Chestal Childrens Cough And Cold
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Topotecan hydrochloride for injection is indicated for the treatment of:
- small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies (14)].
Topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of:
- Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
History
There is currently no drug history available for this drug.
Other Information
Topotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.
Topotecan hydrochloride for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. The reconstituted solution ranges in color from yellow to yellow-green and is intended for administration by intravenous infusion.
Inactive ingredients are mannitol, 48 mg, and tartaric acid, 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5.
The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3’,4’:6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. It has the molecular formula C23H23N3O5•HCl and a molecular weight of 457.9.
Topotecan hydrochloride has the following structural formula:
It is soluble in water and melts with decomposition at 213° to 218°C.
Sources
Chestal Childrens Cough And Cold Manufacturers
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Laboratoires Boiron
![Chestal Childrens Cough And Cold (Solanum Dulcamara Top, Ferrum Phosphoricum, Goldenseal, Potassium Dichromate, Strychnos Nux-vomica Seed) Syrup [Laboratoires Boiron]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Chestal Childrens Cough And Cold | Pd-rx Pharmaceuticals, Inc.
NOTE: CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE NOT SUBSTITUTABLE ON A MILLIGRAM PER MILLIGRAM BASIS (see CLINICAL PHARMACOLOGY ).
Table 6: Cefuroxime Axetil Tablets (May be administered without regard to meals) * The safety and effectiveness of cefuroxime axetil tablets administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. Population/Infection
Dosage
Duration (days)
Adolescents and Adults (13 years and older)
Pharyngitis/tonsillitis
250 mg twice daily
10
Acute bacterial maxillary sinusitis
250 mg twice daily
10
Acute bacterial exacerbations of chronic bronchitis
250 or 500 mg twice daily
10*
Secondary bacterial infections of acute bronchitis
250 or 500 mg twice daily
5 to 10
Uncomplicated skin and skin-structure infections
250 or 500 mg twice daily
10
Uncomplicated urinary tract infections
250 mg twice daily
7 to 10
Uncomplicated gonorrhea
1,000 mg once daily
single dose
Early Lyme disease
500 mg twice daily
20
Pediatric Patients (who can swallow tablets whole)
Acute otitis media
250 mg twice daily
10
Acute bacterial maxillary sinusitis
250 mg twice daily
10
Patients with Renal ImpairmentBecause cefuroxime is eliminated primarily by the kidney, a dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/ min, as listed in Table 7.
Table 7. Dosing in Patients with Renal Impairment Creatinine Clearance (mL/min)
Recommended Dosage
≥30
No dosage adjustment
10 to <30
Standard individual dose given every 24 hours
<10 (without hemodialysis)
Standard individual dose given every 48 hours
Hemodialysis
A single additional standard dose should be given at the end of each dialysis
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