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DRUGS & SUPPLEMENTS
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Pneumopent for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.
Contraindicated in patients with a history of hypersensitivity to Pneumopent.
Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with Pneumopent, 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 PRECAUTIONS ). The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated. Patients should be closely monitored for the development of serious adverse reactions (see PRECAUTIONS and ADVERSE REACTIONS ).
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 Pneumopent 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.
Pneumopent 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.
Patients may develop sudden, severe hypotension after a single dose of Pneumopent, 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 Pneumopent is administered IV, it should be infused over a period of 60 to 120 minutes.
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 Pneumopent. Therefore, blood glucose levels should be monitored daily during therapy with Pneumopent, and several times thereafter.
The efficacy or safety of alternative Pneumopent dosing protocols have not been established for patients with impaired renal or hepatic function.
The following tests should be carried out before, during and after therapy:
No drug interaction studies with Pneumopent have been conducted.
Because the nephrotoxic effects may be additive, the concomitant or sequential use of Pneumopent and other nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet, or vancomycin should be closely monitored and avoided, if possible.
No studies have been conducted to evaluate the potential of Pneumopent as a carcinogen, mutagen, or cause of impaired fertility.
Animal reproduction studies have not been conducted with Pneumopent. It is also not known whether Pneumopent can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pneumopent should not be given to a pregnant woman unless the potential benefits are judged to outweigh the unknown risks.
It is not known whether Pneumopent is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Pneumopent, 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, Pneumopent should not be given to a nursing mother unless the potential benefits are judged to outweigh the unknown risks.
Intravenous and intramuscular pentamidine has been described as an effective treatment for Pneumocystis carinii 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 DOSAGE AND ADMINISTRATION and OVERDOSAGE).
CAUTION: Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with Pneumopent, both by the IM and IV routes. Nephrotoxic events (increased creatinine, impaired renal function, azotemia, and renal failure) are common with the parenteral administration of Pneumopent. The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated.
The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to Pneumopent therapy were as follows (n=424):
Cardiovascular: Hypotension | 5.0% |
Gastrointestinal: Anorexia/Nausea | 5.9% |
Hematologic: Anemia Leukopenia Thrombocytopenia | 1.2% 10.4% 2.6% |
Hepatic: Elevated liver function tests | 8.7% |
Metabolic: Hypoglycemia | 5.9% |
Neurologic: Confusion/hallucinations | 1.7% |
Skin: Sterile abscess and/or necrosis, pain, or induration at the site of IM injection Rash | 11.1% 3.3% |
Special Senses: Bad taste | 1.7% |
Urogenital: Azotemia Elevated serum creatinine Elevated blood urea nitrogen Impaired renal function | 8.5% 23.6% 6.6% 28.8% |
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):
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. |
From post-marketing clinical experience with Pneumopent, the following adverse events have been reported: cough, diabetes mellitus/ketoacidosis, dyspnea, infiltration (extravasation–see WARNINGS ), and torsades de pointes.
A 17 month old infant inadvertently received 1600 mg of intravenous Pneumopent 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. 1
CAUTION: DO NOT USE SODIUM CHLORIDE INJECTION, USP FOR INITIAL RECONSTITUTION BECAUSE PRECIPITATION WILL OCCUR. Pneumopent should be administered IM or IV only. The recommended regimen for adults and pediatric patients beyond 4 months of age is 4 mg/kg once a day for 14 to 21 days. Therapy for longer than 21 days with Pneumopent has also been used but may be associated with increased toxicity.
The contents of one vial should be dissolved in 3 mL of Sterile Water for Injection, USP at 22° - 30°C (72° - 86°F). The calculated daily dose should then be withdrawn and administered by deep IM injection.
The contents of one vial (300 mg) should first be dissolved in 3 to 5 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP at 22°- 30°C (72° - 86°F). The calculated dose of Pneumopent should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.
The diluted IV solutions containing Pneumopent should be infused over a period of 60 to 120 minutes.
Aseptic technique should be employed in preparation of all solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
After reconstitution with sterile water, the Pentam solution is stable for 48 hours in the original vial at room temperature if protected from light. To avoid crystallization, store at 22° - 30°C (72° - 86°F). Intravenous infusion solutions of Pneumopent at 1 mg/mL and 2.5 mg/mL prepared in 5% Dextrose Injection, USP are stable at room temperature for up to 24 hours.
Intravenous (IV) solutions of Pneumopent have been shown to be incompatible with fluconazole and foscarnet sodium. IV solutions of Pneumopent have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.
NDC No. | |
13925-515-10 | Pneumopent for injection 300 mg, lyophilized product in single-dose vials, packages of 10. |
Store dry product at 20° to 25°C (68° to 77°F). Protect from light.
Preservative Free. Discard unused portion.
Manufactured for:
Seton Pharma, LLC
Manasquan, NJ 08736
Revised: January 2014
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Single Dose Vial Label
NDC 13925-515-10
Pneumopent for Injection
300 mg
Lyophilized
For IM or IV Use
Single-Dose Vial
Rx only
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Single Dose Vial Carton Label
NDC 13925-515-10
Pneumopent for Injection
300 mg
Lyophilized
For Intramuscular or Intravenous Use
10 Single-Dose Vial
Rx only
Depending on the reaction of the Pneumopent after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pneumopent not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Pneumopent addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology