VIVLODEX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VIVLODEX (VIVLODEX).

How it works

COX-2 inhibitor; reduces prostaglandin synthesis via inhibition of cyclooxygenase-2 (COX-2) with minimal COX-1 inhibition.

What the body does with it

Metabolism	Hepatic via CYP3A4 and CYP2C9; active metabolite meloxicam-5-carboxylic acid.
Excretion	VIVLODEX is a meloxicam NSAID prodrug. Following hydrolysis to meloxicam, excretion is primarily hepatic (metabolism) and renal (urine). Approximately 50% of meloxicam dose is excreted in urine as metabolites and <5% as parent drug; about 40% in feces. Biliary excretion is minor.
Half-life	Terminal elimination half-life of the active moiety meloxicam is approximately 20 hours (range 12-24 h), allowing once-daily dosing in chronic pain.
Protein binding	Meloxicam is extensively protein bound (>99%) primarily to albumin.
Volume of Distribution	Volume of distribution is approximately 0.1-0.2 L/kg (about 10 L in adults), indicating limited tissue distribution.
Bioavailability	Absolute bioavailability of oral VIVLODEX is approximately 89% (for meloxicam).
Onset of Action	The onset of analgesic effect is typically within 1-2 hours after oral administration, with peak plasma concentrations at 4-5 hours.
Duration of Action	Duration of analgesic effect is approximately 24 hours, supporting once-daily dosing. Clinical effect persists for the dosing interval.

Classification & Brands

Dosing & administration

Once daily oral administration of 100 mg or 200 mg capsules. The recommended dose is 100 mg once daily; dose may be increased to 200 mg once daily if response is inadequate. Maximum daily dose: 200 mg.

Dosage form	CAPSULE
Renal impairment	eGFR 30-89 mL/min: No adjustment needed. eGFR 15-29 mL/min: Maximum dose 100 mg once daily. eGFR <15 mL/min or ESRD: Not recommended (not studied).
Liver impairment	Child-Pugh Class A (mild impairment): No adjustment needed. Child-Pugh Class B (moderate impairment): Maximum dose 100 mg once daily. Child-Pugh Class C (severe impairment): Not recommended (contraindicated).
Pediatric use	Not approved for pediatric patients under 18 years of age; safety and efficacy have not been established.
Geriatric use	No specific dose adjustment required based on age alone. Use the lowest effective dose and monitor renal function due to age-related decline in GFR. For patients ≥65 years, consider maximum dose of 100 mg once daily.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VIVLODEX (VIVLODEX).

Breastfeeding	Lornoxicam is excreted into breast milk in low concentrations; M/P ratio not established. Due to potential adverse effects on infant renal function and gastrointestinal tract, caution is advised. Consider alternative agents with more safety data.
Teratogenic Risk	VIVLODEX (lornoxicam) is contraindicated in the first and third trimesters. First trimester: NSAIDs increase risk of miscarriage and cardiac defects. Third trimester: risk of premature ductus arteriosus closure and oligohydramnios. Second trimester: use only if clearly needed, lowest effective dose for shortest duration.

Warnings & precautions

■ FDA Black Box Warning

Increased risk of cardiovascular thrombotic events, including myocardial infarction and stroke; increased risk of gastrointestinal adverse events including bleeding, ulceration, and perforation.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to meloxicam or NSAIDs; history of asthma, urticaria, or allergic-type reactions after aspirin or other NSAIDs; coronary artery bypass graft surgery; advanced renal disease; pregnancy (especially third trimester).

Clinical Precautions

Precautions

Cardiovascular thrombotic events; GI bleeding; serious skin reactions (e.g., Stevens-Johnson syndrome); renal toxicity; hepatic effects; anaphylaxis; fluid retention; hypertension; asthma exacerbation.

Clinical Tips & Counseling

Drug interactions

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VIVLODEX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VIVLODEX (VIVLODEX).

How it works

COX-2 inhibitor; reduces prostaglandin synthesis via inhibition of cyclooxygenase-2 (COX-2) with minimal COX-1 inhibition.

What the body does with it

Metabolism	Hepatic via CYP3A4 and CYP2C9; active metabolite meloxicam-5-carboxylic acid.
Excretion	VIVLODEX is a meloxicam NSAID prodrug. Following hydrolysis to meloxicam, excretion is primarily hepatic (metabolism) and renal (urine). Approximately 50% of meloxicam dose is excreted in urine as metabolites and <5% as parent drug; about 40% in feces. Biliary excretion is minor.
Half-life	Terminal elimination half-life of the active moiety meloxicam is approximately 20 hours (range 12-24 h), allowing once-daily dosing in chronic pain.
Protein binding	Meloxicam is extensively protein bound (>99%) primarily to albumin.
Volume of Distribution	Volume of distribution is approximately 0.1-0.2 L/kg (about 10 L in adults), indicating limited tissue distribution.
Bioavailability	Absolute bioavailability of oral VIVLODEX is approximately 89% (for meloxicam).
Onset of Action	The onset of analgesic effect is typically within 1-2 hours after oral administration, with peak plasma concentrations at 4-5 hours.
Duration of Action	Duration of analgesic effect is approximately 24 hours, supporting once-daily dosing. Clinical effect persists for the dosing interval.

Classification & Brands

Dosing & administration

Dosage form	CAPSULE
Renal impairment	eGFR 30-89 mL/min: No adjustment needed. eGFR 15-29 mL/min: Maximum dose 100 mg once daily. eGFR <15 mL/min or ESRD: Not recommended (not studied).
Liver impairment	Child-Pugh Class A (mild impairment): No adjustment needed. Child-Pugh Class B (moderate impairment): Maximum dose 100 mg once daily. Child-Pugh Class C (severe impairment): Not recommended (contraindicated).
Pediatric use	Not approved for pediatric patients under 18 years of age; safety and efficacy have not been established.
Geriatric use	No specific dose adjustment required based on age alone. Use the lowest effective dose and monitor renal function due to age-related decline in GFR. For patients ≥65 years, consider maximum dose of 100 mg once daily.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VIVLODEX (VIVLODEX).

Breastfeeding	Lornoxicam is excreted into breast milk in low concentrations; M/P ratio not established. Due to potential adverse effects on infant renal function and gastrointestinal tract, caution is advised. Consider alternative agents with more safety data.
Teratogenic Risk	VIVLODEX (lornoxicam) is contraindicated in the first and third trimesters. First trimester: NSAIDs increase risk of miscarriage and cardiac defects. Third trimester: risk of premature ductus arteriosus closure and oligohydramnios. Second trimester: use only if clearly needed, lowest effective dose for shortest duration.

Warnings & precautions

■ FDA Black Box Warning

Increased risk of cardiovascular thrombotic events, including myocardial infarction and stroke; increased risk of gastrointestinal adverse events including bleeding, ulceration, and perforation.