[Name of drug]

Acyclovir Capsules

Chinese Name:阿昔洛韦胶囊

Commodity name: Shaweiluo

Chinese Pinyin: Axiluowei Jiaonang

[Ingredients] Acyclovir

Chemical name: 9- (2- hydroxymethyl) guanine

Chemical formula:

Molecular formula: C8H11N5O3

Molecular weight: 225.21

[Character] The content of this product is white to white powder.

[Indications]

1. Herpes simplex virus infection: for the initial and recurrent cases of genital herpes virus infection, oral prophylaxis is used for recurrent attacks.
2. Herpes zoster: oral treatment for patients with normal immune function, herpes zoster and immune deficiency of mild cases of treatment.
3. Treatment of varicella in 3. immunodeficiency patients.

[Specification] 0.2g/ granule

[Usage and Dosage]

1. Initial treatment of genital herpes and immunodeficiency are mucocutaneous herpes simplex: the amount of adults used a 0.2g (1 tablets), 5 times a day, a total of 10 days; or a 0.4g (2 tablets), 3 times a day, a total of 5 days; a recurrence of 0.2g infection (1 grains), 1 5 times, a total of 5 days; chronic suppressive therapy of recurrent infections, a 0.2g (1 tablets), 3 times a day, a total of 6 months, when necessary dose may be increased to 5 times a day, a 0.2g (1 tablets), a total of 6-12 months.
2. Shingles: adults often take 0.8g (4 pills) once a day, 5 times a day, for 7~10 days.
3. Adult patients with renal dysfunction should adjust the dose by pressing the table:

                                           Creatinine clearance rate (ml/ minutes) (ml/ seconds)         dose (g)        interval (hour)

Genital herpes
Initial or intermittent therapy
                                                                                     >10 (0.17)                                      0.2             4 (5 times per day)
                                                                                      0-10 (0 to 0.17)                             0.2                     12
Chronic suppression therapy
                                                                                     >10 (0.17)                                      0.4                     12
                                                                                      0-10 (0 to 0.17)                             0.2                     12
Zoster
                                                                                     >25 (0.42)                                      0.8             4 (5 times per day)
                                                                                     10-25 (0.17 to 0.42)                       0.8                      8
                                                                                     0-10 (0 to 0.17)                              0.8                     12

4. Varicella: children over 2 years old, according to weight 20mg/kg, 4 times a day, a total of 5 days, symptoms, immediately began treatment. More than 40kg of children and adults commonly used once a 0.8g (4 tablets), 4 times a day, a total of 5 days.

[Adverse Effects] Occasionally dizziness, headache, joint pain, nausea, vomiting, diarrhea, stomach discomfort, loss of appetite, thirst, leukopenia, proteinuria and blood urea nitrogen increased, skin itching, long term administration of occasional acne, insomnia, menstrual disorders.

[Contraindicated] Anyone who is allergic to any ingredient in this product is prohibited.

[Matters Needing Attention]

1. Allergic to ganciclovir may also be allergic to this product.
2. Dehydration or liver or kidney dysfunction should be used with caution.
3. Patients with severe immune function defects may cause herpes simplex virus and herpes zoster virus resistance to this product after long-term or repeated use of this product. If herpes simplex is not improved in patients with herpes simplex, the sensitivity of the herpes simplex virus to the product should be tested.
4. Follow up examination: most patients with genital herpes are susceptible to cervical cancer, so patients should be examined at least once a year for early detection.
5. Once the symptoms and signs of herpes appear, should be given as soon as possible.
6. The influence of food intake on serum concentration is not obvious. However, sufficient water should be given to the patient during the period of administration so as to prevent the deposit of the product in the renal tubule.
7. Genital recurrent herpes infection is effective by intermittent short range therapy. Since animal experiments have found the effect of this product on fertility and mutagenicity, oral dosage and course of treatment should not exceed the recommended standards. Long range therapy for genital herpes should not last more than 6 months.
8. Hemodialysis reduces blood concentration by 60% and should be given a dose after hemodialysis.
9. This product has no obvious effect on the latent infection and recurrence of herpes simplex virus. It can not eradicate virus.

[Medication for Pregnant Women and Lactating Women] Drugs through the placenta, although animal experiments confirmed that no effect on embryos, but the use of pregnant women still need to weigh the pros and cons. The concentration of the drug in the milk is 0.6 to 4.1 times of the concentration of the blood, although the abnormality of the baby is not found, the lactating women should be used with caution.

[Child Medication] The dose of children under 2 years of age has not been determined.

[Senile Medication] Due to the decline of physiological renal function, the dosage and interval need to be adjusted.

[Drug Interactions]

1. Combined with Zidorf (Zidovudine) can cause nephrotoxicity and show deep lethargy and fatigue.
2. With probenecid competitively inhibit the secretion of organic acids, combined with probenecid can make the product excretion slowed down, the half-life and the amount of drug accumulation in vivo.

[Overdose] Symptomatic treatment and supportive treatment should be used to give adequate water and blood to help excrete the blood.

[Pharmacology and Toxicology]

Antiviral agents. It has inhibitory effects on herpes simplex virus, varicella zoster virus and giant cell virus in vitro. This product into the herpes virus infected cells, and deoxyriboside competition virus thymidine kinase or cellular kinases phosphorylate activated by drugs, acyclovir three phosphate, and then through two ways: the inhibition of virus replication interference virus DNA polymerase, inhibits the replication of virus; DNA polymerase II in the role, combined with the growth of DNA chain extension of DNA chain disruptions caused by. This product has a special affinity for viruses, but it has low cytotoxicity to mammalian host cells. In vitro cell transformation assay is carcinogenic, but there is no evidence of carcinogenicity in animal studies. Some animal studies have shown that high levels of drugs can cause mutations, but there is no evidence for chromosomal changes. The carcinogenic and mutagenic effects of this product are not clear. A large dose of injection may cause atrophy of the testis and decrease in sperm count. The drug can pass through the placenta, and animal experiments have shown no effect on the embryo.

[Pharmacokinetics]

Oral absorption is poor, about 15% to 30% absorbed by the gastrointestinal tract. The influence of food intake on serum concentration is not obvious. It can be widely distributed in tissues and body fluids, including brain, kidney, lung, liver, small intestine, muscle, spleen, milk, uterus, vagina, mucous membrane and secretions, cerebrospinal fluid and herpes fluid. In the kidney, liver, and small intestine, the concentration is high, and the concentration in the cerebrospinal fluid is about half of the concentration in the blood. Drugs can pass through the placenta. 200mg and 400mg were taken every 4 hours, and the peak concentration of serum (Cmax) after 5 days was 0.6mg/L and 1.2mg/L, respectively. The protein binding rate of this product is low (9% ~ 33%). In the liver metabolism, the main metabolic Wuzhan dosage of 9% ~ 14%, the urinary excretion. The blood elimination half-life (T1/2 beta) is about 2.5 hours. When the creatinine clearance rate was 50 to 80ml/ minutes and 15 to 50ml/ minutes, the blood elimination half-life (T1/2, beta) was 3 hours and 3.5 hours respectively. The blood elimination half-life (T1/2 beta) was 19.5 hours in the urine and decreased to 5.7 hours during hemodialysis. This product is mainly excreted by glomerular filtration and renal tubular secretion, and approximately 14% of the drugs are excreted by urine and excreted less than 2% by fecal excretion, containing trace amounts of drugs in exhaled air. 6 weeks of hemodialysis, about 60% of the blood is removed. Peritoneal dialysis has little clearance.

[Storage] Sealed storage.

[Packing] Aluminum plastic packing, 10 tablets / plate * 1 plates / boxes.

[Validity]  24 months.

[Implementation Criteria] Chinese Pharmacopoeia, 2010 edition, two parts

[Approval Number] SFDA approval number H10940158

[Production Enterprise]

Name of enterprise: Zhejiang Chengyi Pharmaceutical Co., Ltd

Production address: No. 118, Chemical Road, Dongtou District, Wenzhou city,Zhejiang province,China

Phone number: 86-577-6348-3979

Fax number: 86-577-6348-5135

URL:http://en.chengyipharma.com