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ZYAVIR (Acyclovir )500mg Injection

Generic Name

Acyclovir


Brand Name

ZYAVIR


Dosage Form

Injection


Strength and Dosage

500mg


Therapeutic Category

Antiviral



Patient Information Leaflet

Summary of Product Characteristics pdfIcon

Product Description


Acyclovir is an antiviral drug. It slows the growth and spread of the herpes virus in the body. It will not cure herpes, but it can lessen the symptoms of the infection.

Acyclovir is used to treat infections caused by herpes viruses, such as genital herpes, cold sores, shingles, and chicken pox.Acyclovir may also be used for purposes not listed in this medication guide.


BEFORE TAKING THIS MEDICINE

You should not take this medicine if you are allergic to acyclovir or valacyclovir (Valtrex). You should not take acyclovir buccal tablets (Sitavig) if you are allergic to milk proteins.

To make sure acyclovir is safe for you, tell your doctor if you have:
kidney disease; or a weak immune system (caused by disease or by using certain medicine).

FDA pregnancy category B. Acyclovir is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.


SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction to acyclovir: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

–easy bruising or bleeding, purple or red pinpoint spots under your skin; or
–signs of a kidney problem–little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common acyclovir side effects may include:

–nausea, vomiting;
–diarrhea;
–general ill feeling;
–headache; or
–mouth pain while using an acyclovir buccal tablet.

This is not a complete list of side effects and others may occur.


FOR HEALTHCARE PROFESSIONALS


Applies to acyclovir: buccal tablet, compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral suspension, oral tablet
Gastrointestinal
Gastrointestinal side effects have been the most frequently reported side effects, and include nausea, vomiting, abdominal pain, and diarrhea.

Nausea and vomiting have been reported with oral and intravenous administration, and have preceded neurotoxicity and nephrotoxicity. Gagging and anorexia have also been reported.
Renal

Renal side effects have included renal failure, renal pain (may be associated with renal failure), elevated blood urea nitrogen, elevated serum creatinine, and hematuria. Renal effects generally are transient and resolve over several days following discontinuation of therapy; however fatal renal failure has occurred. Renal damage is most commonly due to crystallization of the drug in the renal tubules. Acute tubular necrosis and interstitial nephritis have also been reported.

Transient renal dysfunction has been reported with both oral and intravenous acyclovir therapy. Crystallization of the drug in renal tubules is thought to be the mechanism for the development of renal dysfunction, based on findings of crystalluria in several case reports and at least one prospective study.

Elderly or renally impaired patients are at greater risk for developing neurotoxicity and further deterioration in renal function.
Nervous system
Nervous system side effects have included aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, delusions, disorientation, dizziness, EEG changes, abnormal cerebrospinal fluid findings, encephalopathy, focal neurological signs, hallucinations, headache, insomnia, irritability, lightheadedness, major depression, mania, myoclonus, obtundation, paresthesia, psychosis, seizure, somnolence, tremors, and Cotard’s syndrome. Neurotoxicity generally develops early in acyclovir treatment and has most commonly been reported in patients with renal failure, the elderly, and in patients following bone marrow transplant. It is thought to be associated with high serum concentrations of acyclovir. Guillain Barre syndrome has been reported in at least one patient receiving acyclovir prophylaxis following allogeneic marrow transplantation.

Acyclovir neurotoxicity is almost exclusively seen in patients with renal failure. These patients may have longstanding chronic renal failure or acute failure associated with acyclovir. Although more commonly seen with intravenous administration of larger doses, neurotoxicity has also been reported in patients receiving oral doses of acyclovir. Following discontinuation of acyclovir, mental status recovers within about a week. Several patients with chronic renal failure exhibiting neurotoxicity improved dramatically following hemodialysis. In one study of renal transplant patients receiving oral acyclovir therapy, one patient developed neurotoxicity, manifested as disorientation, confusion and myoclonus. The symptoms responded to a decrease in dosage. Three other case reports have also described neurologic symptoms, including visual hallucinations, delusions, mania, tremors, myoclonus and EEG changes, which improved following discontinuation of intravenous acyclovir. Rechallenge in one case using a lower dosage resulted in no sequelae.

Local
Local adverse effects associated with intravenous administration of acyclovir have included inflammation or phlebitis at the injection site. Phlebitis is more common when concentrated solutions (greater than 7 mg/mL) are administered. Skin eruptions have been reported at venipuncture sites and tissue necrosis has occurred after infiltration into extravascular tissues.
Cardiovascular

Cardiovascular side effects have included hypotension.
Dermatologic
Dermatologic side effects have included alopecia, erythema multiforme, hives, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria.
Hematologic
Hematologic and lymphatic side effects have included anemia, disseminated intravascular coagulation, hemolysis, leukocytoclastic vasculitis, leukocytosis, leukopenia, lymphadenopathy, neutropenia, neutrophilia, thrombocytosis, thrombocytopenia, and pancytopenia.
Hepatic
Hepatic side effects have included elevated liver function tests, hepatitis, hyperbilirubinemia, and jaundice


“Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir ,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

ZYAVIR (Acyclovir )500mg Injection – TAJ PHARMA INDIA |Acyclovir is an antiviral drug. It slows the growth and spread of the herpes virus in the body. It will not cure herpes, but it can lessen the symptoms of the infection.

ZYAVIR (Acyclovir )500mg Injection – TAJ PHARMA INDIA

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