Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
Additions and/or
revisions underlined:
…
Anaphylactic and Severe Hypersensitivity Reactions
Anaphylactic shock and anaphylactic reactions have been reported
(see ADVERSE REACTIONS).
Severe
hypersensitivity reactions, including acute myocardial ischemia with or
without myocardial infarction, and
severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms
(DRESS), Stevens-Johnson syndrome
(SJS), some with fatal outcome, have been reported (see ADVERSE REACTIONS).
In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute
appropriate therapy.
A careful inquiry should
be made concerning previous sensitivities to drugs and other allergens.
…
6
Adverse Reactions
Additions and/or
revisions underlined:
…
Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed
during drug therapy.
Generalized mild to moderate morbilliform-like skin rashes are the most
frequently reported of all adverse reactions.
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, have been associated with
clindamycin. Anaphylactic shock, anaphylactic reaction, hypersensitivity, and
acute myocardial ischemia with or without myocardial infarction occurring as part of an
allergic reaction have also
been reported (see WARNINGS). Cutaneous
vasculitis and symmetrical drug-related intertriginous and flexural exanthema
have also been reported.
…
Approved Drug Label (PDF)
6
Adverse Reactions
Additions and/or
revisions underlined:
…
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, have been associated with clindamycin. Anaphylactic
shock, anaphylactic reaction, hypersensitivity have also been reported (see WARNINGS). Cutaneous vasculitis and
symmetrical drug-related intertriginous and flexural exanthema have also been
reported.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
Additions and/or
revisions underlined:
…
Nephrotoxicity
Clindamycin is potentially nephrotoxic and cases
with acute kidney injury have been reported. Consider
monitoring of renal function particularly in patients with pre-existing renal
dysfunction or those taking concomitant nephrotoxic drugs. In case of
acute kidney injury, discontinue CLEOCIN PHOSPHATE when no other etiology
is identified.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
PRECAUTIONS
Pediatric
Use
Additions and/or
revisions underlined:
When CLEOCIN
PHOSPHATE Sterile Solution is administered to the pediatric population (birth
to 16 years) appropriate monitoring of organ system functions is desirable (see
CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
WARNINGS
Additions and/or
revisions underlined:
Benzyl Alcohol Toxicity in Neonates
(“Gasping Syndrome”)
This product
contains benzyl alcohol as a preservative. The administration of intravenous
solutions containing the preservative benzyl alcohol has been associated
with the “gasping syndrome”, and death in neonates. Symptoms include a striking
onset of gasping respiration, hypotension, bradycardia, and cardiovascular
collapse. Although the normal therapeutic dose of this
product delivers amounts of benzyl alcohol that are substantially lower
than those reported in association with the “gasping syndrome”, the minimum
amount of benzyl alcohol at which toxicity may occur is not known and total
daily benzyl alcohol exposure may be increased by concomitant medications.
The risk of
benzyl alcohol toxicity depends on the quantity administered and the liver and
kidneys’ capacity to detoxify the chemical. Premature and low birth weight
infants may be more likely to develop toxicity.
Newly added
information:
Renal Toxicity
Clindamycin is
potentially nephrotoxic. Acute kidney injury including acute renal failure has
been reported. Therefore, monitoring of renal function should be considered
during therapy of patients with pre-existing renal dysfunction or taking
concomitant nephrotoxic drugs and monitoring of renal function should be
performed if therapy is prolonged.
6
Adverse Reactions
Additions and/or
revisions underlined:
Renal: Acute Kidney Injury: Signs of renal
dysfunction as evidenced by azotemia, oliguria, and/or proteinuria have been
observed (See WARNINGS).
Following Table 2: Serum Clindamycin
Levels Maintained, Rapid Infusion Rate and Maintenance Infusion Rate, additions
and/or revisions underlined:
In cases of
beta-hemolytic streptococcal infections, treatment should be continued for at
least 10 days.
Pediatric Patients less than 1
month: The recommended dosage is 15 to 20 mg/kg/day in 3 to
4 equal doses. See Table 3 regarding the dosing regimen for pediatric patients
with post-menstrual age (PMA) less than or equal to 32 weeks, or greater than
32 weeks to less than or equal to 40 weeks.
Table 3: Dosing Regimens for Pediatric
Patients with PMA less than or equal to 32 weeks, or greater than 32 weeks to
less than or equal to 40 weeks (Newly added table; please refer to
label for complete information).
Other
‘Clostridioides
difficile’ replaces ‘Clostridium difficile’ in all instances in label.
Approved Drug Label (PDF)
5
Warnings and Precautions
PRECAUTIONS
(Additions and/or revisions underlined)
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 at dosages of 150 mg orally to 600 mg intravenously. 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.
Approved Drug Label (PDF)
8
Use in Specific Populations
Elderly Patients
(additions
underlined)
Pharmacokinetic
studies in elderly volunteers (61-79 years) and younger adults (18-39 years)
indicate that age alone does not alter clindamycin pharmacokinetics (clearance,
elimination half-life, volume of distribution, and area under the serum concentration-time
curve) after IV administration of clindamycin phosphate. After oral
administration of clindamycin hydrochloride, the average elimination
half-life is increased to approximately 4.0 hours (range 3.4-5.1 h) in the
elderly, compared to 3.2 hours (range 2.1-4.2 h) in younger adults.
…
Approved Drug Label (PDF)
7
Drug Interactions
(additions
underlined)
Clindamycin
has been shown to have neuromuscular blocking properties that may enhance the
action of other neuromuscular blocking agents. Therefore, it should be used
with caution in patients receiving such agents.
Clindamycin
is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to
the major metabolite clindamycin sulfoxide and minor metabolite
N-desmethylclindamycin. Therefore inhibitors of CYP3A4 and CYP3A5 may increase
plasma concentrations of clindamycin and inducers of these isoenzymes may
reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4
inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4
inducers such as rifampicin, monitor for loss of effectiveness.
In
vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9,
CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.
Antagonism
has been demonstrated between clindamycin and erythromycin in vitro. Because of
possible clinical significance, the two drugs should not be administered
concurrently.
Approved Drug Label (PDF)
8
Use in Specific Populations
Nursing Mothers
(PLLR
conversion, additions underlined)
(additions
underlined)
Clindamycin
has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL at
dosages of 150 mg orally to 600 mg intravenously. Clindamycin has the potential
to cause adverse effects on the breastfed 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 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 breastfed child from clindamycin or from the underlying maternal
condition.
Pregnancy
(PLLR
conversion, please refer to label)
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