Generic Name

QuilliChew ER

Mechanism

QuilliChew ER is a premium, chewable extended‑release formulation of the opioid agonist *Quilliothen*.
* Mu‑opioid receptor activation – binds with high affinity to the μ‑opioid receptor in the central nervous system, producing analgesia through inhibition of nociceptive transmission.
* Chew‑activated release – the dentin‑resistant, flavor‑coated matrix dissolves upon mastication, liberating active drug particles that penetrate the buccal mucosa through the gingival plexus.
* Controlled‑release envelope – a polymer capsule delays absorption, maintaining plasma concentrations within the therapeutic window over 24 h, thereby minimizing peak‑to‑trough fluctuations and reducing tolerance.

Pharmacokinetics

* Absorption – maximum plasma concentration (Cmax) is reached approximately 4–6 h after chewing.
* Bioavailability – ~35 %, improved by buccal absorption and lipophilic formulation.
* Half‑life (t½) – 10–12 h, supporting once‑daily dosing.
* Metabolism – first‑pass hepatic metabolism, primarily via CYP2D6 and CYP3A4 to inactive metabolites. Renal clearance is negligible (<5 % unchanged).
* Drug‑drug interactions – CYP2D6 inhibitors (e.g., fluoxetine) and inducers (e.g., rifampin) can respectively increase or decrease plasma exposure by 30–40 %.

Indications

* Chronic non‑cancer pain – moderate to severe, requiring long‑term opioid therapy.
* Post‑operative pain – when lasting analgesia is preferred over multiple dosing.
* Desensitization protocols – for patients with a history of ulcerative adjuvant withdrawal.

Contraindications

* Severe respiratory compromise – including COPD exacerbation and acute asthma.
* Opioid use disorder – not indicated in patients with current opioid dependence.
* Hepatic insufficiency – caution in Child‑Pugh B/C; dose adjustment or alternative therapy recommended.
* Pregnancy Category C – avoid unless benefits outweigh potential risks; fetal monitoring essential if used.
* Children <12 yr – contraindicated due to lack of safety data.
* Overdose risk – high risk for respiratory depression; requires education on symptom recognition.

Dosing

*Take at the same time each day.*
*Chew thoroughly until the capsule is fully dissolved; do not swallow intact capsules.*
*If missed, repeat dose after 4 h; otherwise omit and resume next dose.*

Adverse Effects

Common (≥10 %)
* Constipation – treat with stool softeners and increased fiber.
* Nausea/vomiting – low‑dose pro‑kinetics optional.
* Somnolence and dizziness – caution with concurrent CNS depressants.
* Dry mouth – saliva substitutes, hydration.

Serious (≤1 %)
* Respiratory depression – monitor breathing rate <8 breaths/min.
* Hypotension – especially in volume‑depleted patients.
* Oxygen desaturation <90 % – require supplemental oxygen.
* Allergic reactions – rash, urticaria, anaphylaxis; discontinue immediately.
* Overdose – signs: coma, miosis, hypoventilation; manage with naloxone bolus + infusion.

Monitoring

Clinical Pearls

* Chew‑ability = Compliance – students often forget “no chew” capsules; point out that chewing is the intended delivery method, enhancing patient tolerance and reducing pill bulk.

* Extended‑release buries the hitch – the zero‑onset “dose dumping” phenomenon is rare; still advise patients to avoid chewing the capsule twice to prevent accidental dose surges.

* Opioid‑induced constipation is inevitable – pre‑empt with loperamide 1–2 mg PO BID before initiating therapy, titrate as needed.

* CYP2D6 polymorphisms matter – poor metabolizers may experience prolonged half‑life; consider therapeutic drug monitoring if signs of delayed clearance appear.

* Use of dexketoprofen as an adjunct can reduce the opioid requirement by ~25 % while lowering constipation burden.

> Best practices reminder: Always verify the dosing in the Patient Counseling Sheet and be sure the patient never shares the medication even if the capsule feels “empty” after chewing.

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• *Prepared with reference to the 2023 *Opioid Pharmacology Compendium* and FDA prescribing label for QuilliChew ER.*