U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drug Safety-related Labeling Changes

Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

CLEOCIN HYDROCHLORIDE (NDA-050162)

(CLINDAMYCIN HYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

07/29/2024 (SUPPL-105)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Additions and/or revisions underlined:

Due to the risk of esophagitis and esophageal ulcer, it is important to ensure adherence with administration guidance (See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS).

6 Adverse Reactions

Additions and/or revisions underlined:

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.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

Advise patients that due to the risk of esophagitis and esophageal ulcer, it is important to adhere to the administration guidance for CLEOCIN HCl Capsules (See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS).

05/20/2022 (SUPPL-104)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Additions and/or revisions underlined:

Nephrotoxicity

Clindamycin is potentially nephrotoxic and cases with acute kidney injury have been reported. Consider monitoring of renal function particularly in patients with pre-existing renal dysfunction or those taking concomitant nephrotoxic drugs. In case of acute kidney injury, discontinue CLEOCIN HCl when no other etiology is identified.

6 Adverse Reactions

Renal: Acute kidney injury

8 Use in Specific Populations

Additions and/or revisions underlined:

Specific Populations

Patients with Renal/Hepatic Impairment

The elimination half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Dosage schedules do not need to be modified in patients with renal disease.

Geriatric Patients

Pharmacokinetic studies in elderly volunteers (61–79 years) and younger adults (18–39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, the average elimination half-life is increased to approximately 4.0 hours (range 3.4–5.1 h) in the elderly compared to 3.2 hours (range 2.1– 4.2 h) in younger adults. The extent of absorption, however, is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function.

06/13/2019 (SUPPL-101)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Nursing Mothers

Additions and/or revisions underlined:

Limited published data based on breast milk sampling reports that clindamycin appears in human breast milk in the range of less than 0.5 to 3.8 mcg/mL … Monitor the breast-fed infant for possible adverse effects …

05/02/2017 (SUPPL-98)

Approved Drug Label (PDF)

7 Drug Interactions

(additions underlined)

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.

Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

05/02/2017 (SUPPL-99)

Approved Drug Label (PDF)

8 Use in Specific Populations

Nursing Mothers

(PLLR conversion, additions underlined)

(additions underlined)

Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL. has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. Monitor the infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.

Pregnancy

(PLLR conversion, please refer to label)

08/02/2016 (SUPPL-97)

5 Warnings and Precautions

Anaphylactic and Severe Hypersensitivity Reactions replaces Severe Skin Reactions (renamed)

Additions are bolded:

  • Anaphylactic shock and anaphylactic reactions have been reported.
  • Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported.
  • In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy.

6 Adverse Reactions

The following reactions have been reported with the use of clindamycin:

  • Infections and Infestations: Clostridium difficile colitis (addition)

03/23/2016 (SUPPL-95)

Approved Drug Label (PDF)

6 Adverse Reactions

  • An unpleasant or metallic taste has been reported after intravenous administration of the higher doses of clindamycin phosphate.