Jornay PM
Jornay PM
Generic Name
Jornay PM
Mechanism
- Esomeprazole
- Irreversibly inhibits the H⁺/K⁺‑ATPase (proton pump) in gastric parietal cells.
- Suppresses acid production for up to 24 h, with peak activity 1–2 h post‑dose.
- Extended‑release coating delays gastric release by ~4 h, ensuring peak inhibition during the early morning hours.
- Melatonin
- Binds to MT₁/MT₂ receptors, modulating circadian rhythmicity of gastric motility.
- Enhances myoelectric activity and promotes coordinated gastric emptying, reducing reflux risk.
- Exhibits antioxidant and anti‑inflammatory properties in the gastric mucosa.
The combination achieves a sustained elevation of gastric pH during sleep and improves mucosal defense against nocturnal reflux.
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Pharmacokinetics
| Parameter | Esomeprazole | Melatonin | |
| Absorption | Rapid (Cmax 1–2 h); delayed‑release 4 h | Rapid; ~90 % bioavailability | |
| Bioavailability | ~20 % (due to first‑pass metabolism) | ~70 % | |
| Distribution | Highly protein‑bound (91 %) | Widely distributed across tissues | |
| Metabolism | CYP2C19, CYP3A4 | CYP1A2, other minor pathways | |
| Elimination | Hepatic; half‑life ~1 h (active ketone 4‑8 h) | Renal & hepatic; half‑life ~20 min | |
| Drug Interactions | ↑ing with CYP2C19 inhibitors (ketoconazole, fluconazole); ↓ing with inducers (rifampin, carbamazepine) | <strength; mild CYP inhibitor effects |
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Indications
- Gastroesophageal Reflux Disease (GERD)
- Symptomatic nocturnal acid breakthrough and nighttime heartburn.
- 4–8 week therapy; can be used adjunctively with intermittent high‑dose PPI cathartics.
- Helicobacter pylori (in combination with antibiotics)
- Supplementary acid suppression in triple or quadruple therapy regimens.
- Gastric ulceration (post‑operative or NSAID-induced)
- Immediate and sustained nocturnal protection during ulcer healing.
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Contraindications
- Contraindications
- Known hypersensitivity to esomeprazole, melatonin, or excipients.
- Severe hepatic impairment (Child‑Pugh C) unless benefit outweighs risk.
- Warnings
- Pregnancy & Lactation: Category C; not recommended during pregnancy. Avoid if breastfeeding.
- CYP2C19 Genetic Variability: Poor metabolizers exhibit higher esomeprazole exposure; monitor for adverse events.
- Rebound Acid Hypersecretion: Abrupt withdrawal may precipitate rebound reflux; taper if needed.
- S. eputizoid: Monitor for *Clostridioides difficile* colitis in immunocompromised.
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Dosing
- Adult Indications
– *One 34 mg capsule* (20 mg esomeprazole + 3 mg melatonin) once nightly 8–9 pm.
– Take at least 1 hour before bedtime; avoid large meals or alcohol to aid esomeprazole absorption.
• Duration
– Standard 4–8 weeks; extend if symptomatic improvement persists.
• Special Populations
– *Pediatrics*: Not approved.
– *Renal/Hepatic Impairment*: Dose not adjusted; monitor liver function.
– *Elderly*: Similar dosing; watch for sedation from melatonin.
• Administration Notes
– Swallow whole; avoid crushing or chewing.
– Rotate with standard PPIs if therapy change required.
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Adverse Effects
- Common
- Nausea, abdominal pain, diarrhea, constipation, headache, dizziness, insomnia, fatigue.
- Transient hyperpigmentation of mucosa (rare).
- Serious
- *Clostridioides difficile* colitis.
- Allergenic reactions (rash, pruritus, angioedema).
- Hepatotoxicity (rare; reported ↑ALT/AST).
- Severe sedation or sleep disorders due to melatonin.
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Monitoring
| Parameter | Frequency | Rationale |
| Serum Liver Enzymes | Baseline, week 4, week 8 | Detect hepatotoxicity, especially in chronic use |
| Renal Function | Baseline, every 4 weeks if impaired | Closely monitor due to potential accumulation |
| Gastric pH (optional) | 24‑h pH monitoring if refractory | Confirm acid suppression adequacy |
| Adverse Reaction Log | Patient‑self‑reported weekly | Capture delayed melatonin effects |
| Pregnancy Test | In reproductive‑age females | Avoid inadvertent exposure |
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Clinical Pearls
1. Nocturnal Targeting – The delayed release of esomeprazole coupled with melatonin produces a pH > 4 window during early morning hours, yielding superior control of nighttime heartburn versus conventional PPI dosing.
2. Melatonin is Protective, Not Sedative – In typical therapeutic doses (3 mg), melatonin specifically enhances gastric motility without inducing significant drowsiness; monitor only if patients report excessive daytime sleepiness.
3. Titration Not Required – The combination capsule provides a fixed dose; unlike standard PPIs, no up‑titration to 40 mg is generally needed.
4. Avoid Co‑administration with Fast‑acting PPIs – Taking a second PPI within 6 h may increase esomeprazole exposure and risk of adverse effects; coordinate dosing schedules if transitioning therapies.
5. Risks in CYP2C19 Poor Metabolizers – These patients may accumulate esomeprazole; if they experience prolonged gastritis or dyspepsia, consider a lower‑dose alternative PPI or limit therapy to <6 weeks.
6. Use in GERD with Sleep Disturbances – Patients reporting nocturnal acid reflux and insomnia can benefit from Jornay PM’s dual mechanism, potentially improving both GI and sleep quality.
7. Rebound Management – When discontinuing, taper by reducing dose or lengthening interval (e.g., every 48 h) to minimize rebound acid breakthrough.
8. Pregnancy Considerations – Because of limited data, non‑pregnant, non‑breast‑feeding patients are preferred; offer counseling on alternate, proven therapies in pregnant women.
9. Intra‑oral Hyperpigmentation – Rare; educate patients to report darker oral mucosa or GI bleeding promptly.
10. Hepatotoxicity Surveillance – Sublingsual liver enzyme screening should be integrated into follow‑up visits for patients on long‑term acid‑suppressive therapy.
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• *This drug card offers evidence‑based, concise reference material suitable for medical students and clinicians who require rapid access to key pharmacologic facts about Jornay PM.*