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Rx Item-Casodex 50mg Tab 30 By ANI Pharma

Image 0 of Rx Item-Casodex 50mg Tab 30 By ANI PharmaBRAND: CASODEX NDC: 00310-0705-30,310070530 UPC: 3-03100-70530-2,303100705302 Astra Zeneca PharmaOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Image 5 of Rx Item-Casodex 50mg Tab 30 By ANI Pharma

Rx Item-Casodex 50mg Tab 30 By ANI Pharma

$692.47$599.00

Item No.: RX761961 NDC No.NEW 62559-0680-30 62559-680-30 6255968030 6255968030 OLD 310070530 UPC No.: NEW 362559-680301 OLD 303100705302 NDC No. 00310-0705-30 UPC/GTIN No. NEW 3-62559-68030-1 362559680301 OLD 3-03100-70530-2 MPN No. 70530 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order RX Item. R

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BICALUTAMIDE- bicalutamide tablet
Sandoz Inc

1 INDICATIONS AND USAGE

Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.

Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

? 2.1 Recommended Dose and Schedule


? The recommended dose for bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide be taken at the same time each day. Treatment with bicalutamide should be started at the same time as treatment with an LHRH analog. If a dose of bicalutamide is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

2.2 Dosage Adjustment in Renal Impairment
No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)].

2.3 Dosage Adjustment in Hepatic Impairment
No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary [see Use in Specific Populations (8.6)].

3 DOSAGE FORMS AND STRENGTHS

Bicalutamide tablets, USP 50 mg for oral administration.

4 CONTRAINDICATIONS

4.1 Hypersensitivity
Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see Adverse Reactions (6.2)].
DESCRIPTION

Bicalutamide tablets, USP for oral administration contain 50 mg of bicalutamide, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N- [4-cyano-3 -(trifluoromethyl)phenyl] -3 - [(4-fluorophenyl)sulfonyl] -2-hydroxy-2-methyl-,(+-).
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.

BRAND: CASODEX NDC: 00310-0705-30,310070530 UPC: 3-03100-70530-2,303100705302 Astra Zeneca Pharma
Casodex 50Mg Tab 30 By Astra Zeneca Phar
BRAND: CASODEX NDC: 00310-0705-30,310070530 UPC: 3-03100-70530-2,303100705302 Astra Zeneca Pharma

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
BICALUTAMIDE ORAL TABLET
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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