Carbaglu

Pronunciation: kar-GLOO-mik AS-id
Generic Name: Carglumic Acid
Brand Name: Carbaglu

Carbaglu is used for:

Treating high blood ammonia levels that are caused by the lack of a certain liver enzyme (n-acetylglutamate synthase [NAGS]). It may be used along with other medicines or methods for lowering blood ammonia levels.

Carbaglu is similar to n-acetylglutamate (NAG), a substance which activates the process that removes ammonia from the blood. Carbaglu works by acting as a replacement for NAG in patients who cannot produce it on their own.

Do NOT use Carbaglu if:

• you are allergic to any ingredient in Carbaglu

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

Before using Carbaglu:

Some medical conditions may interact with Carbaglu. 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

Some MEDICINES MAY INTERACT with Carbaglu. However, no specific interactions with Carbaglu are known at this time.

Ask your health care provider if Carbaglu 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 Carbaglu:

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

• Take Carbaglu by mouth immediately before meals.


• Do not swallow Carbaglu whole or crush the tablet.


• Mix each tablet in at least one-half teaspoon (2.5 mL) of water. The tablet may not dissolve completely. Swallow Carbaglu immediately after mixing.


• Rinse the container with water right away and swallow the rinse to be sure you receive the complete dose.


• Do not use any liquid other than water to mix Carbaglu.


• Check with your pharmacist about how to give Carbaglu if you will be using an oral syringe or a nasogastric (NG) tube.


• If you miss a dose of Carbaglu, 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 Carbaglu.

Important safety information:

• Follow the diet program given to you by your healthcare provider.


• Lab tests, including blood ammonia levels, may be performed while you use Carbaglu. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Carbaglu should be used with caution in the ELDERLY; safety and effectiveness in the elderly have not been established.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Carbaglu while you are pregnant. It is not known if Carbaglu is found in breast milk. Do not breast-feed while taking Carbaglu.

Possible side effects of Carbaglu:

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:

Changes in taste; diarrhea; drowsiness; headache; sore throat; stomach pain; vomiting.

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); ear pain; fever or chills; increased sweating; loss of appetite; severe or persistent sore throat; unusual tiredness or weakness.

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: Carbaglu 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. Symptoms may include fast heartbeat, fever, increased phlegm production, increased sweating, or restlessness.

Proper storage of Carbaglu:

Store unopened bottles of Carbaglu in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After the bottle has been opened, do not refrigerate. Store opened bottles of Carbaglu at room temperature below 86 degrees F (30 degrees C) away from heat, moisture, and light. Keep the bottle tightly closed. Do not store in the bathroom. Write the date of opening on the bottle. Throw away any medicine that is left 1 month after opening or if the expiration date on the bottle has passed, whichever is earlier. Keep Carbaglu out of the reach of children and away from pets.

General information:

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


• Carbaglu 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 Carbaglu. 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 Carbaglu resources

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

• Carbaglu Consumer Overview


• Carbaglu Prescribing Information (FDA)


• carglumic acid Advanced Consumer (Micromedex) - Includes Dosage Information


• Carglumic Acid Professional Patient Advice (Wolters Kluwer)

Compare Carbaglu with other medications

• Hyperammonemia

Videx

Generic Name: Didanosine
Class: Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: 2′,3′-Dideoxyinosine
CAS Number: 69655-05-6

• 
  

  Fatal and nonfatal pancreatitis reported.^{1 248} Temporarily interrupt didanosine therapy in patients with suspected pancreatitis; discontinue in patients with confirmed pancreatitis.^{1 248} (See Pancreatitis under Cautions.)

  
  


• 
  

  Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.^{1 248} (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

  
  


• 
  

  Fatal lactic acidosis reported in pregnant women receiving didanosine and stavudine with other antiretrovirals.^{1 248} Didanosine in conjunction with stavudine should be used with caution in pregnant women and only if potential benefits outweigh potential risks.^{1 248} (See Pregnancy under Cautions.)

  
  

REMS:

FDA approved a REMS for didanosine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antiretroviral; nucleoside reverse transcriptase inhibitor (NRTI).^{1 2 3 8 21 30 34 36 40 44 72}

Uses for Videx

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals.^{1 248}

Used in 3-drug antiretroviral regimens that include another NRTI (dual NRTIs) and either a nonnucleoside reverse transcriptase inhibitor (NNRTI) or an HIV protease inhibitor (PI) (NNRTI- or PI-based regimens).^{165 207} Monotherapy or 2-drug regimens that include only NRTIs are no longer recommended for treatment of HIV infection in adults, adolescents, or children.^{165 207}

For initial therapy in adults and adolescents, some experts state that didanosine in conjunction with either emtricitabine or lamivudine is an acceptable (not a preferred or alternative) dual NRTI option for use in conjunction with efavirenz in an NNRTI-based regimen.²⁰⁷ Acceptable dual NRTI options may be selected for some patients, but are less satisfactory than preferred or alternative dual NRTI options.²⁰⁷

