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Famciclovir capsule

Product description
Approved date: March 16, 2007
 
Date of revision: October 1, 2010
 
         November 30, 2015
 
Famciclovir capsule instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Generic name: famciclovir capsule
 
Product Name: Bixin
 
English name: Famciclovir Capsules
 
Pinyin: Fanxiluowei Jiaonang
 
[Ingredients] The main ingredient of this product is famciclovir. The chemical name is: 2-[2-[9-(2-amino-9H-indenyl)]ethyl]-1,3-propanediol diacetate.
 
 
 
 
 
 
 
Molecular formula: C14H19N5O4
 
Molecular weight: 321.34
 
【Properties】 This product is a capsule, and the content is white or off-white powder.
 
[Indications] For herpes zoster and primary genital herpes.
 
[Specification] 0.125g
 
[Usage and Dosage] Oral, 0.25g (2 capsules) per adult, 3 times a day for 7 days. Patients with renal insufficiency should adjust their usage and dosage according to renal function. The recommended dose is as follows:
 
        Creatinine clearance
 
        ≥60ml/min Adult 0.25g (2 capsules) every 8 hours
 
        40~59ml/min Adult 0.25g (2 capsules) every 12 hours
 
        20~39ml/min Adult 0.25g (2 capsules) every 24 hours
 
<20ml/min Adult 0.125g (1 capsule) each time, every 48 hours
 
Hepatic patients with liver function compensation do not need to adjust the dose, and pharmacokinetic studies have not been performed on liver disease patients with decompensated liver function.
 
【Adverse reactions】
 
Common side effects are headache and nausea, in addition to the following reactions:
 
1. Nervous system: dizziness, insomnia, lethargy, paresthesia, etc.;
 
2. Digestive system: diarrhea, abdominal pain, indigestion, anorexia, vomiting, constipation, flatulence, etc.;
 
3. Systemic reactions: fatigue, pain, fever, chills, etc.;
 
4. Other reactions: rash, itchy skin, sinusitis, pharyngitis, etc.
 
[Contraindications] Disabled for allergic to famciclovir.
 
【Precautions】
 
    1. The efficacy of famciclovir in preventing recurrence of genital herpes, ocular herpes zoster, disseminated herpes zoster and herpes in immunocompromised patients has not been confirmed.
 
2. Patients with renal insufficiency should pay attention to adjusting usage and dosage.
 
3. When this product is combined with probenecid or other drugs that are actively excreted by the renal tubules, it may cause an increase in the concentration of penciclovir in the plasma.
 
4. This product may interact with other drugs catalyzed by aldehyde oxidase.
 
[Pregnant women and lactating women] This product is generally not recommended for pregnant women and lactating women. If you use this product, you should confirm that the benefit to the fetus or the baby after using this product outweighs the disadvantages.
 
[Children's medication] The safety and efficacy of famciclovir in children is still to be determined, so children are not recommended.
 
[Geriatric Use] Unless there is renal insufficiency, the dose can be unchanged.
 
[Drug interactions] No obvious pharmacological interactions were found clinically. Probenecid and other drugs that affect kidney physiology can also affect the blood concentration of penciclovir.
 
[Drug overdose] There is no report of acute overdose of famciclovir. If it occurs, the corresponding symptom and supportive treatment should be given. In the plasma, penciclovir can be removed by hemodialysis, and after 4 hours of hemodialysis, the plasma concentration can be reduced by 75%.
 
[Pharmacology and Toxicology] This product is rapidly transformed into the antiviral activity of penciclovir in the body, the latter for herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2) and varicella Herpes simplex virus (VZV) has an inhibitory effect. The mechanism of action is as follows: In cells infected with the above virus, viral thymidine kinase phosphorylates penciclovir to penciclovir monophosphate, which in turn is converted to penciclovir triphosphate by cellular kinase. In vitro studies have shown that penciclovir triphosphate inhibits the activity of HSV-2 polymerase by competing with guanosine triphosphate to selectively inhibit the synthesis and replication of herpesvirus DNA.
 
In cell culture studies, penciclovir inhibited the following viruses (in order of strength): HSV-1, HSV-2, VZV.
 
The sensitivity of the virus to penciclovir is associated with a variety of factors. The qualitative change of viral thymidine kinase or DNA polymerase can lead to the production of penciclovir resistant mutant strains by HSV or VZV. It is common for acyclovir-resistant mutants to be resistant to penciclovir due to the lack of viral thymidine kinase. If the patient's clinical efficacy is poor, the virus may be considered to be resistant to penciclovir.
 
【Pharmacokinetics】
 
Famciclovir is a diacetyl-6-deoxy analog of penciclovir that is rapidly deacetylated and oxidized to active penciclovir after oral absorption in the intestinal wall. The results of oral administration of famciclovir 500mg and intravenous penciclovir 400mg in 12 healthy male volunteers showed that the absolute bioavailability of famciclovir was 77±8%, and 12 male volunteers received intravenous injection of penciclovir 400mg. The penciclovir elimination volume was 125±21.3L, and the steady-state volume was 85.3±10.8L. When the plasma concentration is in the range of 0.1 to 20 mg/ml, the plasma protein binding rate of penciclovir is less than 20%, and the whole blood/plasma distribution ratio is close to 1.
 
According to foreign literature reports, the peak concentration of penciclovir obtained from oral administration of famciclovir 500mg in 124 healthy male volunteers was 3.3±0.8mg/ml, the peak time was 0.9±0.5h, and the area under the blood concentration-time curve was At 8.6 ± 1.9 mg·h/ml, the plasma elimination half-life was 2.3 ± 0.4 h.
 
Food had no significant effect on bioavailability. Oral famciclovir 500 mg, 3 times a day for 7 consecutive days, showed no accumulation of penciclovir.
 
Famciclovir is administered orally in vivo via aldehyde oxidase to penciclovir, and the inactive metabolites are 6-deoxycycloviroxivir, monoacetyl penciclovir and 6-deoxyacetyl pencilolol. Wei et al, each less than 0.5% of the dose, almost no detectable famciclovir in blood and urine.
 
Famciclovir is mainly excreted in the form of penciclovir and 6-deoxycyclovir.
 
The apparent plasma clearance, renal clearance, and plasma clearance rate constant of penciclovir in patients with renal insufficiency decreased with decreasing renal function.
 
The results of the pharmacological study of famciclovir in China are basically consistent with the results of foreign studies.
 
[Storage] Sealed (10 ~ 30 ° C) for storage.
 
[Packing] Aluminum-plastic packaging, 6 capsules per box; 8 capsules per box; 12 capsules per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H20020184
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
             400-8899-328 (National Service Phone)
 
Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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