BACiiM

Generic Name: Bacitracin
Class: Bacitracins
VA Class: AM900
Molecular Formula: C₆₆H₁₀₃N₁₇O₁₆S
CAS Number: 1405-87-4

• 
  

  May cause renal failure due to tubular and glomerular necrosis.^{104 137}

  
  


• 
  

  Restrict use to infants with pneumonia and empyema caused by susceptible staphylococci.^{104 137} Use only if adequate laboratory facilities are available and constant supervision of the patient is possible.^{104 137}

  
  


• 
  

  Determine renal function prior to and daily during therapy.^{104 137} Do not exceed recommended daily dosage.^{104 137} Maintain fluid intake and urinary output at proper levels to avoid kidney toxicity.^{104 137}

  
  


• 
  

  Discontinue drug if renal toxicity occurs.^{104 137} Avoid concurrent use of other nephrotoxic drugs, particularly aminoglycosides (streptomycin, kanamycin, neomycin, viomycin [not commercially available in the US]), polymyxin B, and colistimethate/colistin.^{104 137}

  
  

Introduction

Antibacterial; polypeptide antibiotic derived from Bacillus subtilis.^{104 137}

Uses for BACiiM

Staphylococcal Pneumonia and Empyema in Infants

Has been used in infants for treatment of pneumonia and empyema caused by susceptible staphylococci.^{104 137}

Not considered a drug of choice or alternative for staphylococcal infections.^{139 144} Penicillinase-resistant penicillins (nafcillin, oxacillin) are the usual drugs of choice for infections caused by penicillinase-producing staphylococci, and vancomycin (with or without gentamicin and rifampin) or linezolid usually is recommended for infections caused by methicillin-resistant staphylococci.^{105 138 139}

Clostridium difficile-associated Diarrhea and Colitis

Has been used orally for the treatment of Clostridium difficile-associated diarrhea and colitis† (CDAD; antibiotic-associated diarrhea and colitis) or pseudomembranous colitis.^{100 101 102 103 105 117 140 143} Designated an orphan drug by FDA for use in this condition.¹¹⁴

Oral metronidazole or, alternatively, oral vancomycin usually is recommended for the treatment of CDAD.^{105 108 109 110 111 112 113 116 117 119 120 121 122 123 124 139 140 143} Some clinicians have suggested that oral bacitracin may be an alternative to metronidazole or vancomycin^{101 102 105} and may also be useful in patients who are allergic to vancomycin¹⁰⁰ or whose diarrhea and/or colitis does not respond to vancomycin.^{100 101 102} However, oral preparations of bacitracin are not commercially available in the US.

BACiiM Dosage and Administration

Administration

Administer IM.^{104 137}

IM Administration

Inject into the upper outer quadrant of the buttocks, alternating right and left.^{104 137} Avoid multiple injections in the same region because of transient pain following injection.^{104 137}

Reconstitution

Dissolve powder for injection in 0.9% sodium chloride injection containing 2% procaine hydrochloride. ^{104 137} Add 9.8 mL of this diluent to a vial containing 50,000 units to provide a solution containing 5000 units/mL.^{104 137} Bacitracin solutions containing <5,000 units/mL or >10,000 units/mL should not be used.^{104 137}

Do not use diluents containing parabens.^{104 137}

Dosage

Pediatric Patients

Staphylococcal Pneumonia and Empyema in Infants

IM

Infants <2.5 kg: 900 units/kg daily given in 2 or 3 divided doses.^{104 137}

Infants >2.5 kg: 1000 units/kg daily in 2 or 3 divided doses.^{104 137}

Adults

Clostridium-difficile-associated Diarrhea and Colitis

Oral

20,000–25,000 units every 6 hours for 7–10 days has been used.^{100 101 102 103} Oral dosage form not commercially available in the US.

Prescribing Limits

Pediatric Patients

Staphylococcal Pneumonia and Empyema in Infants

Do not exceed recommended dosage;^{104 137} do not exceed 12 days of therapy.^a

Special Populations

No special population dosage recommendations at this time.^a

Cautions for BACiiM

Contraindications

• 
  

  History of hypersensitivity or toxic reactions to bacitracin.^{104 137}

  
  

Warnings/Precautions

Warnings

Nephrotoxicity

IM bacitracin may cause renal failure due to tubular and glomerular necrosis.^{104 137} Albuminuria,^{104 137} hematuria,^a cylindruria,^{104 137} and rising blood concentrations of the drug^{104 137} may occur initially followed eventually by oliguria,^a azotemia,^{104 137} and renal failure.^{104 137}