When PI- or NNRTI-based regimens are used in children, some experts state that didanosine and emtricitabine is a preferred dual NRTI option and didanosine and zidovudine is an alternative dual NRTI option.¹⁶⁵

Because of insufficient data in treatment-naive patients, the dual NRTI option of didanosine and abacavir is not recommended for use in initial antiretroviral regimens in adults and adolescents.²⁰⁷

The dual NRTI option of didanosine and tenofovir is not recommended for use in initial regimens in treatment-naive adults and adolescents because limited data indicate such regimens are associated with early virologic failure, rapid selection of resistant mutations, and potential for immunologic nonresponse or decline in CD4⁺ T-cell counts.²⁰⁷

The dual NRTI option of didanosine and stavudine has been associated with a high incidence of toxicities (e.g., peripheral neuropathy, pancreatitis, lactic acidosis)^{1 207 212 248} and is not recommended except in special circumstances when there are no other options and potential benefits outweigh risks.^{1 165 207 212 248} (See Pregnancy under Cautions.)

Postexposure Prophylaxis of HIV

Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with risk for transmission of the virus.⁹⁵ Used in conjunction with other antiretrovirals.⁹⁵

Postexposure prophylaxis of HIV infection† in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission.²⁵⁸ Used in conjunction with other antiretrovirals.²⁵⁸

Videx Dosage and Administration

Administration

Oral Administration

Delayed-release capsules containing enteric-coated pellets of didanosine are administered once daily without food and should be swallowed intact.²⁴⁸

Didanosine pediatric oral solution admixed with antacid is administered orally at least 30 minutes before or 2 hours after a meal.^{1 165 207} The pediatric oral solution is administered twice daily in children.¹ Twice-daily administration also preferred in adults and adolescents,^{1 165 207} but a once-daily regimen of the oral solution can be considered in adults and adolescents if needed.^{1 165}

Reconstitution and Dilution

The pediatric powder for oral solution must be reconstituted and admixed with an antacid at time of dispensing.¹ Reconstitute by adding 100 or 200 mL of water to the bottle containing 2 or 4 g of didanosine, respectively, to provide a solution containing 20 mg/mL.¹ Immediately after reconstitution, mix the 20-mg/mL solution with an equal amount of Maximum Strength Mylanta oral liquid to provide a final admixture containing 10 mg/mL.¹ Shake the final admixture thoroughly prior to removing each dose.¹

Dosage

Adult dosage is based on weight.^{1 248} Dosage in pediatric patients is based on body surface area or weight.^{1 248}

Delayed-release capsules are used in adults and also can be used in children weighing ≥20 kg who can swallow capsules.²⁴⁸ Pediatric oral solution generally used in children, but may be used in adults.¹

Must be given in conjunction with other antiretrovirals.^{1 248} If used with atazanavir, darunavir, delavirdine, indinavir, lopinavir, nelfinavir, tenofovir, or tipranavir, adjustment in the treatment regimen necessary.^{1 248} (See Specific Drugs under Interactions.)

Pediatric Patients

Treatment of HIV Infection

Oral

Pediatric oral solution admixed with antacid: Infants and children 2 weeks through 8 months of age: 100 mg/m² twice daily.^{1 165}

Pediatric oral solution admixed with antacid: Children >8 months of age: 120 mg/m² twice daily.^{1 165}

Pediatric oral solution admixed with antacid: Adolescents: 200 mg twice daily in those weighing ≥60 kg or 125 mg twice daily in those weighing <60 kg.¹⁶⁵ Alternatively, in adolescents whose management requires once-daily dosing, 400 mg once daily in those weighing ≥60 kg or 250 mg once daily in those weighing <60 kg.¹⁶⁵

Delayed-release capsules: Children and adolescents weighing 20 to <25 kg: 200 mg once daily.^{165 248}

Delayed-release capsules: Children and adolescents weighing 25 to <60 kg: 250 mg once daily.^{165 248}

Delayed-release capsules: Children and adolescents weighing ≥60 kg: 400 mg once daily.^{165 248}

Adults

Treatment of HIV Infection

Treatment in Adults Weighing <60 kg

Oral

Delayed-release capsules: 250 mg once daily.^{207 248}

Pediatric oral solution admixed with antacid: 125 mg twice daily.¹ If once-daily administration required, 250 mg once daily.¹

Treatment in Adults Weighing ≥60 kg

Oral

Delayed-release capsules: 400 mg once daily.^{207 248}

Pediatric oral solution admixed with antacid: 200 mg twice daily.¹ If once-daily administration required, 400 mg once daily.¹

Postexposure Prophylaxis of HIV†

Occupational Exposure†

Oral

Delayed-release capsules: Adults weighing <60 kg: 250 mg once daily.^{95 207}

Delayed-release capsules: Adults weighing ≥60 kg: 400 mg once daily.^{95 207}

Initiate postexposure prophylaxis as soon as possible following exposure and continue for 4 weeks, if tolerated.⁹⁵

