Clindamycin Palmitate Hydrochloride (Page 3 of 3)

Pregnancy: Teratogenic Effects

In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.

Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m2 , respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m2 , respectively) revealed no evidence of teratogenicity.

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 palmitate hydrochloride for oral solution 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 subjects (18-39 years) and elderly subjects (61-79 years) 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). 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).

Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate HCl contained in clindamycin palmitate hydrochloride flavored granules.

Serious infections: 8-12 mg/kg/day (4-6 mg/lb/day) divided into 3 or 4 equal doses.

Severe infections: 13-16 mg/kg/day (6.5-8 mg/lb/day) divided into 3 or 4 equal doses.

More severe infections: 17-25 mg/kg/day (8.5-12.5 mg/lb/day) divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose. Clindamycin should be dosed based on total body weight regardless of obesity.

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 palmitate hydrochloride for oral solution.

NOTE: In cases of ß-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

Reconstitution Instructions: When reconstituted with water as follows, each 5 mL (teaspoon) of solution contains clindamycin palmitate HCl equivalent to 75 mg clindamycin.

Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.

Storage Conditions:

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

Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.

HOW SUPPLIED

Clindamycin Palmitate Hydrochloride for Oral Solution, USP is available in bottles of 100 mL (NDC 0574-0129 -01).

When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL.

Rx only

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.

Manufactured By

Perrigo

Minneapolis, MN 55427

www.perrigorx.com

2202098 3G200 RC J5 Rev 08-20 F

PRINCIPAL DISPLAY PANEL — Carton

Rx Only

NDC 0574-0129 -01

Clindamycin Palmitate Hydrochloride for Oral Solution, USP 75 mg

When reconstituted each 5 mL contains

Cherry Flavored

100 mL

(when mixed)

carton-rev-04-17a
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

serialization-template
(click image for full-size original)
CLINDAMYCIN PALMITATE HYDROCHLORIDE
clindamycin palmitate hydrochloride granule, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-0129
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Clindamycin) Clindamycin 75 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ETHYLPARABEN
POLOXAMER 188
SUCROSE
ICODEXTRIN
DIMETHICONE
SILICON DIOXIDE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0574-0129-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 100 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (0574-0129-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090902 01/21/2010
Labeler — Padagis US LLC (967694121)

Revised: 08/2021 Padagis US LLC

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