Famciclovir

Famciclovir Recall

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Questions & Answers

Side Effects & Adverse Reactions

For external use only

condition worsens or does not improve after regular use

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

helps prevent recurrence of flaking and itching associated with dandruff

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Sources

Famciclovir Manufacturers

Cipla Usa Inc.

Famciclovir | Wakefern Food Corp

shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor

No Recall
H3 Medical Inc.

Famciclovir | H3 Medical Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
American Health Packaging

Famciclovir | American Health Packaging

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.
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
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

No Recall
Watson Laboratories, Inc.

Famciclovir | Actavis Pharma, Inc.

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.
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
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

No Recall
Physicians Total Care, Inc.

Famciclovir | Physicians Total Care, Inc.

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 to 59 500 every 12 hours for 1 day 20 to 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 to 59 750 single dose 20 to 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 to 59 500 every 12 hours 20 to 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 to 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 to 39 500 every 24 hours < 20 250 every 24 hours HD* 250 following each dialysis

No Recall
Pd-rx Pharmaceuticals, Inc.

Famciclovir | Pd-rx Pharmaceuticals, Inc.

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 to 59 500 every 12 hours for 1 day 20 to 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 to 59 750 single dose 20 to 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 to 59 500 every 12 hours 20 to 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 to 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 to 39 500 every 24 hours < 20 250 every 24 hours HD* 250 following each dialysis

No Recall
Golden State Medical Supply, Inc.

Famciclovir | Golden State Medical Supply, Inc.

Famciclovir 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.
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 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

No Recall
Avkare, Inc.

Famciclovir | Avkare, Inc.

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 to 59 500 every 12 hours for 1 day 20 to 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 to 59 750 single dose 20 to 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 to 59 500 every 12 hours 20 to 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 to 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 to 39 500 every 24 hours < 20 250 every 24 hours HD* 250 following each dialysis

No Recall
Roxane Laboratories, Inc.

Famciclovir | Unifirst First Aid Corporation

do not use more than directed Adults and children: (12 years and older)
Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
Children under 12 years:
Do not give to children under 12 years of age.

No Recall
Teva Pharmaceuticals Usa Inc

Famciclovir | Teva Pharmaceuticals Usa Inc

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
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 to 59
500
every 12 hours for 1 day
20 to 39
500
single dose
< 20
250
single dose
HDa
250
single dose following dialysis
Recurrent Herpes Labialis
1500 mg single dose
≥ 60
1500
single dose
40 to 59
750
single dose
20 to 39
500
single dose
< 20
250
single dose
HDa
250
single dose following dialysis
Multiple-Day Dosing Regimens
Herpes Zoster
500 mg every 8 hours
≥ 60
500
every 8 hours
40 to 59
500
every 12 hours
20 to 39
500
every 24 hours
< 20
250
every 24 hours
HDa
250
following each dialysis
Suppression of Recurrent Genital Herpes
250 mg every 12 hours
≥ 40
250
every 12 hours
20 to 39
125
every 12 hours
< 20
125
every 24 hours
HDa
125
following each dialysis
Recurrent Orolabial or Genital Herpes in HIV-Infected Patients
500 mg every 12 hours
≥ 40
500
every 12 hours
20 to 39
500
every 24 hours
< 20
250
every 24 hours
HDa
250
following each dialysis

No Recall
Sandoz Inc

Famciclovir | Sandoz Inc

Famciclovir may be taken with or without food.
2.1 Dosing Recommendation in Immunocompetent Adult Patients
Herpes labialis (cold sores): The recommended dosage of famciclovir 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 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 for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.
Herpes zoster (shingles): The recommended dosage of famciclovir 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 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

No Recall
Mylan Pharmaceuticals Inc.

Famciclovir | Mylan Pharmaceuticals Inc.

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 one 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 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 one day
≥ 60
1000
every 12 hours for one day
40 to 59
500
every 12 hours for one day
20 to 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 to 59
750
single dose
20 to 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 to 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 to 39
500
every 24 hours
< 20
250
every 24 hours
HD*
250
following each dialysis

No Recall
Apotex Corp.