Nonoccupational Exposure†

Oral

Delayed-release capsules: Adults weighing <60 kg: 250 mg once daily.^{207 258}

Delayed-release capsules: Adults weighing ≥60 kg: 400 mg once daily.^{207 258}

Initiate postexposure prophylaxis as soon as possible following exposure (preferably ≤72 hours after exposure) and continue for 28 days.²⁵⁸

Special Populations

Renal Impairment

Treatment of HIV Infection

Oral

Dosage in Adults with Renal Impairment (Delayed-release Capsules)248

Clcr (mL/minute)	Weighing <60 kg	Weighing ≥60 kg
≥60	250 mg once daily	400 mg once daily
30–59	125 mg once daily	200 mg once daily
10–29	125 mg once daily	125 mg once daily
<10	Not recommended; use alternative didanosine formulation	125 mg once daily
Hemodialysis or CAPD Patients	Not recommended; use alternative didanosine formulation	125 mg once daily; supplemental doses unnecessary after hemodialysis

Dosage in Adults with Renal Impairment (Pediatric Oral Solution Admixed with Antacid)1

Clcr (mL/minute)	Weighing <60 kg	Weighing ≥60 kg
≥60	125 mg twice daily or 250 mg once daily	200 mg twice daily or 400 mg once daily
30–59	150 mg once daily or 75 mg twice daily	200 mg once daily or 100 mg twice daily
10–29	100 mg once daily	150 mg once daily
<10	75 mg once daily	100 mg once daily
Hemodialysis or CAPD Patients	75 mg once daily; supplemental doses unnecessary after hemodialysis	100 mg once daily; supplemental doses unnecessary after hemodialysis

Didanosine clearance may be decreased in pediatric patients with impaired renal function.^{1 248} Although data are insufficient to date to make specific dosage recommendations for pediatric patients with impaired renal function,^{1 248} manufacturer recommends that dosage reduction be considered.^{1 248}

Hepatic Impairment

Dosage adjustment not needed.^{1 248}

Cautions for Videx

Contraindications

• 
  

  Concomitant use with allopurinol.^{1 248} (See Specific Drugs under Interactions.)

  
  


• 
  

  Concomitant use with ribavirin.^{1 248} (See Specific Drugs under Interactions.)

  
  

Warnings/Precautions

Warnings

FDA required and approved a Risk Evaluation and Mitigation Strategy (REMS) for didanosine;²⁶⁹ goal of the didanosine REMS is to inform patients of the serious risks associated with the drug.²⁶⁹ The REMS requires that a didanosine medication guide be provided to the patient each time the drug is dispensed and requires the manufacturer to periodically submit REMS assessments to FDA.²⁶⁹

Pancreatitis

Fatal and nonfatal pancreatitis reported in patients receiving didanosine alone or in conjunction with other antiretrovirals in both treatment-naive and previously treated patients, regardless of degree of immunosuppression.^{1 19 29 34 36 39 41 44 47 49 69 145 248}

Interrupt didanosine therapy in patients with signs or symptoms of pancreatitis; discontinue the drug in patients with confirmed pancreatitis.^{1 248}

Use with extreme caution and only if clearly needed in patients at increased risk for pancreatitis, including those receiving didanosine in conjunction with stavudine and those with advanced HIV infection (especially geriatric individuals).^{1 248} Patients with renal impairment also are at increased risk for pancreatitis if didanosine dosage is not reduced.^{1 248}

Discontinue didanosine if treatment with a life-sustaining drug known to cause pancreatic toxicity is required.^{1 248}

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving NRTIs (including didanosine) alone or in conjunction with other antiretrovirals.^{1 65 82 129 248} Reported most frequently in women; obesity and long-term NRTI therapy also may be risk factors.^{1 248} Has been reported in patients with no known risk factors.^{1 248}

Reported in pregnant women receiving didanosine in conjunction with stavudine.^{1 248} (See Pregnancy under Cautions.)

Use with caution in patients with known risk factors for liver disease.^{1 248}

Interrupt didanosine therapy if there are clinical or laboratory findings suggestive of symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).^{1 248}

Other Warnings and Precautions

Noncirrhotic Portal Hypertension

Rare, but serious, cases of noncirrhotic portal hypertension reported in patients 10–66 years of age receiving didanosine; some cases resulted in liver transplantation or death.^{1 248 268 271}

Didanosine-associated noncirrhotic portal hypertension was confirmed by liver biopsy in patients with no evidence of viral hepatitis or other alternative etiologies.^{1 248 268}

Onset of signs and symptoms ranged from months to years after initiation of didanosine therapy; common presenting features included elevated liver enzymes, esophageal varices, hematemesis, ascites, and splenomegaly.^{1 248 268 271} Medical interventions consisted of banding or ligation of esophageal varices, transjugular intrahepatic portosystemic shunting (TIPSS), and liver transplantation.²⁶⁸ There were 4 deaths among 42 reported postmarketing cases.²⁶⁸

Although a causal relationship is difficult to determine, after excluding other causes of portal hypertension (e.g., alcohol-related cirrhosis, hepatitis C virus [HCV] infection), FDA concluded that there is an association between use of didanosine and development of noncirrhotic portal hypertension.²⁶⁸ However, FDA states that the clinical benefits of the drug for some patients continue to outweigh potential risks and that the decision to use didanosine must be made on an individual basis.²⁶⁸

