Famciclovir 125 mg/1
Famciclovir · TABLET, FILM COATED · Aurobindo Pharma Limited
Famciclovir is a tablet, film coated containing famciclovir at 125 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Famciclovir
- Generic Name
- Famciclovir
- NDC Code (Product)
65862-465- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 125 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091114
- Drug Class
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
- Marketing Start
- 03/21/2011
Recall History
Macleods Pharmaceuticals Ltd
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD49448_1, EXP: 5/17/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD54559_1, EXP: 5/20/2014.
AVKARE Inc.
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Hetero Labs Limited Unit V
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients ( 1.2 ) • Treatment of recurrent episodes of orolabial or genital herpes 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 episodes of orolabial or genital herpes in HIV-infected patients • Black and African American patients with recurrent genital herpes 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 ta…
Dosage & Administration
2 DOSAGE & ADMINISTRATION Famciclovir tablets may be taken with or without food. Immunocompetent Adult Patients ( 2.1 ) Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes Suppressive therapy Herpes Zoster (shingles) 1000 mg twice daily for 1 day 250 mg twice daily 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 ) 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). Suppre…
Contraindications
4 CONTRAINDICATIONS Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream). Known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream). ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity. (7.2) 7.1 Potential for Famciclovir to Affect Other Drugs The steady-state pharmacokinetics of digoxin were not altered by concomitant administration of multiple doses of famciclovir (500 mg three times daily). No clinically significant effect on the pharmacokinetics of zidovudine, its metabolite zidovudine glucuronide, or emtricitabine was observed following a single oral dose of 500 mg famciclovir coadministered with zidovudine or emtricitabine. An in vitro study using human liver microsomes suggests that famciclovir is not an inhibitor of CYP3A4enzymes. 7.2 Potential for Other Drugs to Affect Penciclovir No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid (magnesium and aluminum hydroxide), or concomitantly with emtricitabine. No clinically significant effect on penciclovir pharmacokinetics was observed following multiple-dose (three times …
Adverse Reactions
6 ADVERSE REACTIONS 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. The most common adverse events reported in at least 1 indication by greater than 10% of adult patients are headache and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience in Adult Patients 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 (Fam…
Frequently Asked Questions
What is Famciclovir used for?
Famciclovir contains Famciclovir. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Famciclovir a controlled substance?
Famciclovir is not classified as a controlled substance by the DEA.
What is the generic name for Famciclovir?
The generic name for Famciclovir is Famciclovir. There are no other listed brand versions of Famciclovir.
What is the NDC code for Famciclovir 125 mg/1?
The NDC (National Drug Code) for Famciclovir 125 mg/1 is 65862-465, listed by Aurobindo Pharma Limited.
Other Famciclovir Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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