(klin'' da mye' sin)
P / L : Caution - pregnancy & lactation (breast feeding)
|| See TERMINOLOGY & ABBREVIATIONS ||
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficle.
Because Clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections.
C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
|Indication(s) & Usage||
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin and other antibacterial drugs, Clindamycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
|Dosage & Administration||
If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).
Adults: Serious infections â€“ 150 to 300 mg every 6 hours. More severe infections â€“ 300 to 450 mg every 6 hours. Pediatric Patients: Serious infections â€“ 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections â€“ 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.
To avoid the possibility of esophageal irritation, Clindamycin Capsules should be taken with a full glass of water.
Serious infections due to anaerobic bacteria are usually treated with Clindamycin Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with Clindamycin Capsules.
In cases of Î²-hemolytic streptococcal infections, treatment should continue for at least 10 days.
Granules: Should be taken with food.
Prophylaxis of endocarditis
Severe Renal impairment: dosage adjustment may be needed.
Toxic shock syndrome
Pelvic inflammatory disease
|Overdosage||Dialysis or peritoneal dialysis unlikely to be helpful.|
|Special Precautions||Renal and hepatic diseases; pregnancy and lactation; GI disease; elderly, females, neonates, atopic patients. Regular monitoring of blood counts, liver and kidney functions.|
|Adverse Drug Reaction(s)||Diarrhoea, nausea, vomiting, abdominal pain; erythema multiforme, contact dermatitis, exfoliative and vesiculous dermatitis, urticaria; eosinophilia; local irritation, thrombophloebitis.
Potentially Fatal: Gasping syndrome (neonates); pseudomembranous colitis.
|Drug Interactions||Antagonises effects of parasympathetics.
Potentially Fatal: Respiratory depression with neuromuscular blockers. Please consult detailed drug interactions before prescribing. Please consult detailed drug interactions before prescribing.
|Food Interaction||May reduce rate of absorption.|
|Pregnancy Category (FDA) and use in Specific Population||
Pregnancy Category B
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.
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.
Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.
When Clindamycin is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.
Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridium difficile) seen in association with most antibiotics occur more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.
|Storage||All Clindamycin formulations: Store at 20-25°C.
|Pharmacology||Clindamycin inhibits protein synthesis by reversibly binding to the 50S subunit of the ribosomal thus blocking the transpeptidation or translocation reactions of susceptible organisms resulting to stunted cell growth.
Absorption: 90% absorbed from the GI tract (oral), absorbed from the skin (topical), systemically (intravaginal); rate of absorption may be reduced by the presence of food.
Distribution: Body tissues and fluids (wide), bone, bile (high concentrations), leukocytes, macrophages; crosses the placenta and enters breast milk. Protein-binding: >90%
Metabolism: Hepatic; converted to N-demethyl and sulfoxide metabolites and some inactive metabolites.
Excretion: Via urine (10% as active drug or metabolites), via faeces (4% as inactive metabolites); 2-3 hr (elimination half-life), may be prolonged in preterm neonates and severe renal impairment.
|ATC Classification||D10AF01 - clindamycin; Belongs to the class of topical antiinfective preparations used in the treatment of acne.
G01AA10 - clindamycin; Belongs to the class of antibiotics. Used in the treatment of gynecological infections.