Monitor patients for early signs of portal hypertension (e.g., thrombocytopenia, splenomegaly) and esophageal varices; consider use of appropriate laboratory tests (e.g., liver enzymes, serum bilirubin, albumin, CBC, INR, ultrasonography).^{1 248 271} Discontinue didanosine in patients with evidence of noncirrhotic portal hypertension.^{1 248 271}

Peripheral Neuropathy

Peripheral neuropathy, manifested by numbness, tingling, or pain in the hands or feet, reported; these effects occur more frequently in patients with advanced HIV, a history of neuropathy, or those receiving other neurotoxic drugs, including stavudine.^{1 248}

Consider discontinuance of didanosine if peripheral neuropathy occurs.^{1 248}

Ocular Effects

Retinal changes and optic neuritis reported in adults and pediatric patients.^{1 66 82 248} Consider periodic retinal examinations.^{1 248}

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.^{1 248}

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.^{1 248}

The mechanisms and long-term consequences of these adipogenic effects are unknown.^{1 248} A causal relationship has not been established.^{1 248}

Cardiovascular Effects

There is some evidence that recent use of didanosine (within 6 months) is associated with an increased risk of MI.^{207 267}

Specific Populations

Pregnancy

Category B.^{1 248}

Antiretroviral Pregnancy Registry at 800-258-4263.^{1 248}

An alternative (not a preferred) NRTI for dual NRTI option for use in multiple-drug antiretroviral regimens in pregnant women.²¹²

Fatal lactic acidosis reported in pregnant women receiving didanosine and stavudine with other antiretrovirals.^{1 248} Unclear whether pregnancy potentates risk of lactic acidosis and severe hepatotoxicity with steatosis that occurs in NRTI-treated individuals.^{1 248} The dual NRTI option of didanosine and stavudine should be used with caution in pregnant women and only if there are no other treatment options and potential benefits outweigh risks.^{1 212 248}

Clinicians caring for pregnant patients receiving didanosine should be alert for early diagnosis of lactic acidosis and hepatitis steatosis syndrome.^{1 248}

Lactation

Didanosine and/or its metabolites distributed into milk in rats; not known whether distributed into human milk.^{1 248}

Instruct HIV-infected women not to breast-feed^{1 212 248} because of risk of HIV transmission and risk of adverse effects in the infant.^{1 248}

Pediatric Use

Delayed-release capsules: Use in children weighing ≥20 kg supported by pharmacokinetic data.²⁴⁸

Pediatric oral solution admixed with antacid: Safety and efficacy in pediatric patients 2 weeks of age through adolescence supported by evidence from adequate and well-controlled studies in adult and pediatric patients.¹

Adverse effects reported in pediatric patients 2 weeks through 18 years of age are similar to those in adults and include pancreatitis, peripheral neuropathy, ophthalmic effects, GI effects, and hepatic effects.^{1 35 45 131 237}

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.^{1 248}

Substantially eliminated by kidneys; risk of toxic reactions may be greater in patients with decreased renal function.^{1 248} Consider age-related decreases in renal function when selecting dose.^{1 248} Monitor renal function and adjust dosage as necessary.^{1 248}

Hepatic Impairment

Safety and efficacy not evaluated in patients with clinically important underlying liver disease; risk of liver function abnormalities, including severe and potentially fatal adverse hepatic events, in patients with underlying liver dysfunction (e.g., chronic active hepatitis).^{1 248}

Use with caution and monitor patients with liver disease.^{1 248} Interrupt or discontinue if liver disease worsens.^{1 248}

Because noncirrhotic portal hypertension has been reported rarely in patients receiving didanosine,^{1 248 268 271} monitor patients for early signs of portal hypertension (e.g., thrombocytopenia, splenomegaly) and esophageal varices; consider obtaining appropriate laboratory tests (e.g., liver enzymes, serum bilirubin, albumin, CBC, INR, ultrasonography).^{1 248 271} Discontinue didanosine if there is evidence of noncirrhotic portal hypertension.^{1 248 271} (See Noncirrhotic Portal Hypertension under Cautions.)

Renal Impairment

Risk of toxic reactions may be greater in patients with decreased renal function.^{1 248}

Dosage adjustment needed based on degree of renal impairment.^{1 248} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Diarrhea, peripheral neurologic symptoms/neuropathy, rash/pruritus, nausea, headache, vomiting, abdominal pain, pancreatitis.^{1 248}

Interactions for Videx

Drug interaction studies have used buffered preparations of didanosine (chewable/dispersible, buffered tablets [no longer commercially available in the US], pediatric oral solution admixed with antacid) or didanosine delayed-release capsules.²⁴⁸ Although there are a few exceptions (e.g., ciprofloxacin, indinavir, ketoconazole),^{48 248} results of drug interaction studies that used buffered preparations of didanosine are expected to apply to delayed-release capsules.²⁴⁸

