SOLTAMOX- tamoxifen citrate liquid

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

TAMOXIFEN CITRATE (UNII: 7FRV7310N6) (Tamoxifen - UNII:094ZI81Y45)

Beschikbaar vanaf:

Mayne Pharma

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive metastatic breast cancer. SOLTAMOX is indicated: - for the adjuvant treatment of adult patients with early stage estrogen receptor-positive breast cancer - to reduce the occurrence of contralateral breast cancer in adult patients when used as adjuvant therapy for the treatment of breast cancer. In adult women with DCIS, following breast surgery and radiation, SOLTAMOX is indicated to reduce the risk of invasive breast cancer [see Boxed Warning and Clinical Studies (14.3)] . SOLTAMOX is indicated to reduce the incidence of breast cancer in adult women at high risk for breast cancer. [see Boxed Warning and Clinical Studies (14.4)] . - SOLTAMOX is contraindicated in patients with known hypersensitivity (e.g., angioedema, serious skin reactions) to tamoxifen or any other SOLTAMOX ingredient [see Adverse Reactions (6.2)] . - SOLTAMOX is contraindicated in patients who require concomitant warfarin therapy or have a history of

Product samenvatting:

SOLTAMOX oral solution is a sugar-free, clear colorless liquid, with licorice and aniseed odor and taste. It is supplied in a 150 mL bottle with a dosing cup intended for the measurement of SOLTAMOX oral solution only. Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate. NDC# 51862-682 -01 Store at room temperatures 20° to 25°C (68° - 77°F); excursions permitted between 15° to 30°C (59° - 86°F) [see USP Controlled Room Temperature]. DO NOT freeze or refrigerate. Store in original packaging in order to protect from light. Discard any unused portion after 3 months of first opening of the bottle.

Autorisatie-status:

New Drug Application

Bijsluiter

Mayne Pharma
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MEDICATION GUIDE
SOLTAMOX® (SOL-ta-mox)
(tamoxifen citrate)
oral solution
Before taking SOLTAMOX, you and your healthcare provider should talk
about the possible benefits and
risks.
•
The benefits and risks are different for women at high risk for breast
cancer and women with breast
cancer that is only inside the milk ducts (ductal carcinoma in-situ or
DCIS) than for women who have
been diagnosed with invasive breast cancer.
•
For most people who already have invasive breast cancer, the benefits
of SOLTAMOX are greater
than the risks.
•
Talk to your healthcare provider about which risks may affect you.
What is the most important information I should know about SOLTAMOX?
SOLTAMOX can cause serious side effects, including:
•
Uterine cancer. Cancer of the lining of the uterus (endometrial
adenocarcinoma) or cancer of the body
of the uterus (uterine sarcoma) may happen more often in women who
take SOLTAMOX and can
lead to death. People who take or have taken SOLTAMOX should have a
gynecologic exam every
year.
SOLTAMOX can also cause other non-cancer effects on the uterus,
including:
•
overgrowth of the lining of the uterus (hyperplasia) and uterine
polyps
•
endometriosis
•
fibroids
•
irregular menstrual periods or no menstrual periods (amenorrhea)
Tell your healthcare provider right away if you get any of the
following symptoms during or after
treatment with SOLTAMOX:
•
irregular menstrual periods
•
abnormal vaginal bleeding
•
a change in your vaginal discharge
•
pelvic pain or pressure
•
Blood clots in your veins or lungs. Blood clots in your veins or lungs
may happen more often in
people who take SOLTAMOX and can lead to death, especially in people
who take SOLTAMOX
during their treatment with chemotherapy.
Tell your healthcare provider right away if you get any of the
following symptoms of a blood clot
during treatment with SOLTAMOX:
•
sudden chest pain, shortness of breath, or coughing up blood
•
pain, tenderness, or swelling in one or both of your legs
•
S

Productkenmerken

SOLTAMOX- TAMOXIFEN CITRATE LIQUID
MAYNE PHARMA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOLTAMOX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOLTAMOX .
SOLTAMOX (TAMOXIFEN CITRATE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1977
WARNING: UTERINE MALIGNANCIES AND THROMBOEMBOLIC EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
SERIOUS, LIFE-THREATENING, AND FATAL EVENTS FROM USE OF TAMOXIFEN
INCLUDE UTERINE
MALIGNANCIES, STROKE, AND PULMONARY EMBOLISM. (5.1, 5.2)
DISCUSS RISKS AND BENEFITS OF TAMOXIFEN WITH WOMEN AT HIGH RISK FOR
BREAST CANCER
AND WOMEN WITH DUCTAL CARCINOMA IN SITU (DCIS) WHEN CONSIDERING
TAMOXIFEN USE TO
REDUCE THE RISK OF DEVELOPING BREAST CANCER. (5.1, 5.2)
FOR MOST PATIENTS ALREADY DIAGNOSED WITH BREAST CANCER, THE BENEFITS
OF TAMOXIFEN
OUTWEIGH ITS RISKS. (5.1, 5.2)
INDICATIONS AND USAGE
SOLTAMOX is an estrogen agonist/antagonist indicated:
For treatment of adult patients with estrogen receptor-positive
metastatic breast cancer (1.1)
For adjuvant treatment of adult patients with early stage estrogen
receptor- positive breast cancer
(1.2)
To reduce risk of invasive breast cancer following breast surgery and
radiation in adult women with
ductal carcinoma in situ (DCIS) (1.3)
To reduce the incidence of breast cancer in adult women at high risk
(1.4)
DOSAGE AND ADMINISTRATION
Metastatic breast cancer: 20-40 mg per day. For doses greater than 20
mg per day, administer in
divided doses (morning and evening). (2)
Adjuvant treatment of breast cancer, DCIS, reduction of breast cancer
incidence in women at high risk:
20 mg per day (2)
DOSAGE FORMS AND STRENGTHS
Oral solution: Each 10 mL of solution contains 20 mg tamoxifen,
equivalent to 30.4 mg tamoxifen
citrate. (3)
CONTRAINDICATIONS
Known hypersensitivity to tamoxifen or any other SOLTAMOX ingredient
(4)
In patients who require concomitant warfarin therapy or have a history
of deep vein thrombosis or
pulmonary embolus, if the indication for tre