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Pentamidine (Systemic)


VA CLASSIFICATION
Primary: AP109

Commonly used brand name(s): Pentacarinat; Pentam 300.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiprotozoal{28}

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Pneumonia, Pneumocystis carinii (treatment)—Pentamidine is indicated in the treatment of Pneumocystis carinii pneumonia (PCP) in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS). Sulfamethoxazole and trimethoprim combination is considered to be the primary agent for PCP in patients who can tolerate it. {02} {08} {27} {29} {52} {53} {54}

[Leishmaniasis, visceral (treatment)]1—Pentamidine is used as a secondary agent in the treatment of visceral leishmaniasis (kala-azar) caused by Leishmania donovani . Stibogluconate sodium, a pentavalent antimony derivative, is considered to be the primary agent for visceral leishmaniasis. {06} {07}

[Leishmaniasis, cutaneous (treatment)]1—Pentamidine is used as a secondary agent in the treatment of cutaneous leishmaniasis caused by Leishmania tropica , L. major , L. mexicana , L. aethiopica , L. peruviana , L. guyanensis , and L. braziliensis . Stibogluconate sodium, a pentavalent antimony derivative, is considered to be the primary agent for cutaneous leishmaniasis. {31} {32} {34}

[Trypanosomiasis, African (treatment)]1—Pentamidine is used as a secondary agent in the treatment of African trypanosomiasis (trypanosome fever; African sleeping sickness) caused by Trypanosoma brucei gambiense and T. b. rhodesiense in patients with early or hemolymphatic disease without central nervous system (CNS) involvement. Suramin is considered to be the primary agent for African trypanosomiasis in these patients. {06} {07} {22}
—In patients with late or chronic trypanosomiasis involving the CNS, melarsoprol, an arsenical complexed with dimercaprol, is considered the primary agent. {06} {07}

—Not all species or strains of a particular organism may be susceptible to pentamidine.

Unaccepted
Since pentamidine does not cross the blood-brain barrier, it is not useful in patients with late or chronic trypanosomiasis involving the CNS.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Pentamidine: 340.42 {04}

Mechanism of action/Effect:

Not clearly defined; pentamidine may interfere with incorporation of nucleotides into RNA and DNA and inhibit oxidative phosphorylation and biosynthesis of DNA, RNA, protein, and phospholipid; may also interfere with folate transformation. {09} {22} {31}


Other actions/effects:

May also have antifungal activity. {52}

Absorption:

Poorly absorbed from the gastrointestinal tract; must be given parenterally. {10}

Distribution:

Rapidly distributed after administration; distribution half-life of 5 to 15 minutes after intravenous administration {11} {13} {37}, 0.9 hours after intramuscular administration {13}. In humans, highest concentrations of pentamidine were found in the liver, kidneys, adrenal glands, and spleen; {11} {26} lung concentrations were lower than concentrations in these organs, and accumulated over a 4 to 5 day period. {26} There were indications of very slow uptake into the CNS, with pentamidine being detected in brain tissue approximately 30 days after the start of daily therapy. {26}

Apparent Vol D at steady state—3 to 32 liters per kg (L/kg). {10} {37}

Protein binding:

High (69%). {12} Rapidly bound to tissues following administration.


Storage

In humans, appears to be stored in the body to some extent, and slowly excreted; in mice, may be stored for months in the kidneys and liver. {11}

Biotransformation:

In rats, metabolized to as many as 6 primary metabolic forms; human metabolism is unknown. {33}

Half-life:

Intramuscular—9.1 to 13.2 hours. {13} {14}

Intravenous—Approximately 6.5 hours. {13} {14}

Terminal half-life—2 to 4 weeks. {30}

Renal function impairment—Pentamidine half-life may be prolonged in patients with renal dysfunction {25}; however, no correlation between renal function and plasma clearance of pentamidine has been found. {10} {12} {14}

Time to peak serum concentration

Intramuscular—0.5 to 1 hour. {10} {13}

Intravenous—End of infusion (1 to 2 hours). {10} {13}

Peak serum concentration:

