Clindamycin 150 MG Oral Capsule
Generic Name: CLINDAMYCIN HYDROCHLORIDE
Brand Name: Clindamycin hydrochloride
- Substance Name(s):
- CLINDAMYCIN HYDROCHLORIDE
WARNINGS
See WARNING box.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C.
difficile.
C.
difficile produces toxins A and B, which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated.
A careful inquiry should be made concerning previous sensitivities to drugs and other allergens.
Usage in Meningitis-Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
DRUG INTERACTIONS
Drug Interactions 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.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro.
Because of possible clinical significance, these two drugs should not be administered concurrently.
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.
DESCRIPTION
Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin.
Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin.
Inactive ingredients: 150 mg – black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no.
1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg – black iron oxide, corn starch, FD&C Blue no.
1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide.
The structural formula is represented below: C18H33ClN2O5S•HCl M.W.
461.45 The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.
structure
HOW SUPPLIED
Clindamycin hydrochloride capsules, USP are available in the following strengths, colors and sizes: Clindamycin hydrochloride capsules, USP, 150 mg are size ‘1’ capsules with turquoise blue opaque cap and light green body imprinted with “RX692” on cap and body in black ink containing white to off white powder.
They are supplied as follows: NDC 00440-7300-40 Bottles of 40 Store at 20° – 25° C (68° – 77° F) [See USP Controlled Room Temperature].
TO report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
GERIATRIC USE
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.
INDICATIONS AND USAGE
Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.
Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.
Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
PEDIATRIC USE
Pediatric Use When clindamycin hydrochloride is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.
PREGNANCY
Pregnancy: Teratogenic effects Pregnancy Category B 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.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.
NUSRING MOTHERS
Nursing Mothers Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL.
BOXED WARNING
WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C.
difficile.
Because clindamycin hydrochloride therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section.
It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
C.
difficile produces toxins A and B, which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated.
INFORMATION FOR PATIENTS
Information for Patients Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride capsules, should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold).
When clindamycin hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin hydrochloride capsules or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.
Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as possible.
DOSAGE AND ADMINISTRATION
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Serious infections—150 to 300 mg every 6 hours.
More severe infections – 300 to 450 mg every 6 hours.
Pediatric Patients: 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.
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.