MEDSKIN CLOVIR 400

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INFORMATION FOR MEDICAL STAFF

COMPOSITION:

Acyclovir ............................... 400 mg

Excipients q.s ........................ 1 tablet

(Microcrystalline cellulose M101, lactose monohydrate, ponceau, povidone K30, colloidal silicon dioxide, magnesium stearate, talc, kollidon CL-M).

PHARMACEUTICAL FORM: Tablet.

PHARMACODYNAMIC PROPERTIES:

ATC code: J05AB01

Acyclovir is similar to nucleoside. It interferes with DNA synthesis and selectively viral replication by inhibiting the DNA polymerase enzyme as well as being incorporated into viral DNA, resulting in not affecting the metabolism of normal cells.

Acyclovir is potently active against Herpes simplex virus type 1 (HSV-1) and less active against Herpes simplex virus type 2 (HSV-2) and Varicella zoster virus (VZV). The Epstein-Barr virus and Cytomegalovirus are also susceptible to acyclovir to a lesser extent.

Acyclovir has no activity against latent viruses, but there is some evidence that it inhibits latent Herpes simplex virus at an early stage of reactivation.

PHARMACOKINETIC PROPERTIES:

Acyclovir is slowly and poorly absorbed from the gastrointestinal tract and the time taken to reach peak concentrations is 1.5 to 2 hours. Oral bioavailability is 13 to 21%. In adult patients with normal renal function the plasma half-life is 3.3 hours. Acyclovir persists in the plasma of patients with renal insufficiency and the mean terminal plasma half-life recorded in patients with end stage renal disease is 19.5 hours. Acyclovir is readily removed by haemodialysis. In infants of less than three months of age, the plasma half-life is slightly prolonged to about 3.8 hours and clearance is about one third of that found in older children and adults.

Acyclovir is widely distributed in tissues and body fluids including brain, kidney, lung, liver, muscle, spleen, uterus, vaginal mucosa, vaginal secretions, cerebrospinal fluid and herpetic vesicular fluid. Concentrations in kidney and lung were 10 to 13 times those of plasma concentrations after multiple dose therapy and 25 to 70% of the plasma level was found in the brain, spinal cord and cerebrospinal fluid. Acyclovir passes into breast milk and levels can be three to four times higher than in serum.

The pharmacokinetics of acyclovir in children over one year old seem to be similar to those of adults.

PRESENTATIONS: Box of 6 blisters x 10 tablets.

THERAPEUTIC INDICATIONS:

Treatment of Herpes simplex virus (HSV) infections of the skin and mucous membranes including initial and recurrent genital Herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).

Suppression of recurrent Herpes simplex infections in immunocompetent patients.

Prophylaxis of Herpes simplex infections in immunocompromised patients.

Treatment of Varicella (chickenpox) and Herpes zoster (shingles) infections.

DOSAGE & ADMINISTRATION:

Route of administration: Oral.

Treatment of Herpes simplex infections:

- Adults and children aged > 14 years: 200 mg acyclovir (400 mg acyclovir in immunocompromised patients) should be taken five times daily at approximately four hourly intervals. Treatment should continue for 5 - 10 days.

- Children aged 2 - 14 years: as the adult dose.

- Children under two years: half the adult dose.

Suppression of Herpes simplex infections in immunocompetent patients: 200 mg four times daily or 400 mg twice daily which can be reduced to 200 mg two or three times daily. Therapy should be interrupted every 6 to 12 months for reassessment of the condition.

Suppression of recurrent Herpes simplex in immunodeficiency individuals, visceral transplant patients using the hypo-immune drugs, HIV-infected person, chemotherapy-using individuals.

- Adults and children aged > 14 years: The recommended oral dosage is 200 - 400 mg x 4 times daily every 6 hours.

- Children aged 2 - 14 years: as the adult dose.

- Children under two years: half the adult dose.

Treatment of chickenpox: The recommended oral dosage is 800 mg four to five times daily for 5 - 7 days.

Treatment of Herpes zoster infections: The recommended oral dosage is 800 mg five times daily for 7 to 10 days.

