Friday, 13 April 2012

quetiapine



kwe-TYE-a-peen FUE-ma-rate


Oral route(Tablet;Tablet, Extended Release)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death were varied in clinical trials, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Regular strength tablets not approved for use in patients under 10 years of age ; extended-release tablets not approved for use in patients under 18 years of age .



Commonly used brand name(s)

In the U.S.


  • Seroquel

  • Seroquel XR

Available Dosage Forms:


  • Tablet

  • Tablet, Extended Release

Therapeutic Class: Antipsychotic


Chemical Class: Quetiapine


Uses For quetiapine


Quetiapine is used to treat nervous, emotional, and mental conditions (e.g., schizophrenia). It may be used alone or together with other medicines (e.g., lithium or divalproex) to treat symptoms of bipolar disorder (manic-depressive illness) or mania that is part of bipolar disorder. quetiapine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.


Quetiapine extended-release tablets is also used together with other medicines to treat major depressive disorder (MDD) in adults.


quetiapine is available only with your doctor's prescription.


Before Using quetiapine


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For quetiapine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to quetiapine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of quetiapine tablets in children with schizophrenia younger than 13 years of age, in children with bipolar mania younger than 10 years of age, and in children with bipolar depression younger than 18 years of age. Safety and efficacy have not been established in these age groups.


Appropriate studies have not been performed on the relationship of age to the effects of quetiapine extended-release tablets in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of quetiapine in the elderly. However, elderly patients are more likely to have dementia or age-related heart, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving quetiapine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking quetiapine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using quetiapine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Bepridil

  • Cisapride

  • Dronedarone

  • Fluconazole

  • Mesoridazine

  • Metoclopramide

  • Pimozide

  • Posaconazole

  • Terfenadine

  • Thioridazine

Using quetiapine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acecainide

  • Ajmaline

  • Alfuzosin

  • Amiodarone

  • Amitriptyline

  • Amobarbital

  • Amoxapine

  • Apomorphine

  • Aprindine

  • Aprobarbital

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Azimilide

  • Azithromycin

  • Betamethasone

  • Bretylium

  • Butabarbital

  • Butalbital

  • Chloral Hydrate

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Clozapine

  • Cortisone

  • Crizotinib

  • Dasatinib

  • Deflazacort

  • Desipramine

  • Dexamethasone

  • Dibenzepin

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Doxepin

  • Droperidol

  • Encainide

  • Enflurane

  • Erythromycin

  • Eterobarb

  • Flecainide

  • Fluoxetine

  • Foscarnet

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Halothane

  • Hydrocortisone

  • Hydromorphone

  • Hydroquinidine

  • Ibutilide

  • Iloperidone

  • Imipramine

  • Isoflurane

  • Isradipine

  • Lapatinib

  • Levofloxacin

  • Lidoflazine

  • Lorcainide

  • Lumefantrine

  • Mefloquine

  • Mephobarbital

  • Methadone

  • Methohexital

  • Methylprednisolone

  • Milnacipran

  • Moxifloxacin

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Paliperidone

  • Paramethasone

  • Pazopanib

  • Pentamidine

  • Pentobarbital

  • Perflutren Lipid Microsphere

  • Phenobarbital

  • Pirmenol

  • Prajmaline

  • Prednisolone

  • Prednisone

  • Primidone

  • Probucol

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quinidine

  • Quinine

  • Ranolazine

  • Rifampin

  • Risperidone

  • Salmeterol

  • Secobarbital

  • Sematilide

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Sparfloxacin

  • Spiramycin

  • Sulfamethoxazole

  • Sunitinib

  • Tedisamil

  • Telavancin

  • Telithromycin

  • Tetrabenazine

  • Thiopental

  • Toremifene

  • Trazodone

  • Triamcinolone

  • Trifluoperazine

  • Trimethoprim

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vasopressin

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

  • Zolmitriptan

Using quetiapine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Fosphenytoin

  • Ketoconazole

  • Phenytoin

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using quetiapine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use quetiapine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of quetiapine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood vessel or circulation problems or

  • Dehydration or

  • Heart attack or stroke, history of or

  • Heart disease (e.g., heart hypertrophy) or

  • Heart failure or

  • Heart rhythm problems (e.g., QT prolongation), or

  • Hypotension (low blood pressure) or

  • Hypovolemia (low blood volume)—May cause side effects to become worse.

  • Bradycardia (slow heartbeat), history of or

  • Heart rhythm problem (e.g., congenital long QT interval) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood)—May increase risk for more serious side effects.

  • Breast cancer, prolactin dependent or

  • Cataracts or

  • Hyperlipidemia (high blood cholesterol or fats) or

  • Hyperprolactinemia (high prolactin in the blood) or

  • Hypertension (high blood pressure) or

  • Hypothyroidism (underactive thyroid) or

  • Liver disease or

  • Seizures, history of or

  • Trouble with swallowing—Use with caution. May make these conditions worse.

  • Diabetes or

  • Hyperglycemia—quetiapine may raise your blood sugar levels.

Proper Use of quetiapine


Take quetiapine exactly as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


quetiapine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.


Quetiapine tablets may be taken with or without food on a full or empty stomach. However, if your doctor tells you to take it a certain way, take it as directed.


Swallow the extended-release tablets whole. Do not break, crush, or chew it. It is best to take quetiapine without food or with a light meal (approximately 300 calories).


Dosing


The dose of quetiapine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of quetiapine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (extended-release tablets):
    • For treatment of depression with bipolar disorder:
      • Adults—At first, 50 milligrams (mg) once per day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.

      • Children—Use and dose must be determined by the doctor.


    • For treatment of mania with bipolar disorder:
      • Adults—At first, 300 milligrams (mg) once per day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.

      • Children—Use and dose must be determined by the doctor.


    • For treatment of major depressive disorder (MDD):
      • Adults—At first, 50 milligrams (mg) once per day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.

