Ciclevir 800 Abbott treated the herpes simplex virus tube 1 and 2 (10 blisters x 5 tablets)

Dosage form Box of 10 blisters x 5 tablets
Specifications Acyclovir
Ingredient Glomed

Ingredient

Composition information	Content
Acyclovir	800mg

Uses

Indications

CICLEVIR 800 drugs are indicated in the following cases:

Treatment of the herpes simplex virus (HSV) on the skin and mucous membrane including genital herpes contamination and recurrence (except for heavy HSV infection in children with immunodeficiency). Herpes Zoster infection (shingles).

ATC code: J05AB01.

Aciclovir is an antivirus, in in vitro has a strong effect on the herpes simplex virus (HSV) type 1 and type 2, Varicella Zoster virus. Toxicity for the host cell of mammals is low.

Aciclovir is phosphoryl turned into activity form as aciclovir triphosphate after entering the cells contaminated with herpes. The first step in this process depends on the presence of thymidin kinase encoded by HSV.

Aciclovir Triphosphate acts as a inhibitor and substrate of the specific herpes polymerase DNA, and the synthesis of the virus's DNA without affecting the metabolism of normal cells.

Herpes Simplex virus develops aciclovir resistance due to the appearance of a short -term deficiency of KYMIDIN KINASE, often reduced toxic with the ability to infect and hidden state decreases. Rare drug resistance in patients with normal immune response in short -term treatments, but more common in patients with long -term immunodeficiency. Herpes Zoster's resistance develops in a similar mechanism and has been reported in immunodeficiency patients using prolonged therapy with aciclovir.

pharmacokinetic

absorption

Aciclovir absorbs slowly and not completely from the digestive tract. Peak concentration in plasma is about 2 hours after drinking.

Distribution

Widely distributed into different tissues, including cerebrospinal fluid reaches about 50% compared to plasma. Protein bonds are reported from 9-33%. Aciclovir passes through the placenta and excreted in breast milk at a concentration about 3 times higher than the mother's serum.

Metabolism and elimination

Elimination through the kidneys is the main excretion path including glomerular filtration and elimination in the renal tubules. The final waste sale time or the beta period is reported as about 2-3 hours for adults without kidney failure. Because aciclovir is still in the plasma of patients with renal impairment, in patients with chronic renal impairment this value increases and can be up to 19.5 hours in difficult patients.

When kidney function decreases, a larger rate is eliminated by converting into carboxymethylylethylyl guuanin. During the process of hemorrhage, the sale time is reduced to 5.7 hours, with 60% of aciclovir doses were removed for 6 hours. The excretion of division accounts for 2% of the dose.

Before taking Ciclevir 800 Abbott treated the herpes simplex virus tube 1 and 2 (10 blisters x 5 tablets)

How to use

CICLEVIR 800 drug used oral. Patients have difficulty swallowing pills that can disperse them in at least 50 ml of water and need to stir before drinking.

Dosage

adults:

Treatment of herpes Simplex infection: Should use 200mg of aciclovir 5 times a day about 4 hours away to avoid having to drink at night. Can be treated within 5 days, but may be longer for severe output virus infections.

In patients with severe immunodeficiency (as after the marrow transplant) or patients with reduced absorption in the intestine, the dosage can double to 400mg of aciclovir or may change by considering intravenous lines.

should start therapy as soon as possible as soon as infected; For recurrence, therapeutic stages should be applied in millions or at the beginning of the injury.

Preventing herpes simplex in people with normal immune response: 200mg of aciclovir 4 times a day, about 6 hours.

Many patients find it convenient to take the dose of 400 mg 2 times daily about 12 hours.

Reduce the dose to 200mg of aciclovir 3 times a day about 8 hours or even 2 times a day about 12 hours can give effective results.

Some patients may be exposed to a total daily dose of 800mg of aciclovir.

Treatment should be stopped every 6 - 12 months to observe the changes that may occur in the natural process of the disease.

Prevention of herpes Simplex infection in immunodeficiency patients: Should use 200 mg of aciclovir 4 times a day about 6 hours away.

In patients with serious immunodeficiency (as after the marrow transplant) or a decrease in the absorption of the intestinal drug, can double the dose to 400 mg of aciclovir or may consider changing by intravenous injection.

Time to use prevention drugs depends on the period of long or short risk.

Children:

Treatment of Herpes Simplex infection, and prevent herpes simplex infection in immunodeficiency patients:

Children over 2 years of age should be used for adults and children under 2 years of age should take half the dose of adults.

Chickenpox treatment:

Children under 2 years of age should use 200 mg of aciclovir 4 times daily. The dose may be more accurate than 20 mg/kg body weight (not exceeding 800 mg 4 times daily).

There is no specific data on preventing herpes Simplex infection or treating shingles (Herpes Zoster) in children with normal immune response. When treating herpes zoster infection in children with immunodeficiency, it is possible to consider changing by intravenous injection.

Older people: must consider the possibility of renal failure in the elderly and should adjust the dose accordingly.

In the elderly, the body's total aciclovir clearance decreases in parallel with creatinine clearance. Supplementation should be maintained for patients with aciclovir in high doses. Should pay special attention to reducing the dose in elderly patients with renal failure.

Renal failure: Precautions when taking aciclovir in patients with renal function impairment. Should maintain complete water compensation.

In control of the herpes simplex infection in patients with renal impairment, oral doses do not lead to aciclovir accumulation above the level that is determined to be safe when intravenous injection. However, in serious renal failure (creatinine clearance below 10 ml/min) should adjust the dose to 200 mg 2 times a day, about 12 hours.

In the treatment of shingles (Herpes Zoster), should use 800 mg 2 times daily, about 12 hours for patients with severe renal impairment (clearing creatinine below 10 ml/min) and 800 mg 3 times at a time, about 8 hours for medium renal impaired patients (clearing creatinine in about 10-25 ml/minute).

