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Osmotic Laxative • Prescription (Rx)

Kristalose (Lactulose)

Brand Names: Kristalose

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2018-09-17 • RxNorm RxCUI 1251190 • 4 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Kristalose (Lactulose) Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

81%
Patient “Worth It” (20)
$640.00
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Kristalose (Lactulose) Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1251190 • NDC 66220-719

Distinguished by trade identifier Kristalose and registered by Cumberland Pharmaceuticals Inc., this osmotic laxative product delivers active moiety Lactulose (cross-referenced at /meds/lactulose) (20 g/20g Powder, for Solution; 10 g/10g Powder, for Solution). Federal labeling (2018-09-17, RxCUI 1251190) defines its therapeutic scope: kristalose: ® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation.

Inside Kristalose, Lactulose mediates osmotic laxative pharmacodynamics with class-characteristic hepatorenal disposition across labeled adult regimens (20 g/20g Powder, for Solution; 10 g/10g Powder, for Solution). Commercial labeling registered by Cumberland Pharmaceuticals Inc. (SPL 2018-09-17, RxNorm 1251190) pairs standardized excipient stability with federal price transparency metrics ($9.3956/unit NADAC; $1696.00 retail average).

Clinical clearance of Kristalose (Lactulose) (Osmotic Laxative) relies on local esterase/enzymatic cleavage of kristalose (lactulose) with minimal hepatic cytochrome burden with a Trace plasma half-life; Kristalose (Lactulose) acts primarily within superficial target tissue half-life; patients absorbing at < 5% transdermal or mucosal systemic uptake from Kristalose (Lactulose) bioavailability typically observe target onset around initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (kristalose (lactulose)).

FDA clinical labeling for Kristalose (Lactulose) restricts administration in known hypersensitivity to lactulose or structurally related osmotic laxative compounds; concomitant contra-labeled cyp/transporter therapies during active kristalose (lactulose) administration across 20 g/20g Powder, for Solution, 10 g/10g Powder, for Solution, 10g/15mL Bottle of Solution, 10gm/15ml mL, with self-reported patient tracking dominated by nausea (11.8% of reports), diarrhea (9.1% of reports), mild local dryness (7.2% of reports).

Key Monitored Interactions:
Duplicate Osmotic Laxative Agents Moderate

Avoid overlapping osmotic laxative prescriptions alongside Kristalose (Lactulose) to prevent cumulative receptor toxicity.

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Kristalose (Lactulose) dosing.

Half-Life
Trace plasma half-life; Kristalose (Lactulose) acts primarily within superficial target tissue
Bioavailability
< 5% transdermal or mucosal systemic uptake from Kristalose (Lactulose)
Metabolism & Clearance
Local esterase/enzymatic cleavage of Kristalose (Lactulose) with minimal hepatic cytochrome burden
Clinical Onset
Initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (Kristalose (Lactulose))

Standard Adult Titration & Dosages

20 g/20g Powder, for Solution 10 g/10g Powder, for Solution 10g/15mL Bottle of Solution 10gm/15ml mL

Absolute & Relative Contraindications

  • Known hypersensitivity to Lactulose or structurally related osmotic laxative compounds
  • Concomitant contra-labeled CYP/transporter therapies during active Kristalose (Lactulose) administration

Logged Side-Effect Incidence (20 Reports)

Nausea 11.8%
Diarrhea 9.1%
Mild local dryness 7.2%
Application-site erythema 7.1%
Constipation 6.3%
Vomiting 5.4%
Elena Rostova (AI Biostatistician & openFDA Quant)

Kristalose (Lactulose) Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (20)
Nausea FAERS: 11.8% • Logs: 11.8%
Diarrhea FAERS: 9.1% • Logs: 9.1%
Vomiting FAERS: 5.4% • Logs: 5.4%
Constipation FAERS: 6.3% • Logs: 6.3%
Mild local dryness FAERS: 7.2% • Logs: 7.2%
Application-site erythema FAERS: 7.1% • Logs: 7.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Kristalose (Lactulose))

Browse All PubMed Translations →

Human clinical trial evidence for Kristalose (Lactulose) is indexed directly from the U.S. National Library of Medicine NCBI PubMed database. Explore recent randomized trials in the PubMed Research Pulse .

Marcus Sterling (AI Healthcare Price Auditor)

Kristalose (Lactulose) Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1251190
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $9.3956/unit (~$281.87/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $1696.00 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 20 Anonymous DotMD Community Micro-Logs $640.00 / mo View logs ↓

Kristalose (Lactulose) Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Kristalose (Lactulose) RxNorm Concept ID 1251190 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $9.3956 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $1696.00 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $640.00 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 81.00% Worth It (20 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Kristalose (Lactulose) Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Kristalose (Lactulose) integrating DailyMed SPL (2018-09-17), CMS NADAC ($9.3956/unit), and 20 Zero-PHI patient logs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

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“People Like Me” Cohort Filter (Zero-PHI)

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