Symproic naldemedine .2 mg Tablet, 30-count — NDC 59385-041-30 (Billing 59385-0041-30)
This is a package of 30 tablets of Symproic naldemedine .2 mg Tablet from BioDelivery Sciences International Inc, marketed since Jun 2019 and currently FDA-listed; retail pharmacies pay about $16.26 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 59385-041-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 59385 labeler · 041 product · 30 package
- Package marketed since
- Jun 14, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 30 EA per package
- Barcode (UPC)
- 0359385041307
- Medicaid fills, this package
- 3,981 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 077258
- GCN: 43216
- GPI-14 (Medi-Span): 52580057200320
- HICL (First Databank): 044176
- AHFS class code: 56:18.04.00
- RxCUI (RxNorm): 1876603
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Opioid Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats constipation caused by opioid pain medicine. It is for adults with long-term pain that is not from active cancer, including pain related to past cancer or its treatment....
- Take one tablet by mouth once a day. You can take it with or without food. Follow your prescriber's directions, and stop it if you stop your opioid pain medicine.
- It is designed to stay mostly out of the brain, so it is not expected to interfere much with your opioid pain relief. Still, tell your doctor if your pain feels worse or you notice...
- The most common are belly pain, diarrhea, nausea, gastroenteritis, and vomiting. Call your doctor right away if belly pain is severe, lasts, or keeps getting worse. That can signal...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Naldemedine Tosylate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $16.256 | $487.67 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $15.82 | $474.73 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $15.95 | $478.51 / 30 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 59385-0041-07 59385-041-07 | 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK | — | — | 2020-07-01 | — | Discontinued by firm |
| 59385-0041-30 You're viewing this Main listing | 30 TABLET in 1 BOTTLE, PLASTIC | $16.26 / ea | $487.67 | 2019-06-14 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 59385-0041-07?
What NDC number is used to bill for this package of Symproic naldemedine .2 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Symproic .2 mgthis 59385-0041-30 | BioDelivery | 30 tablets | $16.256 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US RE46375 ↗ | Drug substance | U-1185 | Oct 5, 2026 |
| US RE46365 ↗ | Drug substance | — | Feb 24, 2031 |
| US 9108975 ↗ | Drug substance | — | Nov 11, 2031 |
| US 10952968 ↗ | Drug substance | — | May 13, 2033 |
| US 12350377 ↗ | Drug product | — | May 13, 2033 |
Is there a generic version of SYMPROIC 0.2 MG TABLET?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Naldemedine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from BioDelivery Sciences International Inc labeler code 59385
- Belbuca buprenorphine hydrochloride 150 ug Film, Soluble NDC 59385-022-60
- Belbuca buprenorphine hydrochloride 300 ug Film, Soluble NDC 59385-023-60
- Belbuca buprenorphine hydrochloride 450 ug Film, Soluble NDC 59385-024-60
- Belbuca buprenorphine hydrochloride 600 ug Film, Soluble NDC 59385-025-60
- Belbuca buprenorphine hydrochloride 750 ug Film, Soluble NDC 59385-026-60
- Belbuca buprenorphine hydrochloride 900 ug Film, Soluble NDC 59385-027-60
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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. SYMPROIC is an opioid antagonist 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 ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ) : 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 Discontinue SYMPROIC if treatment with the opioid pain medication is also discontinued Dosage ( 2.2 ) : In adults, the recommended dosage is 0.2 mg once daily with or without food
2.1Administration 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.
2.2Adult Dosage The recommended dosage of SYMPROIC is 0.2 mg orally once daily with or without food.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 0.2 mg naldemedine; supplied as yellow, round, film-coated, debossed with Shionogi marking above the identifier code 222 on one side and 0.2 on the other side. Tablets: 0.2 mg naldemedine ( 3 )
⛔ Contraindications ▾
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) ] .