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? Aciclovir precipitate may be precipitated in the renal tubules when the concentration in the renal tubular fluid exceeds the solubility (2.5 mg/ml).

Handling: In case of anatomy and acute renal failure, hemolyticity until the renal function recovers can help the patient.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using CICLEVIR 800, you may experience unwanted effects (ADR).

The frequency related to the adverse effects below is the estimated figures. For most effects, there is no appropriate data available to estimate the ratio. In addition, the adverse effects may vary depending on indications.

Estimates the frequency of unwanted effects, but not sure for all side effects. The following convention has been used to classify the frequency of unwanted effects: very common (> 1/10), common (> 1/100, 1/1000,

Disorders of blood systems and lymph

Very rare: anemia, leukopenia and thrombocytopenia.

immune system disorders

Rare: Anaphylaxis.

Common: Dizziness and headache. These effects are often reported in patients with high doses of aciclovir (often intravenously), kidney failure, or with other previous influential factors. Be cautious to use aciclovir in patients with neurological abnormalities.

Rare: Difficulty breathing.

Digestive disorders

Common: Nausea, vomiting, diarrhea and abdominal pain.

Rare: Increasing bilirubin and liver enzymes with recovery.

Common: skin rash, itching (including light sensitivity). Stevens-Johnson, poisoned epidermal necrosis.

Rare: Increasing urea and blood creatinine, kidney failure, often in intravenous infusion, often recovering and responding to water rehydration and or decreased dose but can cause acute kidney failure in patients with previous exposure factors.

Common: fatigue, fever.

Notify the doctor with unwanted effects when using the drug.

Harmful reaction report

The reaction report is harmful after the drug is licensed to circulate very important to continue monitoring the benefits/risks of the drug. Health workers need to report all the harmful reactions to the National Center or regional center on drug information and monitor the harmful reactions of the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

CICLEVIR 800 drugs in the following cases:

Hypersensitivity to Aciclovir, Valaciclovir or any excipients of the drug.

Precautions when using

Used in patients with renal failure and the elderly:

The risk of renal failure increases if used simultaneously with poison with kidneys.

Aciclovir is eliminated through the kidneys, so the dose adjustments in patients with renal failure must be adjusted. Older patients often impaired renal function and therefore need to adjust the dose for this group of patients. Both older patients and patients with renal impairment increases the risk of nervous side effects and should carefully monitor the signs of side effects.

In the reported cases, these reactions generally recover when stopped.

The process of using aciclovir is prolonged or repeated in people with serious immunodeficiency, which can lead to reduced sensitivity of some virus strains and do not continue to respond to aciclovir treatment.

Water compensation: To avoid the risk of kidney toxicity, be careful to maintain enough water in patients with higher doses or intravenous infusion, for example: Treatment of herpes Zoster infection (4G injection per day).

Use drugs for women during pregnancy and lactation

Pregnant women: data on the use of aciclovir in pregnant women is limited. Consider
between treatment benefits compared to any risks that may occur.

breastfeeding women: aciclovir is excreted in breast milk when used orally, but not yet
has recorded harmful effects for breastfed babies when the mother is using aciclovir. Should be cautious when using aciclovir to drink for women who are breastfeeding.

The effect of the drug on the ability to drive and operate machinery

should note the patient's clinical status and the unwanted effects of aciclovir when considering the ability to drive or operate the patient's machinery. Because using aciclovir is sometimes related to drowsiness and sleeping (usually in patients with high doses or impaired renal function), patients should ensure not being affected before driving or using machines.

There have been no studies to prove the impact of aciclovir on driving or operating machinery. Moreover, an adverse impact on such activities cannot be predicted from the pharmacological characteristics of the active ingredient.

Drug interactions

Probenecid prevents aciclovir from the kidneys.

The risk of renal failure increases if used simultaneously with poison with kidneys.

Aciclovir inhibits theophylin that leads to drug accumulation.

Excessive fatigue has been reported when shared with aciclovir with zidovudin.

Amphotericin B has been shown to increase the antiviral effect of aciclovir against the Pseudorabies In Vitro virus.

Ketoconazole and Aciclovir have been shown to have antiviral effects that are dosely -dependented against the herpes simplex type 1 and 2 virus (HSV -1 and -2) in vitro.

Aciclovir is excreted mainly in the form of unchanged urine through excretion activities in the renal tubules.

Any drug used simultaneously will compete with this mechanism, resulting in an increase in aciclovir levels in plasma.

ciclosporin: There have been a few patients with implants with increased ciclosporin levels in serum and signs of kidney toxicity when used simultaneously with aciclovir. Kidney function should be closely monitored in patients taking both drugs.

cimetidine and probenecid: cimetidine and probenecid increases the AUC of aciclovir by competing active excretion through the renal tubules and reducing the renal waste of aciclovir. Adjusting the dose is usually not necessary because of the wide therapy of aciclovir.

Mycophenolat mofetil: When used simultaneously, it shows an increase in AUC in the plasma of aciclovir and the non -activity metabolitus of Mycophenolat Mofetil, an immunosuppressant agent used in transplant patients. However, there is no need to adjust the dose because of the wide therapy of aciclovir.

A experimental study on five male subjects showed that simultaneous therapy with aciclovir increased the AUC of theophylin about 50%. Recommended measurement of plasma concentrations when treated simultaneously with aciclovir.

Zidovudin: Although simultaneously used zidovudin and aciclovir is usually not related to toxicity, there is a single report of fatigue occurring in patients using these two drugs at the same time. This does not happen when zidovudin and aciclovir use alone.

Storage

Store in a dry place, avoid light, temperature not exceeding 30 ° C.

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