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What is Clinika Gel?
Clinika Gel belongs to the family of medicines called antibiotics.
Topical Clinika Gel 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 Clinika Gel may also be used for other problems as determined by your doctor.
Clinika Gel is available only with your doctor's prescription.
Clinika Gel indications
Clinika Gel Pediatric (Clinika Gel palmitate HCl) is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clinika Gel 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 Clinika Gel 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.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to Clinika Gel.
In Vitro Susceptibility Testing
A standardized disk testing procedure2 is recommended for determining susceptibility of aerobic bacteria to Clinika Gel. A description is contained in the Clinika Gel® Susceptibility Disk (Clinika Gel) 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 Clinika Gel® 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.
Clinika Gel Susceptibility Disks 2 mcg. See package insert for use.
Clinika Gel Susceptibility Powder 20 mg. See package insert for use.
For anaerobic bacteria the minimal inhibitory concentration (MIC) of Clinika Gel 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 Clinika Gel Pediatric and other antibacterial drugs, Clinika Gel Pediatric 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 Clinika Gel?
Use Clinika Gel cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Clinika Gel cream is for vaginal use only.
- Wash your hands before and after using Clinika Gel 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 Clinika Gel cream at bedtime. This will help keep the medicine in the vagina and reduce leaking.
- Clinika Gel cream works best if it is used at the same time each day.
- To clear up your infection completely, use Clinika Gel 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 Clinika Gel 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 Clinika Gel cream.
Uses of Clinika Gel in details
Clinika Gel is used to treat certain bacterial infections including infections of the lungs, skin, blood, female reproductive organs, and internal organs.
Clinika Gel description
Clinika Gel is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.
Clinika Gel phosphate is a water soluble ester of Clinika Gel and phosphoric acid.
Clinika Gel phosphate is L-threo-α-D-galacto-Octopyranoside, methyl 7-chloro-6, 7, 8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-.
The molecular formula is C18H34CIN2O8PS and the molecular weight is 504.96.
Clinika Gel hydrochloride is the hydrated hydrochloride salt of Clinika Gel. Clinika Gel 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.
Clinika Gel palmitate hydrochloride is a water soluble salt of ester of Clinika Gel and palmitic acid. Clinika Gel 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.
Clinika Gel dosage
Clinika Gel phosphate IM administration should be used undiluted.
Clinika Gel phosphate IV administration should be diluted.
Adults: Clinika Gel phosphate (IM or IV administration): The usual daily adult dosage of Clinika Gel phosphate for infections of the intraabdominal area, female pelvis, and other complicated or serious infections is 2400-2700 mg given in 2, 3, or 4 equal doses. Less complicated infections due to more susceptible microorganisms may respond to lower doses such as 1200-1800 mg/day administered in 3 or 4 equal doses.
Doses of up to 4800 mg daily have been used successfully.
Single IM doses of greater than 600 mg are not recommended.
Clinika Gel hydrochloride capsules (oral administration): 600-1800 mg/day divided in 2, 3 or 4 equal doses. To avoid the possibility of esophageal irritation, Clinika Gel HCl capsules should be taken with a full glass of water.
Children (>1 month): Clinika Gel phosphate (IM or IV administration): 20-40 mg/kg/day in 3 or 4 equal doses.
Clinika Gel hydrochloride capsules or Clinika Gel palmitate solution (oral administration): To avoid the possibility of esophageal irritation, Clinika Gel HCl capsules should be taken with a full glass of water. Doses of 8-25 mg/kg/day in 3 or 4 equal doses. In children weighing ≤10 kg, ½ teaspoon (37.5 mg) of Clinika Gel palmitate solution three times a day should be considered the minimum recommended dose.
Neonates (<1 month): Clinika Gel phosphate (IM or IV administration): 15-20 mg/kg/day in 3 or 4 equal doses. The lower dosage may be adequate for small premature infants.
Elderly: Pharmacokinetic studies with Clinika Gel 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. Therefore, dosage adjustments are not necessary in the elderly with normal hepatic function and normal (age-adjusted) renal function.
Renal Impairment: Clinika Gel dosage modification is not necessary in patients with renal insufficiency.
Hepatic Impairment: Clinika Gel dosage modification is not necessary in patients with hepatic insufficiency.
