Vancomycin Hydrochloride

Class: Glycopeptides
VA Class: AM900
CAS Number: 1404-93-9
Brands: Vancocin

Introduction

Antibacterial; tricyclic glycopeptide antibiotic.^{266 267}

Uses for Vancomycin Hydrochloride

Endocarditis

Treatment of native valve or prosthetic valve endocarditis caused by susceptible Staphylococcus aureus or S. epidermidis, including oxacillin-resistant (methicillin-resistant) strains.^{155 265 266 267} AHA and IDSA recommend vancomycin as drug of choice for treatment of endocarditis caused by oxacillin-resistant staphylococci.²⁶⁵ Also recommended as alternative to nafcillin (or oxacillin) or cefazolin for treatment of endocarditis caused by oxacillin-susceptible staphylococci in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.²⁶⁵ May be used alone for native valve endocarditis caused by oxacillin-susceptible staphylococci; used in conjunction with rifampin and gentamicin for endocarditis caused by oxacillin-resistant staphylococci and for prosthetic valve staphylococcal endocarditis.²⁶⁵

Treatment of native valve or prosthetic valve endocarditis caused by viridans streptococci or Streptococcus bovis.^{155 265 266 267} Recommended by AHA and IDSA as an alternative to penicillin G or ceftriaxone for treatment of streptococcal endocarditis in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.²⁶⁵

Treatment of native valve or prosthetic valve enterococcal endocarditis; used in conjunction with gentamicin or streptomycin.^{155 265 266 267} Recommended by AHA and IDSA as an alternative to penicillin G or ampicillin for treatment of enterococcal endocarditis in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.²⁶⁵

Empiric treatment of culture-negative endocarditis†.²⁶⁵ For culture-negative native valve endocarditis, regimen of ampicillin-sulbactam and gentamicin recommended by AHA and IDSA; regimen of vancomycin, gentamicin, and ciprofloxacin recommended for those unable to tolerate penicillin.²⁶⁵ For culture-negative prosthetic valve endocarditis occurring ≤1 year after valve replacement, regimen of vancomycin, gentamicin, and rifampin recommended; this regimen also should include cefepime if onset of infection is within 2 months of valve replacement.²⁶⁵ Selection of the most appropriate anti-infective regimen is difficult and should be guided by epidemiologic features and clinical course of the infection.²⁶⁵ Consultation with an infectious diseases specialist is recommended.²⁶⁵

Treatment of early-onset prosthetic valve endocarditis caused by Corynebacterium jeikeium (JK group);^{149 266 267 c} used in conjunction with rifampin and/or an aminoglycoside.^c

Prevention of bacterial endocarditis in patients undergoing certain genitourinary and GI (except esophageal) procedures† who have cardiac conditions that put them at moderate or high risk.¹⁴⁵ AHA recommends ampicillin as a drug of choice; vancomycin recommended in those hypersensitive to penicillins.¹⁴⁵ Used alone in penicillin-allergic individuals at moderate risk or in conjunction with gentamicin in those at high risk.¹⁴⁵ Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.¹⁴⁵

Meningitis

Treatment of meningitis† caused by S. pneumoniae that are highly resistant to penicillins.^{122 149 235 236 237} .^{122 149 203 204 205 206 235 236 237} For empiric treatment, usually used in conjunction with a third generation cephalosporin (ceftriaxone, cefotaxime) with or without rifampin;^{122 203 204 205 206 235 236 237} vancomycin should be discontinued if the causative organism is found to be susceptible to the cephalosporin.^{235 236 237}

Should not be used alone for treatment of meningitis since effective CSF concentrations may not be attained.^{122 148 235 237}

Osteomyelitis

Treatment of osteomyelitis caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.^{266 267}

Respiratory Tract Infections

Treatment of pneumonia caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.^{266 267}

Treatment of pneumonia caused by S. pneumonia highly resistant to penicillins.^{122 149 235 236 237 266 267} Used alone or in conjunction with a third generation cephalosporin (ceftriaxone, cefotaxime) with or without rifampin.^{122 149 235 236 237}

Septicemia

Treatment of septicemia caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.^{149 155 266 267} Used alone or in conjunction with gentamicin and/or rifampin.¹⁴⁹

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.^{155 266 267}

Bacillus Infections

Treatment of infections caused by Bacillus cereus or B. subtilis†.¹⁴⁹ Drug of choice.¹⁴⁹

Capnocytophaga Infections

Treatment of infections caused by Capnocytophaga†.¹⁴⁹

Optimum regimens for treatment of infections caused by Capnocytophaga not identified; some clinicians recommend use of penicillin G or, alternatively, a third generation cephalosporin (cefotaxime, ceftizoxime, ceftriaxone), a carbapenem (imipenem or meropenem), vancomycin, a fluoroquinolone, or clindamycin.¹⁴⁹

Clostridium difficile-associated Diarrhea andColitis

Treatment of Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis, and pseudomembranous colitis) in seriously ill patients (i.e., with severe or potentially life-threatening colitis) or those who cannot tolerate or do not respond to oral metronidazole.^{122 149 197 198 199 200 211 212 213 214 215 266 267}

