Acyclovir (Acyclovir)

Trade Name : Acyclovir

Heritage Pharmaceuticals Inc.

CAPSULE

Strength 200 mg/1

ACYCLOVIR DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acyclovir (Acyclovir) which is also known as Acyclovir and Manufactured by Heritage Pharmaceuticals Inc.. It is available in strength of 200 mg/1 per ml. Read more

Acyclovir (Acyclovir) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

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Acyclovir is a synthetic nucleoside analogue activeu00a0against herpesviruses.u00a0Acyclovir capsules, USP are a formulation for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients, microcrystalline cellulose, povidone, sodium starch glycolate, pregelatinized starch and magnesium stearate. The capsule shell consists of gelatin, FD&C Blue No. 2 and titanium dioxide. Printed with edible black ink with the following components: shellac, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide.
Acyclovir is a white, crystalline powder with the molecular formula Cn- Hn- Nn- On- and a molecular weight of 225. The maximum solubility in water at 37u00b0C is 2.5 mg/mL. The pkau2019s 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 a synthetic purine nucleoside analogue with n- in vitron- andn- in vivon- inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (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, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. n- In vitron- , acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 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 n- in vitron- 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 (ICn- ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the ICn- 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 ICn- 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 a mean ICn- 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.

Pharmacokinetics:n- 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.
Table 1. Acyclovir Pharmacokinetic Characteristics (Rangen- )
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 a function of the dose and not the dosage form.
Table 2. Acyclovir Peak and Trough Concentrations at Steady Statn- e
There was no effect of food on the absorption of acyclovir (n = 6); therefore, acyclovir capsules may be administered with or without food.
The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.

Herpes Zoster Infections: n- Acyclovir capsules, USP are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes:u00a0 n- Acyclovir capsules, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: n- Acyclovir capsules, USP are indicated for the treatment of chickenpox (varicella).

Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

No data

DOSAGE AND ADMINISTRATION

No data

DOSAGE AND ADMINISTRATION

Acute Treatment of Herpes Zoster: n- 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.
Genital Herpes:
Treatment of Initial Genital Herpes: n- 200 mg every 4 hours, 5 times daily for 10 days.
Chronic Suppressive Therapy for Recurrent Disease: n- 400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patientu2019s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.
Intermittent Therapy:n- 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox:
Children (2 years of age and older):n- 20 mg/kg n- per dosen- orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and Children over 40 kg:n- 800 mg 4 times daily for 5 days.
Intravenous acyclovir 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 information 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 acyclovir capsules should be modified as shown in Table 3.
Table 3. Dosage Modification for Renal Impairmenn- t
Hemodialysis:
For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patientu2019s 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.
Bioequivalence of Dosage Forms:
Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and one acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

Acyclovir Capsules, USP are available as:
200 mgn- Bottles of 100 NDC 23155- 229-01
Bottles of 500 NDC 23155- 229-05
Each capsule is a light blue opaque cap and aqua blue opaque body both imprinted with HP 229 in black ink.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature] and protect from light and moisture.
Manufactured for:
Heritage Pharmaceuticals Inc.
East Brunswick, NJ 08816
1.866.901.DRUG (3784)
51U000000153US02
Iss. 03/2018

Acyclovir Capsules, USP
200 mg - 100 count
100 ct

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Acyclovir (Acyclovir)

Trade Name : Acyclovir

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Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Acyclovir (Acyclovir)

Trade Name : Acyclovir

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

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