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Uses
Fluocinolone Acetonide Oil 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older.
History
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Other Information
Fluocinolone Acetonide Oil 0.01% Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide is C24 H30 F2O6 anhydrous. It has the following structural formula:
Fluocinolone acetonide in Fluocinolone Acetonide Oil 0.01% has a molecular weight of 452.49. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of Fluocinolone Acetonide Oil 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF.
Sources
Carbamazepine Suspension Manufacturers
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Morton Grove Pharmaceuticals, Inc.
Carbamazepine Suspension | Amneal Pharmaceuticals, Llc
For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil 0.01% into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.
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Precision Dose Inc.
Carbamazepine Suspension | Precision Dose Inc.
(see table below)
Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs. (See PRECAUTIONS, Drug Interactions.) Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents.
Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals.
Since a given dose of carbamazepine suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years; 1/2 teaspoon q.i.d.) and to increase slowly to avoid unwanted side effects.
Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).
Epilepsy(See INDICATIONS AND USAGE.)
Adults and Children over 12 Years of AgeInitial: 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.
Children 6 to 12 Years of AgeInitial: 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.
Children under 6 Years of AgeInitial: 10 to 20 mg/kg/day q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.
Combination TherapyCarbamazepine may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions and Usage in Pregnancy, Pregnancy Category D).
Trigeminal Neuralgia(See INDICATIONS AND USAGE.)
Initial: On the first day, 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 50 mg (1/2 teaspoon) q.i.d. for suspension, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even discontinue the drug.
Dosage Information Initial Dose Subsequent Dose Maximum Daily Dose Indication Tablet* Suspension Tablet* Suspension Tablet*/Suspension * Tablet = Chewable or conventional tablets. Epilepsy
Under 6 yr 10 to 20 mg/kg/day
b.i.d. or t.i.d. 10 to 20 mg/kg/day
q.i.d. Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d. Increase weekly to achieve optimal clinical response, t.i.d. or q.i.d. 35 mg/kg/24 hr (See Dosage and Administration section above) 6 to 12 yr 100 mg b.i.d.
(200 mg/day) 1/2 tsp q.i.d.
(200 mg/day) Add up to 100 mg/day at weekly intervals, t.i.d. or q.i.d. Add up to 1 tsp (100 mg)/day at weekly intervals, t.i.d. or q.i.d. 1000 mg/24 hr Over 12 yr 200 mg b.i.d.
(400 mg/day) 1 tsp q.i.d.
(400 mg/day) Add up to 200 mg/day at weekly intervals, t.i.d. or q.i.d. Add up to 2 tsp (200 mg)/day at weekly intervals, t.i.d. or q.i.d. 1000 mg/24 hr (12 to 15 yr)
1200 mg/24 hr (> 15 yr)
1600 mg/24 hr (adults, in rare instances) Trigeminal Neuralgia 100 mg b.i.d.
(200 mg/day) 1/2 tsp q.i.d.
(200 mg/day) Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 2 tsp (200 mg)/day in increments of 50 mg (1/2 tsp) q.i.d. 1200 mg/24 hr
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