Promethazine Hydrochloride And Dextromethorphan Hydrobromide Solution
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
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
Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies (14.1)].
Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinical Studies (14.2)].
History
There is currently no drug history available for this drug.
Other Information
Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration.
Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:
Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc.
In addition, individual tablets contain:
50 mg tablets: iron oxide yellow
100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake
200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black
Sources
Promethazine Hydrochloride And Dextromethorphan Hydrobromide Solution Manufacturers
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Hi-tech Pharmacal Co., Inc.
![Promethazine Hydrochloride And Dextromethorphan Hydrobromide Solution [Hi-tech Pharmacal Co., Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Promethazine Hydrochloride And Dextromethorphan Hydrobromide Solution | Kvk-tech, Inc.
For most patients, the recommended dose of Cyclobenzaprine hydrochloride tablets, USP is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of Cyclobenzaprine hydrochloride tablets, USP for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).
Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and PRECAUTIONS Use in the Elderly).
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Bryant Ranch Prepack
Promethazine Hydrochloride And Dextromethorphan Hydrobromide Solution | Bryant Ranch Prepack
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is contraindicated for children under 2 years of age (see WARNINGS - Black Box Warning andUse in Pediatric Patients).
The average effective dose is given in the following table:
Adults 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. Children 6 years to under 12 years 1/2 to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours. Children 2 years to under 6 years 1/4 to 1/2 teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.
![Promethazine Hydrochloride And Dextromethorphan Hydrobromide Solution [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2322882-f276-4f71-89be-18b3163bb6ef&name=15881.jpg)
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