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Cytotam 10mg (Tamoxifen)

Brand: Cipla Ltd.
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CYTOTAM 10MG

DESCRIPTION 

Cytotam 10mg is a medication in pill form which has been needed for more than 25 years to treat breast cancer in women and men. Cytotam 10mg is one of the most common endocrine therapy drugs. It has been shown to reduces the chance of relapsed in some early-stage breast cancers and to inhibit the development of cancer in the opposite breast. Cytotam 10mg can also reduce or stop the growth of cancer cells present in the body.

INDICATION OF CYTOTAM 10MG

  • Cytotam 10mg is used in patients for the treatment of early breast cancer in women whose been already treated with surgery, radiation, and chemotherapy.
  • Cytotam 10mg may also be indicated to cure local recurrenceor locally advanced breast cancer (known as regional recurrence). It can also be indicated if you’ve been diagnosed with secondary breast cancer
  • Cytotam 10mg will prohibits the risk of developing a more serious type of breast cancer in women who had breast cancer which will not spread outer part of the milk duct where it forms(ductal carcinoma).

PHARMACOLOGY

Tamoxifen which belongs to nonsteroidal agent whichtarget to estrogen receptors (ER), initiating a conformational change in the receptor. This results in a stopping or alter in the expression of estrogen dependent genes. The extended binding of tamoxifen to the nuclear chromatin of these leads in decreased DNA polymerase activity, impaired thymidine utilization, blockade of estradiol uptake, and reduces estrogen response. It is likely that tamoxifen combines with other coactivators or corepressors in the tissue and joints with different estrogen receptors, ER-alpha or ER-beta, producing both estrogenic and antiestrogenic effects.

PHARMACOKINETICS

The time to high plasma concentration is 40mg/ml and Tmax is 5 hours after dosing.

In hepatic Cytotam 10mg is metabolized.

Route of excretion is 30% via fecal and 65% was excreted from the body

Half life is 5 to 7 days

DOSAGE & ADMINISTRATION

The recommended dose for metastatic breast cancer

20-40 mg/day per oral; if doses is >20mg/day then should be divided into twice daily (morning and evening).

The recommended dose for adjuvant breast cancer

20-40 mg/day per oral; if doses is >20mg/day then should be divided into twice daily (morning and evening).

Continue with adjuvant treatment for at least 5 years

The recommended dose for ductal carcinoma in situ

20mg PO qDay for 5years

The recommended dose foe ovulation induction (off-Label)

5-40 mg PO q12hr for 4 days

The recommended dose for mastalgia (off-label)

10mg PO qDay for 4 months

OVERDOSAGE

Acute overdose is not considered in humans, there is no specific treatment for overdose. Hence provide the patients by symptomatic supportive measures

SIDE EFFECTS

Common Side Effect

Serious side effects may be as follows, immediately inform the doctor

  • Restlessness
  • loss of appetite
  • Vision difficulty
  • Abscess on the, throat, face, lips, eyes, tongue, ankles or lower legs
  • Thirst
  • muscle weakness
  • Fever
  • Blisters

DRUG INTERACTIONS

  • Cytotam 10mg in combination with selective serotonin reuptake inhibitors (SSRIs) antidepressant, paroxetine will reduce the effectiveness of tamoxifen
  • While concomitant use of Cytotam 10mg with coumarin type anticoagulants combination will leads to increase in anticoagulant effects may occur.
  • Co administration of Bromocriptine with Cytotam 10mg will increase the serum level of Cytotam 10mg and N-desmethyl tamoxifen.

WARNING & PRECAUTIONS

Consult with the doctor that are you pregnant or plan to become pregnant. Do not have plan for children while on treatment with Cytotam 10mg. You must use a specific method of conceiving to prevent pregnancy in yourself or your partner during your treatment with Cytotam 10mg the drug will harm the fetus.

Avoid breast feeding while on treatment with Cytotam 10mg

Use drug with caution due to early breast cancer signs hence during treatment with tamoxifen aware about development of breast cancer.

Consult with the doctor or pharmacist as if you have allergic condition against Cytotam 10mg or any of the compound inTamoxifen tablets.

Consult with the doctor that you have or have ever had renal, hepatic, or cardiac problem

Some important precautions should take care;

Some breast cancer patients may have reported from hypercalcemia by starting few weeks treatment, if the condition occur and became severe then tamoxifen should discontinue.

An incidence may increase with uterine malignancies and endometrial carcinoma is resulted with tamoxifen treatment.

Due to estrogen properties of tamoxifen, an increased incidence of endometrial changes occurs involves like hyperplasia and polyps has been resulted. Hence the drug causes menstrual irregularity or amenorrhea.

CONTRAINDICATIONS

Cytotam 10mg 20mg is contraindicated in patients with as follows:

Women interaction with coumarin- type anticoagulant treatment

Known hypersensitivity to the drug or its any ingredients

In women with deep vein thrombosis or pulmonary embolus history.

PREGNANCY & LACTATION

Category D: If Cytotam 10mg administrated to pregnant women will cause harm to fetal. Women are advised to stop the drug within 2 months and not become pregnant while taking Cytotam 10mg. And If sexually active then should use non-hormonal contraceptive measures.

STORAGE

Store the drug at 200C – 250C

Keep away from children, do not freeze          

Keep the drug in a closed container at room temperature.

MISSED DOSE

If the dose isfailed to take, then have the dose immediately before next dose duration

Or left off the missed dose and follow regular schedule.

Avoid takingextra dose at same time.

Please consult the doctor for further details

  • Trade name Cytotam 10mg
  • Substance Tamoxifen
  • Manufacturer Cipla Limited
  • Packaging 100 tablets
  • Country of origin India
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