Clindamycin Palmitate Hydrochloride (Pediatric)

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Overview

What is Clindamycin Palmitate Hydrochloride (Pediatric)?

Clindamycin palmitate hydrochloride is a water soluble hydrochloride salt of the ester of clindamycin and palmitic acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

The structural formula is represented below:

The chemical name for clindamycin palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl--4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L--α-D--octopyranoside 2-palmitate monohydrochloride.

Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules containing clindamycin palmitate hydrochloride USP and becomes colorless to off-white with cherry flavored solution after reconstitution. Each 5 mL contains the equivalent of 75 mg clindamycin. Inactive ingredients: artificial cherry flavor, dextrin, ethylparaben, isopropyl alcohol, poloxamer, simethicone emulsion, and sucrose.

What does Clindamycin Palmitate Hydrochloride (Pediatric) look like?

What are the available doses of Clindamycin Palmitate Hydrochloride (Pediatric)?

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What should I talk to my health care provider before I take Clindamycin Palmitate Hydrochloride (Pediatric)?

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How should I use Clindamycin Palmitate Hydrochloride (Pediatric)?

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see ).

Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate hydrochloride contained in clindamycin palmitate hydrochloride for oral solution (Pediatric).

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

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

More severe infections: 17 to 25 mg/kg/day (8.5 to 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.

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:

Reconstitution Instructions

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

Reconstitute bottles of 100 mL with 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

Do 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.

What interacts with Clindamycin Palmitate Hydrochloride (Pediatric)?

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

What are the warnings of Clindamycin Palmitate Hydrochloride (Pediatric)?

Array

See .

Clostridium difficile

If CDAD is suspected or confirmed, ongoing antibiotic use not directed againstmay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of and surgical evaluation should be instituted as clinically indicated.

Anaphylactic and Severe Hypersensitivity Reactions

Anaphylactic shock and anaphylactic reactions have been reported (see ).

Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported (see ).

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.

Usage in Meningitis:

What are the precautions of Clindamycin Palmitate Hydrochloride (Pediatric)?

General

Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency. Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Clindamycin palmitate hydrochloride for oral solution (Pediatric) should be prescribed with caution in atopic individuals. Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

The use of clindamycin palmitate hydrochloride for oral solution (Pediatric) occasionally results in overgrowth of nonsusceptible organisms-particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease.

Prescribing clindamycin palmitate hydrochloride for oral solution (Pediatric) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be counseled that antibacterial drugs including clindamycin palmitate hydrochloride for oral solution (Pediatric) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin palmitate hydrochloride for oral solution (Pediatric) is 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 palmitate hydrochloride for oral solution (Pediatric) 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.

Laboratory Tests

During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed.

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. 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 . Because of possible clinical significance, these two drugs should not be administered concurrently.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative. Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest recommended adult human oral dose based on mg/m) revealed no effects on fertility or mating ability.

Pregnancy

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, 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, respectively) revealed no evidence of teratogenicity.

Nursing Mothers

Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL. 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.

Pediatric Use

When clindamycin palmitate hydrochloride for oral solution (Pediatric) 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 ) 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 to 39 years) and elderly subjects (61 to 79 years) with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.

What are the side effects of Clindamycin Palmitate Hydrochloride (Pediatric)?

The following reactions have been reported with the use of clindamycin. colitis Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see ). An unpleasant or metallic taste has been reported after oral administration. 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 ). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported. Pruritus, vaginitis, angioedema, and rare instances of exfoliative dermatitis have been reported. (See .) Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. 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. 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. Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Cases of polyarthritis have been reported.

What should I look out for while using Clindamycin Palmitate Hydrochloride (Pediatric)?

Clostridium difficile

C.difficile

Because clindamycin 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 section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.

What might happen if I take too much Clindamycin Palmitate Hydrochloride (Pediatric)?

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.

How should I store and handle Clindamycin Palmitate Hydrochloride (Pediatric)?

Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Clindamycin palmitate hydrochloride for oral solution, USP (Pediatric) is white flavored granules and becomes colorless to off-white with cherry flavored solution after reconstitution. It is available in bottles of 100 mL. Bottles of 100 mL NDC 16714-483-01 When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL. 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology

Clostridium difficile

C.difficile

Because clindamycin 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 section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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