J01FF01 - clindamycin; Belongs to the class of lincosamides. Used in the treatment of systemic infections.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|CINAMYCIN||IBN SINA Pharmaceutical Industry Ltd.||Clindamycin hydrochloride 150mg & 300||Capsule||30's each: 240.00 & 450.00 MRP|
|CLIMYCIN 150||Square Pharmaceuticals Ltd.||Clindamycin 150mg||Capsule||3x10's: 241.80 MRP|
|CLIMYCIN 300||Square Pharmaceuticals Ltd.||Clindamycin 300mg||Capsule||3x10's: 453.00 MRP|
|Clindacin 150||Incepta Pharmaceuticals Limited||Clindamycin Hydrochloride BP equivalent to Clindamycin 150 mg||Capsule||10x3's:MRP 240 Tk|
|Clindacin 300||Incepta Pharmaceuticals Limited||Clindamycin Hydrochloride BP equivalent to Clindamycin 300 mg||Capsule||10x3's:MRP 450 Tk|
|Clindacin 300 Injection||Incepta Pharmaceuticals Limited||Clindamycin Phosphate 300mg/2ml||Injection||1x5's:MRP 200 Tk|
|Clindacin 600 Injection||Incepta Pharmaceuticals Limited||Clindamycin Phosphate 300mg/4ml||Injection||1x5's:MRP 350 Tk|
|Clindacin Cream||Incepta Pharmaceuticals Limited||Clindamycin 2% Vaginal Cream||Cream||20gm x 1:MRP 70 Tk|
|Clindacin Lotion||Incepta Pharmaceuticals Limited||Clindamycin 1% Lotion||Lotion||25ml:MRP 125 Tk|
|Clindacin plus||Incepta Pharmaceuticals Limited||Clindamycin Phosphate 1.2% +Tretinoin 0.025% Gel||Gel||15gm x 1:MRP 150 Tk|
|Clindacin Powder||Incepta Pharmaceuticals Limited||Clindamycin 75 mg/5 ml Powder For Suspension||Powder for oral solution||1x1's:MRP 280 Tk|
|CLINDAX||Opsonin Pharma Limited||Clindamycin hydrochloride 75mg/5ml||Oral Solution||100ml: 250.00 MRP|
|CLINDAX 300||Opsonin Pharma Limited||Clindamycin phosphate BP equivalent to Clindamycin 300mg/2ml (I/V)||Injection||5's: 200.00 MRP|
|CLINDAX 600||Opsonin Pharma Limited||Clindamycin phosphate BP equivalent to Clindamycin 600mg/4ml (I/V)||Injection||5's: 350.00 MRP|
|CLINDAX Capsule||Opsonin Pharma Limited||Clindamycin hydrochloride 150mg & 300||Capsule||30's each: 240.00 & 450.00 MRP|
|CLINDAX Cream||Opsonin Pharma Limited||Clindamycin phosphate BP 20mg/gm||Cream||20gm: 70.00 MRP|
|CLINDAX Lotion||Opsonin Pharma Limited||Clindamycin Phosphate USP 10mg/ml (1% w/v)||Lotion||25ml: 125.00 MRP|
|CLINEX||Aristopharma Ltd.||Clindamycin Phosphate USP 10mg/ml (1% w/v)||Lotion||25ml: 125.00 MRP|
|CLINEX Capsule||Aristopharma Ltd.||Clindamycin hydrochloride 300mg||Capsule||30's: 450.00 MRP|
|DACLIN||ACI Ltd.||Clindamycin Phosphate USP 10mg/ml (1% w/v)||Lotion||25ml: 125.00 MRP|
|DACLIN Capsule||ACI Ltd.||Clindamycin hydrochloride 150mg & 300||Capsule||30's each: 240.00 & 450.00 MRP|
|DALACIN C||Janata Traders||Clindamycin hydrochloride 300mg||Capsule||16's: 848.16 MRP|
|DALACIN C Injection||Janata Traders||Clindamycin phosphate BP equivalent to Clindamycin 600mg/4ml (I/V)||Injection||4ml: 332.03 MRP|
|LINDAMAX||Eskayef Bangladesh Ltd||Clindamycin Hydrochloride BP equivalent to Clindamycin 150mg & 300mg||Capsule||30's each, MRP: 240.00 & 450.00|
|XINDAL||Orion Pharma Ltd.||Clindamycin hydrochloride 300mg||Capsule||30's: 450.00 MRP|
Many antibiotics, including clindamycin, may cause overgrowth of dangerous bacteria in the large intestine. This may cause mild diarrhea or may cause a life-threatening condition called colitis (inflammation of the large intestine). Clindamycin is more likely to cause this type of infection than many other antibiotics, so it should only be used to treat serious infections that cannot be treated by other antibiotics. Tell your doctor if you have or have ever had colitis or other conditions that affect your stomach or intestines.
You may develop these problems during your treatment or up to several months after your treatment has ended. Call your doctor if you experience any of the following symptoms during your treatment with clindamycin or during the first several months after your treatment has finished: watery or bloody stools, diarrhea, stomach cramps, or fever.
Talk to your doctor about the risks of taking clindamycin.
Why is this medication prescribed?
