Clinika Gel Actions

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Actions of Clinika Gel in details

infoThe action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Pharmacodynamics: Although Clinika Gel phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the antibacterially active Clinika Gel. Clinika Gel 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 Clinika Gel.

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

Topical Solution and Lotion:

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

Clinika Gel has no fungicidal activity.

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

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

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

Clinika Gel activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of Clinika Gel (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 Clinika Gel 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 Clinika Gel 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 Clinika Gel?

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

For patients using the topical foam form of Clinika Gel:

  • After washing or shaving, it is best to wait 30 minutes before applying Clinika Gel. The alcohol in it may irritate freshly washed or shaved skin.
  • Clinika Gel contains alcohol and is flammable. Do not use near heat, near open flame, or while smoking.
  • To apply Clinika Gel:
    • Do not dispense Clinika Gel 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 Clinika Gel 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 Clinika Gel in the eyes, nose, or mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If Clinika Gel 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 Clinika Gel 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 Clinika Gel:

  • After washing or shaving, it is best to wait 30 minutes before applying Clinika Gel. The alcohol in it may irritate freshly washed or shaved skin.
  • Clinika Gel contains alcohol and is flammable. Do not use near heat, near open flame, or while smoking.
  • To apply Clinika Gel:
    • Clinika Gel 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 Clinika Gel 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 Clinika Gel in the eyes, nose, or mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If Clinika Gel 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 Clinika Gel 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 Clinika Gel:

  • Shake well before applying.

Dosing

The dose of Clinika Gel 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 Clinika Gel. 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 Clinika Gel, 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.

Clinika Gel administration

infoAdministration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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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. Clinika Gel 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 Clinika Gel. You may need to stop using the medicine for a short time.

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

Clinika Gel pharmacology

infoPharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Although Clinika Gel phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the active antibiotic Clinika Gel. Clinika Gel inhibits bacterial protein synthesis by binding to the 50S subunit of ribosomes. Clinika Gel in vitro inhibits Propionibacterium acnes.

Bacterial resistance may develop to Clinika Gel. Resistance to Clinika Gel may be associated with resistance to erythromycin. Also, cross-resistance has been demonstrated between Clinika Gel and lincomycin. Following multiple topical applications of Clinika Gel phosphate at a concentration equivalent to 10 mg per mL in an isopropyl alcohol and water solution, very low levels of Clinika Gel are present in the serum (0-3 ng/mL) and less than 0.2% of the dose is recovered in urine as Clinika Gel.

Microbiology

Clinika Gel is active against anaerobic gram-positive bacilli such as Corynebacteria but resistant subspecies of Clostridium may occur. Aerobic gram-negative bacteria are nearly all resistant to Clinika Gel. In-vitro susceptibility of P. acnes and related species to Clinika Gel is shown in Table 3.

Table 3: In-vitro susceptibility of P. acnes and related species to Clinika Gel (Hoeffler et al, 1976)

Species No. of strains Cumulative % of strains inhibited at MICs (mg/L)
<0.02 0.04 0.1 0.2 0.4
P.acnes 38 - 34 87 95 100
P.granulosum 15 7 87 93 100 -
P.avidum 16 - 56 69 81 100
C.minutissimum 3 - - - 100 -
C.parvum 1 - - - 100 -

Resistant strains of P. acnes (MIC ≥0.5mg/mL), reaching 48% in certain areas of the world, have been reported in recent years. Calculated Clinika Gel concentrations representing about of 600 mg/L in the epidermis have been reported following the topical application of Clinika Gel phosphate;">Pharmacology). Cross-resistance has been demonstrated between Clinika Gel and lincomycin. Cross resistance between Clinika Gel and erythromycin has also been identified.

In one study involving human volunteers who used an alcoholic topical 1% Clinika Gel phosphate solution for eleven days, average P. acnes counts were reduced by 81%. Concurrent measurement of free fatty acid levels did not show significant changes over time.

Pharmacology

Topical Clinika Gel phosphate seems less prone to be systemically absorbed than Clinika Gel hydrochloride. In one study involving humans it was found that less than 1% of a 20 mg dose (1 mL b.i.d.; 0.25 mg/kg/day) of Clinika Gel phosphate was absorbed and peak serum levels of only 1.7 ng/mL were reached. The vehicle used in this study was unspecified.

Clinika Gel was not detected in urine samples from patients who used topical 1% Clinika Gel phosphate solution (50% v/v isopropyl alcohol) b.i.d. for eight weeks. If systemic absorption of Clinika Gel occurred, the amount excreted in urine was below the bioassay detectable limits of 0.25 ng/mL.

Extracted comedones from twenty subjects treated for four weeks with topical 1% Clinika Gel phosphate solution (50% v/v isopropyl alcohol) were assayed for free Clinika Gel. Comedones in 18 subjects contained Clinika Gel. In those comedones, the mean Clinika Gel content was 0.60 μg/mg; corresponding to the mean epidermis Clinika Gel concentration of approximately 600 mg/L.

Clinika Gel concentrations in the mother, umbilical cord and neonate were assayed in 54 caesarean section human patients receiving perioperative Clinika Gel and gentamicin for prophylaxis. Each patient received 5.5 to 11.1 mg/kg of intravenous Clinika Gel. A half hour after the injection, the average level of Clinika Gel in the mother’s blood was around 5.5 mg/L and gradually declined over six to eight hours. About twenty minutes after the injection, the peak concentration of Clinika Gel in the venous blood of the umbilical cord was 3 mg/L. Neonatal venous blood concentrations of Clinika Gel during the first six hours of life were below 2 mg/L. Amniotic fluid samples obtained thirty and sixty minutes after injection showed no antibiotics.

