AZLIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AZLIN (AZLIN).

How it works

Azlin is a penicillin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis.

What the body does with it

Metabolism	Minimally metabolized; primarily excreted unchanged in urine via glomerular filtration and tubular secretion.
Excretion	Renal excretion of unchanged drug (approximately 60-70% via glomerular filtration and tubular secretion); biliary/fecal excretion accounts for <10%.
Half-life	Terminal elimination half-life is approximately 1.0–1.5 hours in adults with normal renal function; prolonged to 3–5 hours in moderate renal impairment (CrCl 10–50 mL/min) and up to 10 hours in severe renal impairment (CrCl <10 mL/min).
Protein binding	Approximately 30–40%, primarily to albumin.
Volume of Distribution	0.2–0.3 L/kg, indicating distribution mainly in extracellular fluid; higher in neonates (0.4 L/kg) and critically ill patients with increased capillary permeability.
Bioavailability	Not orally bioavailable; administered intravenously (100% bioavailability by IV route).
Onset of Action	Immediate (within minutes) after intravenous administration; no oral absorption.
Duration of Action	Duration of antimicrobial effect is 4–6 hours after IV administration, corresponding to time above MIC; continuous infusion may be used to optimize exposure.

Classification & Brands

Dosing & administration

1-2 grams intravenously every 4-6 hours; total daily dose up to 12 grams for serious infections.

Dosage form	INJECTABLE
Renal impairment	GFR 30-49 mL/min: 1-2 grams every 6-8 hours. GFR 10-29 mL/min: 1-2 grams every 8-12 hours. GFR <10 mL/min: 1-2 grams every 12 hours. Hemodialysis: 2 grams after dialysis.
Liver impairment	No specific dose adjustment recommended for Child-Pugh A or B. Child-Pugh C: use with caution, monitor liver function; dose reduction not formally established.
Pediatric use	Neonates: 50 mg/kg/dose every 12 hours if <7 days old, every 8 hours if 7-28 days old. Infants and children: 50-75 mg/kg/dose every 4-6 hours, maximum 12 g/day.
Geriatric use	Elderly patients may require lower doses due to decreased renal function; base dose on creatinine clearance. Monitor for nephrotoxicity and neurotoxicity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for AZLIN (AZLIN).

Breastfeeding	Excretion into human milk unknown; caution advised. M/P ratio not established. Consider developmental benefits of breastfeeding vs potential adverse effects.
Teratogenic Risk	No well-controlled studies in pregnant women. Animal studies have not shown teratogenic effects. Risk cannot be ruled out; use only if clearly needed. First trimester: minimal data; avoid unless essential. Second/third trimesters: no known fetal harm.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including Azlin, and may range in severity from mild diarrhea to fatal colitis.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to penicillins, cephalosporins, or beta-lactam antibiotics. Also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with Azlin.

Clinical Precautions

Precautions	Hypersensitivity reactions including anaphylaxis have been reported. Use with caution in patients with renal impairment, history of seizures, or electrolyte imbalances. Monitor renal function and electrolyte levels during therapy.
Food/Dietary	No specific food interactions. However, alcohol should be avoided due to potential increased gastrointestinal and CNS side effects. Take with food if gastrointestinal upset occurs.

Clinical Tips & Counseling

Drug interactions

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AZLIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AZLIN (AZLIN).

How it works

Azlin is a penicillin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis.

What the body does with it

Metabolism	Minimally metabolized; primarily excreted unchanged in urine via glomerular filtration and tubular secretion.
Excretion	Renal excretion of unchanged drug (approximately 60-70% via glomerular filtration and tubular secretion); biliary/fecal excretion accounts for <10%.
Half-life	Terminal elimination half-life is approximately 1.0–1.5 hours in adults with normal renal function; prolonged to 3–5 hours in moderate renal impairment (CrCl 10–50 mL/min) and up to 10 hours in severe renal impairment (CrCl <10 mL/min).
Protein binding	Approximately 30–40%, primarily to albumin.
Volume of Distribution	0.2–0.3 L/kg, indicating distribution mainly in extracellular fluid; higher in neonates (0.4 L/kg) and critically ill patients with increased capillary permeability.
Bioavailability	Not orally bioavailable; administered intravenously (100% bioavailability by IV route).
Onset of Action	Immediate (within minutes) after intravenous administration; no oral absorption.
Duration of Action	Duration of antimicrobial effect is 4–6 hours after IV administration, corresponding to time above MIC; continuous infusion may be used to optimize exposure.

Classification & Brands

Dosing & administration

1-2 grams intravenously every 4-6 hours; total daily dose up to 12 grams for serious infections.

Dosage form	INJECTABLE
Renal impairment	GFR 30-49 mL/min: 1-2 grams every 6-8 hours. GFR 10-29 mL/min: 1-2 grams every 8-12 hours. GFR <10 mL/min: 1-2 grams every 12 hours. Hemodialysis: 2 grams after dialysis.
Liver impairment	No specific dose adjustment recommended for Child-Pugh A or B. Child-Pugh C: use with caution, monitor liver function; dose reduction not formally established.
Pediatric use	Neonates: 50 mg/kg/dose every 12 hours if <7 days old, every 8 hours if 7-28 days old. Infants and children: 50-75 mg/kg/dose every 4-6 hours, maximum 12 g/day.
Geriatric use	Elderly patients may require lower doses due to decreased renal function; base dose on creatinine clearance. Monitor for nephrotoxicity and neurotoxicity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for AZLIN (AZLIN).

Breastfeeding	Excretion into human milk unknown; caution advised. M/P ratio not established. Consider developmental benefits of breastfeeding vs potential adverse effects.
Teratogenic Risk	No well-controlled studies in pregnant women. Animal studies have not shown teratogenic effects. Risk cannot be ruled out; use only if clearly needed. First trimester: minimal data; avoid unless essential. Second/third trimesters: no known fetal harm.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including Azlin, and may range in severity from mild diarrhea to fatal colitis.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to penicillins, cephalosporins, or beta-lactam antibiotics. Also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with Azlin.

Clinical Precautions

Precautions	Hypersensitivity reactions including anaphylaxis have been reported. Use with caution in patients with renal impairment, history of seizures, or electrolyte imbalances. Monitor renal function and electrolyte levels during therapy.
Food/Dietary	No specific food interactions. However, alcohol should be avoided due to potential increased gastrointestinal and CNS side effects. Take with food if gastrointestinal upset occurs.

Clinical Tips & Counseling

Drug interactions

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