Controlok - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Controlok

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 230 rubles.

Buy

Controlok is a drug that helps to reduce the secretion of the gastric glands.

Release form and composition

Controlok is produced in the following dosage forms:

• Enteric-coated tablets: biconvex, oval, yellow film-coated, with an almost white to white core; on one side - marking in brown ink (tablets of 20/40 mg) "P20" or "P40" (5 pcs. in blisters, 3 blisters in a cardboard box; 7 pcs. in blisters, 1, 4 blisters each) in a cardboard box; 14 pcs. in blisters, 1, 2 blisters in a cardboard box);
• Powder for preparation of a solution for intravenous administration: an almost white or white dry substance (in vials, 1 bottle in a cardboard box).

The composition of 1 tablet includes:

• Active ingredient: pantoprazole - 20 or 40 mg (in the form of pantoprazole sodium sesquihydrate - 22.57 or 45.1 mg);
• Auxiliary components: anhydrous sodium carbonate - 5/10 mg, crospovidone - 25/50 mg, mannitol - 21.33 / 42.7 mg, povidone K90 - 2/4 mg, calcium stearate - 1.6 / 3.2 mg, purified water - 4.5 / 9 mg.

The composition of the shell (tablets of 20/40 mg, respectively): hypromellose 2910 - 11.88 / 19 mg, povidone K25 - 0.24 / 0.38 mg, titanium dioxide (E171) - 0.21 / 0.34 mg, dye iron oxide yellow (E172) - 0.02 / 0.03 mg, propylene glycol - 2.66 / 4.25 mg, eudragit L30D-55 - 8.18 / 14.56 mg (ethyl acrylate and methacrylic acid copolymer [1: 1] - 7.94 / 14.13 mg, polysorbate 80 - 0.18 / 0.33 mg, sodium lauryl sulfate - 0.06 / 0.1 mg), triethyl citrate - 0.82 / 1.45 mg.

Composition of Opacode S-1-16530 brown ink for marking on tablets: shellac (shellac) - 0.036 mg, concentrated ammonia solution 25% - 0.001 mg, dyes (iron oxide red (E172) - 0.009 mg, iron oxide black (E172)) - 0.009 mg, iron oxide yellow (E172) - 0.0009 mg).

The composition of 1 bottle for preparation of solution for injection includes:

• Active ingredient: pantoprazole - 40 mg (in the form of pantoprazole sodium sesquihydrate - 45.1 mg);
• Auxiliary components: disodium edetate - 1 mg, sodium hydroxide - 0.24 mg.

Indications for use

• Mild gastroesophageal reflux disease in adults, including heartburn, nausea, sour belching (symptomatic treatment);
• Peptic ulcer of the stomach and duodenum (with exacerbation), erosive gastritis (including those associated with the use of non-steroidal anti-inflammatory drugs);
• Zollinger-Ellison syndrome;
• Eradication of Helicobacter pylori (along with antibacterial drugs).

Contraindications

• Dyspepsia of neurotic genesis;
• Concomitant use with atazanavir;
• Age under 18;
• Pregnancy and lactation;
• Hypersensitivity to the components of the drug, as well as to soy.

Method of administration and dosage

Controls in the form of tablets are taken orally before meals with a sufficient amount of liquid. The tablets should not be chewed or crushed.

The dosage regimen is determined by the indications.

When treating symptoms of gastroesophageal reflux disease (such as nausea, heartburn, sour belching), occurring with a mild degree of severity, adults are prescribed 20 mg of Controlok inside. As a rule, positive dynamics is achieved within 2-3 days of taking the drug, however, to completely eliminate the symptoms, therapy is usually continued for 7 days. If in the first 3 days of treatment the condition worsens, as well as in cases of no improvement with continuous use of Controloc for 14 days, you should consult your doctor.