      • Children—Use and dose must be determined by the doctor.


    • For treatment of schizophrenia:
      • Adults—At first, 300 milligrams (mg) once per day in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.

      • Children—Use and dose must be determined by the doctor.



  • For oral dosage form (tablets):
    • For treatment of depression with bipolar disorder:
      • Adults—At first, 50 milligrams (mg) once per day at bedtime. The dose is usually increased daily to reach 300 mg per day on the fourth day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.

      • Children—Use and dose must be determined by the doctor. .


    • For treatment of mania with bipolar disorder:
      • Adults—At first, 100 milligrams (mg) per day, given in two equally divided doses. The dose is usually increased to 400 mg per day, which is divided and given in two doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.

      • Children 10 to 17 years of age—At first, 25 milligrams (mg) two times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 600 mg per day.

      • Children younger than 10 years of age—Use and dose must be determined by the doctor.


    • For treatment of schizophrenia:
      • Adults—At first, 25 milligrams (mg) two times per day. The dose is usually increased to 300 to 400 mg per day, which is divided and given in two or three doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.

      • Teenagers 13 to 17 years of age—At first, 25 milligrams (mg) two times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 800 mg per day.

      • Children younger than 13 years of age—Use and dose must be determined by the doctor.



Missed Dose


If you miss a dose of quetiapine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using quetiapine


It is very important that your doctor should check the progress of you or your child at regular visits to make sure quetiapine is working properly. Blood tests may be needed to check for unwanted effects. You may also need to have your or your child's eyes tested on a regular basis.


quetiapine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using quetiapine.


For some patients, quetiapine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.


Quetiapine may cause drowsiness, trouble with thinking, or trouble with your vision (especially during the first week of use). Make sure you know how you react to quetiapine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.


quetiapine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. If you or your child have diabetes, you may notice a change in the results of your urine or blood sugar tests. Check your blood sugar closely and talk with your doctor if you have any questions.


Check with your doctor right away if you or your child are having convulsions (seizures); difficulty with breathing; a fast heartbeat; high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).


Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.


Quetiapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

  • Check with your doctor immediately if you or your child notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

quetiapine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you or your child have any of the following symptoms while taking quetiapine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.


Quetiapine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.


quetiapine may increase your weight. Your doctor may need to check your or your child's weight on a regular basis while you are using quetiapine.


You will need to have your blood pressure measured before starting quetiapine and while you or your child are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.


quetiapine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.


Quetiapine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you or your child are too hot and can not cool down.


Do not suddenly stop taking your quetiapine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This is to decrease the chance of having symptoms such as nausea, sleeplessness, trouble in sleeping, unable to sleep, or vomiting.


Before you have any medical tests, tell the medical doctor in charge that you are taking quetiapine. The results of some tests (e.g., urine drug screens) may be affected by quetiapine.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


quetiapine Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Chills

  • cold sweats

  • confusion

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • sleepiness or unusual drowsiness

Less common
  • Black, tarry stools

  • blurred vision

  • changes in patterns and rhythms of speech

  • chest pain

  • cough

  • difficulty with swallowing

  • drooling

  • fever, muscle aches, or sore throat

  • inability to move the eyes

  • inability to sit still

  • increased blinking or spasms of the eyelid

  • lip smacking or puckering

  • loss of balance control

  • mask-like face

  • need to keep moving

  • painful or difficult urination

  • puffing of the cheeks

  • rapid or worm-like movements of the tongue

  • restlessness

  • shakiness in the legs, arms, hands, or feet

  • shortness of breath

  • shuffling walk

  • slowed movements

  • slurred speech

  • sores, ulcers, or white spots on the lips or in the mouth

  • sticking out of the tongue

  • stiffness of the arms or legs

  • sweating

  • swelling of the face, arms, hands, feet, or lower legs

  • swollen glands

  • trembling and shaking of the hands and fingers

  • trouble with breathing, speaking, or swallowing

  • uncontrolled chewing movements

  • uncontrolled movements of the arms and legs

  • uncontrolled twisting movements of the neck, trunk, arms, or legs

  • unusual bleeding or bruising

  • unusual facial expressions

  • unusual tiredness or weakness

Rare
  • Dry, puffy skin

  • fast, pounding, or irregular heartbeat

  • loss of appetite

  • menstrual changes

  • tiredness

  • unusual secretion of milk (in females)

  • weight gain

Incidence not known
  • Aching or discomfort in the lower legs or sensation of crawling in the legs

  • hives

  • itching

  • painful or prolonged erection of the penis

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • skin rash

  • tightness in the chest

  • tingling of the hands or feet

  • unusual weight gain or loss

  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Convulsions (seizures)

  • decreased urine

  • dry mouth

  • increased thirst

  • low blood pressure

  • mood changes

  • muscle pain or cramps

  • nausea or vomiting

  • numbness or tingling in the hands, feet, or lips

  • weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Constipation

  • headache

Less common
  • Abnormal vision

  • acid or sour stomach

  • belching

  • decreased appetite

  • decreased strength and energy

  • headache

  • heartburn

  • increased appetite

  • increased muscle tone

  • increased sweating

  • increased weight

  • indigestion

  • sneezing

  • stomach discomfort, upset, or pain

  • stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: quetiapine side effects (in more detail)



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More quetiapine resources


  • Quetiapine Side Effects (in more detail)
  • Quetiapine Use in Pregnancy & Breastfeeding
  • Quetiapine Drug Interactions
  • Quetiapine Support Group
  • 277 Reviews for Quetiapine - Add your own review/rating


  • Quetiapine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Quetiapine Fumarate Monograph (AHFS DI)

  • Seroquel Prescribing Information (FDA)

  • Seroquel Consumer Overview

  • Seroquel XR Prescribing Information (FDA)

  • Seroquel XR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare quetiapine with other medications