Patients with known or suspected gastrointestinal obstruction or at increased risk of recurrent obstruction ( 4 , 5.1 ) Patients with a history of a hypersensitivity reaction to naldemedine ( 6.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Gastrointestinal perforation : Consider the overall risk benefit in patients with known or suspected lesions of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if development of symptoms ( 5.1 ) Opioid withdrawal : Consider the overall risk benefit in patients with disruptions to the blood-brain barrier. Monitor symptoms of opioid withdrawal ( 5.2 )
5.1Gastrointestinal Perforation Cases of gastrointestinal (GI) perforation have been reported with use of another peripherally acting opioid antagonist, including SYMPROIC. Postmarketing cases of GI perforation, including fatal cases, were reported when SYMPROIC was used in patients at risk of GI perforation (e.g., GI cancer, past GI surgery, diverticulitis, chemotherapy/radiation). SYMPROIC is contraindicated in patients with known or suspected gastrointestinal obstruction or in patients at risk of recurrent obstruction.
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.
5.2Opioid 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.
🤒 Adverse Reactions ▾
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) ] Most common adverse reactions (≥2%) are: abdominal pain, diarrhea, nausea and gastroenteritis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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. Table 1: Common Adverse Reactions Adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo in Patients with OIC and Chronic Non-Cancer Pain (12-week data from Studies 1 and 2) Adverse Reaction SYMPROIC 0.2 mg once daily N=542 Placebo N=546 Abdominal pain Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, gastrointestinal pain. 8% 2% Diarrhea 7% 2% Nausea 4% 2% Gastroenteritis 2% 1% Table 2: Common Adverse Reactions Adverse reactions occurring in at least 2% of patients receiving SYMPROIC and at an incidence greater than placebo in Patients with OIC and Chronic Non-Cancer Pain (12-week data from Study 3) Adverse Reaction SYMPROIC 0.2 mg once daily N=621 Placebo N=619 Abdominal pain Abdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper.
11% 5% Diarrhea 7% 3% Nausea 6% 5% Vomiting 3% 2% Gastroenteritis 3% 1% Adverse reactions up to 12 months in Study 3 are similar to those listed in Tables 1 and 2 (diarrhea: 11% vs. 5%, abdominal pain: 8% vs. 3%, and nausea: 8% vs.
6% for SYMPROIC and placebo, respectively). Opioid Withdrawal In Studies 1, 2 and 3, adverse reactions consistent with opioid withdrawal were based on investigator assessment and adjudicated based upon the occurrence of at least 3 adverse reactions potentially related to opioid withdrawal with onset of a constellation of those symptoms occurring on the same day or within one day of each other. Adverse reactions of possible opioid withdrawal could include non-gastrointestinal (GI) symptoms (e.g., hyperhidrosis, hot flush or flushing, chills, tremor, tachycardia, anxiety, agitation, yawning, rhinorrhea, increased lacrimation, sneezing, feeling cold, and pyrexia), GI symptoms (e.g., vomiting, diarrhea, or abdominal pain), or both GI and non-GI symptoms.
In pooled Studies 1 and 2, the incidence of adverse reactions of opioid withdrawal was 1% (8/542) for SYMPROIC and 1% (3/546) for placebo. In Study 3 (52-week data),… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 3 includes drugs with clinically important drug interactions with SYMPROIC and instructions for preventing or managing the interaction. Table 3: Clinically Relevant Interactions Affecting Naldemedine When Co-Administered with Other Drugs Strong CYP3A Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) Clinical Impact Significant decrease in plasma naldemedine concentrations, which may reduce efficacy [see Clinical Pharmacology (12.3) ] Intervention Avoid use of SYMPROIC with strong CYP3A inducers.
Other Opioid Antagonists Clinical Impact Potential for additive effect of opioid receptor antagonism and increased risk of opioid withdrawal. Intervention Avoid use of SYMPROIC with another opioid antagonist. Moderate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A Inhibitors Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ] .
P-glycoprotein (P-gp) Inhibitors (e.g., amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil) Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ] . Strong CYP3A inducers (e.g., rifampin) : Decreased naldemedine concentrations; avoid concomitant use ( 7 ) Other opioid antagonists : Potential for additive effect and increased risk of opioid withdrawal; avoid concomitant use ( 7 ) Moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A4 inhibitors : Increased naldemedine concentrations; monitor for adverse reactions ( 7 ) P-gp inhibitors (e.g., cyclosporine) : Monitor for adverse reactions ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy : May precipitate opioid withdrawal in a fetus ( 8.1 ) Lactation : Discontinue drug or breastfeeding taking into consideration importance of drug to mother ( 8.2 ) Hepatic Impairment : Avoid in severe impairment ( 8.6 )
8.1Pregnancy Risk Summary There are no available data with naldemedine in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. There is a potential for opioid withdrawal in a fetus when SYMPROIC is used in pregnant women [see Clinical Considerations ]. SYMPROIC should be used during pregnancy only if the potential benefit justifies the potential risk.
