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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

VALTREX Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

GlaxoSmithKline LLC

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1. Indications and Usage

1.1 Adult Patients Cold Sores (Herpes Labialis) VALTREX is indicated for treatment of cold sores (herpes labialis). The efficacy of VALTREX initiated after the development of clinical signs of a cold sore ...

2. Dosage and Administration

VALTREX may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg VALTREX tablets for use in pediatric patients for whom a solid ...

3. Dosage Forms and Strengths

<b>Tablets:</b> 500-mg: Each blue, film‑coated, capsule‑shaped tablet printed with VALTREX 500 mg contains 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg of the free base. 1-gram: Each blue, ...

4. Contraindications

VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation ...

5. Warnings and Precautions

5.1 Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS) TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV-1 disease and also in allogeneic bone marrow ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome <em>[see Warnings and Precautions ...

6.3. Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of VALTREX. Because they are reported voluntarily from a population of unknown ...

7. Drug Interactions

No clinically significant drug-drug or drug-food interactions with VALTREX are known <em>[see Clinical Pharmacology (12.3)]</em>.

8.1. Pregnancy

Risk Summary Clinical data over several decades with valacyclovir and its metabolite, acyclovir, in pregnant women, have not identified a drug associated risk of major birth defects. There are insufficient ...

8.2. Lactation

Risk Summary Although there is no information on the presence of valacyclovir in human milk, its metabolite, acyclovir, is present in human milk following oral administration of valacyclovir. Based on ...

8.4. Pediatric Use

VALTREX is indicated for treatment of cold sores in pediatric patients aged greater than or equal to 12 years and for treatment of chickenpox in pediatric patients aged 2 to less than 18 years <em>[see ...

8.5. Geriatric Use

Of the total number of subjects in clinical trials of VALTREX, 906 were 65 and over, and 352 were 75 and over. In a clinical trial of herpes zoster, the duration of pain after healing (post-herpetic neuralgia) ...

8.6. Renal Impairment

Dosage reduction is recommended when administering VALTREX to patients with renal impairment <em>[see Dosage and Administration (2.4), Warnings and Precautions (5.2, 5.3)]</em>.

10. Overdosage

Caution should be exercised to prevent inadvertent overdose <em>[see Use in Specific Populations (8.5, 8.6)]</em>. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) ...

11. Description

Valtrex (valacyclovir hydrochloride) is the hydrochloride salt of the <em>L</em>‑valyl ester of the antiviral drug acyclovir. VALTREX tablets are for oral administration. Each tablet contains 556.2 mg ...

12.1. Mechanism of Action

Valacyclovir is an antiviral drug active against α-herpes viruses <em>[see Microbiology (12.4)]</em>.

12.3. Pharmacokinetics

The pharmacokinetics of valacyclovir and acyclovir after oral administration of VALTREX have been investigated in 14 volunteer trials involving 283 adults and in 3 trials involving 112 pediatric subjects ...

12.4. Microbiology

Mechanism of Action Valacyclovir is a deoxynucleoside analogue DNA polymerase inhibitor. Valacyclovir hydrochloride is rapidly converted to acyclovir, which has demonstrated antiviral activity against ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

The data presented below include references to the steady‑state acyclovir AUC observed in humans treated with 1 gram of VALTREX given orally 3 times a day to treat herpes zoster. Plasma drug concentrations ...

14. Clinical Studies

14.1 Cold Sores (Herpes Labialis) Two double‑blind, placebo‑controlled clinical trials were conducted in 1,856 healthy adults and adolescents (aged greater than or equal to 12 years) with a history of ...

16.1. How Supplied

VALTREX tablets (blue, film‑coated, capsule‑shaped tablets printed with VALTREX 500 mg) containing 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg valacyclovir. Bottle of 30 (NDC 0173-0933-08). ...

16.2. Storage and Handling

Store at 15° to 25°C (59° to 77°F). Dispense in a well-closed container as defined in the USP.

17. Patient Counseling Information

<em>Advise the patient to read the FDA-approved patient labeling (Patient Information).</em> Importance of Adequate Hydration Patients should be advised to maintain adequate hydration. Missed Dose Instruct ...