Infants less prone to bacitracin nephrotoxicity than older children and adults.^a Toxicity is related to total daily dosage and duration of therapy.^a

Assess renal function prior to and daily during therapy.^{104 137} Discontinue drug if renal toxicity occurs.^{104 137}

Keep patient well hydrated using oral or, if necessary, parenteral fluids.^{104 137} Maintain urine output at proper levels to avoid renal toxicity.^{104 137} Some suggest using sodium bicarbonate or another alkali to keep urine at pH 6 or greater to avoid renal irritation.^a

Avoid concurrent use of other nephrotoxic drugs.^{104 137} (See Specific Drugs under Interactions.)

Sensitivity Reactions

Hypersensitivity

Rash,^{104 137} urticaria,^a and anaphylactoid reactions^a have occurred.

General Precautions

Neurotoxicity

Respiratory paralysis may occur as a result of neuromuscular blockade, especially in patients with a neuromuscular disease such as myasthenia gravis.^a Severe neuromuscular blockade resulting in respiratory depression unresponsive to calcium or neostigmine has occurred in several patients treated with bacitracin and neomycin sulfate instilled intrapleurally or into a pancreatic pseudocyst.^a

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of bacitracin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^{104 137}

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^{104 137} In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.^{104 137}

Superinfection

Overgrowth of nonsusceptible organisms, including fungi, may occur.^{104 137} Institute appropriate therapy if superinfection occurs.^{104 137}

Specific Populations

Pregnancy

Category C.¹⁴⁵

Not labeled for use in adults, including pregnant women.^{104 137}

Lactation

Not known whether bacitracin is distributed into milk.¹⁴⁵ Not labeled in adults, including nursing women.^{104 137}

Common Adverse Effects

Nephrotoxicity (albuminuria, cylindruria, azotemia, rising blood concentrations of the drug);^{104 137} GI effects (nausea, vomiting);^{104 137} pain at injection site;^{104 137} hypersensitivity reactions (rash).^{104 137}

Interactions for BACiiM

Specific Drugs

Drug	Interaction	Comments
Aminoglycosides (streptomycin, neomycin, kanamycin)	Possible potentiation of nephrotoxic effects104 137	Avoid concomitant use 104 137
Colistimethate/colistin	Possible potentiation of nephrotoxic effects104 137	Avoid concomitant use 104 137
Polymyxin b sulfate	Possible potentiation of nephrotoxic effects104 137	Avoid concomitant use 104 137
Neuromuscular blocking agents and general anesthetics	Possible prolongation of skeletal muscle relaxation and potentiation of neuromuscular blockadea

BACiiM Pharmacokinetics

Absorption

Bioavailability

Not absorbed from GI tract, pleura, or synovia.^a

Completely and rapidly absorbed following IM injection.^{104 137}

Following a single IM dose of 10,000–20,000 units in adults with normal renal function, peak serum concentrations occur after 1–2 hours and are detectable in serum for 6–8 hours after the dose.^a

Distribution

Extent

Widely distributed in all body organs and is present in ascitic and pleural fluids following IM injection.^{104 137}

Only trace amounts cross the blood-brain barrier into the CSF, unless the meninges are inflamed.^a

Elimination

Elimination Route

IM: 10–40% of the dose is excreted slowly by glomerular filtration and appears in urine within 24 hours.^a

Oral: Excreted in the feces.^a

Stability

Storage

Parenteral

Powder for Injection

2–8°C.^{104 137} Protect from direct sunlight.^a

Following reconstitution, stable at 2–8°C for up to one week.¹⁰⁴

Actions and SpectrumActions

• 
  

  Polypeptide antibiotic.^{104 137}

  
  


• 
  

  Has a potency of not less than 50 units of bacitracin activity per mg.^{104 137}

  
  


• 
  

  May be bactericidal or bacteriostatic, depending on drug concentration at site of infection.^a

  
  


• 
  

  Inhibits bacterial cell wall synthesis.^a

  
  


• 
  

  Active in vitro against some gram-positive bacteria, including some staphylococci and streptococci.¹⁴⁴ Also active in vitro against some gram-negative bacteria, including Neisseria, but not against most gram-negative bacilli.^a

  
  


• 
  

  Some strains of Clostridium difficile are susceptible to bacitracin in vitro,¹⁴² but other strains are resistant to the drug.^{141 144}

  
  


• 
  

  Staphylococci, including penicillin G-resistant staphylococci, resistant to bacitracin have been reported.^a Does not exhibit cross-resistance with any other antibiotic.^a