In a rat embryo-fetal development study following oral administration of naldemedine during the period of organogenesis at doses resulting in systemic exposure approximately 23,000 times the human area under the plasma-concentration time curve (AUC) at the recommended human dose of 0.2 mg/day, no developmental abnormalities were observed. In rabbits, there were no adverse effects on embryo-fetal development following oral administration of naldemedine during the period of organogenesis at doses resulting in systemic exposure approximately 226 times the human AUC at the recommended human dose of 0.2 mg/day [see Data ].
No effects on pre- and postnatal development were observed in rats at exposures 12 times human exposures at the recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Naldemedine crosses the placenta, and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Data Animal Data In rats, there were no adverse effects on embryo-fetal development following oral administration of naldemedine during the period of organogenesis at doses up to 1000 mg/kg/day (approximately 23,000 times the human exposures (AUC) at the recommended human dose). In rabbits, there were no adverse effects on embryo-fetal development following oral administration of naldemedine during the period of organogenesis at doses up to 100 mg/kg/day (approximately 226 times the human exposures (AUC) at the recommended human dose).
At 400 mg/kg/day (approximately 844 times the human exposures (AUC) at the recommended human dose), effects in maternal animals included body weight loss/decreased body weight gain and food consumption, fetal loss, and premature delivery. Decreased fetal body weights at this dose may be related to the maternal toxicity observed. In the pre- and postnatal development study, pregnant rats were administered naldemedine at oral doses up to 1000 mg/kg/day from gestation day 7 through lactation day 20.
No effects on pre- and postnatal development were observed in rats at 1 mg/kg/day (approximately 12 times the human exposures (AUC) at the recommended human dose). A single dam died at parturition at 1000 mg/kg/day, and decreased body weights/body weight gain and food consumption, poor nursing, and total litter loss were noted at 30 and 1000 mg/kg/day (approximately 626 and 17,000 times the human exposures (AUC) at the recommended human dose, respectively). Decreases in the offspring viability index on Day 4 after birth were noted at 30 and 1000 mg/kg/day, and low body weights and delayed pinna unfolding in pups were noted at 1000 mg/kg/day.
8.2Lactation Risk Summary There is no information regarding the presence of naldemedine in human milk, the effects on the breastfed infant, or the effects on milk production. Naldemedine was present in the milk of rats [see Data ] . Because of the potential for serious adverse reactions, including opioid withdrawal in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the drug,… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data with naldemedine in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. There is a potential for opioid withdrawal in a fetus when SYMPROIC is used in pregnant women [see Clinical Considerations ]. SYMPROIC should be used during pregnancy only if the potential benefit justifies the potential risk.
In a rat embryo-fetal development study following oral administration of naldemedine during the period of organogenesis at doses resulting in systemic exposure approximately 23,000 times the human area under the plasma-concentration time curve (AUC) at the recommended human dose of 0.2 mg/day, no developmental abnormalities were observed. In rabbits, there were no adverse effects on embryo-fetal development following oral administration of naldemedine during the period of organogenesis at doses resulting in systemic exposure approximately 226 times the human AUC at the recommended human dose of 0.2 mg/day [see Data ].
No effects on pre- and postnatal development were observed in rats at exposures 12 times human exposures at the recommended human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Naldemedine crosses the placenta, and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Data Animal Data In rats, there were no adverse effects on embryo-fetal development following oral administration of naldemedine during the period of organogenesis at doses up to 1000 mg/kg/day (approximately 23,000 times the human exposures (AUC) at the recommended human dose). In rabbits, there were no adverse effects on embryo-fetal development following oral administration of naldemedine during the period of organogenesis at doses up to 100 mg/kg/day (approximately 226 times the human exposures (AUC) at the recommended human dose).
At 400 mg/kg/day (approximately 844 times the human exposures (AUC) at the recommended human dose), effects in maternal animals included body weight loss/decreased body weight gain and food consumption, fetal loss, and premature delivery. Decreased fetal body weights at this dose may be related to the maternal toxicity observed. In the pre- and postnatal development study, pregnant rats were administered naldemedine at oral doses up to 1000 mg/kg/day from gestation day 7 through lactation day 20.
