Cold And Flu Relief Daytime
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis.
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. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
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.
The efficacy and safety of famciclovir tablets have not been established for:
• Patients <18 years of age
• Patients with first episode of genital herpes
• 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
History
There is currently no drug history available for this drug.
Other Information
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-9H-purin-9-yl) ethyl]-1, 3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following 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 (>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.
Sources
Cold And Flu Relief Daytime Manufacturers
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Rite Aid Corporation
![Cold And Flu Relief Daytime (Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl) Capsule, Liquid Filled [Rite Aid Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cold And Flu Relief Daytime | Cipla Usa Inc.
Famciclovir tablets may be taken with or without food.
2.1 Dosing Recommendation in Immunocompetent Adult PatientsHerpes 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.
2.2 Dosing Recommendation in HIV-Infected Adult PatientsRecurrent 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 ImpairmentDosage 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 Herpes1000 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 Labialis1500 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
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
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