Famciclovir
Famciclovir Prescribing Information
Famciclovir tablets may be taken with or without food.
Famciclovir tablets, USP are available in 3 strengths:
- 125 mg: Famciclovir 125 mg tablets are white, round, biconvex, film-coated tablets, engraved “APO” on one side and “FAM” over “125” on the other side.
- 250 mg: Famciclovir 250 mg tablets are white, round, biconvex, film-coated tablets engraved “APO” on one side and “FAM” over “250” on the other side.
- 500 mg: Famciclovir 500 mg tablets are white, oval, biconvex film-coated tablets, engraved “APO” on one side and “FAM500” on the other side.
Famciclovir is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir® (penciclovir cream).
Acute renal failure is discussed in greater detail in other sections of the label
Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of famciclovir for their level of renal function. Reduce dosage in patients with renal impairment.
Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir tablets for their level of renal function. Dosage reduction is recommended when administering famciclovir tablets to patients with renal impairment [see Dosage and Administration , Use in Specific Populations ].
The active ingredient in famciclovir tablets is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9
Famciclovir is a white to off-white powder. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8)
Famciclovir tablets, USP contain 125 mg, 250 mg or 500 mg of famciclovir, together with the following inactive ingredients: hypromellose, poloxamer, polyethylene glycol, stearic acid, and titanium dioxide.
Meets USP Dissolution Test 2.
Famciclovir 125 mg tablets are white, round, biconvex, film-coated tablets, engraved “APO” on one side and “FAM” over “125” on the other side
- Bottles of 30------NDC 60505-3245-3
Famciclovir 250 mg tablets are white, round, biconvex, film-coated tablets engraved “APO” on one side and “FAM” over “250” on the other side.
- Bottles of 30s-----NDC 60505-3246-3
Famciclovir 500 mg tablets are white, oval, biconvex film-coated tablets, engraved “APO” on one side and “FAM500” on the other side.
- Bottles of 30s-----NDC 60505-3247-3
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
Dispense in a tight container [see USP].