Intramuscular—0.2 to 1.4 mcg per mL (mcg/mL) after 4 mg per kg of body weight (mg/kg). {10} {11} {13}

Intravenous—0.5 to 3.4 mcg/mL after 4 mg/kg infused over 1 to 2 hours. {10} {11} {13}

Multiple dosing results in progressive drug accumulation; this may occur even in patients with normal renal function who receive a reduced daily dose of intravenous pentamidine. {37}

Elimination:
    Renal—4 to 17% of intramuscular dose excreted in urine over 24 hours {13} {15}; approximately 2.5% of intravenous dose excreted in urine over 24 hours. {13} Patients may continue to excrete decreasing amounts in urine for up to 8 weeks following discontinuation of therapy {15}.
    Fecal—In humans, no information available; in mice, excreted in feces in an amount approximately 1/4 that in urine. {10}
    In dialysis—Neither peritoneal dialysis nor hemodialysis appears to significantly reduce plasma pentamidine concentrations. {10} {12} {14}


Precautions to Consider

Carcinogenicity/Mutagenicity

No studies have been conducted to evaluate the potential of pentamidine as a carcinogen or mutagen. {29}

Pregnancy/Reproduction
Fertility—
Studies have not been done. {05}

Pregnancy—
Adequate and well-controlled studies in humans have not been done.

Pentamidine has been found to cross the placenta in rats given high doses late in pregnancy. {42} Studies in rabbits have also shown pentamidine to be mildly embryotoxic, with an increase in post-implantation losses and delayed fetal ossification at doses of 1, 3, and 8 mg per kg of body weight (mg/kg) {10}

FDA Pregnancy Category C. {05}

Breast-feeding

It is not known whether pentamidine is distributed into breast milk. {02} {05} However, because of the potential risks to the newborn, breast-feeding is not recommended during pentamidine therapy.

Pediatrics

Limited clinical and pharmacokinetic data are available in children; however, the mg/kg dose used in children is the same as that used in adults, and side effects seen in children are similar to those seen in adults. {10} {16} {17} No pediatrics-specific problems have been documented to date.


Geriatrics


No information is available on the relationship of age to the effects of pentamidine in geriatric patients.


Dental

Systemic pentamidine may rarely cause an unpleasant metallic taste. {29}

Pentamidine may cause leukopenia and thrombocytopenia {29}, resulting in an increased incidence of certain microbial infections, delayed healing, and gingival bleeding. Dental work, whenever possible, should be completed prior to initiation of therapy or deferred until blood counts have returned to normal. Patients should be instructed in proper oral hygiene during treatment, including caution in use of regular toothbrushes, dental floss, and toothpicks.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Blood dyscrasia–causing medications (See Appendix II ) or
» Bone marrow depressants, other (See Appendix II ) or
» Radiation therapy{10}    (concurrent use with pentamidine may increase the abnormal hematologic effects of these medications and radiation therapy; dosage reduction may be required)


» Didanosine{38}    (concurrent use with pentamidine may increase the potential for development of pancreatitis)


Erythromycin{45}    (concurrent use of intravenous erythromycin with pentamidine may increase the potential for development of torsades de pointes)


» Foscarnet{43}    (concurrent use with pentamidine may result in severe, but reversible, hypocalcemia, hypomagnesemia, and nephrotoxicity)


» Nephrotoxic medications, other (See Appendix II ){10}{21}{44}    (concurrent use of other nephrotoxic medications with pentamidine may increase the potential for nephrotoxicity; renal function determinations, dosage reductions, and/or dosage interval adjustments may be required)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Alanine aminotransferase (ALT [SGPT]) and
Alkaline phosphatase, serum, and
Aspartate aminotransferase (AST [SGOT]) and
Bilirubin, serum    (values may be increased {29})


» Blood urea nitrogen (BUN) and
» Creatinine, serum    (concentrations may be increased {29})


Calcium, serum and{29}
Magnesium, serum{35}{36}{41}{51}    (concentrations may be decreased)