Specific Drugs

Drug	Interaction	Comments
Allopurinol	Increased didanosine concentrations and AUC;1 207 248 possible increased risk of didanosine toxicity1 207 248	Concomitant use contraindicated1 207 248
Antacids	Aluminum- and magnesium-containing antacids increase oral bioavailability of didanosine1 2 3 38 39 62 Possible increased antacid adverse effects if additional antacids are used in patients receiving didanosine pediatric oral solution admixed with antacid1	Used to therapeutic advantage; didanosine pediatric oral solution is admixed with antacid prior to administration1 Additional antacids should be used with caution in patients receiving didanosine pediatric oral solution admixed with antacid1
Antifungals, azoles	Itraconazole: Decreased itraconazole concentrations with buffered didanosine preparations1 132 Ketoconazole: Decreased ketoconazole peak plasma concentrations and AUC with buffered didanosine preparations;1 no changes in ketoconazole concentrations with didanosine delayed-release capsules48 248	Administer itraconazole or ketoconazole at least 2 hours before buffered didanosine (pediatric oral solution admixed with antacid)1
Antimycobacterials	Rifabutin: Pharmacokinetic interaction unlikely238 Isoniazid: Pharmacokinetic interaction unlikely78
Atazanavir	Decreased plasma concentrations and AUC of atazanavir if administered concomitantly with buffered didanosine preparations260 Decreased didanosine concentrations and AUC if administered concomitantly with didanosine delayed-release capsules207 260 No in vitro evidence of antagonistic antiretroviral effects260	Administer atazanavir (with food) 2 hours before or 1 hour after buffered didanosine (pediatric oral solution admixed with antacid) or delayed-release capsules207 260
Dapsone	No effect on dapsone concentrations or AUC1 181 248 Some reports of failure of dapsone to prevent Pneumocystis carinii pneumonia in HIV-infected patients receiving didanosine concomitantly71	Some clinicians suggest that didanosine be administered at least 2 hours after dapsone71 207
Darunavir	Didanosine delayed-release capsules: No change in didanosine or darunavir concentrations261 Conflicting administration instructions with regard to food261	Administer didanosine 1 hour before or 2 hours after ritonavir-boosted darunavir261
Delavirdine	Decreased delavirdine and didanosine concentrations if given at the same time as buffered didanosine preparations;1 210 clinically important pharmacokinetic interaction not observed when buffered didanosine administered 1 hour after delavirdine1 In vitro evidence of additive or synergistic antiretroviral effects210	Administer at least 1 hour before or at least 1 hour after buffered didanosine (pediatric oral solution admixed with antacid)1 210
Drugs associated with pancreatitis (pentamidine, co-trimoxazole)	Increased risk of pancreatitis1 19 36 39 248	Use with extreme caution and only if other alternative agents are not available; if clearly indicated, consider discontinuing didanosine1 19 36 39 248
Drugs associated with neurotoxicity	Increased risk of neuropathy1 248	Use with caution1 248
Efavirenz	In vitro evidence of additive antiretroviral effects217
Fluoroquinolones (ciprofloxacin, levofloxacin moxifloxacin, ofloxacin)	Decreased absorption and lower concentrations of fluoroquinolones with buffered didanosine preparations1 262 263 264 Studies using ciprofloxacin indicate didanosine delayed-release capsules do not affect pharmacokinetics of the fluoroquinolone48 248	Ciprofloxacin: Administer 2 hours before or 6 hours after buffered didanosine (pediatric oral solution admixed with antacid)1 Levofloxacin: Administer at least 2 hours before or 2 hours after buffered didanosine (pediatric oral solution admixed with antacid)262 Moxifloxacin: Administer at least 4 hours before or 8 hours after buffered didanosine (pediatric oral solution admixed with antacid)263 Ofloxacin: Administer at least 2 hours before or 2 hours after buffered didanosine (pediatric oral solution admixed with antacid)264
Ganciclovir and valganciclovir	Didanosine given 2 hours before ganciclovir results in increased didanosine AUC1 207 248 and decreased ganciclovir AUC1 207 Concomitant administration of didanosine with IV ganciclovir results in increased didanosine AUC and peak plasma concentrations; no change in ganciclovir pharmacokinetics250 Because valganciclovir is rapidly and completely converted to ganciclovir, didanosine interaction reported with ganciclovir is expected to occur with valganciclovir251	Appropriate dosages for concomitant use with respect to safety and efficacy not established207 Manufacturer of didanosine states that, if there is no suitable alternative to ganciclovir, the drugs should be used with caution and the patient monitored for didanosine toxicity1 248
Histamine H2-receptor antagonists	Pharmacokinetic interaction unlikely with ranitidine and buffered didanosine preparations1
Hydroxyurea	Concomitant use of didanosine and hydroxyurea: Potential for increased risk of pancreatitis1 228 248 Concomitant use of didanosine, hydroxyurea, and stavudine: Potential for increased risk of fatal hepatotoxicity1 248 In vitro evidence of synergistic antiretroviral effects221 227 229 235	Avoid concomitant use of didanosine and hydroxyurea (with or without stavudine)1 248
