Razadyne ER

Generic Name: galantamine (ga LAN ta meen)

Brand Names: Razadyne, Razadyne ER

What is Razadyne ER (galantamine)?

Galantamine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Galantamine is used to treat mild to moderate dementia caused by Alzheimer's disease.

Galantamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Razadyne ER (galantamine)?

Before taking galantamine, tell your doctor if you are allergic to any drugs, or if you have urination problems, heart disease, a heart rhythm disorder, stomach ulcers or bleeding, a seizure disorder, kidney disease, liver disease, or asthma.

Stop using galantamine and call your doctor at once if you have chest pain, slow heart rate, blood in your stools, coughing up blood, decreased urination, weakness, confusion, extreme thirst, or hot, dry skin.

There are many other medicines that can interact with galantamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking galantamine. You may need to stop using the medicine for a short time.

If you have stopped taking galantamine for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose. Galantamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking Razadyne ER (galantamine)?

Do not use this medication if you are allergic to galantamine.

Before taking galantamine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  urination problems;

  
  


• 
  

  heart disease or a heart rhythm disorder;

  
  


• 
  

  a history of stomach ulcer or bleeding;

  
  


• 
  

  seizures or epilepsy;

  
  


• kidney disease;


• liver disease; or


• 
  

  a history of asthma or obstructive pulmonary disease.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take galantamine.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether galantamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Razadyne ER (galantamine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Galantamine is usually taken once or twice a day with a meal. You may also take the medication without food. Follow your doctor's instructions.

Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Take the capsule or tablet with a full glass of water. Drink 6 to 8 full glasses of water each day to keep from getting dehydrated while taking galantamine.

The liquid form of this medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Measure the liquid using only the special dose-measuring device provided. Empty the medicine into 3 to 4 ounces of any non-alcoholic beverage. Stir this mixture and drink all of it right away. Rinse the dose-measuring device with water after each use.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking galantamine. You may need to stop using the medicine for a short time.

If you have stopped taking galantamine for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose. Store galantamine at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe nausea, vomiting, stomach cramps, muscle weakness or spasm, watery eyes, drooling, increased urination or bowel movements, sweating, slow heart rate, feeling light-headed or fainting, and seizure (convulsions).

What should I avoid while taking Razadyne ER (galantamine)?

Galantamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Razadyne ER (galantamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using galantamine and call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, slow heart rate;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  weakness, confusion, decreased sweating, extreme thirst, hot dry skin; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  feeling tired, dizzy, or light-headed;

  
  


• 
  

  nausea, vomiting, gas, loss of appetite;

  
  


• 
  

  weight loss; or

  
  


• 
  

  headache.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Razadyne ER (galantamine)?

Before taking galantamine, tell your doctor if you are using any of the following drugs:

• 
  

  atropine (Donnatal, and others);

  
  


• 
  

  belladonna;

  
  


• 
  

  clidinium (Quarzan);

  
  


• 
  

  dicyclomine (Bentyl);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);

  
  


• ketoconazole (Nizoral);


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  methantheline (Provocholine);

  
  


• 
  

  methscopolamine (Pamine);

  
  


• 
  

  paroxetine (Paxil, Pexeva);

  
  


• 
  

  propantheline (Pro-Banthine); or

  
  


• 
  

  scopolamine (Transderm-Scop).

  
  

This list is not complete and there may be other drugs that can interact with galantamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Razadyne ER resources

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

• Razadyne ER Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Razadyne ER Advanced Consumer (Micromedex) - Includes Dosage Information


• Galantamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Galantamine Prescribing Information (FDA)


• Galantamine Hydrobromide Monograph (AHFS DI)


• Razadyne Prescribing Information (FDA)

Compare Razadyne ER with other medications

• Alzheimer's Disease

Where can I get more information?

• Your pharmacist can provide more information about galantamine.