» Glucose, blood{29}    (concentrations may be increased or decreased since both hypoglycemia and hyperglycemia have occurred)


Potassium, serum{29}    (concentrations may be increased)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Previous allergic reaction to pentamidine    (pentamidine is contraindicated in patients with a history of an anaphylactic reaction to inhaled or systemic pentamidine)


Risk-benefit should be considered when the following medical problems exist
Anemia or
» Bleeding disorders, history of, or
» Bone marrow depression{05}{10}    (pentamidine may cause hematologic abnormalities, resulting in anemia, leukopenia, and thrombocytopenia)


» Cardiac disease or arrhythmias{05}{10}{19}    (pentamidine may cause fatal cardiac arrhythmias, tachycardia, torsades de pointes, or other cardiotoxicity)


» Dehydration or
» Renal function impairment{05}{10}    (pentamidine may cause azotemia or acute renal insufficiency; dehydration may contribute to renal toxicity)


» Diabetes mellitus or
» Hypoglycemia{05}{10}{18}    (pentamidine may cause hypoglycemia or hyperglycemia and may aggravate diabetes mellitus)


Hepatic function impairment{10}    (pentamidine may cause an increase in AST [SGOT], ALT [SGPT], bilirubin, and alkaline phosphatase)


» Hypotension{23}    (pentamidine may cause sudden severe hypotension; this is seen most frequently after intramuscular injections and rapid intravenous infusions)


» Risk-benefit should also be considered in patients who have had previous cytotoxic drug therapy or radiation therapy.

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Blood pressure determinations{10}{15}{20}    (since sudden, severe hypotension may occur, even after a single intramuscular or intravenous dose of pentamidine, patients should be lying down and their blood pressure should be closely monitored during administration and several times thereafter until blood pressure is stable)


» Blood urea nitrogen (BUN) and
» Creatinine, serum{05}{10}{20}    (concentrations may be required prior to and daily during therapy since pentamidine may be nephrotoxic; serum creatinine concentrations up to 6 mg per dL, as well as acute renal failure with even higher serum creatinine concentrations, have been reported; patients with severely impaired renal function may require a reduction in dose)


Calcium, serum and
Magnesium, serum{10}{20}{35}{36}{51}    (concentrations may be required prior to and every 3 days during therapy since hypocalcemia and hypomagnesemia due to pentamidine-induced tubular injury may occur)


» Complete blood counts (CBCs) or
» Platelet counts{10}{15}{20}    (may be required prior to and every 3 days during therapy since pentamidine may cause severe leukopenia, thrombocytopenia, and, occasionally, anemia)


» Electrocardiograms (ECGs){05}{46}    (may be required at regular intervals during therapy since fatalities due to cardiac arrhythmias, tachycardia, torsades de pointes, or other cardiotoxicity have been reported; potassium and magnesium concentrations should also be monitored; patients who develop monomorphic and polymorphic ventricular tachycardia may benefit from rapid intravenous injection of magnesium sulfate)


» Glucose concentrations, blood{18}{20}    (pentamidine may cause hypoglycemia, which may be associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations; blood glucose concentrations below 20 mg per dL have been reported; hyperglycemia and permanent diabetes mellitus, with or without preceding hypoglycemia, have also occurred, sometimes up to several months after therapy is discontinued; therefore, blood glucose determinations may be required prior to therapy, daily during therapy, and up to several months following therapy)


Liver function tests{10}{20}    (hepatic function determinations, including bilirubin, alkaline phosphatase, AST [SGOT], and ALT [SGPT], may be required prior to and every 3 days during therapy since elevated hepatic function test results have been reported)




