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(clindamycin hydrochloride) Capsules, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN (clindamycin) HCl and other antibacterial drugs, CLEOCIN (clindamycin) HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN (clindamycin) HCL 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.difficle.
Because CLEOCIN (clindamycin) HCL therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
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.
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.
CLEOCIN HCl Capsules contain clindamycin hydrochloride equivalent to 75 mg, 150 mg or 300 mg of clindamycin.
Inactive ingredients: 75 mg-corn starch, FD&C blue no. 1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate and talc; 150 mg-corn starch, FD&C blue no. 1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium dioxide; 300 mg-corn starch, FD&C blue no. 1, gelatin, lactose, magnesium stearate, talc and titanium dioxide.
The structural formula is represented below:
The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranosidemonohydrochloride.
What are the possible side effects of clindamycin (Cleocin HCl, Cleocin Pediatric)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using clindamycin and call your doctor at once if you have any of these serious side effects:
- diarrhea that is watery or bloody;
- jaundice (yellowing of the skin or eyes);
- urinating less than usual or not at all;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),...
What are the precautions when taking clindamycin (Cleocin)?
Before taking clindamycin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, stomach/intestinal diseases (e.g., colitis, Clostridium difficile-associated diarrhea), allergic conditions (e.g., asthma, hay fever, eczema).
Before having surgery, tell your doctor or dentist that you are using this medication (unless your doctor/dentist has directed you to take this drug before surgery as a precaution).
Older adults may be more sensitive to...
Last reviewed on RxList: 1/13/2010
This monograph has been modified to include the generic and brand name in many instances.
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