5. stroke หรือ heart attack มาแล้วเป็นเวลา 1 ปี ภาวะเส้นเลือดขอดที่
ขา ผู้ป่วยที่มีปัญหาตับหรืออาการแพ้ที่เกิดจากการใช้ EstroGel® ผู้
ป่วยที่ตั้งครรภ์ หรือ อยู่ในระหว่างให้นมบุตร ผู้ป่วยที่เป็น
endometriosis หรือมี abnormal mammogram
ผู้ป่วยที่ได้รับฮอร์โมนเอสโตรเจน ควรมีการตรวจเซ็คสุขภาพ
เนื่องจากเมื่อเอสโตรเจนสูงขึ้นจะเพิ่มโอกาสการเกิดมะเร็ง
มดลูกได้
อาการข้างเคียง ปวดหัว เจ็บหน้าอกและหัวนม มีเลือดไหลกระปิดกระ
ปรอย ปวดเกร็งที่ช่องท้อง คลื่นไส้ อาเจียน และผมร่วง
การใช้ยาเอสโตรเจนชนิดทา มีโอกาสทำาให้เกิดอาการข้างเคียงน้อย
กว่า ยาเอสโตรเจนชนิดรับประทาน
ยาบางชนิดอาจเกิดปฏิกิริยากับ Estradiol Gel เช่น
• Azole antifungals (eg, ketoconazole), HIV protease
inhibitors (eg, ritonavir), or macrolide antibiotics (eg,
erythromycin) because they may increase the risk of
Estradiol Gel's side effects
• Barbiturates (eg, phenobarbital), carbamazepine,
hydantoins (eg, phenytoin), rifampin, or St. John's
wort because they may decrease Estradiol Gel's
effectiveness
• Thyroid hormones (eg, levothyroxine) because their
effectiveness may be decreased by Estradiol Gel
• การดื่ม grapefruit อาจเพิ่มความเสี่ยงของการเกิดอาการข้าง
เคียงได้
• ควรหยุดให้ Estradiol Gel อย่างน้อย 4 to 6 สัปดาห์ก่อนการ
ผ่าตัด
• Estradiol Gel อาจทำาให้ผิวหนังเป็นรอยดำาที่ใบหน้าได้ และการ
สัมผัสแสงแดดจะทำาให้หน้ามีรอยดำามากขึ้น อาจแก้ไขโดยการใช้
ครีมกันแดด หรือปกป้องผิวจากแสงแดด
6. • ควรระมัดระวังในการใช้ในผู้ป่วยเบาหวานเนื่องจาก Estradiol
Gel อาจมีผลต่อระดับนำ้าตาลได้
การเก็บรักษา Estradiol Gel
เก็บยาที่อุณหภูมิ 20 - 25 degrees C. เก็บให้ห่างจากความร้อน
ความชื้นและแสง ห้ามเก็บไว้ในห้องนำ้าและเก็บให้พ้นมือเด็ก
Literature References
Schmidt JW, Wollner D, Curcio J, Riedlinger J, Kim LS
Hormone replacement therapy in menopausal women:
Past problems and future possibilities. Gynecological
endocrinology : the official journal of the International
Society of Gynecological Endocrinology 2006
Oct;22(10):564-77.
Archer DF; EstroGel Study Group Percutaneous 17beta-
estradiol gel for the treatment of vasomotor symptoms in
postmenopausal women. Menopause (New York, N.Y.)
2003 Nov-Dec;10(6):516-21.
ตอบคำาถามโดย อ.ดร.อรนุช ธนเขตไพศาล
7. ESTRADIOL-TOPICAL GEL
GENERIC NAME: ESTRADIOL - TOPICAL GEL (ess-truh-
DYE-all)
BRAND NAME(S): Estrogel
USES: This medication is a female hormone (an estrogen)
and is usually given to women who no longer produce the
proper amount. It is used to reduce menopause
symptoms (e.g., hot flashes, vaginal dryness). If you are
only being treated for vaginal menopause symptoms,
products applied locally such as vaginal creams, tablets,
or rings should be considered before products absorbed
through the skin.
OTHER USES: Estrogens have also been used to prevent
bone loss (osteoporosis) in people at high risk, and to
treat other conditions as determined by your doctor.
There are several medications (e.g., raloxifene or
bisphosphonates) that are safe and effective to prevent
or treat bone loss. These medicines should be considered
for use before estrogen therapy. If you have other
medical conditions as well, and are prescribed estrogens
for more than one condition, consult your doctor about
your treatment plan and its options.
HOW TO USE: Read the Patient Information Leaflet which
contains instructions for proper use of this medication.
Consult your doctor or pharmacist if you have any
questions. Use this medication exactly as prescribed. This
medicine is usually applied once daily; or as directed by
your doctor. Apply it to clean, dry, unbroken skin on one
arm. A thin layer of medicine should be spread on the
inside and outside of your arm from the wrist to the
shoulder. It is not necessary to rub this medicine into the
skin. Allow the drug to dry for up to 5 minutes before
8. dressing. Wash your hands with soap and water after you
have finished applying this medicine. If you shower or
take a bath before applying this medicine, allow the skin
to dry before applying it. Do not apply to any skin that is
red or irritated, and do not apply directly on the breasts.
Use this medication regularly in order to get the most
benefit from it. Remember to use it at the same time
each day. Keep this medicine away from your eyes. If this
medicine gets in your eyes, rinse your eyes immediately
with warm water and call your doctor. Do not apply
sunscreen with this medication. It is not known if
sunscreen may affect the amount of medicine you
absorb. To prevent transfer of this medicine to other
people through contact, allow the medicine to dry
completely and cover with clothing. Also, keep others
from touching the skin where you applied the drug for at
least one hour after applying it. If your medicine comes in
a pump, it must be primed before use. After priming, the
pump is ready for use and will provide the same amount
of drug with each pump action.
SIDE EFFECTS: See also Warning section. Dizziness,
lightheadedness, headache, stomach upset, bloating,
nausea, weight changes, increased/decreased interest in
sex, breast tenderness, or skin redness/irritation at the
application site may occur. If any of these effects persist
or worsen, notify your doctor promptly. Tell your doctor
immediately if any of these unlikely but serious side
effects occur: mental/mood changes (e.g., severe
depression, memory loss), calf pain/swelling, sudden
severe headache, chest pain, trouble breathing, one-sided
weakness, slurred speech, vision changes (e.g., change in
contact lens fit, loss of vision), swelling of hands or feet,
unusual vaginal discharge/itching/odor, yellowing of the
eyes or skin. A serious allergic reaction to this drug is
unlikely, but seek immediate medical attention if it
occurs. Symptoms of a serious allergic reaction include:
9. rash, itching, swelling, severe dizziness, trouble
breathing. If you notice other effects not listed above,
contact your doctor or pharmacist.
PRECAUTIONS: Before taking estradiol, tell your doctor
or pharmacist if you are allergic to it; or if you have any
other allergies. This medication should not be used if you
have certain medical conditions. Before using this
medicine, consult your doctor or pharmacist if you have:
undiagnosed abnormal vaginal bleeding, certain cancers
(e.g., breast cancer, especially non-metastatic type),
blood clots, active/recent stroke or heart attack, liver
disease. Before using this medication, tell your doctor or
pharmacist your medical history, especially of: family
medical history (especially breast lumps and cancer),
asthma, diabetes, seizures, migraine headaches, heart
disease (e.g., high blood pressure, heart attacks,
congestive heart failure), kidney disease, low thyroid
hormone (hypothyroidism), abnormal calcium level in the
blood, depression, high blood pressure during pregnancy
(toxemia), yellowing of eyes and skin (cholestatic
jaundice) during pregnancy or with past estrogen use,
womb problems (e.g., uterine fibroids, endometriosis),
cholesterol or lipid problems, gallbladder disease,
overweight (obese), certain blood disorder (porphyria). If
you will be having surgery or will be confined to a chair
or bed for a long period of time (e.g., a long plane flight),
notify your doctor beforehand. Special precautions may
need to be taken in these circumstances while you are
taking this drug. This drug may make you dizzy; use
caution engaging in activities requiring alertness such as
driving or using machinery. Limit alcoholic beverages.
