Valclovir Tablets (Generic Valacyclovir Hydrochloride Tablets) – Product Information
Valclovir tablets (Generic Valacyclovir Hydrochloride tablets) are indicated for the treatment of various herpes virus infections, in adults including Herpes zoster (shingles), Initial and recurrent episodes of genital herpes, Suppression of recurrent episodes of genital herpes and Reduction of the transmission of genital herpes.
Valclovir tablets are manufactured by Healing Pharma India Private Limited in the strengths of 500 mg and 1000 mg.
We also stock Virovir tablets (Generic Famciclovir 250 mg and 500 mg tablets) which are used for treating Herpes labialis (cold sores), Genital herpes as well as Herpes zoster infection (shingles).
Name of Drug
Valclovir tablets
Manufacturer of Valclovir Tablets (Valacyclovir Hydrochloride Tablets)
Healing Pharma India Private Limited
Website: www.healingpharma.in
Active Pharmaceutical Ingredient
The active pharmaceutical ingredients contained in Valclovir tablets is Valacyclovir Hydrochloride.
Each film-coated Valclovir tablet contains Valacyclovir Hydrochloride IP equivalent to 500 mg or 1000 mg of Valacyclovir respectively.
Mechanism of Action
Valacyclovir hydrochloride is rapidly converted to Acyclovir which has demonstrated antiviral activity against herpes simplex virus types 1 (HSV -1) and 2 (HSV -2) and varicella-zoster virus (VZV) both in vitro and in vivo.
The inhibitory activity of Acyclovir is highly selective due to its affnity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into
acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes.
In vitro, acyclovir triphosphate stops replication of herpes viral DNA.
Uses of Valclovir Tablets (Generic Valacyclovir Hydrochloride Tablets)
Valclovir Tablets are indicated for the treatment of various herpes virus infection
Varicella zoster virus (VZV) infections – herpes zoster.
Valaciclovir is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults
Valaciclovir is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression
Herpes simplex virus (HSV) infections
Valaciclovir is indicated
• for the treatment and suppression of HSV infections of the skin and mucous membranes including:
– treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults
– treatment of recurrences of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults
– suppression of recurrent genital herpes in immunocompetent adults and adolescents and in immunocompromised adults.
• Treatment and suppression of recurrent ocular HSV infections in immunocompetent adults and adolescents and in immunocompromised adults
Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection
Cytomegalovirus (CMV) infections:
Valaciclovir is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents.
Valclovir Tablets (Generic Valacyclovir Hydrochloride Tablets) – Dosage
The dosage for Adult for various indications is as follows:
Cold Sores (Herpes Labialis)
The recommended dosage of Valacyclovir tablets for treatment of cold sores 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).
Genital Herpes
Initial Episode: The recommended dosage of Valacyclovir tablets for treatment of initial genital herpes is 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 tablets 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 tablets 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-1-infected patients with a CD4 + cell count greater than or equal to 100 cells/mm3, the recommended dosage of Valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
Reduction of Transmission: The recommended dosage of Valacyclovir tablets 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
The recommended dosage of Valacyclovir tablets for treatment of herpes zoster is 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.
Missed Dosage Instructions for Valclovir Tablets
If a dose of Valclovir tablets is missed, the patient should be advised to take it as soon as he/she remembers, and then continue with the next dose at the proper time interval.
If you remember the next day, skip the missed dose and take your scheduled dose. Do not take a double dose to compensate the missed dose.
Contraindications
Valclovir tablets are contraindicated in persons with a hypersensitivity (allergy) to Valacyclovir Hydrochloride or any of the other ingredients of this medicine.
Storage Instructions for Valclovir tablets (Generic Valacyclovir Hydrochloride tablets) Tablets
Store Valclovir tablets at controlled room temperature (20°C to 25°C),protected from heat, moisture, and sunlight. Excursions are permitted from 15°C to 30°C.
Retain the original packing of the medication and do not consume past its expiration date printed on the blister pack. Keep the pack of Generic Valacyclovir tablets away from the reach of children and pets.
Do not dispose along with domestic waste or sewage. Consult your doctor or pharmacist about the correct method of disposal.
Warnings and Precautions to be taken when using Valclovir tablets (Generic Valacyclovir Hydrochloride tablets)
Before using Valclovir tablets please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.
Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS):
Has occurred in patients with advanced HIV disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of Valacyclovir tablets in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur.
Acute renal failure:
May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher than recommended doses of Valacyclovir tablets for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients and reduce dosage in patients with renal impairment.
Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy):
May occur in elderly patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher than recommended doses of Valacyclovir tablets for their level of renal function. Use with caution in elderly patients and reduce dosage in patients with renal impairment.
Side Effects of Valclovir tablets (Generic Valacyclovir tablets)
The most common adverse reactions reported in at least one indication by more than 10% of adult patients treated with Valacyclovir tablets and more commonly
than in patients treated with placebo are headache, nausea, and abdominal pain.
The only adverse reaction occurring in more than 10% of pediatric patients less than 18 years of age was headache.
The possible Side Effects of Valacyclovir tablets are (Post Marketing Data):
Blood and lymphatic system disorders
Uncommon: leucopenia, thrombocytopenia
Leucopenia is mainly reported in immunocompromised patients.
Immune system disorders
Rare: anaphylaxis
Psychiatric and nervous system disorders
Common: dizziness
Uncommon: confusion, hallucinations, decreased consciousness, tremor, agitation
Rare: ataxia, dysarthria, convulsions, encephalopathy, coma, psychotic symptoms, delirium.
Neurological disorders, sometimes severe, may be linked to encephalopathy and include confusion, agitation, convulsions, hallucinations, coma. These events are generally reversible and usually seen in patients with renal impairment or with other predisposing factors. In organ transplant patients receiving high doses (8000 mg daily) of Valaciclovir for CMV prophylaxis, neurological reactions occurred more frequently compared with lower doses used for other indications.
Respiratory, thoracic and mediastinal disorders
Uncommon: dyspnoea
Gastrointestinal disorders
Common: vomiting, diarrhoea
Uncommon: Abdominal discomfort
Hepatobiliary disorders
Uncommon: reversible increases in liver function tests (e.g. bilirubin, liver enzymes)
Skin and subcutaneous tissue disorders
Common: rashes including photosensitivity, pruritus
Uncommon: urticaria
Rare: angioedema
Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS).
Renal and urinary disorders
Uncommon: Renal pain, haematuria (often associated with other renal events).
Rare: Renal impairment, acute renal failure (especially in elderly patients or in patients with renal impairment receiving higher than the recommended doses).
Not known: Tubulointerstitial nephritis
Renal pain may be associated with renal failure.Intratubular precipitation of aciclovir crystals in the kidney has also been reported. Adequate fluid intake should be ensured during treatment
Drug Interactions
The combination of valaciclovir with nephrotoxic medicinal products should be made with caution, especially in subjects with impaired renal function, and warrants regular monitoring of renal function. This applies to concomitant administration with aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin and tacrolimus.
Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Following 1000 mg valaciclovir, cimetidine and probenecid reduce aciclovir renal clearance and increase the AUC of aciclovir by about 25% and 45%, respectively, by inhibition of the active renal secretion of aciclovir. Cimetidine and probenecid taken together with valaciclovir increased aciclovir AUC by about 65%.
Other medicinal products (including e.g. tenofovir) administered concurrently that compete with or inhibit active tubular secretion may increase aciclovir concentrations by this mechanism. Similarly, valaciclovir administration may increase plasma concentrations of the concurrently administered substance.
Overdosage
Caution should be exercised to prevent inadvertent overdose.Precipitation of Acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the
intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored
Valacyclovir Hydrochloride tablets During Pregnancy
Valacyclovir Hydrochloride is classified by the US FDA as Pregnancy Category B.
There are no adequate and well-controlled studies of Valacyclovir Hydrochloride or Acyclovir in pregnant women. Based on prospective pregnancy registry data on 749 pregnancies, the overall rate of birth defects in infants exposed to acyclovir in-utero appears similar to the rate for infants in the general population. Valacyclovir tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A 500 mg maternal dosage of Valacyclovir tablets twice daily would provide a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day. This would result in less than 2% of the exposure obtained after administration of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir to the nursing infant. Unchanged Valacyclovir was not detected in maternal serum, breast milk, or infant urine. Caution should be exercised when Valacyclovir tablets is administered to a nursing woman.
Buy Generic Valacyclovir 500 mg and 1000 mg tablets Online From Only $1.05 per Tablet
You can buy Generic Valacyclovir Hydrochloride tablets online at a cheap price from the Swiss Pharmacy.
Valclovir tablets are manufactured by Healing Pharma India Private Limited in the strengths of 500 mg and 1000 mg. The 500 mg pills are priced at only $1.05 per unit if you place an order for 200 tablets.