No effects on pre- and postnatal development were observed in rats at 1 mg/kg/day (approximately 12 times the human exposures (AUC) at the recommended human dose). A single dam died at parturition at 1000 mg/kg/day, and decreased body weights/body weight gain and food consumption, poor nursing, and total litter loss were noted at 30 and 1000 mg/kg/day (approximately 626 and 17,000 times the human exposures (AUC) at the recommended human dose, respectively). Decreases in the offspring viability index on Day 4 after birth were noted at 30 and 1000 mg/kg/day, and low body weights and delayed pinna unfolding in pups were noted at 1000 mg/kg/day.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of SYMPROIC have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1163 patients exposed to SYMPROIC in clinical studies, 183 (16%) were 65 years of age and over, while 37 (3%) were 75 years and over. No overall differences in safety or effectiveness between these and younger patients were observed, but greater sensitivity of some older individuals cannot be ruled out. In a population pharmacokinetic analysis, no age-related alterations in the pharmacokinetics of naldemedine were observed [see Clinical Pharmacology (12.3) ].
🆘 Overdosage ▾
10 OVERDOSAGE Single doses of naldemedine up to 100 mg (500 times the recommended dose) and multiple doses of up to 30 mg (150 times the recommended dose) for 10 days have been administered to healthy subjects in clinical studies. Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhea, and nausea, were observed. Single doses of naldemedine up to 3 mg (15 times the recommended dose) and multiple doses of 0.4 mg (twice the recommended dose) for 28 days have been administered to patients with OIC in clinical studies.
Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhea, nausea, and vomiting, were observed. Also, chills, hyperhidrosis, and dizziness were reported more frequently at 1 and 3 mg doses and hyperhidrosis at the 0.4 mg dose. No antidote for naldemedine is known.
Hemodialysis is not an effective means to remove naldemedine from the blood [see Clinical Pharmacology (12.3) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Naldemedine is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB).
Naldemedine is also a substrate of the P-glycoprotein (P-gp) efflux transporter. Based on these properties, the CNS penetration of naldemedine is expected to be negligible at the recommended dose levels, limiting the potential for interference with centrally-mediated opioid analgesia.
12.2Pharmacodynamics Use of opioids induces slowing of gastrointestinal motility and transit. Antagonism of gastrointestinal mu-opioid receptors by naldemedine inhibits opioid-induced delay of gastrointestinal transit time. Effect on Cardiac Repolarization At a dose up to 5 times the recommended dose, SYMPROIC does not prolong the QT interval to any clinically relevant extent.
12.3Pharmacokinetics Absorption Following oral administration, naldemedine is absorbed with a time to achieve peak concentrations (T max ) of approximately 0.75 hours in a fasted state. Across the range of doses evaluated, the maximum plasma concentration (C max ) and area under the plasma concentration-time curve (AUC) increased in a dose-proportional or almost dose-proportional manner. Accumulation was minimal following multiple daily doses of naldemedine.
Food Effect A high-fat meal decreased the rate but not the extent of naldemedine absorption. The C max was decreased by approximately 35% and time to achieve C max was delayed from 0.75 hours in the fasted state to 2.5 hours in the fed state, whereas there was no meaningful change in the AUC in the fed state [see Dosage and Administration (2.2) ] . Distribution Plasma protein binding of naldemedine in humans is 93% to 94%.
The mean apparent volume of distribution during the terminal phase (Vz/F) is 155 L. Elimination The terminal elimination half-life of naldemedine is 11 hours. Metabolism Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with minor contribution from UGT1A3 to form naldemedine 3-G.
Nor-naldemedine and naldemedine 3-G have been shown to have antagonistic activity for opioid receptors, with less potent effect than naldemedine. Following oral administration of [ 14 C]-labeled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9% to 13%. Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%.
Naldemedine also undergoes cleavage in the GI tract to form benzamidine and naldemedine carboxylic acid. Excretion Following oral administration of [ 14 C]-labeled naldemedine, the total amount of radioactivity excreted in the urine and feces was 57% and 35% of the administered dose of naldemedine, respectively. The amount of naldemedine excreted unchanged in the urine was approximately 16% to 18% of the administered dose.