  • Bipolar Disorder
  • Borderline Personality Disorder
  • Depression
  • Generalized Anxiety Disorder
  • Insomnia
  • Obsessive Compulsive Disorder
  • Paranoid Disorder
  • Post Traumatic Stress Disorder
  • Schizoaffective Disorder
  • Schizophrenia
  • Tourette's Syndrome

Saturday, 7 April 2012

Acyclovir Sodium


Class: Nucleosides and Nucleotides
VA Class: AM800
CAS Number: 59277-89-3
Brands: Zovirax

Introduction

Antiviral; purine nucleoside analog derived from guanine.403 409


Uses for Acyclovir Sodium


Mucocutaneous, Ocular, and Systemic Herpes Simplex Virus (HSV) Infections


Treatment of initial and recurrent mucocutaneous HSV-1 and HSV-2 infections (e.g., orofacial, esophageal, genital, nasal, labial) in immunocompromised adults, adolescents, and children, including HIV-infected individuals.322 381 396 409 410 412 413 Drug of choice.322 381 396 410 412 413


Chronic suppressive or maintenance therapy (secondary prophylaxis) of recurrent HSV infections in immunocompromised adults, adolescents, and children, including HIV-infected individuals who have frequent or severe recurrences.322 392 404 412


Treatment of orolabial HSV infections (including gingivostomatitis) in immunocompetent adults and children;322 381 418 generally ineffective or minimally effective for prevention of recurrence of herpes labialis in immunocompetent individuals.322 422


Treatment of eczema herpeticum in patients with a history of atopic dermatitis.223 224


Treatment of HSV keratitis in HIV-infected patients.407


Prophylaxis against recurrence of ocular HSV disease in immunocompetent adults and children ≥12 years of age who had ocular HSV disease (blepharitis, conjunctivitis, epithelial keratitis, stromal keratitis, iritis) in one or both eyes within the preceding 12 months.408 419 Has been used for prophylaxis after penetrating keratoplasty for herpetic keratitis.420


Drug of choice for treatment of HSV encephalitis.211 212 246 248 322 381 395 409 410 412 413


Drug of choice for treatment of neonatal HSV infections, including mucocutaneous infections, infections involving skin, eyes, and mouth, and disseminated or CNS infections.244 322 324 353 356 381 395 408 409 410 413


Drug of choice for prevention of HSV recurrence in hematopoietic stem cell transplant (HSCT) recipients seropositive for HSV; such prophylaxis not indicated in those seronegative for HSV.414


Genital Herpes


Treatment of initial episodes of genital herpes in adults and adolescents,206 207 208 244 305 313 322 381 403 409 including HIV-infected individuals.412


Treatment of first episodes of herpes proctitis.305


Episodic treatment of recurrent episodes of genital herpes in adults and adolescents,244 313 322 381 403 including HIV-infected individuals.244 412


Chronic suppressive therapy of recurrent episodes of genital herpes in adults and adolescents,202 203 210 242 244 313 317 318 319 320 321 322 381 384 386 403 including HIV-infected individuals.244 412


CDC and others recommend oral acyclovir, oral famciclovir, or oral valacyclovir as drugs of choice for treatment of initial episodes of genital herpes and for episodic treatment or chronic suppressive therapy of recurrent genital herpes.244 313 381 412


Varicella-Zoster Infections


Treatment of varicella (chickenpox) in immunocompromised adults, adolescents, and children, including HIV-infected individuals.249 277 279 322 352 353 368 403 409 410 412 413 Drug of choice.249 277 279 322 352 353 368 410 412 413


Treatment of varicella (chickenpox) in immunocompetent adults, adolescents, and children.239 322 337 338 340 344 348 352 353 368 381 394 403 410 415 Varicella usually is a self-limited disease in otherwise healthy individuals and the role of acyclovir for treatment in these individuals is controversial;239 329 330 331 332 333 335 336 337 338 344 349 350 355 368 routine use not recommended by AAP and other clinicians.322 331 332 335 344 345 368


Treatment of herpes zoster (shingles, zoster) in immunocompetent261 284 285 309 353 or immunocompromised adults, adolescents, and children, including HIV-infected individuals.322 358 359 381 403 409 410 412 413 Drug of choice for serious or disseminated herpes zoster in immunocompromised patients.381 413


Treatment of herpes zoster ophthalmicus in HIV-infected patients.407 412


Treatment of dermatomal herpes zoster in immunocompromised patients including transplant recipients225 and HIV-infected patients.219 407 412


Alternative to varicella-zoster immune globulin (VZIG) for postexposure prophylaxis of VZV infection in HSCT recipients.414 Although long-term prophylaxis not routinely recommended for prevention of recurrent VZV infections in HSCT recipients, such prophylaxis may be considered in those with severe, long-term immunodeficiency.414


Prevention of Cytomegalovirus (CMV) Disease in Transplant Recipients


Has been used for prevention of CMV disease in solid organ transplant recipients354 360 363 364 365 366 367 398 399 414 and bone marrow transplant (BMT) recipients at risk for the disease; data regarding efficacy are conflicting.354 360 365 367 382


Has been used for prevention of CMV disease in HSCT recipients; generally ineffective after autologous HSCT.414 Ganciclovir is drug of choice for prevention of CMV following autologous or allogeneic HSCT in adults, adolescents, and children.414


Not effective for prevention of CMV disease in HIV-infected individuals.404


Epstein-Barr Virus Infections and Disorders


Treatment of uncomplicated or complicated infectious mononucleosis, chronic infectious mononucleosis, and various disorders (e.g., oral hairy leukoplakia) associated with Epstein-Barr virus infections;262 270 271 272 369 396 efficacy appears to be variable.230 262 272 273 274 275 276 369


Acyclovir Sodium Dosage and Administration


Administration


Administer orally or by IV infusion.403 409


Parenteral preparation should not be administered orally or by IM or sub-Q injection and should not be applied topically or to the eye.409


Oral Administration


Administer without regard to meals.213 403


IV Infusion


For solution and drug compatibility information, see Compatibility under Stability.


