Drug Catalog - Product Detail
FAMCICLOVIR 125MG TAB 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69097-0269-02 | CIPLA USA | 30 | 125MG | TABLET |
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Description
11 DESCRIPTION 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 H -purin-9-yl)-ethyl]-1, 3-propanediol diacetate. Its molecular formula is C 14 H 19 N 5 O 4 ; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure structure Famciclovir is a white to pale yellow solid. 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%-3% w/v) monohydrate. Famciclovir is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P =1.09 and octanol/phosphate buffer (pH 7.4) P =2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, together with the following inactive ingredients: croscarmellose sodium, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, polyethylene glycols 6000 and titanium dioxide. Meets USP dissolution Test 2. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Famciclovir tablets are supplied as film-coated tablets as follows: 125 mg in bottles of 30; 250 mg in bottles of 30; and 500 mg in bottles of 30. Famciclovir 125 mg tablet: White coloured, circular, film-coated, biconvex tablet debossed with 'C' and' 269' on one side and plain on other side. 125 mg 30's…………………………………………………………..NDC 69097-269-02 Famciclovir 250 mg tablet: White coloured, circular, film-coated, biconvex tablet debossed with 'C' and '271' on one side and plain on other side. 250 mg 30's…………………………………………………………...NDC 69097-271-02 Famciclovir 500 mg tablet: White coloured, capsule shaped, film-coated, biconvex tablets debossed with 'C272' on one side and plain on other side. 500 mg 30's…………………………………………………………...NDC 69097-272-02 Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) Human Immunodeficiency Virus (HIV)-Infected Adult Patients ( 1.2 ) Limitation of Use ( 1.3 ) The efficacy and safety of famciclovir have not been established for: 1.1 Immunocompetent Adult Patients Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients. Genital herpes: Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established. Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established. Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established. 1.2 HIV-Infected Adult Patients Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established. Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: • Patients with first episode of genital herpes • Patients with ophthalmic zoster • Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients • Black and African American patients with recurrent genital herpes
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Immunocompetent Adult Patients ( 2.1 ) Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes Suppressive therapy 1000 mg twice daily for 1 day 250 mg twice daily Herpes zoster (shingles) 500 mg every 8 hours for 7 days HIV-Infected Adult Patients ( 2.2 ) Recurrent episodes of orolabial or genital herpes 500 mg twice daily for 7 days Patients with renal impairment: Adjust dose based on creatinine clearance. ( 2.3 ) Famciclovir tablets may be taken with or without food. 2.1 Dosing Recommendation in Immunocompetent Adult Patients Herpes labialis (cold sores): The recommended dosage of famciclovir tablets for the treatment of recurrent herpes labialis is 1500 mg as a single dose. Therapy should be initiated at the first sign or symptom of herpes labialis (e.g., tingling, itching, burning, pain, or lesion). Genital herpes: Recurrent episodes: The recommended dosage of famciclovir tablets for the treatment of recurrent episodes of genital herpes is 1000 mg twice daily for 1 day. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion). Suppressive therapy: The recommended dosage of famciclovir tablets for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily. Herpes zoster (shingles): The recommended dosage of famciclovir tablets for the treatment of herpes zoster is 500 mg every 8 hours for 7 days. Therapy should be initiated as soon as herpes zoster is diagnosed. 2.2 Dosing Recommendation in HIV-Infected Adult Patients Recurrent orolabial or genital herpes: The recommended dosage of famciclovir tablets for the treatment of recurrent orolabial or genital herpes in HIV-infected patients is 500 mg twice daily for 7 days. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion). 2.3 Dosing Recommendation in Patients with Renal Impairment Dosage recommendations for adult patients with renal impairment are provided in Table 1 [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 ) ] . Table 1: Dosage Recommendations for Adult Patients with Renal Impairment * Hemodialysis. Indication and Normal Dosage Regimen Creatinine Clearance (mL/min) Adjusted Dosage Regimen Dose (mg) Dosing Interval Single-Day Dosing Regimens Recurrent Genital Herpes 1000 mg every 12 hours for 1 day ≥60 1000 every 12 hours for 1 day 40-59 500 every 12 hours for 1 day 20-39 500 single dose <20 250 single dose HD* 250 single dose following dialysis Recurrent Herpes Labialis 1500 mg single dose ≥60 1500 single dose 40-59 750 single dose 20-39 500 single dose <20 250 single dose HD* 250 single dose following dialysis Multiple-Day Dosing Regimens Herpes zoster 500 mg every 8 hours ≥60 500 every 8 hours 40-59 500 every 12 hours 20-39 500 every 24 hours <20 250 every 24 hours HD* 250 following each dialysis Suppression of Recurrent Genital Herpes 250 mg every 12 hours ≥40 250 every 12 hours 20-39 125 every 12 hours <20 125 every 24 hours HD* 125 following each dialysis Recurrent Orolabial or Genital Herpes in HIV-Infected Patients 500 mg every 12 hours ≥40 500 every 12 hours 20-39 500 every 24 hours <20 250 every 24 hours HD* 250 following each dialysis