AfyaIndex — Drug Search

01 Risk first

Safety essentials

The information most likely to change a prescribing or dispensing decision.

Contraindications

CONTRAINDICATIONS Clindamycin phosphate topical lotion is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Precautions

WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death.
Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface.
Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis.
The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus.
Endoscopic examination may reveal pseudomembranous colitis.
Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
When significant diarrhea occurs, the drug should be discontinued.
Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.
Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition.
Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile .
The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.

02 Point of care

Dosing matrix

Population and organ-function guidance, shown together for faster comparison.

Adult

DOSAGE AND ADMINISTRATION Apply a thin film of clindamycin phosphate topical lotion twice daily to affected area. Lotion: Shake well immediately before using. Keep all liquid dosage forms in containers tightly closed.

Paediatric

Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Renal

Metabolites accumulate in renal failure; review dosing in ESRD.

CrCl 0–120: Confirm renal dosing in product SmPC / primary label.

Hepatic

Hepatic metabolism — reduce dose in severe liver disease.

03 Clinical use

Use, effects & interactions

Indications

INDICATIONS AND USAGE Clindamycin phosphate topical lotion is indicated in the treatment of acne vulgaris.
In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).

Adverse effects

ADVERSE REACTIONS In 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].
Number of Patients Reporting Events Treatment Emergent Adverse Event Solution n=553(%) Gel n=148(%) Lotion n=160(%) Burning 62 (11) 15 (10) 17 (11) Itching 36 ( 7) 15 (10) 17 (11) Burning/Itching 60 (11) # ( – ) # ( – ) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 ( 7) 22 (14) Oiliness/Oily Skin 8 ( 1) 26 (18) 12* (10) Peeling 61 (11) # ( – ) 11 ( 7) # not recorded * of 126 subjects Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.
Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ).
Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Drug interactions

Open multi-drug checker ↗

Fixed-dose/multi-ingredient product.
Clinical details partially inherited from component monographs: Clindamycin, Clotrimazole / Beclomethasone Dipropionate, Metronidazole.
Confirm combination SmPC for exact dosing.

04 Pharmacology

Mechanism & disposition

Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown.

Mechanism of Action The mechanism of actio…Nitroimidazoles are reduced by ferredoxin-…Selective for anaerobic/microaerophilic or…

Read complete mechanism

Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown. Nitroimidazoles are reduced by ferredoxin-like systems in anaerobic bacteria and protozoa to reactive nitro radicals that damage DNA and other macromolecules, causing cell death. Selective for anaerobic/microaerophilic organisms.

Onset

1–2 hours

Duration

8–24 hours

Route

ORAL / IV / TOPICAL / VAGINAL

05 Special populations

Pregnancy, lactation & diet

Pregnancy

Pregnancy: Teratogenic effects 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. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

Lactation

Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora. Monitor the breast-fed 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 breast-fed child from clindamycin or from the underlying maternal condition. Clinical Considerations If used during lactation and clindamycin phosphate topical lotion is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

06 Kenya market

Brands & loaded prices

FromKES 220

MedianKES 650

Listings6

Brand	Manufacturer	Pack	Observed price
Amlocip	Afya Index / Retail Reference	tabs 5mg 30's	KES 453.00afya_index_book
Amlo denk	Afya Index / Retail Reference	tabs 5mg 30's	KES 799.00afya_index_book
Amlodipine	Afya Index / Retail Reference	tabs 5mg 50's	KES 1,128.00afya_index_book
Amlopres	Afya Index / Retail Reference	tabs 5mg 3x10's	KES 220.00afya_index_book
Ke:1	Afya Index / Retail Reference	tabs 5mg 3x10's	KES 650.00afya_index_book
Lowvasc	Afya Index / Retail Reference	caps 5mg 28's	KES 1,625.00afya_index_book

07 Provenance

Sources & review state

Primary sourceLocal active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Nitroimidazole antimicrobial / antiprotozoal)

Last reviewedNot recorded

EvidenceSource-linked

Open source document ↗

Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.