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Cleocin Hydrochloride

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Overview

What is Cleocin Hydrochloride?

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.

CLEOCIN HCl Capsules contain clindamycin hydrochloride equivalent to 75 mg, 150 mg, or 300 mg of clindamycin.

Inactive ingredients: – corn starch, FD&C blue no. 1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate, and talc; – corn starch, FD&C blue no. 1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium dioxide; – corn starch, FD&C blue no. 1, gelatin, lactose, magnesium stearate, talc, and titanium dioxide.

The structural formula is represented below:

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



What does Cleocin Hydrochloride look like?



What are the available doses of Cleocin Hydrochloride?

Sorry No records found.

What should I talk to my health care provider before I take Cleocin Hydrochloride?

Sorry No records found

How should I use Cleocin Hydrochloride?

Clindamycin 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, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

Anaerobes:

Streptococci:

Staphylococci:

Pneumococci:

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 CLEOCIN HCl and other antibacterial drugs, CLEOCIN HCl 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.

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

Adults:

Serious infections

More severe infections

Pediatric Patients (

:

Serious infections

More severe infections

To avoid the possibility of esophageal irritation, CLEOCIN HCl Capsules should be taken with a full glass of water.

CLEOCIN HCl Capsules are not suitable for children who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the clindamycin palmitate oral solution in some cases.

Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATESterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN HCl Capsules.

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


What interacts with Cleocin Hydrochloride?

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



What are the warnings of Cleocin Hydrochloride?

Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see and ).  Thrombotic thrombocytopenic purpura/ hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

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Clostridium difficile

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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.

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


What are the precautions of Cleocin Hydrochloride?

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.

CLEOCIN HCl should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

CLEOCIN HCl should be prescribed with caution in atopic individuals.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

The use of CLEOCIN HCl 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.

The 75 mg and 150 mg capsules contain FD&C yellow no. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Prescribing CLEOCIN HCl 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 CLEOCIN HCl, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When CLEOCIN HCl 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 CLEOCIN HCl 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.

In vitro

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 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 CLEOCIN HCl 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 and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.


What are the side effects of Cleocin Hydrochloride?

The following reactions have been reported with the use of clindamycin.

Infections and Infestations:

Clostridium difficile

Gastrointestinal:

Hypersensitivity 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.

Skin and Mucous Membranes:

Liver:

Renal:

Hematopoietic:

Immune System

Musculoskeletal:


What should I look out for while using Cleocin Hydrochloride?

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

See


What might happen if I take too much Cleocin Hydrochloride?

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 Cleocin Hydrochloride?

Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze or shake. Do not use beyond the expiration date printed on the vial.Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze or shake. Do not use beyond the expiration date printed on the vial.CLEOCIN HCl Capsules are available in the following strengths, colors and sizes:


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
CLEOCIN HCl is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

See

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

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.

CLEOCIN HCl should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

CLEOCIN HCl should be prescribed with caution in atopic individuals.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

The use of CLEOCIN HCl 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.

The 75 mg and 150 mg capsules contain FD&C yellow no. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Prescribing CLEOCIN HCl 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.

The following reactions have been reported with the use of clindamycin.

Infections and Infestations:

Clostridium difficile

Gastrointestinal:

Hypersensitivity 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.

Skin and Mucous Membranes:

Liver:

Renal:

Hematopoietic:

Immune System

Musculoskeletal:

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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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Professional

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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Tips

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Interactions

Interactions

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