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Acyclovir 5% Ont 30gm by Sandoz Pharma

Acyclovir 5% Ont 30gm by Sandoz Pharma Generic Name:
ACYCLOVIR
Description:
ACYCLOVIR OI 5% 30GM 
NDC:
00168-0825-30
UPC:
301680-825304
Contract:
NBG SOURCE BACKUP C APPROVAL
Contract Alias:Mylan PharmaThis Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).Mylan PharmaAcyclovir 5% Ont 30gm by Tolmar PharmaAcyclovir 5% Ont 30gm by Tolmar PharmaNDC 00378-8700-49 UPC/GTIN No.3-03788-70049-1 Mfg.Part No.870049Acyclovir 5% Ont 30gm by Sandoz Pharma

Acyclovir 5% Ont 30gm by Sandoz Pharma

$797.59$699.00

NDC No.00168-0825-30 00168-825-30 UPC/GTIN No. 3-01680-82530-4 MPN 82530 Only Physician,Pharmacy or Licensed Facility can order this Rx Item No.Rx601447 Acyclovir 5% Ont 30gm by Tolmar Pharma Item No.601447 NDC No.00168082530 0016882530 UPC No.301680-825304 301680825304 Other Name Zovirax Therapeutic Code 840406 Therapeutic Class Ntivirals (Skin & Mucous Membrane) Item Class Non Controlled Rx. Case Qnty: 24 Therapeutic Code 840406 Ntivirals (Skin & Mucous Membrane) Info Dna Polymerase I

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ZOVIRAX
DESCRIPTION
ZOVIRAX is the brand name for acyclovir, synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Capsules, Tablets, and Suspension are formulations for oral administration. Each capsule of ZOVIRAX contains 200 mg of acyclovir and the inactive ingredients corn starch, lactose, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 2, and titanium dioxide. May contain one or more parabens. Printed with edible black ink. Each 800-mg tablet of ZOVIRAX contains 800 mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of ZOVIRAX contains 400 mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each teaspoonful L) of ZOVIRAX Suspension contains 200 mg of acyclovir and the inactive ingredients methylparaben 0.1% and propylparaben 0.02% (added as preservatives), carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, and sorbitol. Acyclovir is white, crystalline powder with the molecular formula C8H11N5O3 and molecular weight of 225. The maximum solubility in water at 37?C is 2.5 mg/mL. The pka?s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:
VIROLOGY
Mechanism of Antiviral Action:
Acyclovir is synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types (HSV-1), (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK.
Antiviral Activities:
The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with mean IC50 of 1.35 mcg/mL.
Drug Resistance:
Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.
CLINICAL PHARMACOLOGY
Pharmacokinetics:
The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir pharmacokinetic parameters are summarized in Table 1.
Parameter
Range
Plasma protein binding
9% to 33%
Plasma elimination half-life
2.5 to 3.3 hr
Average oral bioavailability
10% to 20%*
*Bioavailability decreases with increasing dose.
In one multiple-dose, crossover study in healthy subjects (n 23), it was shown that increases in plasma acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2. The decrease in bioavailability is function of the dose and not the dosage form.
Parameter
200 mg
400 mg
800 mg

Table 2. Acyclovir Peak and Trough Concentrations at Steady State
Table 2. Acyclovir Peak and Trough Concentrations at Steady State
0.83 mcg/mL
1.21 mcg/mL
1.61 mcg/mL

Table 2. Acyclovir Peak and Trough Concentrations at Steady State
Table 2. Acyclovir Peak and Trough Concentrations at Steady State
0.46 mcg/mL
0.63 mcg/mL
0.83 mcg/mL
There was no effect of food on the absorption of acyclovir (n 6); therefore, ZOVIRAX Capsules, Tablets, and Suspension may be administered with or without food. The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.
Special Populations:
Adults With Impaired Renal Function: The half-life and total body clearance of acyclovir are dependent on renal function. dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION). Geriatrics: Acyclovir plasma concentrations are higher in geriatric patients compared with younger adults, in part due to age-related changes in renal function. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use). Pediatrics: In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. Mean half-life after oral doses of 300 mg/m2 and 600 mg/m2 in pediatric patients aged months to years was 2.6 hours (range 1.59 to 3.74 hours).
Drug Interactions:
Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.

