Top Quality Mfg. Topical Anesthetic
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Questions & Answers
Side Effects & Adverse Reactions
See WARNING box.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.
C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.
Usage in Meningitis-Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
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
Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
History
There is currently no drug history available for this drug.
Other Information
Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin.
Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide.
The structural formula is represented below:
C18H33ClN2O5S•HCl M.W. 461.45
The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.
Sources
Top Quality Mfg. Topical Anesthetic Manufacturers
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Top Quality Manufacturing, Inc.
![Top Quality Mfg. Topical Anesthetic (Benzocaine) Gel [Top Quality Manufacturing, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Top Quality Mfg. Topical Anesthetic | Proficient Rx Lp
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Serious infections—150 to 300 mg every 6 hours. More severe infections - 300 to 450 mg every 6 hours. Pediatric Patients: Serious infections - 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections - 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.
To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.
Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.
In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
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Top Quality Manufacturing, Inc.
Top Quality Mfg. Topical Anesthetic | Top Quality Manufacturing, Inc.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
-
Top Quality Manufacturing, Inc.
Top Quality Mfg. Topical Anesthetic | Top Quality Manufacturing, Inc.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
-
Top Quality Manufacturing, Inc.
Top Quality Mfg. Topical Anesthetic | Top Quality Manufacturing, Inc.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
-
Top Quality Manufacturing, Inc.
Top Quality Mfg. Topical Anesthetic | Top Quality Manufacturing, Inc.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
-
Top Quality Manufacturing, Inc.
Top Quality Mfg. Topical Anesthetic | Top Quality Manufacturing, Inc.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
-
Top Quality Manufacturing, Inc.
Top Quality Mfg. Topical Anesthetic | Top Quality Manufacturing, Inc.
Apply only amount needed to the oral mucosa to prevent or relieve pain.
![Top Quality Mfg. Topical Anesthetic (Benzocaine) Gel [Top Quality Manufacturing, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e2e53f9c-5c5c-4771-8345-ff7dcc7bcc4e&name=LB.TopQualityTopical_wrap.jpg)
![Top Quality Mfg. Topical Anesthetic (Benzocaine) Gel [Top Quality Manufacturing, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=891d54a9-5cbd-4897-90bf-ade9a3d046fc&name=LB.TopQualityTopical_wrap.jpg)
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