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Rx Item-Symproic Naldemedine 0.2 Mg Tab 90 By Biodelivery Sci.

Symproic Naldemedine 0.2 Mg Tab 90 By Biodelivery Sci. Item No.:RX760393 760393  NDC No.59630-0222-90 59630-222-90 59630022290 59630022290 UPC No.:3-59630-22290-1 359630-222901 359630222901 MPN 22290 SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue PharmaSYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue PharmaSYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue PharmaPURDUESYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue PharmaWant 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-Symproic Naldemedine 0.2 Mg Tab 90 By Biodelivery Sci.

$1130.22$1076.40

Symproic Naldemedine 0.2 Mg Tab 90 By Biodelivery Sci. Item No.: RX760393 760393 NDC No.59630-0222-90 59630-222-90 59630022290 59630022290 UPC No.:3-59630-22290-1 359630-222901 359630222901 MPN 22290 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

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logo 222, 0.2
tablet , film-coated , yellow , round round
Debossed
for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

Symproic: Package Insert and Label Information
By Purdue Pharma LP | Last revised: 17 August 2017
SYMPROIC- naldemedine tosylate tablet
Purdue Pharma LP

1  INDICATIONS AND USAGE

​ SYMPROIC is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

2  DOSAGE AND ADMINISTRATION

2.1 Administration
Alteration of analgesic dosing regimen prior to initiating SYMPROIC is not required.
Patients receiving opioids for less than 4 weeks may be less responsive to SYMPROIC [see Clinical Studies (14)].
Discontinue SYMPROIC if treatment with the opioid pain medication is also discontinued.
2.2 Adult Dosage


The recommended dosage of SYMPROIC is 0.2 mg orally once daily with or without food.

3  DOSAGE FORMS AND STRENGTHS

Tablets: 0.2 mg naldemedine; supplied as yellow, round, film-coated, debossed with Shionogi marking markingabove the identifier code 222 on one side and 0.2 on the other side.

4  CONTRAINDICATIONS

SYMPROIC is contraindicated in:

Patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation [see Warnings and Precautions (5.1)].
Patients with a history of a hypersensitivity reaction to naldemedine. Reactions have included bronchospasm and rash [see Adverse Reactions (6.1)].
5  WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Perforation
Cases of gastrointestinal perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases). Take into account the overall risk-benefit profile when using SYMPROIC in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue SYMPROIC in patients who develop this symptom [see Contraindications (4)].

5.2 Opioid Withdrawal
Clusters of symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with SYMPROIC [see Adverse Reactions (6.1)].

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using SYMPROIC in such patients. Monitor for symptoms of opioid withdrawal in such patients.

6  ADVERSE REACTIONS

Serious and important adverse reactions described elsewhere in labeling include:

Gastrointestinal perforation [see Warnings and Precautions (5.1)]
Opioid withdrawal [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to SYMPROIC in 1163 patients in clinical trials, including 487 patients with exposures greater than six months and 203 patients with exposures of 12 months.

The following safety data are derived from three double-blind, placebo-controlled trials in patients with OIC and chronic non-cancer pain: two 12-week studies (Studies 1 and 2) and one 52-week study (Study 3) [see Clinical Studies (14)].

In Studies 1 and 2, patients on laxatives were required to discontinue their use prior to study enrollment. All patients were restricted to bisacodyl rescue treatment during the study. In Study 3, approximately 60% of patients in both treatment groups were on a laxative regimen at baseline; patients were allowed to continue using their laxative regimen throughout the study duration. The safety profile of SYMPROIC relative to placebo was similar regardless of laxative use.

Tables 1 and 2 list common adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo. Table 1 shows pooled 12-week data from Studies 1 and 2. Table 2 shows 12-week data from Study 3.

Symproic Naldemedine 0.2 Mg Tab 90 By Biodelivery Sci. Item No.:RX760393 760393  NDC No.59630-0222-90 59630-222-90 59630022290 59630022290 UPC No.:3-59630-22290-1 359630-222901 359630222901 MPN 22290
RX ITEM-Symproic Naldemedine 0.2 Mg Tab
Symproic Naldemedine 0.2 Mg Tab 90 By Biodelivery Sci. Item No.:RX760393 760393 NDC No.59630-0222-90 59630-222-90 59630022290 59630022290 UPC No.:3-59630-22290-1 359630-222901 359630222901 MPN 22290

SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma
SYMPROIC NALDEMEDINE 0.2 MG TA
SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma

SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma
SYMPROIC NALDEMEDINE 0.2 MG TA
SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma

SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma
SYMPROIC NALDEMEDINE 0.2 MG TA
SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma

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SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma
SYMPROIC NALDEMEDINE 0.2 MG TA
SYMPROIC NALDEMEDINE 0.2 MG TAB 90 by Purdue Pharma

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

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