In case of gastric ulcer and duodenal ulcer and erosive gastritis (including those associated with the use of non-steroidal anti-inflammatory drugs), Controlok is prescribed in a daily dose of 40-80 mg. In case of exacerbation of duodenal ulcer, the course of therapy is 14 days, stomach - 4-8 weeks. To prevent the development of recurrence of gastric ulcer and duodenal ulcer, the drug is taken at 20 mg per day.

For the eradication of Helicobacter pylori, Controloc in a single dose of 20-40 mg is recommended to be used simultaneously with the following drugs (single dose):

• Amoxicillin - 1000 mg, clarithromycin - 500 mg;
• Metronidazole - 500 mg, clarithromycin - 500 mg;
• Amoxicillin - 1000 mg, metronidazole - 500 mg.

The frequency of use of all drugs is 2 times a day. The duration of the therapeutic course is 1-2 weeks.

With Zollinger-Ellison syndrome, Controloc is prescribed in a daily dose of 40-80 mg.

In patients with severe functional disorders of the liver, the dose is reduced to 40 mg 1 time in 2 days, while it is necessary to monitor the biochemical parameters of the blood. With an increase in the level of liver enzymes, the use of Controloc should be discontinued.

Elderly patients, as well as patients with functional impairments of the kidneys, do not need dose adjustment, but the daily dose should not exceed 40 mg (except for combined antibiotic therapy for Helicobacter pylori, when the drug is taken at 40-80 mg in 2 divided doses).

Controlok should not be taken as a preventive measure.

Intravenous Controloc solution is administered in cases when the drug is not taken orally. The recommended daily dose is 40 mg.

With prolonged therapy of Zollinger-Ellison syndrome and other pathological conditions with increased secretory function at the beginning of treatment, the drug is administered at 80 mg per day. Depending on the reaction to Controloc, the daily dose may be increased or decreased. If the daily dose exceeds 80 mg, the drug should be administered in 2 divided doses. If necessary, a temporary increase in the dose to 160 mg per day is possible.

The same dosage regimen is used in the prevention and treatment of stress ulcers and their complications (perforation, bleeding, penetration).

To prepare a solution of Controloc, 10 ml of physiological sodium chloride solution should be added to a bottle containing dry matter. The solution can be used after mixing with 100 ml of physiological sodium chloride solution, as well as with 5% glucose solution.

The solution of Controloc for intravenous administration should have a pH = 9. The drug is administered within 2-15 minutes.

You can store the prepared solution for no more than 3 hours.

Side effects

When using Controlok according to indications and in compliance with the recommended doses, side effects are extremely rare.

Most often (about 1% of cases) headache and diarrhea occur.

Also, during the use of Controloc, the following disorders may develop (≥1 / 10 - very often, ≥1 / 100 and <1/10 - often, ≥1 / 1000 and <1/100 - infrequently, ≥ 1/10 000 and <1 / 1000 - rarely, <1/10 000 (including individual cases) - very rare; if it is impossible to estimate the frequency of occurrence based on the available data - with an unknown frequency):

• Digestive system: infrequently - dry mouth, diarrhea, vomiting / nausea, flatulence, bloating, constipation, abdominal pain;
• Musculoskeletal system: rarely - myalgia, arthralgia;
• Endocrine system: rarely - gynecomastia;
• Immune system: rarely - hypersensitivity (including anaphylactic shock and anaphylactic reactions);
• Urinary system: with unknown frequency - interstitial nephritis;
• Nervous system: infrequently - dizziness, headache; rarely - dysgeusia;
• Hematopoietic system: rarely - agranulocytosis; very rarely - leukopenia, thrombocytopenia, pancytopenia;
• Liver and biliary tract: infrequently - increased activity of liver enzymes (aspartate aminotransferase, gamma-glutamyltransferase); rarely - an increase in the level of bilirubin; with an unknown frequency - jaundice, hepatocellular damage;
• Organ of vision: rarely - visual impairment (in the form of fogging);
• Skin and subcutaneous tissues: infrequently - rash / exanthema, itching; with an unknown frequency - exudative erythema multiforme, malignant exudative erythema (Stevens-Johnson syndrome), photosensitization, toxic epidermal necrolysis;
• Metabolism: rarely - hyperlipidemia and increased concentration of lipids (cholesterols, triglycerides), changes in body weight; with an unknown frequency - hypomagnesemia, hyponatremia;
• Psyche: infrequently - sleep disturbance; rarely - depression (including exacerbation of existing disorders); very rarely - disorientation (including exacerbation of existing disorders); with an unknown frequency - confusion, hallucinations (especially in patients predisposed to this), as well as exacerbation of symptoms if they exist before starting treatment;
• Allergic reactions: rarely - angioedema, urticaria;
• General reactions: infrequently - malaise, fatigue, weakness; rarely - peripheral edema, an increase in body temperature.

