Source: Health Sciences Authority (SG) Revision Year: 2022 Publisher: Product Owner: Takeda GmbH, Konstanz, Germany
Controloc 20 mg:
Controloc 40 mg:
Controloc i.v.:
Short term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
Controloc 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with water.
| Therapeutic Indication | Posology and method of oral administration |
|---|---|
| Mild reflux disease and associated Symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) | The recommended oral dosage is one gastro- resistant tablet Controloc 20 mg per day. Symptom relief is generally accomplished within 2-4 weeks, and a 4-week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will normally be achieved within a further 4 weeks. |
| Long-term management and prevention of relapse in reflux oesophagitis | For long-term management, a maintenance dose of one gastroresistant tablet Controloc 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Controloc 40 mg is available for this case. After healing of the relapse the dosage can be reduced again to 20 mg pantoprazole. |
| Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment | The recommended oral dosage is one gastro- resistant coated tablet Controloc 20mg per day. The use of pantoprazole 20 mg as a preventive of gastroduodenal ulcers induced by non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications. The increased risk should be assessed according to individual risk factors, e.g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding |
Controloc 40 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with water.
| Therapeutic Indication | Posology and method of oral administration |
|---|---|
| Eradication of H.pylori in combination with appropriate antibiotics | In Helicobacter pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of H. pylori: a) twice daily one tablet Controloc 40 mg + twice daily 1000 mg amoxycillin + twice daily 500 mg clarithromycin b) twice daily one tablet Controloc 40 mg + twice daily 500 mg metronidazole + twice daily 500 mg clarithromycin c) twice daily one tablet Controloc 40 mg + twice daily 1000 mg amoxycillin + twice daily 500 mg metronidazole In combination therapy for eradication of Helicobacter pylori infection, the second Controloc 40 mg tablet should be taken before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged to up to two weeks maximum. If, to ensure healing of the ulcers, further treatment with pantoprazole is indicated, the dosage recommendations for duodenal and gastric ulcers should be considered. A duodenal ulcer generally heals within 2 weeks. If a 2‐week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks. A 4‐week period is usually required for the treatment of gastric ulcers and reflux esophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. |
| Treatment of gastric ulcer and duodenal ulcer | If combination therapy is not an option, e.g. if the patient has tested negative for Helicobacter pylori, the following dosage guidelines apply for Controloc 40 mg monotherapy: For the treatment of gastric and duodenal ulcer and reflux esophagitis one tablet of Controloc 40 mg per day. In individual cases the dose may be doubled (increase to 2 tablets Controloc 40 mg daily) especially when there has been no response to other treatment. |
The intravenous administration of Controloc i.v. is recommended only if oral application is not appropriate.
| Therapeutic Indication | Posology and method of IV administration |
|---|---|
| Duodenal ulcer, gastric ulcer, moderate and severe reflux esophagitis | The recommended intravenous dosage is one vial (40 mg pantoprazole) Controloc i.v. per day. As soon as oral therapy is possible, treatment with Controloc i.v. should be discontinued and 40 mg pantoprazole p. o. should be administered instead. This medicine should be administered by a healthcare professional and under appropriate medical supervision. Intravenous administration of pantoprazole is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Method of administration Pantoprazole should be administered intravenously after reconstitution, or reconstitution and dilution. A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride solution for injection. The prepared solution may be administered directly or may be administered after mixing it with 100 ml physiological sodium chloride solution for injection or 5% Glucose solution for injection. After preparation, the solution must be used within 12 h. The medicinal product should be administered intravenously over 2-15 minutes. General instructions Keep the vial in the outer carton in order to protect from light. As soon as oral therapy is possible, treatment with pantoprazole i.v. should be discontinued and 40 mg pantoprazole p. o. (by mouth) should be administered instead. |
The experience in children is limited. Pantoprazole 20 mg and 40 mg tablet is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group. Pantoprazole 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age.
A daily dose of Pantoprazole 20 mg should not be exceeded in patients with severe liver impairment (See section 4.4).
In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin) for eradication of H. pylori in patients with moderate to severe hepatic dysfunction since currently no data are available on the efficacy and safety of pantoprazole in combination treatment of these patients (See section 4.3).
No dose adjustment is necessary in those with impaired renal function.
In addition, pantoprazole 40 mg tablet must not be used in combination treatment (e.g. amoxicillin, clarithromycin) for eradication of H. pylori in patients with impaired renal function, since currently no data are available on the efficacy and safety of pantoprazole in combination treatment for these patients.
Generally, no dose adjustment is necessary in elderly patients. However, the daily dose of 40 mg should not be exceeded in treatment of gastric or duodenal ulcer.
Systemic exposure with doses up to 240 mg administered intravenously over 2 minutes was well tolerated.
As pantoprazole is extensively protein bound, it is not readily dialyzable.
In the case of overdose with clinical signs of intoxication, the usual rules of intoxication therapy apply.
Controloc 20 mg:
The expiry date of this pack is printed on the Container and on the folding box. Do not use this pack after the expiry date.
Controloc 40 mg:
The expiry date of this pack is printed on the Container and on the folding box. Do not use this pack after the expiry date.
Controloc i.v:
2 years. The reconstituted solution must be used within 12 hours after preparation.
The expiry date of this pack is printed on the container and on the folding box. Do not use this pack after the expiry date.
Controloc 20 mg:
Controloc 20 mg gastro-resistant tablets stored below 30°C remain unchanged for 3 years.
Controloc 40 mg:
Controloc 40 mg gastro-resistant tablets stored below 25°C remain unchanged for 3 years.
Controloc i.v:
Controloc i.v. should be stored below 25°C. Keep container in the outer carton
Keep the vial in the outer carton in order to protect from light.
(Applies to Controloc i.v only)
A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride solution (0.9%) into the vial containing the dry substance (powder). The appearance of the product after reconstitution is a clear yellowish solution. This solution may be administered directly or may be administered after mixing with 100 ml physiological sodium chloride (0.9%) solution for injection or 5% Glucose solution for injection. Glass or plastic containers should be used for dilution.
After preparation, the solution must be used within 12 h. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25°C.
Controloc i.v. should not be manufactured or mixed with solvents other than those stated. The drug should be administered intravenously over 2-15 minutes.
Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) has to be discarded.
The contents of the vial is for single use only. Any unused product or waste material should be disposed in accordance with local requirements.
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