Alcon cilodex

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Ciprodex, owned by Alcon Laboratories, Inc. In October , Alcon sued Dr. A judge in the UK upheld the Alcon patent. From Wikipedia, the free encyclopedia. Pharmaceutical product. National Library of Medicine. Retrieved 5 November List of nationally authorised medicinal products. Europeans Medicines Agency. Mississauga, Ontario: Alcon Canada Inc. Archived from the original PDF on Retrieved Food and Drug Administration. US Food and Drug Administration. Archived from the original on 4 March Law Drugs used for diseases of the ear S Betamethasone Dexamethasone Fluocinolone acetonide Hydrocortisone Prednisolone.

Lidocaine Cocaine Phenazone. Portal : Medicine. Categories : Combination drugs Novartis brands. Safety Based on the frequency and incidence of adverse events reported. MITT is a term of art in the clinical sciences. For this study, the MITT population is defined as the population that received study drug, met inclusion criteria and was culture positive for bacteria on Day 1. A summary of the study details for this OM study is provided below.

Clinical Twice daily patient assessment of cessation of otorrhea using a daily Evaluation: diary. Physician evaluation of signs and symptoms of AOMT, including presence of otorrhea, characteristics of otorrhea, presence of granulation tissue, tube patency, and overall clinical response by visit.

Efficacy Cessation of otorrhea was defined as ending on the first day on which Criteria: the otorrhea is absent and remains absent for all subsequent diary entries.

For this study, the MITT population is defined as the population that received study drug, met inclusion criteria, participated in at least one on-therapy visit, and was culture positive for bacteria on Day 1.

N Min. The study duration was approximately three weeks long with four scheduled visits. Conditions between the treatment groups were identical except for the study drugs and the respective dosing regimens.

Outcome differences between the two groups are therefore attributed to the differences in treatment. The mean age was 2. Safety Results:. No serious adverse events related to therapy were reported during this study.

Adverse events in the overall safety population were all nonserious with the exception of three reports abdominal pain, pneumonia, cellulitis , were generally mild to moderate, usually resolved with or without treatment, and generally did not interrupt patient continuation in the study.

Only three patients in the adolescent population were enrolled, and none of the adolescents reported adverse events. CIPRODEX administered twice daily in the affected ear s is safe and well tolerated in pediatric patients with acute otitis media with tympanostomy tubes, based upon a review of adverse events and an assessment of audiometry parameters.

The invention has been described by reference to certain preferred embodiments; however, it should be understood that it may be embodied in other specific forms or variations thereof without departing from its spirit or essential characteristics.

The embodiments described above are therefore considered to be illustrative in all respects and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description. What is claimed is: 1. A method of treating a middle ear infection in a human patient comprising the steps of: a diagnosing the patient as having otitis media and an open tympanic membrane in at least one ear; and. The method of claim 1 wherein the dexamethasone is dexamethasone alcohol and the ciprofloxacin is ciprofloxacin hydrochloride, monohydrate.

The method of claim 1 wherein the aqueous suspension composition contains 0. The method of claim 1 wherein the aqueous suspension composition consists essentially of a 0. The method of claim 1 wherein the method further comprises the step of pumping the tragus to force the aqueous suspension composition through the open tympanic membrane and into the middle ear. The method of claim 1 wherein the otitis media is acute otitis media. The method of claim 1 wherein the otitis media is chronic supprative otitis media.

The method of claim 1 wherein the aqueous suspension composition containing a combination of ciprofloxacin and dexamethasone is packaged with directions for use that indicate the composition may be used to treat otitis media in patients with an open tympanic membrane.

