Pentamidine Isethionate

Pentamidine Isethionate is an FDA-registered drug product whose active ingredient is PENTAMIDINE ISETHIONATE. It is labelled by PAI Holdings, LLC dba PAI Pharma taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 0121-1102, application ANDA206667, label effective 20260612. It is one of 3 FDA drug label records sharing the active ingredient PENTAMIDINE ISETHIONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PENTAMIDINE ISETHIONATE are most often described in connection with: pentamidine isethionate, two weeks, hiv-infected patients, history one, episodes pjp, week dosage, prevention pneumocystis, jiroveci pneumonia. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE 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. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies. The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposi’s sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive Pentamidine Isethionate via the Respirgard® II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at some time during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of Pentamidine Isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.

DOSAGE AND ADMINISTRATION 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.

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

WARNINGS 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 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. Infection : Bacterial pneumonia, central venous line related sepsis, cryptococcal meningitis, cytomegalovirus (CMV) colitis, CMV retinitis, esophageal Candida, histoplasmosis, Kaposi’s sarcoma, non-specific mycoplasma, oral herpes, non-specific otitis, non-specific pharyngitis, pharyngeal herpes, non-specific serious infection, tonsillitis, tuberculosis, and viral encephalitis. Metabolic : Hyperglycemia, hypoglycemia, and hypocalcemia. Musculoskeletal : Arthralgia, gout, and myalgia. Neurological : Anxiety, confusion, depression, drowsiness, emotional lability, hallucination, hypesthesia, insomnia, memory loss, neuralgia, neuropathy, non-specific neuropathy, nervousness, paranoia, paresthesia, peripheral neuropathy, seizure, tremors, unsteady gait, and vertigo. Reproductive : Miscarriage. Respiratory system : Asthma, bronchitis, bronchospasm, chest congestion, chest tightness, coryza, cyanosis, eosinophilic or interstitial pneumonitis, gagging, hemoptysis, hyperventilation, laryngitis, laryngospasm, non-specific lung disorder, nasal congestion, pleuritis, pneumothorax, rales, rhinitis, shortness of breath, non-specific sputum, and tachypnea. Skin : Desquamation, dry and breaking hair, dry skin, erythema, non-specific dermatitis, pruritus, rash, and urticaria. Special senses : Blepharitis, blurred vision, conjunctivitis, contact lens discomfort, eye pain or discomfort, hemianopsia, loss of taste, non-specific odor, and smell. Urogenital : Flank pain, incontinence, nephritis, renal failure, and renal pain. In a clinical trial where some adverse events were solicited by investigators, the incidences were as follows: Cough (62.7%) Decreased appetite (50.0%) Dizziness or light-headedness (45.1%) Fatigue (65.7%) Fever (51.0%) Non-specific serious infection (15.2%) Shortness of breath (48.3%) Wheezing (32.4%) From post-marketing clinical experience with Pentamidine Isethionate the following spontaneous adverse events have been reported: anaphylaxis, colitis, diabetes, dyspnea, esophagitis, hematochezia, increased blood urea nitrogen (BUN) and serum creatinine levels, melena, pancreatitis (see WARNINGS ), syndrome of inappropriate antidiuretic hormone (SIADH), and torsade de pointes.

FDA lists 3 drug label records with PENTAMIDINE ISETHIONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Pentamidine Isethionate used for?
INDICATIONS AND USAGE 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. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm 3 . These indications are based on the results of an 18-month …

Who makes Pentamidine Isethionate?
PAI Holdings, LLC dba PAI Pharma is the labeler of record for Pentamidine Isethionate. 3 FDA label records share the active ingredient PENTAMIDINE ISETHIONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pentamidine Isethionate come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pentamidine Isethionate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PENTAMIDINE ISETHIONATE?
Yes. 3 FDA drug label records list PENTAMIDINE ISETHIONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pentamidine Isethionate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.