Oral metronidazole appears to be as effective as oral vancomycin for treatment of Clostridium difficile-associated diarrhea and colitis.^{172 178 179 180 181 182 183 184 185 193 211 212 213 214 215}

Because of cost considerations^{122 172 178 179 180 181 182 183 184 185 211 212 213 214 215} and concerns about increasing resistance to vancomycin in enterococci and other bacteria (e.g., staphylococci) and the risk of selection of such strains secondary to widespread and/or injudicious use of the drug,^{115 122 169 172 173 174 175 176 189 190 191 192 200} most experts state that oral metronidazole is preferred (unless a resistant strain of C. difficile is suspected or therapy with metronidazole is contraindicated or not tolerated) when anti-infective therapy is indicated for most cases of Clostridium difficile-associated diarrhea and colitis.^{122 149 172 178 179 180 181 182 183 184 185 198 200 211 212 213 214 215}

Oral vancomycin is the drug of choice when anti-infective therapy is indicated for critically ill patients or those who cannot tolerate or do not respond to oral metronidazole.^{122 149 180 181 182 184 193 198 199 200 211 212 213 214 215} (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)

Has been used to prevent nosocomial outbreaks of Clostridium difficile-associated diarrhea and colitis† in institutionalized patients who asymptomatically harbor the organism.^{186 187 188 194} However, current evidence suggests that the risks of such prophylaxis (e.g., in selecting potentially resistant organisms such as enterococci) outweigh any possible benefit.^{172 177 181 186 188 189 190 192 194} Most experts currently recommend that appropriate enteric and barrier precautions (e.g., isolation of patients, private bathroom facilities, strict hygiene) rather than prophylactic anti-infective therapy be implemented to prevent nosocomial transmission of the organisms.^{177 180 187 188 190 192 193 194 212 213}

Rhodococcus Infections

Treatment of infections caused by Rhodococcus equi†.^{149 240 241 242 243} Optimum regimens not identified; combination regimens usually recommended, including vancomycin given with a fluoroquinolone, rifampin, a carbapenem (imipenem or meropenem), or amikacin.^{149 240 241 242 243}

Staphylococcal Enterocolitis

Treatment of enterocolitis caused by S. aureus (including oxacillin-resistant strains).¹⁹⁹ Considered the drug of choice for staphylococcal enterocolitis because it does not affect the normal coliform bacteria present in the GI tract.^c

Prevention of Perinatal Group B Streptococcal (GBS) Infection

Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease† in penicillin-allergic pregnant women at risk for anaphylaxis with a β-lactam anti-infective when clindamycin or erythromycin cannot be used.^{158 159}

Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.^{158 159}

Penicillin G is the regimen of choice and ampicillin is the preferred alternative.^{158 159} Cefazolin can be used in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity, but clindamycin or erythromycin are the drugs of choice in penicillin-allergic women at high risk for anaphylaxis.¹⁵⁸

Because S. agalactiae (group B streptococci) with in vitro resistance to clindamycin and erythromycin has been reported with increasing frequency,¹⁵⁸ in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening is necessary.¹⁵⁸ If in vitro susceptibility testing is not possible, results are unknown, or isolates are found to be resistant to erythromycin or clindamycin, vancomycin should be used for intrapartum prophylaxis in penicillin-allergic women at high risk for anaphylaxis with β-lactams.¹⁵⁸

Perioperative Prophylaxis

Perioperative prophylaxis† to reduce the risk of infection in patients undergoing cardiac surgery (e.g., placement of electrophysiologic devices, ventricular assist devices, ventriculoatrial shunts, arterial patches), neurosurgery (e.g., craniotomy, spinal surgery), orthopedic surgery (e.g., joint replacement, internal fixation of compound or open fractures with nails, plates, screws, or wires), noncardiac thoracic surgery (pulmonary resection, closed-tube thoracostomy for chest trauma with hemothorax or pneumothorax), or vascular surgery (arterial reconstructive surgery involving the abdominal aorta, leg procedures that include a groin incision, lower extremity amputation for ischemia) at institutions where oxacillin-resistant S. epidermidis are frequent causes of postoperative wound infection.²⁰⁸ Also used in these procedures when drugs of first choice (cefazolin, cefuroxime) cannot be used because patient is hypersensitive to β-lactams.²⁰⁸

Routine use of vancomycin for perioperative prophylaxis is not recommended since such use may promote emergence of vancomycin-resistant enterococci or staphylococci.^{200 208 224} (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)

Empiric Therapy in Febrile Neutropenic Patients

Has been used in conjunction with 1 or 2 other anti-infectives for empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients†.²⁵⁶

Some clinicians suggest that it may be prudent to include vancomycin in an initial empiric regimen in selected patients with clinically suspected serious catheter-related infections (e.g., bacteremia, cellulitis); known colonization with penicillin- and cephalosporin-resistant S. pneumoniae or oxacillin-resistant (methicillin-resistant) S. aureus; initial blood culture results indicating presence of gram-positive bacteria; or hypotension or other evidence of cardiovascular impairment.²⁵⁶

