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Clindamycin

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Cleocin

Cleocin HCl®
(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.

Cleocin

WARNING

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.

DRUG DESCRIPTION

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:

Clindamycin hydrochloride structural formula illustration

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;
  • skin rash with severe tingling, numbness, pain, muscle...

Read All Potential Side Effects and See Pictures of Cleocin »

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.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain intestinal condition (Clostridium difficile-associated diarrhea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, other stomach/intestinal diseases (e.g., colitis), allergic conditions (e.g., asthma, hay fever, eczema).

Before having surgery, tell your...

Read All Potential Precautions of Cleocin »

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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Cleocin - User Reviews

Cleocin User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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