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 sufficient 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 Clostridioides difficile) seen in association with most antibiotics 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: Clostridioides difficile colitis
Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis 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 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 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: Acute kidney injury (See WARNINGS).
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 intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous 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 infections —150 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 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.
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 usually treated with clindamycin injection. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules.
In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
HOW SUPPLIED
Clindamycin hydrochloride capsules, USP, 300 mg are size ‘0’ capsules with turquoise blue opaque cap and turquoise blue opaque body imprinted with “RX693” on cap and body in black ink containing white to off white powder. They are supplied as follows:
NDC: 70518-0732-00
NDC: 70518-0732-01
NDC: 70518-0732-02
NDC: 70518-0732-03
PACKAGING: 28 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 14 in 1 BOTTLE PLASTIC
Store at 20° — 25° C (68° — 77° F) [See USP Controlled Room Temperature].
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
REFERENCES
- Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
DRUG: Clindamycin hydrochloride
GENERIC: Clindamycin hydrochloride
DOSAGE: CAPSULE
ADMINSTRATION: ORAL
NDC: 70518-0732-0
NDC: 70518-0732-1
NDC: 70518-0732-2
NDC: 70518-0732-3
COLOR: blue
SHAPE: CAPSULE
SCORE: No score
SIZE: 22 mm
IMPRINT: RX693
PACKAGING: 28 in 1 BLISTER PACK
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 30 in 1 BOTTLE PLASTIC
PACKAGING: 14 in 1 BOTTLE PLASTIC
ACTIVE INGREDIENT(S):
- CLINDAMYCIN HYDROCHLORIDE 300mg in 1
INACTIVE INGREDIENT(S):
- LACTOSE MONOHYDRATE
- STARCH, CORN
- TALC
- MAGNESIUM STEARATE
- GELATIN, UNSPECIFIED
- TITANIUM DIOXIDE
- FD&C BLUE NO. 1
- SHELLAC
- POTASSIUM HYDROXIDE
- PROPYLENE GLYCOL
- FERROSOFERRIC OXIDE
| CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule | ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| Labeler — REMEDYREPACK INC. (829572556) |
Revised: 09/2023 REMEDYREPACK INC.
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.
https://medlibrary.org/lib/rx/meds/clindamycin-hydrochloride-38/page/3/