Benzamidine was the most predominant metabolite excreted in the urine and feces, representing approximately 32% and 20% of the administered dose of naldemedine, respectively. The percentage of unchanged drug in feces has not been estimated. Use in Specific Populations Age: Geriatric Population, Sex, Race/Ethnicity A population pharmacokinetic analysis from clinical studies with naldemedine did not identify a clinically meaningful effect of age, sex, or race on the pharmacokinetics of naldemedine.
Renal Impairment The pharmacokinetics of naldemedine after administration of a 0.2 mg single oral dose of SYMPROIC was studied in subjects with mild (n=8, estimated glomerular filtration rate [eGFR] of 60 to 89 mL/min/1.73… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Naldemedine is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naldemedine is a derivative of naltrexone to which a side chain has been added that increases the molecular weight and the polar surface area, thereby reducing its ability to cross the blood-brain barrier (BBB).
Naldemedine is also a substrate of the P-glycoprotein (P-gp) efflux transporter. Based on these properties, the CNS penetration of naldemedine is expected to be negligible at the recommended dose levels, limiting the potential for interference with centrally-mediated opioid analgesia.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING SYMPROIC is supplied as 0.2 mg naldemedine tablets as follows: bottle of 30 tablets - NDC 59385-041-30 Store SYMPROIC in a light resistant container at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store SYMPROIC in a light resistant container at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION SYMPROIC (naldemedine), an opioid antagonist, contains naldemedine tosylate as the active ingredient. The chemical name for naldemedine tosylate is: 17-(cyclopropylmethyl)-6,7-didehydro-4,5α-epoxy-3,6,14-trihydroxy-N-[2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl]morphinan-7-carboxamide 4-methylbenzenesulfonic acid. The structural formula is: The empirical formula for naldemedine tosylate is C 32 H 34 N 4 O 6 ∙C 7 H 8 O 3 S and the molecular weight is 742.84.
Naldemedine tosylate is a white to light tan powder, soluble in dimethylsulfoxide and methanol, slightly soluble in alcohol and water, and independent of pH. SYMPROIC (naldemedine) tablets for oral use contain 0.2 mg naldemedine (equivalent to 0.26 mg of naldemedine tosylate). Excipients are: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, and yellow ferric oxide.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Advise patients to discontinue SYMPROIC if treatment with the opioid pain medication is also discontinued. Gastrointestinal Perforation Advise patients to discontinue SYMPROIC and to promptly seek medical attention if they develop unusually severe, persistent or worsening abdominal pain [see Warnings and Precautions (5.1) ] .
Opioid Withdrawal Advise patients that clusters of symptoms consistent with opioid withdrawal may occur while taking SYMPROIC and to contact their healthcare provider if these symptoms occur [see Warnings and Precautions (5.2) ] . Pregnancy Advise females of reproductive potential, who become pregnant or are planning to become pregnant, that the use of SYMPROIC during pregnancy may precipitate opioid withdrawal in a fetus due to the undeveloped blood-brain barrier [see Use in Specific Populations (8.1) ] . Lactation Advise women that breastfeeding is not recommended during treatment with SYMPROIC and for 3 days after the final dose [see Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 07/2025 MEDICATION GUIDE SYMPROIC ® (sim proe' ik) (naldemedine) tablets, for oral use What is the most important information I should know about SYMPROIC?
SYMPROIC may cause serious side effects, including: Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that does not go away, stop taking SYMPROIC and get emergency medical help right away.
Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with SYMPROIC including sweating, chills, tearing, warm or hot feeling to your face (flush), sneezing, fever, feeling cold, abdominal pain, diarrhea, nausea, and vomiting. Tell your healthcare provider if you have any of these symptoms.
What is SYMPROIC? SYMPROIC is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids in adults with long-lasting (chronic) pain that is not caused by active cancer. It is not known if SYMPROIC is safe and effective in children.
Do not take SYMPROIC if you: have a bowel blockage (intestinal obstruction) or have a history of bowel blockage. are allergic to SYMPROIC or any of the ingredients in SYMPROIC. See the end of this Medication Guide for a complete list of ingredients in SYMPROIC. Tell your healthcare provider or pharmacist before you start or stop any medicines during treatment with SYMPROIC.
