Description overdue on 07/31/2014
- Latin name: Controloc
- ATC code: A02BC02
- Active substance: Pantoprazole (Pantoprazole)
- Manufacturer: NYCOMED, GmbH (Germany)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Kontrolok, instructions for use (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Synonyms
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Because the drug may have the form of a powder or tablet, the drug will depend on its form of production, the nominal volume.
The chemical composition of one tablet Kontroloka coated specific enteric coating may contain 22, 57 mg. 45 or 1 mg. active drug action pantoprazole sodium sesquihydrate.
In addition, in its composition preparation contains auxiliary substances such as purified water, anhydrous sodium carbonate, calcium stearate, mannitol, povidone K90, crospovidone as well.
The composition of the shell medicament contains: hypromellose 2910, yellow iron oxide (E172), titanium dioxide (E171), povidone K25, propylene glycol and triethyl citrate, and Eudragit L 30D-55, which is polysorbate 80, sodium lauryl sulfate, obtained by reaction of ethyl acrylate and methacrylic acid copolymer.
For coating the tablet markings using specialized ink brown which contain soy lecithin, titanium dioxide (E171), emulsion of polydimethylsiloxane (Dimethicone 1510), red iron oxide (E172) CL 77491, as well as black and yellow iron oxide (CL 77499 and CL 77492 respectively).
In chemical composition one vial powder Kontrolok, intended for solution preparation, is contained 45, 1 mg. active compound pantoprazole sodium sesquihydrate . As auxiliary compounds in the manufacture of a medicament sodium hydroxide is used (0, 24 mg.) And disodium edetate (1 mg.).
Product form
Kontrolok produced in the form of tablets, which have a lenticular shape and a special coating enteric coating . The core of the tablet is almost transparent white and shell - yellow. On top of the drug in brown ink marking indicating the dosage in milligrams "P20" or "P40".
The carton may contain 3, 4, or 1 to 5 respectively blister or 7 tablets each, and one or two blisters 14 tablets each.
The powder Kontrolok, intended for preparation of solution for internal administration , Is a dry substance of white color. Generally, powdered medicament compound is packaged into vials.
Pharmacological action
The drug has the inhibitory effect of proton pump .
Pharmacodynamics and pharmacokinetics
Due to the presence of the drug pantoprazole Compounds having the ability to influence the gastric secretion, promotes Kontrolok proton pump inhibition of parietal cells. If you get of pantoprazole in acidic medium, the compound goes into its active form, and starts a process oppression of hydrochloric acid .
It should be noted that active pharmaceutically active compound affects hydrochloric acid in the final stages of its allocation, regardless of the origin of the stimulus. The drug has a positive effect on basal gastric acid secretion.
In result under the influence pantoprazole reduced level acidity in the digestive tract That stimulates increased production gastrin . The drug is absorbed quickly enough by the digestive system, and even after a single application reaches the necessary optimal dose for treatment in humans. With further reception Kontroloka concentration actively acting compound as an organism does not varies and stored at the level in 1, 5 mcg / ml.
It is rare, but the drug compound can induce raising endocrine cells in the stomach. However, this occurs only after prolonged treatment with therapeutic Kontroloka. It is noteworthy that pharmacokinetics It remains the same as in Oral application And when intravenous medicinal compounds.
The effectiveness of the drug varies depending on dosage, but the average antisecretory effect It is reached, usually after a maximum of 4 hours and continued for the next day. When treating duodenal ulcer Induced Gram negative bacteria type Helicobacter pylori , The drug reduces gastric secretion And significantly increases the sensitivity of harmful microorganisms to antibiotics.
Kontrolok has no effect on the motility of the gastrointestinal tract. Metabolization of drug compound in the liver, about 80% pantoprazole excreted in the kidney and 20% excreted in the feces. Taking the drug with food did not affect the concentration of the active compound in the body.
As compared with similar drugs Kontrolok having neutral pH It differs most chemical stability and has the least adverse impact on the oxidase system liver Directly dependent on P450 . For this reason, the drug compound does not interact with other preparatami- proton pump inhibitors .
Indications
Kontrolok recommended for use in the presence of:
- non-erosive reflux disease (NERD) ;
- gastroezofagenalnoy reflux disease (GERD);
- erosive reflux esophagitis;
- duodenal ulcers and stomach Including exacerbation;
- eradication of Helicobacter pylori;
- erosive gastritis , Including those caused by NSAID;
- Zollinger-Ellison .
The medicament in powder form is generally used in the treatment and prevention:
- complications caused ulcer For example, when perforations or krovotecheniyah ;
- stressful of ulcers .
Contraindications
The drug is not recommended for use in dyspepsia neurotic origin, as well as hypersensitivity or intolerance to individual components of the drug compound. Kontrolok not recommended for use for children under 18 years of age, as well as during pregnancy and lactation. In addition, the drug may not be used in conjunction with atazanavir.
