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Pulmozyme

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Pulmozyme

Pulmozyme®
(dornase alfa) Inhalation Solution

Pulmozyme

DRUG DESCRIPTION

Pulmozyme® (dornase alfa) Inhalation Solution is a sterile, clear, colorless, highly purified solution of recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100-200 mg/L. However, the presence of the antibiotic is not detectable in the final product. The product is purified by tangential flow filtration and column chromatography. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons1. The primary amino acid sequence is identical to that of the native human enzyme.

Pulmozyme (dornase alfa) is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer system (see Clinical Experience, DOSAGE AND ADMINISTRATION). Each Pulmozyme (dornase alfa) single-use ampule will deliver 2.5 mL of the solution to the nebulizer bowl. The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate and 8.77 mg/mL sodium chloride. The solution contains no preservative. The nominal pH of the solution is 6.3.

What are the possible side effects of dornase alfa (Pulmozyme)?

If you experience any of the following serious side effects while taking dornase alfa, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • increased difficulty breathing;
  • chest pain; or
  • fever.

Less serious side effects may be more likely to occur with the use of dornase alfa. Talk to your doctor if you experience any of the following side effects:

  • voice alteration;
  • sore...

Read All Potential Side Effects and See Pictures of Pulmozyme »

What are the precautions when taking dornase alfa (Pulmozyme)?

Before using dornase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Pulmozyme »

Last reviewed on RxList: 12/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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Pulmozyme - User Reviews

Pulmozyme User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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