Clindamycin Hydrochloride (Page 3 of 3)

Nursing Mothers

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. Clindamycin has the potential to cause adverse effects on the breast-fed 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 breast-fed 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 breast-fed child from clindamycin or from the underlying maternal condition.

Pediatric Use

When clindamycin hydrochloride is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric Use

Clinical studies of clindamycin did not include suffi‑cient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridium difficile) seen in association with most anti‑biotics occur more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.
Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.

ADVERSE REACTIONS

The following reactions have been reported with the use of clindamycin.
Infections and Infestations: Clostridium difficile colitis
Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see BOXED WARNING). The onset of pseudomembranous coli‑tis symptoms may occur during or after antibacterial treatment (see WARNINGS). Esophageal ulcer has been reported. An unpleasant or metallic taste has been reported after oral administration.
Hypersensitivity Reactions: Generalized mild to moder‑ate 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 and hypersensitivity have also been reported.
Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions.)
Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunc‑tion as evidenced by azotemia, oliguria, and/or proteinuria has been observed.
Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.
Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.
Musculoskeletal: Cases of polyarthritis have been reported.

OVERDOSAGE

Significant mortality was observed in mice at an intra‑venous dose of 855 mg/kg and in rats at an oral or sub‑cutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed.
Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

DOSAGE AND ADMINISTRATION

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING).
Adults
Serious infections150 to 300 mg every 6 hours. More severe infections — 300 to 450 mg every 6 hours.
Pediatric Patients (for children who are able to swallow capsules)

Serious infections8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses.
More severe infections16 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.
To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water.
Clindamycin hydrochloride capsules are not suitable for children 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 usu‑ally treated with clindamycin injection. However, in clinically appropriate circum‑stances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.
In cases of β-hemolytic streptococcal infections, treat‑ment should continue for at least 10 days.

HOW SUPPLIED


Clindamycin Hydrochloride Capsules USP, 300 mg are light blue opaque/light blue opaque size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘C’ on light blue opaque cap and ‘40’ on light blue opaque body with black ink.
Available in cartons of 100 capsules (10 capsules per blister pack x 10), NDC 0904-7194-61
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Pharmacist: Dispense in a tight container with child-resistant closure.

REFERENCES

1.
Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.

Trademarks are the property of their respective owners.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 038, India

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number Revised: 04/2020

Package/Label Display Panel

Clindamycin Hydrochloride Capsules, USP

300 mg*

100 Capsules

Carton label
(click image for full-size original)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7194(NDC:65862-186)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
MAGNESIUM STEARATE
FD&C BLUE NO. 1
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color BLUE (Light Blue Opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code C;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7194-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0904-7194-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065442 08/26/2009
Labeler — Major Pharmaceuticals (191427277)

Revised: 02/2022 Major Pharmaceuticals

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.