CLINDAMYCIN Capsule Ref.[6725] Active ingredients: Clindamycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Rivopharm UK Ltd., 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, El4 5NR, United Kingdom

Therapeutic indications

Clindamycin is indicated for the treatment of:

Serious infections caused by anaerobic bacteria, including intra-abdominal infections, skin and soft tissue infections. As needed, clindamycin should be administered in conjunction with another antibacterial agent that is active against gram negative aerobic bacteria.

  • Tonsillitis
  • Dental infection

Consideration should be given to the official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

Adults

The usual dose is 150-450 mg every six hours, depending on the severity of the infection.

Elderly patients

Dosage requirements in elderly patients should not be influenced by age alone

Paediatric population

The usual dose is 3-6-mg/kg every six hours depending on the severity of the infection (not to exceed the adult dose).

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 an alternative formulation in some cases.

Renal impairment

No dose adjustment is necessary in patients with mild to moderate impairment of renal function. In patients with severe renal impairment or anuria, plasma concentration should be monitored. Depending on the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12 hours necessary.

Hepatic impairment

In patients with moderate to severe hepatic impairment, elimination half-life of clindamycin is prolonged. A reduction in dosage is generally not necessary if clindamycin is administered every 8 hours. However, the plasma concentration of clindamycin should be monitored in patients with severe hepatic impairment. Depending on the results, this measure can make a reduction in dosage or an increase in the dose intervals necessary.

Method of administration

Clindamycin capsules are given orally. The product should always be taken with a full glass of water in an upright position.

Absorption of Clindamycin capsules is not appreciably modified by the presence of food.

Overdose

The serum biological half-life of clindamycin is 2.4 hours. Clindamycin cannot readily be removed from the blood by haemodialysis or peritoneal dialysis.

If an allergic adverse reaction occurs, therapy should be with the usual emergency treatments, including corticosteroids, adrenaline and antihistamines.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Store in the original package in order to protect from light.

Nature and contents of container

The blister pack (PVC/aluminium) contains 24, 30, 32, 40 or 100 tablets, respectively.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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