DRUGS & SUPPLEMENTS

Pentam

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Pentam uses


INDICATIONS AND USAGE

Pentam for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.

CONTRAINDICATIONS

Contraindicated in patients with a history of hypersensitivity to Pentam.

WARNINGS

Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with Pentam, 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 Pentam 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.

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PRECAUTIONS

General

Pentam 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 Pentam, 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 Pentam 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 Pentam. Therefore, blood glucose levels should be monitored daily during therapy with Pentam, and several times thereafter.

Renal and Hepatic Impairment

The efficacy or safety of alternative Pentam 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:

  • Daily blood urea nitrogen and serum creatinine determinations.
  • Daily blood glucose determinations.
  • Complete blood count and platelet count.
  • Liver function test, including serum bilirubin, alkaline phosphatase, AST, and ALT (SGPT).
  • Serum calcium determinations.
  • Electrocardiograms.

Drug Interactions

No drug interaction studies with Pentam have been conducted.

Because the nephrotoxic effects may be additive, the concomitant or sequential use of Pentam 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 Pentam as a carcinogen, mutagen, or cause of impaired fertility.

Pregnancy-Pregnancy Category C

Animal reproduction studies have not been conducted with Pentam. It is also not known whether Pentam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentam 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 Pentam is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Pentam, 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, Pentam 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 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).

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ADVERSE REACTIONS

CAUTION: Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with Pentam, 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 Pentam. 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 Pentam 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 Pentam, the following adverse events have been reported: cough, diabetes mellitus/ketoacidosis, dyspnea, infiltration (extravasation–see WARNINGS ), and torsades de pointes.

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OVERDOSAGE

A 17 month old infant inadvertently received 1600 mg of intravenous Pentam 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

DOSAGE AND ADMINISTRATION

CAUTION: DO NOT USE SODIUM CHLORIDE INJECTION, USP FOR INITIAL RECONSTITUTION BECAUSE PRECIPITATION WILL OCCUR. Pentam 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 Pentam has also been used but may be associated with increased toxicity.

Intramuscular Injection

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.

Intravenous 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 Pentam should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.

The diluted IV solutions containing Pentam 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.

Stability

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 Pentam 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 Pentam have been shown to be incompatible with fluconazole and foscarnet sodium. IV solutions of Pentam have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.

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HOW SUPPLIED


NDC

No.


13925-515-10


Pentam 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.

REFERENCE

  • Watts RG; Conte JE, Jr.; Zurlinden E; Waldo FB: Effect of charcoal hemoperfusion on clearance of Pentam after accidental overdose. J Toxicol Clin Toxicol 1997;35:89-92.

Manufactured for:

Seton Pharma, LLC

Manasquan, NJ 08736

Revised: January 2014

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Single Dose Vial Label

NDC 13925-515-10

Pentam 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

Pentam for Injection

300 mg

Lyophilized

For Intramuscular or Intravenous Use

10 Single-Dose Vial

Rx only

Pentam pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Pentam available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Pentam destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Pentam Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Pentam pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SETON PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Pentam?

Depending on the reaction of the Pentam after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pentam 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 Pentam 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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Review

sDrugs.com conducted a study on Pentam, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Pentam consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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