Epivir HBV

Generic Name: lamivudine (Oral route)

la-MIV-ue-deen

Oral route(Tablet;Solution)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Severe acute exacerbations of hepatitis B have been reported in patients who have hepatitis B infection or are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy. EPIVIR(R) tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV(R) tablets and oral solution (used to treat chronic hepatitis B). Patients with HIV infection should receive only dosage forms appropriate for treatment of HIV-1. EPIVIR-HBV(R) tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR(R) tablets and oral solution used to treat HIV infection. If treatment with EPIVIR-HBV(R) is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy .

Commonly used brand name(s)

In the U.S.

• Epivir


• Epivir A/F


• Epivir HBV

In Canada

• 3tc


• Heptovir

Available Dosage Forms:

• Solution


• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Epivir HBV

Lamivudine is used in the treatment of the infection caused by the human immunodeficiency virus (HIV) or hepatitis B virus. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Lamivudine is taken together with zidovudine (AZT) or other medications used to treat HIV.

Lamivudine will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lamivudine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease. Lamivudine is not a cure for the hepatitis B virus; the long-term effects of the drug on the infection and the liver are unknown at this time.

Lamivudine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, lamivudine is used in certain patients with the following medical condition:

• Human immunodeficiency virus (HIV) infection due to occupational exposure (possible prevention of)

Before Using Epivir HBV

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Lamivudine can cause serious side effects. In one study, children with advanced AIDS were more likely than children who were less ill to develop pancreatitis (inflammation of the pancreas) and peripheral neuropathy (a problem involving the nerves). Therefore, it is especially important that you discuss with your child's doctor the good that this medicine may do as well as the risks of using it. Your child must be seen frequently and your child's progress carefully followed by the doctor while the child is taking lamivudine.

Geriatric

Lamivudine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults. Talk to your doctor first if you have liver, kidney, heart problems or other diseases. Your doctor may need to adjust your dose.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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 this medicine, 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 this medicine 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.

• Interferon Alfa


• Ribavirin


• Zalcitabine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Combined infection of HIV and hepatitis B—May make the condition of either of these infections worse

• Diabetes mellitus (sugar diabetes)—Lamivudine oral solution contains sucrose

• Hepatitis C or


• Hepatitis delta—Caution should be used; lamivudine safety has not been determined in patients who have hepatitis infections

• Human immunodeficiency virus—For patients with hepatitis B virus, your physician will talk to you about HIV before you begin taking lamivudine. You may be tested for HIV. Lamivudine tablets and oral solution for hepatitis B virus contain lower amounts of the drug than the tablets and solution for HIV. If you start on the lower-dose medication and later learn that you have HIV, the higher-dose lamivudine may not then be effective against the infection caused by HIV.


• Inflamed pancreas or


• Problems with inflamed pancreas in the past or


• Other risk factors for developing an inflamed pancreas or


• Nerve damage—These conditions may occur or worsen when taking lamivudine

• Kidney disease—Patients with kidney disease may have an increased chance of side effects

• Liver disease or


• Risk factors for liver disease or


• Obesity (being overweight)—This medicine may make liver disease worse in patients with liver disease, obesity and other HIV medicine use.

• Organ transplant—Caution should be used; lamivudine safety has not been determined in patients who have received an organ transplant

Proper Use of lamivudine

This section provides information on the proper use of a number of products that contain lamivudine. It may not be specific to Epivir HBV. Please read with care.

Take this medicine exactly as directed by your doctor. 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. Also, do not stop taking lamivudine or zidovudine without checking with your doctor first.

Keep taking lamivudine for the full time of treatment , even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses . If you need help in planning the best times to take your medicine, check with your health care professional.

If you are using lamivudine oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid. The lamivudine oral suspension contains sucrose. Tell your doctor if you are diabetic before you start taking this medicine.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing

The dose of this medicine 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 this medicine. 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 forms (oral solution and tablets):
  
  • For treatment of hepatitis B infection:
    
    • Adults —100 milligrams (mg) once a day.
    
