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Acylex

CG Biostadt Limited
387, Agege Motor Road, Cappa, Lagos, Nigeria
Tel: 234-17746708, 17358796
Fax: 234-12802099
Website: http://biostadtgroup.com/

Brand Name

Acylex

Manufacturer

FEROZSONS LABORATORIES LIMITED P.O. Ferozsons, Amangarh Nowshera-Pakistan

Therapeutic Class

Antivirals, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablets (NRN: A4-7681): - Aciclovir 200 mg

Pack size: Acylex 200 mg film coated tablets are available in 5 x 5’s blister pack.

 

Tablets (NRN: A4-7495): - Aciclovir 400 mg

Pack Size: Acylex 400 mg film coated tablets are available in 2 x 10's blister pack.

 

Tablets (NRN: A4-7495): - Aciclovir 800 mg

Pack Size: Acylex 800 mg film coated tablets are available in 2 x 10's blister pack.

 

Suspension (NRN: A4-7647):- Aciclovir 200 mg

Pack Size: Acylex Suspension 200 mg/5 mL (60 mL bottle)

 

Ointment (NRN: A4-7650): - Aciclovir 50 mg

Pack Size: Acylex Ointment 5% (5 gm Tube)

Pharmacology

PROPERTIES

ACYLEX (aciclovir) is a guanine derivative. It is phosphorylated in herpes virus infected cells 30 to 100 times faster than in uninfected cell. This is due to the action of herpes-specific thymidine kinase.

Aciclovir inhibits many herpes viruses in cell culture and has some beneficial clinical effects in vivo. Aciclovir is active against herpes simplex virus type 1 and type 2 and against varicella zoster virus. This activity is due to intracellular conversion of aciclovir by viral thymidine kinase to the monophosphate with subsequent conversion to the diphosphate and the active triphosphate.

This active form inhibits the herpes virus DNA polymerase enzyme as well as being incorporated into viral DNA. This terminates elongation of the viral DNA and prevents its replication.

PHARMACOKINETICS

Up to 20% of a dose of ACYLEX given by mouth is considered to be absorbed from the gastro-intestinal tract.

Oral administration of 400 mg of ACYLEX results in peak concentrations in plasma of 1.2 µg/mL (after approximately 90 minutes)

Indications

ACYLEX is used for the treatment of viral infections due to herpes simplex virus (types 1 and 2) and varicella zoster virus (herpes zoster, chickenpox).

Herpes simplex infections include herpes labialis and genital herpes.

Contra-indications

ACYLEX is contraindicated in patients known to be hypersensitive to it.

Precautions/Warnings

ACYLEX should be administered with caution to patients with renal impairment and doses should be adjusted accordingly to creatinine clearance. Probenecid can block the renal clearance of ACYLEX.

Caution should be exercised when ACYLEX is administered during pregnancy and lactation.

To be dispensed on the prescription of a Registered Medical Practitioner only.

Interactions

Adverse Effects

ACYLEX is generally well tolerated.

Occasional adverse effects include gastrointestinal disturbances, increased values for liver enzymes, hematological and encephalopathic changes and skin rashes.

Topical application of ACYLEX sometimes may produce burning or erythema.

TREATMENT OF ADVERSE EFFECTS

Renal impairment is reported to respond rapidly to hydration and or dosage reduction or withdrawal.

Dosage & Administration

Oral Administration

ADULTS

Treatment of Herpes Zoster:

800 mg every 4 hours, 5 times daily for 7 days.

Treatment of Herpes Simplex:

Usual dose is 200 mg every 4 hours, 5 times daily for 5 days. Prolonged treatment may consist of 200 mg or 400 mg every 6 hours.

Treatment of Initial Genital Herpes:

200 mg every 4 hours, 5 times daily for 10 days.

Dosage for chronic suppressive therapy of recurrent disease is 200 mg 3 to 5 times daily for up to 6 months.

For prophylaxis of Herpes simplex infection in immunocompromised patients. 200 mg daily every 6 hours.

CHILDREN

Chickenpox:

Children 2 years and above: 20 mg/kg (max. 800 mg). 4 times daily for 5 days.

Children under 2 years, half adult dose, over 2 years, adult dose.

Topical Administration

For the treatment of Herpes simplex ACYLEX Ointment should be applied every 4 hours.

ACYLEX Ointment 5% is indicated in the management of initial herpes genitalis and in a limited non-life­threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

Storage/Handling Recommendations

Store at or below 25°C in a dry place and protect from light.

Keep out of the reach of children.

Review Date

2016-07-12 07:52:45