Toxicology

Acute Animal Toxicity

The systemic acute toxicity of Clinika Gel phosphate and Clinika Gel hydrochloride has been extensively studied in mice and rats. Results from these studies are summarized in Table 4.

Table 4: Acute toxicity of Clinika Gel

Species Treatment Route LD Observations
Mouse (ICR line white Swiss, 20 g) Clinika Gel HCl ip 361 mg/kg Depression and convulsions, death

occurred 15 min to 4 days

depending on the dose

iv 245 mg/kg Depression and convulsions, death

occurred 1-2 min after dose.

Rat (young adult TUC/SD, 175 g) Clinika Gel HCl po 2618 mg/kg Death in 1 to 2 days after

treatment.

Rat (adult TUC/SD, 400 g) Clinika Gel HCl sc 2618 mg/kg Death in 1 to 2 days after

treatment.

Rat (newborn TUC/SD, 6 g) Clinika Gel HCl sc 245 mg/kg
Rat (adult TUC/SD) Clinika Gel phosphate sc >2000 mg/kg
Rat (newborn TUC/SD) Clinika Gel phosphate sc 179 mg/kg

Chronic Animal Toxicity

Chronic toxicity of Clinika Gel phosphate and Clinika Gel hydrochloride has been studied in a number of animal species. Results from these studies are summarized in Table 5.

Table 5: Chronic toxicity of Clinika Gel

Species Treatment Route Length Results
1. Chronic Toxicity
Rat (Sprague - Dawley) n=10M Clinika Gel phosphate

120 mg/kg once daily

sc 6 days SUBCUTANEOUS TOLERANCE Body

weight and food conversion were regarded as comparable to the control group. Normal haematology and necropsy.

Rat (Sprague - Dawley) n=5M, 5F/ group Clinika Gel phosphate

30, 60, 90 mg/kg once

daily

sc 1 month SUBCUTANEOUS TOLERANCE 30 mg/kg

for 30 days produced low grade

inflammatory changes and were

accompanied by focal necrosis. No

systemic effects.

Dogs n=4/group Clinika Gel phosphate

60, 120 mg/kg 6 days a

week twice daily

iv 1 month INTRAVENOUS TOLERANCE No drug related effects and no deviation among the hemogram, blood chemistry and urinalyses were observed. There was no difference in

haemolysis between treated dogs and

control dogs. In Heinz body formation or

increased fragility of erythrocytes were

observed in blood samples of treated

animals.

2. Dermal Toxicity
Rat n=10/group Clinika Gel phosphate 3% aqueous solution,

Dose: 50 to 72 mg/kg

Topical,

abraded

and intact

skin

22 days No skin changes, abrasions healed

normally, females larger increase in body weight by 31.1% and 19.8% (abraded),

haematology and organ weights normal.

Syrian Hamster

n= 7/ group

Clinika Gel HCl 0.1, 1, 10, 40 mg/day; 0.01

mg/day with and without 0.1% tretinoin

Topical

2 weeks

or less

All hamsters given 40,10 and 1 mg died in less than 2 weeks, 50% mortality 0.1 mg, no mortality 0.01mg, mortality associated with

clostridial toxin in cecal contents

Pig n=6 (one group) Clinika Gel HCl 3% Aq. solution, Dose: 7.33 to

10.26 mg/kg

Topical

22 days No irritation
3. Photo toxicity
Rats n=10M, 10F/group Clinika Gel HCl 0, 30, 100, 300, 600 mg/kg/day;

exposed to sunlight once

for 2.75 hr

po 8

months

No photo toxic reactions, excessive

exposure produced severe periorbital

inflammation in all groups

Teratology

Teratological studies were not conducted with Clinika Gel (Clinika Gel phosphate pledget).

Subcutaneous injections of Clinika Gel phosphate at 100 and 180 mg/kg/day (aqueous solution) on gestation days six through fifteen in ICR and CF1 mice and Sprague- Dawley rats had no detrimental effects on the litter weight, number of live and dead pups per litter and the number of resorptions per litter. Fetuses of rats and DV1 mice showed no sign of teratogenic activity as evidenced by examination for gross external, visceral and skeletal malformations. In fetus of ICR mice, a low incidence of cleft palate was observed. The incidence of cleft palate in the Clinika Gel phosphate treated litter was not significantly different from the incidence reported in the control litter.

Bibliography

Crawford, W.W., et al., Laboratory Induction and Clinical Occurrence of Combined Clinika Gel and Erythromycin Resistance in Corynebacterium acnes, J. Invest. Dermatol. 1979;72:187-190.

Guin, J.D., and W.L., Lummis Comedonal Levels of Free Clinika Gel Following

Topical Treatment with a 1% Solution of Clinika Gel Phosphate,

J. Am. Acad Dermatol. 1982;7:265-268.

Guin, G.D.,

Topical Clinika Gel: A Double-Blind Study Comparing Clinika Gel Phosphate with Clinika Gel Hydrochloride, Int. J. Dermatol. 1979;18:164-166.

Kuhlman DS, Callen JP. A Comparison of Clinika Gel phosphate 1 percent topical lotion and placebo in the treatment of acne vulgaris. Cutis 1986; Sept: 203-206.

Leigh DA. Antibacterial Activity and Pharmacokinetics of Clinika Gel. J Antimicrobial Chemotherapy 1981;7 Suppl A: 3-9.

Parry, M.F. and C.K. Rha, Pseudo membraneous Colitis Caused by

Topical Clinika Gel Phosphate

Arch Dermatol 1986;122:583-584.

Weinstein, A.J., et al., Placental transfer of Clinika Gel and gentamicin in term pregnancy, AM.J. Obstet. Genecol.1976; 124: 688-69.



References

  1. 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).
  2. EPA DSStox. "Clindamycin: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).

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