    
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of HIV infection or AIDS:
    
    • Adults weighing 50 kilograms (kg) (110 pounds) or more—150 milligrams (mg) twice a day together with other HIV medications.
    
    
    • Adults weighing less than 50 kg (110 pounds)—2 mg per kg of body weight twice a day together with other HIV medications.
    
    
    • Children 3 months to 16 years of age—4 mg per kg of body weight, up to 150 mg per dose, twice a day together with other HIV medications.
    
    
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Note: Patients that require treatment for both hepatitis B and either AIDS or HIV should follow the dosing schedule for HIV or AIDS

Missed Dose

If you miss a dose of this medicine, 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.

Precautions While Using Epivir HBV

It is very important that your doctor check your progress at regular visits.

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from lamivudine.

If you have both HIV and hepatitis B virus (HBV) infections, deterioration of liver disease has occurred when lamivudine treatment is stopped. Discuss any changes in your treatment and medicines with your doctor.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Epivir HBV 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—especially in children

• Abdominal or stomach pain (severe)


• feeling of fullness


• nausea


• sensation or pins and needles


• skin rash


• stabbing pain


• tingling, burning, numbness, or pain in the hands, arms, feet, or legs


• unsteadiness or awkwardness


• vomiting

Rare

• Abdominal discomfort


• decreased appetite


• diarrhea


• fast, shallow breathing


• feeling of fullness


• fever, chills, or sore throat


• general feeling of discomfort


• muscle pain or cramping


• nausea


• shortness of breath


• sleepiness


• unusual tiredness or weakness

Incidence not determined

• Cough


• dark urine


• difficulty swallowing


• dizziness


• fast heartbeat


• fever


• hives or welts


• itching


• light-colored stools


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


• redness of skin


• tightness in chest


• upper right abdominal pain


• wheezing


• yellow eyes and skin

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

• Canker sores


• difficulty in moving


• discouragement


• ear discharge


• ear swelling


• feeling sad or empty


• general feeling of discomfort or illness


• irritability


• loss of appetite


• loss of interest or pleasure


• nasal discharge or congestion


• pain in joints


• sores, ulcers, or white spots on lips or tongue or inside the mouth


• stomach pain or cramps


• swollen and painful spots on neck, armpit, or groin


• swollen joints


• trouble concentrating


• trouble sleeping


• unusually warm skin


• weight loss

Less common

• Acid or sour stomach


• belching


• cough


• heartburn


• indigestion


• stomach discomfort or upset

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: Epivir HBV side effects (in more detail)

Incidence not determined

• Body fat redistribution or accumulation


• blurred vision


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• hair loss


• increased hunger or thirst


• increased urination


• sweating


• thinning of hair

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Epivir HBV resources

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

• Epivir Prescribing Information (FDA)


• Epivir Consumer Overview


• Epivir MedFacts Consumer Leaflet (Wolters Kluwer)


• Lamivudine Prescribing Information (FDA)


• Lamivudine Monograph (AHFS DI)

Compare Epivir HBV with other medications

• Hepatitis B
• HIV Infection
• Nonoccupational Exposure
• Occupational Exposure

Flurbiprofen Sodium eent

Class: Nonsteroidal Anti-inflammatory Agents
ATC Class: S01BC04
VA Class: OP900
Molecular Formula: C₁₅H₁₃FO₂•Na
CAS Number: 56767-76-1
Brands: Ocufen

Introduction

Prototypical NSAIA; propionic acid derivative.^{1 2 3 4 16 17 18 19 20 21 23}

Uses for Flurbiprofen Sodium

Inhibition of Intraoperative Miosis

Prophylactically before ocular surgery (e.g., cataract extraction)^{74 102} to prevent or reduce intraoperative miosis.^{1 74 102}

Postoperative Ocular Inflammation

Has been used for prevention and management of postoperative ocular inflammation† associated with argon laser trabeculoplasty and cyclocryotherapy.^{75 76 78}

Cystoid Macular Edema

Has been used for prevention of postoperative cystoid macular edema† associated with cataract extraction.^{48 120}

