Nolvadex-D


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Related to Nolvadex-D: Apo-Tamox

tamoxifen citrate

Apo-Tamox, Gen-Tamoxifen, Nolvadex, Nolvadex-D, Novo-Tamoxifen, PMS-Tamoxifen, Soltamox, TamofenBazetham, Contiflo XL, Flomax, Flomax CR, Flomaxtra, Novo-Tamsulosin, Omnic MR, Ran-TamsulosinW, Ratio-Tamsulosin, Sandoz Tamsulosin, Stronazon, Tabphyn

Pharmacologic class: Nonsteroidal antiestrogen

Therapeutic class: Antineoplastic

Pregnancy risk category D

Pharmacologic class: Alpha-adrenergic blocker

Therapeutic class: Anti-adrenergic

Pregnancy risk category B

FDA Box Warning

For women with ductal carcinoma in situ or high risk of breast cancer, serious and life-threatening events associated with drug use in riskreduction setting include stroke, pulmonary embolism, and uterine cancer. Some of these events were fatal. Discuss potential benefits versus potential risks of these events with these patients. In women already diagnosed with breast cancer, drug's benefits outweigh risks.

Action

Competes with estrogen receptors in tumor cells for binding to target tissues (such as breast); reduces DNA synthesis and estrogen response

Availability

Oral solution: 10 mg/5 ml

Tablets: 10 mg, 20 mg

Tablets (enteric-coated): 20 mg

Indications and dosages

Adjunctive treatment of breast cancer

Adults: 20 to 40 mg P.O. daily for 5 years. Daily dosages of 20 mg may be taken as a single dose; daily dosages above 20 mg should be divided and taken b.i.d. (morning and evening).

To reduce breast cancer incidence in high-risk women; treatment of ductal carcinoma in situ

Adults: 20 mg P.O. daily for 5 years

Off-label uses

• Mastalgia
• Ovulation stimulation

Contraindications

• Hypersensitivity to drug
• Concurrent warfarin use
• Women with a history of deep-vein thrombosis or pulmonary embolism
• Pregnancy or breastfeeding

Precautions

Use cautiously in:
• decreased bone marrow reserve, leukopenia, thrombocytopenia, cataracts, hyperlipidemia
• females of childbearing age.

Administration

• Don't break or crush enteric-coated tablets.
• Know that drug is indicated for reducing breast cancer risk only in high-risk women, defined as those older than age 35 who have at least a 1.67% chance of developing breast cancer over 5 years.

Adverse reactions

CNS: confusion, depression, headache, weakness, fatigue, light-headedness

CV: chest pain, deep-vein thrombosis

EENT: blurred vision, ocular lesion, retinopathy, corneal opacity

GI: nausea, vomiting, abdominal cramps, anorexia

GU: vaginal bleeding, discharge, or dryness; irregular menses; amenorrhea; oligomenorrhea; ovarian cyst; pruritus vulvae; endometrial or uterine cancer

Hematologic: leukopenia, thrombocytopenia

Metabolic: hypercalcemia, fluid retention

Musculoskeletal: bone pain

Respiratory: cough, pulmonary embolism

Skin: skin changes, hair thinning or partial hair loss

Other: altered taste, weight loss, tumor flare, tumor pain, hot flashes, edema

Interactions

Drug-drug. Aminoglutethimide, estrogens: decreased tamoxifen effects

Antineoplastics: increased risk of thromboembolic events

Bromocriptine: increased tamoxifen blood level

Warfarin: increased anticoagulant effect

Drug-diagnostic tests. Aspartate aminotransferase, bilirubin, calcium, creatinine, hepatic enzymes: increased levels

Platelets, white blood cells: decreased counts

Patient monitoring

• Monitor lipid panel, calcium level, mammography results, and gynecologic exam results.

Watch for signs and symptoms of thromboembolic events, including cerebrovascular accident and pulmonary embolism.
• Monitor menstrual cycle pattern for changes that may signal endometrial or uterine cancer.

