Zovirax (Aciclovir Tablets)

Zovirax (Aciclovir Tablets)
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Zovirax (Aciclovir Tablets) are used for the treatment of herpes
simplex virus infections of the skin and mucous membranes
including initial and recurrent genital herpes (excluding neonatal
HSV and severe HSV infections in immunocompromised children).
Zovirax Tablets are indicated for the suppression (prevention of
recurrences) of recurrent herpes simplex infections in
immunocompetent patients.
Zovirax Tablets are indicated for the prophylaxis of herpes simplex
infections in immunocompromised patients.
Zovirax Tablets are indicated for the treatment of varicella
(chickenpox) and herpes zoster (shingles) infections.

Zovirax Tablets are manufactured by GlaxoSmithKline
Pharmaceuticals Limited, India in the strengths of
200mg, 400mg and 800mg.

Chemical Structure - Aciclovir

The active ingredient contained in Zovirax
tablets is Aciclovir (ACV), also known as
Acyclovir.
Each Zovirax tablet contains 200 mg, 400 mg
or 800 mg of Aciclovir.

Uses of Zovirax 200 mg, 400 mg and 800 mg Tablets:
Zovirax (Acyclovir Tablets) is used for the following conditions:
The treatment of initial episodes of herpes genitalis.
The suppression of unusually frequent recurrences of herpes genitalis (6
or more episodes per year).
The acute treatment of herpes zoster (shingles) and varicella
(chickenpox).
The results of clinical studies suggest that some patients with recurrent
genital herpes may derive clinical benefit from the administration of oral
Zovirax if taken at the first sign of an impending episode.

Uses of Zovirax 200 mg, 400 mg and 800 mg Tablets:
Early treatment of acute herpes zoster (shingles) in immunocompetent
individuals with oral Zovirax resulted in decreased viral shedding;
decreased time to healing; less dissemination; and alleviation of acute
pain.
Treatment of varicella (chickenpox) in immunocompetent patients with
oral Zovirax reduced the total number of lesions, accelerated the
progression of lesions to the crusted and healed stages, and decreased the
number of residual hypopigmented lesions.
In addition, Zovirax decreased fever and constitutional symptoms
associated with chickenpox. The prophylactic use of Aciclovir in
chickenpox has not been established.

Recommended Adult Dosage
The dose of Zovirax (Aciclovir Tablets) for various indications
is given below:
Herpes Zoster: For treatment of herpes zoster infections, 800 mg
Zovirax (Generic Acyclovir tablets) should be taken five times
daily at approximately 4-hourly intervals, omitting the night-time
dose. Treatment should continue for 7 days.
Dosing should begin as early as possible after the start of an
infection. Treatment yields better results if started as soon as
possible after onset of the rash.

Recommended Dosage
Genital Herpes (Adult Dosage): For treatment of initial episodes of
genital herpes the dosage is 200 mg taken 5 times a day for 10 days
In case of treatment of episodic therapy of Genital Herpes the dosage
is 200 mg taken 5 times a day for 5 days.
For Suppressive therapy in immunocompetent adults the dosage is
200 mg taken 4 times a day for 1 year or 400 mg taken twice a
day for 1 year
For Suppressive therapy in HIV-infected patients the dosage is 800
mg taken 4 times a day for 1 year

Recommended Dosage
Chickenpox (Paediatric Dosage): For treatment of chickenpox,
children over the age of 6 years can be given 800 mg Zovirax
(Generic Acyclovir Tablets) four times daily, and children
between the ages of 2 and 6 years can be given 400 mg Zovirax
four times daily.
Children below the age of 2 years can be given 200 mg Zovirax
four times daily. Dosing can be more accurately calculated as 20
mg Aciclovir/kg bodyweight (not to exceed 800 mg) four times
daily. Treatment should continue for 5 days.

Recommended Dosage
Chickenpox (Adult Dosage): For the treatment of
chickenpox in adults, 800 mg Zovirax should be taken
five times daily at approximately 4-hourly intervals,
omitting the night-time dose. Treatment should continue
for 7 days.