INDICATIONS AND USAGE
Herpes Zoster Infections:
ZOVIRAX is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes:
ZOVIRAX is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox:
ZOVIRAX is indicated for the treatment of chickenpox (varicella).
CONTRAINDICATIONS
ZOVIRAX is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
WARNINGS
ZOVIRAX Capsules, Tablets, and Suspension are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
PRECAUTIONS
Dosage adjustment is recommended when administering ZOVIRAX to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering ZOVIRAX to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.
info. for Patients:
Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered ZOVIRAX or they have any other questions. Patients should be advised to maintain adequate hydration. Herpes Zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after diagnosis of herpes zoster. Genital Herpes Infections: Patients should be informed that ZOVIRAX is not cure for genital herpes. There are no data evaluating whether ZOVIRAX will prevent transmission of infection to others. Because genital herpes is sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. Chickenpox: Chickenpox in otherwise healthy children is usually self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no info. regarding the effects of treatment begun later in the disease course.
Drug Interactions:
See CLINICAL PHARMACOLOGY: Pharmacokinetics.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with 800 mg given orally times day (dosing appropriate for treatment of herpes zoster) or 200 mg given orally times day (dosing appropriate for treatment of genital herpes). Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by gavage. There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Maximum plasma concentrations were to times human levels in the mouse bioassay and to times human levels in the rat bioassay. Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in of the assays. Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p.o.) or in rats (25 mg/kg/day, s.c.). In the mouse study, plasma levels were to 18 times human levels, while in the rat study, they were to 15 times human levels. At higher doses (50 mg/kg/day, s.c.) in rats and rabbits (11 to 22 and 16 to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In rat peri- and post-natal study at 50 mg/kg/day, s.c., there was statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses. No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for month (21 to 41 times human levels) or in dogs given 60 mg/kg/day orally for year (6 to 12 times human levels). Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels.
Pregnancy:
Teratogenic Effects: Pregnancy Category B. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). These exposures resulted in plasma levels and 18, 16 and 106, and 11 and 22 times, respectively, human levels. There are no adequate and well-controlled studies in pregnant women. prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Acyclovir concentrations have been documented in breast milk in women following oral administration of ZOVIRAX and ranged from 0.6 to 4.1 times corresponding plasma levels. These concentrations would potentially expose the nursing infant to dose of acyclovir up to 0.3 mg/kg/day. ZOVIRAX should be administered to nursing mother with caution and only when indicated.
Pediatric Use:
Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than years of age have not been established.
Geriatric Use:
Of 376 subjects who received ZOVIRAX in clinical study of herpes zoster treatment in immunocompetent subjects ?50 years of age, 244 were 65 and over while 111 were 75 and over. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. The duration of pain after healing was longer in patients 65 and over. Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS: Observed During Clinical Practice, and DOSAGE AND ADMINISTRATION).
ADVERSE REACTIONS
Herpes Simplex:
Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with ZOVIRAX 200 mg administered orally times daily every hours for 10 days were nausea and/or vomiting in of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in of 287 (0.7%) patients who received placebo. Long-Term Administration: The most frequent adverse events reported in clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) times daily for year in 586 patients treated with ZOVIRAX were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with ZOVIRAX for year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).
Herpes Zoster:
The most frequent adverse event reported during clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral ZOVIRAX times daily for to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).
Chickenpox:
The most frequent adverse event reported during clinical trials of treatment of chickenpox with oral ZOVIRAX at doses of 10 to 20 mg/kg times daily for to days or 800 mg times daily for days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).

OVERDOSAGE
Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION).
DOSAGE AND ADMINISTRATION
Acute Treatment of Herpes Zoster:
800 mg every hours orally, times daily for to 10 days.
Genital Herpes:
Treatment of Initial Genital Herpes: 200 mg every hours, times daily for 10 days. Chronic Suppressive Therapy for Recurrent Disease: 400 mg times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg times daily to 200 mg times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After year of therapy, the frequency and severity of the patient?s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with ZOVIRAX Intermittent Therapy: 200 mg every hours, times daily for days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox:
Children (2 years of age and older): 20 mg/kg per dose orally times daily (80 mg/kg/day) for days. Children over 40 kg should receive the adult dose for chickenpox. Adults and Children over 40 kg: 800 mg times daily for days. Intravenous ZOVIRAX is indicated for the treatment of varicella-zoster infections in immunocompromised patients. When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no info. about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients With Acute or Chronic Renal Impairment:
In patients with renal impairment, the dose of ZOVIRAX Capsules, Tablets, or Suspension should be modified as shown in Table 3.
Normal Dosage
Regimen
Creatinine
Clearance
(mL/min/1.73 m2)
Adjusted Dosage Regimen
Dose
(mg)
Dosing Interval
200 mg every hours
>10
0-10
200
200
every hours, 5x daily
every 12 hours
400 mg every 12 hours
>10
0-10
400
200
every 12 hours
every 12 hours
800 mg every hours
>25
10-25
0-10
800
800
800
every hours, 5x daily
every hours
every 12 hours
Hemodialysis:
For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately hours. This results in 60% decrease in plasma concentrations following 6-hour dialysis period. Therefore, the patient?s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal Dialysis:
No supplemental dose appears to be necessary after adjustment of the dosing interval.

Acyclovir 5% Ont 30gm by Sandoz Pharma Generic Name:
ACYCLOVIR
Description:
ACYCLOVIR OI 5% 30GM 
NDC:
00168-0825-30
UPC:
301680-825304
Contract:
NBG SOURCE BACKUP C APPROVAL
Contract Alias:
Acyclovir 5% Ont 30gm by Sando
Acyclovir 5% Ont 30gm by Sandoz Pharma Generic Name: ACYCLOVIR Description: ACYCLOVIR OI 5% 30GM NDC: 00168-0825-30 UPC: 301680-825304 Contract: NBG SOURCE BACKUP C APPROVAL Contract Alias:

Mylan Pharma
http://www.prestoimages.net/store30/rd14
Mylan Pharma

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
Click above for Generics!
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).

Acyclovir 5% Ont 30gm by Tolmar Pharma
Acyclovir 5% Ont 30gm by Tolma
Acyclovir 5% Ont 30gm by Tolmar Pharma

Acyclovir 5% Ont 30gm by Tolmar Pharma
Acyclovir 5% Ont 30gm by Tolma
Acyclovir 5% Ont 30gm by Tolmar Pharma

NDC 00378-8700-49 UPC/GTIN No.3-03788-70049-1 Mfg.Part No.870049
Acyclovir 5% Ont 30gm by Mylan Pharma
NDC 00378-8700-49 UPC/GTIN No.3-03788-70049-1 Mfg.Part No.870049

Acyclovir 5% Ont 30gm by Sandoz Pharma
Acyclovir 5% Ont 30gm by Sando
Acyclovir 5% Ont 30gm by Sandoz Pharma