Poor
Poorly Aligned
Patient Risk:
Low
Summary
The label describes topical SOOLANTRA cream and provides no information supporting claims about oral ivermectin tablets, binders, tablet properties, or sustained-release formulations. The accompanying evaluation correctly notes this limitation, but the listed claims themselves are not supported by the supplied label.
Category Scores
Accurate Statements
The SOOLANTRA label describes a topical cream and does not discuss oral tablets or binders.
Section 11 identifies SOOLANTRA as a topical cream and lists its inactive ingredients; it does not describe tablets or binders.
Section 12.3 does not address binder effects on bioavailability.
Section 12.3 reports pharmacokinetic information for topical SOOLANTRA cream but does not discuss binders.
Unsupported Statements
The choice of binder for an ivermectin dosage form can influence tablet hardness.
The label does not discuss tablets, binders, or tablet hardness.
The choice of binder for an ivermectin dosage form can influence disintegration time.
The label does not discuss tablet disintegration or binders.
The choice of binder for an ivermectin dosage form can influence the drug’s bioavailability.
The label reports absorption data for topical cream but does not address binder effects on bioavailability.
The choice of binder for an ivermectin tablet depends on the desired characteristics of the final tablet.
The label does not describe ivermectin tablets, binders, or tablet characteristics.
For oral ivermectin dosage forms, a binder that promotes rapid disintegration can help release the drug quickly for absorption.
The label describes topical cream and does not discuss oral dosage forms, disintegration, or drug release.
For sustained-release ivermectin formulations, a binder that slows disintegration might be preferred.
The label does not discuss sustained-release formulations, tablets, or binders.
A binder used with ivermectin must be chemically and physically compatible with it to prevent degradation or altered efficacy.
The label does not address binder compatibility, degradation, or effects on efficacy.
Starch is frequently used as a binder in oral ivermectin formulations.
The label does not describe oral ivermectin formulations or starch as an ingredient.
Microcrystalline cellulose is frequently used as a binder in oral ivermectin formulations.
The label does not describe oral ivermectin formulations or microcrystalline cellulose as an ingredient.
Povidone is frequently used as a binder in oral ivermectin formulations.
The label does not describe oral ivermectin formulations or povidone as an ingredient.
Starch, microcrystalline cellulose, and povidone are used in oral ivermectin formulations for their established safety, efficacy, and cost-effectiveness in pharmaceutical manufacturing.
The label makes no statements about these excipients in oral ivermectin formulations or their safety, efficacy, or cost-effectiveness.
These binders help produce ivermectin tablets with consistent hardness and disintegration times, contributing to reliable patient dosing.
The label does not discuss tablets, binders, hardness, disintegration, or dosing consistency.
A binder is generally recommended for ivermectin tablets to provide mechanical strength and tablet integrity.
The label does not describe ivermectin tablets or recommend binders.
Without an adequate binder, ivermectin tablets may be fragile, leading to breakage and inaccurate dosing.
The label does not discuss tablets, binders, breakage, or dosing accuracy.
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The unsupported claims concern formulation practices rather than a patient-specific dose or administration instruction. The supplied label does not establish their accuracy.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
Yes |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Poorly Aligned
Primary Issue
The claims about oral ivermectin tablets and binder selection are not supported by the supplied label, which describes topical SOOLANTRA cream.
Suggested Improvement
Limit conclusions to the topical formulation and label information, or clearly identify tablet and binder statements as information not established by this label.