Smart Sense Anti Itch
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Side Effects & Adverse Reactions
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Uses
Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Temozolomide Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
History
There is currently no drug history available for this drug.
Other Information
Temozolomide Capsules contain temozolomide, USP, an imidazotetrazine derivative. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:
C6H6N6O2 M.W. 194.15
The material is a white to light tan/light pink powder. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.
Each capsule contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for Temozolomide Capsules are anhydrous lactose, colloidal silicon dioxide, povidone, sodium starch glycolate, stearic acid, and tartaric acid. The 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsule shells contain D&C yellow no. 10, FD&C red no. 40, FD&C yellow no. 6, gelatin, and titanium dioxide. The 140 mg capsule shell also contains D&C red no. 28, FD&C blue no. 1, and FD&C green no. 3. The 180 mg capsule shell also contains FD&C blue no. 1. The 5 mg imprinting ink contains ammonium hydroxide, black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, propylene glycol, and shellac. The 20 mg imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol, red iron oxide, shellac, and yellow iron oxide. The 100 mg imprinting ink contains FD&C blue no. 1 aluminum lake, polyvinylpyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. The 140 mg, 180 mg, and 250 mg imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and shellac.
Sources
Smart Sense Anti Itch Manufacturers
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Kmart Corporation
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Smart Sense Anti Itch | Perrigo Company
Specific PopulationsRenal Impairment:
Cyclosporine undergoes minimal renal elimination and its pharmacokinetics do not appear to be significantly altered in patients with end-stage renal disease who receive routine hemodialysis treatments (See CLINICAL PHARMACOLOGY). However, due to its nephrotoxic potential (SeeWARNINGS), careful monitoring of renal function is recommended; cyclosporine dosage should be reduced if indicated. (See WARNINGS andPRECAUTIONS.)
Hepatic Impairment:
The clearance of cyclosporine may be significantly reduced in severe liver disease patients (See CLINICAL PHARMACOLOGY). Dose reduction may be necessary in patients with severe liver impairment to maintain blood concentrations within the recommended target range. (See WARNINGS and PRECAUTIONS.)
Pediatrics:
In pediatric usage, the same dose and dosing regimen may be used as in adults although in several studies, children have required and tolerated higher doses than those used in adults.
Adjunct therapy with adrenal corticosteroids is recommended. Different tapering dosage schedules of prednisone appear to achieve similar results. A dosage schedule based on the patient’s weight started with 2.0 mg/kg/day for the first 4 days tapered to 1.0 mg/kg/day by 1 week, 0.6 mg/kg/day by 2 weeks, 0.3 mg/kg/day by 1 month, and 0.15 mg/kg/day by 2 months and thereafter as a maintenance dose. Another center started with an initial dose of 200 mg tapered by 40 mg/day until reaching 20 mg/day. After 2 months at this dose, a further reduction to 10 mg/day was made. Adjustments in dosage of prednisone must be made according to the clinical situation.
Cyclosporine Injection, USP
FOR INTRAVENOUS INFUSION ONLY
Note: Anaphylactic reactions have occurred with cyclosporine injection. (See WARNINGS.)
Patients unable to take cyclosporine soft gelatin capsules or oral solution pre- or postoperatively may be treated with the intravenous concentrate. Cyclosporine injection is administered at 1/3 the oral dose. The initial dose of cyclosporine injection should be given 4 to 12 hours prior to transplantation as a single intravenous dose of 5 to 6 mg/kg/day. This daily single dose is continued postoperatively until the patient can tolerate the soft gelatin capsules or oral solution. Patients should be switched to cyclosporine soft gelatin capsules or oral solution as soon as possible after surgery. In pediatric usage, the same dose and dosing regimen may be used, although higher doses may be required.
Adjunct steroid therapy is to be used. (See aforementioned.)
Immediately before use, the intravenous concentrate should be diluted 1 mL cyclosporine injection in 20 mL to 100 mL 0.9% Sodium Chloride Injection or 5% Dextrose Injection and given in a slow intravenous infusion over approximately 2 to 6 hours.
Diluted infusion solutions should be discarded after 24 hours.
The Cremophor® EL (polyoxyethylated castor oil) contained in the concentrate for intravenous infusion can cause phthalate stripping from PVC.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Blood Concentration MonitoringSeveral study centers have found blood concentration monitoring of cyclosporine useful in patient management. While no fixed relationships have yet been established, in one series of 375 consecutive cadaveric renal transplant recipients, dosage was adjusted to achieve specific whole blood 24-hour trough concentrations of 100 to 200 ng/mL as determined by high-pressure liquid chromatography (HPLC).
Of major importance to blood concentration analysis is the type of assay used. The above concentrations are specific to the parent cyclosporine molecule and correlate directly to the new monoclonal specific radioimmunoassays (mRIA-sp). Nonspecific assays are also available which detect the parent compound molecule and various of its metabolites. Older studies often cited concentrations using a nonspecific assay which were roughly twice those of specific assays. Assay results are not interchangeable and their use should be guided by their approved labeling. If plasma specimens are employed, concentrations will vary with the temperature at the time of separation from whole blood. Plasma concentrations may range from 1/2 to 1/5 of whole blood concentrations. Refer to individual assay labeling for complete instructions. In addition, Transplantation Proceedings (June 1990) contains position papers and a broad consensus generated at the Cyclosporine-Therapeutic Drug Monitoring conference that year. Blood concentration monitoring is not a replacement for renal function monitoring or tissue biopsies.
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