Drugplain

CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mL

CLINDAMYCIN PALMITATE HYDROCHLORIDE · GRANULE, FOR SOLUTION · Bryant Ranch Prepack

No Recall HistoryCurrently in Shortage
Plain English

Clindamycin Palmitate Hydrochloride is an antibiotic used to treat bacterial infections in children. This medication comes as a liquid suspension that is mixed from granules and taken by mouth.

Key Facts

Brand Name
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)
Generic Name
CLINDAMYCIN PALMITATE HYDROCHLORIDE
NDC Code (Product)
72162-1809
Manufacturer
Bryant Ranch Prepack
Strength
75 mg/5mL
Dosage Form
GRANULE, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA201821
Marketing Start
09/11/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective30 reports
pyrexia16 reports
product use in unapproved indication13 reports
diarrhoea11 reports
drug reaction with eosinophilia and systemic symptoms11 reports
vomiting11 reports
nausea10 reports
product odour abnormal10 reports
product taste abnormal10 reports
rash10 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) (clindamycin palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is 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 BOXED WARNING , before selecting clindamycin 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 postsur…

Dosage & Administration

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 for oral solution (Pediatric) 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 (Pediatric). NOTE: In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 …

Warnings

WARNINGS See BOXED WARNING. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cindamycin palmitate hydrochloride for oral solution (Pediatric), 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 c…

Contraindications

CONTRAINDICATIONS This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

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. 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.

Adverse Reactions

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 .) Li…

Frequently Asked Questions

What is CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) used for?

Clindamycin Palmitate Hydrochloride is an antibiotic used to treat bacterial infections in children. This medication comes as a liquid suspension that is mixed from granules and taken by mouth.

Is CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) a controlled substance?

CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) is not classified as a controlled substance by the DEA.

What is the generic name for CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)?

The generic name for CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) is CLINDAMYCIN PALMITATE HYDROCHLORIDE. There are 8 other brand versions of CLINDAMYCIN PALMITATE HYDROCHLORIDE.

What is the NDC code for CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mL?

The NDC (National Drug Code) for CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) 75 mg/5mL is 72162-1809, listed by Bryant Ranch Prepack.

Product NDC

72162-1809

Package NDC

72162-1809-1

Other Clindamycin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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