Cleocin Hydrochloride 75 mg/1

clindamycin hydrochloride · CAPSULE · Pharmacia & Upjohn Company LLC

No Recall HistoryCurrently in Shortage

Plain English

Cleocin Hydrochloride is a capsule containing clindamycin hydrochloride at 75 mg/1, taken oral. Manufactured by Pharmacia & Upjohn Company LLC.

Key Facts

Brand Name: Cleocin Hydrochloride
Generic Name: clindamycin hydrochloride
NDC Code (Product): 0009-0331
Manufacturer: Pharmacia & Upjohn Company LLC
Strength: 75 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA050162
Marketing Start: 05/22/1970

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea282 reports

rash268 reports

off label use250 reports

nausea248 reports

pain226 reports

dyspnoea205 reports

drug ineffective201 reports

drug hypersensitivity193 reports

headache175 reports

fatigue156 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is 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 BOXED WARNING , before selecting clindamycin, 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; s…

Dosage & Administration

DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, this antibacterial drug should be discontinued (See BOXED WARNING ). Administer CLEOCIN HCl Capsules with a full glass of water (6 to 8 ounces, approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce the potential for esophageal irritation (See ADVERSE REACTIONS ). Adults: Serious infections – 150 to 300 mg every 6 hours. More severe infections – 300 to 450 mg every 6 hours. Pediatric Patients (who are able to swallow capsules) : 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. Clindamycin should be dosed based on total body weight regardless of obesity. CLEOCIN HCl Capsules are not suitable for pediatric patients who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the clindamycin palmitate oral solution in some cases. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE ® Sterile Solution. However, in clinically appropriate circumst…

Warnings

WARNINGS See BOXED WARNING Clostridioides difficile- Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN 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. 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indic…

Contraindications

CONTRAINDICATIONS CLEOCIN HCl is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Drug Interactions

Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore, inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.

Adverse Reactions

ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (See BOXED WARNING ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (See WARNINGS ). Esophagitis and esophageal ulcer have been reported, particularly when taken in a lying position or with a small amount of water. An unpleasant or metallic taste has been reported after oral administration. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as toxic epidermal necrolysis, some with fatal outcome, have been reported (See WARNINGS ). Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction, acute myocardial ischemia with or without myocardial infarction occurring as part of an …

Frequently Asked Questions

What is Cleocin Hydrochloride used for?

Cleocin Hydrochloride contains clindamycin hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Cleocin Hydrochloride a controlled substance?

Cleocin Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Cleocin Hydrochloride?

The generic name for Cleocin Hydrochloride is clindamycin hydrochloride. There are 11 other brand versions of clindamycin hydrochloride.

What is the NDC code for Cleocin Hydrochloride 75 mg/1?

The NDC (National Drug Code) for Cleocin Hydrochloride 75 mg/1 is 0009-0331, listed by Pharmacia & Upjohn Company LLC.

Product NDC

0009-0331

Package NDC

0009-0331-02

Other Clindamycin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)