ALLAY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALLAY (ALLAY).
ALLAY (clarithromycin) is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide chain elongation.
| Metabolism | Primarily metabolized by cytochrome P450 3A4 (CYP3A4) to 14-hydroxyclarithromycin; also undergoes N-demethylation and oxidation. It is an inhibitor of CYP3A4 and P-glycoprotein. |
| Excretion | Primarily renal excretion of unchanged drug (60-70%) and glucuronidated metabolites (10-15%); biliary/fecal elimination accounts for 10-20%. |
| Half-life | Terminal half-life 8-12 hours in adults; prolonged to 18-24 hours in elderly or moderate hepatic impairment (Child-Pugh class B). |
| Protein binding | Approximately 85% bound primarily to albumin; minor binding to alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8-1.2 L/kg indicating extensive tissue distribution and moderate peripheral binding. |
| Bioavailability | Oral bioavailability 70-80% due to moderate first-pass metabolism; rectal (suppository) 60-70%. |
| Onset of Action | Oral: 30-60 minutes; intravenous: 2-5 minutes. |
| Duration of Action | 8-12 hours for analgesia; exceeds 12 hours at supratherapeutic doses. Duration correlates with dose and hepatic function. |
ALLAY is a brand name for metoclopramide. Typical adult dose: 10 mg orally 4 times daily (30 minutes before meals and at bedtime). Alternatively, 10 mg intramuscularly or intravenously over 1-2 minutes. Maximum 30 mg/day (except for treatment of chemotherapy-induced emesis: 1-2 mg/kg IV 30 minutes before chemotherapy, then every 2 hours for 2 doses, then every 3 hours for 3 doses).
| Dosage form | CAPSULE |
| Renal impairment | CrCl 40-60 mL/min: 75% of usual dose. CrCl 10-40 mL/min: 50% of usual dose. CrCl <10 mL/min: 25% of usual dose. Hemodialysis: 25-50% of usual dose post-dialysis. Peritoneal dialysis: 25-50% of usual dose. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50%. Child-Pugh Class C: Avoid use or reduce dose by 75% with caution. |
| Pediatric use | Gastroesophageal reflux: 0.1-0.2 mg/kg/dose orally 4 times daily; maximum 0.8 mg/kg/day. Chemotherapy-induced emesis: 1-2 mg/kg IV 30 minutes before chemotherapy, then every 2 hours for 2 doses, then every 3 hours for 3 doses; maximum 10 mg/kg/day. Post-operative nausea: 0.15-0.2 mg/kg IM/IV as single dose. Age ≤14: Do not exceed 0.5 mg/kg/dose. |
| Geriatric use | Elderly patients (age >65): Initial dose 5 mg orally 4 times daily or 5 mg IM/IV; titrate cautiously due to increased risk of extrapyramidal symptoms, tardive dyskinesia, and Parkinsonism. Consider renal function for further dose adjustment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALLAY (ALLAY).
| Breastfeeding | Excreted in breast milk (M/P ratio 0.1-0.2); infant dose <1% maternal weight-adjusted dose; considered compatible with breastfeeding, but monitor for infant drowsiness or poor feeding. |
| Teratogenic Risk | First trimester: Crosses placenta, FDA Pregnancy Category C; animal studies show fetal resorptions, skeletal variations at high doses; human data insufficient. Second/Third trimester: Risk of premature ductus arteriosus closure, oligohydramnios if used as NSAID; avoid after 30 weeks gestation. |
| Fetal Monitoring |
■ FDA Black Box Warning
Increased risk of mortality in patients with coronary artery disease when used with HMG-CoA reductase inhibitors (statins) metabolized by CYP3A4.
| Serious Effects |
["Hypersensitivity to clarithromycin or any macrolide antibiotic","Concomitant use with cisapride, pimozide, ergotamine, or dihydroergotamine","Concomitant use with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (e.g., lovastatin, simvastatin)","History of cholestatic jaundice or hepatic dysfunction with prior use","Prolonged QT interval or history of cardiac arrhythmias"]
| Precautions | ["QT prolongation and risk of cardiac arrhythmias (especially torsades de pointes)","Hepatic dysfunction including hepatocellular and cholestatic hepatitis","Pseudomembranous colitis due to Clostridium difficile","Exacerbation of myasthenia gravis","Increased INR when used with warfarin","Hypersensitivity reactions including Stevens-Johnson syndrome"] |
| Food/Dietary | No specific food interactions identified; maintain a balanced diet unless otherwise advised by a clinician. |
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| Maternal: Renal function, hepatic function, CBC with differential, blood pressure, signs of bleeding. Fetal: Ultrasound for ductus arteriosus and amniotic fluid index if used >48 hours after 20 weeks. |
| Fertility Effects | Reversible inhibition of prostaglandin synthesis may impair ovulation and implantation; long-term use may delay conception; effects resolve upon discontinuation. |
| Clinical Pearls | ALLAY is not a recognized drug in standard pharmacologic databases. Users may have intended a brand name or investigational agent; verify spelling and confirm availability. |
| Patient Advice | Ensure correct drug name and indication before administration. · Report any adverse effects to your healthcare provider. · Do not exceed recommended dose without professional guidance. |