TREVICTA

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 - trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L.

• threo -α-D.

• galacto -octopyranoside 2-palmitate monohydrochloride.

Clindamycin palmitate hydrochloride for oral solution (Pediatric) flavored granules contain clindamycin palmitate hydrochloride for reconstitution.

Each 5 mL contains the equivalent of 75 mg clindamycin.

Inactive ingredients: natural cherry flavor, dextrin, ethylparaben, poloxamer 188, simethicone, sucrose. structure.

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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.

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.

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.

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.

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.

Immune system

Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Cases of polyarthritis have been reported.

To report SUSPECTED ADVERSE

REACTIONS, contact Rising Pharma Holdings, Inc.FDA.gov/medwatch.

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.

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 clinically indicated.

Anaphylactic and Severe Hypersensitivity Reactions

Anaphylactic shock and anaphylactic reactions have been reported See ADVERSE REACTIONS.

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 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.

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

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

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

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).

In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

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

Reconstitute bottles of 100 mL with 75 mL 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.

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

Do NOT 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.

Clindamycin palmitate hydrochloride for oral solution, (Pediatric) flavored granules is available in bottles of 100 mL (NDC 64980-511-10).

When reconstituted as directed, each bottle yields a solution containing 75 mg of clindamycin per 5 mL.

Rx only.

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/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.

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.

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.

Clinical studies of clindamycin did not include sufficient numbers of patients age 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 subjects (18 - 39 years) and elderly subjects (61 - 79 years) with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.