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PENTAMIDINE ISETHIONATE
Overview
What is Pentam 300?
Pentam 300 (pentamidine isethionate for injection), an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see ). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform. It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid with the following structural formula:
Each vial contains:
What does Pentam 300 look like?
What are the available doses of Pentam 300?
Sorry No records found.
What should I talk to my health care provider before I take Pentam 300?
Sorry No records found
How should I use Pentam 300?
Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to .
CAUTION:
DO NOT USE SODIUM CHLORIDE INJECTION, USP FOR INITIAL RECONSTITUTION BECAUSE PRECIPITATION WILL OCCUR.
What interacts with Pentam 300?
Contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.
What are the warnings of Pentam 300?
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globuline (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Severe hypotension may result after a single IM or IV dose and is more likely with rapid IV administration (see ). The administration of the drug should, therefore, be limited to the patients in whom has been demonstrated. Patients should be closely monitored for the development of serious adverse reactions (see and ).
Extravasations have been reported which, in some instances, proceeded to ulceration, tissue necrosis and/or sloughing at the injection site. While not common, surgical debridement and skin grafting has been necessary in some of these cases; long-term sequelae have been reported. Prevention is the most effective means of limiting the severity of extravasation. The intravenous needle or catheter must be properly positioned and closely observed throughout the period of pentamidine isethionate administration. If extravasation occurs, the injection should be discontinued immediately and restarted in another vein. Because there are no known local treatment measures which have proven to be useful, management of the extravasation should be symptomatic.
What are the precautions of Pentam 300?
General
Pentamidine isethionate should be used with caution in patients with hypertension, hypotension, ventricular tachycardia, hypoglycemia, hyperglycemia, hypocalcemia, pancreatitis, leukopenia, thrombocytopenia, anemia, hepatic or renal dysfunction and Stevens-Johnson syndrome.
Pentamidine isethionate-induced hypoglycemia has been associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations. Hyperglycemia and diabetes mellitus, with or without preceding hypoglycemia, have also occurred, sometimes several months after therapy with pentamidine isethionate. Therefore, blood glucose levels should be monitored daily during therapy with pentamidine isethionate, and several times thereafter.
Patients may develop sudden, severe hypotension after a single dose of pentamidine isethionate, whether given IV or IM. Therefore, patients receiving the drug should be lying down and the blood pressure should be monitored closely during administration of the drug and several times thereafter until the blood pressure is stable. Equipment for emergency resuscitation should be readily available. If pentamidine isethionate is administered IV, it should be infused over a period of 60 to 120 minutes.
Renal and Hepatic Impairment
The efficacy or safety of alternative Pentam 300 dosing protocols have not been established for patients with impaired renal or hepatic function.
Laboratory Tests
The following tests should be carried out before, during and after therapy:
a) Daily blood urea nitrogen and serum creatinine determinations.
b) Daily blood glucose determinations.
c) Complete blood count and platelet count.
d) Liver function test, including serum bilirubin, alkaline phosphatase, AST (SGOT), and ALT (SGPT).
e) Serum calcium determinations.
f) Electrocardiograms.
Drug Interactions
No drug interaction studies with Pentam 300 have been conducted.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted to evaluate the potential of pentamidine isethionate as a carcinogen, mutagen, or cause of impaired fertility.
Pregnancy-Pregnancy Category C
Animal reproduction studies have not been conducted with pentamidine isethionate. It is also not known whether pentamidine isethionate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentamidine isethionate should not be given to a pregnant woman unless the potential benefits are judged to outweigh the unknown risks.
Nursing Mothers
It is not known whether pentamidine isethionate is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pentamidine isethionate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, pentamidine isethionate should not be given to a nursing mother unless the potential benefits are judged to outweigh the unknown risks.
Pediatric Use
Intravenous and intramuscular pentamidine has been described as an effective treatment for pneumonia (PCP) in immunocompromised pediatric patients beyond 4 months of age. The efficacy and safety profiles in these pediatric patients were similar to those observed in adult patients (See and .
What are the side effects of Pentam 300?
The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424):
Adverse events with a frequency of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events):
From post-marketing clinical experience with pentamidine isethionate, the following adverse events have been reported: cough, diabetes mellitus/ketoacidosis, dyspnea, infiltration (extravasation–see ), and torsades de pointes.