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including bacitracin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).^{104 137}

  
  


• 
  

  Advise patients that it is common to begin feeling better after a few days, but that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with bacitracin or other antibacterials in the future.^{104 137}

  
  


• 
  

  Importance of informing clinicians of existing concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^a

  
  


• 
  

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

  
  

Preparations

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

Bacitracin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use	50,000 units	BACiiM	X-Gen
			Bacitracin for Injection

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

100. Tedesco FJ. Bacitracin therapy in antibiotic-associated pseudomembranous colitis. Dig Dis Sci. 1980; 25:783-4. [IDIS 126500] [PubMed 6903494]

101. Chang TW, Gorbach SL, Bartlett JG et al. Bacitracin treatment of antibiotic-associated colitis and diarrhea caused by Clostridium difficile toxin. Gastroenterology. 1980; 78:1584-6. [IDIS 113759] [PubMed 7372074]

102. Young GP, Ward PB, Bayley N et al. Antibiotic-associated colitis due to Clostridium difficile: double-blind comparison of vancomycin with bacitracin. Gastroenterology. 1985; 89:1038-45. [IDIS 207130] [PubMed 4043661]

103. Dudley MN, McLaughlin JC, Carrington G et al. Oral bacitracin vs vancomycin therapy for Clostridium difficile-induced diarrhea: a randomized double-blind trial. Arch Intern Med. 1986; 146:1101-4. [IDIS 217153] [PubMed 3521518]

104. Pharmacia & Upjohn. Bacitracin for injection, USP prescribing information. Kalamazoo, MI. 2003 Sept.

105. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

108. Centers for Disease Control and Prevention. Recommendations for preventing the spread of vancomycin resistance: recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR Morb Mortal Wkly Rep. 1995; 44(No. RR 12):1-13. [PubMed 7799912]

109. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]

110. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]

111. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile- associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]

112. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

113. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]

114. Food and Drug Administration. List of orphan designations and approvals. From FDA website. Accessed 2009 Mar 3.

115. Souney PF, Braun L, Steele L et al. Stability of bacitracin solution frozen in glass vials or plastic syringes. Am J Hosp Pharm. 1987; 44:1125-6. [PubMed 3605124]

116. Bartlett JG. Antibiotic-associated diarrhea. Clin Infect Dis. 1992; 15:573-81. [IDIS 302937] [PubMed 1420669]

117. Kelly CP, Pothoulakis C, LaMont JT. Clostridium difficile colitis. N Engl J Med. 1994; 330:257-62. [IDIS 324298] [PubMed 8043060]

118. Reinke CM, Messick CR. Update on Clostridium difficile-induced colitis, part 2. Am J Hosp Pharm. 1994; 51:1892-901. [PubMed 7942924]

119. Fekety R, Shah AB. Diagnosis and treatment of Clostridium difficile colitis. JAMA. 1993; 269:71-5. [IDIS 307078] [PubMed 8416409]

120. Barlett JG. Antibiotic-associated diarrhea. Clin Infect Dis. 1992; 269:2088.

121. Caputo GM, Weitekamp MR. The treatment of Clostridium difficile colitis. JAMA. 1993; 269:2088. [IDIS 313397] [PubMed 8468761]

122. Spera RV, Farber BF. Multiply-resistant Enterococcus faecium: the nosocomial pathogen of the 1990s. JAMA. 1992; 268:2563-4. [PubMed 1308665]

123. Spera RV, Farber BF. The treatment of Clostridium difficile colitis. JAMA. 1993; 269:2088.

124. Oh T, Mostes de Oca G, Osorno RJ. Antibiotic-associated pseudomembranous colitis. Am J Dis Child. 1990; 144:526. [IDIS 266029] [PubMed 2330918]

126. Wilcox MH, Spencer RC. Clostridium difficile infection: responses, relapses, and reinfections. J Hosp Infect. 1992; 22:85-92. [PubMed 1358964]

127. Courvalin P. Resistance of enterococci to glycopeptides. Antimicrob Agents Chemother. 1990; 34:2291-6. [IDIS 281901] [PubMed 2088183]

128. Handwerger S, Perlman DC, Altarac D et al. Concomitant high-level vancomycin and penicillin resistance in clinical isolates of enterococci. Clin Infect Dis. 1992; 14:655-61. [IDIS 292447] [PubMed 1562656]

129. Livornese LL, Dias S, Samel C et al. Hospital-acquired infection with vancomycin-resistant Enterococcus faecium. transmitted by electronic thermometers. Ann Intern Med. 1992; 117:112-6. [PubMed 1605425]