Reconstitution

Reconstitute vial containing 500 mg or 1 g of acyclovir powder with 10 or 20 mL of sterile water for injection, respectively, to provide a solution containing 50 mg/mL.409


Shake well to ensure complete dissolution.409 Must be diluted further before IV administration.409


Dilution

For IV infusion, dilute concentrate containing acyclovir 25 or 50 mg/mL with a compatible IV solution (see Solution Compatibility under Stability) to a concentration of ≤7 mg/mL.409


Alternatively, dilute solutions reconstituted from powder prior to IV infusion with 50–125 mL of a compatible IV infusion solution.409 (See Solution Compatibility under Stability.) For fluid-restricted patients, dilute reconstituted solution in a ratio of approximately 1 part reconstituted solution to 9 parts infusion solution to a concentration of ≤7 mg/mL.409


Rate of Administration

Administer by IV infusion at a constant rate over at least 1 hour.409 Do not administer by rapid IV infusion (over <10 minutes) or rapid IV injection.409 (See Renal Effects under Cautions.)


Ensure adequate hydration.409


Dosage


Available as acyclovir and acyclovir sodium; dosage expressed in terms of acyclovir.409


Pediatric Patients


Mucocutaneous, Ocular, and Systemic Herpes Simplex Virus (HSV) Infections

Treatment of Mucocutaneous HSV Infections

Oral

Immunocompromised children: 1 g daily given in 3–5 divided doses for 7–14 days.322


IV

Immunocompromised children <12 years of age: 10 mg/kg every 8 hours for 7–14 days.322 381 409


HIV-infected or immunocompromised adolescents and children ≥12 years of age: 5 mg/kg every 8 hours for 7–14 days.322 381 409 412 Alternatively, after lesions begin to regress, consider switching to oral acyclovir in a dosage of 400 mg 3 times daily and continue until lesions are completely healed.412


HSV Gingivostomatitis

Oral

HIV-infected children with mild, symptomatic gingivostomatitis: CDC and others recommend 20 mg/kg (up to 400 mg) 3 times daily for 7–14 days.413


Immunocompetent children: 15 mg/kg (up to 200 mg) 5 times daily for 7 days has been used in a few children 1–6 years of age.418


IV

HIV-infected children with moderate to severe gingivostomatitis: CDC and others recommend 5–10 mg/kg 3 times daily for 7–14 days.413 Consider chronic oral suppressive or maintenance therapy (secondary prophylaxis) in those with frequent or severe recurrences of gingivostomatitis.413


Chronic Suppressive or Maintenance Therapy (Secondary Prophylaxis) of HSV Infections

Oral

HIV-infected infants and children: 80 mg/kg daily (up to 1 g daily) in 3 or 4 divided doses.404


HIV-infected adolescents: 200 mg 3 times daily or 400 mg twice daily.404


Prophylaxis Against Recurrent Ocular HSV Disease

Oral

Children ≥12 years of age: 400 mg twice daily.408 419 AAP recommends 80 mg/kg daily (up to 1 g daily) given in 3 divided doses.322


Optimum duration of prophylaxis unclear;419 has been continued for 12–18 months in clinical studies.408 419


Treatment of HSV Encephalitis or Disseminated Disease

IV

Immunocompromised children: 20 mg/kg every 8 hours in those 3 months to 12 years of age381 409 and 10–15 mg/kg every 8 hours in those ≥12 years of age.211 246 322 409 413 Manufacturer recommends a treatment duration of 10 days,409 but AAP and others recommend 14–21 days for disseminated or CNS infections.235 236 311 322 381 413


HIV-infected children: CDC and others recommend 10 mg/kg or 500 mg/m2 3 times daily for 21 days.413


HIV-infected adolescents: CDC and others recommend 10 mg/kg 3 times daily for 14–21 days.412


Treatment of Neonatal HSV Infections

IV

Neonates and children ≤3 months of age: Manufacturer recommends 10 mg/kg every 8 hours for 10 days.409


Neonates and children ≤3 months of age: AAP recommends 20 mg/kg every 8 hours given for 14 days for infections of skin, eyes, or mouth or 21 days for disseminated or CNS infections.322


HIV-infected or -exposed neonates: CDC and others recommend 20 mg/kg 3 times daily given for 14 days for infections of skin, eyes, or mouth or 21 days for disseminated or CNS infections.413


Prevention of HSV Recurrence in Hematopoietic Stem Cell Transplant (HSCT) Recipients

Oral

HSV-seropositive children: 0.6–1 g daily given in 3–5 divided doses.414


HSV-seropositive adolescents: 200 mg 3 times daily.414


Initiate prophylaxis at beginning of conditioning therapy and continue until engraftment or until mucositis resolves (approximately 30 days after allogeneic HSCT).414 Routine prophylaxis for >30 days after HSCT not recommended.414


IV

HSV-seropositive children: 250 mg/m2 every 8 hours or 125 mg/m2 every 6 hours.414


HSV-seropositive adolescents: 250 mg/m2 every 12 hours.