Indications:Treatment of Beta-Hemolytic Streptococcal Infections: Refer to the dosage recommendations above under Dosage in Adults, Dosage in Children and Dosage in Neonates. Treatment should be continued for at least 10 days.
Inpatient Treatment of Pelvic Inflammatory Disease: Clinika Gel phosphate 900 mg (IV) every 8 hrs daily plus an antibiotic with an appropriate gram negative aerobic spectrum administered IV, eg, gentamicin 2 mg/kg followed by 1.5 mg/kg every 8 hrs daily in patients with normal renal function. Continue (IV) drugs for at least 4 days and at least 48 hrs after the patient improves. Then continue oral Clinika Gel hydrochloride 450-600 mg q6h daily to complete 10-14 days total therapy. Treatment of Chlamydia trachomatis Cervicitis: Clinika Gel hydrochloride capsules orally 450-600 mg 4 times daily for 10-14 days.
Treatment of Toxoplasmic Encephalitis in Patients with AIDS: Clinika Gel phosphate IV or Clinika Gel hydrochloride orally 600-1200 mg every 6 hrs for 2 weeks followed by 300-600 mg orally every 6 hrs. The usual total duration of therapy is 8 to 10 weeks. The dose of pyrimethamine is 25 to 75 mg orally each day for 8 to 10 weeks. Folinic acid 10 to 20 mg/day should be given with higher doses of pyrimethamine.
Treatment of Pneumocystis carinii Pneumonia in Patients with AIDS: Clinika Gel phosphate IV 600 to 900 mg every 6 hrs or 900 mg IV every 8 hrs or Clinika Gel hydrochloride 300 to 450 mg orally every 6 hrs for 21 days and Primaquine 15 to 30 mg dose orally once daily for 21 days. Treatment of Acute Streptococcal Tonsillitis/Pharyngitis: Clinika Gel hydrochloride capsules 300 mg orally twice daily for 10 days.
Treatment of Malaria: Clinika Gel hydrochloride capsules or Clinika Gel palmitate solution (oral administration).
Uncomplicated Malaria/P. falciparum: Adults: Quinine sulfate: 650 mg orally three times daily for 3 or 7 days plus Clinika Gel: 20 mg base/kg/day orally divided three times daily for 7 days. Children: Quinine sulfate: 10 mg/kg orally three times daily for 3 or 7 days plus Clinika Gel: 20 mg base/kg/day orally divided three times daily for 7 days.
Severe Malaria: Adults: Quinidine gluconate: 10 mg/kg loading dose IV over 1-2 hrs, then 0.02 mg/kg/min continuous infusion for at least 24 hrs (for alternative dosing regimen please refer to quinidine label). Once parasite density <1% and patient can take oral medication, complete treatment with oral quinine, dose as above, plus Clinika Gel: 20 mg base/kg/day orally divided three times daily for 7 days. If patient not able to take oral medication, give 10 mg base/kg Clinika Gel loading dose IV followed by 5 mg base/kg IV every 8 hrs. Avoid rapid IV administration. Switch to oral Clinika Gel (oral dose as above) as soon as patient can take oral medication. Treatment course=7 days.
Children: Quinidine gluconate: Same mg/kg dosing and recommendations as for adults plus Clinika Gel: 20 mg base/kg/day orally divided three times daily for 7 days. If patient not able to take oral medication, give 10 mg base/kg Clinika Gel loading dose IV followed by 5 mg base/kg IV every 8 hrs. Avoid rapid IV administration. Switch to oral Clinika Gel (oral dose as above) as soon as patient can take oral medication. Treatment course=7 days.
Prophylaxis of Endocarditis in Patients Sensitive to Penicillin: Clinika Gel hydrochloride capsules or Clinika Gel palmitate solution (oral administration).
Adults: 600 mg 1 hr before procedure; children: 20 mg/kg 1 hr before procedure. Alternatively, when parenteral administration is required: Clinika Gel phosphate 600 mg IV 1 hr before procedure. Prophylaxis of Infection in Head and Neck Surgery: Clinika Gel phosphate 900 mg diluted in 1000 mL normal saline for use as an intraoperative irrigant in contaminated head and neck surgery prior to wound closure.
