Rx Item-Relistor 150Mg 90 Tab By Valeant Pharma

RELISTOR- methylnaltrexone bromide tablet
RELISTOR- methylnaltrexone bromide injection, solution
Salix Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
? RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

1.2 Opioid-Induced Constipation in Adult Patients with Advanced Illness


RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

Limitations of Use

Use of RELISTOR injection beyond four months has not been studied in the advanced illness population.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information
�
Be within close proximity to toilet facilities once RELISTOR is administered.
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Discontinue RELISTOR if treatment with the opioid pain medication is also discontinued.
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In adult patients with chronic non-cancer pain and OIC:
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RELISTOR has been shown to be efficacious in patients who have taken opioids for at least 4 weeks. Sustained exposure to opioids prior to starting RELISTOR may increase the patient�s sensitivity to the effects of RELISTOR [see Clinical Studies (14.1)].
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Discontinue all maintenance laxative therapy prior to initiation of RELISTOR. Laxative(s) can be used as needed if there is a suboptimal response to RELISTOR after three days.
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Re-evaluate the continued need for RELISTOR when the opioid regimen is changed to avoid adverse reactions.
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In patients with chronic non-cancer pain and OIC, take RELISTOR tablets with water on an empty stomach at least 30 minutes before the first meal of the day.
2.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
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The recommended dosage of RELISTOR tablets is 450 mg taken orally once daily in the morning.
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The recommended dosage of RELISTOR injection is 12 mg administered subcutaneously once daily
DOSAGE FORMS AND STRENGTHS

Tablets:
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150 mg methylnaltrexone bromide supplied as film-coated, white, round, biconvex, debossed with �REL" on one side and plain on the other side.
Injection:

Single-dose Vial:

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12 mg/0.6 mL methylnaltrexone bromide supplied as colorless to pale yellow solution.
Single-dose Pre-filled Syringe:

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8 mg/0.4 mL methylnaltrexone bromide supplied as colorless to pale yellow solution.
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12 mg/0.6 mL methylnaltrexone bromide supplied as colorless to pale yellow solution.

RX ITEM-Relistor 150Mg 90 Tab By Valeant
NDC 65649-0552-04 UPC/GTIN No.3-65649-55204-5 Mfg.Part No.55204

Relistor 150Mg 90 Tab By Valeant Pharma
BRAND: RELISTOR NDC: 65649-0150-90,65649015090 UPC: 3-65649-55204-5,365649552045 Valeant Pharma

METHYLNALTREXONE BROMIDE
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