Clindamycin is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, female reproductive organs, and internal organs. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Antibiotics such as clindamycin will not kill the viruses that cause colds, flu, and other infections. Clindamycin injection is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, bones, joints, female reproductive organs, and internal organs. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Antibiotics such as clindamycin will not kill the viruses that cause colds, flu, and other viral infections. Vaginal clindamycin is used to treat bacterial vaginosis (an infection caused by an overgrowth of harmful bacteria in the vagina). Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Vaginal clindamycin cannot be used to treat vaginal irritation caused by yeast infections or by sexually transmitted diseases such as chlamydia and trichomoniasis.
How should this medicine be used?
Clindamycin may come as a tablet, capsule and a solution (liquid) to take by mouth or as an injection or cream. It is usually taken three to four times a day. The length of your treatment depends on the type of infection you have. Take clindamycin at around the same times every day.
Clindamycin injection comes as a liquid to be injected intravenously (into a vein) over a period of 10 to 40 minutes or intramuscularly (into a muscle). It is usually given two to four times a day.
You may receive clindamycin injection in a hospital, or you may be given the medication to use at home. If you have been told to use clindamycin injection at home, it is very important that you use the medication exactly as directed. Use clindamycin injection at about the same times every day. Follow the directions that you are given carefully, and ask your doctor if you have any questions. Do not use more or less of it or use it more often than prescribed by your doctor. You should begin to feel better during the first few days of treatment with clindamycin injection. If your symptoms do not improve or if they get worse, call your doctor.
Use clindamycin injection until you finish the prescription, even if you feel better. If you stop using clindamycin injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Vaginal clindamycin comes as a suppository to place in the vagina and a cream to apply to the inside of the vagina. The vaginal suppositories are usually used once a day, preferably at bedtime, for 3 days in a row. Most brands of the vaginal cream are used once a day, preferably at bedtime, for 3 days in a row or for 7 days in a row. Some brands come as a single dose, given at any time of day. If you are using more than one dose of vaginal clindamycin, use it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Use vaginal clindamycin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. This medication is for vaginal use only. Do not swallow the cream or suppositories, and do not apply the cream to any other part of your body. Be careful not to get the cream in your eyes. If you do get the cream in your eyes, rinse your eyes with plenty of cool water.
Your medication will come with directions for use. Read these directions and follow them carefully. Ask your doctor if you have any questions about how to use vaginal clindamycin.
Use vaginal clindamycin until you finish the prescription, even if you feel better. If you stop using vaginal clindamycin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take clindamycin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Shake the liquid well before each use to mix the medication evenly.
Take the capsules/tablets with a full glass of water so that the medication will not irritate your throat.
You should begin to feel better during the first few days of treatment with clindamycin. If your symptoms do not improve or if they get worse, call your doctor.
Take clindamycin until you finish the prescription, even if you feel better. If you stop taking clindamycin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Other uses for this medicine
Clindamycin is also sometimes used to treat acne and is used along with other medications to treat anthrax (a serious infection that may be deliberately spread as part of a terror attack) and malaria (a serious infection that is spread by mosquitoes in certain parts of the world). Clindamycin is also sometimes used to treat ear infections and toxoplasmosis (an infection that may cause serious problems in people who do not have healthy immune systems or in unborn babies whose mothers are infected) when these conditions cannot be treated with other medications. Clindamycin is also sometimes used to prevent endocarditis (infection of the heart valves) in certain people who are at risk of developing this infection as a result of a dental procedure. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking clindamycin,
- tell your doctor if you are allergic to clindamycin, lincomycin, or any other medications. If you will be taking clindamycin capsules, tell your doctor if you are allergic to aspirin or tartrazine (a yellow dye found in some medications).
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention erythromycin (E.E.S, E-Mycin, Erythrocin, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had asthma, allergies, eczema (sensitive skin that often becomes itchy or irritated) or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking clindamycin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clindamycin.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Clindamycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
pain when swallowing
white patches in the mouth
thick, white vaginal discharge
- burning, itching, and swelling of the vagina
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
difficulty breathing or swallowing
yellowing of the skin or eyes
Clindamycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate clindamycin liquid because it may thicken and become hard to pour. Throw away any unused clindamycin solution after 2 weeks. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to clindamycin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the clindamycin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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*Trademark name & prescribing information are the property of their respective Manufacturers.