NebuPent


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Related to NebuPent: Pentamidine isethionate

pentamidine isethionate

NebuPent, Pentacarinat (UK), Pentam 300

Pharmacologic class: Antiprotozoal

Therapeutic class: Anti-infective

Pregnancy risk category C

Action

Unknown. May interfere with nuclear metabolism and synthesis of DNA, RNA, and proteins.

Availability

Aerosol: 300 mg

Injection: 300 mg/vial

Indications and dosages

Pneumocystis jiroveci pneumonia

Adults and children ages 5 and older: 4 mg/kg I.V. or deep I.M. daily for 14 days

To prevent P. jiroveci pneumonia in high-risk patients with human immunodeficiency virus

Adults: 300 mg by inhalation once q 4 weeks using Respigard II nebulizer

Off-label uses

• Trypanosomiasis
• Visceral leishmaniasis

Contraindications

• History of anaphylaxis from pentamidine or diamidine compounds (inhalation only)

(Note: No absolute contraindications exist for patients with P. jiroveci.)

Precautions

Use cautiously in:
• anemia, blood dyscrasias, hepatic or renal disease, hypoglycemia, diabetes mellitus, ventricular tachycardia, hypocalcemia, hypertension, hypotension
• pregnant or breastfeeding patients
• children (safety and efficacy of inhalation solution not established).

Administration

• For I.V. infusion, dilute 300 mg-vial with sterile water for injection. Withdraw prescribed dosage, then dilute further in 50 to 250 ml of dextrose 5% in water; infuse over 60 to

120 minutes.
• For I.M. use, dilute 300 mg-vial with 3 ml of sterile water for injection. Withdraw prescribed dosage; administer deep I.M. using Z-track method.
• Keep patient supine during I.M. or I.V. administration to minimize hypotension.
• For inhalation, dilute in 6 ml of sterile water and administer through nebulizer at a flow rate of 6 L/minute from 50-psi compressed air source. Don't mix inhalation solution with other drugs.

Adverse reactions

CNS: headache, disorientation, hallucinations, dizziness, confusion, fatigue, neuralgia

CV: chest pain, ECG abnormalities, syncope, vasodilation, vasculitis, phlebitis, hypertension, palpitations, arrhythmias, severe hypotension

EENT: pharyngitis

GI: nausea, vomiting, diarrhea, abdominal pain, anorexia, acute pancreatitis

Hematologic: anemia, leukopenia, thrombocytopenia

Metabolic: hypocalcemia, hypergly-cemia, hypoglycemia, hyperkalemia Musculoskeletal: myalgia

Respiratory: cough, dyspnea, congestion, pneumothorax, bronchospasm

Skin: rash, night sweats, urticaria, sterile abscess or induration at injection site

Other: metallic or bad taste, fever, chills, pain at injection site or elsewhere, edema, allergic reactions

Interactions

Drug-diagnostic tests.Blood urea

nitrogen, creatinine, liver function tests,

potassium: increased values

Calcium, hemoglobin, hematocrit,

platelets, white blood cells: decreased levels

ECG: alterations

Glucose: increased or decreased level

Patient monitoring

Closely monitor blood pressure and blood glucose. Watch for arrhythmias and evidence of pulmonary infection, blood dyscrasias, and pancreatitis during and after I.M. or I.V. administration, until patient is stable. (Severe, life-threatening reactions may occur.)
• Assess I.V. site closely during and after I.V. administration. Know that sterile abscess, pain, or induration may occur at injection site.
• Evaluate neurologic status.
• Monitor CBC (including platelet count), calcium and potassium levels, and kidney and liver function tests.

Patient teaching

• Explain purpose of therapy. Stress importance of completing entire course of treatment.

