Premarin Vaginal Cream

Premarin Vaginal Cream

estrogens

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
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, may be adjusted to 2 g. Dyspareunia 0.5 g twice wkly administered in cyclic regimen (daily for 21 days & then off for 7 days).
Contraindications
Hypersensitivity. Undiagnosed abnormal uterine bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active or history of arterial or venous thromboembolic disease, thrombophilic disorders. Active or chronic hepatic dysfunction or disease. Known or suspected pregnancy.
Special Precautions
Increased risk of MI, pulmonary embolism, invasive breast & ovarian cancer. CV risk, stroke, venous thromboembolism; endometrial, breast & ovarian cancer; dementia, gallbladder disease, hypercalcemia, angioedema, fluid retention, hypertriglyceridemia, elevated BP, exacerbation of asthma, epilepsy, migraine w/ or w/o aura, otosceloris, porphyria, SLE & hepatic hemangiomas, endometriosis; hypocalcemia, hypothyroidism; impaired glucose tolerance. Systemic absorption. Use w/ latex. History of cholestatic jaundice. Hepatic impairment. Women. Not to be used during pregnancy & lactation. Not for 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, phenobarb, phenytoin, carbamazepine, rifampicin & dexamethasone. Increased plasma conc w/ CYP3A4 inhibitors eg, cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir & grapefruit juice. Reduced response to metyrapone.
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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