ded in half and taken withwater or crushed and administered with applesauce. The crushed tablet mixed with applesauce is stable for up to
4 hours.
3 DOSAGE FORMS AND STRENGTHS
EGATEN (triclabendazole) tablet: 250 mg pale red, speckled, capsule shaped, biconvex with imprint of “EG EG” on one side and functionally scored on both sides.
4 CONTRAINDICATIONS
EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to otherbenzimidazole derivatives or to any of the excipients in EGATEN.
5 WARNINGS AND PRECAUTIONS
5.1 QT Prolongation
Transient prolongation of the mean QTc interval was noted on the electrocardiographic recordings in dogs [seeNonclinical Toxicology (13.2)].
Monitor ECG in patients with a history of prolongation of the QTc interval or ahistory of symptoms compatible with a long QT interval or when EGATEN is used in patients who receivedrugs that prolong the QT interval.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflectthe rates observed in clinical practice.
The safety of triclabendazole was eva luated in 208 adult and pediatric patients 5 years of age and older whoparticipated in 6 clinical trials for the treatment of fascioliasis and received 10 mg/kg or 20 mg/kg oftriclabendazole; of these, 6 patients failed the 10 mg/kg dose and were retreated with 20 mg/kg. The 10 mg/kg
dosing regimen is not approved [see Dosage and Administration (2)]. In these trials, 186 patients received asingle dose of 10 mg/kg and 28 patients received a dose of 20 mg/kg as two divided doses. Pooled data foradverse reactions reported in more than 2% of the patients in these clinical trials for the 10 mg/kg and 20 mg/kg
dosing regimens are presented in Table 1.
Table 1: Adverse Reactions Occurring in >2% of Patients Who Received a Total of 10 mg/kg or 20 mg/kg
Triclabendazole for Fascioliasis Treatment (Pooled across 6 studies)
Adverse Reactions Triclabendazole 10 mg/kg
N = 186, n (%)
Triclabendazole 20 mg/kg in
two divided doses1
N = 28, n (%)
Abdominal pain2
105 (56) 26 (93)
Adverse Reactions Triclabendazole 10 mg/kg
N = 186, n (%)
Triclabendazole 20 mg/kg in
two divided doses1
N = 28, n (%)
Hyperhidrosis 42 (23) 7 (25)
Vertigo 16 (9) 0
Nausea 15 (8) 5 (18)
Urticaria 12 (7) 3 (11)
Vomiting 11 (6) 2 (7)
Headache 11 (6) 4 (14)
Dyspnea 9 (5) 0
Pruritus 8 (4) 1 (4)
Asthenia 7 (4) 0
Musculoskeletal chest pain 7 (4) 1 (4)
Cough 7 (4) 0
Decreased appetite 6 (3) 5 (18)
Chest pain 6 (3) 0
Pyrexia 4 (2) 0
Jaundice3
4 (2) 0
Chest discomfort 4 (2) 0
Diarrhea 0 2 (7)
1Divided doses were given 6-48 hours apart
2Abdominal pain upper and abdominal pain
3
Jaundice and ocular icterus
Adverse reactions reported in less than or equal to 2% of patients who received a total of 10 mg/kg oftriclabendazole were constipation, biliary colic, arthralgia, back pain, spinal pain, and chromaturia. Someadverse reactions associated with triclabendazole treatment in fascioliasis, e.g. abdominal pain, biliary colic,and jaundice, could be secondary to the infection and may be more frequent and/or severe in patients with aheavy worm burden.
The safety profile of triclabendazole 20 mg/kg in divided doses in a non-hepat |
