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JAMP 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: JAMP Clindamycin Capsules (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. JAMP Clindamycin Capsules is also…
Verbatim from this product's HC label. Tap a section to expand.
Note:
JAMP Clindamycin Capsules is only available in a 150 mg and 300 mg capsule formulation. 1 Dosing Considerations JAMP Clindamycin Capsules dose modification may not be necessary in patients with renal disease. JAMP Clindamycin Capsules dosage modification is not necessary in patients with hepatic insufficiency.
Dosage adjustments are not necessary in the elderly with normal hepatic function and normal (age-adjusted) renal function. 2 Recommended Dose and Dosage Adjustment Adults: Mild infections: 150 mg every 6 hours. Moderately severe infections: 300 mg every 6 hours.
Severe infections: 450 mg every 6 hours.
Children (over one month of age and able to swallow capsules):
Clindamycin should be dosed based on total body weight regardless of obesity. One of the following two dosage ranges should be selected depending on the severity of the infection: 1. 8-16 mg/kg/day (4-8 mg/lb/day) divided into 3 or 4 equal doses.
2. 16-20 mg/kg/day (8-10 mg/lb/day) divided into 3 or 4 equal doses. Product Monograph JAMP Clindamycin Capsules (clindamycin hydrochloride) Page 6 of 35 Protected B / Protégé B JAMP Clindamycin 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 granules for oral solution in some cases.
Note:
JAMP Clindamycin Capsules is only available in a 150 mg and 300 mg capsule formulation. Pneumocystis jiroveci pneumonia in patients with AIDS JAMP Clindamycin Capsules (clindamycin hydrochloride) 300-450 mg may be given orally every 6 hours in combination with 15-30 mg of primaquine for 21 days.
Alternatively, DALACIN C PHOSPHATE (clindamycin phosphate) 600-900 mg (IV) may be given every 6 hours or 900 mg (IV) every 8 hours in combination with oral daily dose of 15-30 mg of primaquine. If patients should develop serious hematologic adverse effects, reducing the dosage regimen of primaquine and / or JAMP Clindamycin Capsules should be considered.
For prevention of endocarditis Adults: 300 mg orally 1 hour before procedure; then 150 mg 6 hours after initial dose. Children: 10 mg / kg (not to exceed adult dose) orally 1 hour before procedure; then 5 mg / kg 6 hours after initial dose.
). 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 Product Monograph JAMP Clindamycin Capsules (clindamycin hydrochloride) Page 9 of 35 Protected B / Protégé B 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 JAMP Clindamycin Capsules 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 JAMP Clindamycin Capsules (clindamycin hydrochloride) should be prescribed with caution in atopic individuals. 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.
General Clindamycin hydrochloride capsules do not diffuse adequately into cerebrospinal fluid and thus should not be used in the treatment of meningitis. Product Monograph JAMP Clindamycin Capsules (clindamycin hydrochloride) Page 8 of 35 Protected B / Protégé B The use of antibiotics occasionally results in overgrowth of non-susceptible organisms - particularly yeasts.
Should super-infections occur, appropriate measures should be taken as dictated by the clinical situation. Care should be exercised when treating patients with multiple medications (see 9 DRUG INTERACTIONS). 4 Administration). Gastrointestinal JAMP Clindamycin Capsules should be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis, inflammatory bowel disease (including regional enteritis and ulcerative colitis), or a history of antibiotic-associated colitis (including pseudomembranous colitis).
Clostridioides difficile-associated disease (CDAD):
Clostridioides difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including clindamycin hydrochloride capsules. CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridioides difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridioides difficile.
JAMP
Clindamycin Capsules (clindamycin hydrochloride) 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 JAMP Clindamycin Capsules 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.
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Note:
With β-hemolytic streptococcal infections, treatment should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis. 4 Administration Absorption of JAMP Clindamycin Capsules is not appreciably modified by ingestion of food and the capsules may be taken with meals.
To avoid the possibility of oesophageal irritation, JAMP Clindamycin Capsules should be taken with a full glass of water and no less than 30 minutes before lying down. 5 Missed Dose If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose.
The dose should not be doubled to make up for a missed dose.
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 JAMP Clindamycin Capsules 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. Product Monograph JAMP Clindamycin Capsules (clindamycin hydrochloride) Page 10 of 35 Protected B / Protégé B 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 JAMP Clindamycin Capsules 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 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 Product Monograph JAMP Clindamycin Capsules (clindamycin hydrochloride) Page 11 of 35 Protected B / Protégé B 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 JAMP Clindamycin Capsules 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 JAMP Clindamycin Capsules and any potential adverse effects on the breastfed child from JAMP Clindamycin Capsules 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 […]
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridioides difficile. Surgical evaluation should be instituted as clinically indicated; as surgical intervention may be required in certain severe cases (see