If vancomycin is included in an initial empiric regimen, it should be discontinued within 24–48 hours if results of cultures do not identify gram-positive bacteria susceptible to the drug.²⁵⁶ (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)

Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.²⁵⁶ Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.²⁵⁶

Vancomycin Hydrochloride Dosage and Administration

Administration

Administer orally¹⁹⁷ or by slow IV infusion.^{155 266 267} Should not be given IM;^{266 267} safety and efficacy of intrathecal† (intralumbar or intraventricular) or intraperitoneal† administration have not been determined.^{266 267}

Given orally as capsules for treatment Clostridium difficile-associated diarrhea and colitis or for treatment of staphylococcal enterocolitis;¹⁹⁷ if necessary, the parenteral formulation (500-mg single-use vial) may be diluted and administered orally or by NG tube for treatment of these infections.²⁶⁷

Oral vancomycin is not effective for treatment of systemic infections^{197 266 267}

Oral Administration

Administer orally as capsules.¹⁹⁷ Alternatively, an oral solution prepared using the IV preparation of the drug can be given orally or via NG tube.²⁶⁷

Reconstitution

When necessary, an oral solution can be prepared by diluting the appropriate dose of vancomycin powder for IV infusion in 30 mL of water.²⁶⁷ The 500-mg single-use vial should be used to prepare these oral solutions;²⁶⁷ ADD-Vantage vials should not be used.²⁶⁶

IV Infusion

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

Usually administered by intermittent IV infusion.^{266 267} Has been administered by continuous IV infusion when intermittent infusions were not feasible.^c

Reconstitution and Dilution

Reconstitute powder for IV infusion by adding 10 or 20 mL of sterile water for injection to a vial containing 500 mg or 1 g of vancomycin.²⁶⁷ Further dilute reconstituted solutions containing 500 mg or 1 g with at least 100 mL or at least 200 mL, respectively, of a compatible IV solution.²⁶⁷

Alternatively, ADD-Vantage vials containing 500 mg or 1 g of vancomycin may be reconstituted according to the manufacturer’s directions using 5% dextrose injection or 0.9% sodium chloride injection.²⁶⁶ ADD-Vantage vials should be used only when actual doses of 500 mg or 1 g are appropriate and should not be used in neonates, infants, or young children who require doses <500 mg.²⁶⁶

The pharmacy bulk package is not intended for direct IV infusion; doses of the drug from the reconstituted bulk package must be further diluted in a compatible IV infusion solution prior to administration.¹⁵⁷

Thaw the commercially available injection (frozen) at room temperature or in a refrigerator; do not force thaw by immersion in a water bath or by exposure to microwave radiation.¹⁵⁵ A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.¹⁵⁵ Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.¹⁵⁵

The thawed injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.¹⁵⁵

Rate of Administration

Administer by IV infusion over ≥1 hour.^{266 267}

Rapid IV infusion should be avoided and patients monitored closely to detect a hypotensive reaction if it occurs.^{266 267}

Adverse effects may be minimized if infusion rate is ≤10 mg/minute,^{266 267} but consider that adverse effects associated with vancomycin infusions could occur with any infusion rate.^{155 247 266 267} (See Infusion Reactions under Cautions.)

If intermittent IV infusion is not feasible, 1–2 g of reconstituted vancomycin may be added to a sufficient volume of 0.9% sodium chloride or 5% dextrose injection to permit administration of the desired daily dosage over a 24-hour period.^c

Dosage

Available as vancomycin hydrochloride; dosage expressed in terms of vancomycin.^{197 266 267}

Pediatric Patients

General Dosage for Neonates

Systemic Infections

IV

AAP states optimal dosage in neonates should be based on serum vancomycin concentrations, especially in those with low birthweight (i.e., <1.5 kg).¹²²

Manufacturer recommends 15 mg/kg initially, followed by 10 mg/kg every 12 hours in neonates <1 week of age and 10 mg/kg every 8 hours in neonates 1 week to 1 month of age.^{266 267}

Neonates <1 week of age: AAP recommends 15 mg/kg every 24 hours in those weighing <1.2 kg, 10–15 mg/kg every 12–18 hours in those weighing 1.2–2 kg, or 10–15 mg/kg every 8–12 hours for those weighing > 2 kg.¹²²

Neonates ≥1 week of age: AAP recommends 15 mg/kg every 24 hours in those weighing <1.2 kg, 10–15 mg/kg every 8–12 hours in those weighing 1.2–2 kg, or 10–15 mg/kg every 6–8 hours in those weighing >2 kg.¹²²

General Pediatric Dosage

Systemic Infections

IV

10 mg/kg every 6 hours.^{266 267}

Children ≥1 month of age: AAP recommends 40 mg/kg daily given in 3–4 divided doses for mild to moderate infections or 40–60 mg/kg daily given in 4 divided doses for severe infections.¹²²

Endocarditis

Treatment of Endocarditis Caused by Staphylococci (Including Oxacillin-resistant Staphylococci)

