pharmacopeia
GET
/api/v1/drug/pentamidine

Mechanism of action

Sourced from openFDA

Studies suggest that the pentamidine isethionate interferes with microbial nuclear metabolism by inhibition of DNA, RNA, phospholipid and protein synthesis. However, the mode of action is not fully understood.

Indications

Sourced from openFDA
  • Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii.ICD-10: B20, J18.9

Contraindications

Sourced from openFDA
  • Pentamidine Isethionate is contraindicated in patients with a ­history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.contraindicated

Dosage & administration

Sourced from openFDA

IMPORTANT: PENTAMIDINE ISETHIONATE MUST BE DISSOLVED ONLY IN STERILE WATER FOR INJECTION, USP. DO NOT USE SALINE SOLUTION FOR RECONSTITUTION BECAUSE THE DRUG WILL PRECIPITATE. DO NOT MIX THE PENTAMIDINE ISETHIONATE SOLUTION WITH ANY OTHER DRUGS. DO NOT USE THE RESPIRGARD ® II NEBULIZER TO ADMINISTER A BRONCHODILATOR. Reconstitution The contents of one vial (300 mg) must be dissolved in 6 mL Sterile Water for Injection, USP. Place the entire reconstituted contents of the vial into the Respirgard ® II nebulizer reservoir for administration. Dosage The recommended adult dosage of Pentamidine Isethionate for the prevention of Pneumocystis jiroveci pneumonia is 300 mg once every four weeks administered via the Respirgard ® II nebulizer. The dose should be delivered until the nebulizer chamber is empty (approximately 30 to 45 minutes). The flow rate should be 5 to 7 liters per minute from a 40 to 50 pounds per square inch (PSI) air or oxygen source. Alternatively, a 40 to 50 PSI air compressor can be used with flow limited by setting the flowmeter at 5 to 7 liters per minute or by setting the pressure at 22 to 25 PSI. Low pressure (less than 20 PSI) compressors should not be used. Stability Freshly prepared solutions for aerosol use are ­recommended. After reconstitution with sterile water, the pentamidine isethionate solution is stable for 48 hours in the original vial at room temperature if protected from light.

Warnings & precautions

Sourced from openFDA

The potential for development of acute PJP still exists in patients receiving Pentamidine Isethionate prophylaxis. Therefore, any patient with symptoms suggestive of the presence of a pulmonary infection, including but not limited to dyspnea, fever or cough, should receive a thorough medical evaluation and appropriate diagnostic tests for possible acute PJP as well as for other opportunistic and nonopportunistic pathogens. The use of Pentamidine Isethionate may alter the clinical and radiographic features of PJP and could result in an atypical presentation, including but not limited to mild disease or focal ­infection. Prior to initiating Pentamidine Isethionate prophylaxis, symptomatic patients should be evaluated appropriately to exclude the presence of PJP. The recommended dose of Pentamidine Isethionate for the prevention of PJP is insufficient to treat acute PJP.

Adverse reactions

Sourced from openFDA

The most frequently reported unsolicited adverse events (1 to 5%) in clinical trials, regardless of their relation to Pentamidine Isethionate therapy were as follows (n=931): Body as a Whole: Night sweats. Gastrointestinal: Diarrhea and nausea. Hematologic: Anemia. Infection: Bronchitis, non-specific herpes, ­herpes zoster, non-specific influenza, oral Candida, pharyngitis, sinusitis, and upper ­respiratory tract. Nervous System: Headache. Respiratory System: Chest pain, cough, and wheezing. Special Senses: Bad taste. Adverse events of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events): Body as a Whole: Allergic reaction, non-specific allergy, body odor, facial edema, fever, leg edema, lethargy, low body temperature, and temperature abnormality. Cardiovascular: Cerebrovascular accident, hypotension, hypertension, palpitations, poor circulation, syncope, tachycardia, vasodilatation and vasculitis. Gastrointestinal: Abdominal cramps, abdominal pain, constipation, dry mouth, dyspepsia, gastritis, gastric ulcer, gingivitis, hiatal hernia, hypersalivation, oral ulcer/abscess, splenomegaly, and vomiting. Hematological: Eosinophilia, neutropenia, non-specific cytopenia, pancytopenia, and thrombocytopenia. Hepatic: Hepatitis, hepatomegaly, and hepatic dysfunction.