Side effects
When using Kontroloka may experience the following side effects:
- dizziness;
- headache;
- diarrhea or constipation;
- nausea;
- bloating;
- allergic reaction Expressed as itching and burning, skin rash, angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, and photosensitivity ;
- blurred vision;
- myalgia;
- depression;
- disorientation;
- liver cell damage;
- fever;
- peripheral edema;
- increase the level TG , and liver enzymes .
The above side effects of the drug are rare and disappear, usually after drug withdrawal.
Kontrolok, instructions for use (method and dosage)
In accordance with the instructions on Kontrolok, the drug in tablet form taken orally, washed down with plenty of water. While a meal or day does not have any decisive influence on the effectiveness of the impact of the drug to achieve the best result of treatment, doctors recommend that a certain dosage schedule that will vary depending on the type of disease and its severity.
For example, when duodenal ulcer or gastric And when erosive gastritis Kontrolok take 80 mg. a day for two weeks. In the acute form of diseases the drug can last from four to eight weeks.
With eradication of the bacterium Helicobacter pylo type r i drugs taken 2 times a day, morning and evening before the meal 1 tablet (20 mg.) together with 1,000 mg. Amoxicillin and 500 mg. clarithromycin . In this case, the treatment lasts for more than two weeks.
As of anti-money and during treatment reflux esophagitis Kontrolok take 20-40 mg. (respectively) per day for four to eight weeks.
In the course of therapeutic treatment hypersecretory states , and Zollinger-Ellison drug taking 80 mg. per day. The same dosage of the drug used in the prophylaxis and treatment of ulcers Aggravated due to stress.
In Kontrolok powder applied if necessary administration of the drug intravenously. To prepare the drug for injection saline solution (10 ml.) Was added to the vial with a dry substance. In some cases, the powder is added in addition to saline atria chloride and glucose solution (5%).
Important to use solution was for administration medicines intravenously within not more than 3 chasov after cooking. PH Level the solution should be equal to nine.
Overdose
Total application Kontroloka overdoses were reported. Kontrolok not used in hemodialysis .
Cooperation
When using the drug together with the drugs, which responds to pH gastric environment, e.g., Ketoconazole or iron, reduced absorption of the active compounds identified above. Appoint Kontrolok and use without the risk of complications is possible in conjunction with such drugs as:
- Digoxin, metoprolol, nifedipine in the presence of diseases of the cardiovascular system;
- oral contraceptives , Composed of ethinylestradiol and levonorgestrel ;
- Group NSAID medicines , eg, Fenazol, piroxicam or diclofenac;
- Levothyroxine, glibenclamide endocrine diseases;
- Phenytoin and Carbamazepine at epilepsy ;
- Diazepam at sleep disorders;
- Phenprocoumon, warfarin (indirect anticoagulants);
- Tacrolimus and Cyclosporine when recovering transplantation.
Terms of sale
A doctor's prescription is required, except Kontrolok tablets (20 mg.), Which refer to drugs without prescription from pharmacies.
Storage conditions
The drug should be stored out of reach of children at a temperature of 25 ° C.
Shelf life
3 years.
Cautions
Before you start using direct Kontroloka in tablet form should undergo a medical examination and to exclude the presence of malignancy . Using Kontroloka may hinder early diagnosis of symptoms of cancer.
The preparation in powder form is recommended for use only in those cases where it is not possible to use the tablets Kontrolok. This medicine is not intended for use in the event of minor ailments of the digestive tract.
Elderly patients suffering violations renal function First, it is important to follow the dosing regimen.
Patients with severe forms renal failure, should be used in the treatment of minimal dosage formulation.
During treatment should monitor the Kontrolokom liver enzymes patients, in case a sharp increase in their amount of use of the drug to terminate.
Prior to the use of the drug and after treatment, experts recommend to go endoscopic control To timely detect the presence of malignancies d.
Analogs Kontroloka
Losek MAPS
Losek
Sanpraz
Emanera
Omez
Insta omez
Rabeprazole
Ortanol
Nexium
Nolpaza
Geerdin
Omeprazole
Lansoprazole
Kontroloka analogs are the following drugs:
- Nolpaza;
- Zipantola;
- Panum;
- Pantazi;
- Peptazol;
- Sanpraz.
Synonyms
Controloc, Kontrolok control
Babies
The drug is not recommended for people under 18 of age.
During pregnancy (and lactation)
Kontrolok is not worth use during a pregnancy and breastfeeding .
Reviews about the Kontroloke
Patients using the drug for treating ulcerous of illnesses, of gastritis and other diseases of the digestive tract is left, usually Kontroloke positive feedback on the forums. According to them, the drug is really effective to cope with the symptoms of ailments and quickly relieves eliminating heartburn . severity, and abdominal pain , Thus rarely causing unpleasant side effects.
Price Kontroloka where to buy
The cost of the drug varies depending on the form of and nominal volume.
Price Kontroloka 20 mg. (14 tablets per pack) on average no more than 700 rubles.
Price Kontroloka 40 mg. (14 tablets per pack) hovers around 800-900 rubles.
One vial of powder for solution for intravenous injection costs about 350 rubles.
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