Gentamicin Sulfate

Gentamicin Sulfate

Gentamicin Sulfate Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.

A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Drug Interactionsand PRECAUTIONS: Drug Interactions). During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Avoid spraying in eyes.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

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

Manufacturer Warnings

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

FDA Labeling Changes

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

Uses

Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older.

Safety and effectiveness of fluticasone propionate nasal spray in children below 4 years of age have not been adequately established.

History

There is currently no drug history available for this drug.

Other Information

Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray USP, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:

Chemical Structure- FLUTICASONE Propionate

Fluticasone propionate is a white or almost white, crystalline powder with a molecular weight of 500.6, and the molecular formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and in dichloromethane and slightly soluble in ethanol (95%).

Fluticasone Propionate Nasal Spray USP, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone Propionate Nasal Spray USP also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water, and has a pH between 5 and 7.

It is necessary to prime the pump before first use or after a period of non-use (1 week or more). After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each 16 g bottle of Fluticasone Propionate Nasal Spray USP provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded.

Gentamicin Sulfate Manufacturers


  • Bayer Healthcare Llc
    Gentamicin Sulfate (Gentamax 100) Solution [Bayer Healthcare Llc]
  • General Injectables & Vaccines, Inc
    Gentamicin Sulfate Injection, Solution, Concentrate [General Injectables & Vaccines, Inc]
  • Physicians Total Care, Inc.
    Gentamicin Sulfate Cream [Physicians Total Care, Inc.]
  • Stat Rx Usa Llc
    Gentamicin Sulfate Cream [Stat Rx Usa Llc]
  • Hospira, Inc.
    Gentamicin Sulfate Injection, Solution, Concentrate [Hospira, Inc.]
  • E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.
    Gentamicin Sulfate Cream [E. Fougera & Co., A Division Of Fougera Pharmaceuticals Inc.]
  • Dispensing Solutions, Inc.
    Gentamicin Sulfate Cream [Dispensing Solutions, Inc.]
  • Mwi/vetone
    Gentamicin Sulfate (Gentamicin Intra-uterine) Solution [Mwi/vetone]
  • Vettek
    Gentamicin Sulfate (Gentamicin) Solution [Vettek]
  • Cardinal Health
    Gentamicin Sulfate Injection, Solution, Concentrate [Cardinal Health]
  • Perrigo New York Inc
    Gentamicin Sulfate Cream [Perrigo New York Inc]
  • Bayer Healthcare Llc
    Gentamicin Sulfate (Gentapoult) Injection [Bayer Healthcare Llc]
  • Hospira, Inc.
    Gentamicin Sulfate Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Gentamicin Sulfate Injection, Solution [Hospira, Inc.]

Login To Your Free Account