DELFEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELFEN (DELFEN).
Pine bark extract; antioxidant and anti-inflammatory effects via inhibition of cyclooxygenase and lipoxygenase pathways, and modulation of nitric oxide synthesis.
| Metabolism | Not systematically studied; likely hepatic metabolism via conjugation. |
| Excretion | Renal 50-70% as unchanged drug; fecal 20-30% via biliary excretion; remainder metabolized. |
| Half-life | Terminal half-life 18-24 hours; prolonged in renal impairment (up to 48 hours). |
| Protein binding | 95-98% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.6-1.2 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral: 60-80% (first-pass effect); intramuscular: 90-100%; intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes; intramuscular: 15-30 minutes; intravenous: 2-5 minutes. |
| Duration of Action | Oral: 6-8 hours; parenteral: 4-6 hours; extended-release: 12-24 hours. |
| Action Class | H1 Antihistaminics (second Generation) |
| Brand Substitutes | Lcfex 180 Tablet, Fexofen 180mg Tablet, Mavifex 180mg Tablet, Histafree 180 Tablet, Fexert 180mg Tablet |
Intravaginal: One applicatorful (5 g) of 4% gel (200 mg progesterone) inserted once daily at bedtime for 12 consecutive days per 28-day cycle, starting on day 15 of the menstrual cycle. Use in conjunction with estrogen replacement therapy in postmenopausal women.
| Dosage form | AEROSOL |
| Renal impairment | No dosage adjustment required for mild to moderate renal impairment. Not studied in severe renal impairment; use with caution. |
| Liver impairment | Contraindicated in patients with severe hepatic impairment (Child-Pugh class C). For mild to moderate impairment (Child-Pugh A or B), no dosing adjustment provided; use with caution. |
| Pediatric use | Not indicated for use in pediatric patients. |
| Geriatric use | No specific dose adjustment; use lowest effective dose. Monitor for adverse effects such as dizziness, somnolence, and fluid retention. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELFEN (DELFEN).
| Breastfeeding | Excretion into breast milk unknown; minimal systemic absorption unlikely to affect infant. Use caution; M/P ratio not established. |
| Teratogenic Risk | No adequate human data; animal studies not available. Theoretical risk of systemic effects from vaginal absorption. Avoid in 1st trimester unless clearly indicated. No known specific teratogenicity with vaginal use. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to pine bark extract."]
| Precautions | ["Use with caution in patients with bleeding disorders or those on anticoagulant therapy due to potential antiplatelet effects.","Pregnancy and lactation: insufficient data; avoid use."] |
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| No specific required monitoring. Assess for local adverse effects. Monitor pregnancy outcome if used during gestation. |
| Fertility Effects | No known effect on fertility. Local vaginal contraceptive designed to impair sperm motility; no systemic reproductive impact. |