Professional Drug Information > NebuPent

Pentamidine (Inhalation)

VA CLASSIFICATION
Primary: AP109

Commonly used brand name(s): NebuPent; Pentacarinat; Pneumopent.

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



Category:


Antiprotozoal^{46}{47}—

Indications

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

Accepted

Pneumonia, Pneumocystis carinii (PCP) (prophylaxis)—Aerosolized pentamidine is indicated in both secondary prophylaxis (patients who have already had at least one episode of Pneumocystis carinii pneumonia), and primary prophylaxis (HIV-infected patients with a CD4 lymphocyte count less than or equal to 200 cells per cubic millimeter) of Pneumocystis carinii pneumonia. ^{{01} {26}}

[Pneumonia, Pneumocystis carinii (PCP) (treatment)]¹—Aerosolized pentamidine is used in the treatment of mild (A-a gradient < 30 mm Hg) Pneumocystis carinii pneumonia. However, preliminary studies have suggested that aerosolized pentamidine may be less effective than conventional systemic therapies; patients receiving this regimen should be followed closely for evidence of progressive disease. ^{{10} {12} {57} {58} {60} {61}}

¹ Not included in Canadian product labeling.

Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    340.42 ^{06}

Mechanism of action/Effect:

Not clearly defined; pentamidine may interfere with incorporation of nucleotides into RNA and DNA and may inhibit oxidative phosphorylation, resulting in inhibition of DNA, RNA, phospholipid, and protein biosynthesis; may also interfere with folate transformation. ^{08}

Absorption:

Systemic absorption of inhaled pentamidine is minimal, with serum pentamidine concentrations less than 20 nanograms per mL after a nebulized dose of 4 mg per kg in most cases ^{{04} {09} {10} {11} {12} {26}} (versus 612 nanograms per mL after a single intravenous dose of 4 mg per kg). ^{26} Peak systemic absorption occurs at, or near, completion of inhalation therapy. ^{11}

Distribution:

Aerosolized pentamidine produces concentrations approximately 10 to 100 times higher in the lungs than would a comparable dose of intravenous pentamidine. ^{{09} {12} {26} {57}}

Elimination:
    Unknown; in one study, cumulative percentage of total dose renally excreted was 0.4% over a 72-hour period. ^{11}


Precautions to Consider

Carcinogenicity/Mutagenicity

Pentamidine has not been shown to be mutagenic in Ames studies. Carcinogenicity studies have not been done. ^{{08} {26} {56}}

Pregnancy/Reproduction
Fertility—
Studies have not been done.

Pregnancy—
Studies with aerosolized pentamidine have not been done in humans. ^{26}

Studies with aerosolized pentamidine have not been done in animals. However, studies in rabbits have shown that systemic pentamidine was associated with an increased incidence of post-implantation losses and delayed fetal ossification ^{07}.

FDA Pregnancy Category C.

Breast-feeding

It is not known whether pentamidine is distributed into breast milk. ^{26}

Pediatrics

No information is available on the relationship of age to the effects of aerosolized pentamidine in pediatric patients. Safety and efficacy have not been established. However, if sulfamethoxazole and trimethoprim combination is not tolerated, aerosolized pentamidine is recommended for children 5 years of age and older. ^{72}


Geriatrics


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


Dental

Pentamidine may cause a bitter or metallic taste, gingivitis, hypersalivation, or dry mouth. ^{{07} {08} {26}}

Drug interactions and/or related problems
At this time, no clinically significant drug interactions and/or related problems have been documented in patients receiving prophylactic aerosolized pentamidine.

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:
» Allergy to pentamidine    (aerosolized pentamidine is contraindicated in patients with a history of an anaphylactic reaction to inhaled or systemic pentamidine ^{26})


Risk-benefit should be considered when the following medical problem exists
Asthma^{15}{26}    (aerosolized pentamidine may induce acute bronchospasm, usually in patients with a history of asthma; this may be reduced by pretreatment with a bronchodilator)



Patient monitoring
At this time, there are no particular laboratory tests or monitoring parameters recommended routinely for patients receiving prophylactic aerosolized pentamidine. However, baseline parameters, including pulmonary function tests, serum amylase and lipase, may be obtained for the first treatment, and then followed as needed.


Side/Adverse Effects

Note: The prophylactic use of aerosolized pentamidine has a very low incidence of severe side effects. Many adverse reactions will be due to other medications, other concurrent infections, or the HIV disease itself, and may be difficult to differentiate.
Coughing and bronchospasm occur primarily in patients who are cigarette smokers and continue to smoke, or have an underlying pulmonary disease, such as asthma. ^{{10} {15} {26}}
A number of cases of extrapulmonary pneumocystosis and pneumothorax have been reported in patients receiving aerosolized pentamidine. These are thought to be infectious complications due to subclinical, peripheral infection and poor systemic distribution of aerosolized pentamidine. ^{{67} {77}} Although the incidence is not known at this time, one study found that extrapulmonary pneumocystosis appears to occur more frequently in, but is not limited to, patients who have been diagnosed with AIDS for longer than 12 months. These patients usually have had prior episodes of Pneumocystis carinii pneumonia (PCP), often do not have concurrent pneumonia, are receiving concurrent zidovudine, and have had prolonged treatment with aerosolized pentamidine. It is suggested that use of zidovudine and prophylactic aerosolized pentamidine may allow for the emergence of extrapulmonary pneumocystosis. ^{45}