+ Treatment of varicella infection in children: Treatment should continue for 5 days.

- 6 years and over: 800 mg four times daily.

- 2 to 5 years: 400 mg four times daily.

- Under 2 years: 200 mg four times daily.

Dosing may be more accurately calculated as 20 mg/kg body weight (not to exceed         800 mg) four times daily.

Dosage in renal impairment: The dose of acyclovir should be reduced in patients with renal impairment depending on creatinine clearance:

- Creatinine clearance 10 - 25 ml/minute:

Varicella - Herpes zoster infections: 800 mg three times daily every 8 hours.

- Creatinine clearance below 10 ml/minute:

Varicella - Herpes zoster infections: 800 mg twice daily every 12 hours.

Herpes simplex infections: 200 mg twice daily every 12 hours.

Children younger than 14 years should be given a suitable dosage form.

CONTRAINDICATIONS:

Hypersensitivity to any ingredients of the drug. 

Patients with lactose intolerance.

PRECAUTIONS:

In patients with renal impairment, the dose must be adjusted according to creatinine clearance.

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. In the reported cases, these reactions were generally reversible on discontinuation of treatment.

The risk of renal impairment is increased by use with other nephrotoxic drugs.

Pregnancy:

There are no adequate and controlled studies on a pregnant woman. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:

Following oral administration of 200 mg acyclovir five times a day, acyclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding levels, about 3 times higher than in serum concentrations. Caution is therefore advised if acyclovir is to be administered to a nursing woman.

Effects on work: There have been no studies to investigate the effect of acyclovir on driving performance, the ability to operate machinery, or working at height and other cases.

INTERACTIONS:

Concurrent use of zidovudine and acyclovir may cause states of doze and deep sleep.

Probenecid is reported to inhibit the renal elimination of acyclovir, reduce the uric excretion and the purification of acyclovir. Probenecid and cimetidine increase the AUC of acyclovir by this mechanism, and reduce acyclovir renal clearance.

Acyclovir may increase serum theophylline levels.

UNDESIRABLE EFFECTS (ADRs):

The frequency categories associated with the adverse events below are estimates:

 

Common

Rare

Very rare

Blood and the lymphatic system disorders

   

Anaemia, leukopenia, thrombocytopenia.

Immune system disorders

 

Anaphylaxis

 

Nervous system disorders

Headache dizziness

 

Agitation, confusion, tremor, hallucinations, convulsions, somnolence, coma.

Respiratory, thoracic and mediastinal disorders

 

Dyspnoea

 

Gastrointestinal disorders

Nausea, vomiting, diarrhoea abdominal pains

   

Hepato-biliary disorders

 

Reversible rises in bilirubin and liver related enzymes

Hepatitis, jaundice

Skin and subcutaneous tissue disorders

Pruritus, rashes

Angioedema

 

Renal and urinary disorders

 

Increases in blood urea and creatinine

Renal failure, renal pain

OVERDOSE:

Symptoms: Patients have ingested overdoses of up to 20 g acyclovir on a single occasion, usually without toxic effects. Repeated overdoses of oral acyclovir over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion).

Management: Patients should be observed closely for signs of toxicity. Haemodialysis is advised until recovery of renal function. The drug should be discontinued and patients should receive fluids and electrolytes.

Read the directions carefully before use.

This drug is for prescription only.

STORAGE CONDITIONS:

Store in dry places, not exceeding 300C, protect from light.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: June 7, 2018.

INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

Keep out of reach of children.

Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.

The drug is for prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Acyclovir ................................................... 400 mg

Excipients q.s ............................................ 1 tablet

(Microcrystalline cellulose M101, lactose monohydrate, ponceau, povidone K30, colloidal silicon dioxide, magnesium stearate, talc, kollidon CL-M).

PRODUCT DESCRIPTION: Oval, pink tablet, smooth on one side, a sign       on other side, intact edges.

PRESENTATION: Box of 6 blisters x 10 tablets.

