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 ] .
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 ] .
• 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: • 1 gram: Each 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 contain 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir.
Caution should be exercised to prevent inadvertent overdose [see , ]. 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 ] .
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 containing 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir. Bottles of 10 NDC 82804-093-10 Bottles of 14 NDC 82804-093-14 Bottles of 21 NDC 82804-093-21 Bottles of 30 NDC 82804-093-30 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.
NDC 82804-093-30 Rx only Valacyclovir Tablets, USP 1 gram 30 Tablets
| Name | UNII | Kind |
|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE | G447S0T1VC | ACTIR |
| CROSPOVIDONE (120 .MU.M) | 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 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: • 1 gram: Each 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 contain 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir.
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 ] .
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see ] . • Acute Renal Failure [see Warnings and Precautions (5.2) ] . • Central Nervous System Effects [see ] . The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride compared with placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18 years was headache.
No clinically significant drug-drug or drug-food interactions with valacyclovir hydrochloride are known [see ] .
Caution should be exercised to prevent inadvertent overdose [see , ]. 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 ] .
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 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, 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, 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 containing 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir. Bottles of 10 NDC 82804-093-10 Bottles of 14 NDC 82804-093-14 Bottles of 21 NDC 82804-093-21 Bottles of 30 NDC 82804-093-30 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.
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Importance of Adequate Hydration Patients should be advised to maintain adequate hydration. Missed Dose Instruct patients that if they miss a dose of valacyclovir hydrochloride, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose. Cold Sores (Herpes Labialis) Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). Patients should be instructed that treatment for cold sores should not exceed 1 day (2 doses) and that their doses should be taken about 12 hours apart. Patients should be informed that valacyclovir hydrochloride is not a cure for cold sores. Genital Herpes Patients should be informed that valacyclovir hydrochloride is not a cure for genital herpes. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices in combination with suppressive therapy with valacyclovir hydrochloride. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists. Valacyclovir hydrochloride has not been shown to reduce transmission of sexually transmitted infections other than HSV-2. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 1 year’s duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months’ duration in HIV-1-infected patients. Herpes Zoster There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Chickenpox Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 07/2021
Valacyclovir Tablets, USP (val’’ ay sye’ kloe vir) What are valacyclovir tablets? Valacyclovir tablets are a prescription medicine used in adults: • to treat cold sores (herpes labialis). • to treat or control genital herpes outbreaks in adults with normal immune systems. • to control genital herpes outbreaks in adults with human immunodeficiency virus-1 (HIV-1). • with safer sex practices to lower the chance of spreading genital herpes to others, in adults with normal immune systems. Even with safer sex practices, it is still possible to spread genital herpes. o Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes. o Use a condom made of latex or polyurethane whenever you have sexual contact. o Ask your healthcare provider for more information about safer sex practices. • to treat shingles (herpes zoster) in adults with normal immune systems. Valacyclovir tablets are used in children to treat: • cold sores in children 12 years of age and older. • chickenpox in children with normal immune systems 2 years of age to less than 18 years of age. Valacyclovir tablets do not cure cold sores, chickenpox, shingles, or genital herpes. • It is not known if valacyclovir tablets are safe and effective in people with weakened immune systems, other than for control of outbreaks of genital herpes in people with HIV-1. • It is not known if valacyclovir tablets are safe and effective in people 18 years of age and older with chickenpox. • It is not known if valacyclovir tablets are safe and effective in children: o less than 12 years of age with cold sores o less than 2 years of age with chickenpox o less than 18 years of age with genital herpes or shingles Do not take valacyclovir tablets if you are allergic to valacyclovir, acyclovir, or any of the ingredients in valacyclovir tablets. See the end of this leaflet for a complete list of ingredients in valacyclovir tablets. Before you take valacyclovir tablets, tell your healthcare provider about all of your medical conditions, including if you: • have had a bone marrow transplant or kidney transplant, or if you have advanced HIV-1 infection or acquired immune deficiency syndrome (AIDS). • have kidney problems, including if you receive dialysis. • are pregnant or plan to become pregnant. It is not known if valacyclovir tablets will harm your unborn baby. You and your healthcare provider will decide if you will take valacyclovir tablets if you are pregnant. • are breastfeeding or plan to breastfeed. Valacyclovir hydrochloride may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your child if you take valacyclovir tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take valacyclovir tablets? • Take valacyclovir tablets exactly as your healthcare provider tells you to take it. • Your dose of valacyclovir tablets and length of treatment will depend on the type of infection that you have and any other medical problems that you have. • Do not stop valacyclovir tablets or change your treatment without talking to your healthcare provider. • Take valacyclovir tablets with or without food. • Tell your healthcare provider if your child cannot swallow valacyclovir tablets. Your healthcare provider can prescribe valacyclovir tablets as an oral suspension for your child. • If you are taking valacyclovir tablets to treat outbreaks of cold sores, chickenpox, shingles, or genital herpes, take valacyclovir tablets as soon as you have the first symptoms of infection such as tingling, itching, or burning, or when the sore appears. • It is important for you to stay well hydrated during treatment with valacyclovir tablets. Be sure to drink plenty of fluids during this time. • If you miss a dose of valacyclovir tablets, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time or take more valacyclovir tablets than prescribed. • If you take too much valacyclovir hydrochloride, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of valacyclovir tablets? Valacyclovir tablets can cause serious side effects including: • Thrombotic Thrombocytopenic Purpura (TTP) and Hemolytic Uremic Syndrome (HUS). TTP and HUS have happened in people with weakened immune systems taking valacyclovir tablets and have led to death. TTP and HUS are disorders that can cause small blood clots to form throughout the body and decrease blood flow to body organs such as the brain, heart, and kidneys. Your healthcare provider will stop treatment with valacyclovir tablets if you have signs or symptoms of TTP and HUS. • kidney failure. • nervous system problems. Tell your healthcare provider right away if you get any of these signs or symptoms of nervous system problems during treatment with valacyclovir tablets: o aggressive behavior o unsteady movement o shaky movements o confusion o speech problems o hallucinations (seeing or hearing things that are really not there) o seizures o coma Elderly people are more likely to get certain side effects. Talk to your healthcare provider if this is a concern for you. The most common side effects of valacyclovir tablets in adults include: • headache • nausea • stomach (abdominal) pain The most common side effect of valacyclovir tablets in children less than 18 years of age is headache. These are not all the possible side effects of valacyclovir tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store valacyclovir tablets? • Store valacyclovir tablets at 20º to 25ºC (68º to 77ºF). • Store valacyclovir suspension between 2º to 8ºC (36º to 46ºF) in a refrigerator. Throw away (discard) any remaining valacyclovir suspension after 28 days. • Shake valacyclovir suspension bottle well before using. • Keep valacyclovir tablets in a tightly closed container. Keep valacyclovir tablets and all medicines out of the reach of children. General information about the safe and effective use of valacyclovir tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valacyclovir tablets for a condition for which it was not prescribed. Do not give valacyclovir tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about valacyclovir tablets that is written for health professionals. What are the ingredients in valacyclovir tablets? Active ingredient: valacyclovir hydrochloride Inactive ingredients: crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. This Patient Information has been approved by the U.S. Food and Drug Administration. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 07/2021
NDC 82804-093-30 Rx only Valacyclovir Tablets, USP 1 gram 30 Tablets
Official SPL XML cached by FDA.report · DailyMed PDF
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