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 ^{26}
Incidence more frequent
    
Chest pain or congestion
    
coughing
    
dyspnea (difficulty in breathing)
    
pharyngitis (burning pain, dryness, or sensation of lump in throat; difficulty in swallowing)
    
skin rash
    
wheezing

Incidence rare
    
Extrapulmonary pneumocystosis —most frequent sites include the spleen, liver, lymph nodes, and eyes^{{36}{37}{38}{39}{40}{41}{42}{43}{44}{51}{67}{73}}
    
pancreatitis (nausea; pain in upper abdomen, possibly radiating to the back; vomiting)—may occur more frequently with prolonged use^{33}{53}{54}
    
pneumothorax (sudden onset of severe breathing difficulty; severe pain in chest)^{{20}{74}{75}{76}}

Incidence rare
—with daily treatment doses only    
Hypoglycemia, mild (anxiety; chills; cold sweats; cool, pale skin; headache; increased hunger; nausea; nervousness; shakiness)^{13}
    
renal insufficiency (decreased urination; loss of appetite; nausea; unusual tiredness)^{34}{48}



Those not indicating need for medical attention
Incidence less frequent
    
Bitter or metallic taste





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

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

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

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

» Proper dosing
Missed dose: Receiving therapy as soon as possible

Precautions while using this medication
If also using a bronchodilator inhaler, using about 5 to 10 minutes prior to aerosolized pentamidine

Possible bitter or metallic taste; dissolving a hard candy in mouth after administration of medication ^{{15} {16}}

Cigarette smokers who continue to smoke are more likely to experience coughing and bronchospasm during aerosolized pentamidine therapy


Side/adverse effects
Signs of potential side effects, especially chest pain or congestion, coughing, dyspnea, pharyngitis, skin rash, wheezing, extrapulmonary pneumocystosis, pancreatitis, pneumothorax, hypoglycemia, and renal insufficiency

A bitter or metallic taste may occur; however, it is medically insignificant


General Dosing Information
Coughing and bronchospasm occur primarily in cigarette smokers who continue to smoke, or patients with an underlying pulmonary disease, such as asthma. ^{{10} {15}} A higher incidence of coughing and bronchospasm may be related to larger particle sizes ^{{64} {65}}; however, these symptoms appear to occur most frequently due to an increased particle load with larger doses. ^{{15} {65} {66}} Pretreatment with a bronchodilator, e.g., albuterol, metaproterenol, or terbutaline, helps to alleviate this problem and may improve pentamidine distribution in the lung. ^{{04} {15} {26}}

It is important that as much medication as possible reach the upper lobes of the lungs, since upper lobe P. carinii pneumonia relapses have occurred in patients while they were receiving aerosolized pentamidine. ^{{22} {23} {24} {52}} There appears to be a more uniform distribution of aerosolized pentamidine in the lungs when it is administered to patients in a supine or recumbent position. ^{62}

Before aerosolized pentamidine treatment is started, a tuberculin skin test, chest x-ray, and sputum culture, if possible, should be performed to rule out tuberculosis due to Mycobacterium tuberculosis . A tuberculin skin test alone may not be useful because false negative readings often occur in AIDS patients. The risk of active disease or reactivation of latent tuberculosis infection is more prevalent in HIV-infected people. Also, the risk of transmission of tuberculosis to health care workers or others in the vicinity may exist. ^{{28} {29}}

Health care workers are advised to administer aerosolized pentamidine in a well-ventilated room if possible. Although one study found the environmental levels of pentamidine in a treatment room to be low, long-term occupational studies have not been done and the risk has not been established. ^{71} Of primary concern is the previously mentioned risk of transmission of tuberculosis or other respiratory pathogens via aerosols, as well as anecdotal reports of a reversible decrease in pulmonary function testing parameters and chemical conjunctivitis due to ocular exposure to aerosolized pentamidine. ^{71}

Two types of nebulizers have been shown to be effective in decreasing the incidence of P. carinii pneumonia. Respirgard II is a jet nebulizer and is used with NebuPent and Pentacarinat; Fisoneb is an ultrasonic nebulizer and is used with Pneumopent. Jet nebulizers use a high-flow gas to shear liquid strands from a thin layer of solution. The liquid strands hit a baffle, creating a wide variety of particle sizes. Larger particles generally fall by gravity and get reincorporated into the solution. ^{{59} {68}} Ultrasonic nebulizers generate an ultrahigh frequency sound, creating a geyser from which particles are expelled. When the flow through the nebulizer is interrupted, as with tidal breathing, the smaller particles coalesce into larger particles. Because of this, measurements of output and particle size will vary with different operating conditions. ^{{59} {68}}

