MEDSKIN ACYCLORVIR 200

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COMPOSITION:
Acyclovir ............................... 200 mg
Excipients q.s ....................... 1 tablet
(Wheat starch, avicel, lactose, ponceau red,
PVP K30, magnesium stearate, aerosil, talc).
DOSAGE FORM: Tablets
PRESENTATION: Box of 5 blisters x 10 tablets.
PHARMACODYNAMICS: Acyclovir is similar to nucleoside, acts to inhibit DNA synthesis and the selective multiplication of Herpes virus, so it does not influence the metabolism of normal cells. Acyclovir gives the strongest effect on Herpes simplex virus type 1 (HSV-1) and decreases slowly on 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%. Acyclovir by oral route is mainly absorbed in the intestine; food does not impact the acyclovir absorption. Acyclovir is widely distributed in the body fluids and organs such as brain, kidney, lung, intestine, liver, spleen, uterus, mucosa, vaginal fluid, tears, aqueous humor, seminal fluid, encephalospinal fluid. Acyclovir has a low rate of protein-bound in plasma, only 9 to 33%. The time of getting plasma peak concentration of acyclovir is 1.5 to 2 hours. The elimination half-life of acyclovir is approximately 2 to 3 hours. Only a small amount of acyclovir is metabolized by the liver, mainly by the renal secretion in the unchanged form.
INDICATIONS: Treatment of initial and recurrent infections due to Herpes simplex virus type 1 and type 2 on skin and mucosa, meningitis due to Herpes simplex.
Treatment of acute infections of Herpes zoster, ocular shingles, pneumonia caused by Herpes zoster in adults.
Treatment of initial and recurrent infections of genital Herpes.
Haemorrhagic chickenpox, chickenpox in immunodeficiency patients and in new-born babies.
CONTRAINDICATIONS: Hypersensitivity to any components of the drug.
PRECAUTIONS:
Patients with renal impairment. Pregnant women, nursing mothers.
VIHICLE DRIVERS AND MACHINERY OPERATORS: The drug does not affect the possibility of driving vehicles 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.
Digestive: nausea, vomiting, diarrhea, colic, anorexia, gastrointestinal disorders.
Hematologic: anemia, hypoleukemia, lymphadenitis, thrombocytopenia. Thrombocytopenic purpura, haemolytic uraemic syndrome; death which was happened in patients with immunodeficiency taking high doses of acyclovir.
Central nervous: headache, dizziness, aggressive behavior. Nervous reactions or coma, tremor, hallucination, seizure have been rarely reported.
Skin: 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: Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/ ml) is exceeded in the intratubular fluid or elevated serum creatinine. Adverse events that have been also reported in association with overdosage include renal failure, excitement, anxiety, convulsion, palpitation, hypertension, and dysuria.
In the event of overdosage, the patient may benefit from hemodialysis until renal function is restored, also stop taking the drug, transfer fluid and electrolyte.
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, patients with visceral transplant 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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