• 125 mg: White coloured, circular, film-coated, biconvex tablet debossed with ‘C’ and’269′ on one side and plain on other side.
• 250 mg: White coloured, circular, film-coated, biconvex tablet debossed with ‘C’ and ‘271’ on one side and plain on other side.
• 500 mg: White coloured, capsule shaped, film-coated, biconvex tablets debossed with ‘C272’ on one side and plain on other side.
Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir for their level of renal function. Dosage reduction is recommended when administering famciclovir to patients with renal impairment [see Dosage and Administration (2.3), Use in Specific Populations (8.6) ].
Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions (5)].
The most common adverse events reported in at least 1 indication by greater than 10% of adult patients treated with famciclovir are headache and nausea.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Immunocompetent patients: The safety of famciclovir has been evaluated in active-and placebo-controlled clinical studies involving 816 famciclovir-treated patients with herpes zoster (famciclovir, 250 mg three times daily to 750 mg three times daily); 163 famciclovir -treated patients with recurrent genital herpes (famciclovir, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with famciclovir as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received famciclovir (open-labeled and/or double-blind) for at least 10 months; and 447 famciclovir -treated patients with herpes labialis (famciclovir, 1500 mg once daily or 750 mg twice daily). Table 2 lists selected adverse events.
* Patients may have entered into more than one clinical trial.
† 7 days of treatment
‡ 1 day of treatment
§ daily treatment
|Events||Herpes Zoster †||Recurrent Genital Herpes‡||Genital Herpes- Suppression§||Herpes Labialis ‡|
|Famciclovir (n=273) %||Placebo (n=146) %||Famciclovir (n=163) %||Placebo (n=166) %||Famciclovir (n=458) %||Placebo (n=63) %||Famciclovir (n=447) %||Placebo (n=254) %|
|Body as a Whole|
|Skin and Appendages|
*Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges.
†n values represent the minimum number of patients assessed for each laboratory parameter.
NRH=Normal Range High.
NRL=Normal Range Low.
|Parameter||Famciclovir (n=660)† %||Placebo (n=210)† %|
|Anemia (<0.8 x NRL)||0.1||0.0|
|Leukopenia (<0.75 x NRL)||1.3||0.9|
|Neutropenia (<0.8 x NRL)||3.2||1.5|
|AST (SGOT) (>2 x NRH)||2.3||1.2|
|ALT (SGPT) (>2 x NRH)||3.2||1.5|
|Total Bilirubin (>1.5 x NRH)||1.9||1.2|
|Serum Creatinine (>1.5 x NRH)||0.2||0.3|
|Amylase (>1.5 x NRH)||1.5||1.9|
|Lipase (>1.5 x NRH)||4.9||4.7|
HIV-infected patients: In HIV-infected patients, the most frequently reported adverse events for famciclovir (500 mg twice daily; n=150) and acyclovir (400 mg, 5x/day; n=143), respectively, were headache (17% vs. 15%), nausea (11% vs. 13%), diarrhea (7% vs. 11%), vomiting (5% vs. 4%), fatigue (4% vs. 2%), and abdominal pain (3% vs. 6%).
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