See also: Razadyne ER side effects (in more detail)

Denavir

Generic Name: Penciclovir
Class: Antivirals
VA Class: DE103
Molecular Formula: C₁₀H₁₅N₅O₃
CAS Number: 39809-25-1

Introduction

Antiviral; acyclic purine nucleoside analog of guanine.^{1 2 3 5 9 10 11 12 14}

Uses for Denavir

Herpes Labialis

Treatment of recurrent herpes labialis (oral and perioral herpes, cold sores, fever blisters) in adults.^{1 2 6 7 8 20}

Efficacy not established in immunocompromised patients or children.^{1 20}

Denavir Dosage and Administration

Administration

Topical Administration

Appy topically to lesions of the lips and surrounding skin as a 1% cream.^{1 2 7 12 21}

Do not apply in or near the eyes since irritation may occur.¹ Application to mucous membranes not recommended.¹

Dosage

Adults

Herpes Labialis

Topical

Rub 1% cream gently into the affected area every 2 hours while awake (about 9, but at least 6, times daily) for 4 days.^{1 2 12} Use sufficient quantity to adequately cover all lesions of the lips and surrounding skin.²¹

Initiate at the earliest sign or symptom (i.e., within 1 hour of the prodrome or appearance of the first lesion) of herpes labialis.^{1 2 12}

Cautions for Denavir

Contraindications

• 
  

  Hypersensitivity to penciclovir or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into human milk after topical application.¹ Penciclovir is distributed into milk in rats following oral administration of famciclovir (the oral prodrug of penciclovir).¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

Adverse effects profile in adults ≥65 years of age is similar to that in younger adults.¹

Common Adverse Effects

Headache.¹

Denavir Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed into systemic circulation following topical application to the skin.^{1 2 5 7 12}

Not detected in plasma or urine of adults following single or repeated application of 1% penciclovir cream at a dosage of 180 mg daily (about 67 times the estimated usual topical dosage).^{1 2 5 7 12} Systemic absorption not evaluated in children <18 years of age.¹

Elimination

Metabolism

Converted in vivo to the pharmacologically active triphosphate metabolite.^{1 2 5 7 9 10 11 12 13 14}

Stability

Storage

Topical

Cream

20°–25°C.¹

Actions and SpectrumActions

• 
  

  Converted in vivo to the pharmacologically active triphosphate metabolite.^{1 2 5 7 9 10 11 12 13 14}

  
  


• 
  

  Exerts its antiviral effect by interfering with DNA synthesis and inhibiting viral replication.^{1 2 3 9 12}

  
  


• 
  

  Active against various Herpesviridae,^{1 2 5 7 9 10 11 12 13 14} including herpes simplex virus types 1 and 2 (HSV-1 and HSV-2),^{1 2 3 5 10 12 14} varicella-zoster virus (VZV),^{2 5 10 12 13 14} and Epstein-Barr virus (EBV).^{5 9 10 11} Only limited activity in vitro against cytomegalovirus (CMV).^{5 11}

  
  


• 
  

  In vitro, penciclovir triphosphate is 10–20 times more stable than acyclovir triphosphate within HSV-infected cells, resulting in more prolonged antiviral activity.^{2 5 8 9 14}

  
  


• 
  

  Resistance to penciclovir reported in HSV and VZV.^{1 4 5 8 12 14 15}

  
  


• 
  

  Most (but not all) acyclovir-resistant HSV and VZV are cross-resistant to penciclovir.^{1 4 5 8 12 13 14 15}

  
  

Advice to Patients

• 
  

  Importance of avoiding contact with eyes.¹ If contact with the eye(s) occurs, the affected eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists.

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Penciclovir

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Cream	1%	Denavir (with propylene glycol)	Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Denavir 1% Cream (NEW AMERICAN THERAPEUTICS): 1/$95.99 or 4/$275.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis. Denavir (penciclovir) topical cream 1% prescribing information. East Hanover, NJ; 2001 Jan.

