Clodale belongs to the family of medicines called antibiotics.
Topical Clodale is used to help control acne. It may be used alone or with one or more other medicines that are used on the skin or taken by mouth for acne.
Topical Clodale may also be used for other problems as determined by your doctor.
Clodale is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Clodale (Clodale palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clodale 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 Clodale 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 Clodale.
In Vitro Susceptibility Testing
A standardized disk testing procedure2 is recommended for determining susceptibility of aerobic bacteria to Clodale. A description is contained in the Clodale® Susceptibility Disk (Clodale) insert. Using this method, the laboratory can designate isolates as resistant, intermediate, or susceptible. Tube or agar dilution methods may be used for both anaerobic and aerobic bacteria. When the directions in the Clodale® Susceptibility Powder insert are followed, an MIC (minimal inhibitory concentration) of 1.6 mcg/mL may be considered susceptible; MICs of 1.6 to 4.8 mcg/mL may be considered intermediate and MICs greater than 4.8 mcg/mL may be considered resistant.
Clodale Susceptibility Disks 2 mcg. See package insert for use.
Clodale Susceptibility Powder 20 mg. See package insert for use.
For anaerobic bacteria the minimal inhibitory concentration (MIC) of Clodale can be determined by agar dilution and broth dilution (including microdilution) techniques. If MICs are not determined routinely, the disk broth method is recommended for routine use. THE KIRBY-BAUER DISK DIFFUSION METHOD AND ITS INTERPRETIVE STANDARDS ARE NOT RECOMMENDED FOR ANAEROBES.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clodale and other antibacterial drugs, Clodale 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.
How should I use Clodale?
Use Clodale cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Clodale cream is for vaginal use only.
Wash your hands before and after using Clodale cream. To use, remove the cap from the tube. Screw the plastic applicator on the threaded end of the tube. Rolling the tube from the bottom, squeeze gently and force the medicine into the applicator. The applicator is filled when the plunger reaches its predetermined stopping point.
Unscrew the applicator from the tube and replace the cap. While lying on your back, firmly grasp the applicator barrel and insert into the vagina as far as it will possibly go without causing discomfort. Slowly push the plunger until it stops. Carefully remove the applicator from the vagina and throw the applicator away.
Use Clodale cream at bedtime. This will help keep the medicine in the vagina and reduce leaking.
Clodale cream works best if it is used at the same time each day.
To clear up your infection completely, use Clodale cream for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Clodale cream and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Clodale cream.
Uses of Clodale in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Bone and joint infections: Treatment of bone and joint infections, including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections caused by susceptible organisms.
Gynecological infections: Treatment of gynecologic infections, including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.
Intraabdominal infections: Treatment of intraabdominal infections, including peritonitis and intraabdominal abscess caused by susceptible anaerobic organisms.
Lower respiratory tract infections: Treatment of lower respiratory tract infections, including pneumonia, empyema, and lung abscess caused by susceptible anaerobes, Streptococcus pneumoniae, other streptococci (except Enterococcus faecalis), and S. aureus.
Septicemia: Treatment of septicemia caused by S. aureus, streptococci (except E. faecalis), and susceptible anaerobes.
Skin and soft tissue infection: Treatment of skin and soft tissue infection caused by Streptococcus pyogenes, S. aureus, and susceptible anaerobes.
Off Label Uses
Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax in adults, Clodale is an effective and acceptable alternative for postexposure prophylaxis or treatment of cutaneous anthrax; it is also a first-line option, in combination with other antimicrobials, for the treatment of systemic anthrax. Alternative regimens have also been suggested for other patient populations with anthrax, including injectable drug users who develop injectional anthrax.
Streptococcal (group A) pharyngitis and chronic carriage
Based on the IDSA guidelines for the diagnosis and management of group A streptococcal pharyngitis, Clodale is an effective and recommended alternative agent for the treatment of streptococcal pharyngitis and an option for treatment of chronic group A streptococcal carriage.
Based on the American Society of Health-System Pharmacists (ASHP) clinical practice guidelines for antimicrobial prophylaxis in surgery, Clodale, given as an alternative antibiotic in patients with beta-lactam allergy requiring surgical prophylaxis, is effective and recommended for a number of surgical procedures.