special instructions

Before starting therapy, it is necessary to exclude the possibility of the presence of malignant neoplasms, since Controloc can mask their signs and delay the diagnosis.

Consult the prescribing physician prior to performing a urea breath test or endoscopy. You should also consult a doctor for the following diseases / conditions:

• Anemia, unintentional weight loss, gastrointestinal bleeding, swallowing disorders, vomiting of blood or persistent vomiting (the use of Controloc may partially alleviate the symptoms of the disease and delay correct diagnosis);
• Peptic ulcer or previous surgery on the gastrointestinal tract;
• Continuous long-term (from 4 weeks) symptomatic therapy of heartburn and dyspepsia;
• Liver disease, including jaundice and liver failure;
• Other serious illnesses that worsen general health.

Patients over 55 years of age should consult a doctor if new or recently changed symptoms appear.

With simultaneous use with drugs that reduce the acidity of gastric juice, the risk of developing infections slightly increases, the causative agents of which are bacteria of the gastrointestinal genus Campylobacter spp., Salmonella spp. or Clostridia difficile.

During therapy, it is recommended to refrain from driving vehicles and other mechanisms that require quick reactions and increased attention (due to the likelihood of developing visual impairment and dizziness).

Drug interactions

Controloc may reduce the absorption of drugs, the bioavailability of which depends on the pH of the stomach (including ketoconazole, iron salts).

Without the risk of drug interactions, Controloc can be used simultaneously with drugs such as:

• Beta-blockers (metoprolol), slow calcium channel blockers (nifedipine), cardiac glycosides (digoxin): in diseases of the cardiovascular system;
• Antacids, antibiotics (clarithromycin, amoxicillin): for diseases of the gastrointestinal tract;
• Diazepam: for anxiety and sleep disorders;
• Levothyroxine, glibenclamide: for diseases of the endocrine system;
• Tacrolimus, cyclosporine: after transplantation;
• Oral contraceptives containing levonorgestrel and ethinyl estradiol;
• Non-steroidal anti-inflammatory drugs (piroxicam, diclofenac, naproxen, phenazone);
• Phenytoin, carbamazepine;
• Indirect anticoagulants (phenprocoumon, warfarin).

The development of clinically significant drug interactions with ethanol, caffeine and theophylline was not observed.

Analogs

Analogues of Controloka are: Krosatsid, Nolpaza, Panum, Sanpraz, Zipantola, Pantaz, Peptazol.

Terms and conditions of storage

Keep out of reach of children at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

20 mg tablets are available without a prescription.

40 mg tablets and lyophilisate are available by prescription.

Controlok: prices in online pharmacies

Drug name Price Pharmacy

Controlok 40 mg lyophilisate for preparation of solution for intravenous administration 1 pc. 230 RUB Buy

Controlok 20 mg enteric-coated tablets 14 pcs. 264 r Buy

Tablet control p.o. 20mg 14 pcs. 271 r Buy

Controloc 40 mg enteric coated tablets 28 pcs. RUB 350 Buy

Controloc 40 mg enteric-coated tablets 14 pcs. 398 RUB Buy

Tablet control p.o. 40mg 14 Pcs. 422 r Buy

Tablet control p.o. 40mg 28 Pcs. 594 RUB Buy

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!