Valaciclovir Hydrochloride Tablets Is Suitable for The Treatment of Herpes Zoster

• Transport Package: Box
• Specification: 0.3g*6tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC110
• Production Capacity: 10000PCS/ Month

Product Description

Item Name:valaciclovir hydrochloride tablets
Molecular formula:C₁₃H₂₀N₆O₄·HCl

Item Description

Item nanme: valaciclovir hydrochloride tablets
Item character: This product is white.

Indication:
This product is suitable for the treatment of herpes zoster.
This product is suitable for the treatment of herpes simplex virus infection.
This product is suitable for preventing (inhibiting) the recurrence of herpes simplex virus infection.

Item specifications:  0.3g*6tab/box

Usage and dosage: adult
Herpes zoster treatment: take 500mg of this product, 2 tablets, 3 times a day, 7 days of treatment. Herpes simplex treatment: take 500mg of this product orally, twice a day. The first onset may be more serious, and the course of treatment needs to be extended to 10 days. For recurrent infections, the treatment course should be 5 days. It is suggested that treatment should be started in the pre-onset symptom period or when symptoms and signs appear.
Treatment of herpes simplex virus infection (inhibition):
For patients with normal immune function, take 500 mg of the product orally once a day.
For patients with frequent recurrence (10 times a year), the 250mg twice a day was better.
For immunodeficient patients, the drug regimen was 500 mg twice a day.
Renal function damage
For patients with obvious impairment of renal function, the dosage of this product shall be adjusted in the following ways:
Renal function (dose adjustment of creatinine
Clearance rate ml / min)
Herpes zoster
Treatment and Prevention
Normal immune deficiency of immune function
15-30 1000mg twice a day without adjustment no adjustment
< 15 1000mg once a day 500mg once a day 250mg once a day 500mg once a day
For hemodialysis patients, the dosage of this product should be in accordance with the recommended dose of patients with creatinine clearance rate less than 15ml/min, but should be given after hemodialysis.
Liver function damage
In patients with mild to moderate cirrhosis (liver synthesis function can be maintained), no need to adjust the dosage of this product.
Pharmacokinetic data of patients with advanced cirrhosis (liver synthesis function is damaged and portal vein system shunt) suggest that drug dose need not be adjusted, but clinical experience in this field is limited.

Adverse reactions
According to MedDRA human organ classification and occurrence frequency, adverse reactions were classified as follows.
The frequency classification criteria are as follows:
Very common: (≥ 10%),
Common (≥ 1%, < 10%),
Not common (≥ 0.1%, < 1%),
Rare (≥ 0.01%, < 0.1%),
Very rare (< 0.01%).
The adverse reactions in the clinical trial data were classified according to the above frequency criteria, and the trial data proved that the adverse reactions were related to this product (i.e. there was a statistically significant difference in the incidence of adverse reactions between patients treated with this product and placebo). The frequency of all other adverse events was allocated according to the self reported post marketing data.
Clinical trial data
nervous system
Common: headache.
gastrointestinal tract
Common: nausea.
Post market data
Blood and lymphatic system
Very rare: leukopenia, thrombocytopenia.
Leukopenia mainly occurs in patients with immune deficiency.
immune system
Very rare: allergic reactions.
Mind and nervous system
Rare: vertigo, blurred consciousness, hallucination, loss of consciousness.
Very rare: excitement, tremor, ataxia, dysarthria, psychotic symptoms, convulsions, encephalopathy, coma.
The above adverse reactions are generally reversible, usually seen in patients with renal dysfunction or other predisposing factors. The incidence of neurological reaction in organ transplant patients receiving high-dose valaciclovir hydrochloride for prevention of CMV was higher than that in low-dose group.
respiratory system
Uncommon: dyspnea.
gastrointestinal tract
Rare: abdominal discomfort, vomiting, diarrhea.
liver
Very rare: reversible increase of liver function test.
Hepatitis is occasionally described.
Skin and connective tissue
Uncommon: rashes include photosensitive reactions.
Rare: itching.
Very rare: rubella, angioedema.
Kidney and urinary system
Rare: renal function damage.
Very rare: acute renal failure, kidney pain.
Renal pain may be related to renal failure.
Others: in extended clinical trials, patients with severe immunosuppression, especially those with advanced HIV infection, took large doses (8g daily) of valaciclovir, and there were reports of renal insufficiency, capillary hemolytic anemia and thrombocytopenia (sometimes both exist). This was also seen in patients with the same underlying diseases or complications but not treated with valaciclovir.

Taboo:
This product is banned from patients with allergy to valaciclovir, acyclovir or any other ingredient in this product.

Matters needing attention:
Humoral state
Special attention should be paid to ensure that patients (especially elderly patients) take enough water to prevent dehydration.
Patients with renal damage:
The dosage of valaciclovir should be adjusted in patients with obvious renal damage (see [usage and dosage]). Patients with a history of renal function changes have a higher risk of neurological adverse reactions (see [adverse reactions]).
Influence on driving and mechanical operation ability
No special precautions.


Medication for pregnant and lactating women:
gestation
The information of pregnant patients using this product is limited. Pregnant women can only use it when the expected curative effect of treatment obviously exceeds the risk.
The existing research data of pregnant women exposed to acyclovir (the active metabolite of valaciclovir) show that the incidence of fetal birth defects does not increase compared with the incidence of fetal birth defects in the general population. The reported fetal defects have no special commonality, which can not explain that they have a common cause. However, due to the limited records and data on the use of valaciclovir, it is not possible to draw a clear conclusion on the safety and reliability of valaciclovir during pregnancy.
After 1000 mg and 3000 mg of acyclovir, the daily AUC was 2-4 times higher than that of acyclovir 1000 mg / day.
lactation
The main metabolite of valaciclovir in milk is acyclovir. The concentration of acyclovir detected in milk was 0.6-4.1 times of that in plasma. It is estimated that oral administration of acyclovir (suweile) ®) The mean steady-state plasma peak concentration (Cmax) was 3.1 μ M(0.7 μ g/ml). This is equivalent to exposing the infant to approximately 0.3 mg / day of acyclovir. The clearance half-life of acyclovir in milk was 2.8 hours, similar to that in plasma. Therefore, when this product is used for breast-feeding women, special care should be taken. However, the intravenous dose of acyclovir in the treatment of neonatal herpes simplex is 30mg / kg / day.

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Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

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At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.




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