Famciclovir | Cardinal Health

2.1       Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia ‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and
pediatric patients > 50 kg Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mg see Table 2 below (2.2)

60 ß
60 ß
Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
1* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à    Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
2.2       Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure) ‡,§



Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days§
Plague¶

Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2.3       Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)
Dosage in Normal Renal Function Every 24 hours
Creatinine Clearance 20 to 49 mL/min
Creatinine Clearance 10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg
750 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
750 mg initial dose, then 500 mg every 48 hours
500 mg
500 mg initial dose, then 250 mg every 24 hours
500 mg initial dose, then 250 mg every 48 hours
500 mg initial dose, then 250 mg every 48 hours
250 mg
No dosage adjustment required
250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required
No information on dosing adjustment is available
2.4       Drug Interaction With Chelation Agents:
Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5     Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].

No Recall
Macleods Pharmaceuticals Limited

Famciclovir | Macleods Pharmaceuticals Limited

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 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 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 for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes zoster (shingles): The recommended dosage of famciclovir 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 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 Recommendation for Adult Patients with Renal Impairment
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 to 59
500
every 12 hours for 1 day
20 to 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 to 59
750
single dose
20 to 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 to 59
500
every 12 hours
20 to 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 to 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 to 39
500
every 24 hours
<20
250
every 24 hours
HD*
250
following each dialysis
*Hemodialysis

No Recall
Greenstone Llc

Famciclovir | Greenstone Llc

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.
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
   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

No Recall
Northstar Rx Llc

Famciclovir | Northstar Rx Llc

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.
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 to 59
500
every 12 hours for 1 day
20 to 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 to 59
750
single dose
20 to 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 to 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 to 39
500
every 24 hours
<20
250
every 24 hours
HD*
250
following each dialysis

No Recall
Aurobindo Pharma Limited

Famciclovir | Mylan Pharmaceuticals Inc.

