Clodale Actions

• Actions of Clodale in details
• Clodale administration
• Clodale pharmacology
• Clodale reviews

Actions of Clodale in details

Pharmacology: Pharmacodynamics: Although Clodale phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active Clodale. Clodale has been shown to have in vitro activity against isolates of Propionibacterium acnes cultures tested [minimum inhibitory concentration (MICs) 0.4 mcg/mL]. This may account for its usefulness in acne. Free fatty acids on the skin surface have been decreased from approximately 14-2% following application of Clodale.

Cross-resistance has been demonstrated between Clodale and lincomycin. Antagonism has been demonstrated between Clodale and erythromycin.

Topical Solution and Lotion:

In addition, Clodale has shown a wide range of in vitro activities that are described in the inserts for oral and parenteral administration.

Clodale has no fungicidal activity.

The in vitro inactive Clodale phosphate is hydrolysed by phosphatases of the skin to active Clodale base.

Pharmacokinetics: Following multiple topical applications of Clodale phosphate at a concentration equivalent to Clodale 10 mg/mL in an isopropyl alcohol and water solution, very low levels of Clodale are present in the serum (0-3 ng/mL) and <0.2% of the dose is recovered in urine as Clodale.

Following multiple topical applications of Clodale phosphate at a concentration equivalent to Clodale 10 mg/g in the gel formulation, 0.053% (morning) and 0.07% (evening) of the administered dose was recovered in the urine as Clodale. Average absolute bioavailability was 1.6% and 2.2% after morning and evening doses, respectively.

Clodale activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of Clodale (10 mg/mL) in an isopropyl alcohol and water solution for 4 weeks was 597 mcg/g of comedonal material (range 0-1,490 mcg/g).

Geriatric Use: Clinical studies for topical Clodale did not include sufficient numbers of subjects ≥65 years to determine whether they respond differently from younger subjects.

Toxicology: Preclinical Safety Data: Carcinogenesis: Long-term studies in animals have not been performed with Clodale to evaluate carcinogenic potential.

Mutagenesis: Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

Impairment of Fertility: Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.1 times the highest recommended adult human dose based on mg/m²) revealed no effects on fertility or mating ability.

In oral embryofetal development studies in rats and SC embryofetal development studies in rats and rabbits, no developmental toxicity was observed except at doses that produced maternal toxicity.

How should I take Clodale?

Before applying Clodale, thoroughly wash the affected areas with warm water and soap, rinse well, and pat dry.

When applying the medicine, use enough to cover the affected area lightly. You should apply the medicine to the whole area usually affected by acne, not just to the pimples themselves. This will help keep new pimples from breaking out.

You should avoid washing the acne-affected areas too often. This may dry your skin and make your acne worse. Washing with a mild, bland soap 2 or 3 times a day should be enough, unless you have oily skin. If you have any questions about this, check with your doctor.

Topical Clodale will not cure your acne. However, to help keep your acne under control, keep using Clodale for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using Clodale every day for months or even longer in some cases. If you stop using Clodale too soon, your symptoms may return. It is important that you do not miss any doses.

For patients using the topical foam form of Clodale:

• After washing or shaving, it is best to wait 30 minutes before applying Clodale. The alcohol in it may irritate freshly washed or shaved skin.
• Clodale contains alcohol and is flammable. Do not use near heat, near open flame, or while smoking.
• To apply Clodale:
  • Do not dispense Clodale topical foam directly onto your hands because the foam will begin to melt on contact with warm skin.
  • Remove the clear cap. Align the black mark with the nozzle of the actuator.
  • Hold the can upright and press firmly to dispense. Dispense amount that will cover the affected area(s) directly into the cap or onto a cool surface.
  • The can may be placed under cold running water if the can seems warm or the foam seems runny.
  • A small amount of topical foam should be picked up with your fingertips and massaged gently into the affected areas until the foam disappears.
  • Unused medicine that was removed from the can should be throw away.
  • Since Clodale contains alcohol, it will sting or burn. In addition, it has an unpleasant taste if it gets on the mouth or lips. Therefore, do not get Clodale in the eyes, nose, or mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If Clodale does get in the eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
• It is important that you do not use Clodale more often than your doctor ordered. It may cause your skin to become too dry or irritated.

For patients using the topical solution form of Clodale:

• After washing or shaving, it is best to wait 30 minutes before applying Clodale. The alcohol in it may irritate freshly washed or shaved skin.
• Clodale contains alcohol and is flammable. Do not use near heat, near open flame, or while smoking.
• To apply Clodale:
  • Clodale comes in a bottle with an applicator tip, which may be used to apply the medicine directly to the skin. Use the applicator with a dabbing motion instead of a rolling motion (not like a roll-on deodorant, for example). Tilt the bottle and press the tip firmly against your skin. If needed, you can make the medicine flow faster from the applicator tip by slightly increasing the pressure against the skin. If the medicine flows too fast, use less pressure. If the applicator tip becomes dry, turn the bottle upside down and press the tip several times to moisten it.
  • Since Clodale contains alcohol, it will sting or burn. In addition, it has an unpleasant taste if it gets on the mouth or lips. Therefore, do not get Clodale in the eyes, nose, or mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If Clodale does get in the eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
• It is important that you do not use Clodale more often than your doctor ordered. It may cause your skin to become too dry or irritated.

For patients using the topical suspension form of Clodale:

• Shake well before applying.

Dosing

The dose of Clodale will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Clodale. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (foam):
  • For acne:
    • Adults and children 12 years of age and over—Apply once a day to areas affected by acne.
    • Infants and children up to 12 years of age—Use and dose must be determined by your doctor.
• For topical dosage forms (gel, solution, and suspension):
  • For acne:
    • Adults and children 12 years of age and over—Apply two times a day to areas affected by acne.
    • Infants and children up to 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of Clodale, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Clodale administration

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water to keep it from irritating your throat.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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.

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.

Store at room temperature away from moisture and heat. Do not store Clodale liquid in the refrigerator.

Clodale pharmacology

Mechanism of Action

Mechanism of action in acne vulgaris is unknown.

Pharmacodynamics

Pharmacodynamics of Clodale Foam is unknown.

Pharmacokinetics

In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of Clodale Foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a Clodale gel, 1%, once daily for five days. On Day 5, the mean Cmax and AUC(0-12) were 23% and 9% lower, respectively, for Clodale Foam than for the Clodale gel, 1%.

Following multiple applications of Clodale Foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

Microbiology

No microbiology studies were conducted in the clinical trials with this product.

Clodale binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clodale has been shown to have in vitro activity against Propionibacterium acnes (P. acnes), an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with Clodale Foam. P. acnes resistance to Clodale has been documented.

Inducible Clodale Resistance

The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in P. acnes as well as other bacteria (e.g. Staphylococcus aureus, Streptococcus pyogenes). The use of Clodale may result in developing inducible resistance in these organisms. This resistance is not detected by routine susceptibility testing.

Cross Resistance

Resistance to Clodale is often associated with resistance to erythromycin.

References

1. 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).
2. NCIt. "Clotrimazole: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
3. NCIt. "Clindamycin: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

Reviews

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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Information checked by Dr. Sachin Kumar, MD Pharmacology