Pentam 300 label

Pentam 300

Pentam 300 Recall

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Side Effects & Adverse Reactions

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 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 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.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii.

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History

There is currently no drug history available for this drug.

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Other Information

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 DOSAGE AND ADMINISTRATION).  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:

pentam-structure 

Each vial contains:
Pentamidine isethionate . . . . . . . . . . . . . 300 mg

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Pentam 300 Manufacturers

  • App Pharmaceuticals, Llc
    Pentam 300 | App Pharmaceuticals, Llc
    No Recall

    Pentam 300 | App Pharmaceuticals, Llc

    Pentam 300 | App Pharmaceuticals, Llc

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

    Intramuscular Injection

    The contents of one vial (300 mg) 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 pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.

    The diluted IV solutions containing pentamidine isethionate 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 pentamidine isethionate 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 pentamidine isethionate have been shown to be incompatible with fluconazole and foscarnet sodium.  IV solutions of pentamidine isethionate have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.

    Intramuscular Injection

    The contents of one vial (300 mg) 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 pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP.

    The diluted IV solutions containing pentamidine isethionate 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 pentamidine isethionate 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 pentamidine isethionate have been shown to be incompatible with fluconazole and foscarnet sodium.  IV solutions of pentamidine isethionate have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.

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