Protogut
Protogut Uses, Dosage, Side Effects, Food Interaction and all others data.
Protogut is a substituted benzimidazole, and is also known as PPI due to its property to block the final step of acid secretion by inhibiting H+/K+ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.
Protogut decreases gastric acid secretion by targeting H+,K+-ATPase, which is the enzyme that catalyzes the final step in the acid secretion pathway in parietal cells. Conveniently, lansoprazole administered any time of day is able to inhibit both daytime and nocturnal acid secretion. The result is that lansoprazole is effective at healing duodenal ulcers, reduces ulcer-related pain, and offers relief from symptoms of heartburn Protogut also reduces pepsin secretion, making it a useful treatment option for hypersecretory conditions such as Zollinger-Ellison syndrome.[F4352]
| Trade Name | Protogut |
| Availability | Rx and/or OTC |
| Generic | Lansoprazole |
| Lansoprazole Other Names | Lansoprazol, Lansoprazole, Lansoprazolum |
| Related Drugs | amoxicillin, omeprazole, famotidine, pantoprazole, metronidazole, Nexium, Pepcid, Protonix, esomeprazole, sucralfate |
| Type | Capsule |
| Formula | C16H14F3N3O2S |
| Weight | Average: 369.361 Monoisotopic: 369.075882012 |
| Protein binding | 97% of lansoprazole is plasma protein bound. |
| Groups | Approved, Investigational |
| Therapeutic Class | Proton Pump Inhibitor |
| Manufacturer | Novartis India Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Protogut is used for:
- Short term treatment of active duodenal ulcer
- Maintenance of healed duodenal ulcers
- Short term treatment of active benign gastric ulcers
- Short term treatment of active erosive esophagitis
- Maintenance of healing of erosive esophagitis
- Pathological hypersecretory conditions including Zollinger- Ellison Syndrome
- H. pylori eradication to reduce the risk of duodenal ulcer recurrence
Protogut is also used to associated treatment for these conditions: Gastro-esophageal Reflux Disease (GERD), Gastrointestinal Bleeding, Helicobacter Pylori Infection, Peptic Ulcer Disease, Hypersecretory conditions
How Protogut works
As a PPI, lansoprazole is a prodrug and requires protonation via an acidic environment to become activated. Once protonated, lansoprazole is able to react with cysteine residues, specifically Cys813 and Cys321, on parietal H+,K+-ATPase resulting in stable disulfides. PPI's in general are able to provide prolonged inhibition of acid secretion due to their ability to bind covalently to their targets.
Dosage
Protogut dosage
Benign gastric ulcer: 30 mg daily in the morning for 8 weeks.
Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg.
NSAID-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed.
Zollinger-Ellison syndrome (and other hypersecretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses.
Gastroesophageal reflux disease: 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily.
Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.
Side Effects
Severe or irreversible adverse effects: The possible induction of carcinoid tumors by profound acid suppression, and a rise in serum gastrin may occur. There is a rise in serum gastrin levels in the first 3 months of treatment, which are then maintained though at a lower level than those found in pernicious anaemia. Long term treatment with a proton pump inhibitor in patients with Helicobacter pylori infection may accelerate the development of atrophic gastritis.
Symptomatic adverse effect: Dose dependent diarrhoea occurs with an incidence of about 4% at 30 mg per day, rising to 8% at 60 mg per day. Headache occurs in 2-3% of treated patients
Toxicity
The most commonly reported adverse events occurring more frequently in lansoprazole treated patients compared to placebo include abdominal pain, constipation, diarrhea, and nausea. There is a case report of toxic epidermal necrolysis (TEN), which is a rare but very serious cutaneous reaction, caused by lansoprazole. The previously healthy patient presented with symptoms of TEN 15 days after starting lansoprazole to manage peptic disease. Although the use of PPI's is rarely associated with TEN, causation should be considered if a patient presents with TEN shortly after newly commencing a PPI.
In a single case report, a patient ingested 600 mg of lansoprazole and did not experience any adverse effects or symptoms of overdose. Overall, lansoprazole is well tolerated with relatively few adverse effects.
Protogut is classified as Pregnancy Category B. Although there are animal studies that suggest lansoprazole does not cause harm to the fetus, there is still a paucity of human data. Hence, lansoprazole should only be administered to pregnant women if other options with more safety data have been exhausted.
It is unknown if lansoprazole is excreted in human breast milk. It is worth mentioning that lansoprazole has been used safely in infants, and is therefore likely safe to use during breastfeeding.
Precaution
Gastric malignancy should be ruled out. Hepatic impairment. Pregnancy and lactation.
Interaction
Protogut appears to be a selective inhibitor of the cytochrome P-450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Protogut on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.
Food Interaction
- Take before a meal. Take 30-60 minutes before meals.