Toxoplasma gondii encephalitis and pneumonitis (treatment/long-term maintenance)
Based on the US Department of Health and Human Services guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents and the American Society of Transplantation Infectious Diseases Community of Practice guidelines on parasitic infections in solid organ transplantation, Clodale (with pyrimethamine and leucovorin) is an effective and recommended alternative regimen for the treatment and long-term maintenance therapy of Toxoplasma gondii encephalitis and pneumonitis.
Clodale is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clodale phosphate is a water soluble ester of Clodale and phosphoric acid.
The molecular formula is C18H34CIN2O8PS and the molecular weight is 504.96.
Clodale hydrochloride is the hydrated hydrochloride salt of Clodale. Clodale hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.
Clodale palmitate hydrochloride is a water soluble salt of ester of Clodale and palmitic acid. Clodale palmitate hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-palmitate monohydrochloride.
Generic name: Clodale HYDROCHLORIDE 75mg
Dosage form: capsule
Clodale granule, for oral solution
Clodale Phosphate injection, solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
If significant diarrhea occurs during therapy, this antibiotic should be discontinued.
Adults: Serious infections – 150 to 300 mg every 6 hours. More severe infections – 300 to 450 mg every 6 hours. Pediatric Patients: Serious infections – 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections – 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, Clodale HCl Capsules should be taken with a full glass of water.
Serious infections due to anaerobic bacteria are usually treated with Clodale PHOSPHATE® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with Clodale HCl Capsules.
In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
With simultaneous use of Clodale with theophylline, aminophylline, caffeine, there is an increase in their concentration in blood plasma and thus increases the risk of toxic effects.
Erythromycin increases the concentrations of cyclosporine in the blood plasma and may increase the risk of nephrotoxicity.
Drugs that block tubular secretion prolongs T1/2 of erythromycin.
Incompatible with lincomycin, Clodale and chloramphenicol (antagonism).
Clodale reduces the bactericidal action of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).
With simultaneous use of erythromycin increases the concentration of theophylline.
At the same time receiving chemotherapy, which is carried metabolism in the liver (carbamazepine, valproic acid, hexobarbital, phenytoin, alfentanil, dizopiramid, lovastatin, bromocriptine), may increase the concentration of these drugs in plasma (an inhibitor of microsomal liver enzymes).
IV injection of erythromycin increases the effects of ethanol (accelerating gastric emptying and decrease the duration of alcohol dehydrogenase in the gastric mucosa).
Erythromycin reduces the clearance of triazolam and midazolam and therefore may increase the pharmacological effects of benzodiazepines.
At the same time taking with terfenadine or astemizole may develop arrhythmias (fibrillation and ventricular flutter, ventricular tachycardia, until death); with dihydroergotamine or non hydrated ergot alkaloids may vasoconstriction to spasm, dysesthesia.
With simultaneous application Clodale slows elimination (increases the effect) of methylprednisolone, felodipine and anticoagulants of cumarine series.
In a joint appointment with lovastatin increased rhabdomyolysis.
Erythromycin increases the bioavailability of digoxin.
Erythromycin reduces the effectiveness of hormonal contraceptives.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with Clodale Foam.
The incidence of adverse reactions occurring in ≥1% of the subjects in clinical trials comparing Clodale Foam and its vehicle is presented in Table 1.
Table 1: Adverse Reactions Occurring in ≥1% of Subjects
Number (%) of Subjects
N = 439
N = 154
Application site burning
Application site pruritus
Application site dryness
Application site reaction, not otherwise specified
In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to Clodale Foam.
The following adverse reactions have been identified during post approval use of Clodale Foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, pain of skin, colitis (including pseudomembranous colitis), and hemorrhagic diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of Clodale.
Orally and parenterally administered Clodale have been associated with severe colitis, which may end fatally.
You should not use this medication if you are allergic to Clodale or lincomycin (Bactramycin, L-Mycin, Lincocin).
Do not take Clodale together with erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others).
Before using Clodale, tell your doctor if you have kidney disease, liver disease, an intestinal disorder such as colitis or Crohn's disease, or a history of asthma, eczema, or allergic skin reaction.
Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Clodale will not treat a viral infection such as the common cold or flu.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Clodale and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.
If you need surgery, tell the surgeon ahead of time that you are using Clodale. You may need to stop using the medicine for a short time.
DailyMed. "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Clodale are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Clodale. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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