Before you take SYMPROIC, tell your healthcare provider about all of your medical conditions, including if you: have any stomach or bowel (intestines) problems, including, cancer or past surgery of the stomach or bowel, diverticulitis, or had chemotherapy or radiation treatment.. have liver problems. are pregnant or plan to become pregnant. Taking SYMPROIC during pregnancy may cause opioid withdrawal symptoms in your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with SYMPROIC. are breastfeeding or plan to breastfeed.
It is not known if SYMPROIC passes into your breast milk. You should not breastfeed during treatment with SYMPROIC and for 3 days after your last dose. Taking SYMPROIC while you are breastfeeding may cause opioid withdrawal symptoms in your baby.
You and your healthcare provider should decide if you will take SYMPROIC or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Other medicines may affect the way SYMPROIC works. How should I take SYMPROIC? Take SYMPROIC exactly as your healthcare provider tells you to take it.
Take your prescribed dose of SYMPROIC 1 time each day. SYMPROIC can be taken with or without food. SYMPROIC has been shown to be effective in people who have taken opioid pain medicines for at least 4 weeks.
Tell your healthcare provider if you stop taking your opioid pain medicine. If you stop taking your opioid pain medicine, you should also stop taking SYMPROIC. What are the possible side effects of SYMPROIC?
See " What is the most important information I should know about SYMPROIC? " The most common side effects of SYMPROIC include stomach (abdomen) pain, diarrhea, nausea and vomiting (gastroenteritis). Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SYMPROIC.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store SYMPROIC?
Store SYMPROIC at room temperature between 68°F to 77°F (20°C to 25°C). Keep SYMPROIC in the bottle that it comes in. Keep SYMPROIC and all medicines out of the reach of children.
General information about the safe and effective use of SYMPROIC. Medicines are sometimes prescribed for purposes other than those in a Medication Guide. Do… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following oral administration, naldemedine is absorbed with a time to achieve peak concentrations (T max ) of approximately 0.75 hours in a fasted state. Across the range of doses evaluated, the maximum plasma concentration (C max ) and area under the plasma concentration-time curve (AUC) increased in a dose-proportional or almost dose-proportional manner. Accumulation was minimal following multiple daily doses of naldemedine.
Food Effect A high-fat meal decreased the rate but not the extent of naldemedine absorption. The C max was decreased by approximately 35% and time to achieve C max was delayed from 0.75 hours in the fasted state to 2.5 hours in the fed state, whereas there was no meaningful change in the AUC in the fed state [see Dosage and Administration (2.2) ] . Distribution Plasma protein binding of naldemedine in humans is 93% to 94%.
The mean apparent volume of distribution during the terminal phase (Vz/F) is 155 L. Elimination The terminal elimination half-life of naldemedine is 11 hours. Metabolism Naldemedine is primarily metabolized by CYP3A to nor-naldemedine, with minor contribution from UGT1A3 to form naldemedine 3-G.
Nor-naldemedine and naldemedine 3-G have been shown to have antagonistic activity for opioid receptors, with less potent effect than naldemedine. Following oral administration of [ 14 C]-labeled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9% to 13%. Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%.
Naldemedine also undergoes cleavage in the GI tract to form benzamidine and naldemedine carboxylic acid. Excretion Following oral administration of [ 14 C]-labeled naldemedine, the total amount of radioactivity excreted in the urine and feces was 57% and 35% of the administered dose of naldemedine, respectively. The amount of naldemedine excreted unchanged in the urine was approximately 16% to 18% of the administered dose.
Benzamidine was the most predominant metabolite excreted in the urine and feces, representing approximately 32% and 20% of the administered dose of naldemedine, respectively. The percentage of unchanged drug in feces has not been estimated. Use in Specific Populations Age: Geriatric Population, Sex, Race/Ethnicity A population pharmacokinetic analysis from clinical studies with naldemedine did not identify a clinically meaningful effect of age, sex, or race on the pharmacokinetics of naldemedine.
Renal Impairment The pharmacokinetics of naldemedine after administration of a 0.2 mg single oral dose of SYMPROIC was studied in subjects with mild (n=8, estimated glomerular filtration rate [eGFR] of 60 to 89 mL/min/1.73 m 2 ), moderate (n=8, eGFR 30 to 59 mL/min/1.73 m 2 ), and severe (n=6, eGFR less than 30 mL/min/1.73 m 2 ) renal impairment, and subjects with end-stage renal disease (ESRD) requiring hemodialysis (n=8), and compared to healthy subjects with normal renal function (n=8, estimated creatinine clearance of at least 90 mL/min).