Indinavir	When buffered didanosine preparations administered at the same time as indinavir, decreased AUC of indinavir1 No evidence of pharmacokinetic interaction with didanosine delayed-release capsules248 In vitro evidence of synergistic antiretroviral effects187	Administer buffered didanosine (pediatric oral solution admixed with antacid) and indinavir at least 1 hour apart; indinavir and buffered didanosine oral solution should be administered on an empty stomach1 187
Loperamide	Concomitant administration with didanosine pediatric oral solution admixed with antacid decreases peak didanosine plasma concentrations but does not affect didanosine AUC1
Lopinavir	Fixed-combination oral solution containing lopinavir and ritonavir: Conflicting administration instructions with regard to food244	Fixed-combination oral solution containing lopinavir and ritonavir: Administer didanosine (without food) 1 hour before or 2 hours after lopinavir (with food)244 Fixed-combination tablets containing lopinavir and ritonavir: May be administered at the same time as didanosine244
Macrolides (clarithromycin)	Pharmacokinetic interaction with clarithromycin unlikely158
Methadone	Decreased didanosine concentrations and AUC;1 243 248 no change in methadone concentrations243	If concomitant use is considered necessary, manufacturer of didanosine states that didanosine delayed-release capsules (not pediatric oral solution admixed with antacid) should be used and patients monitored closely for adequate clinical response to the antiretroviral agent (e.g., monitor for changes in viral load)1 248
Metoclopramide	Concomitant administration with didanosine pediatric oral solution admixed with antacid results in slight increase in peak didanosine plasma concentrations but does not affect didanosine AUC1
Nelfinavir	No change in nelfinavir concentrations when didanosine administered 1 hour before nelfinavir1 211 248 In vitro evidence of additive or synergistic antiretroviral effects186 211	Administer didanosine (without food) 1 hour before or 2 hours after nelfinavir (with food) 1 211 248
Nevirapine	No effect on nevirapine or didanosine pharmacokinetics204 In vitro evidence of additive or synergistic antiretroviral effects204
Ribavirin	Pharmacokinetic interaction;1 248 increased intracellular concentrations of active didanosine metabolite1 248 Serious adverse effects (fatal hepatic failure, peripheral neuropathy, pancreatitis, hyperlactatemia/lactic acidosis) reported with concomitant use1 207 248	Concomitant use contraindicated1 207 248
Ritonavir	Slight decrease in didanosine peak plasma concentrations and AUC;172 no effect on ritonavir peak plasma concentrations or AUC172 In vitro evidence of additive or synergistic antiretroviral effects172 186
Saquinavir	In vitro evidence of additive or synergistic antiretroviral effects163 186
Stavudine	Pharmacokinetic interactions unlikely1 Concomitant use of didanosine and stavudine: Possible increased risk of toxicities (pancreatitis, peripheral neuropathy, hyperlactatemia)1 212 207 248 Concomitant use of didanosine, hydroxyurea, and stavudine: Potential for increased risk of fatal hepatic events1 248 In vitro evidence of additive or synergistic antiretroviral effects189	Concomitant use of didanosine and stavudine not recommended;1 165 207 212 248 use with caution and only in special circumstances when there are no other options and potential benefits outweigh risks1 165 207 212 248 Avoid concomitant use of didanosine, hydroxyurea, and stavudine1 248
Sulfamethoxazole	Pharmacokinetic interaction unlikely1
Tenofovir	Increased plasma concentrations and AUC of didanosine; no effect on tenofovir pharmacokinetics1 207 248 265 Limited data indicate early virologic failure, rapid selection of resistant mutants, and potential for immunologic nonresponse or decline in CD4+ T-cell counts207 Possible increased risk of didanosine-associated adverse effects (e.g., pancreatitis, neuropathy)1 248 265 In vitro evidence of additive or synergistic antiretroviral effects265	Avoid concomitant use of didanosine and tenofovir if possible207 Concomitant use not recommended for initial therapy in adults or adolescents;207 triple NRTI regimen of tenofovir, didanosine, and lamivudine (or emtricitabine) not recommended in pediatric patients165 If didanosine and tenofovir used concomitantly in adults and adolescents, reduce didanosine dosage1 207 248 265 If didanosine and tenofovir used concomitantly in any patient, use caution and closely monitor for didanosine-associated adverse effects and clinical response; discontinue didanosine if necessary1 207 248 265 In adults or adolescents weighing ≥60 kg with Clcr ≥60 mL/minute, reduce didanosine dosage to 250 mg once daily; in those weighing <60 kg with Clcr ≥60 mL/minute, reduce didanosine dosage to 200 mg once daily;1 207 248 administer didanosine delayed-release capsules and tenofovir without food or with a light meal;248 administer didanosine pediatric oral solution and tenofovir without food or administer pediatric oral solution on an empty stomach (i.e., ≥30 minutes before or 2 hours after food) if tenofovir is taken with food1
Tetracyclines	Decreased tetracycline concentrations with buffered didanosine preparations1	Caution if used with buffered didanosine (pediatric oral solution admixed with antacid)1
Tipranavir	Decreased didanosine concentrations;207 259 clinical importance unknown259 In vitro evidence of additive antiretroviral effects259	Administer ritonavir-boosted tipranavir at least 2 hours before or 2 hours after didanosine delayed-release capsules

Vicodin

Generic Name: hydrocodone and acetaminophen (Oral route)

a-seet-a-MIN-oh-fen, hye-droe-KOE-done bye-TAR-trate

Oral route(Solution;Tablet)

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 .