A total of patients enrolled into the study at 48 investigative sites in. Cessation of ear pain was defined as the first day where the patient dairy. Physician's assessment of clinical response of the patient at TOC on a. A total of patients enrolled into the study at 21 investigative sites in. USP USA1 en. EPB1 en. JPA en. KRA en. CNC en. ATT en. AUB2 en. BRA en. CAC en. DET2 en. DKT3 en. EST3 en. MXPAA en. PLB1 en. RUC2 en. WOA1 en. ZAB en. USB2 en. Pharmaceutical formulation comprising an antibiotic, a triazole and a corticosteroid.

Extracellular polysaccharide solvating system for treatment of bacterial ear conditions. Methods for treating, preventing, or reducing the risk of opthalmic, otic, and nasal infections.

Otic compositions for the treatment of infections of the internal and external ear in mammals. Product for the treatment of chronic wounds with an extracellular system of solvation of polymeric substances. Controlled release antimicrobial compositions and methods for the treatment of ear disorders. Controlled release antimicrobial compositions and methods for the treatment of otic disorders. EPA4 en. TWA en. Pharmaceutical composition for delivery of receptor tyrosine kinase inhibiting rtki compounds to the eye.

EPA1 en. CAA1 en. Topical pharmaceutical compositions of antibiotics and steroidal anti inflammatory agents. USB1 en. USA en. Topically applicable formulations of gyrase inhibitors in combination with corticosteroids. ESA1 en. Pharmaceutical formulation based on a steroidal or non- steroidal anti-inflammatory agent and an antibiotic belonging to the DNA Girase inhibitors group for topical ophthalmic use.

Pharmaceutical formulation containing clobetasone and tobramycin and applications thereof. EPA2 en. Method and composition of a topical treatment of inner ear and labyrinth symptoms. WOA2 en. Methods of treating ophthalmic, otic and nasal infections and attendant inflammation. Alper, et al. Andrew Florea, et al. Arnes, et al. Bartzokas, et al. Bluestone, et al. Saunders Company, Philadelphia, PA.

Brown, et al. Charles Pudrith, et al. Claros, et al. Deschepper, et al. Dohar, et al. Donald Y M Leung, et al. Doshi, et al. Drug Facts and Comparisions, Edition, pp. Langhoff, et al. Engel, et al. Epstein, et al. Esposito, et al.

Otolaryngol Head Neck Surg, , pp. Otolaryngol Head Neck Surg. Falser, et al. SS54, vol. Force, et al. Otolaryngol, Head, Neck, Surg. Fradis, et al. Hobden, et al. Isaacson, et al.

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Registered Class: 25 Word Delhi. Registered Class: 5 Word Maharashtra. Abandoned Class: 9, 35, 42 Word Delhi. Registered Class: 9 Device Maharashtra. Withdrawn Class: 20 Word Chandigarh.

Registered Class: 37 Device Karnataka. Registered Class: 6 Word Chandigarh. Registered Class: 5 Word Chandigarh. Registered Class: 6 Word Uttarakhand. Registered Class: 23 Device Maharashtra. Trademarks Alcon Cilodex.

Cancelled Class: 5 Word. Alcon Cilodex Documents. Updated about 10 hours ago. Novartis Ag. Lall Lahiri And Salhotra.

The Trademark is registered to Novartis Ag. Trademark Proprietor Novartis Ag. Related Trademarks. Alcon cilodex was applied on 13 November Who is the trademark proprietor? Components: Ciprofloxacin , Dexamethasone. The information provided in of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

Qualitative and quantitative composition. The information provided in Qualitative and quantitative composition of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

Therapeutic indications. The information provided in Therapeutic indications of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

CIPRODEX is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media in pediatric patients age 6 months and older with tympanostomy tubes due to Staphylococcus aureus , Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. Acute Otitis Externa in pediatric age 6 months and older , adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Dosage Posology and method of administration. The information provided in Dosage Posology and method of administration of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Dosage Posology and method of administration in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

Shake well immediately before use. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the drops should be instilled.

The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.

Discard unused portion after therapy is completed. This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. The information provided in Contraindications of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

CIPRODEX is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections and fungal otic infections.