Contraindications
➔
Zovirax tablets are contraindicated in patients with a
known hypersensitivity to Acyclovir, Valacyclovir or
any component of the tablet.

Storage Instructions
Zovirax (Acyclovir Tablets) have to be stored at
controlled room temperature i.e. from 20°C to
25°C (68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Aciclovir (Zovirax Tablets) is eliminated by renal clearance, therefore the
dose must be adjusted in patients with renal impairment.
Elderly patients are likely to have reduced renal function and therefore
the need for dose adjustment must be considered in this group of
patients. Both elderly patients and patients with renal impairment are at
increased risk of developing neurological side effects and should be
closely monitored for evidence of these effects.
Prolonged or repeated courses of Acyclovir (Zovirax Tablets) in severely
immune-compromised individuals may result in the selection of virus
strains with reduced sensitivity, which may not respond to continued
Aciclovir treatment.

Warnings
Hydration status: Care should be taken to maintain adequate
hydration in patients receiving high oral doses of Acyclovir
(Zovirax Tablets).
The risk of renal impairment is increased by use with other
nephrotoxic medications.
The data currently available from clinical studies is not sufficient
to conclude that treatment with Aciclovir reduces the incidence
of chickenpox-associated complications in immunocompetent
patients.

Possible Side Effects
The most frequent adverse events reported during clinical trials of
treatment of genital herpes with Aciclovir 200 mg tablets (Zovirax )
administered orally 5 times daily every 4 hours for 10 days were nausea
and/or vomiting in 8 of 298 patient treatments (2.7%).
The most frequent adverse events reported in a clinical trial for the
prevention of recurrences of genital herpes with continuous
administration of 400 mg (two 200 mg tablets) 2 times daily for one year
in 586 patients treated with Aciclovir were nausea (4.8%) and diarrhea
(2.4%). The 589 control patients receiving intermittent treatment of
recurrences with Acyclovir for one year reported diarrhea (2.7%), nausea
(2.4%), and headache (2.2%).

In addition to side effects reported from clinical trials, the following events
have been identified during post-approval use of Acyclovir.
General: Anaphylaxis, angioedema, fever, headache, pain, peripheral
edema.
Nervous: Aggressive behavior, agitation, ataxia, coma, confusion,
decreased consciousness, delirium, dizziness, dysarthria, encephalopathy,
hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These
symptoms may be marked, particularly in older adults or in patients with
renal impairment.
Digestive: Diarrhea, gastrointestinal distress, nausea.
Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis,
leukopenia, lymphadenopathy, thrombocytopenia.

In addition to side effects reported from clinical trials, the following
events have been identified during post-approval use of Acyclovir.
Hepatobiliary Tract and Pancreas: Elevated liver function tests,
hepatitis, hyperbilirubinemia, jaundice.
Musculoskeletal: Myalgia.
Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus,
rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, urticaria.
Special Senses: Visual abnormalities.
Urogenital: Renal failure, renal pain (may be associated with renal
failure), elevated blood urea nitrogen, elevated creatinine, hematuria

Zovirax Tablets Overdosage
Overdoses involving ingestion of up to 20 grams have been reported.
Adverse events that have been reported in association with Acyclovir
(Zovirax Tablets) 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.

Zovirax Tablets During Pregnancy
Acyclovir (Zovirax Tablets) has been classified by the US FDA
as Pregnancy Category B.
There are no adequate and well controlled studies in pregnant
women.
There were 749 pregnancies followed in women exposed to
systemic Aciclovir during the first trimester of pregnancy,
resulting in 756 outcomes. The occurrence rate of birth defects
approximates that found in the general population.

Zovirax Tablets During Pregnancy
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
aciclovir in pregnant women and their developing foetuses.
Aciclovir tablets (Zovirax Tablets) should be used during
pregnancy only if the potential benefit justifies the
potential risk to the fetus.

Zovirax Tablets manufactured by
GlaxoSmithKline Pharmaceuticals Limited, India.
For More details Click Here

Zovirax (Aciclovir Tablets)

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