Inhibition of Corneal Neovascularization

Has been reported to inhibit corneal neovascularization† induced by chemical or thermal burns or prolonged use of contact lenses in preliminary research in animals.^{79 80 81 121}

Flurbiprofen Sodium Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.^{1 74}

Avoid contamination of the solution container.⁹⁴

Dosage

Available as flurbiprofen sodium; dosage expressed in terms of flurbiprofen sodium.^{1 113}

Adults

Inhibition of Intraoperative Miosis

Ophthalmic

1 drop of 0.03% solution into the eye(s) undergoing surgery beginning 2 hours before the surgery; repeat at approximately 30-minute intervals for a total of 4 drops per affected eye.¹

Cautions for Flurbiprofen Sodium

Contraindications

Known hypersensitivity to flurbiprofen sodium or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Hematologic Effects

May inhibit platelet aggregation and prolong bleeding time.^{1 4 28 29 30 31 32 33}

May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.¹

Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.¹ (See Specific Drugs under Interactions.)

Sensitivity Reactions

Hypersensitivity Reactions

Possible cross-sensitivity with aspirin and other NSAIAs.^{1 3} Use with caution in patients with history of hypersensitivity to these drugs (severe, nearly fatal anaphylactic reaction to oral flurbiprofen reported)⁸⁶ and in whom asthma, rhinitis, or urticaria is precipitated by aspirin or other NSAIAs.^{1 3}

General Precautions

Wound-healing Complications

May slow or delay wound healing (including corneal).^{1 84}

Ocular Effects

Exacerbation of active epithelial herpes simplex keratitis (dendritic keratitis), more severe conjunctivitis, corneal perforation, and/or clouding of cornea reported in animals.⁸⁵ Use with extreme caution in patients with active epithelial herpes simplex keratitis.¹⁰³

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk after systemic administration;^{117 118} not known whether distributed into milk after topical application to the eye.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Common Adverse Effects

Ocular stinging,^{1 74 101} burning,^{1 76 78 101} or discomfort⁷⁸ and other minor symptoms of ocular irritation¹ (e.g., tearing, dry eye sensation, dull eye pain, photophobia);^{101 103 105} itching;^{78 101 105} foreign body sensation;^{78 105} fibrosis;¹ miosis;¹ and mydriasis.¹

Interactions for Flurbiprofen Sodium

Interactions with other topical ophthalmic drugs not fully evaluated.¹

Specific Drugs

Drug	Interaction	Comments
Acetylcholine chloride	Diminished miotic effect reported when used with flurbiprofen, although recent clinical and animal studies suggest no interaction1 115 116
Anesthetics, local (e.g., benoxinate, capsaicin)	Additive effects on miotic inhibition during ocular surgery demonstrated in animals40
Anticoagulants	Possible bleeding complications1	Use with caution1
Carbachol	Diminished miotic effect reported when used with flurbiprofen, although recent clinical and animal studies suggest no interaction1 115 116

Flurbiprofen Sodium Pharmacokinetics

Absorption

Bioavailability

Ophthalmic: Absorbed through the aqueous humor.¹¹⁹ Extent of systemic absorption not fully elucidated.^{1 101 104}

Distribution

Extent

Distribution into human ocular tissues and fluids not fully characterized to date.^{101 103 104}

Not known whether flurbiprofen crosses the placenta.¹⁰³ Distributed into milk after systemic administration;^{117 118} not known whether distributed into milk after topical application to the eye.¹

Plasma Protein Binding

≥99% (mainly albumin).^{3 67 69}

May bind to erythrocytes.⁶⁸

Stability

Storage

Ophthalmic

Solution

Tight, light-resistant containers¹⁰⁵ at 15–25°C.¹

ActionsActions

• 
  

  Systemic pharmacologic actions similar to other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.^{1 3 7 8 10 11 12 14 15 16 17 21 26 27} However, risk of systemic effects appears minimal following topical ophthalmic use.^{1 74 75 76 78 103 105}

  
  