Patient teaching

• Tell patient to swallow enteric-coated tablets whole without breaking or crushing.

Instruct patient to immediately report leg or calf pain, swelling, or tenderness; unexpected shortness of breath; sudden chest pain; coughing up blood; new breast lumps; vaginal bleeding; menstrual irregularities; changes in vaginal discharge; pelvic pain or pressure; and vision changes.
• Inform patient that increase in bone or tumor pain usually means drug will be effective. Advise her to discuss pain management with prescriber.
• Stress importance of undergoing regular blood tests, mammograms, and gynecologic exams to identify early signs of serious adverse reactions.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


tamsulosin hydrochloride

Bazetham, Contiflo XL, Flomax, Flomax CR, Flomaxtra, Novo-Tamsulosin, Omnic MR, Ran-TamsulosinW, Ratio-Tamsulosin, Sandoz Tamsulosin, Stronazon, Tabphyn


Pharmacologic class: Alpha-adrenergic blocker

Therapeutic class: Anti-adrenergic

Pregnancy risk category B

 

Action

Decreases smooth muscle contractions of prostate by binding to alpha1-adrenergic receptors. This action increases urine flow and reduces symptoms of benign prostatic hyperplasia (BPH).

Availability

Capsules: 0.4 mg

Indications and dosages

BPH

Adults: 0.4 mg/day P.O. after a meal. After 2 to 4 weeks, may increase to 0.8 mg/day.

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• concurrent use of other alpha-adrenergic blockers or strong CYP3A4 inhibitors (avoid use)
• concurrent use of moderate CYP3A4 inhibitors, strong or moderate CYP2D6 inhibitors, other cytochrome P450 inhibitors, warfarin, and in patients who are poor CYP2D6 metabolizers
• patients at increased risk for prostate cancer.

Administration

• Give 30 minutes after same meal each day.

Adverse reactions

CNS: dizziness, headache, asthenia, insomnia, drowsiness, syncope, vertigo

CV: orthostatic hypotension, chest pain

EENT: rhinitis, amblyopia, pharyngitis, sinusitis

GU: retrograde or diminished ejaculation, decreased libido

Musculoskeletal: back pain

Respiratory: increased cough

Other: tooth disorder, infection

Interactions

Drug-drug. Cimetidine: increased tamsulosin blood level, greater risk of toxicity

Doxazosin, prazosin, terazosin: increased risk of hypotension

Ketoconazole (strong CYP3A4 inhibitor), paroxetine (strong CYP2D6 inhibitor): increased tamsulosin Cmax and area under the curve

Drug-behaviors. Alcohol use: increased risk of hypotension

Patient monitoring

• Monitor blood pressure. Stay alert for orthostatic hypotension.

Patient teaching

• Tell patient to take 30 minutes after same meal each day.
• Instruct patient not to chew or open capsule. Advise him to swallow it whole.
• Tell patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness from sudden blood pressure decrease.
• Caution patient to avoid hazardous activities on first day of therapy.
• Inform patient that drug may cause abnormal ejaculation. Advise him to discuss this issue with prescriber.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

tamoxifen

(ta-mox-i-fen) ,

Nolvadex

(trade name),

Nolvadex-D

(trade name),

Tamofen

(trade name),

Tamone

(trade name),

Tamoplex

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: antiestrogens
Pregnancy Category: D

Indications

Adjuvant therapy of breast cancer after surgery and radiation (delays recurrence).Palliative or adjunctive treatment of advanced breast cancer.Prevention of breast cancer in high-risk patients.Treatment of ductal carcinoma in situ following breast surgery and radiation.

Action

Competes with estrogen for binding sites in breast and other tissues.
Reduces DNA synthesis and estrogen response.

Therapeutic effects

Suppression of tumor growth.
Reduced incidence of breast cancer in high-risk patients.

Pharmacokinetics

Absorption: Absorbed after oral administration.
Distribution: Widely distributed.
Metabolism and Excretion: Mostly metabolized by the liver. Slowly eliminated in the feces. Minimal amounts excreted in the urine.
Half-life: 7 days.

