Nebupent

NebuPent (pentamidine isethionate) is an antibiotic used to prevent and treat serious infections such as Pneumocystis pneumonia (PCP), often seen in people with acquired immunodeficiency syndrome (AIDS). Common side effects of NebuPent include:

• cough,
• upset stomach,
• loss of appetite,
• nausea,
• vomiting,
• diarrhea,
• dizziness,
• headache,
• burning feeling in the throat,
• unusual taste in the mouth, or
• dry mouth

The recommended adult dosage of NebuPent for the prevention of Pneumocystis pneumonia is 300 mg once every four weeks administered via the Respirgard II nebulizer. NebuPent may interact with azathioprine, carbamazepine, antibiotics, anti-inflammatory drugs, cisplatin, didanosine, zidovudine, birth control pills, ganciclovir, blood pressure medications, medication for diabetes, valproic acid, medication for psychiatric disorders, or metoclopramide. Tell your doctor all medications and supplements you use. During pregnancy, NebuPent should be used only when prescribed. It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our NebuPent (pentamidine isethionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nebupent Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication with a nebulizer;
• a light-headed feeling, like you might pass out;
• fast or uneven heart rate;
• painful or difficult urination;
• confusion, hallucinations;
• pain, burning, irritation, or skin changes where the injection was given;
• worsening symptoms, or signs of a new infection (fever, cough, trouble breathing, night sweats);
• a blood cell disorder--pale skin, feeling light-headed or short of breath, easy bruising, unusual bleeding, purple or red pinpoint spots under your skin;
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, or feeling jittery; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• loss of appetite; or
• unusual or unpleasant taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nebupent (Pentamidine Isethionate)

 

Nebupent Professional Information

SIDE EFFECTS

The most frequently reported unsolicited adverse events (1 to 5%) in clinical trials, regardless of their relation to NebuPent (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 NebuPent (pentamidine isethionate) the following spontaneous adverse events have been reported: anaphylaxis, colitis, diabetes, dyspnea, esophigitis, hematochezia, increased blood urea nitrogen (BUN) and serum creatinine levels, melena, pancreatitis (see WARNINGS), syndrome of inappropriate antidiuretic hormone (SIADH), and torsade de pointes.

Read the entire FDA prescribing information for Nebupent (Pentamidine Isethionate)