Teach patient to recognize and immediately report serious cardiovascular and neurologic reactions, abdominal pain, and easy bruising or bleeding.
• Teach patient how to use aerosol.
• Tell patient to notify prescriber if infection worsens.
• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

pentamidine

(pen-tam-i-deen) ,

NebuPent

(trade name),

Pentam 300

(trade name)

Classification

Therapeutic: anti infectives
Pregnancy Category: C

Indications

Intravenous: Intramuscular: Treatment of Pneumocystis jirovecii pneumonia (PJP). Inhalation: Prevention of PJP in AIDS or HIV-positive patients who have had PJP or who have a peripheral CD4 lymphocyte count of ≤200/mm3. Inhalation: Treatment of PJP.

Action

Appears to disrupt DNA or RNA synthesis.
Also has a direct toxic effect on pancreatic islet cells.

Therapeutic effects

Death of susceptible organism.

Pharmacokinetics

Absorption: Well absorbed parenterally; Minimal systemic absorption occurs following inhalation.
Distribution: Widely and extensively distributed but does not cross the blood-brain barrier. Concentrates in liver, kidneys, lungs, and spleen, with prolonged storage in some tissues.
Metabolism and Excretion: 1–30% excreted unchanged by the kidneys. Remainder of metabolic fate unknown.
Half-life: 5–11 hr (↑ in renal impairment).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVunknownend of infusion24 hr
Inhalnunknownunknownunknown

Contraindications/Precautions

Contraindicated in: History of previous anaphylactic reaction to pentamidine.
Use Cautiously in: Hypotension;Hypertension;Hypoglycemia;Hyperglycemia;Hypocalcemia;Leukopenia;Thrombocytopenia;Anemia;Renal impairment (dose ↓ required);Diabetes mellitus;Liver impairment;Cardiovascular disease;Bone marrow depression, previous antineoplastic therapy, or radiation therapy;Asthma (aerosol can induce bronchospasm); Obstetric / Lactation: Safety not established during pregnancy; breast feeding not recommended.

Adverse Reactions/Side Effects

For parenteral form, unless otherwise indicated

Central nervous system

  • anxiety (most frequent)
  • headache (most frequent)
  • confusion
  • dizziness
  • hallucinations

Ear, Eye, Nose, Throat

    inhalation:
  • burning in throat

Respiratory

    inhalation:
  • bronchospasm (most frequent)
  • cough (most frequent)

Cardiovascular

  • arrhythmias (life-threatening)
  • hypotension
  • chest pain

Gastrointestinal

  • pancreatitis (life-threatening)
  • abdominal pain
  • anorexia
  • drug-induced hepatitis
  • nausea
  • unpleasant metallic taste
  • vomiting

Genitourinary

  • nephrotoxicity (most frequent)

Dermatologic

  • pallor
  • rash

Endocrinologic

  • hypoglycemia
  • hyperglycemia

Fluid and Electrolyte

  • hyperkalemia
  • hypocalcemia

Hematologic

  • anemia (most frequent)
  • leukopenia (most frequent)
  • thrombocytopenia (most frequent)

Local

    IV:
  • phlebitis
  • pruritus
  • urticaria at IV site
  • IM:
  • sterile abscesses at IM sites

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • stevens-johnson syndrome (life-threatening)
  • chills (most frequent)
  • fever

Interactions

Interactions listed for parenteral administration

Drug-Drug interaction

Concurrent use with erythromycin IV may ↑ risk of potentially fatal arrhythmias.Additive nephrotoxicity with other nephrotoxic agents, including aminoglycosides, amphotericin B, and vancomycin.Additive bone marrow depression with antineoplastics or previous radiation therapy.↑ risk of pancreatitis with didanosine.↑ risk of nephrotoxicity, hypocalcemia, and hypomagnesemia with foscarnet.

Route/Dosage

Intravenous Intramuscular (Adults and Children >5 mo) 4 mg/kg once daily for 14–21 days (longer treatment may be required in AIDS patients; some patients may respond to 3 mg/kg/day).
Inhalation (Adults) NebuPent—300 mg q 4 wk, using a Respirgard II jet nebulizer (150 mg q 2 wk has also been used).
Inhalation (Children >5 yr) NebuPent—300 mg q 4 wk, using a Respirgard II jet nebulizer (for patients who cannot tolerate trimethoprim/sulfamethoxazole; unlabeled).

