Clindamycin Hydrochloride (Page 3 of 4)

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 HCl 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 Clostridium 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:

Clostridium 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:

Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction 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 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 HCl capsules, USP should be taken with a full glass of water.

Clindamycin HCl 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 HCl capsules, USP.

In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

HOW SUPPLIED

Clindamycin HCl capsules, USP (equivalent to 75 mg of clindamycin) are available as light green capsules imprinted with logo “LANNETT” on the cap and “1381” on the body and are supplied in:
Bottles of 100 (NDC 0527-1381-01).
Bottles of 200 (NDC 0527-1381-04).

Clindamycin HCl capsules, USP (equivalent to 150 mg of clindamycin) are available as light blue opaque and light green capsules imprinted with logo “LANNETT” on the cap and “1382” on the body and are supplied in:
Bottles of 100 (NDC 0527-1382-01).

Clindamycin HCl capsules, USP (equivalent to 300 mg of clindamycin) are available as light blue opaque capsules imprinted with logo “LANNETT” on the cap and “1383” on the body and are supplied in:
Bottles of 16 (NDC 0527-1383-02).
Bottles of 100 (NDC 0527-1383-01).

Dispense in a tight container with a child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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.

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

CIB70355G

Rev. 04/20

PRINCIPAL DISPLAY PANEL — 75 mg

NDC 0527-1381 -04

Clindamycin HCl Capsules, USP

75 mg*

Rx Only

200 Capsules

Lanne tt

75 mg
(click image for full-size original)

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