The pharmacokinetics of naldemedine between subjects in all groups were similar. Plasma concentrations of naldemedine in subjects with ESRD requiring hemodialysis were similar when SYMPROIC was administered either pre- or post-hemodialysis, indicating that naldemedine was not removed from the blood by hemodialysis. Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of a 0.2 mg single oral dose of SYMPROIC was studied in subjects with hepatic impairment classified as mild (n=8, Child-Pugh Class A) or moderate (n=8, Child-Pugh Class B) and compared with healthy subjects with normal hepatic function (n=8).
The pharmacokinetics of naldemedine between subjects in all groups were similar. The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naldemedine was not evaluated [see Use in Specific Populations (8.6) ] . Drug Inter… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Use of opioids induces slowing of gastrointestinal motility and transit. Antagonism of gastrointestinal mu-opioid receptors by naldemedine inhibits opioid-induced delay of gastrointestinal transit time. Effect on Cardiac Repolarization At a dose up to 5 times the recommended dose, SYMPROIC does not prolong the QT interval to any clinically relevant extent.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES SYMPROIC was evaluated in two replicate, 12-week, randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in which SYMPROIC was used without laxatives in patients with OIC and chronic non-cancer pain. Patients receiving a stable opioid morphine equivalent daily dose of at least 30 mg for at least 4 weeks before enrollment and self-reported OIC were eligible for clinical trial participation. Patients with evidence of significant structural abnormalities of the GI tract were not enrolled in these trials.
In Studies 1 and 2, patients had to either be not using laxatives or willing to discontinue laxative use at the time of screening and willing to use only the provided rescue laxatives during the screening and treatment periods. In Studies 1 and 2, OIC was confirmed through a two-week run in period and was defined as no more than 4 spontaneous bowel movements (SBMs) total over 14 consecutive days and less than 3 SBMs in a given week with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining; (2) hard or lumpy stools; (3) having a sensation of incomplete evacuation; and (4) having a sensation of anorectal obstruction/blockage.
An SBM was defined as a bowel movement (BM) without rescue laxative taken within the past 24 hours. Patients with no BMs over the 7 consecutive days prior to and during the 2-week screening period or patients who had never taken laxatives were excluded. In the screening and treatment periods, bisacodyl was used as rescue laxative if patients had not had a BM for 72 hours and were allowed one-time use of an enema, if after 24 hours of taking bisacodyl they still had not had a BM.
A total of 547 patients in Study 1 and 553 patients in Study 2 were randomized in a 1:1 ratio to receive SYMPROIC 0.2 mg once daily or placebo for 12 weeks. Study medication was administered without regard to meals. The mean age of subjects in Studies 1 and 2 was 54 years; 59% were women; and 80% were white.
The most common types of pain in Studies 1 and 2 were back or neck pain (61%). The mean baseline number of SBMs was 1.3 and 1.2 per week for Studies 1 and 2, respectively. Prior to enrollment, patients were using their current opioid for a mean duration of approximately 5 years.
A wide range of types of opioids were used. The mean baseline opioid morphine equivalent daily dosage was 132 mg and 121 mg per day for Studies 1 and 2, respectively. The efficacy of SYMPROIC was assessed in Studies 1 and 2 using a responder analysis.
A responder was defined as a patient who had at least 3 SBMs per week and a change from baseline of at least 1 SBM per week for at least 9 out of the 12 weeks and 3 out of the last 4 weeks in Studies 1 and 2. The responder rates in Studies 1 and 2 are shown in Table 4. Table 4: Efficacy Responder Rates in Studies 1 and 2 in Patients with OIC and Chronic Non-Cancer Pain Study 1 Study 2 SYMPROIC 0.2 mg once daily (N=273) Placebo (N=272) Treatment Difference [95% CI] SYMPROIC 0.2 mg once daily (N=276) Placebo (N=274) Treatment Difference [95% CI] CI=Confidence Interval Responder The primary endpoint was defined as a patient who had at least 3 SBMs per week and a change from baseline of at least 1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks.
