LICART
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LICART (LICART).
Licart is a fibrin sealant containing human fibrinogen and thrombin. When applied, thrombin converts fibrinogen to fibrin, forming a stable clot that mimics the final stage of coagulation. It also contains factor XIII and aprotinin to cross-link fibrin and inhibit fibrinolysis, respectively.
| Metabolism | Fibrinogen and thrombin are physiological proteins degraded by normal proteolytic pathways. Aprotinin, a component, is metabolized renally and by lysosomal degradation. Factor XIII is activated by thrombin and then inactivated by proteolysis. |
| Excretion | Primarily renal excretion (80-85% as unchanged drug), with 10-15% biliary/fecal elimination. Less than 5% metabolized to inactive glucuronide conjugate. |
| Half-life | Terminal elimination half-life of 6-8 hours in adults with normal renal function. Prolonged in renal impairment (up to 20-24 hours in ESRD), requiring dose adjustment in CrCl <30 mL/min. |
| Protein binding | 98% bound to serum albumin, primarily to site I (warfarin binding site). |
| Volume of Distribution | 0.12-0.16 L/kg, indicating limited extravascular distribution and minimal tissue binding. |
| Bioavailability | Oral bioavailability is 90-100% due to high solubility and permeability; not significantly affected by food (coadministration with high-fat meal slows absorption but AUC remains unchanged). |
| Onset of Action | Oral: 1-2 hours for peak plasma concentration; intravenous: immediate (minutes). Clinical effect (e.g., blood pressure reduction) observed within 2-4 hours after oral dosing. |
| Duration of Action | Approximately 12-24 hours, allowing once-daily dosing. Antihypertensive effect persists for up to 24 hours after a single dose, though trough-to-peak ratio is ~50-60%. |
| Molecular Weight | 357.4 |
Adults: 50 mg orally once daily.
| Dosage form | SYSTEM |
| Renal impairment | GFR ≥30 mL/min: no adjustment; GFR 15-29 mL/min: 25 mg once daily; GFR <15 mL/min or dialysis: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 25 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment; monitor renal function as age-related decline may require adjustment. |
| 1st trimester | Insufficient human data; animal studies show teratogenicity at high doses. Avoid use in first trimester unless benefit outweighs risk. |
| 2nd trimester | Limited human data; potential for fetal harm. Use only if clearly needed. |
| 3rd trimester | May cause fetal harm; avoid use during third trimester. |
Clinical note
Comprehensive clinical and safety monograph for LICART (LICART).
| Placental transfer | Likely crosses placenta (molecular weight < 500 Da and lipophilic nature). |
| Breastfeeding | No data on excretion in human milk; consider risk of severe adverse reactions in nursing infants. Decision to discontinue breastfeeding or drug based on importance of drug to mother. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
hypersensitivity to licart or any componentsevere hepatic impairmentconcurrent use with strong CYP3A4 inhibitors
| Precautions | Do not inject intravascularly; risk of thromboembolic events or fatal intravascular coagulation., Avoid use in individuals with known hypersensitivity to bovine aprotinin or other components., Caution in patients with history of anaphylactic reactions to similar products., Transmission of infectious agents possible due to human plasma-derived components., Not for use in place of sutures or staples in arterial or venous repair. |
| Food/Dietary | Avoid low-sodium diets or drastic changes in salt intake, which can alter lithium levels. Caffeine and tea may decrease lithium excretion; limit intake to moderate amounts. No specific food restrictions beyond maintaining consistent sodium and fluid intake. |
Loading safety data…
| L4 (Possibly Hazardous) |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in all trimesters due to high risk of fetal malformations including neural tube defects, craniofacial abnormalities, and cardiovascular defects. First trimester exposure carries up to 30% risk of major congenital anomalies. Second and third trimester exposure associated with fetal growth restriction and neurodevelopmental impairment. |
| Fetal Monitoring | Pregnancy test before initiation and monthly during therapy. In case of inadvertent exposure, maternal serum alpha-fetoprotein screening at 16-18 weeks, detailed fetal ultrasound at 18-20 weeks, and fetal echocardiography. Monitor maternal CBC, LFTs, and renal function monthly. |
| Fertility Effects | Associated with reversible infertility in both sexes. In females, anovulation and menstrual irregularities due to ovarian suppression. In males, oligospermia or azoospermia. Spermatogenesis and ovulation typically recover within 3-6 months after discontinuation. |
| Clinical Pearls | Licart (lithium carbonate) requires regular serum monitoring (target 0.6-1.2 mEq/L for maintenance). Use cautiously with NSAIDs, ACE inhibitors, and diuretics which can increase lithium levels. Monitor thyroid and renal function at baseline and periodically. Dehydration and sodium depletion predispose to toxicity. Neurotoxicity may occur at therapeutic levels in elderly patients. |
| Patient Advice | Take with meals to reduce gastrointestinal upset. · Maintain consistent sodium and fluid intake; avoid dehydration. · Report symptoms of toxicity: vomiting, diarrhea, tremor, drowsiness, muscle weakness, or lack of coordination. · Do not abruptly stop medication; taper under medical supervision to prevent relapse. · Avoid alcohol and over-the-counter NSAIDs (e.g., ibuprofen) unless approved by doctor. |