ANAZBOL - Anastrozole 1mg

Category:- Hormones | Type:- Tablet

COMPOSITION

Each Tablet Contains: Anastrozole 1 mg

PHARMACOLOGICAL CLASSIFICATION

ATC Code: L02B G 03(Enzyme Inhibitor)

PHARMACOLOGY

Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues. Estrone is subsequently converted to estradiol. Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer. In postmenopausal women, Anastrozole Tablets at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay. Anastrozole does not possess any progestogenic, androgenic or oestrogenicactivity.

INDICATIONS

Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.

Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.

Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.

CONTRAINDICATIONS

Anastrozole is contraindicated in: Premenopausal women.

Pregnant or lactating women.

Patients with severe renal impairment (creatinine clearance less than 20 ml/min).

Patients with moderate or severe hepatic disease.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Anastrozole Tablets is not recommended for use in children as safety and efficacy have not been established in this group of patients.

The menopause should be defined biochemically in any patient where there is doubt about hormonal status. There are no data to support the safe use of Anastrozole Tablets in patients with moderate or severe hepatic impairment, or patients with severe impairment of renal function (creatinine clearance less than 20 ml/min).

Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed by bone densitometry e.g. DEXA scanning at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored. Lowers circulating oestrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture. The use of bisphosphonates may stop further bone mineral loss caused by anastrozole in postmenopausal women and could be considered.

INTERACTIONS

Antipyrine and cimetidine clinical interaction studies indicate that the co-administration of Anastrozole Tablets with other drugs is unlikely to result in clinically significant drug interactions mediated by cytochrome P450. Oestrogencontaining therapies should not be co-administered with Anastrozole Tablets as they would negate its pharmacological action. Tamoxifen should not be co-administered with Anastrozole Tablets, as this may diminish its pharmacological action.

PREGNANCY AND LACTATION

Anastrozole Tablets is contraindicated in pregnant or lactating women.

DOSAGE AND DIRECTIONS FOR USE

Adults including the elderly: One 1 mg tablet to be taken orally once a day

Children: Not recommended for use in children. Renal impairment: No dose change is recommended in patients with mild or moderate renal impairment.

Hepatic impairment: No dose change is recommended in patients with mild hepatic disease. For early disease, the recommended duration of treatment should be 5 years.

SIDE-EFFECTS

There are following possible side effect reported based on very common ( ≥10%), common( ≥1% and <10% , uncommon(≥0.1% and <1%) & rare (≥0.01% and< 0.1%) are:

Very common: hot flushes, asthenia, joint pain/stiffness, headache, nausea, rash

Common: Hair thinning(Alopecia), Diarrhoea, somnolence, increase in alkaline phosphate, alanine amionotransferase and aspartate amionotransferase, vaginal bleeding, anorexia, hypercholesterolameia

Uncommon:Increases in gamma-GTand bilirubin, Hepatitis, Urticaria, trigger finger

Rare: Erythema multiforme anaphylactoid reaction

KNOWN SYMPTOMS OFOVERDOSAGE AND PARTICULARS OF ITS TREATMENT

There is limited clinical experience of accidental overdosage. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages of Anastrozole Tablets, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of Anastrozole Tablets that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic.

PRESENTATION

5 x 10 tablets in a blister packed in carton along with package insert.

STORAGE INSTRUCTIONS

Store below 30°C in a dry place. Protect from light.

KEEP OUT OF REACH OF CHILDREN

Manufactured by: COOPER PHARMA LIMITED