Commonly used brand name(s)

In the U.S.

• Anexsia


• Ceta Plus


• Co-Gesic


• Dolorex Forte


• Hycet


• Lorcet


• Lortab


• Maxidone


• Norco


• Stagesic


• Vicodin


• Zydone

Available Dosage Forms:

• Tablet


• Solution


• Syrup


• Elixir


• Capsule


• Liquid

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Hydrocodone

Uses For Vicodin

Hydrocodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Hydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Vicodin

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

Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and acetaminophen tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen oral solution in children. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

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

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

• Naltrexone

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.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Fospropofol


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Phenobarbital


• Prazepam


• Propoxyphene


• Quazepam


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiopental


• Triazolam

Using this medicine 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.

• Acenocoumarol


• Carbamazepine


• Escitalopram


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

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 this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

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:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, history of or


• Breathing or lung problems (e.g., asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale, emphysema, hypoxia) or


• CNS depression or


• Drug dependence, especially narcotic abuse or dependence, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Hypothyroidism (an underactive thyroid) or


• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Brain tumor or


• Head injuries or


• Increased pressure in the head—Some of the side effects of hydrocodone can cause serious problems in people who have these medical problems.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Lung disease or


• Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make these conditions worse.

• Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.

Proper Use of hydrocodone and acetaminophen

This section provides information on the proper use of a number of products that contain hydrocodone and acetaminophen. It may not be specific to Vicodin. Please read with care.

Take this medicine only 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

This medicine should come with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

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 moderate to moderately severe pain:
  
  • For oral dosage form (solution):
    
    • Adults and teenagers 14 years of age and older—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
    
    
    • Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
    
    
    • Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
    
    
    • Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.
    
    
    • Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—One or two tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 5 to 12 tablets per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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.

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

Precautions While Using Vicodin

It is very important that your doctor check the progress of you or your child while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before you or your child have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of certain tests may be affected by this medicine.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause the neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or failure to gain weight.

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.

Vicodin 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:

Incidence not known

• Back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• blood in vomit


• bluish lips or skin


• chills


• choking


• cough or hoarseness


• dark urine


• decrease in the frequency of urination


• decrease in urine volume


• difficult or troubled breathing


• difficulty in passing urine (dribbling)


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever


• fever with or without chills


• general body swelling


• general feeling of tiredness or weakness


• headache


• hives


• irregular, fast or slow, or shallow breathing


• itching


• light-colored stools


• loss of appetite


• lower back or side pain


• nausea or vomiting


• nosebleeds


• not breathing


• painful or difficult urination


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red spots on the skin


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


• severe or continuing stomach pain


• shortness of breath or troubled breathing


• skin rash


• sore throat


• sore tongue


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


• tightness in the chest


• unable to speak


• unusual bleeding or bruising


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• wheezing


• yellow eyes and skin

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

Symptoms of overdose

• Bloody or cloudy urine


• change in consciousness


• chest pain or discomfort


• cold and clammy skin


• decreased awareness or responsiveness


• extreme drowsiness


• general feeling of discomfort or illness


• increased sweating


• irregular heartbeat


• lightheadedness, dizziness, or fainting


• loss of consciousness


• no blood pressure or pulse


• no muscle tone or movement


• not breathing


• severe sleepiness


• slow or irregular heartbeat


• stopping of heart


• sudden decrease in the amount of urine


• unconsciousness


• unpleasant breath odor


• vomiting of blood

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

• Drowsiness


• relaxed and calm


• sleepiness

Incidence not known

• Belching


• changes in mood


• difficulty having a bowel movement (stool)


• fear or nervousness


• feeling of indigestion


• hearing loss


• impaired hearing


• pain in the chest below the breastbone


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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: Vicodin side effects (in more detail)

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 Vicodin resources

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

• Vicodin Consumer Overview


• Vicodin Prescribing Information (FDA)


• Vicodin MedFacts Consumer Leaflet (Wolters Kluwer)


• Co-gesic Prescribing Information (FDA)


• Dolacet MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycet Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycet Prescribing Information (FDA)


• Liquicet Prescribing Information (FDA)


• Lorcet Plus Prescribing Information (FDA)


• Lortab Consumer Overview


• Lortab Prescribing Information (FDA)


• Maxidone Prescribing Information (FDA)


• Norco Consumer Overview


• Norco Prescribing Information (FDA)


• Vicodin ES Prescribing Information (FDA)


• Vicodin HP Prescribing Information (FDA)


• Xodol Prescribing Information (FDA)


• Zolvit Prescribing Information (FDA)


• Zydone Prescribing Information (FDA)

Compare Vicodin with other medications

• Back Pain
• Pain
• Rheumatoid Arthritis

velaglucerase alfa

Generic Name: velaglucerase alfa (VEL a GLOO ser ase AL fa)

Brand Names: VPRIV

What is velaglucerase alfa?