Initiate prophylaxis at beginning of conditioning therapy and continue until engraftment or until mucositis resolves (approximately 30 days after allogeneic HSCT).414 Routine prophylaxis for >30 days after HSCT not recommended.414


Genital Herpes

Treatment of First Episodes

Oral

Children: AAP recommends 40–80 mg/kg daily (maximum 1 g daily) given in 3 or 4 divided doses for 5–10 days.322


Adolescents: CDC recommends 400 mg 3 times daily or 200 mg 5 times daily for 7–10 days;244 duration may be extended if healing is incomplete after 10 days.244


HIV-infected adolescents: CDC and others recommend 20 mg/kg (up to 400 mg) or 400 mg 3 times daily for 7–14 days.412


IV

Adolescents and children ≥12 years of age with severe initial episodes: 5–10 mg/kg every 8 hours.244 381 409 410


Manufacturer and some clinicians recommend 5–7 days of IV acyclovir;381 409 CDC states IV acyclovir should be given for 2–7 days or until clinical improvement occurs, followed by an oral antiviral to complete at least 10 days of treatment.244


Episodic Treatment of Recurrent Episodes

Oral

Adolescents: CDC recommends 400 mg 3 times daily for 5 days, 800 mg twice daily for 5 days, or 800 mg 3 times daily for 2 days.244


HIV-infected adolescents: CDC recommends 400 mg 3 times daily for 5–10 days.244 Alternatively, acyclovir can be given for 7–14 days.412


Initiate episodic therapy at the earliest prodromal sign or symptom of recurrence or within 1 day of the onset of lesions.244 403


Chronic Suppression of Recurrent Episodes

Oral

Adolescents: CDC recommends 400 mg twice daily.244


HIV-infected adolescents: CDC recommends 400–800 mg 2 or 3 times daily.244


Discontinue periodically (e.g., after 12 months or once yearly) to reassess need for continued therapy.244 403


Varicella-Zoster Infections

Treatment of Varicella (Chickenpox)

Oral

Immunocompetent children ≥2 years of age: Manufacturer recommends 20 mg/kg 4 times daily (maximum 80 mg/kg daily) for 5 days in those weighing ≤40 kg and 800 mg 4 times daily for 5 days in those weighing >40 kg.403 Alternatively, some clinicians recommend 20 mg/kg (up to 800 mg) 4 times daily for 5 days.239 322 329 331 336 368 381 410


HIV-infected children with mild immunosuppression and mild varicella: CDC and others recommend 20 mg/kg (up to 800 mg) 4 times daily for 7 days or until no new lesions have appeared for 48 hours.413


Initiate therapy at the earliest sign or symptom of infection (within 24 hours of onset of rash).368 403


IV

Immunocompromised children: AAP recommends 10 mg/kg 3 times daily for 7–10 days for those <1 year of age and 500 mg/m2 3 times daily for 7–10 days in those ≥1 year of age.322


Immunocompromised adolescents and children: Some clinicians recommend 20 mg/kg every 8 hours for 7–10 days in those ≤12 years of age and 10 mg/kg every 8 hours for 7 days in those >12 years of age.381


HIV-infected children with moderate or severe immunosuppression and varicella associated with high fever or necrotic lesions: CDC and others recommend 10 mg/kg 3 times daily for 7 days or until no new lesions have appeared for 48 hours.413 Alternatively, a dosage of 500 mg/m2 every 8 hours has been suggested for those ≥1 year of age.413


HIV-infected adolescents: CDC and others recommend 10 mg/kg every 8 hours for 7–10 days.412 After defervescence and if there is no evidence of visceral involvement, switch to oral acyclovir in a dosage of 800 mg 4 times daily.412


Treatment of Herpes Zoster (Shingles, Zoster)

Oral

Immunocompetent children ≥12 years of age: 800 mg every 4 hours 5 times daily (4 g daily) for 5–10 days.261 284 285 309 322 381 403 410


HIV-infected children with mild immunosuppression and mild varicella: CDC and others recommend 20 mg/kg (up to 800 mg) 4 times daily for 7–10 days.413


Initiate therapy preferably within 48 hours of onset of rash.261 284 285 309 322 381 403 410


IV

Immunocompetent children: AAP recommends 10 mg/kg 3 times daily for 7–10 days for those <1 year of age and 500 mg/m2 3 times daily for 7–10 days in those ≥1 year of age.322


Immunocompromised children: 20 mg/kg every 8 hours for 7–10 days in those <12 years of age381 322 409 413 and 10 mg/kg every 8 hours for 7 days in those ≥12 years of age.381 409 410


HIV-infected children with severe immunosuppression and extensive multidermatomal zoster or zoster with trigeminal nerve involvement: CDC and others recommend 10 mg/kg 3 times daily for 7–10 days.413


HIV-infected adolescents: CDC and others recommend 10 mg/kg every 8 hours until cutaneous and visceral disease resolves.412


Adults


Mucocutaneous, Ocular, and Systemic Herpes Simplex Virus (HSV) Infections

Treatment of Mucocutaneous HSV Infections

Oral

Immunocompromised or HIV-infected adults: 400 mg every 4 hours while awake (5 times daily) for 7–14 days.381 410


IV

Immunocompromised or HIV-infected adults: CDC and others recommend 5 mg/kg every 8 hours for 7–14 days.381 409 412 Alternatively, after lesions begin to regress, consider switching to oral acyclovir in a dosage of 400 mg 3 times daily and continue until lesions are completely healed.412


Chronic Suppressive or Maintenance Therapy (Secondary Prophylaxis) of HSV Infections

Oral

HIV-infected adults: 200 mg 3 times daily or 400 mg twice daily.404


Treatment of Orolabial HSV Infections

Oral

400 mg 5 times daily for 5 days.381


HIV-infected adults: CDC and others recommend 400 mg 3 times daily for 7–14 days.381 412


Treatment of HSV Keratitis

Oral

HIV-infected adults: 400 mg 5 times daily.407 Long-term therapy may be required to prevent recurrence.407


Prophylaxis Against Recurrent Ocular HSV Disease

Oral

Immunocompetent adults: 400 mg twice daily.408 419 420 Optimum duration of prophylaxis unclear;419 has been continued for 12–18 months in clinical studies.408 419


Treatment of HSV Encephalitis or Disseminated Disease

IV

10–15 mg/kg every 8 hours.211 246 322 381 409 412 Manufacturer recommends a treatment duration of 10 days,409 but CDC and others recommend 14–21 days for disseminated or CNS infections.235 236 311 381 412


HIV-infected adults: CDC and others recommend 10 mg/kg 3 times daily for 14–21 days.412


