Clindamycin

Adults 150 mg every six hours 300 mg every six hours - more serious infections 450 mg every six hours - severe infections Absorption of clindamycin hydrochloride is not appreciably modified by ingestion of food, and CLINDAMYCIN LU may be taken with meals with no significant reduction of the serum level. To avoid the possibility of oesophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water and at least 30 minutes before lying down. In the treatment of anaerobic infections (see Section 4.1 Therapeutic Indications), clindamycin phosphate injection should be used initially. This may be followed by oral therapy with clindamycin hydrochloride capsules at the discretion of the physician. In cases of beta- haemolytic streptococcal infections, treatment should continue for at least 10 days. Children For formulation reasons, CLINDAMYCIN LU capsules are not recommended in newborns, infants and

Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin, lincomycin or any of the ingredients as listed under Section 6.1 List of

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), and Kounis syndrome have been reported in patients receiving clindamycin therapy. lf a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see Section 4.3 - Contraindications and Section 4.8 - Adverse effects (undesirable effects)). The usual agents (adrenaline, corticosteroids, antihistamines, colloid infusion) should be available for emergency treatment of serious reactions. The use of clindamycin hydrochloride capsules can lead to the development of severe colitis. Fatalities have been reported. Most of these patients have been found to be colonised with Clostridiosis difficile. Therefore, the drug should be reserved for serious infections where …

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, clindamycin hydrochloride should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently. Clindamycin may be less effective in the presence of strong CYP3A4 inducers such

The adverse effects listed in the table below are presented by system organ class. Within each frequency category, the adverse effects are presented in the order of frequency and then of clinical importance. System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10000 to <1/1000) Frequency not known (cannot be estimated from available data) Infections and infestations Pseudomembranous colitis C. difficile colitis* Vaginal infection* Blood and lymphatic system disorders Eosinophilia Agranulocytosis* Neutropenia* Thrombocytopenia* Leucopenia* Immune system disorders Anaphylactic shock* Anaphylactoid reactions* Anaphylactic reaction* Kounis syndrome* Hypersensitivity* Nervous system disorders Dysgeusia Gastrointestinal disorders Diarrhoea, Abdominal pain Nausea Vomiting Oesophagitis# * Oesphageal ulcer# * Hepatobiliary disorders Jaundice* Skin and subcutaneous tissue disorders Rash maculo- papular Urticaria Erythema multiforme Pruritus Toxic epidermal …

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur (see Section 4.8 Adverse effects (undesirable effects)). The minimal toxic or lethal dose is not well established. At therapeutic doses, the primary toxic effects may involve the gastrointestinal tract and may include severe diarrhoea and pseudomembranous colitis that may result in death. Dermatitis, nephrotoxicity, hepatotoxicity, and various haematological abnormalities are toxic effects that occur less frequently. Rapid administration of large doses intravenously has resulted in ventricular dysrhythmias, hypotension and cardiac arrest. Recommended treatment No specific antidote is known. Support respiratory and cardiac function. In cases of overdose, drug levels of clindamycin are not clinically useful. However, monitoring serum concentrations in patients with markedly reduced renal and hepatic function …

Effects on Fertility Fertility was not impaired in rats given 300mg/kg/day in the diet. Use in Pregnancy: Category A Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin hydrochloride should be used in pregnancy only if clearly needed. Use in Lactation Clindamycin hydrochloride has been reported to appear in breast milk in ranges of < 0.5 to 3.8 micrograms/mL. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora such as diarrhoea or blood in the stool, or rash. Therefore, Clindamycin is not recommended for nursing mothers. 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse …