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NRA-CLINDAMYCIN is a brand name for Clindamycin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NRA-Clindamycin (Clindamycin Hydrochloride Capsules) is indicated in the treatment of serious infections due to sensitive anaerobic bacteria, such as Bacteroides species, Peptostreptococcus, anaerobic streptococci, Clostridium species and microaerophilic streptococci. NRA-Clindamycin is also indicated in serious…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 11/2024 7 WARNINGS AND PRECAUTIONS, Renal 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. …………2 PART I: HEALTH PROFESSIONAL INFORMATION ...........................................................................
4 1 INDICATIONS ........................................................................................................................ 1 Pediatrics ........................................................................................................................
2 Geriatrics......................................................................................................................... 5 2 CONTRAINDICATIONS ............................................................................................................
5 4 DOSAGE AND ADMINISTRATION ........................................................................................... 1 Dosing Considerations ....................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................... 4 Administration ................................................................................................................
5 Missed Dose .................................................................................................................... 6 5 OVERDOSAGE ........................................................................................................................
6
). Hematologic In patients with G-6-PD deficiency, the combination of clindamycin with primaquine may cause hemolytic reactions. Routine blood examinations should be done during therapy with primaquine to monitor potential hematologic toxicities.
Reference should also be made to the primaquine product monograph for other possible risk groups for other hematologic reactions (see 8 ADVERSE REACTIONS). If patients should develop serious hematologic adverse effects, reducing the dosage regimen of primaquine and/or NRA-Clindamycin capsule should be considered (see 4 DOSAGE AND ADMINSTRATION).
Hepatic/Biliary/Pancreatic In patients with moderate to severe liver disease, prolongation of the half-life of clindamycin has been found. However, it was postulated from studies that when given every eight hours, accumulation of clindamycin should rarely occur.
Therefore, dosage reduction in liver disease is not generally considered necessary. Periodic liver enzyme determinations should be made when treating patients with severe liver disease. Immune NRA-Clindamycin should be prescribed with caution in atopic individuals.
NRA-Clindamycin (Clindamycin Hydrochloride Capsules) Page 9 of 33 Unclassified / Non classifié Serious hypersensitivity reactions, including anaphylactoid reactions, severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), and dermatological reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) have been reported in patients on clindamycin therapy.
If a hypersensitivity reaction occurs clindamycin should be discontinued and appropriate therapy should be initiated (see 2 CONTRAINDICATIONS, 8 ADVERSE REACTIONS). Monitoring and Laboratory Tests Routine blood examinations should be done during concomitant therapy with primaquine to monitor potential hematologic toxicities.
, Renal 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. …………2 PART I: HEALTH PROFESSIONAL INFORMATION ...........................................................................
4 1 INDICATIONS ........................................................................................................................ 1 Pediatrics ........................................................................................................................
2 Geriatrics......................................................................................................................... 5 2 CONTRAINDICATIONS ............................................................................................................
5 4 DOSAGE AND ADMINISTRATION ........................................................................................... 1 Dosing Considerations ....................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................... 4 Administration ................................................................................................................
5 Missed Dose .................................................................................................................... 6 5 OVERDOSAGE ........................................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................... 7 7 WARNINGS AND PRECAUTIONS............................................................................................. 1 Special Populations........................................................................................................
NRA-Clindamycin is contraindicated in patients with a known hypersensitivity to clindamycin or lincomycin or to any ingredient in the formulation or component of the container. Until further clinical experience is obtained NRA-Clindamycin is not indicated in the newborn (infant below 30 days of age).
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clindamycin in Canada.
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Periodic liver and kidney function tests and blood counts should be performed during prolonged therapy when treating patients with severe liver disease. As with all antibiotics, perform culture and sensitivity studies in conjunction with drug therapy.
Renal NRA-Clindamycin dose modification may not be necessary in patients with renal disease. The serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Clindamycin is potentially nephrotoxic.
Acute kidney injury including acute renal failure has been reported. Therefore, monitoring of renal function should be considered during therapy of patients with pre-existing renal dysfunction or taking concomitant nephrotoxic drugs and monitoring of renal function should be performed if therapy is prolonged.
Sensitivity/Resistance Development of drug-resistant bacteria:
Prescribing NRA-Clindamycin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug- resistant bacteria. 1 Pregnant Women: There are no adequate and well-controlled studies in pregnant women.
Safety for use in pregnancy has not been established. Clindamycin should not be used in pregnancy unless clearly needed and unless the expected benefits to the mother outweigh any potential risks to the fetus. Clindamycin crosses the placenta in humans.
After multiple doses, amniotic fluid concentrations were approximately 30% of maternal blood concentrations. Clindamycin was NRA-Clindamycin (Clindamycin Hydrochloride Capsules) Page 10 of 33 Unclassified / Non classifié widely distributed in fetal tissues with the highest concentration found in liver.
Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 20 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin except at doses that caused maternal toxicity.
In one mouse strain, cleft palates were observed in treated fetuses; this response was not produced in other mouse strains or in other species, and therefore may be a strain specific effect. Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus due to clindamycin, except at doses that caused maternal toxicity.
Animal reproduction studies are not always predictive of human response. 8 mcg/mL. Clindamycin has the potential to cause adverse effects on the breastfed infant’s gastrointestinal flora such as diarrhea or blood in the stool, or rash.
Because of the potential for serious adverse reactions in nursing infants, if clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. If NRA-Clindamycin is used by a nursing mother, monitor the infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or 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 NRA-Clindamycin and any potential adverse effects on the breastfed child from NRA-Clindamycin or from the underlying maternal condition.
3 Geriatrics Geriatrics (> 60 years of age): Experience has demonstrated that antibiotic-associated colitis may occur more frequently and with increased severity among elderly and debilitated patients. These patients should be carefully monitored for the development of diarrhea.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
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10 8 ADVERSE REACTIONS ........................................................................................................... 2 Clinical Trial Adverse Reactions ....................................................................................
3 Less Common Clinical Trial Adverse Reactions ............................................................ 5 Post-Market Adverse Reactions .................................................................................... 11 9 DRUG INTERACTIONS ..........................................................................................................
2 Drug Interactions Overview .......................................................................................... 4 Drug-Drug Interactions .................................................................................................
5 Drug-Food Interactions................................................................................................. 6 Drug-Herb Interactions .................................................................................................
7 Drug-Laboratory Test Interactions ............................................................................... 14 10 CLINICAL PHARMACOLOGY ................................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics .....................................................................................................
3 Pharmacokinetics ........................................................................................................ 14 11 STORAGE, STABILITY AND DISPOSAL .................................................................................
16 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................... 16 PART II: SCIENTIFIC INFORMATION ...........................................................................................
17 13 PHARMACEUTICAL INFORMATION .................................................................................... 17 14 CLINICAL TRIALS .................................................................................................................
3 Comparative Bioavailability Studies………………………………………………………………………18 15 MICROBIOLOGY................................................................................................................. 19 16 NON-CLINICAL TOXICOLOGY ..............................................................................................
25 17 SUPPORTING PRODUCT MONOGRAPHS ............................................................................. 26 PATIENT MEDICATION INFORMATION .......................................................................................
27 NRA-Clindamycin (Clindamycin Hydrochloride Capsules) Page 4 of 33 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NRA-Clindamycin (Clindamycin Hydrochloride Capsules) is indicated in the treatment of serious infections due to sensitive anaerobic bacteria, such as Bacteroides species, Peptostreptococcus, anaerobic streptococci, Clostridium species and microaerophilic streptococci.
NRA-Clindamycin is also indicated in serious infections due to sensitive […]