Prevention of HSV Recurrence in Hematopoietic Stem Cell Transplant (HSCT) Recipients

Oral

HSV-seropositive adults: 200 mg 3 times daily initiated at beginning of conditioning therapy and continued until engraftment or until mucositis resolves (i.e., approximately 30 days after allogeneic HSCT).414 Routine prophylaxis for >30 days after HSCT not recommended.414


IV

HSV-seropositive adults: 250 mg/m2 every 12 hours initiated at beginning of conditioning therapy and continued until engraftment or until mucositis resolves (i.e., approximately 30 days after allogeneic HSCT).414 Routine prophylaxis for >30 days after HSCT not recommended.414


Genital Herpes

Treatment of First Episodes

Oral

Manufacturer recommends 200 mg every 4 hours while awake (5 times daily) for 10 days.403


CDC and others recommend 400 mg 3 times daily or 200 mg 5 times daily for 7–10 days;244 313 381 410 duration may be extended if healing is incomplete after 10 days.244


HIV-infected adults: CDC and others recommend 400 mg 3 times daily for 7–14 days.412


IV

Adults with severe initial episodes: 5–10 mg/kg every 8 hours.244 313 381 409 410


Manufacturer and some clinicians recommend 5–7 days of IV acyclovir;313 381 409 CDC states IV acyclovir should be given for 2–7 days or until clinical improvement occurs, followed by an oral antiviral to complete at least 10 days of therapy.244


Treatment of First Episode of Herpes Proctitis

Oral

400 mg 5 times daily for 10 days or until clinical resolution occurs.305


Episodic Treatment of Recurrent Episodes of Genital Herpes

Oral

Manufacturer recommends 200 mg every 4 hours while awake (5 times daily) for 5 days.403


CDC recommends 400 mg 3 times daily for 5 days, 800 mg twice daily for 5 days, or 800 mg 3 times daily for 2 days.244


HIV-infected adults: CDC recommends 400 mg 3 times daily for 5–10 days.244 Alternatively, acyclovir can be given for 7–14 days.412


Initiate episodic therapy at the earliest prodromal sign or symptom of recurrence or within 1 day of the onset of lesions.244 403 410


Chronic Suppression of Recurrent Episodes of Genital Herpes

Oral

400 mg twice daily;244 313 381 403 alternatively, 200 mg 3–5 times daily.403


HIV-infected adults: 400–800 mg 2 or 3 times daily.244


Discontinue periodically (e.g., after 12 months or once yearly) to reassess need for continued therapy.244 403


Varicella-Zoster Infections

Treatment of Varicella (Chickenpox)

Oral

20 mg/kg (up to 800 mg) 4 times daily for 5 days.239 322 329 331 336 353 368 381 403 410 412


Initiate therapy at the earliest sign or symptom of infection (within 24 hours of onset of rash).368 403


IV, then Oral

HIV-infected or immunocompromised adults: CDC and others recommend 10 mg/kg every 8 hours for 7–10 days.381 412 After defervescence and if there is no evidence of visceral involvement, switch to oral acyclovir in a dosage of 800 mg 4 times daily.412


Treatment of Herpes Zoster (Shingles, Zoster)

Oral

800 mg every 4 hours (5 times daily) for 7–10 days.261 284 285 309 322 381 403 410


Initiate therapy preferably within 48 hours of onset of rash.261 284 285 309 322 381 410


IV

HIV-infected or immunocompromised adults: CDC and others recommend 10 mg/kg every 8 hours for 7 days or until cutaneous and visceral disease resolves.381 409 410 412


Treatment of Herpes Zoster Ophthalmicus

Oral

Immunocompetent adults: 600 mg every 4 hours 5 times daily (3 g daily) for 10 days.281 282 286


Initiate therapy within 72 hours (but no later than 7 days) after rash onset.281 282 286


IV, then Oral

HIV-infected adults: 10 mg/kg IV 3 times daily for 7 days followed by 800 mg orally 3–5 times daily has been used.407


Treatment of Dermatomal Herpes Zoster

Oral

Immunocompromised adults: 800 mg 5 times daily for 10 days has been used,219 225 but CDC and others recommend oral famciclovir or valacyclovir for localized dermal infections in HIV-infected individuals.412


Prescribing Limits


Pediatric Patients


Oral:

Maximum 20 mg/kg 4 times daily (1 g daily)322 403 in children ≥2 years of age weighing ≤40 kg.403


IV:

Maximum 20 mg/kg every 8 hours.409


Adults


Oral:

800 mg per dose.239 322 329 331 336 353 368 381 410


IV:

Maximum 20 mg/kg every 8 hours.409


Special Populations


Renal Impairment


Adjustment of Usual Oral Dosage


























Oral Dosage in Renal Impairment403

Usual Dosage Regimen



Clcr (mL/min per 1.73 m2)



Adjusted Dosage Regimen



200 mg every 4 h 5 times daily



>10



No adjustment necessary



0–10



200 mg every 12 h



400 mg every 12 h



>10



No adjustment necessary



0–10



200 mg every 12 h



800 mg every 4 h 5 times daily



>25



No adjustment necessary



10–25



800 mg every 8 h



0–10



800 mg every 12 h


Hemodialysis

Give supplemental oral dose immediately after each dialysis period.403


Peritoneal Dialysis

Supplemental doses do not appear necessary.403


Adjustment of Usual IV Dosage

















IV Dosage in Renal Impairment409

Clcr (mL/min per 1.73 m2)



Percent of Recommended Dose



Dosing Interval (hours)



>50



100%



8



25–50



100%



12



10–25



100%



24



0–10



50%



24


Hemodialysis

Adjust dosing schedule so that a supplemental IV dose is administered immediately after each dialysis period.409


CAPD

Supplemental doses do not appear necessary.316


Alternative IV Dosage Regimens for End-Stage Renal Disease

93–185 mg/m2 as a loading dose, followed by a maintenance dosage of 35–70 mg/m2 every 8 hours, and 56–185 mg/m2 immediately after dialysis.a


