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Nasalcrom

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Nasalcrom

WARNINGS

Do not use if you are allergic to any of the ingredients.

PRECAUTIONS

Nasal Solution: Some patients may experience transient nasal stinging and/or sneezing immediately following instillation of cromolyn sodium nasal solution. Except in rare occurrences, these experiences have not caused discontinuation of therapy.

Ask a doctor before use if you have:

  • fever
  • discolored nasal discharge
  • sinus pain
  • wheezing

Information for the Patient

Please read the drug facts label.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long term studies in mice (12 months intraperitoneal treatment followed by 6 months observation), hamsters (12 months intraperitoneal treatment followed by 12 months observation), and rats (18 months subcutaneous treatment) showed no neoplastic effect of cromolyn sodium.

No evidence of chromosomal damage or cytotoxicity was obtained in various mutagenesis studies.

No evidence of impaired fertility was shown in laboratory animal reproduction studies.

Pregnancy

Pregnancy Category B

Reproduction studies with cromolyn sodium administered parenterally to pregnant mice, rats, and rabbits in doses up to 338 times the human clinical dose produced no evidence of fetal malformations. Adverse fetal effects (increased resorptions and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pediatric Use

Nasal Solution: Safety and effectiveness in children below the age of 6 years have not been established.

Last reviewed on RxList: 4/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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Nasalcrom - User Reviews

Nasalcrom 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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