Medskin Acyclovir 200

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MEDSKIN ACYCLOVIR 200

COMPOSITION:

Acyclovir ............................... 200 mg

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

(Wheat starch, avicel, lactose, ponceau red, PVP K30, magnesium stearate, aerosil, talc).

DOSAGE FORM: Tablet.

PRESENTATION: Box of 5 blisters x 10 tablets.

PHARMACODYNAMICS:

Acyclovir is similar to nucleoside. It interferes DNA synthesis and selective replication of Herpes virus, 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), cytomegalovirus (CMV).

Acyclovir has a good effect on treatment of severe encephalitis caused by HSV-1; the death rate may be reduced from 70% to 20%. Among the patients recovered, the serious complications are also reduced.

PHARMACOKINETICS:

Oral bioavailability is about 10 to 20%. Oral acyclovir is mainly absorbed by the gastrointestinal tract; the influence of food on the absorption of acyclovir was not apparent. Acyclovir is widely distributed in body tissues and fluids including the brain, kidney, lung, intestine, liver, spleen, uterus, mucosa, vaginal secretions, tears, aqueous humor, seminal fluid, encephalospinal fluid. Plasma protein binding is relatively low (9 to 33%). Peak plasma concentrations of acyclovir usually occur with 1.5 to 2 hours. The elimination half-life of acyclovir is approximately 2 to 3 hours. Acyclovir is excreted principally in the kidneys as unchanged; a small amount of acyclovir is metabolized by the liver.

INDICATIONS:

Treatment of initial and recurrent Herpes simplex virus type 1 and type 2 infections on skin and mucosa, Herpes simplex encephalitis.

Treatment of acute Herpes zoster (shingles), ocular shingles, pneumonia due to Herpes zoster in adults.

Treatment of initial and recurrent episodes of genital Herpes.

Treatment of haemorrhagic chickenpox, chickenpox in immunodeficiency patients, neonatal chickenpox.

CONTRAINDICATIONS:

Hypersensitivity to any components of the drug.

PRECAUTIONS:

Patients with renal impairment. Pregnant women, nursing mothers.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug does not affect the possibility of driving and operating machinery.

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.

Amphotericin B and ketoconazole enhance the antiviral effect of acyclovir.

ADVERSE EFFECTS:

The adverse effects have been rarely reported, including

GI disorders: nausea, vomiting, diarrhea, colic, anorexia, dyspepsia.

Blood disorders: anemia, hypoleukemia, lymphadenitis, thrombocytopenia. Thrombocytopenic purpura, haemolytic uraemic syndrome; death which was happened in patients with immunodeficiency taking high doses of acyclovir.

Nervous system disorders: headache, dizziness, aggressive behavior. Nervous and sedative reactions (including coma, tremor, hallucination, seizure) have been rarely reported.

Skin disorders: rash, itching, urticaria.

Other reactions: fever, pains, increased hepatic test, hepatitis, jaundice, muscular pain, angioedema, lipsotrichia.

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

OVERDOSAGE:

Symptoms: Precipitation of acyclovir in renal tubules may occur when renal concentrations the solubility of 2.5 mg/ ml or the serum creatinine  is elevated. Adverse events that have been also reported in association with overdosage include renal failure, excitement, anxiety, convulsion, palpitation, hypertension, and dysuria.

Management: Hemodialysis is advised until recovery of renal function. The drug should be discontinued and patients should receive fluids and electrolytes.

DOSAGE & ADMINISTRATION:

For treatment of Herpes simplex infections:

- Adults and children aged > 2 years: oral dose of 1 tablet 5 times a day, every 4 hours, for 5 - 10 days.

For suppression of recurrent Herpes simplex in immunocompromised patients, visceral transplant patients using the hypo-immune drugs, HIV-infected person, chemotherapy-treating individuals.

- Adults and children aged > 2 years: oral dose of 1 - 2 tablets, 4 times a day.

For treatment of chickenpox and shingles:

- Adults: oral dose of 4 tablets 5 times a day, for 7 days.

- Children: oral dose of 20 mg / kg body-weight, 4 times a day for 5 days.

For patients with renal impairment:

The dosage and frequency should be adjusted on the level of renal damage.

The dosage should be adjusted in patients with renal impairment.

Hemodialysis: An additional dose is administered after each dialysis.

The dose of Medskin Acyclovir for patients with renal impairment associated with HIV infection should be modified as follows:

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is for prescription only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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