Time/action profile (tumor response)

ROUTEONSETPEAKDURATION
PO4–10 wkseveral moseveral wk

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Concurrent warfarin therapy with history of deep vein thrombosis (patients at high risk for breast cancer only); Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: ↓ bone marrow reserve;Women with childbearing potential.

Adverse Reactions/Side Effects

Central nervous system

  • stroke (life-threatening)
  • confusion
  • depression
  • headache
  • weakness

Ear, Eye, Nose, Throat

  • blurred vision

Cardiovascular

  • thromboembolism (life-threatening)
  • edema

Gastrointestinal

  • nausea (most frequent)
  • vomiting

Genitourinary

  • uterine malignancies (life-threatening)
  • vaginal bleeding

Fluid and Electrolyte

  • hypercalcemia

Hematologic

  • leukopenia
  • thrombocytopenia

Metabolic

  • hot flashes (most frequent)

Musculoskeletal

  • bone pain

Miscellaneous

  • tumor flare

Interactions

Drug-Drug interaction

Estrogens may ↓ effectiveness of concurrently administered tamoxifen.Blood levels are ↑ by bromocriptine.May ↑ the anticoagulant effect of warfarin.Risk of thromboembolic events is ↑ by concurrent use of other antineoplastics.

Route/Dosage

Treatment of Breast Cancer
Oral (Adults) 10–20 mg twice daily; doses of 20 mg/day may be taken as a single dose.
Prevention of Breast Cancer/Ductal Carcinoma in situ
Oral (Adults) 20 mg once daily for 5 yr.

Availability (generic available)

Tablets: 10 mg, 20 mg
Enteric-coated tablets: 20 mg

Nursing implications

Nursing assessment

  • Assess for an increase in bone or tumor pain. Confer with health care professional regarding analgesics. This transient pain usually resolves despite continued therapy.
  • Lab Test Considerations: Monitor CBC, platelets, and calcium levels before and during therapy. May cause transient hypercalcemia in patients with metastases to the bone. An estrogen receptor assay should be assessed before initiation of therapy.
    • Monitor serum cholesterol and triglyceride concentrations in patients with pre-existing hyperlipidemia. May cause ↑ concentrations.
    • Monitor hepatic function tests and thyroxine (T4) periodically during therapy. May cause ↑ serum hepatic enzyme and thyroxine concentrations.
    • Gynecologic examinations should be performed regularly; may cause variations in Papanicolaou and vaginal smears.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Oral: Administer with food or fluids if GI irritation becomes a problem. Consult health care professional if patient vomits shortly after administration of medication to determine need for repeat dose.
    • Do not crush, break, chew, or administer an antacid within 1–2 hr of enteric-coated tablet.

Patient/Family Teaching

  • Instruct patient to take medication as directed. If a dose is missed, it should be omitted.
  • If skin lesions are present, inform patient that lesions may temporarily increase in size and number and may have increased erythema.
  • Advise patient to report bone pain to health care professional promptly. This pain may be severe. Analgesics should be ordered to control pain. Inform patient that this may be an indication of the drug’s effectiveness and will resolve over time.
  • Instruct patient to monitor weight weekly. Weight gain or peripheral edema should be reported to health care professional.
  • Advise patient that medication may cause hot flashes. Notify health care professional if these become bothersome.
  • Instruct patient to notify health care professional promptly if pain or swelling of legs, shortness of breath, weakness, sleepiness, confusion, nausea, vomiting, weight gain, dizziness, headache, loss of appetite, or blurred vision occurs. Patient should also report menstrual irregularities, vaginal bleeding, pelvic pain or pressure.
  • This medication may induce ovulation and may have teratogenic properties. Advise patient to use a nonhormonal method of contraception during and for 1 mo after the therapy.

Evaluation/Desired Outcomes

  • Decrease in the size or spread of breast cancer. Observable effects of therapy may not be seen for 4–10 wk after initiation.

Nolvadex-D

A brand name for TAMOXIFEN.