Special warnings and precautions for use. The information provided in Special warnings and precautions for use of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex.

Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy. Continued Or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

This product is not approved for use in the eye. Administration Instructions Patients should be instructed to warm the bottle in their hand for one to two minutes prior to use and shake well immediately before using. Allergic Reactions Advise patients to discontinue use immediately and contact their physician, if rash or allergic reaction occurs.

Avoid Contamination of the Product Advise patients to avoid contaminating the tip with material from the ear, fingers, or other sources. Duration of Use Advise patients that it is very important to use the ear drops for as long as their doctor has instructed, even if the symptoms improve. Protect from Light Advise patients to protect the product from light. Unused Product Advise patients to discard unused portion after therapy is completed.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. Nursing Mothers Ciprofloxacin and corticosteroids, as a class, appear in milk following oral administration.

Undesirable effects. The information provided in Undesirable effects of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex.

Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy. The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Potential for Microbial Overgrowth with Prolonged Use Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Acute Otitis Externa The following adverse reactions occurred in 0. The information provided in Overdose of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex.

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Abandoned Class: 5 Word Tamil Nadu. Class: 11 Word Punjab. Registered Class: 9 Device Punjab. Registered Class: 25 Word Delhi. Registered Class: 5 Word Maharashtra. Abandoned Class: 9, 35, 42 Word Delhi. Registered Class: 9 Device Maharashtra.

Withdrawn Class: 20 Word Chandigarh. Registered Class: 37 Device Karnataka. Registered Class: 6 Word Chandigarh. Registered Class: 5 Word Chandigarh. Registered Class: 6 Word Uttarakhand. Registered Class: 23 Device Maharashtra. Trademarks Alcon Cilodex.

Cancelled Class: 5 Word. Alcon Cilodex Documents. Updated about 10 hours ago. Novartis Ag. Lall Lahiri And Salhotra. The Trademark is registered to Novartis Ag. Trademark Proprietor Novartis Ag. The information provided in Qualitative and quantitative composition of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex.

Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy. Therapeutic indications.

The information provided in Therapeutic indications of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

CIPRODEX is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media in pediatric patients age 6 months and older with tympanostomy tubes due to Staphylococcus aureus , Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Acute Otitis Externa in pediatric age 6 months and older , adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. Dosage Posology and method of administration. The information provided in Dosage Posology and method of administration of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex.

Be careful and be sure to specify the information on the section Dosage Posology and method of administration in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy. Shake well immediately before use. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.

The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear. Discard unused portion after therapy is completed.

This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. The information provided in Contraindications of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

CIPRODEX is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections and fungal otic infections.

Special warnings and precautions for use. The information provided in Special warnings and precautions for use of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy. Continued Or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

This product is not approved for use in the eye. Administration Instructions Patients should be instructed to warm the bottle in their hand for one to two minutes prior to use and shake well immediately before using.

Allergic Reactions Advise patients to discontinue use immediately and contact their physician, if rash or allergic reaction occurs. Avoid Contamination of the Product Advise patients to avoid contaminating the tip with material from the ear, fingers, or other sources.

Duration of Use Advise patients that it is very important to use the ear drops for as long as their doctor has instructed, even if the symptoms improve. Protect from Light Advise patients to protect the product from light. Unused Product Advise patients to discard unused portion after therapy is completed. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin.

Nursing Mothers Ciprofloxacin and corticosteroids, as a class, appear in milk following oral administration. Undesirable effects. The information provided in Undesirable effects of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Potential for Microbial Overgrowth with Prolonged Use Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Acute Otitis Externa The following adverse reactions occurred in 0. The information provided in Overdose of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.

Pharmacokinetic properties. The information provided in Pharmacokinetic properties of Alcon Cilodex is based on data of another medicine with exactly the same composition as the Alcon Cilodex. Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Alcon Cilodex directly from the package or from the pharmacist at the pharmacy.