Velaglucerase is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people with Type I Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Velaglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, velaglucerase is not a cure for this condition.

Velaglucerase may also be used for purposes not listed in this medication guide.

What is the most important information I should know about velaglucerase alfa?

You should not use velaglucerase alfa if you are allergic to it. Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection. Velaglucerase is not a cure for Gaucher disease.

What should I discuss with my health care provider before receiving velaglucerase alfa?

You should not use velaglucerase alfa if you are allergic to it. FDA pregnancy category B. Velaglucerase alfa is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether velaglucerase alfa 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 is velaglucerase alfa given?

Velaglucerase alfa is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Velaglucerase alfa must be given slowly, and the IV infusion can take at least 1 hour to complete.

Velaglucerase alfa is usually given every other week. Follow your doctor's dosing instructions very carefully.

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

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your velaglucerase alfa injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving velaglucerase alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Velaglucerase alfa side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Some people receiving a velaglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  low fever;

  
  


• 
  

  dizziness, tired feeling;

  
  


• 
  

  nausea, stomach pain;

  
  


• 
  

  knee pain, back pain; or

  
  


• 
  

  cold symptoms such as stuffy nose, sneezing, sore throat.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Velaglucerase alfa Dosing Information

Usual Adult Dose for Gaucher Disease:

For use in the treatment of type 1 Gaucher disease:

Recommended dose: 60 Units/kg administered as a 60 minute intravenous infusion every other week

Usual Pediatric Dose for Gaucher Disease:

For use in the treatment of type 1 Gaucher disease:

Recommended dose: 60 Units/kg administered as a 60 minute intravenous infusion every other week

What other drugs will affect velaglucerase alfa?

There may be other drugs that can interact with velaglucerase alfa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More velaglucerase alfa resources

• Velaglucerase alfa Side Effects (in more detail)
• Velaglucerase alfa Dosage
• Velaglucerase alfa Use in Pregnancy & Breastfeeding
• Velaglucerase alfa Support Group
• 0 Reviews for Velaglucerase alfa - Add your own review/rating

• velaglucerase alfa Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Velaglucerase alfa MedFacts Consumer Leaflet (Wolters Kluwer)


• Velaglucerase alfa Professional Patient Advice (Wolters Kluwer)


• VPRIV Consumer Overview


• Vpriv Prescribing Information (FDA)

Compare velaglucerase alfa with other medications

• Gaucher Disease

Where can I get more information?

• Your doctor or pharmacist can provide more information about velaglucerase alfa.

See also: velaglucerase alfa side effects (in more detail)

Tussi 12D S Suspension

Pronunciation: car-beta-PEN-tane/fen-ill-EF-rin/peer-IL-a-meen
Generic Name: Carbetapentane/Phenylephrine/Pyrilamine
Brand Name: Examples include Tannate-12D S and Tussi 12D S

Tussi 12D S Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tussi 12D S Suspension is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing, while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tussi 12D S Suspension if:

• you are allergic to any ingredient in Tussi 12D S Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tussi 12D S Suspension:

Some medical conditions may interact with Tussi 12D S Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Tussi 12D S Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tussi 12D S Suspension may be increased


• Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects ma y be increased by Tussi 12D S Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tussi 12D S Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tussi 12D S Suspension 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 Tussi 12D S Suspension:

Use Tussi 12D S Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tussi 12D S Suspension may be taken with or without food.


• Shake well before using.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Tussi 12D S Suspension, 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 Tussi 12D S Suspension.

Important safety information:

• Tussi 12D S Suspension may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tussi 12D S Suspension. Using Tussi 12D S Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Tussi 12D S Suspension without checking with your doctor.


• Tussi 12D S Suspension contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Tussi 12D S Suspension for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Tussi 12D S Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tussi 12D S Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• If you are scheduled for allergy skin testing, do not take Tussi 12D S Suspension for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tussi 12D S Suspension.


• Use Tussi 12D S Suspension with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Tussi 12D S Suspension in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tussi 12D S Suspension, discuss with your doctor the benefits and risks of using Tussi 12D S Suspension during pregnancy. It is unknown if Tussi 12D S Suspension is excreted in breast milk. Do not breast-feed while taking Tussi 12D S Suspension.

Possible side effects of Tussi 12D S Suspension:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.

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: Tussi2D S 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. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tussi 12D S Suspension:

Store Tussi 12D S Suspension 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 Tussi 12D S Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Tussi 12D S Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Tussi 12D S Suspension 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 Tussi 12D S Suspension. 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 Tussi 12D S resources

• Tussi 12D S Side Effects (in more detail)
• Tussi 12D S Use in Pregnancy & Breastfeeding
• Tussi 12D S Drug Interactions
• Tussi 12D S Support Group
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