250–500 mg/m2 as a loading dose, followed by a maintenance dosage of 250–500 mg/m2 every 48 hours, and 150–500 mg/m2 immediately after dialysis.a


2.5 mg/kg every 24 hours and 2.5 mg/kg after each dialysis period.a


HIV-infected Patients with Impaired Renal Function (Oral Administration)














Oral Dosage for HIV-infected Patients with Impaired Renal Function (Based on Usual Dosage of 200–800 mg Every 4–6 Hours)411

Clcr (mL/min per 1.73 m2)



Adjusted Dosage Regimen



>80



No adjustment necessary



50–80



200–800 mg every 6–8 h



25–50



200–800 mg every 8–12 h



10–25



200–800 mg every 12–24 h



<10



200–400 mg every 24 h


Hemodialysis

Give supplemental usual oral dose after each dialysis period.411


HIV-infected Patients with Impaired Renal Function (IV Administration)














IV Dosage for HIV-infected Patients with Impaired Renal Function (Based on Usual Dosage of 5 mg/kg Every 8 hours)409411

Clcr (mL/min per 1.73 m2)



Adjusted Dosage Regimen



>80



No adjustment necessary



50–80



No adjustment necessary



25–50



5 mg/kg every 12–24 hours



10–25



5 mg/kg every 12–24 hours



<10



2.5 mg/kg every 24 hours


Hemodialysis

Adjust dosing schedule so that daily IV dose is given after hemodialysis on dialysis days.411


Geriatric Patients


Cautious dosage selection; reduced dosage may be needed because of age-related decreases in renal function.403 409 (See Geriatric Use under Cautions.)


Obese Patients


Use ideal body weight to determine IV dosage.409


Cautions for Acyclovir Sodium


Contraindications



  • Known hypersensitivity to acyclovir or valacyclovir.403 409



Warnings/Precautions


Warnings


Renal Effects

Increased BUN and/or Scr, anuria, and hematuria have been reported.403 409 Transient increases in BUN and/or Scr and decreases in Clcr reported in patients receiving IV acyclovir, particularly following rapid (over <10 minutes) IV infusion.409


Abnormal urinalysis (increase in formed elements in urine sediment) and pain or pressure on urination reported rarely with IV acyclovir.409


Renal failure, resulting in death, has occurred.341 403 409


Possible precipitation of acyclovir in renal tubules, resulting in renal tubular damage and acute renal failure, when the solubility of free acyclovir in the collecting duct is exceeded or following rapid IV administration.409


Risk of adverse renal effects during IV therapy depends on degree of hydration, urine output, concomitant therapy (i.e., nephrotoxic drugs), preexisting renal disease, and rate of administration (see Rate of Administration under Dosage and Administration).409


Alterations in renal function during IV acyclovir therapy can progress to acute renal failure but generally are transient and resolve spontaneously or following improved hydration and electrolyte balance, dosage adjustment, or discontinuance of the drug.409


Hematologic Effects

Potentially fatal thrombotic thrombocytopenic purpura/hemolytic uremic syndrome reported in immunocompromised patients receiving acyclovir.403 409


General Precautions


Nervous System Effects

Possible encephalopathic effects (e.g., lethargy, obtundation, tremors, confusion, hallucinations, agitation, seizures, coma) in patients receiving IV acyclovir.409


Use with caution in patients with underlying neurologic abnormalities and in those with serious renal, hepatic, or electrolyte abnormalities or substantial hypoxia.409


Local Effects

Severe local inflammatory reactions, including tissue necrosis, have occurred following infusion of acyclovir into extravascular tissues.409


Sodium Content

Sodium salt of acyclovir contains 4.2 mEq of sodium per gram of acyclovir.409


Specific Populations


Pregnancy

Category B.403 409


CDC, AAP, and others state that oral acyclovir may be used during pregnancy to treat first episodes or severe recurrent episodes of genital herpes244 322 381 412 421 and IV acyclovir may be used during pregnancy to treat severe HSV infection (especially life-threatening disseminated infections).244 322 412 421 CDC and others also recommend acyclovir for treatment of varicella during pregnancy,412 415 particularly during the second and third trimesters.415


Lactation

Distributed into milk following oral or IV administration.251 308 403 409 421 Use with caution.403 409


Women with active herpetic lesions near or on the breast should refrain from breast-feeding.322


Pediatric Use

Safety and efficacy of oral acyclovir not established in children <2 years of age.403


Geriatric Use

For treatment of herpes zoster (shingles, zoster), no substantial differences in efficacy of oral acyclovir relative to younger adults, but duration of pain after healing may be longer in geriatric patients.403


Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently to IV acyclovir than younger adults.409


Select dosage with caution because of age-related decreases in renal function and potential for concomitant disease and drug therapy.409 Consider monitoring renal function.409


Possible increased incidence of adverse CNS effects (coma, confusion, hallucinations, somnolence), GI effects (nausea, vomiting), or dizziness during oral acyclovir therapy compared with younger adults.403


Hepatic Impairment

Use with caution.a


Renal Impairment

Wednesday, 4 April 2012

Elmiron



Pronunciation: PEN-toe-san
Generic Name: Pentosan
Brand Name: Elmiron


Elmiron is used for:

Relieving bladder pain or discomfort caused by bladder inflammation.


Elmiron is an interstitial cystitis agent. The exact way it works is not known, but it is thought to protect the bladder wall while it heals.


Do NOT use Elmiron if:


  • you are allergic to any ingredient in Elmiron

Contact your doctor or health care provider right away if any of these apply to you.



