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RX ITEM-Nilandron 150Mg Tab 30 By Concordia Pharma

NDC 24987-0111-14 UPC/GTIN No.3-24987-11114-7 Mfg.Part No.11114BRAND: NILANDRON NDC: 24987-0111-14,24987011114 UPC: 3-24987-11114-7,324987111147 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 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.

RX ITEM-Nilandron 150Mg Tab 30 By Concordia Pharma

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item No.:RX288151 NDC No.24987011114 UPC No.:324987111147 NDC No. 24987-0111-14 UPC/GTIN No. 3-24987-11114-7 MPN 11114 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx288151 Nilandron 150mg Tab 30 by Concordia Pharma Item No. 3288151 NDC No. 24987011114 UPC No. 324987111147 Other Name Nilandron,

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NILANDRON- nilutamide tablet
Concordia Pharmaceuticals Inc.

DESCRIPTION

NILANDRON� tablets contain nilutamide, a nonsteroidal, orally active antiandrogen having the chemical name 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione. Nilutamide is a microcrystalline, white to practically white powder with a molecular weight of 317.25. Its molecular formula is C12 H10 F3 N3 O4 .



It is freely soluble in ethyl acetate, acetone, chloroform, ethyl alcohol, dichloromethane, and methanol. It is slightly soluble in water [<0.1% W/V at 25�C (77�F)]. It melts between 153�C and 156�C (307.4�F and 312.8�F).

Each NILANDRON tablet contains 150 mg of nilutamide. Other ingredients in NILANDRON tablets are corn starch, lactose, povidone, docusate sodium, magnesium stearate, and talc.

CLINICAL PHARMACOLOGY

Mechanism of Action
Prostate cancer is known to be androgen sensitive and responds to androgen ablation. In animal studies, nilutamide has demonstrated antiandrogenic activity without other hormonal (estrogen, progesterone, mineralocorticoid, and glucocorticoid) effects. In vitro, nilutamide blocks the effects of testosterone at the androgen receptor level. In vivo, nilutamide interacts with the androgen receptor and prevents the normal androgenic response.

Pharmacokinetics
Absorption:
Analysis of blood, urine, and feces samples following a single oral 150-mg dose of [14 C]-nilutamide in patients with metastatic prostate cancer showed that the drug is rapidly and completely absorbed and that it yields high and persistent plasma concentrations. INDICATIONS AND USAGE

Metastatic Prostate Cancer
NILANDRON tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2 ).

For maximum benefit, NILANDRON treatment must begin on the same day as or on the day after surgical castration. WARNINGS

Interstitial Pneumonitis
Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with NILANDRON, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with NILANDRON. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on NILANDRON. If symptoms occur, NILANDRON should be immediately discontinued until it can be determined if the symptoms are drug related.

Hepatitis
Rare cases of death or hospitalization due to severe liver injury have been reported post-marketing in association with the use of NILANDRON. Hepatotoxicity in these reports generally occurred within the first 3 to 4 months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in 1% of NILANDRON patients in controlled clinical trials.Serum transaminase levels should be measured prior to starting treatment with NILANDRON, at regular intervals for the first 4 months of treatment, and periodically thereafter. Liver function tests should also be obtained at the first sign or symptom suggestive of liver dysfunction, e.g. nausea, vomiting, abdominal pain, fatigue, anorexia, �flu-like" symptoms, dark urine, jaundice, or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, NILANDRON should be immediately discontinued with close followup of liver function tests until resolution.

NDC 24987-0111-14 UPC/GTIN No.3-24987-11114-7 Mfg.Part No.11114
RX ITEM-Nilandron 150Mg Tab 30 By Concor
NDC 24987-0111-14 UPC/GTIN No.3-24987-11114-7 Mfg.Part No.11114

BRAND: NILANDRON NDC: 24987-0111-14,24987011114 UPC: 3-24987-11114-7,324987111147
Nilandron 150Mg Tab 30 By Concordia Phar
BRAND: NILANDRON NDC: 24987-0111-14,24987011114 UPC: 3-24987-11114-7,324987111147

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
NILUTAMIDE ORAL TABLET 15
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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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.