Drug Information

Updated On: 27-02-2024

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Tamoxifen - @ Antiestrogen hormone- (June 2002)

Drug Name:
Tamoxifen - @ Antiestrogen hormone- (June 2002)

List Of Brands:

MAMOFEN
NOLVADEX

Indication Type Description:

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Other Information

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation

Drug Interaction:

Interacting drugs- summary

Tamoxifen

Tamoxifen +Anticoagulants

The hypothrombinemic effect increased by concurrent

Tamoxifen Bromocriptine +

bromocriptine elevate serum tamoxifen and N-desmethyl Tamoxifen tamoxifen

Indication:

Metastatic breast cancer in women.

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Tamoxifen Cancer/Oncology AstraZeneca 20-06-02

citrate

Adverse Reaction:

Hypercalcaemia in patients with bone metatsasis.

Thromboembolic events.

Hot flushes, edema, Vaginal bleeding, pruritis vulvae, GI upsets, dizziness, Rashes, Tumor pain and flare, Transient thrombocytopenia, leucopenia, Increased tendency to develop deep vein thrombosis, Tthromboembolism.

Contra-Indications:

Pregnancy, neonates.

Special precautions:

Routine haematological & liver function tests in long term therapy. Lactation.

Dosages/ Overdosage Etc:

Indications:

Metastatic breast cancer in women.

Dosage:

10 to 20 mg twice daily(morning and evening)

Other Information:

For Availability/supplies

Contact -

1.Indian Drug Manufacturers Association (IDMA)

Phone- 022- 24944624/ 24974308

Fax- 022- 24950723

Email- idma@vsnl.com

Website: www.idma-assn.org

2.Bulk Drug Manufacturers Association (India)(BDMA)

Phone - 040-23703910/ 23706718

Fax- 040-23704804

Email- info@bdmai.org

Website: www.info@bdmai.org

Patient Information:

1.Advise women who are receiving or who have prevoiusly received tamoxifen

to have regular gynaecological examination and promptly infrom physician

of menstrual irregularities, abnormal vaginal bleeding, change in

vaginal discharge or pelvic pain or pressure

2. Advise women not to become pregnant during therapy. barrier or nonhormonal

contraceptive measures are recommended during treatment if sexually active.

3. Notify physician if marked weakness, sleepiness, mental confusion,

pain/swelling of legs , shortness of breath, blurred vision, bone pain,

hot flushes, nausea, vomiting, weight gain, dizziness, headache

or loss of appetite occurs.

Ref - USP PDI Vol II 17th Edition (1997)

TAMOXIFEN- SYSTEMIC

1.Allergies-

Tell your doctor if you have ever had any unusual or allergic reaction to

Tamoxifen. Also tell your healthcare care professional if you are allergic

to any other substances such as foods. preservatives or dyes.

2.Pregnancy-

Tell your doctor if you are pregnant or intend to have children. Tamoxifen

use in women has been shown to cause miscarriages, birth defects , death

of the fetus, and vaginal bleeding.

Tell your doctor right away if you think you have become pregnant or if you

think you are pregnant while taking tamoxifen.

3. Breast-feeding-

Because this medicine may cause serious side effects, breast feeding is

generally not recommended while you are taking it.

4.Older adults-

Although there is no specific information comparing use of tamoxifen

in the elderly with use in other age groups, this medicine is not

expected to cause different side effects or problems in older people.

6. Other medicines-

Tell your doctor if you are using any other prescription or

non-prescription (Over-the counter) OTC medicine.

7. Other medical problems-

The presence of other medical problems may affect the use of tamoxifen.

Make sure you tell your doctor if you have any other medical problems

especially-

Cataracts or other eye problems - tamoxifen may also cause these problems

High cholesterol levels in the blood- tamoxifen can increase cholesterol

levels

Pharmacology/ Pharmacokinetics:

Pharmacology:

Tamoxifen is a nonsteroidal agent with potent antiestrogenic properties due to its ability to compete with estrogen for binding sites in target tisues such as breast. Tmoxifen competes with estradiol for estrogen receptor protein.

Pharmacokinetics:

Tamoxifen is extensively metabolised after oral administration. The drug is excreted as polar conjugates,,with unchanged drug and uncongugated metabolites accounting for less than 30% of the total fecal excretion.

Interaction with Food:

None reported.

Pregnancy and lactation:

Pregnancy:

No adequate and well controlled studies conducted on pregnant women. Spontanoeus abortions and birth defects have reported. Excercise caution while administering drug.

Lactation:

Not known whether drug is excreted in breast milk. Excercise caution and weigh benefits against potential risks to the nursing infant.

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Disclaimer: Every effort has been made to ensure that the information provided in this Database is authentic and accurate. Commissions or omissions in the database, if any, are purely inadvertent and the site owner shall not accept any liability whatsoever for any adverse consequences of any nature arising to any individual or third party, as a result of usage of this information.