Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)].
Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)].
Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3) ] .
Tablets: 500 mg: blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside. 1 gram: blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing “F” on one side and “8” and “3” on the otherside.
Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5) , (8.6) ] . Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4) ] .
Valacyclovir Tablets USP, 500 mg are blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside. Bottles of 30 NDC 65862-448-30 Bottles of 90 NDC 65862-448-90 Bottles of 100 NDC 65862-448-01 Bottles of 500 NDC 65862-448-05 Bottles of 3,500 NDC 65862-448-35 10 x 10 Unit-dose Tablets NDC 65862-448-10 Valacyclovir Tablets USP, 1 gram are blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing “F” on one side and “8” and “3” on the otherside. Bottles of 30 NDC 65862-449-30 Bottles of 90 NDC 65862-449-90 Bottles of 100 NDC 65862-449-01 Bottles of 500 NDC 65862-449-05 Bottles of 1,500 NDC 65862-449-15 Store at 20 o to 25 o C (68 o to 77 o F). [See USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP.
| Name | UNII | Kind |
|---|---|---|
| CROSPOVIDONE (15 MPA.S AT 5%) | 68401960MK | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE K90 | RDH86HJV5Z | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| VALACYCLOVIR HYDROCHLORIDE | G447S0T1VC | ACTIR |
Warnings and Precautions, Central Nervous System Effects (5.3) 3/2010
Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3) ] .
Tablets: 500 mg: blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside. 1 gram: blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing “F” on one side and “8” and “3” on the otherside.
Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)].
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1)]. Acute Renal Failure [see Warnings and Precautions (5.2)]. Central Nervous System Effects [see Warnings and Precautions (5.3)]. The most common adverse reactions reported in at least 1 indication by >10% of adult patients treated with valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride compared to placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in >10% of pediatric patients
No clinically significant drug-drug or drug-food interactions with valacyclovir hydrochloride are known [see Clinical Pharmacology (12.3) ] .
Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5) , (8.6) ] . Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4) ] .
Valacyclovir hydrochloride is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L -valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H -purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula: Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13 H 20 N 6 O 4 •HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk a s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
Valacyclovir Tablets USP, 500 mg are blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside. Bottles of 30 NDC 65862-448-30 Bottles of 90 NDC 65862-448-90 Bottles of 100 NDC 65862-448-01 Bottles of 500 NDC 65862-448-05 Bottles of 3,500 NDC 65862-448-35 10 x 10 Unit-dose Tablets NDC 65862-448-10 Valacyclovir Tablets USP, 1 gram are blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing “F” on one side and “8” and “3” on the otherside. Bottles of 30 NDC 65862-449-30 Bottles of 90 NDC 65862-449-90 Bottles of 100 NDC 65862-449-01 Bottles of 500 NDC 65862-449-05 Bottles of 1,500 NDC 65862-449-15 Store at 20 o to 25 o C (68 o to 77 o F). [See USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP.
See FDA-Approved Patient Labeling .
Valacyclovir Tablets, USP (val'' ay sye' kloe vir) Read the Patient Information that comes with valacyclovir tablets before you start using them and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Ask your healthcare provider or pharmacist if you have questions. What are valacyclovir tablets? Valacyclovir tablets are a prescription antiviral medicine. Valacyclovir tablets lower the ability of herpes viruses to multiply in your body. Valacyclovir tablets are used in adults: to treat cold sores (also called fever blisters or herpes labialis) to treat shingles (also called herpes zoster) to treat or control genital herpes outbreaks in adults with normal immune systems to control genital herpes outbreaks in adults infected with the human immunodeficiency virus (HIV) with CD4+ cell count greater than 100 cells/mm 3 with safer sex practices to lower the chances of spreading genital herpes to others. Even with safer sex practices, it is still possible to spread genital herpes. Valacyclovir tablets used daily with the following safer sex practices can lower the chances of passing genital herpes to your partner. Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes. Use a condom made of latex or polyurethane whenever you have sexual contact. Valacyclovir tablets are used in children: to treat cold sores (for children > 12 years of age) to treat chickenpox (for children 2 to
Official SPL XML cached by FDA.report · DailyMed PDF
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| prescription | 962772f1-a698-4956-e053-2a95a90a9a28.xml | 2019-10-31 |
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| prescription | valacyclovir-str.jpg | 2019-10-31 |