Particle size produced by the nebulizer is an important factor in the location of aerosol deposition. The optimal size for deposition in the alveoli, where Pneumocystis carinii pneumonia (PCP) causes damage, is 1 to 2 microns; the optimal size for tracheobronchial deposition is 4 to 7 microns. ^{59} Many factors can affect and limit aerosol deposition into the alveoli, including inspiratory flowrates, frequency of respiration, breath-holding, tidal volumes, and airway narrowing from bronchospasm, emphysema, mucus, and PCP. ^{59}

Because of the differences in nebulizers and the efficacy with which they deliver aerosolized pentamidine, the nebulizers should not be utilized interchangeably with the different dosing regimens. The two regimens shown to be effective are described below. ^{68}


Inhalation 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 FOR INHALATION SOLUTION

Usual adult and adolescent dose
Pneumonia, Pneumocystis carinii


For NebuPent and Pentacarinat using the Respirgard II jet nebulizer:


Prophylaxis—
Oral inhalation, 300 mg every four weeks, administered via the Respirgard II nebulizer. The aerosol treatment should be continued over a period of approximately thirty to forty-five minutes, until the nebulizer chamber is empty. ^{{26} {69}}

Note: A prophylactic dose of 150 mg every two weeks, administered via the Respirgard II nebulizer, has also been used if the patient cannot tolerate a single monthly dose. One study found that although patients who received 300 mg monthly had a lower rate of PCP than those receiving 150 mg every two weeks, the difference was not significant. ^{63}




[Treatment]¹—
Oral inhalation, 600 mg a day, administered via the Respirgard II nebulizer for twenty-one days. Continue the aerosol treatment over a period of approximately twenty-five to thirty minutes. ^{{10} {35}}

Note: The flow rate for the nebulizer should be 5 to 7 liters per minute from a 40- to 50-pounds-per-square-inch (PSI) air or oxygen source.
Low pressure compressors (<20 PSI) should not be used.





For Pneumopent using the Fisoneb ultrasonic nebulizer ^{55}:


Loading dose (prophylaxis)—
Oral inhalation, 60 mg, administered via the Fisoneb ultrasonic nebulizer, every twenty-four to seventy-two hours for a total of 5 doses over a two week period. The aerosol treatment should be continued over a period of approximately fifteen minutes, until the nebulizer chamber is empty.



Maintenance dose (prophylaxis)—
Oral inhalation, 60 mg, administered via the Fisoneb ultrasonic nebulizer, every two weeks.

Note: The flow rate of the nebulizer should be set at the mid-flow mark.





Usual pediatric dose
Pneumonia, Pneumocystis carinii
Prophylaxis: Dosage has not been established. However, 300 mg every four weeks has been used in children 5 years of age and older who cannot tolerate sulfamethoxazole and trimethoprim combination. ^{72}


Size(s) usually available:
U.S.—


300 mg (Rx) [NebuPent (Respirgard II nebulizer)]

Canada—


60 mg (Rx) [Pneumopent (Fisoneb nebulizer)]


300 mg (Rx) [Pentacarinat (Respirgard II nebulizer)]

Packaging and storage:
Prior to reconstitution, store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. ^{{15} {26}}

Preparation of dosage form:


For NebuPent and Pentacarinat:
To prepare pentamidine for oral inhalation prophylaxis, add 6 mL of sterile water for injection to each 300-mg vial of sterile pentamidine isethionate. ^{15}

To prepare pentamidine for oral inhalation treatment, add 6 mL of sterile water for injection to 600 mg of sterile pentamidine isethionate. ^{35}

For administration, place the entire reconstituted contents into the reservoir chamber of the Respirgard II nebulizer. ^{26}



For Pneumopent:
To prepare for oral inhalation, remove the rubber stopper and put it aside, upside down, on a clean surface for later use. Add 3 to 5 mL of sterile water for inhalation or sterile water for injection to the vial. Do not use tap water and do not use normal saline. Replace the rubber stopper. The powder should dissolve immediately; if it does not, gently shake the vial to mix it. It should form a clear, colorless solution; if the solution is cloudy, do not use it. ^{{55} {56}}

For administration, place the entire reconstituted contents into the chamber of the Fisoneb ultrasonic nebulizer. ^{{55} {56}}


Stability:


For NebuPent:
After reconstitution, solutions in concentrations of 93 mg per mL retain at least 90% of their potency for up to 4 months when frozen in plastic syringes at -20 °C. Do not defrost and refreeze. ^{15}



For Pentacarinat:
Store unopened vials at room temperature; protect from light. ^{69}

After reconstitution, solutions in concentrations of approximately 2 mg per mL are stable for up to 24 hours at room temperature. ^{69}



For Pneumopent:
Store unopened vials at room temperature. ^{55}

After reconstitution, solution may be stored for up to 24 hours at room temperature or up to 48 hours in a refrigerator. Do not freeze. ^{55}


Incompatibilities:
Reconstitution of pentamidine with saline solutions may cause pentamidine to precipitate out of solution. ^{59}

Additional information:
Pentamidine inhalation solution should not be mixed with any other medications.

Do not use the Respirgard II nebulizer to administer a bronchodilator.

Revised: 03/03/1992

References

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31. Panel comment, 8/7/89.
    

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70. Panel comment, 1/91.
    

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77. Panel comments, 12/91.
    

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