21 days & then off for 7 days).
Contraindications
Hypersensitivity. Known or suspected estrogen-dependent neoplasia & breast cancer, thrombophilic disorders; undiagnosed abnormal uterine bleeding; active or history of confirmed arterial thromboembolic or venous thromboembolic disorders. Active or chronic hepatic dysfunction or disease. Known or suspected pregnancy.
Special Precautions
Not to be used for prevention of CV disease or dementia. Increased risk of MI, pulmonary embolism, invasive breast & ovarian cancer; CV risk, stroke, VTE; endometrial, breast & ovarian cancer; dementia; gallbladder disease; hypercalcemia; angioedema; fluid retention, cardiac dysfunction; preexisting hypertriglyceridemia; elevated BP; exacerbation of asthma, epilepsy, migraine w/ or w/o aura, otosclerosis, porphyria, SLE & hepatic hemangiomas, endometriosis; hypocalcemia, hypothyroidism; impaired glucose tolerance. Systemic absorption. Concurrent use w/ latex. History of cholestatic jaundice, hepatic impairment. Renal dysfunction. Not to be used during pregnancy & lactation. Not to be used in childn. Elderly >65 yr.
Adverse Reactions
Vaginitis including vag candidiasis, cystitis-like syndrome; benign, malignant & unspecified neoplasms including cysts & polyps; urticaria, angioedema, hypersensitivity, anaphylactic/anaphylactoid reactions; precocious puberty; glucose intolerance, hypocalcemia; changes in libido, mood disturbances, irritability, depression, dementia; nervous system, eye, cardiac, vascular, GI, hepatobiliary, skin & subcutaneous tissue disorders; arthralgia, leg cramps; breakthrough bleeding/spotting, dysmenorrhea/pelvic pain, breast pain, tenderness, enlargement & discharge, vulvovag discomfort eg, burning, irritation & genital pruritus, vag discharge, leucorrhea, gynecomastia in males, increased size of uterine leiomyomata, endometrial hyperplasia; edema; increased/decreased wt, increased triglycerides & BP.
Drug Interactions
Reduced plasma conc w/ CYP3A4 inducers eg, St. John's wort prep, phenobarb, phenytoin, carbamazepine, rifampicin, dexamethasone. Increased plasma conc w/ CYP3A4 inhibitors eg, cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice. Interference w/ lab & other diagnostic tests.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G03CA57 - conjugated estrogens ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
Presentation/Packing
Form
Premarin Vaginal Cream 0.625 mg/g
Packing/Price
14 g x 1's
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