• 
  

  Exact mechanism of ocular effects not clearly established, but inhibits ocular prostaglandin synthesis by inhibiting COX-1 and COX-2.^{1 3 4 18 19 20 21 23 24 25 35 36 37 39 40 43 45 51 52 59 64 74 101 107 108 109 110 111 112}

  
  


• 
  

  Prostaglandins are mediators of intraocular and extraocular inflammation.^{1 35 36 37 39 40 52 57 58 74 75 76} Prostaglandins also appear to produce a miotic response during ocular surgery by constricting the iris sphincter^{1 35 51 64 74} independently of cholinergic mechanisms.^{1 74}

  
  


• 
  

  Following topical application to the eye, flurbiprofen inhibits or reduces miosis^{1 35 40 74 102} and ocular inflammation^{75 76 78 84 120} induced by ocular trauma (e.g., ocular surgery).

  
  

Advice to Patients

• 
  

  Risk of ocular bleeding.¹ Risk of anaphylactoid and other sensitivity reactions.¹

  
  


• 
  

  Importance of learning and adhering to proper administration techniques to avoid contamination of the product.⁹⁴

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Flurbiprofen Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.03%	Flurbiprofen Sodium Ophthalmic Solution (with thimerosal)	Bausch & Lomb
			Ocufen (with thimerosal)	Allergan

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 August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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2. Reynolds JEF, ed. Martindale: the extra pharmacopoeia. 28th ed. London: The Pharmaceutical Press; 1982:255.

3. Brogden RN, Heel RC, Speight TM et al. Flurbiprofen: a review of its pharmacological properties and therapeutic use in rheumatic diseases. Drugs. 1979; 18:417-38. [IDIS 106659] [PubMed 391529]

4. Adams SS, Buckler JW. Ibuprofen and flurbiprofen. Clin Rheum Dis. 1979; 5:359-79.

5. Mimnaugh MN, Gearien JE. Nonsteroidal anti-inflammatory agents. In: Foye WO, ed. Principles of medicinal chemistry. 2nd ed. Philadelphia: Lea & Febiger; 1981:561-90.

6. Flower RJ, Moncada S, Vane JR. Analgesic-antipyretics and anti-inflammatory agents; drugs employed in the treatment of gout. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:674-715.

7. Moncada S, Roderick JF, Vane JR. Prostaglandins, prostacyclin, thromboxane A2, and leukotrienes. In: Gilman AG, Goodman L, Rall TW et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:660-73.

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11. O’Brien WM. Pharmacology of nonsteroidal anti-inflammatory drugs: practical review for clinicians. Am J Med. 1983; 75(Suppl 4B):32-9.

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14. Robert A. Cytoprotection by prostaglandins. Gastroenterology. 1979; 77:761-7. [PubMed 38173]

15. Miller TA, Jacobson ED. Gastrointestinal cytoprotection by prostaglandins. Gut. 1979; 20:75-87. [PubMed 367886]

16. Glenn EM, Rohloff N, Bowman BJ et al. The pharmacology of 2-(2-fluoro-4-biphenylyl)propionic acid (flurbiprofen): a potent non-steroidal anti-inflammatory drug. Agents Actions. 1973; 3:210-6. [PubMed 4776365]

17. Adams SS, McCullough KF, Nicholson JS. Some biological properties of flurbiprofen, an anti-inflammatory, analgesic and antipyretic agent. Arzneimittelforschung. 1975; 25:1786-91. [PubMed 1081878]

18. Nozu K. Flurbiprofen: highly potent inhibitor of prostaglandin synthesis. Biochim Biophys Acta. 1978; 529:493-6. [PubMed 96864]

19. Crook D, Collins AJ, Rose AJ. A comparison of the effect of flurbiprofen on prostaglandin synthetase from human rheumatoid synovium and enzymatically active animal tissues. J Pharm Pharmacol. 1976; 28:535. [PubMed 7661]

20. Ford-Hutchinson AW, Walker JR, Connor NS et al. Separate anti-inflammatory effects of indomethacin, flurbiprofen and benoxaprofen. J Pharm Pharmacol. 1977; 29:372-3. [PubMed 18578]