Side/Adverse Effects

Note: Rapid intravenous infusion may result in a precipitous drop in blood pressure. The risk of hypotension is decreased if pentamidine is administered by slow intravenous infusion, over at least 60 minutes, and preferably over 2 hours. {10} {29}
Pentamidine can produce prolonged, severe hypoglycemia lasting from 1 day to several weeks. {10} This hypoglycemia has been associated with a direct cytolytic effect on pancreatic beta islet cells, leading to insulin release. {18} It usually occurs after 5 to 7 days of therapy; however, it may not occur until after pentamidine has been discontinued. {10} One study found the risk of hypoglycemia to be increased with higher doses, longer duration of therapy, and retreatment within 3 months. {24}
Hyperglycemia and diabetes mellitus may occur up to several months after pentamidine therapy has been discontinued. {10}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent {05} {10} {15}
    
Diabetes mellitus or hyperglycemia (drowsiness; flushed, dry skin; fruit-like breath odor; increased thirst; increased urination; loss of appetite)
    
elevated liver function tests
    
hypoglycemia (anxiety; chills; cold sweats; cool, pale skin; headache; increased hunger; nausea; nervousness; shakiness)
    
hypotension (blurred vision; confusion; dizziness; fainting; lightheadedness; unusual tiredness or weakness)
    
leukopenia or neutropenia (sore throat and fever)
    
nephrotoxicity (decreased frequency of urination; loss of appetite; weakness)
    
thrombocytopenia (unusual bleeding or bruising)

Incidence less frequent {05} {10} {15}
    
Anemia (unusual tiredness or weakness)
    
cardiac arrhythmias (rapid or irregular pulse; ECG abnormalities; torsades de pointes)—primarily ventricular tachycardia
    
hypersensitivity (skin rash, redness, or itching; fever)
    
pancreatitis (pain in upper abdomen; nausea and vomiting)
    
phlebitis (pain at site of injection)—with intravenous injection
    
sterile abscess (pain, redness, and hardness at site of injection)—with intramuscular injection



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent {05} {10}
    
Gastrointestinal disturbances (nausea and vomiting; loss of appetite; diarrhea)



Those not indicating need for medical attention
Incidence less frequent {05} {10}
    
Unpleasant metallic taste



Those indicating possible hyperglycemia or hypoglycemia and the need for medical attention if they occur after medication is discontinued
Signs of hyperglycemia {48} {49} {50}
    
Drowsiness
    
flushed, dry skin
    
fruit-like breath odor
    
increased thirst
    
increased urination
    
loss of appetite

Signs of hypoglycemia {48} {49} {50}
    
Anxiety
    
chills and cold sweats
    
cool, pale skin
    
headache
    
increased hunger
    
nausea
    
nervousness
    
shakiness





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Pentamidine (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to pentamidine

Pregnancy—Pentamidine crosses the placenta in animals; studies have found it to be mildly embryotoxic in rabbits





Use in children—There are limited data available on the use of pentamidine in children; however, the dose used in children is the same as that used in adults and the side effects seen appear to be similar to those seen in adults

Other medications, especially bone marrow depressants, didanosine, foscarnet, other nephrotoxic medications, or radiation therapy
Other medical problems, especially a history of bleeding disorders, bone marrow depression, cardiac disease, dehydration, diabetes mellitus, hypoglycemia, hypotension, or renal function impairment

Proper use of this medication
» Importance of receiving medication for full course of therapy and on regular schedule

» Proper dosing

Precautions while using this medication
» Severe hypotension may occur; patient should be lying down during administration; physician may need to monitor blood pressure during administration and several times thereafter until blood pressure stabilizes

To reduce the risk of bleeding during periods of low blood counts
» Checking with physician immediately if unusual bleeding or bruising occurs

Using caution in use of regular toothbrushes, dental floss, and toothpicks; physician, dentist, or nurse may suggest alternative methods for cleaning teeth and gums; checking with physician before having dental work done

Avoiding use of safety razor; using electric shaver instead; using caution in use of fingernail or toenail cutters

For visceral leishmaniasis or African trypanosomiasis

Measures for sandfly and tsetse fly control:
Sleeping under fine-mesh netting

Wearing long-sleeved shirts or blouses and long trousers; wearing clothing of moderately heavy material to protect from tsetse fly bites

