Clinical Pharmacology Details


VALACYCLOVIR


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Indications & Dose:


ADULT


Herpes Zoster :


2 tablet three times daily


Herpes Simplex :


1st attack 1 tablet twice daily for 5-10 days starting as soon as possible after onset of lesion. Recurrent attack 1 tablet twice daidy for 5 days starting during prodromal period or as soon as possible after onset of lesion.


Cold Sores (Herpes Labialis):


2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).


Genital Herpes:


1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.


Recurrent Episodes:


The recommended dosage of valacyclovir hydrochloride  for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.


Suppressive Therapy:


The recommended dosage of  valacyclovir hydrochloride  for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.


In HIV-infected patients with a CD4+ cell count = 100 cells/mm³, the recommended dosage of valacyclovir hydrochloride  for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.


Reduction of Transmission:


The recommended dosage of  valacyclovir hydrochloride  for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.


Herpes Zoster:


1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.


Pediatric


Cold Sores (Herpes Labialis):


cold sores in pediatric patients = 12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).


Chickenpox:


pediatric patients 2 to < 18 years of age is 20 mg/ kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom 

Contraindications:

 in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation 

Side Effects:

General: Facial edema, hypertension, tachycardia.


Allergic: Acute hypersensitivity reactions including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria


CNS Symptoms: Aggressive behavior; agitation; ataxia; coma; confusion; decreased consciousness; dysarthria; encephalopathy; mania; and psychosis, including auditory and visual hallucinations, seizures, tremors


Eye: Visual abnormalities.


Gastrointestinal: Diarrhea.


Hepatobiliary Tract and Pancreas: Liver enzyme abnormalities, hepatitis.


Renal: Renal failure, renal pain (may be associated with renal failure


Hematologic: Thrombocytopenia, aplastic anemia, leukocytoclastic vasculitis


Skin: Erythema multiforme, rashes including photosensitivity, alopecia.


 

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