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.²⁶⁵

Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for ≥6 weeks.²⁶⁵ Given in conjunction with oral or IV rifampin (20 mg/kg daily given in 3 equally divided doses for ≥6 weeks) and IM or IV gentamicin (3 mg/kg daily given in 3 divided doses during first 2 weeks of treatment).²⁶⁵

Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 4 weeks.²⁶⁵

Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.²⁶⁵

Treatment of Enterococcal Endocarditis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.²⁶⁵ Used in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (20–30 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.²⁶⁵

Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.²⁶⁵ Used in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (20–30 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.²⁶⁵

Culture-negative Endocarditis†

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses in conjunction with oral or IV ciprofloxacin (20–30 mg/kg daily given in 2 equally divided doses) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses).²⁶⁵ All 3 drugs should be given for 4–6 weeks.²⁶⁵

Prosthetic valve (≤1 year after valve replacement): 40 mg/kg daily given in 2 or 3 equally divided doses in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses) and oral or IV rifampin (20 mg/kg daily given in 3 equally divided doses).²⁶⁵ Cefepime (150 mg/kg daily given IV in 3 equally divided doses) also may be included.²⁶⁵ Vancomycin, rifampin, and cefepime should be given for 6 weeks; gentamicin should be given only during first 2 weeks of treatment.²⁶⁵

Prevention of Bacterial Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures†

IV

For moderate-risk patients, 20 mg/kg given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure.¹⁴⁵

For high-risk patients, 20 mg/kg given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure; given in conjunction with IV or IM gentamicin (1.5 mg/kg given within 30 minutes prior to start of the procedure).¹⁴⁵

Meningitis

IV

Children ≥1 month of age: AAP and other clinicians recommend 60 mg/kg daily given in 4 divided doses.^{122 235 236 237}

Clostridium difficile-associated Diarrhea and Colitis

Oral

40 mg/kg given in 3 or 4 divided doses for 7–10 days.^{122 156 197}

Staphylococcal Enterocolitis

Oral

40 mg/kg given in 3 or 4 divided doses for 7–10 days.^{122 156 197}

Adults

General Adult Dosage

Treatment of Life-threatening Systemic Infections

IV

500 mg every 6 hours or 1 g every 12 hours.^{266 267}

Endocarditis

Treatment of Endocarditis Caused by Staphylococci (Including Oxacillin-resistant Staphylococci)

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.²⁶⁵

Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for ≥6 weeks.²⁶⁵ Given in conjunction with oral or IV rifampin (900 mg daily given in 3 equally divided doses every 8 hours for ≥6 weeks) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses during first 2 weeks of treatment).²⁶⁵

Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 4 weeks.²⁶⁵

Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.²⁶⁵

Treatment of Enterococcal Endocarditis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.²⁶⁵ Given in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (15 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.²⁶⁵

Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.²⁶⁵ Given in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (15 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.²⁶⁵

Culture-negative Endocarditis†

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses in conjunction with ciprofloxacin (1 g daily given orally in 2 equally divided doses or 800 mg daily given IV in 2 equally divided doses) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses).²⁶⁵ All 3 drugs should be given for 4–6 weeks.²⁶⁵

Prosthetic valve (≤1 year after valve replacement): 30 mg/kg daily given in 2 equally divided doses in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses) and oral or IV rifampin (900 mg daily given in 3 equally divided doses).²⁶⁵ Cefepime (6 g daily given IV in 3 equally divided doses) also may be included.²⁶⁵ Vancomycin, rifampin, and cefepime should be given for 6 weeks; gentamicin should be given only during first 2 weeks of treatment.²⁶⁵

Prevention of Bacterial Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures†

IV

For moderate-risk patients, 1 g given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure.¹⁴⁵

For high-risk patients, 1 g given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure; given in conjunction with IV or IM gentamicin (1.5 mg/kg given within 30 minutes prior to start of the procedure).¹⁴⁵

Meningitis

IV

500 mg every 6 hours or 1 g every 12 hours.²⁶⁶

Osteomyelitis

IV

500 mg every 6 hours or 1 g every 12 hours.²⁶⁶

Respiratory Tract Infections

IV

500 mg every 6 hours or 1 g every 12 hours.²⁶⁶

Septicemia

IV

500 mg every 6 hours or 1 g every 12 hours.²⁶⁶

Skin and Skin Structure Infections

IV

500 mg every 6 hours or 1 g every 12 hours.²⁶⁶

Clostridium difficile-associated Diarrhea and Colitis

Oral

0.5–2 g daily given in 3 or 4 divided doses for 7–10 days.^{156 197} Many clinicians recommend 125 mg 4 times daily for 7–10 days.^{212 215 c}

Staphylococcal Enterocolitis

Oral

0.5–2 g daily given in 3 or 4 divided doses for 7–10 days.^{156 197}

Prevention of Perinatal Group B Streptococcal (GBS) Infection†

IV

1 g every 12 hours beginning at time of labor or rupture of membranes and continued until delivery.¹⁵⁸