Applying insect repellant to uncovered areas of skin


Side/adverse effects
Unpleasant metallic taste may occur, although medically insignificant

Signs of potential side effects, especially diabetes mellitus, hyperglycemia, hypoglycemia, hypotension, leukopenia, neutropenia, nephrotoxicity, thrombocytopenia, anemia, cardiac arrhythmias, hypersensitivity, pancreatitis, phlebitis, and sterile abscess


General Dosing Information
Slow intravenous infusion, over 1 to 2 hours, is the preferred route of administration. Intramuscular administration can cause a sterile abscess at the site of injection. If pentamidine must be given intramuscularly, it should be reserved for patients with adequate muscle mass, and the daily dose of pentamidine should be administered by deep injection only. {10}

Pentamidine may cause sudden, severe hypotension, even after a single dose. Therefore, patients should be lying down and their blood pressure should be closely monitored during administration and several times thereafter until blood pressure is stable. {10}

No adjustment of the pentamidine dose is needed in patients with renal impairment. Because less than 3% of a dose of pentamidine is excreted through the kidneys, no correlation has been seen between renal function and plasma drug clearance. Also, the renal excretion increased only marginally with repeated pentamidine dosing. {37}


Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

PENTAMIDINE ISETHIONATE STERILE

Usual adult and adolescent dose
Pneumonia, Pneumocystis carinii
Intravenous infusion, 4 mg per kg of body weight, administered over one to two hours, once a day for fourteen to twenty-one days, depending on clinical response. {02} {03} {05} {10} {29}

Note: In preliminary studies, a reduced intravenous dose of 3 mg per kg of body weight once a day was used successfully in the treatment of mild to moderate P. carinii pneumonia. {39} {40}


[Leishmaniasis, visceral]1
Intravenous infusion, 2 to 4 mg per kg of body weight, administered over one to two hours, once a day for up to fifteen days. Administration may be repeated in one to two weeks if required. {06} {07}

[Leishmaniasis, cutaneous]1
Intravenous infusion, 2 to 4 mg per kg of body weight, administered over one to two hours, once or twice a week until the lesions heal. {31} {32} {34}

[Trypanosomiasis, African (without CNS involvement)]1
Treatment: Intravenous infusion, 4 mg per kg of body weight, administered over one to two hours, once a day for ten days. {06} {07}


Note: The dose of pentamidine isethionate is based on the total weight of the salt, whereas the dose of pentamidine mesylate (methanesulfonate) is based on the weight of pentamidine base. Since both preparations are available in some countries, clinicians should calculate the dose for pentamidine preparations on the basis that 2.4 mg of pentamidine mesylate is equivalent to 4 mg of pentamidine isethionate. {47}


Usual adult prescribing limits
Trypanosomiasis, African
3 to 5 mg per kg of body weight a day.


Usual pediatric dose
See Usual adult and adolescent dose. {02} {05} {10}

Size(s) usually available:
U.S.—


300 mg (Rx) [Pentam 300][Generic]

Canada—


200 mg (Rx) [Pentacarinat]


300 mg (Rx) [Pentacarinat][Generic]

Packaging and storage:
Prior to reconstitution, store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Protect dry powder and reconstituted solution from light.

Preparation of dosage form:
To prepare initial dilution for intramuscular use, add 3 mL of sterile water for injection to each 300-mg vial. {03}

To prepare initial dilution for intermittent intravenous use, add 2.1 mL of sterile water for injection to each 200-mg vial, {02} or add 3 to 5 mL of sterile water for injection or 5% dextrose injection to each 300-mg vial. The solution may be further diluted in 50 to 250 mL of 5% dextrose injection and administered over a period of at least 1 hour, and preferably up to 2 hours. {12}

Stability:
After reconstitution in 5% dextrose injection, pentamidine solutions with concentrations of 1 and 2.5 mg per mL retain their potency for up to 24 hours at room temperature. Discard any unused portion. {03} Reconstituted pentamidine should not be mixed with any solutions other than 5% dextrose. {10}



Revised: 05/27/1994



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