WHAT THE DRUG IS USED FOR:

Treatment of Herpes simplex virus (HSV) infections of the skin and mucous membranes including initial and recurrent genital Herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).

Suppression of recurrent Herpes simplex infections in immunocompetent patients.

Prophylaxis of Herpes simplex infections in immunocompromised patients.

Treatment of Varicella (chickenpox) and Herpes zoster (shingles) infections.

HOW TO TAKE THIS MEDICINE:

Route of administration: Oral.

Treatment of Herpes simplex infections:

- Adults and children aged > 14 years: 200 mg acyclovir (400 mg acyclovir in immunocompromised patients) should be taken five times daily at approximately four hourly intervals. Treatment should continue for 5 - 10 days.

- Children aged 2 - 14 years: as the adult dose.

- Children under two years: half the adult dose.

Suppression of Herpes simplex infections in immunocompetent patients: 200 mg four times daily or    400 mg twice daily which can be reduced to 200 mg two or three times daily. Therapy should be interrupted every 6 to 12 months for reassessment of the condition.

Suppression of recurrent Herpes simplex in immunodeficiency individuals, visceral transplant patients using the hypo-immune drugs, HIV-infected person, chemotherapy-using individuals.

- Adults and children aged > 14 years: The recommended oral dosage is 200 - 400 mg 4 times daily every 6 hours.

- Children aged 2 - 14 years: as the adult dose.

- Children under two years: half the adult dose.

Treatment of chickenpox: The recommended oral dosage is 800 mg four to five times daily for 5 - 7 days.

Treatment of Herpes zoster infections: The recommended oral dosage is 800 mg five times daily for 7 to 10 days.

+ Treatment of varicella infection in children: Treatment should continue for 5 days.

- 6 years and over: 800 mg four times daily.

- 2 to 5 years: 400 mg four times daily.

- Under 2 years: 200 mg four times daily.

Dosing may be more accurately calculated as 20 mg/kg body weight (not to exceed 800 mg) four times daily.

Dosage in renal impairment: The dose of acyclovir should be reduced in patients with renal impairment depending on creatinine clearance:

- Creatinine clearance 10 - 25 ml/minute:

Varicella - Herpes zoster infections: 800 mg three times daily every 8 hours.

- Creatinine clearance below 10 ml/minute:

Varicella - Herpes zoster infections: 800 mg twice daily every 12 hours.

Herpes simplex infections: 200 mg twice daily every 12 hours.

Children younger than 14 years should be given a suitable dosage form.

Or as directed by the physician.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Hypersensitivity to any ingredients of the drug. 

Patients with lactose intolerance.

UNDESIRABLE EFFECTS (ADRs):

The frequency categories associated with the adverse events below are estimates:

 

Common

Rare

Very rare

Blood and the lymphatic system disorders

   

Anaemia, leukopenia, thrombocytopenia.

Immune system disorders

 

Anaphylaxis

 

Nervous system disorders

Headache dizziness

 

Agitation, confusion, tremor, hallucinations, convulsions, somnolence, coma.

Respiratory, thoracic and mediastinal disorders

 

Dyspnoea

 

Gastrointestinal disorders

Nausea, vomiting, diarrhoea abdominal pains

   

Hepato-biliary disorders

 

Reversible rises in bilirubin and liver related enzymes

Hepatitis, jaundice

Skin and subcutaneous tissue disorders

Pruritus, rashes

Angioedema

 

Renal and urinary disorders

 

Increases in blood urea and creatinine

Renal failure, renal pain

Inform your physician about any adverse effects occur during the treatment.

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:

Concurrent use of zidovudine and acyclovir may cause states of doze and deep sleep.

Probenecid is reported to inhibit the renal elimination of acyclovir, reduce the uric excretion and the purification of acyclovir. Probenecid and cimetidine increase the AUC of acyclovir by this mechanism, and reduce acyclovir renal clearance.

Acyclovir may increase serum theophylline levels.

WHAT SHOULD YOU DO IF YOU MISS A DOSE:

The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.

HOW TO STORE THIS MEDICINE:

Store in dry places, not exceed

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