130. Landman D, Mobarakai NK, Quale JM. Novel antibiotic regimens against Enterococcus faecium resistant to ampicillin, vancomycin, and gentamicin. Antimicrob Agents Chemother. 1993; 37:1904-8. [PubMed 8239604]

131. Centers for Disease Control and Prevention. Nosocomial enterococci resistant to vancomycin–United States, 1989-1993. MMWR Morb Mortal Wkly Rep. 1993; 42:597-9. [IDIS 318269] [PubMed 8336690]

132. Rubin LG, Tucci V, Cercenado E et al. Vancomycin-resistant Enterococcus faecium in hospitalized children. Infect Control Hosp Epidemiol. 1992; 13:700-5. [PubMed 1289397]

133. Goldmann DA. Vancomycin-resistant Enterococcus faecium: headline news. Infect Control Hosp Epidemiol. 1992; 13:695-9. [PubMed 1289396]

134. Schaberg D. Major trends in the microbial etiology of nosocomial infection. Am J Med. 1991; 91:72-5.

135. Vemuri RK, Zervos MJ. Enterococcal infections: the increasing threat of nosocomial spread and drug resistance. Postgrad Med. 1993; 93:121-4,127-8. [PubMed 8446521]

136. Centers for Disease Control and Prevention. Preventing the spread of vancomycin resistance—report from the hospital infection control practices advisory committee; comment period and public meeting; notice. Fed Regist. 1994; 59:25758-63. [PubMed 10136017]

137. X-gen. BACiiM (bacitracin for injection USP) prescribing information. Northport, NY. 2003 Dec.

138. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007; 44 Suppl 2:S27-72. [PubMed 17278083]

139. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2007; 5:33-50.

140. Nelson R. Antibiotic treatment for Clostridium difficile-associated diarrhea in adults. Cochrane Database Syst Rev. 2007; :CD004610.

141. Bourgault AM, Lamothe F, Loo VG et al. In vitro susceptibility of Clostridium difficile clinical isolates from a multi-institutional outbreak in Southern Québec, Canada. Antimicrob Agents Chemother. 2006; 50:3473-5. [PubMed 17005836]

142. Bacon AE, McGrath S, Fekety R et al. In vitro synergy studies with Clostridium difficile. Antimicrob Agents Chemother. 1991; 35:582-3. [PubMed 2039211]

143. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent epidemiologic findings and advances in therapy. Pharmacotherapy. 2007; 27:1029-39. [PubMed 17594209]

144. Kucers A, Crowe S, Grayson ML et al, eds. The use of antibiotics. A clinical review of antibacterial, antifungal, and antiviral drugs. 5th ed. Jordan Hill, Oxford: Butterworth-Heinemann; 1997: 542-3.

145. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 8th ed. Baltimore, MD: Williams & Wilkins; 2008:162-3.

a. AHFS drug information 2007. McEvoy GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2007:[page 453-454].

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Bontril

Dosage Form: tablet
Bontril®

PDM

PHENDIMETRAZINE

TARTRATE TABLETS,

USP 35 mg

CIII

Rx only

Bontril Description

Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S,3S)-3,4-Dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1).

The structural formula is:

C12H17NO•C4H6O6                    M.W. 341.36

Phendimetrazine tartrate is a white, odorless crystaline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene.

In addition, the following inactive ingredients are present: Compressible Sugar, Confectioner's Sugar, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Isopropyl Alcohol, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Purified Water, Sodium Starch Glycolate.

Bontril - Clinical Pharmacology

Phendimetrazine tartrate is a sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions or metabolic effects, may be involved for example.

Adult obese subjects instructed in dietary management and treated with anorectic drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebotreated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origin of the increased weight loss due to the various drug effects is not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

The major route of elimination is via the kidneys where most of the drug and metabolites are excreted. Some of the drug is metabolized to phenmetrazine and also phendimetrazine-N-oxide. The average half-life of elimination when studied under controlled conditions is about 3.7 hours for both the extended-release and immediate release forms. The absorption half-life of the drug from the immediate release 35 mg phendimetrazine tablets is appreciably more rapid than the absorption rate of the drug from the extended-release formulation.