Dilution and IV Infusion Rates: The concentration of Clinika Gel in diluent for infusion should not exceed 18 mg/mL and infusion rates should not exceed 30 mg per minute. The usual infusion rates are as follows:.
Administration of >1200 mg in a single 1-hr infusion is not recommended.
Clinika Gel interactions
With simultaneous use of Clinika Gel 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, Clinika Gel and chloramphenicol (antagonism).
Clinika Gel 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 Clinika Gel 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.
Clinika Gel side effects
Clinical Study Experience
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 practice.
The data described below reflect exposure to Clinika Gel (Clinika Gel phosphate) in 368 patients. Clinika Gel (Clinika Gel phosphate) was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20). The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. Patient demographics in the trials were 51% Caucasian, 36% Black, 10% Hispanic, and 3% Asian, other or unknown. All patients received 100 mg Clinika Gel phosphate cream intravaginally in a single dose.
Of the 368 women treated with a single dose of Clinika Gel (Clinika Gel phosphate), 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clinika Gel (Clinika Gel phosphate) and in 32 of 85 patients (38%) treated with placebo.
Adverse reactions occurring in ≥ 1% of patients receiving Clinika Gel (Clinika Gel phosphate) in the three clinical studies are shown in Table 1.
Table 1: Adverse Reactions Occurring in ≥ 1% of Clinika Gel (Clinika Gel phosphate) -Treated Patients and at a Higher Rate than Placebo-Treated Patients
|Adverse Event||Clinika Gel (Clinika Gel phosphate) |
|Vaginosis fungal NOS*||52 (14)||7 (8)|
|Headache NOS||10 (3)||2 (2)|
|Back pain||6 (2)||1 (1)|
|Constipation||4 (1)||0 (0)|
|Urinary tract infection NOS||4 (1)||0 (0)|
|N = number of patients in intent-to-treat population |
n (%) = number and percentage of patients with reported adverse reaction
NOS = not otherwise specified
* The use of Clinika Gel may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment
Other reactions reported by < 1% of those women treated with Clinika Gel (Clinika Gel phosphate) include:
Dermatologic: Pruritic rash
Gastrointestinal: Diarrhea, vomiting
Immune System: Hypersensitivity
Nervous System: Dizziness
Reproductive System: Dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema<, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitis
Other Clinika Gel Formulations
Clinika Gel (Clinika Gel phosphate) affords minimal peak serum levels and systemic exposure (AUCs) of Clinika Gel compared to an oral or intravenous dose of Clinika Gel. Data from well-controlled trials directly comparing Clinika Gel administered orally to Clinika Gel administered vaginally are not available.
The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of Clinika Gel:
Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridium difficile-associated diarrhea
Hematopoietic: Transient neutropenia (leukopenia), eosinophilia, agranulocytosis, and thrombocytopenia have been reported. No direct etiologic relationship to concurrent Clinika Gel therapy could be made in any of these reports.
Hypersensitivity Reactions: Maculopapular rash, vesiculobullous rash, and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with Clinika Gel. A few cases of anaphylactoid reactions have been reported.
Liver: Jaundice and abnormalities in liver function tests have been observed during Clinika Gel therapy.
Musculoskeletal: Cases of polyarthritis have been reported.
Renal: Although no direct relationship of Clinika Gel to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.
The following adverse reactions have been identified during postapproval use of Clinika Gel (Clinika Gel phosphate). 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.
Reproductive System: Vaginal erythema, vulvovaginal pruritis, vaginal discharge, vaginal swelling, vaginal bleeding, vaginal pain
Clinika Gel contraindications
You should not use this medication if you are allergic to Clinika Gel or lincomycin (Bactramycin, L-Mycin, Lincocin).
Do not take Clinika Gel together with erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others).
Before using Clinika Gel, 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. Clinika Gel 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 Clinika Gel 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 Clinika Gel. You may need to stop using the medicine for a short time.