Before using Elmiron:


Some medical conditions may interact with Elmiron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have or have a history of a bleeding disorder due to low platelet levels, bleeding in the brain, hemophilia, stomach ulcers, intestinal polyps, or diverticulitis

  • if you have liver problems or blood-clotting problems, or you are scheduled for surgery or another medical procedure

Some MEDICINES MAY INTERACT with Elmiron. Tell your health care provider if you are taking any medicines, especially any of the following:


  • Anticoagulants (eg, heparin, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Elmiron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Elmiron:


Use Elmiron as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Elmiron comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Elmiron refilled.

  • Take Elmiron by mouth on an empty stomach at least 1 hour before or 2 hours after eating.

  • Take Elmiron with a full glass of water (8 oz/240 mL).

  • Continue to take Elmiron even if you feel well. Do not miss any doses.

  • If you miss a dose of Elmiron, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Elmiron.



Important safety information:


  • Elmiron may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Elmiron with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • It may take 3 to 6 months for Elmiron to reach its full effect. Do not stop taking Elmiron or take more than the recommended dose without checking with your doctor.

  • Elmiron may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Tell your doctor or dentist that you take Elmiron before you receive any medical or dental care, emergency care, or surgery.

  • Elmiron should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Elmiron while you are pregnant. It is not known if Elmiron is found in breast milk. If you are or will be breast-feeding while you use Elmiron, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Elmiron:


All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Diarrhea; dizziness; hair loss; headache; nausea; stomach upset; swelling of fingers, hands, toes, or feet.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; unusual bruising or bleeding; vomiting that looks like coffee grounds.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Elmiron side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Elmiron:

Store Elmiron at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Elmiron out of the reach of children and away from pets.


General information:


  • If you have any questions about Elmiron, please talk with your doctor, pharmacist, or other health care provider.

  • Elmiron is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Elmiron. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Elmiron resources


  • Elmiron Side Effects (in more detail)
  • Elmiron Use in Pregnancy & Breastfeeding
  • Drug Images
  • Elmiron Drug Interactions
  • Elmiron Support Group
  • 15 Reviews for Elmiron - Add your own review/rating


  • Elmiron Prescribing Information (FDA)

  • Elmiron Advanced Consumer (Micromedex) - Includes Dosage Information

  • Elmiron Concise Consumer Information (Cerner Multum)

  • Elmiron Monograph (AHFS DI)

  • Pentosan Polysulfate Sodium Professional Patient Advice (Wolters Kluwer)



Compare Elmiron with other medications


  • Bladder Infection
  • Interstitial Cystitis

Monday, 2 April 2012

ClindaMax Cream


Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Cleocin


ClindaMax Cream is used for:

Treating vaginal infections caused by certain bacteria.


ClindaMax Cream is a topical lincomycin antibiotic. It works by slowing the growth of certain bacteria.


Do NOT use ClindaMax Cream if:


  • you are allergic to any ingredient in ClindaMax Cream or to lincomycin

  • you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

Contact your doctor or health care provider right away if any of these apply to you.



Before using ClindaMax Cream:


Some medical conditions may interact with ClindaMax Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a gastrointestinal (bowel) disease or diarrhea

Some MEDICINES MAY INTERACT with ClindaMax Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because their actions and the risk of their side effects may be increased by ClindaMax Cream

  • Erythromycin because it may decrease ClindaMax Cream's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if ClindaMax Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use ClindaMax Cream:


Use ClindaMax Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • ClindaMax Cream is for vaginal use only.

  • Wash your hands before and after using ClindaMax Cream. To use, remove the cap from the tube. Screw the plastic applicator on the threaded end of the tube. Rolling the tube from the bottom, squeeze gently and force the medicine into the applicator. The applicator is filled when the plunger reaches its predetermined stopping point.

  • Unscrew the applicator from the tube and replace the cap. While lying on your back, firmly grasp the applicator barrel and insert into the vagina as far as it will possibly go without causing discomfort. Slowly push the plunger until it stops. Carefully remove the applicator from the vagina and throw the applicator away.

  • Use ClindaMax Cream at bedtime. This will help keep the medicine in the vagina and reduce leaking.

  • ClindaMax Cream works best if it is used at the same time each day.

  • To clear up your infection completely, use ClindaMax Cream for the full course of treatment. Keep using it even if you feel better in a few days.

  • If you miss a dose of ClindaMax Cream and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use ClindaMax Cream.



Important safety information:


  • Avoid contact with the eyes. Burning and irritation can occur. If contact does occur, rinse the eye with large amounts of cool tap water.

  • Do not have sexual intercourse or use other vaginal products, such as tampons or douches, while using ClindaMax Cream.

  • Use a sanitary napkin rather than a tampon to prevent staining of clothes and bed linens.

  • This cream contains mineral oil that may weaken latex products such as condoms and diaphragms. Therefore, do not use these products within 72 hours of using ClindaMax Cream.They may not provide adequate birth control and you may become pregnant.

  • Be sure to use ClindaMax Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Long-term or repeated use of ClindaMax Cream may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with ClindaMax Cream, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ClindaMax Cream while you are pregnant. It is not known if ClindaMax Cream is found in breast milk. If you are or will be breast-feeding while you use ClindaMax Cream, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of ClindaMax Cream:


All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Fungal infection; genital itching or burning; inflammation or pain; vaginal discharge.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood/mucus in stools; diarrhea; new or worsening vaginal or vulvar itching; painful sex; stomach cramps/pain; white vaginal discharge.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: ClindaMax side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. ClindaMax Cream may be harmful if swallowed.


Proper storage of ClindaMax Cream:

Store ClindaMax Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Protect from freezing. Keep ClindaMax Cream out of the reach of children and away from pets.


General information:


  • If you have any questions about ClindaMax Cream, please talk with your doctor, pharmacist, or other health care provider.

  • ClindaMax Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about ClindaMax Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More ClindaMax resources


  • ClindaMax Side Effects (in more detail)
  • ClindaMax Use in Pregnancy & Breastfeeding
  • ClindaMax Drug Interactions
  • ClindaMax Support Group
  • 3 Reviews for ClindaMax - Add your own review/rating


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