CLINDAMYCIN HYDROCHLORIDE (Page 3 of 3)

Pregnancy

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/m 2 , 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/m 2 , 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 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 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, anap h ylactic shoc k, anaph ylactic reaction a nd h ypersensitivity 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.

To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

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 CLEOCIN PHOSPHATE ® Sterile Solution. 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 is available in the following strengths, colors and sizes:

300 mg- Light blue opaque (body)/ light blue opaque (cap), size 0 hard gelatin capsule printed with “M” on cap and “42” on body filled with white to off white granular powder.

Bottles of 20 NDC 71205-444-20

Bottles of 21 NDC 71205-444-21

Bottles of 28 NDC 71205-444-28

Bottles of 30 NDC 71205-444-30

Bottles of 40 NDC 71205-444-40

Bottles of 60 NDC 71205-444-60

Bottles of 90 NDC 71205-444-90

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
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.

The brands listed are trademarks of their respective owners and are not trademarks of Micro Labs. The makers of these brands are not affiliated with and do not endorse Micro Labs or its products.

Manufactured by:

Micro Labs Limited

Goa-403 722, India.

Manufactured for:

Micro labs USA Inc.

Basking Ridge, NJ 07920

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Revised: January 2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-444-30
Clindamycin Hydrochloride
Capsules, USP
300 mg*
Rx Only
30 Capsules

71205-444-30
(click image for full-size original)
CLINDAMYCIN HYDROCHLORIDE clindamycin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-444(NDC:42571-252)
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
MAGNESIUM STEARATE
STARCH, CORN
TALC
FD&C BLUE NO. 1
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
SHELLAC
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color blue (Light blue) Score no score
Shape CAPSULE (capsule) Size 21mm
Flavor Imprint Code M;42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-444-20 20 CAPSULE in 1 BOTTLE None
2 NDC:71205-444-21 21 CAPSULE in 1 BOTTLE None
3 NDC:71205-444-28 28 CAPSULE in 1 BOTTLE None
4 NDC:71205-444-30 30 CAPSULE in 1 BOTTLE None
5 NDC:71205-444-40 40 CAPSULE in 1 BOTTLE None
6 NDC:71205-444-60 60 CAPSULE in 1 BOTTLE None
7 NDC:71205-444-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207402 01/07/2019
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-444), RELABEL (71205-444)

Revised: 01/2021 Proficient Rx LP

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