Apofarm

Uses

• Herpes Zoster

• Genital Herpes

• Chickenpox

• Herpes Simplex Infections

• Herpes Simplex Encephalitis

Dosage

Apofarm dosage

The total daily dosage of Apofarm should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogens, renal function and body-weight.

Apofarm Tablet

• Acute Herpes Zoster:

800 mg every 4 hours, 5 times daily for 7 to 10 days.

• Genital Herpes:

Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

Chronic suppressive therapy for recurrent disease: 400 mg 2 times daily for up to 12 months.

Intermittent therapy: 200 mg every 4 hours, 5 times daily for 5 days.

• Chickenpox:

Children (2 years of age and older): 20 mg/kg/dose 4 times daily (80 mg/kg/day) for 5 days.

Adults and Children (>40 kg): 800 mg 4 times daily for 5 days.

Apofarm IV

The required dose of Apofarm IV should be administered by slow intravenous infusion over a one-hour period.

• Herpes Simplex (HSV-1 and HSV-2) Infections:

Adults and Adolescents (≥12 years): 5 mg/kg, 8 hourly for 7 days.

Pediatrics (<12 years): 10 mg/kg 8 hourly for 7 days.

• Severe Initial Herpes Genitalis:

Adults and Adolescents (≥12 years): 5 mg/kg 8 hourly for 5 days.

• Herpes Simplex Encephalitis:

Adults and Adolescents (≥12 years): 10 mg/kg 8 hourly for 10 days.

Pediatrics (3 months to 12 years of age): 20 mg/kg 8 hourly for 10 days.

• Neonatal Herpes Simplex (Birth to 3 months):

10 mg/kg 8 hourly for 10 days.

• Varicella Zoster:

Adults and Adolescents (≥12 years): 10 mg/kg 8 hourly for 7 days.

Pediatrics (<12 years): 20 mg/kg 8 hourly for 7 days.

Dose adjustment of Tablet for patients with acute or chronic renal impairment, based on Creatinine Clearance, Cr Cl (mL/min/1.73 m2):

For Cr Cl= > 25 : 800 mg 4 hourly 5 times daily

For Cr Cl = 10 to 25 : 200 mg 4 hourly 5 times daily or 400 mg 12 hourly or 800 mg 8 hourly

For Cr Cl = 0 to 10 : 200 mg 12 hourly or 400 mg 12 hourly or 800 mg 12 hourly

Dose adjustment of IV for patients with acute or chronic renal impairment, based on Creatinine Clearance, Cr Cl (mL/min/1.73 m2):

For Cr Cl = > 50 : 100% of recommended dose, 8 hourly

For Cr Cl = 25 to 50 : 100% of recommended dose, 12 hourly

For Cr Cl = 10 to 25 : 100% of recommended dose, 24 hourly

For Cr Cl = 0 to 10 : 50% of recommended dose, 24 hourly

Caution: Rapid or bolus intravenous injection must be avoided. Intramuscular or subcutaneous injection must be avoided.

Reconstitution procedure of IV infusion

Vial containing 250 mg Apofarm will be reconstituted with 50 ml infusion solution and vial containing 500 mg Apofarm will be reconstituted with 100 ml infusion solution. Besides, Vial containing 1 gm Apofarm will be reconstituted with 250 ml infusion solution. 10 ml of the infusion solution will be added to the vial containing 250 mg, 500 mg and 1 gm Apofarm. Shake well and transfer the required amount of solution to the infusion container. The final concentration of Apofarm will be not more than 5 mg/ml.

The reconstituted solution should be used within 12 hours. Refrigeration of reconstituted solution may result in the formation of a precipitate which will re-dissolve at room temperature.

Compatible infusion fluids

Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)

Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP

Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion BP

Hartmann\\\'s Solution

Side Effects

Rash, gastro-intestinal disturbances, rises in bilirubin and liver-related enzymes, increase in blood urea and creatinine, decreases in hematological indices, headache, neurological reactions, fatigue.

Precaution

Apofarm should be administered with caution in patient with renal impairment and doses should be adjusted according to creatinine clearance.

Pregnancy & Breastfeeding use

Pregnancy category B & caution should be exercised when it is administered to a lactating mother.

Interaction with other Medicine

Probenecid reduces Apofarm excretion and so increases plasma concentration and risk of toxicity.

Storage Condition

Keep in a cool & dry place away from light. Keep drugs out of the reach of children.

Innovators Monograph

You find simplified version here Apofarm