This drug may cause a patchy darkening of the skin on
the face (melasma). Sunlight may intensify this darkening
and you may need to avoid prolonged sun exposure and
sunlamps. Consult your doctor regarding use of
sunscreens and protective clothing. Cigarette smoking
10. can increase the chance of blood clots while taking this
medication (especially in women over the age of 35). If
you go swimming after applying this medicine, allow
enough time for the medicine to dry completely before
swimming. This will decrease transferring this drug to
others. If this medicine is used in children, their growth
pattern should be monitored because it may stunt
growth. This medication must not be used during
pregnancy. If you become pregnant or think you may be
pregnant, inform your doctor immediately. This
medication may pass into breast milk and may have
undesirable effects on a nursing infant. Therefore,
breast-feeding while using this medication is not
recommended. Consult your doctor before breast-
feeding.
DRUG INTERACTIONS: Before using this medication, tell
your doctor or pharmacist of all prescription and
nonprescription/herbal products you may use, especially
of: corticosteroids (e.g., prednisone), hydantoins (e.g.,
phenytoin), warfarin. Also tell your doctor or pharmacist
if you are taking any medications which affect certain
liver enzymes (CYP450-3A4 enzymes), such as: azole
antifungals (e.g., ketoconazole, itraconazole),
carbamazepine, cimetidine, macrolide antibiotics (e.g.,
clarithromycin, erythromycin), phenobarbital, rifamycins
(e.g., rifampin), ritonavir, St. John's wort. This product
can affect the results of certain lab tests. Make sure
laboratory personnel and your doctors know you use this
drug. Do not start or stop any medicine without doctor or
pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local
poison control center or emergency room immediately.
US residents can call the US national poison hotline at 1-
800-222-1222. Canadian residents should call their local
poison control center directly. This medicine may be
11. harmful if swallowed. Symptoms of overdose may
include: severe nausea/vomiting or excessive vaginal
bleeding.
NOTES: Do not share this medication with others. Keep
all appointments with your doctor and the laboratory.
You should have a complete physical examination that
includes blood pressure measurements, breast and pelvic
examination, and a PAP test (for vaginal cancer) at least
once a year. You should also have periodic mammograms
as determined by your doctor. Follow your doctor's
instructions for examining your own breasts, and report
any lumps immediately. Non-drug therapy to help prevent
bone loss includes a weight-bearing exercise plan,
adequate daily calcium and vitamin D. Consult your
doctor or pharmacist for more details.
MISSED DOSE: If you miss a dose, use it as soon as you
remember. If it is near the time of the next dose, skip the
missed dose and resume your usual dosing schedule. Do
not double the dose to catch up.
STORAGE: Store at room temperature between 68-77
degrees F (20-25 degrees C) away from light, moisture
and open flames. Brief storage between 59-86 degrees F
(15-30 degrees C) is permitted. Do not store in the
bathroom. Keep all medicines away from children and
pets.
Elestrin®
เป็นชื่อการค้าอีกชื่อของ Estradiol hydroalcoholic gel ชนิดทา
ขนาดที่แนะนำาคือ 1 pump / day (ซึ่งเท่ากับมีเจล 0.87 g และ
ประกอบด้วย estradiol 0.52 mg).
FDA approval of Elestrin was based on the results of a
phase III trial evaluating Elestrin in the treatment of
vasomotor symptoms associated with menopause. This
12. randomized, double-blind, placebo-controlled trial
enrolled 484 postmenopausal women between 28 and 74
years of age who had at least 60 moderate-to-severe hot
flushes per week at baseline. Subjects applied placebo,
Elestrin 0.87 g (0.52 mg estradiol), 1.7 g (1.02 mg
estradiol), or 2.6 g (1.56 mg estradiol) once daily to the
upper arm for 12 weeks. Statistical significance was seen
in both the frequency and severity of hot flash symptoms
in the Elestrin 1.7 g/day treatment group when compared
to placebo at week four (P<0.0001) and week 12
(P<0.001). Elestrin 0.87 g/day reached statistical
significance at week 12 versus placebo (P<0.0001).