Use in specific populations

Sourced from openFDA

Pregnancy-Pregnancy Category C There are no adequate and well controlled studies of Pentamidine Isethionate in pregnant women. A literature report indicated that intravenously administered pentamidine in pregnant rats at 4 mg/kg/day was embryolethal; teratogenicity was not observed in this study. It is unknown whether pentamidine administered via the aerosolized route crosses the placenta at clinically significant concentrations. It is not known whether Pentamidine Isethionate can cause fetal harm when administered to a pregnant woman. Pentamidine Isethionate should be given to a pregnant woman only if clearly needed.

Pharmacokinetics

Sourced from openFDA
Metabolism
In 5 AIDS patients with suspected Pneumocystis jiroveci pneumonia (PJP), the mean concentrations of pentamidine determined 18 to 24 hours after inhalation therapy were 23.2 ng/mL (range 5.1 to 43.0 ng/mL) in bronchoalveolar lavage fluid and 705 ng/mL (range 140 to 1336 ng/mL) in sediment after administration of a 300 mg single dose via the Respirgard ® II nebulizer.

Overdosage

Sourced from openFDA

Overdosage has not been reported with Pentamidine Isethionate. The symptoms and signs of overdosage are not known. A serious overdosage, to the point of producing systemic drug levels similar to those following parenteral administration, would have the potential of producing similar types of serious systemic toxicity. (See PRECAUTIONS ). Available clinical pharmacology data (see CLINICAL PHARMACOLOGY ) suggest that a dose up to 40 times the recommended Pentamidine Isethionate dosage would be required to produce systemic levels similar to a single 4 mg/kg intravenous dose.

Approval history

Sourced from openFDA
  • Oct 16, 1984NDANDA019264Fresenius Kabi Usa
  • Jun 15, 1989NDANDA019887Fresenius Kabi Usa
  • Sep 28, 2017ANDAANDA206666Pai Holdings
  • Apr 24, 2019ANDAANDA206667Pai Holdings
  • Jan 7, 2021ANDAANDA213806Avet Lifesciences
  • Mar 17, 2022ANDAANDA206982Pharmobedient
  • Jan 20, 2023ANDAANDA206983X-gen Pharms Inc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,216 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Febrile Neutropenia13411%
  2. 2Pyrexia13311%
  3. 3Off Label Use816.7%
  4. 4Diarrhoea806.6%
  5. 5Aplastic Anaemia776.3%
  6. 6Neutropenia776.3%
  7. 7Pneumonia584.8%
  8. 8Sepsis574.7%
  9. 9Mucosal Inflammation564.6%
  10. 10Pancytopenia544.4%
  11. 11Dyspnoea524.3%
  12. 12Thrombocytopenia524.3%
  13. 13Vomiting524.3%
  14. 14Nausea514.2%
  15. 15Platelet Count Decreased443.6%

Literature

View JSON

Recent PubMed references pinned to Pentamidine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 48 ClinicalTrials.gov registrations naming Pentamidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pentamidine work?
Studies suggest that the pentamidine isethionate interferes with microbial nuclear metabolism by inhibition of DNA, RNA, phospholipid and protein synthesis. However, the mode of action is not fully understood.
What is Pentamidine used for?
According to FDA labeling, Pentamidine carries indications including: Pentamidine Isethionate is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of PJP ii.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pentamidine?
Pentamidine is classified as Antiprotozoal, Unknown Cellular or Molecular Interaction, Decreased DNA Replication, Decreased Protein Synthesis, Decreased RNA Replication, DNA Integrity Alteration, Lipid Metabolism Alteration, RNA Integrity Alteration.
What are the brand names for Pentamidine?
Pentamidine is marketed under brand names including NebuPent, Pentam.
What are the contraindications for Pentamidine?
Pentamidine labeling lists contraindications including: Pentamidine Isethionate is contraindicated in patients with a ­history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.. Always consult the full prescribing information and a clinician.
Note. Data for pentamidine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients