GMP Certified / Acyclovir for Injection 250mg

• Customization: Available
• Quality Standard: USP, Bp
• Usage Mode: Injection
• Model NO.: injection
• Factory Certified: GMP
• Transport Package: Carton
• Specification: 250mg
• Trademark: Sinolead
• Origin: China
• Production Capacity: 100000ctns Per Month

Product Description

Generic Name	Acyclovir for Injection 250mg
Strength	250mg
Packing	10 vials /box
Origin	China

 

 

Value-added services:
 Packaging design by our team
 Registration service by our team
 Registration dossier available by our team
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Product name:
Acyclovir for Injection 250mg

Character:
 This product is white loose mass or powder.

Indications:
Acyclovir for injection is used for the following treatments: 1. Herpes simplex virus infection: for the treatment of primary and recurrent mucosal skin infections in immunocompromised persons and for the prevention of recurrent cases; It is also used in the treatment of herpes simplex encephalitis. 2. Shingles: For the treatment of severe shingles in immunodeficient patients or diffuse shingles in normal immunofunctional patients. 3. Treatment of chickenpox in immunodeficient patients.

Adverse reactions:
1. Common adverse reactions: inflammation or phlebitis at the injection site, skin itching or urticaria, rash, fever, mild headache, nausea, vomiting, diarrhea, proteinuria, elevated blood urea nitrogen and serum creatinine values, abnormal liver function such as elevated serum aminotransferase, alkaline phosphatase, lactate dehydrogenase, and total bilirubin.
2. Rare adverse reactions include acute renal insufficiency, decreased white and red blood cells, decreased hemoglobin, elevated cholesterol, triglyceride, hematuria, hypotension, hyperhidrosis, palpitation, dyspnea, chest tightness, etc.
The adverse reactions also observed after the marketing of this product are:
1. Digestive system: including gastrointestinal spasms, diarrhea, anorexia, etc.
2. Systemic hypersensitivity; Including fever, headache, angioneurotic edema, rash, peripheral swelling and so on.
3. Central nervous system: including headache, overexcitement, irritability, ataxia, coma, confusion, dizziness, vertigo, hallucinations, local paralysis, tremor, lethargy, etc.
4. Blood and lymphatic system; Including anemia, leukopenia and thrombocytopenia, lymphadenopathy, vasculitis, DIC, hemolysis and so on.
5. Liver and bile, pancreas: including hepatitis, hyperbilirubinemia, jaundice, etc.
6. Musculoskeletal system: muscle pain response.
7. Skin: alopecia, photosensitive rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrosis, rubella, erythema multiforme, etc.
8. Special sensation: abnormal vision.

Pharmacology and toxicology:
Pharmacological action
This product is a synthetic nucleoside antiviral. It can inhibit herpes simplex virus type I (HSV-1), type II (HSV-2) and varicella zoster virus (VZV) both in vivo and in vitro. The results of cell culture showed that this product had the strongest inhibitory effect on HSV-1 virus, followed by HSV-2 and VZV virus.
Due to its affinity for thymidine kinase (TK) encoded by HSV and VZV, it has highly selective inhibition. This viral enzyme converts acyclovir into acyclovir monophosphates, nucleoside analogues. The monophosphates are further converted into diphosphates by guanylate kinases in the cell, and then into triphosphates by various enzymes in the cell. In vitro, acyclovir triphosphate interrupts herpesvirus DNA replication in three ways: 1) Competitive inhibition of viral DNA polymerase; 2) Enter and terminate the extended viral DNA strand; 3) Inactivate viral DNA polymerase. Compared with VZV, this product has a stronger antiviral activity against HSV due to stronger phosphorylation of the viral thymidine kinase (TK).
Toxicological study
Genotoxicity: 16 genotoxicity tests were performed, and no mutagenicity was observed in 4 microbial studies. The results of 2 in vitro cytogenetic tests on mouse lymphoma cells and human lymphocytes showed that this product has mutagenic effect. In five in vitro cytogenetic tests (three with Chinese hamster ovarian cells and two with mouse lymphoma cells), no mutagenicity was observed. In the two in vitro cell transformation tests conducted after the administration of immunocompromised, wetted, homologous young mice, one of the results was positive, indicating the morphologic transformation of cells into tumor cells, while the same result was not seen in the other test (the reason may be that the chromosome damage did not change significantly when the sensitive multiple dose was administered). Dominant lethal tests in mice (at 36 to 73 times the human dose) were negative.
Reproductive toxicity: Mice (450mg/kg/ day, PO) and rabbits (250mg/kg/ day, SC) showed that this product had no effect on their fertility and reproductive function. The plasma drug concentration of mice and rats was 9 ~ 18 times and 8 ~ 15 times of human blood drug level, respectively. Mice and rabbits given higher doses (50mg/kg/ day, SC, 11 to 22 times and 16 to 31 times of the human level, respectively) could reduce implantation, but did not affect litter size. The mean corpus luteum, the total implantation site and the survival of the fetus were significantly decreased between the groups of rats treated with this product (50mg/kg/ day, SC) before and after delivery.
No testicular abnormalities were found when dogs were given this product (50mg/kg/ day, IV, 21 to 41 times the human dose) for 1 month (21 to 41 times the human blood concentration) or for 1 year (60mg/kg/ day, PO, 6 to 12 times the human dose). At higher doses given to rats and dogs, testicular atrophy and reduced sperm are seen.
Mice (450mg/kg/ day, PO), rabbits (50mg/kg/ day, SC or IV) and rats (50mg/kg/ day, SC) were exposed to 9 to 18, 16 to 106 and 11 to 22 times the human dose, respectively, and no teratogenic effects were observed.
There are no adequate and well-controlled studies in pregnant women, but an epidemiological study that followed 756 pregnant women with systemic medication showed a similar rate of birth defects in infants to the general population, but these data are not enough to prove that it is safe for pregnant women and fetuses. This product should only be considered if its therapeutic effect on the fetus far outweighs its risks.
Lactating women, the concentration of this product in milk is 0.6 to 4.1 times of its blood concentration. When the dosage of breastfeeding women reaches 0.3mg/kg/ day, the concentration may affect the baby, so breastfeeding women should be cautious when using, and only when necessary.
Carcinogenicity: During the whole life cycle of rats and mice, this product was given 450mg/kg/ day by tube feeding. The results showed that there was no statistically significant difference in the number of animals with tumor development between the administration group and the control group, and the incubation period of tumor development was not shortened. The maximum plasma concentrations in mice and rats were 3 to 6 times and 1 to 2 times of the human dose level, respectively.

Storage:
Keep out of light and sealed.