Renal Impairment

Intravenous (Adults) CCr 10–30 mL/min- Administer normal dose q 24 hr; CCr <10 ml/min- Administer normal dose q 48 hr.

Availability (generic available)

Powder for injection: 300 mg/vial
Solution for aerosol use (NebuPent): 300 mg

Nursing implications

Nursing assessment

  • Assess patient for infection (vital signs, sputum, WBC) and monitor respiratory status (rate, character, lung sounds, dyspnea, sputum) at beginning of and throughout therapy.
  • Obtain specimens for culture and sensitivity prior to initiating therapy. First dose may be given before receiving results.
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome or toxic epidermal necrolysis. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
  • Intravenous: Intramuscular: Monitor BP frequently during and following IM or IV administration of pentamidine. Patient should be lying down during administration. Sudden, severe hypotension may occur following a single dose. Resuscitation equipment should be immediately available.
  • Assess patient for signs of hypoglycemia (anxiety; chills; diaphoresis; cold, pale skin; headache; increased hunger; nausea; nervousness; shakiness) and hyperglycemia (drowsiness; flushed, dry skin; fruit-like breath odor; increased thirst; increased urination; loss of appetite), which may occur up to several months after therapy is discontinued.
  • Pulse and ECG should be monitored prior to and periodically during therapy. Fatalities due to cardiac arrhythmias, tachycardia, and cardiotoxicity have been reported.
  • Assess patient for signs of pancreatitis (nausea, vomiting, abdominal pain, increased serum lipase or amylase) periodically during therapy. May require discontinuation of therapy.
  • Inhalation: A tuberculin skin test, chest x-ray, and sputum culture should be performed prior to administration to rule out tuberculosis.
  • Lab Test Considerations: IM, IV—Monitor blood glucose concentrations prior to, daily during, and for several months following therapy. Severe hypoglycemia and permanent diabetes mellitus have occurred.
    • Monitor BUN and serum creatinine prior to and daily during therapy to monitor for nephrotoxicity. Concentrations may be ↑.
    • Monitor CBC and platelet count prior to and every 3 days during therapy. Pentamidine may cause leukopenia, anemia, and thrombocytopenia.
    • May cause ↑ serum bilirubin, alkaline phosphatase, AST, and ALT concentrations. Monitor liver function tests prior to and every 3 days during therapy.
    • Monitor serum calcium and magnesium concentrations prior to and every 3 days during therapy; may cause hypocalcemia and hypomagnesemia.
    • May cause ↑ serum potassium concentrations.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)

