Indications of Protoloc 20 mg
Protoloc 20 mg is recommended when inhibiting acid secretion is therapeutically beneficial, i.e.
Stomach ulcer disorders.
Illnesses caused by gastroesophageal reflux.
Non-steroidal anti-inflammatory drug-induced ulcer (NSAIDs)
Helicobacter pylori eradication (in combination with antibiotics)
Syndrome of Zollinger-Ellison
Theropeutic Class
Proton Pump Blocker.
Pharmacology
Protoloc 20 mg is a proton pump inhibitor that works by covalently attaching to the H+/K+ATPase enzyme system on the surface of the gastric parietal cell to decrease the last stage of gastric acid generation. Regardless of the stimulus that remains for more than 24 hours, this impact results in a suppression of both basal and induced stomach acid secretion.
Dosage & Administration of Protoloc 20 mg
Oral:
Benign gastric ulcer: 40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed.
Gastro-esophageal reflux disease: 20-40 mg daily in the morning for 4 weeks, continued for further 4 weeks, if not fully healed; maintenance dose is 20 mg daily, which may be increased to 40 mg daily.
Duodenal ulcer: 40 mg daily in the morning for 2 weeks, continued for further 2 weeks if not fully healed.
Duodenal ulcer associated with Helicobacter pylori: Protoloc 20 mg is recommended at a dose of 40 mg twice daily in association with antimicrobial agents as detailed below: Amoxycillin 1 g and Clarithromycin 500 mg both twice daily for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice daily for one week.
Prophylaxis of NSAID-associated gastric or duodenal ulcer: 20 mg daily for those require long-term NSAID treatment.
Zollinger-Ellison Syndrome: Initially 80 mg once daily adjusted according to response (elderly max. 40 mg daily); daily doses above 80 mg given in 2 divided doses.
IV Injection:
Duodenal ulcer and gastric ulcer: 40 mg once daily for 7-10 days
Gastroesophageal reflux disease associated with a history of erosive esophagitis: 40 mg once daily for 7-10 days
Prevention of rebleeding in peptic ulcer: IV 80 mg, followed by 8 mg/hour infusion for 72 hours
Prophylaxis of acid aspiration: 80 mg IV every 12 h for 24 h, followed by 40mg every 12 hour
Long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions: 80 mg IV every 12 hours, may increase to 80 mg every 8 hours if needed, may titrate to higher doses depending on acid output.
Interaction of Protoloc 20 mg
In clinical investigations, no significant medication interactions were found.
Contraindications
Those with known hypersensitivity to any of the formulation's ingredients should not take Protoloc 20 mg.
Side Effects of Protoloc 20 mg
Both in the short-term and the long-term, Protoloc 20 mg is well tolerated. The most frequent adverse effects are headache and diarrhea, while abdominal pain, flatulence, rash, sleeplessness, and hyperglycemia are only rarely reported side effects.
Pregnancy & Lactation
Protoloc 20 mg is classified as a B pregnancy drug by the US FDA. Nevertheless, there isn't any good, controlled research on pregnant women. This medication should only be used during pregnancy if clearly necessary, as a human response to treatments is not usually predicted by studies on animal reproduction. It has been demonstrated that Protoloc 20 mg is excreted in human milk. So, a choice should be taken on whether to stop nursing or stop taking the medication, taking into account the benefit of the medication to the mother.
Precautions & Warnings
Patients should be advised not to split, chew, or crush the Protoloc 20 mg pill. The use of Protoloc 20 mg for an extended period of time may cause malabsorption of cyanocobalamin (Vitamin B12) or raise the risk of problems linked to osteoporosis.
Overdose Effects of Protoloc 20 mg
There are no recognized signs of human overdose. Due to its strong protein binding, Protoloc 20 mg is not easily dialyzable. There is no specific therapy that is advised, other symptomatic and supportive management.
Storage Conditions
Keep dry and away from heat and light. Keep out of children's reach.
Reconstitution
Direction for use of IV injection: Protoloc 20 mg lyophilized powder with 0.9% Sodium Chloride Injection must only be administered intravenously and under no other circumstances. A gradual intravenous dose of Protoloc 20 mg should be administered. The powder-containing vial is mixed with 10 ml of 0.9% sodium chloride injection to create the IV injection solution. Upon reconstitution, the injection should be administered gradually over a minimum of 2 to 5 minutes. Use just recently made solutions. The reconstituted solution can be kept for up to 4 hours at room temperature (up to 30° C). How to administer an IV infusion: An intravenous infusion of Protoloc 20 mg should be administered over roughly 15 minutes. An IV infusion of Protoloc 20 mg needs to be reconstituted with 10 ml of 0.9% sodium chloride injection before being further diluted (admixed) to a final volume of 100 ml using 0.9% sodium chloride injection, 5% dextrose, or lactated ringer's injection. Prior to further dilution, the reconstituted solution may be kept at room temperature (up to 30° C) for a maximum of 4 hours. The admixed solution must be used within 24 hours of the initial reconstitution and may be kept at room temperature (up to 30° C).