21. Adams SS. Some aspects of the pharmacology and pharmacokinetics of flurbiprofen. Drugs Exp Clin Res. 1977; 2:27-33.

22. Ringrose PS, Parr MA, McLaren M. Effects of anti-inflammatory and other compounds on the release of lysosomal enzymes from macrophages. Biochem Pharmacol. 1975; 24:607-14. [PubMed 164870]

23. Fitzpatrick FA, Wynalda MA. In vivo suppression of prostaglandin biosynthesis by non-steroidal anti-inflammatory agents. Prostaglandins. 1976; 12:1037-51. [PubMed 1005736]

24. Blackham A, Owen RT. Prostaglandin synthetase inhibitors and leucocytic emigration. J Pharm Pharmacol. 1975; 27:201-3. [PubMed 238006]

25. Adams SS, Burrows CA, Skeldon N et al. Inhibition of prostaglandin synthesis and leucocyte migration by flurbiprofen. Curr Med Res Opin. 1977; 5:11-6. [PubMed 410589]

26. Vakil BJ, Kulkarni RD, Kulkarni VN et al. Estimation of gastro-intestinal blood loss in volunteers treated with non-steroidal anti-inflammatory agents. Curr Med Res Opin. 1977; 5:32-7. [PubMed 334471]

27. Vakil BJ, Shah PN, Dalal NJ et al. Endoscopic study of gastro-intestinal injury with non-steroidal anti-inflammatory drugs. Curr Med Res Opin. 1977; 5:38-42. [PubMed 334472]

28. Sim AK, McCraw AP, Sim MF. An evaluation of the effect of flurbiprofen [2-(2-fluoro-4-biphenylyl) propionic acid] on platelet behaviour. Thromb Res. 1975; 7:655-68. [PubMed 1198551]

29. Davies T, Lederer DA, Spencer AA et al. The effect of flurbiprofen [2-(2-fluoro-4-biphenylyl) propionic acid] on platelet function and blood coagulation. Thromb Res. 1974; 5:667-83. [PubMed 4445988]

30. Gupta KC, Manikeri S, Paul T et al. Effect of RH-8, flurbiprofen and aspirin on platelet function and coagulation. Ind J Med Res. 1979; 69:181-8.

31. Abe T, Goto H, Imaoka S et al. Influence of flurbiprofen on platelet aggregation. Part I: Metabolic and ultrastructural studies in vitro. Acta Haem Jap. 1978; 41:111-26.

32. Nishizawa EE, Wynalda DJ, Suydam DE et al. Flurbiprofen, a new potent inhibitor of platelet aggregation. Thromb Res. 1973; 3:577-88.

33. Nishizawa EE, Wynalda DJ, Suydam DE. Effect of flurbiprofen on platelet function. Thromb Diath Haemorrh. 1974; 60:415-23.

34. Cremoncini CM, Libroia A, Valente C et al. Flurbiprofen and thyroid function tests. Br J Clin Pract. 1984; 38:399-402. [IDIS 197818] [PubMed 6397221]

35. Havener WH. Ocular pharmacology. 5th ed. St. Louis: The CV Mosby Company; 1983:18-43,223-35.

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• Inhibition of Intraoperative Miosis
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Vicodin

Generic Name: hydrocodone bitartrate and acetaminophen

Dosage Form: tablet
Vicodin®

(hydrocodone bitartrate and acetaminophen tablets, USP)

5 mg/500 mg

CS-III

boxed Warning

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

Vicodin Description

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

C18H21NO3•C4H6O6•2½H2O   M.W. 494.50

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2    M.W. 151.16

Each Vicodin tablet contains:

Hydrocodone Bitartrate 5 mg

Acetaminophen 500 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, starch, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, and stearic acid.

Meets USP Dissolution Test 2.

Vicodin - Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.

The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Pharmacokinetics

The behavior of the individual components is described below.

Hydrocodone

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxy-metabolites. See OVERDOSAGE for toxicity information.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See OVERDOSAGE for toxicity information.

Indications and Usage for Vicodin

Vicodin tablets are indicated for the relief of moderate to moderately severe pain.

Contraindications

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

Warnings

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritis, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Vicodin Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Vicodin Tablets for patients with acetaminophen allergy.

Respiratory Depression

At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Misuse, Abuse, and Diversion of Opioids

Vicodin tablets contains hydrocodone an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

Vicodin tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Vicodin tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE ).

Precautions

General

Special Risk Patients

As with any narcotic analgesic agent, Vicodin Tablets should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Cough Reflex

Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Vicodin Tablets are used postoperatively and in patients with pulmonary disease.

Information for Patients/Caregivers

• Do not take Vicodin Tablets if you are allergic to any of its ingredients.


• If you develop signs of allergy such as a rash or difficulty breathing stop taking Vicodin Tablets and contact your healthcare provider immediately.


• Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Hydrocodone, like all narcotics, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Hydrocodone may be habit forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

Patients receiving other narcotic analgesics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Vicodin Tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Vicodin Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

Labor and Delivery

As with all narcotics, administration of Vicodin Tablets to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use

Clinical studies of Vicodin (hydrocodone bitartrate 5 mg and acetaminophen 500 mg) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

Adverse Reactions

The most frequently reported adverse reactions include: lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

Central Nervous System

Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System

Prolonged administration of Vicodin Tablets may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Respiratory Depression

Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. (see OVERDOSAGE).

Special Senses

Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Dermatological

Skin rash, pruritus.

The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Potential effects of high dosage are listed in the OVERDOSAGE section.

Drug Abuse and Dependence

Misuse, Abuse, and Diversion of Opioids

Vicodin contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Vicodin, and other opioids used in analgesia can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Vicodin, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Overdosage

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

Signs and Symptoms

Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment

A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

For hydrocodone overdose, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Vicodin Dosage and Administration

Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

How is Vicodin Supplied

Vicodin is supplied as white, capsule-shaped tablets containing 5 mg hydrocodone bitartrate and 500 mg acetaminophen, bisected on one side and debossed with "Vicodin" on the other.

Bottles of 100-NDC 0074-1949-14.

Bottles of 500-NDC 0074-1949-54.

Hospital Unit Dose Package-100 tablets (4 × 25 tablets)-NDC 0074-1949-12.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

A Schedule CS-III controlled drug substance.

©Abbott

Manufactured for

Abbott Laboratories

North Chicago, IL 60064 U.S.A.

by Halo Pharmaceutical Inc.

Whippany, NJ 07981 U.S.A.

Rev. 09/2011

NDC 0074–1949–12

100 Tablets

Abbo-Pac®

Vicodin®

hydrocodone bitartrate and acetaminophen tablets, USP

Each tablet contains:

hydrocodone bitartrate ........................ 5 mg

acetaminophen ................................ 500 mg

Tamper-Evident: Do not accept if sealed blister unit has been broken or opened.

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only Abbott

NDC 0074–1949–14

100 Tablets

Vicodin®

hydrocodone bitartrate and acetaminophen tablets, USP

Each tablet contains:

hydrocodone bitartrate 5 mg

acetaminophen 500 mg

Rx only Abbott

Vicodin  hydrocodone bitartrate and acetaminophen  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0074-1949 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   CROSCARMELLOSE SODIUM   POVIDONE   STEARIC ACID

Product Characteristics Color WHITE Score 2 pieces Shape CAPSULE Size 17mm Flavor Imprint Code Vicodin Contains

Packaging # NDC Package Description Multilevel Packaging 1 0074-1949-14 100 TABLET In 1 BOTTLE None 2 0074-1949-54 500 TABLET In 1 BOTTLE None 3 0074-1949-12 4 BLISTER PACK In 1 BOX contains a BLISTER PACK 3 25 TABLET In 1 BLISTER PACK This package is contained within the BOX (0074-1949-12)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088058	01/07/1983

Labeler - Abbott Laboratories (001307602)

Revised: 10/2011Abbott Laboratories

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