2. Spruance SL, Rea TL, Thoming C et al. Penciclovir cream for the treatment of herpes simplex labialis. JAMA. 1997; 277:1374-79. [IDIS 384117] [PubMed 9134943]

3. Wiltink EH. New promising antiviral drugs. Drugs of Today. 1995; 31:273-82.

4. Chatis PA, Crumpacker CS. Resistance of herpesviruses to antiviral drugs. Antimicrob Agents Chemother. 1992; 36:1589-95. [IDIS 299816] [PubMed 1416838]

5. Alrabiah FA, Sacks SL. New antiherpesvirus agents. Drugs. 1996; 52:17-32. [PubMed 8799682]

6. Ackerman B (SmithKline Beecham, Philadelphia, PA): Personal communication; 1997 July 10.

7. Raborn GW for the Penciclovir Topical Collaborative Study Group. Penciclovir cream for recurrent herpes simplex labialis: an effective new treatment. Proceedings of ICAAC New Orleans 1996. Abstract No. H81.

8. Boyd MR, Safrin S, Kern ER. Penciclovir: a review of its spectrum of activity, selectivity and cross-resistance patterns. Antiviral Chem Chemother. 1993; 4(Suppl 1): 3-11.

9. Bacon TH, Boyd MR. Activity of penciclovir against Epstein-Barr virus. Antimicrob Agents Chemother. 1995; 39:1599-1602. [IDIS 350501] [PubMed 7492112]

10. Gnann JW Jr. New antivirals with activity against varicella-zoster virus. Ann Neurol. 1994; 34:S69-72.

11. Kulikowski T. Structure-activity relationships and conformational features of antiherpetic pyrimidine and purine nucleoside analogues: a review. Pharm World Sci. 1994; 16:127-138. [IDIS 331981] [PubMed 8032338]

12. Anon. Topical penciclovir for herpes labialis. Med Lett Drugs Ther. 1997; 39:57-8. [PubMed 9205430]

13. Hasegawa T, Kurokawa M, Yukawa TA et al. Inhibitory action of acyclovir (ACV) and penciclovir (PCV) on plaque formation and partial cross-resistance of ACV-resistant varicella-zoster virus to PCV. Antiviral Res. 1995; 27:271-9. [PubMed 8540749]

14. Safrin S, Phan L. In vitro activity of penciclovir against clinical isolates of acyclovir-resistant and foscarnet-resistant herpes simplex virus. Antimicrob Agents Chemother. 1993; 37:2241-3. [IDIS 320621] [PubMed 8257152]

15. Talarico CL, Phelps WC, Biron KK. Analysis of the thymidine kinase genes from acyclovir-resistant mutants of varicella-zoster virus isolated from patients with AIDS. J Virol. 1993; 67:1024-33. [PubMed 8380452]

16. Centers for Disease Control and Prevention. 1993 Sexually transmitted diseases guidelines. 1993; 42(Suppl RR-14):22-5.

17. Shaw M, King M, Best JM et al. Failure of acyclovir cream in treatment of recurrent herpes labialis. BMJ. 1985; 291:7-9. [IDIS 202407] [PubMed 3926067]

18. Spruance SL, Crumpacker CS, Schnipper LE et al. Early, patient-initiated treatment of herpes labialis with topical 10% acyclovir. Antimicrob Agents Chemother. 1984; 25: 553-5. [IDIS 185372] [PubMed 6732224]

19. Spruance SL, Schnipper LE, Overall JC et al. Treatment of herpes simplex labialis with topical acyclovir in polyethylene glycol. J Infect Dis. 1982; 146:85-90. [IDIS 153489] [PubMed 7045255]

20. FDA summary basis of approval.

21. SmithKline Beecham, Philadelphia, PA: Personal communication.

More Denavir resources

• Denavir Side Effects (in more detail)
• Denavir Use in Pregnancy & Breastfeeding
• Denavir Support Group
• 7 Reviews for Denavir - Add your own review/rating

• Denavir Prescribing Information (FDA)


• Denavir Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Denavir MedFacts Consumer Leaflet (Wolters Kluwer)


• Denavir Consumer Overview

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