130 (48%) 94 (35%) 13% [5%, 21%] 145 (53%) 92 (34%) 19% [11%, 27%] p value Cochran-Mantel-Haenszel test adjusted for opioid dose strata (30 to 100 mg; greater than 100 mg) 0.0020 <0.0001 In Studies 1 and 2, the mean increase in frequency of SBMs per week from baseline to the last 2 weeks of the 12-week treatment period was 3.1 for SYMPROIC vs. 2.0 for placebo (difference 1.0, 95% CI 0.6, 1.5), and 3.3 for SYMPROIC vs. 2.1 for placebo (difference 1.2, 95% CI 0.8, 1.7), respectively.
During week 1 of the treatment period, the mean increase in frequency of SBMs per week from baseline was 3.3 for SYMPROIC vs. 1.3 for placebo (difference 2.0, 95% CI 1.5, 2.5) in… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In 2-year carcinogenicity studies, there were no drug-related neoplastic findings following oral administration of naldemedine to mice and rats at doses up to 100 mg/kg/day (approximately 17,500 and 6,300 times the human exposures (AUC) at the recommended human dose, respectively). Mutagenesis Naldemedine was not genotoxic in the in vitro bacterial reverse mutation (Ames) assay, a chromosomal aberration assay with cultured Chinese hamster lung cells, or an in vivo micronucleus assay with rat bone marrow cells.
Impairment of Fertility Naldemedine was found to have no effect on fertility or reproductive performance in male and female rats at oral doses up to 1000 mg/kg/day (approximately 17,000 times the human exposures (AUC) at the recommended human dose). In female rats, prolongation of diestrous phase was noted at 10 mg/kg/day (approximately 179 times the human exposures (AUC) at the recommended human dose).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In 2-year carcinogenicity studies, there were no drug-related neoplastic findings following oral administration of naldemedine to mice and rats at doses up to 100 mg/kg/day (approximately 17,500 and 6,300 times the human exposures (AUC) at the recommended human dose, respectively). Mutagenesis Naldemedine was not genotoxic in the in vitro bacterial reverse mutation (Ames) assay, a chromosomal aberration assay with cultured Chinese hamster lung cells, or an in vivo micronucleus assay with rat bone marrow cells.
Impairment of Fertility Naldemedine was found to have no effect on fertility or reproductive performance in male and female rats at oral doses up to 1000 mg/kg/day (approximately 17,000 times the human exposures (AUC) at the recommended human dose). In female rats, prolongation of diestrous phase was noted at 10 mg/kg/day (approximately 179 times the human exposures (AUC) at the recommended human dose).
📄 Recent Major Changes ▾
Warnings and Precautions, Gastrointestinal Perforation ( 5.1 ) 07/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label - 30 Tablets NDC 59385-041-30 Rx ONLY 30 Tablets Symproic ® (naldemedine) tablets 0.2 mg Dispense the enclosed Medication Guide to each patient. Collegium ® PHARMACEUTICAL © 2023 Collegium Pharmaceutical, Inc. Stoughton, MA 02072 PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label - 30 Tablets
PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Blister Pack 7 Tablets Each tablet contains 0.2 mg of naldemedine (equivalent to 0.26 mg of naldemedine tosylate). Usual adult dosage: See package insert. Store at 20°C to 25°C (68°F to 77°F).
Mfd. for BioDelivery Sciences International, Inc. Raleigh, NC 27612 Symproic ® (naldemedine) tablets 0.2 mg NDC 59385-041-07 Rx ONLY Keep out of reach of children. PHYSICIAN SAMPLES NOT FOR SALE 319623 04/19 SYM-0001.1b DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 DAY 6 DAY 7 LOT: EXP: PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Blister Pack
PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Blister Pack Carton NDC 59385-041-07 7 Tablets Dosage: Take 1 tablet once daily Each tablet contains 0.2 mg of naldemedine (equivalent to 0.26 mg of naldemedine tosylate). Please see the included Prescribing Information. Keep out of reach of children.
Dispense the enclosed Medication Guide to each patient. Symproic ® (naldemedine) tablets 0.2 mg PHYSICIAN SAMPLES NOT FOR SALE FOR ORAL USE ONLY Rx ONLY PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Blister Pack Carton