Divalproex sodium extended-release tablets are an extended-release product intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed.
2.1 Mania
Divalproex sodium extended-release tablets are administered orally. The recommended initial dose is 25 mg/kg/day given once daily. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations. In a placebo-controlled clinical trial of acute mania or mixed type, patients were dosed to a clinical response with a trough plasma concentration between 85 and 125 mcg/mL. The maximum recommended dosage is 60 mg/kg/day.
There is no body of evidence available from controlled trials to guide a clinician in the longer term management of a patient who improves during divalproex sodium extended-release tablet treatment of an acute manic episode. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium extended-release tablets in such longer-term treatment (i.e., beyond 3 weeks).
2.2 Epilepsy
Divalproex sodium extended-release tablets are administered orally, and must be swallowed whole. As divalproex sodium extended-release tablets dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected [see Drug Interactions (7.2)].
Complex Partial Seizures
For adults and children 10 years of age or older.
Monotherapy (Initial Therapy)
Divalproex sodium extended-release tablets have not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.
Conversion to Monotherapy
Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
Concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks. This reduction may be started at initiation of divalproex sodium extended-release tablets therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction. The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency.
Adjunctive Therapy
Divalproex sodium extended-release tablets may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.
In a study of adjunctive therapy for complex partial seizures in which patients were receiving either carbamazepine or phenytoin in addition to valproate, no adjustment of carbamazepine or phenytoin dosage was needed [see Clinical Studies (14.2)]. However, since valproate may interact with these or other concurrently administered AEDs as well as other drugs, periodic plasma concentration determinations of concomitant AEDs are recommended during the early course of therapy [see Drug Interactions (7)].
Simple and Complex Absence Seizures
The recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. The maximum recommended dosage is 60 mg/kg/day.
A good correlation has not been established between daily dose, serum concentrations, and therapeutic effect. However, therapeutic valproate serum concentration for most patients with absence seizures is considered to range from 50 to 100 mcg/mL. Some patients may be controlled with lower or higher serum concentrations [see Clinical Pharmacology (12.3)].
As divalproex sodium extended-release tablets dosage is titrated upward, blood concentrations of phenobarbital and/or phenytoin may be affected [see Drug Interactions (7.2)].
Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
2.3 Migraine
Divalproex sodium extended-release tablets are indicated for prophylaxis of migraine headaches in adults.
The recommended starting dose is 500 mg once daily for one week, thereafter increasing to 1000 mg once daily. Although doses other than 1000 mg once daily of divalproex sodium extended-release tablets have not been evaluated in patients with migraine, the effective dose range of divalproex sodium delayed-release tablets in these patients is 500 to 1000 mg/day. As with other valproate products, doses of divalproex sodium extended-release tablets should be individualized and dose adjustment may be necessary. If a patient requires smaller dose adjustments than that available with divalproex sodium extended-release tablets, divalproex sodium delayed-release tablets should be used instead.
2.4 Conversion from Divalproex Sodium Delayed-release Tablets to Divalproex Sodium Extended-release Tablets
In adult patients and pediatric patients 10 years of age or older with epilepsy previously receiving divalproex sodium delayed-release tablets, divalproex sodium extended-release tablets should be administered once daily using a dose 8% to 20% higher than the total daily dose of divalproex sodium delayed-release tablets (Table 1). For patients whose divalproex sodium delayed-release tablets total daily dose cannot be directly converted to divalproex sodium extended-release tablets, consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.
Table 1. Dose Conversion * These total daily doses of divalproex sodium delayed-release tablets cannot be directly converted to an 8% to 20% higher total daily dose of divalproex sodium extended-release tablets because the required dosing strengths of divalproex sodium extended-release tablets are not available. Consideration may be given at the clinician’s discretion to increase the patient’s divalproex sodium delayed-release tablets total daily dose to the next higher dosage before converting to the appropriate total daily dose of divalproex sodium extended-release tablets.
Divalproex Sodium Delayed-release Tablets
Total Daily Dose (mg)
Divalproex Sodium Extended-release Tablets
(mg)
500* to 625
750
750* to 875
1000
1000* to 1125
1250
1250 to 1375
1500
1500 to 1625
1750
1750
2000
1875 to 2000
2250
2125 to 2250
2500
2375
2750
2500 to 2750
3000
2875
3250
3000 to 3125
3500
There is insufficient data to allow a conversion factor recommendation for patients with divalproex sodium delayed-release tablets doses above 3125 mg/day. Plasma valproate Cmin concentrations for divalproex sodium extended-release tablets on average are equivalent to divalproex sodium delayed-release tablets, but may vary across patients after conversion. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL) [see Clinical Pharmacology (12.2)].
2.5 General Dosing Advice Dosing in Elderly Patients
Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients. Starting doses in the elderly lower than 250 mg can only be achieved by the use of divalproex sodium delayed-release tablets. Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence. The ultimate therapeutic dose should be achieved on the basis of both tolerability and clinical response [see Warnings and Precautions (5.14), Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)].
Dose-Related Adverse Reactions
The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia) may be dose-related. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males) [see Warnings and Precautions (5.8)]. The benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.
G.I. Irritation
Patients who experience G.I. irritation may benefit from administration of the drug with food or by slowly building up the dose from an initial low level.
Compliance
Patients should be informed to take divalproex sodium extended-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose.

No Recall
Camber Pharmaceuticals, Inc.

Famciclovir | Camber Pharmaceuticals, Inc.

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.
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
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 for1 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
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
*Hemodialysis

No Recall
Avpak

Famciclovir | Avpak

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 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 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 for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes zoster (shingles): The recommended dosage of famciclovir 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 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 Recommendation for Adult Patients with Renal Impairments * 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 to 59 500 every 12 hours for 1 day 20 to 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 to 59 750 single dose 20 to 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 to 59 500 every 12 hours 20 to 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 to 39 125 every 12 hours <20 125 every 24 hours HD* 125 following each dialysis Recurrent Orolabial
and Genital Herpes
in HIV-Infected Patients
500 mg every 12 hours
≥40 500 every 12 hours 20 to 39 500 every 24 hours <20 250 every 24 hours HD* 250 following each dialysis

No Recall

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