Pentamidine Isethionate 300 mg/300mg
Pentamidine Isethionate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Seton Pharmaceuticals
Pentamidine Isethionate is a injection, powder, lyophilized, for solution containing pentamidine isethionate at 300 mg/300mg, taken intramuscular. Manufactured by Seton Pharmaceuticals.
Key Facts
- Brand Name
- Pentamidine Isethionate
- Generic Name
- Pentamidine Isethionate
- NDC Code (Product)
13925-515- Manufacturer
- Seton Pharmaceuticals
- Strength
- 300 mg/300mg
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA206666
- Marketing Start
- 04/01/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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…
Dosage & Administration
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 …
Warnings
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.
Contraindications
CONTRAINDICATIONS Pentamidine Isethionate is contraindicated in patients with a history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.
Drug Interactions
Drug Interactions While specific studies on drug interactions with pentamidine isethionate have not been conducted, the majority of patients in clinical trials received concomitant medications, including zidovudine, with no reported interactions. Because the nephrotoxic effects may be additive, the concomitant or sequential use of pentamidine isethionate and other nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet, or vancomycin should be closely monitored and avoided, if possible.
Adverse Reactions
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 vomi…
Frequently Asked Questions
What is Pentamidine Isethionate used for?
Pentamidine Isethionate contains Pentamidine Isethionate. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Pentamidine Isethionate a controlled substance?
Pentamidine Isethionate is not classified as a controlled substance by the DEA.
What is the generic name for Pentamidine Isethionate?
The generic name for Pentamidine Isethionate is Pentamidine Isethionate. There are 4 other brand versions of Pentamidine Isethionate.
What is the NDC code for Pentamidine Isethionate 300 mg/300mg?
The NDC (National Drug Code) for Pentamidine Isethionate 300 mg/300mg is 13925-515, listed by Seton Pharmaceuticals.