Perioperative Prophylaxis†

Cardiac, Neurosurgical, Orthopedic, Thoracic (Noncardiac), or Vascular Surgery†

IV

A single 1-g dose given just prior to the procedure.²⁰⁸

Start infusion 1–2 hours prior to incision to minimize risk of adverse reaction occurring at time of induction of anesthesia and to ensure adequate tissue concentrations at time of incision.²⁰⁸ If surgery is prolonged (>4 hours), additional intraoperative doses may be given every 6–12 hours for duration of the procedure; additional doses also are advisable if substantial blood loss occurs.²⁰⁸ Postoperative doses generally unnecessary and should not be used.²⁰⁸

Prescribing Limits

Pediatric Patients

Maximum 2 g daily.^{122 235 197 236 237}

For treatment of endocarditis, AHA and IDSA state pediatric dosage should not exceed recommended adult dosage.²⁶⁵

Adults

Maximum 2 g daily.²⁶⁵

For treatment of endocarditis, AHA and IDSA recommend maximum 2 g daily unless serum concentrations are inappropriately low.²⁶⁵ These experts recommend dosage be adjusted to obtain peak serum concentrations (1 hour after completion of IV infusion) of 30–45 mcg/mL and trough concentrations of 10–15 mcg/mL.²⁶⁵

Special Populations

Hepatic Impairment

Limited data suggest dosage adjustments not necessary.²⁶⁴

Renal Impairment

Treatment of Systemic Infections

IV

Doses and/or frequency of administration must be modified in response to the degree of renal impairment.^{266 267 c}

Various methods of calculating vancomycin dosage for patients with impaired renal function have been proposed and specialized references should be consulted.^c

If possible, dosage should be based on serum vancomycin concentrations, especially in seriously ill patients with changing renal function.^{105 106 266 267} Peak serum concentrations of 30–40 mg/L and trough concentrations <10–20 mg/L generally have been recommended.²⁶⁴ To ensure efficacy and avoid toxicity, trough serum concentrations may be more useful than peak serum concentrations.²⁶⁴

Some clinicians have recommended that 1 g of vancomycin be administered at 12-hour intervals in patients with S_cr of <1.5 mg/dL, at 3- to 6-day intervals in patients with S_cr of 1.5–5 mg/dL, and at 10- to 14-day intervals in patients with S_cr >5 mg/dL.^c

Others have recommended that the usual individual dose be administered every 3–10 days in patients with GFR 10–50 mL/minute and every 10 days in patients with GFR <10 mL/minute.¹¹⁶

Geriatric Patients

Cautious dosage selection (usually starting at the low end of the dosing range) because of age-related decreases in renal function.^{197 266 267} (See Renal Impairment under Dosage and Administration.)

Cautions for Vancomycin Hydrochloride

Contraindications

• 
  

  Hypersensitivity to vancomycin.^{197 266 267}

  
  


• 
  

  Commercially available frozen vancomycin hydrochloride injection in 5% dextrose may be contraindicated in patients with known allergy to corn or corn products.¹⁵⁵

  
  

Warnings/Precautions

Warnings

Ototoxicity

Ototoxicity, including damage to the auditory branch of the eighth cranial nerve and permanent deafness, vertigo, dizziness, and tinnitus, has been reported.^{132 134 266 267}

Most cases involved patients with renal impairment, patients receiving high dose or prolonged IV therapy, patients with preexisting hearing loss, or those receiving other ototoxic drugs concomitantly.^{266 267}

Ototoxicity usually has been associated with serum or blood vancomycin concentrations of 80–100 mcg/mL, but has occurred with concentrations as low as 25 mcg/mL.¹³²

Ototoxicity may be transient or permanent;^{155 266 267} deafness may progress despite cessation of therapy.^c

Not recommended in patients with previous hearing loss; if use in these patients is considered necessary, reduce dosage.^c

Auditory function testing may minimize risk of ototoxicity during vancomycin therapy.^{155 266 267} In addition, regular determinations of serum or blood vancomycin concentrations is recommended in patients with borderline renal function and in those >60 years of age.^c

If tinnitus occurs, discontinue vancomycin.^c

Nephrotoxicity

Nephrotoxicity has been reported, including increased BUN or S_cr concentrations, presence of hyaline and granular casts and albumin in urine, fatal uremia, and acute interstitial nephritis.^{132 133 134}

Reported most frequently in patients with renal impairment, patients receiving high dose or prolonged IV therapy, or those receiving other nephrotoxic drugs concomitantly.²⁵⁶

Nephrotoxicity usually is associated with serum or blood vancomycin concentrations of 80–100 mcg/mL, but has occurred with concentrations as low as 25 mcg/mL.¹³²

Use with caution in patients with impaired renal function.^{266 267} Perform urinalysis and renal function tests periodically during therapy.^{266 267}

Infusion Reactions

Rapid IV administration may result in a potentially serious hypotensive reaction.^{112 118 119 120 136 137 138 139 143 238 244 247}

These infusion reactions usually involve a sudden and possibly severe decrease in blood pressure and may be accompanied by flushing and/or a maculopapular or erythematous rash on the face, neck, chest, and upper extremities (“red-man syndrome” or “red-neck syndrome”).^{112 118 119 120 135 136 137 142 143} Latter manifestations may occur in the absence of hypotension.^{120 135 136 142 238 244 247} Wheezing, dyspnea, angioedema, urticaria, pruritus, and, rarely, cardiac arrest or seizures may also occur.^{139 121 138}

The reaction usually begin a few minutes after infusion is started, but may not occur until after its completion and usually resolves spontaneously over 1 to several hours after discontinuance.^{118 120 135 136 143 238} If the hypotensive reaction is severe, antihistamines, corticosteroids, or IV fluids are recommended.^{118 120 136}

To minimize risk of an infusion reaction, administer IV over a period of ≥1 hour using a rate ≤10 mg/minute and monitor patient’s blood pressure.^{118 119 120 136 155 266 267} Avoid rapid IV administration (e.g., over several minutes).¹⁵⁵

Pretreatment with antihistamines may attenuate but not eliminate the risk of infusion reactions.^{244 136 141 144}

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis, urticaria, exfoliative dermatitis, macular rashes, exfoliative dermatitis, and Stevens-Johnson syndrome have been reported.^{131 266 267}

Rapid IV administration may result in anaphylactoid reaction involving hypotension, wheezing, dyspnea, urticaria, or pruritus.^{266 267} (See Infusion Reactions under Cautions.)

General Precautions

Hematologic Effects

Neutropenia, eosinophilia, and thrombocytopenia have been reported rarely.

St. Joseph Aspirin

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

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

What is the most important information I should know about aspirin?

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, or if you have:

• 
  

  a recent history of stomach or intestinal bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

• 
  

  asthma or seasonal allergies;

  
  


• 
  

  stomach ulcers;

  
  


• liver disease;


• kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease, high blood pressure, or congestive heart failure;

  
  


• 
  

  gout; or

  
  


• 
  

  nasal polyps.

  
  

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

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

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

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

• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fever lasting longer than 3 days;

  
  


• 
  

  swelling, or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Less serious side effects may include:

• 
  

  upset stomach, heartburn;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  headache.

  
  

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.

What other drugs will affect aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

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

• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

  
  

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

More St. Joseph Aspirin resources

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

• Aspirin Monograph (AHFS DI)


• Aspirin Prescribing Information (FDA)


• Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information


• ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare St. Joseph Aspirin with other medications

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• Ischemic Stroke
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• Myocardial Infarction, Prophylaxis
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• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Transient Ischemic Attack

Where can I get more information?

• Your pharmacist can provide more information about aspirin.

See also: St. Joseph Aspirin side effects (in more detail)

Sominex

Pronunciation: a-seet-a-MIN-oh-fen/dye-fen-HYE-dra-meen
Generic Name: Acetaminophen/Diphenhydramine
Brand Name: Examples include Excedrin PM and Sominex

Sominex is used for:

Relieving short-term sleeplessness due to minor aches and pains. It may also used for other conditions as determined by your doctor.

Sominex is an antihistamine and analgesic combination. Diphenhydramine causes drowsiness to help you fall asleep. Acetaminophen works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Sominex if:

• you are allergic to any ingredient in Sominex


• you are taking sodium oxybate (GHB) or if 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 Sominex:

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

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


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


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


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have a fast, slow, or irregular heartbeat; liver problems (eg, hepatitis); or kidney problems


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

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

• Furazolidone, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Sominex may be increased


• Anticoagulants (eg, warfarin) because the risk of side effects, such as bleeding, may be increased by Sominex


• Hydantoins (eg, phenytoin) because side effects may be increased by Sominex


• Isoniazid because side effects of Sominex may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sominex 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 Sominex:

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

• Sominex may be taken with or without food.


• If you miss a dose of Sominex, 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 Sominex.

Important safety information:

• Sominex 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 Sominex. Using Sominex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do NOT exceed the recommended dose or take Sominex 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.


• Sominex may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Sominex or other pain relievers/fever reducers. Alcohol use combined with Sominex may increase your risk for liver damage.


• Sominex contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.


• Sominex may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Sominex. 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 Sominex 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 Sominex.


• Use Sominex with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Sominex in CHILDREN because they may be more sensitive to its effects.


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

Possible side effects of Sominex:

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; dry mouth, nose, or throat; 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); dark urine or pale stools; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; unusual fatigue; vision changes; yellowing of the skin or eyes.

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: Sominex 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 Sominex:

Store Sominex 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 Sominex out of the reach of children and away from pets.

General information:

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


• Sominex 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 Sominex. 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 Sominex resources

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

• Benadryl Consumer Overview


• Children's Allergy Prescribing Information (FDA)


• Diphen Advanced Consumer (Micromedex) - Includes Dosage Information


• Diphenhydramine Prescribing Information (FDA)


• Diphenhydramine Hydrochloride Monograph (AHFS DI)


• Diphenoxylate Hydrochloride Monograph (AHFS DI)

Compare Sominex with other medications

• Headache
• Insomnia
• Pain

Aplenzin Extended-Release Tablets

Pronunciation: bue-PROE-pee-on HYE-droe-BROE-mide
Generic Name: Bupropion Hydrobromide
Brand Name: Aplenzin

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Aplenzin Extended-Release Tablets outweigh the risks.