| Body as a whole: | Allergic reaction (i.e. urticaria, itching, rash), anaphylaxis, arthralgia, chills, extrapulmonary pneumocystosis, headache, night sweats, and Stevens-Johnson syndrome. | ||
| Cardiovascular: | Abnormal ST segment of electrocardiogram, cardiac arrhythmias, cerebrovascular accident, hypertension, palpitations, phlebitis, syncope, tachycardia, vasodilatation, vasculitis and ventricular tachycardia. | ||
| Gastrointestinal: | Abdominal pain, diarrhea, dry mouth, dyspepsia, hematochezia, hypersalivation, melena, pancreatitis, splenomegaly, and vomiting. | ||
| Hematological: | Defibrination, eosinophilia, neutropenia, pancytopenia, and prolonged clotting time. | ||
| Hepatic: | Hepatic dysfunction, hepatitis and hepatomegaly | ||
| Metabolic: | Hyperglycemia, hyperkalemia, hypocalcemia, and hypomagnesemia. | ||
| Neurological: | Anxiety, confusion, depression, dizziness, drowsiness, emotional lability, hypesthesia, insomnia, memory loss, neuropathy, nervousness, neuralgia, paranoia, paresthesia, peripheral neuropathy, seizure, tremors, unsteady gait, and vertigo. | ||
| 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, and tachypnea. | ||
| Skin: | Desquamation, dry and breaking hair, dry skin, erythema, dermatitis, pruritus, rash, and urticaria. | ||
| Special senses: | Blepharitis, blurred vision, conjunctivitis, contact lens discomfort, eye pain or discomfort, loss of hearing, loss of taste, and loss of smell. | ||
| Urogenital: | Flank pain, hematuria, incontinence, nephritis, renal dysfunction and renal failure. |
What should I look out for while using Pentam 300?
Contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.
Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Severe hypotension may result after a single IM or IV dose and is more likely with rapid IV administration (see ). The administration of the drug should, therefore, be limited to the patients in whom has been demonstrated. Patients should be closely monitored for the development of serious adverse reactions (see and ).
Extravasations have been reported which, in some instances, proceeded to ulceration, tissue necrosis and/or sloughing at the injection site. While not common, surgical debridement and skin grafting has been necessary in some of these cases; long-term sequelae have been reported. Prevention is the most effective means of limiting the severity of extravasation. The intravenous needle or catheter must be properly positioned and closely observed throughout the period of pentamidine isethionate administration. If extravasation occurs, the injection should be discontinued immediately and restarted in another vein. Because there are no known local treatment measures which have proven to be useful, management of the extravasation should be symptomatic.
What might happen if I take too much Pentam 300?
A 17 month old infant inadvertently received 1600 mg of intravenous pentamidine isethionate which was followed by renal and hepatic function impairment, hypotension and cardiopulmonary arrest. Treatment included cardiopulmonary resuscitation, epinephrine, atropine and intubation. In addition, a four hour course of charcoal hemoperfusion was accompanied by reduction of pentamidine serum concentration and stabilization of the patient’s condition. The patient recovered from these adverse events, but later died due to an unknown cause.
How should I store and handle Pentam 300?
Store dry product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Preservative Free. Discard unused portion.Store dry product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Preservative Free. Discard unused portion.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pentamidine isethionate, an aromatic diamidine, is known to have activity against . The mode of action of pentamidine is not fully understood. studies indicate that the drug interferes with protozoal nuclear metabolism by inhibition of DNA, RNA, phospholipid and protein synthesis.
Non-Clinical Toxicology
Contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Severe hypotension may result after a single IM or IV dose and is more likely with rapid IV administration (see ). The administration of the drug should, therefore, be limited to the patients in whom has been demonstrated. Patients should be closely monitored for the development of serious adverse reactions (see and ).
Extravasations have been reported which, in some instances, proceeded to ulceration, tissue necrosis and/or sloughing at the injection site. While not common, surgical debridement and skin grafting has been necessary in some of these cases; long-term sequelae have been reported. Prevention is the most effective means of limiting the severity of extravasation. The intravenous needle or catheter must be properly positioned and closely observed throughout the period of pentamidine isethionate administration. If extravasation occurs, the injection should be discontinued immediately and restarted in another vein. Because there are no known local treatment measures which have proven to be useful, management of the extravasation should be symptomatic.
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to SYNTHROID. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.
The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
Pentamidine isethionate should be used with caution in patients with hypertension, hypotension, ventricular tachycardia, hypoglycemia, hyperglycemia, hypocalcemia, pancreatitis, leukopenia, thrombocytopenia, anemia, hepatic or renal dysfunction and Stevens-Johnson syndrome.
Pentamidine isethionate-induced hypoglycemia has been associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations. Hyperglycemia and diabetes mellitus, with or without preceding hypoglycemia, have also occurred, sometimes several months after therapy with pentamidine isethionate. Therefore, blood glucose levels should be monitored daily during therapy with pentamidine isethionate, and several times thereafter.
The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424):
Adverse events with a frequency of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events):
From post-marketing clinical experience with pentamidine isethionate, the following adverse events have been reported: cough, diabetes mellitus/ketoacidosis, dyspnea, infiltration (extravasation–see ), and torsades de pointes.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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