Acyclovir (Acyclovir)

Trade Name : Acyclovir

Actavis Pharma, Inc.

SUSPENSION

Strength 200 mg/5mL

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 Actavis Pharma, Inc.. It is available in strength of 200 mg/5mL 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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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

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.

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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  • No data
  • Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration.
  • Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), purified water and sorbitol.
  • Acyclovir is a white, crystalline powder with the molecular formula CHNO, and a molecular weight of 225.20. 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 9-[(2-Hydroxyethoxy)methyl]guanine; it has the following structural formula:
  • VIROLOGY
  • Mechanism of Antiviral Action:
  • Acyclovir is a synthetic purine nucleoside analogue with and 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. , acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in three 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 to VZV is due to its more efficient phosphorylation by the viral TK.
  • Antiviral Activities:n- in vitro
  • Drug Resistance:
  • Pharmacokinetics:
  • 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.
  • There was no effect of food on the absorption of acyclovir (n=6); therefore, acyclovir oral 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:
  • Geriatrics
  • Pediatrics
  • Drug Interactions:
  • Clinical Trials:
  • Arrayn- Recurrent Genital Herpes:
  • In a study of patients who received acyclovir 400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively. Serial analyses of the 3-month recurrence rates for the patients showed that 71% to 87% were recurrence free in each quarter.
  • Arrayn- Herpes Zoster Infections:
  • In a similar double-blind, placebo-controlled study, acyclovir (800 mg 5 times daily for 7 days) shortened the times to complete lesion scabbing, healing, and cessation of pain, reduced the duration of new lesion formation, and reduced the prevalence of localized zoster-associated neurologic symptoms (paresthesia, dysesthesia, or hyperesthesia).
  • Treatment was begun within 72 hours of rash onset and was most effective if started within the first 48 hours.
  • Adults greater than 50 years of age showed greater benefit.
  • Arrayn- Chickenpox:
  • Herpes Zoster Infections:
  • Genital Herpes:
  • Chickenpox:
  • Acyclovir oral suspension is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
  • Acyclovir oral suspension is intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see : Observed During Clinical Practice and ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
  • Dosage adjustment is recommended when administering acyclovir to patients with renal impairment (see ). Caution should also be exercised when administering acyclovir 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.
  • Herpes Simplex:n- Array
  • Arrayn- Long-Term Administration:
  • Herpes Zoster:
  • Chickenpox:
  • Observed During Clinical Practice:
  • Arrayn- General:
  • Arrayn- Nervous:
  • Arrayn- Digestive:
  • Arrayn- Hematologic and Lymphatic:
  • Arrayn- Hepatobiliary Tract and Pancreas:
  • Arrayn- Musculoskeletal:
  • Arrayn- Skin:
  • Arrayn- Special Senses:
  • Arrayn- Urogenital:
  • To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or http://n- www.fda.gov/ for voluntary reporting of adverse reactions.
  • 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 ).
  • Acute Treatment of Herpes Zoster:
  • Genital Herpes:
  • Arrayn- Chronic Suppressive Therapy for Recurrent Disease:
  • 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.
  • Arrayn- Intermittent Therapy:
  • Treatment of Chickenpox:n- Arrayn- per dose
  • Adults and Children Over 40 kg: 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:
  • Hemodialysis:
  • Peritoneal Dialysis:
  • Bioequivalence of Dosage Forms:
  • Acyclovir oral suspension, USP (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).
  • Bottle of 1 pint (473 mL) NDC 0472-0082-16.
  • Store between 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F). Protect from light.
  • Dispense in a tight container as defined in the USP.
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Rev. A 1/20203701602-1120 GW7331n
  • NDC 0472-0082-16
  • Acyclovir Oral Suspension, USP
  • 200 mg/5 mL
  • SHAKE WELL BEFORE USING
  • Each 5 mL (One Teaspoonful) Contains: Acyclovir 200 mg and added as preservatives methylparaben 0.1% and propylparaben 0.02%.
  • For indications, dosage, precautions, etc., see accompanying package insert.
  • Store between 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F). Protect from light.
  • Dispense in a tight container as defined in the USP.
  • See label or bottom of container for lot number and expiration date.
  • Rx Only
  • Actavis
  • One Pint (473 mL)

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