Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 26 January 2017
(6.1) To report SUSPECTED
6.1 Clinical Studies Experience Because clinical trials are conducted under widely
The most frequently reported
Changes in the ocular lens and retina have been reported following the use of terbinafine hydrochloride tablets in
The clinical significance of these changes is unknown.
2x the upper limit of normal range.
6.2 Postmarketing Experience The following
Because these events are reported voluntarily from
Psoriasiform eruptions or
In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy [see Warnings and Precautions (5.4)].
Cases of smell
Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin has been reported.
2 DOSAGE AND ADMINISTRATION Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks.
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B There are
Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed,
Oral reproduction studies have been performed in rabbits and
8.3 Nursing Mothers After oral administration, terbinafine is present in breast milk of nursing mothers.
The ratio of terbinafine in milk to plasma is 7:1.
8.4 Pediatric Use The
8.5 Geriatric Use Clinical studies of terbinafine hydrochloride tablets did not include
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
|Date Last Revised||07-05-2012|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Physicians Total Care, Inc.|