Implementation

  • Pentamidine must be given on a regular schedule for the full course of therapy. Administer missed doses as soon as remembered. If almost time for the next dose, skip the missed dose and return to the regular schedule. Do not double doses.
  • Intramuscular: Dilute 300 mg of pentamidine with 3 mL of sterile water for injection for a concentration of 100 mg/mL. IM administration should be used only for patients with adequate muscle mass and given deep IM via Z-track technique. May cause sterile abscesses.
  • Intravenous Administration
  • pH: 4.3–5.4.
  • Intermittent Infusion: Diluent: To reconstitute, add 3–5 mL of sterile water for injection or D5W to each 300-mg vial for a concentration of 100, 75, or 60 mg/mL, respectively. Withdraw dose and dilute further in 50–250 mL of D5W. Solution is stable for 48 hr at room temperature. Discard unused portions.Concentration: Not to exceed 6 mg/mL for administration.
  • Rate: Administer slowly over 1–2 hr.
  • Y-Site Compatibility: alemtuzumab, alfentanyl, aminocaproic acid, anidulafungin, argatroban, atracurium, atropine, benztropine, bleomycin, buprenorphine, calcium gluconate, carboplatin, caspofungin, chlorpromazine, cisplatin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, daptomycin, dexmedetomidine, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doxacurium, doxycycline, enalaprilat, epinephrine, epirubicin, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, fludarabine, gemcitabine, glycopyrrolate, granisetron, hetastarch, hydromorphone, idarubicin, ifosfamide, irinotecan, isoproterenol, labetalol, levofloxacin, lidocaine, lorazepam, mannitol, mechlorethamine, meperidine, metaraminol, methoxamine, metoclopramide, metoprolol, metronidazole, miconazole, midazolam, milrinone, mitoxantrone, multivitamins, naloxone, nesiritide, nitroglycerin, nitroprusside norepinephrine, octreotide, ondansetron, oxaliplatin, oxytocin, paclitaxel, pamidronate, pancuronium, papaverine, pentazocine, phentolamine, phytonadione, potassium acetate, procainamide, promethazine, propranolol, pyridoxime, quinupristin/dalfopristin, ranitidine, rituximab, rocuronium, sodium acetate, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiamine, thiotepa, tigecycline, tolazoline, trastuzumab, trimetaphan, vancomycin, vasopressin, verapamil, vincristine, vinorelbine, voriconazole, zidovudine, zoledronic acid
  • Y-Site Incompatibility: acyclovir, aldesleukin, amikacin, aminophylline, amphotericin B colloidal, amphotericin B lipid complex, amphotericin B liposome, ampicillin, ampicillin/sulbactam, ascorbic acid, azathioprine, aztreonam, bivalirudin, bumetanide, butorphanol, cefazolin, cefoperazone, cefotaxime, cefotetan, cefoxitin, ceftazidime, ceftriaxone, cefuroxime, chloramphenicol, clindamycin, dantrolene, dexamethasone, diazepam, diazoxide, digoxin, doxorubicin, ephedrine, epoetin alfa, eptifibatide, ertapenem, fluorouracil, folic acid, foscarnet, furosemide, gentamicin, heparin, hydrocortisone, indomethacin, insulin, ketorolac, linezolid, magnesium sulfate, methotrexate, methyldopate, methylprednisolone, morphine, nafcillin, nalbuphine, oxacillin, palonosetron, pantoprazole, pemetrexed, penicillin G, pentobarbital, phenobarbital, phenylephrine, phenytoin, piperacillin/tazobactam, potassium chloride, prochlorperazine, protamine, sodium bicarbonate, streptokinase, ticarcillin/clavulanate, tobramycin, trimethoprim/sulfamethoxazole, vecuronium
  • Inhalation: If using inhalation bronchodilator, administer bronchodilator 5–10 min prior to pentamidine administration.
    • Administer in a well-ventilated area.
    • Administration with patient in supine or recumbent position appears to provide a more uniform distribution of pentamidine.
    • NebuPent Dilute 300 or 600 mg (for prophylaxis or treatment, respectively) in 6 mL of sterile water for injection. Place reconstituted solution into Respirgard II nebulizer. Do not dilute with 0.9% NaCl or admix with other medications, as solution will form a precipitate. Do not use Respirgard II nebulizer for other medications.
    • Administer inhalation dose through nebulizer until chamber is empty, approximately 30–45 min.
    • Administer with the flow rate of the nebulizer at the midflow mark (5–7 L/min) over approximately 15 min until the chamber is empty.

Patient/Family Teaching

  • Inform patient of the importance of completing the full course of pentamidine therapy, even if feeling better.
  • Intravenous: Instruct patient to notify health care professional promptly if signs and symptoms of pancreatitis, rash, fever; sore throat; signs of infection; bleeding of gums; unusual bruising; petechiae; or blood in stool, urine, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Patient should not be given IM injections or rectal thermometers. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs, as these may precipitate gastric bleeding.
    • Caution patient to make position changes slowly to minimize orthostatic hypotension.
  • Inhalation: Advise patient that an unpleasant metallic taste may occur with pentamidine administration but is not significant.
    • Inform patients who continue to smoke that bronchospasm and coughing during therapy are more likely.

Evaluation/Desired Outcomes

  • Prevention or resolution of the signs and symptoms of PJP in HIV-positive patients.

NebuPent®

Pentamidine, see there.