Indications and Usage for Bontril

Bontril®PDM (phendimetrazine tartrate) is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)
Weight (pounds)	5'0"	5'3"	5'6"	5'9"	6'0"	6'3"
140	27	25	23	21	19	18
150	29	27	24	22	20	19
160	31	28	26	24	22	20
170	33	30	28	25	23	21
180	35	32	29	27	25	23
190	37	34	31	28	26	24
200	39	36	32	30	27	25
210	41	37	34	31	29	26
220	43	39	36	33	30	28
230	45	41	37	34	31	29
240	47	43	39	36	33	30
250	49	44	40	37	34	31

Phendimetrazine tartrate is indicated for use as monotherapy only.

Contraindications

Known hypersensitivity or idiosyncratic reactions to sympathomimetics.

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma.

Highly nervous or agitated patients.

Patients with a history of drug abuse.

Patients taking other CNS stimulants, including monoamine oxidase inhibitors.

Warnings

Phendimetrazine tartrate should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products.

In a case-control epidemiological study, the use of anorectic agents, including phendimetrazine tartrate, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, phendimetrazine tartrate should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when phendimetrazine tartrate has been used alone.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of phendimetrazine treatment. Phendimetrazine tartrate is not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with phendimetrazine tartrate should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

Tolerance to the anorectic effect of phendimetrazine develops within a few weeks. When this occurs, its use should be discontinued; the maximum recommended dose should not be exceeded.

Use of phendimetrazine tartrate within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis.

Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system, phendimetrazine tartrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Phendimetrazine tartrate is not recommended for patients who used any anorectic agents within the prior year.

Precautions

Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine tartrate and the concomitant dietary regimen.

Phendimetrazine tartrate may decrease the hypotensive effect of guanethidine. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Drug Interactions

Efficacy of phendimetrazine tartrate with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Phendimetrazine Tartrate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregancy

Pregnancy Category C

Animal reproduction studies have not been conducted with phendimetrazine tartrate. It is also not known whether phendimetrazine tartrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Usage in Pregnancy

Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, phendimetrazine tartrate should not be taken by women who are nursing unless, in the opinion of the physician, the potential benefits outweigh the possible hazards.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Cardiovascular: Palpitation, tachycardia, elevated blood pressure, ischemic events.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no case of this valvulopathy has been reported when phendimetrazine tartrate has been used alone.

Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision.

Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain.

Genitourinary: Urinary frequency, dysuria, changes in libido.

Drug Abuse and Dependence

Controlled Substance

Bontril® PDM (phendimetrazine tartrate) is a Schedule lll controlled substance.

Dependence

Phendimetrazine tartrate is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phendimetrazine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Poisoning may result in convulsions, coma, and death.

The management of overdosage is largely symptomatic. It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.

Bontril Dosage and Administration

Usual Adult Dosage

1 tablet (35 mg) twice a day or three times a day one hour before meals.

Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, ½ tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.

How is Bontril Supplied

Three-layered green, white and yellow tablet with "B 35" on the scored side and the letter "V" on the other. Bontril® PDM tablets containing 35 mg of phendimetrazine tartrate are available in bottles of 100 (NDC 0187-0497-01) and 1000 (NDC 0187-0497-02).

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

DEA Order Form Required.

Distributed by:

Valeant Pharmaceuticals North America

One Enterprise

Aliso Viejo, CA 92656 USA

Manufactured by:

Mallinckrodt, Inc.

Hobart, NY 13788

Printed with food grade ink.

MG #20886

Rev. 10/07

Part No. L2BB01

PRINCIPAL DISPLAY PANEL - 35 mg Tablet Bottle Label

NDC 0187-0497-02

RX Only

CIII

Bontril® PDM

(phendimetrazine tartrate tablets, USP)

35 mg

Each three layered

green, white and yellow

tablet contains 35 mg

of phendimetrazine

tartrate

1000

Tablets

VALEANT™

Bontril PDM  phendimetrazine tartrate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0187-0497 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phendimetrazine Tartrate (Phendimetrazine) Phendimetrazine Tartrate 35 mg

Inactive Ingredients Ingredient Name Strength Sucrose   D&C Yellow NO. 10   FD&C Blue NO. 1   FD&C Yellow NO. 6   Isopropyl Alcohol   Anhydrous Lactose   Magnesium Stearate   Cellulose, Microcrystalline   Povidone   Water   Sodium Starch Glycolate Type A Potato

Product Characteristics Color GREEN, WHITE, YELLOW Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code B;35;V Contains

Packaging # NDC Package Description Multilevel Packaging 1 0187-0497-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 0187-0497-02 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA085272	12/22/1976

Labeler - Valeant Pharmaceuticals International (042230623)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt		957414238	MANUFACTURE

Revised: 02/2011Valeant Pharmaceuticals International

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

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