Active ingredient matches for Clinika Gel:
Clindamycin in Indonesia.
|Unit description / dosage (Manufacturer)||Price, USD|
|Clinika Gel 1 % x 10 g x 1's||$ 1.92|
List of Clinika Gel substitutes (brand and generic names):
|Clinika 1 % x 30 mL x 36's (Ikapharmindo)||$ 3.84|
|Clinimycin (Bahrain, Ireland)|
|Clinmas 150 mg x 30's (Lapi)||$ 9.86|
|Clinmas 300 mg x 30's (Lapi)||$ 16.74|
|Clinmax (Hong Kong, India)|
|Clinmax Skin 15 gm Gel (Palsons Drugs & Chemical Industries)||$ 0.99|
|CLINMAX 1% W/W GEL 1 tube / 20 GM gel each (Palsons Drugs & Chemical Industries)||$ 1.68|
|CLINMAX topical gel 1 % w/v x 20g (Palsons Drugs & Chemical Industries)||$ 1.38|
|Clinmax 1% w/w Gel (Palsons Drugs & Chemical Industries)||$ 1.68|
|Clinmide Clindamycin 1 % w/w, Nicotinamide 4 % w/w. GEL / 10g (Moraceae Pharmaceuticals (P) Ltd.)||$ 1.11|
|10g (Moraceae Pharmaceuticals (P) Ltd.)||$ 1.11|
|Clinmide Skin 10 gm Gel (Moraceae Pharmaceuticals (P) Ltd.)||$ 1.03|
|CLINMIDE 1%/4% GEL 1 tube / 10 GM gel each (Moraceae Pharmaceuticals (P) Ltd.)||$ 1.19|
|CLINMIDE topical gel 10g (Moraceae Pharmaceuticals (P) Ltd.)||$ 1.11|
|Clinmide 1%/4% Gel (Moraceae Pharmaceuticals (P) Ltd.)||$ 1.19|
|Clinof 1% w/w GEL / 20g (Intermed)||$ 0.87|
|1 % w/w x 20g (Intermed)||$ 0.87|
|Clinof Skin 20 gm Gel (Intermed)||$ 0.87|
|CLINOF GEL 1 tube / 20 GM gel each (Intermed)||$ 0.85|
|CLINOF topical gel 1 % w/w x 20g (Intermed)||$ 1.03|
|Clinof NA Gel (Intermed)||$ 0.85|
|Clinott -P 150 mg/1 mL x 2 mL (MacroPhar)|
|Clinott -P 150 mg/1 mL x 4 mL (MacroPhar)|
|Clinott 150 mg x 10 x 10's (MacroPhar)|
|Clinott 300 mg x 10 x 10's (MacroPhar)|
|Clinott cap 150 mg 10 x 10's (MacroPhar)|
|Clinott cap 300 mg 10 x 10's (MacroPhar)|
|Clinott-P inj 150 mg/mL 2 mL x 1's (MacroPhar)|
|Clinott-P inj 150 mg/mL 4 mL x 1's (MacroPhar)|
|Clinott-P inj 150 mg/mL 6 mL x 1's (MacroPhar)|
|Clinox 1% w/w T-GEL / 10g (Will Impex)||$ 0.63|
|CLINOX topical gel 1 % w/w x 10g (Will Impex)||$ 0.63|
|Clinox-N Clindamycin 1 % w/w, nicotinamide 4 % w/w. T-GEL / 15g (Will Impex)||$ 1.19|
|CLINOX-N topical gel 15g (Will Impex)||$ 1.19|
|Clinred 1% T-GEL / 20g (Encore)||$ 1.41|
|CLINRED GEL 1 tube / 20 GM gel each (Encore)||$ 1.41|
|CLINRED topical gel 1 % x 20g (Encore)||$ 1.41|
|Clinred 1% w/w Gel (Encore)||$ 1.54|
|Clinscar 1% w/w GEL / 10g (Intra Labs India Pvt Ltd)||$ 0.71|
- PubChem. "clindamycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "clindamycin". http://www.drugbank.ca/drugs/DB01190 (accessed September 17, 2018).
- MeSH. "Protein Synthesis Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Clinika Gel 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 Clinika Gel. 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.
Consumer reported usefulNo survey data has been collected yet
Consumer reported price estimatesNo survey data has been collected yet
Consumer reported time for resultsNo survey data has been collected yet
Consumer reported ageNo survey data has been collected yet
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Information checked by Dr. Sachin Kumar, MD Pharmacology