Aplenzin Extended-Release Tablets has the same ingredient in it that is in Zyban, a medicine used to help certain patients stop smoking. Some patients using bupropion to help them stop smoking have also developed depression and certain other mental or mood problems, including suicidal thoughts or actions.

Family and caregivers must closely watch patients who take Aplenzin Extended-Release Tablets. It is important to keep in close contact with the patient's doctor. Contact the doctor at once if new, worsened, or sudden symptoms, such as agitation, hostility, depressed mood, or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. Discuss any questions with the patient's doctor.

Aplenzin Extended-Release Tablets are used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Aplenzin Extended-Release Tablets are an antidepressant. It works in the brain to treat depression. Exactly how it works is not known.

Do NOT use Aplenzin Extended-Release Tablets if:

• you are allergic to any ingredient in Aplenzin Extended-Release Tablets


• you are taking any other medicine that contains bupropion


• you have a history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)


• you are suddenly stopping the use of alcohol or sedatives (eg, benzodiazepines) after long-term use


• you are taking or have taken linezolid, methylene blue, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Aplenzin Extended-Release Tablets:

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

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


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


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


• if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse


• if you have diabetes, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), or a recent heart attack


• if you have a history of seizures, a head injury, a tumor in the brain or spinal cord, or liver problems (eg, cirrhosis)


• if you are taking nonprescription weight loss medicines or stimulants

Some MEDICINES MAY INTERACT with Aplenzin Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, other antidepressants (eg, amitriptyline, fluvoxamine), antipsychotics (eg, haloperidol, risperidone), clopidogrel, corticosteroids (eg, prednisone), cyclophosphamide, HIV protease inhibitors (eg, nelfinavir), insulin, levodopa, linezolid, MAOIs (eg, phenelzine), methylene blue, nicotine patches, oral hypoglycemics (eg, glipizide), orphenadrine, sympathomimetics (eg, pseudoephedrine), theophylline, thiotepa, tiagabine, or ticlopidine because they may increase the risk of Aplenzin Extended-Release Tablets's side effects


• Carbamazepine, efavirenz, phenobarbital, phenytoin, rifampin, or ritonavir because they may decrease Aplenzin Extended-Release Tablets's effectiveness


• Antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, nortriptyline) because the risk of their side effects may be increased by Aplenzin Extended-Release Tablets


• Tamoxifen because its effectiveness may be decreased by Aplenzin Extended-Release Tablets, which may lead to an increased risk of breast cancer recurrence in women with a history of breast cancer

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aplenzin Extended-Release Tablets 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 Aplenzin Extended-Release Tablets:

Use Aplenzin Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aplenzin Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aplenzin Extended-Release Tablets refilled.


• Take Aplenzin Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Aplenzin Extended-Release Tablets whole. Do not break, crush, divide, or chew before swallowing.


• Several weeks may pass before your symptoms get better. Do not stop taking Aplenzin Extended-Release Tablets without checking with your doctor.


• Take your doses at the same time each day, at least 24 hours apart. This may help to decrease the risk of seizures with Aplenzin Extended-Release Tablets.


• Continue to take Aplenzin Extended-Release Tablets even if you feel well. Do not miss any doses.


• If you miss a dose of Aplenzin Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose within 24 hours. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aplenzin Extended-Release Tablets.

Important safety information:

• Aplenzin Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Aplenzin Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Aplenzin Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Aplenzin Extended-Release Tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Aplenzin Extended-Release Tablets.


• If you already drink alcohol or use sedatives, do not suddenly stop them without first checking with your doctor. Suddenly stopping them may increase your seizure risk.


• Do not take decongestants (eg, pseudoephedrine), stimulants, or diet pills while you are taking Aplenzin Extended-Release Tablets without first checking with your doctor. They may increase your risk of seizures.


• The risk of seizures may be greater if you take Aplenzin Extended-Release Tablets in high doses or for a long time. Do NOT take more than the recommended dose, change your dose, or use Aplenzin Extended-Release Tablets for longer than prescribed without checking with your doctor.


• Children, teenagers, and young adults who take Aplenzin Extended-Release Tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take Aplenzin Extended-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• You may notice the tablet shell in your stool. This is normal and not a cause for concern.


• If you have trouble sleeping, you may be taking your dose too close to bedtime. Talk with your doctor about changing your dosing schedule.


• Aplenzin Extended-Release Tablets has the same ingredients in it as Zyban, a medicine used to help stop smoking, and Wellbutrin, another medicine used to treat depression. Do not take Aplenzin Extended-Release Tablets if you are also taking Zyban or Wellbutrin . Discuss any questions or concerns with your doctor.


• Aplenzin Extended-Release Tablets may interfere with certain lab tests, including urine screenings for amphetamines. Be sure your doctor and lab personnel know you are taking Aplenzin Extended-Release Tablets.


• Use Aplenzin Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Aplenzin Extended-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Aplenzin Extended-Release Tablets:

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; dizziness; drowsiness; dry mouth; flushing; gas; headache; increased sweating; increased urination; loss of appetite; muscle pain; nausea; nervousness; restlessness; ringing in the ears; stomach pain; taste changes; trouble sleeping; vomiting; weakness; weight changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; painful sores in the mouth or around the eyes; tightness in the chest; swollen lymph nodes; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; delusions; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; hearing problems; menstrual changes; new or worsening mental or mood changes (eg, concentration problems, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being or inability to sit still); pale stools; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent joint or muscle pain; severe or persistent nausea, vomiting, or stomach pain; severe or persistent nervousness, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor; unusual swelling; vision changes; worsening depression; yellowing of the skin or eyes.

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: Aplenzin 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; loss of consciousness; rigid or painful muscles; seizures; severe dizziness; slow or difficult breathing.

Proper storage of Aplenzin Extended-Release Tablets:

Store Aplenzin Extended-Release Tablets at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aplenzin Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Aplenzin Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Aplenzin Extended-Release Tablets are 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 Aplenzin Extended-Release Tablets. 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 Aplenzin resources

• Aplenzin Side Effects (in more detail)
• Aplenzin Dosage
• Aplenzin Use in Pregnancy & Breastfeeding
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Nite Time Cold & Flu Relief

Generic Name: acetaminophen, dextromethorphan, and doxylamine (a SEET a MIN oh fen, DEX tro me THOR fan, and dox IL a meen)

Brand Names: All-Nite, Coricidin HBP Nighttime Multi-Symptom Cold, Cough & Sore Throat Nighttime, Delsym Nighttime Cough & Cold, Multi-Symptom Nighttime Cold & Flu Relief, Multi-Symptom Nighttime Cold & Flu Relief (cherry), Night Time Cold/Flu, Nite Time Cold & Flu, Nite Time Cold & Flu Relief, Nyquil Cold & Flu, NyQuil Cold/Flu Relief, NyQuil Cold/Flu Relief Cherry, Tylenol Cold & Cough Nighttime Cool Burst, Tylenol Cough & Sore Throat Night Time, Tylenol Warming Cough & Sore Throat Nightime

What is Nite Time Cold & Flu Relief (acetaminophen, dextromethorphan, and doxylamine)?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

The combination of acetaminophen, doxylamine, and dextromethorphan is used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, doxylamine, and dextromethorphan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

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  liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

  
  


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  a blockage in your digestive tract (stomach or intestines);

  
  


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  kidney disease;

  
  


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  cough with mucus, or cough caused by emphysema or chronic bronchitis;

  
  


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  enlarged prostate or urination problems; or

  
  


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  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen, doxylamine, and dextromethorphan will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, doxylamine, and dextromethorphan may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medicine 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. Stop using this medication and call your doctor at once if you have a serious side effect such as:

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  chest pain, rapid pulse;

  
  


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  fast, slow, or uneven heart rate;

  
  


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  severe dizziness or anxiety, feeling like you might pass out;

  
  


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  severe headache;

  
  


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  mood changes, confusion, hallucinations, severe nervousness;

  
  


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  tremor, seizure (convulsions);

  
  


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  fever, easy bruising or bleeding, unusual weakness;

  
  


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  urinating less than usual or not at all;

  
  


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  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


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  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

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  dizziness, drowsiness, mild headache;

  
  


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  dry mouth, nose, or throat;

  
  


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  constipation, diarrhea, mild nausea, upset stomach;

  
  


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  blurred vision;

  
  


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  feeling restless or irritable; or

  
  


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  sleep problems (insomnia).

  
  

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.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by doxylamine.

Ask a doctor or pharmacist if it is safe for you to use acetaminophen, doxylamine, and dextromethorphan if you are also using any of the following drugs:

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  leflunomide (Arava);

  
  


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  topiramate (Topamax);

  
  


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  zonisamide (Zonegran);

  
  


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  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


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  an antidepressant;

  
  


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  birth control pills or hormone replacement therapy;

  
  


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  bladder or urinary medications;

  
  


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  blood pressure medication;

  
  


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  a bronchodilator;

  
  


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  cancer medicine;

  
  


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  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


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  gout or arthritis medications (including gold injections);

  
  


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  HIV/AIDS medication;

  
  


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  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


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  medicines to treat psychiatric disorders;

  
  


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  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


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  seizure medication.

  
  

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

More Nite Time Cold & Flu Relief resources

• Nite Time Cold & Flu Relief Side Effects (in more detail)
• Nite Time Cold & Flu Relief Use in Pregnancy & Breastfeeding
• Nite Time Cold & Flu Relief Drug Interactions
• Nite Time Cold & Flu Relief Support Group
• 0 Reviews for Nite Time - Add your own review/rating

Compare Nite Time Cold & Flu Relief with other medications

• Cough
• Pain

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, dextromethorphan, and doxylamine.

See also: Nite Time side effects (in more detail)