Protogut Drug Interaction
Moderate: levothyroxine, levothyroxineMinor: aspirin, aspirin, cyanocobalamin, cyanocobalaminUnknown: omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, pregabalin, pregabalin, metoprolol, metoprolol, acetaminophen, acetaminophen, acetaminophen, acetaminophen, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol
Protogut Disease Interaction
Major: C. diffModerate: liver disease, bone fractures, hypomagnesemia
Volume of Distribution
The apparent volume of distribution of lansoprazole is 0.4 L/kg.
Elimination Route
The oral bioavailability of lansoprazole is reported to be 80-90% and the peak plasma concentration(Cmax) is achieved about 1.7 hours after oral dosing. Food reduces the absorption of lansoprazole (both Cmax and AUC are reduced by 50-70%); therefore, patients should be instructed to take lansoprazole before meals.
Half Life
One source reports the half life of lansoprazole to be 0.9 - 1.6 hours, while another source cites 0.9 - 2.1 hours. The general consensus is that lansoprazole has a short half life and is approximately 2 hours or less. These numbers may be misleading since it suggests that lansoprazole has a short duration of action when in practice, lansoprazole can effectively inhibit acid secretion for ~24 hours due to it's mechanism of action.
Clearance
The reported clearance of lansoprazole is 400-650 mL/min.
Elimination Route
A reported 14-23% of a lansoprazole is eliminated in the urine with this percentage range including both conjugated and unconjugated hydroxylated metabolites.
Pregnancy & Breastfeeding use
Protogut should be avoided in pregnancy unless there are compelling reasons.
Contraindication
Protogut is contraindicated in patients with known hypersensitivity to any component of the formulation.
Special Warning
Neonates:There is no relevant human data. The drug is not recommended for use with neonates.
Children: The youngest person to have received Protogut in clinical trials was 13 years old.
The Elderly: No problems have been encoun- tered in clinical use and there has been no increase in adverse drug reaction in the elderly.
Storage Condition
Store at 25° C.
Innovators Monograph
You find simplified version here Protogut
Protogut contains Lansoprazole see full prescribing information from innovator Protogut Monograph, Protogut MSDS, Protogut FDA label
FAQ
What is Protogut used for?
Protogut is used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. Protogut is also taken to prevent and treat stomach ulcers.
How safe is Protogut?
Most adults and children can take Protogut. Protogut is not suitable for some people. To make sure it's safe for you, tell your doctor before taking Protogut if you have ever had an allergic reaction to lansoprazole or any other medicines.
How does Protogut work?
Protogut prevents proton pumps from working properly. This reduces the amount of acid the stomach makes.
What are the common side effects of Protogut?
Common side effects of Protogut are include:
- headaches
- feeling sick
- diarrhoea or being sick (vomiting)
- stomach pain
- constipation
- wind
- itchy skin rashes
- feeling dizzy or tired
- dry mouth or throat
Is Protogut safe during pregnancy?
Protogut is not usually recommended if you're pregnant because there is little information about its use during pregnancy. Your doctor may recommend a similar medicine called omeprazole instead as there is more safety information available.
Is Protogut safe during breastfeeding?
If your doctor or health visitor says your baby is healthy, it's safe to take Protogut while you're breastfeeding.It is not known how much passes into breast milk but it's likely to be a very small amount and your baby will not absorb a lot into their body from the breast milk.
Can I drink alcohol with Protogut?
Yes, you can drink alcohol with Protogut. But it's best not to drink too much, because drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.
Can I drive or ride a bike?
Protogut can make you feel dizzy, sleepy, or get blurred vision. If this happens to you, do not drive, cycle or use machinery or tools until you feel better. It's an offence to drive a car if your ability to drive safely is affected. It's your responsibility to decide if it's safe to drive. If you're in any doubt, do not drive.
When should be taken of Protogut?
You'll usually take Protogut once a day, first thing in the morning.If you take Protogut twice a day, take 1 dose in the morning and 1 dose in the evening.
How to take Protogut?
Swallow the tablets or capsules whole with a drink of water or juice.
If you have problems swallowing capsules, you can open Protogut capsules and mix the granules inside with a little water or fruit juice, or sprinkle them onto soft food, such as yogurt or apple puree, to help you swallow them.
How long can I take Protogut?
Depending on your condition, you may only need to take Protogut for a few weeks or months. Sometimes you might need to take it for longer, even many years.
What happen if I take too much Protogut?
It is very unlikely that taking 1 or 2 extra doses of Protogut will cause any problems.
If you take an extra dose, you might get some of the common side effects. If this happens or you're concerned, contact your doctor.
What happen If I missed dose of Protogut?
If you miss the dose;
- once a day, take the missed dose as soon as you remember, unless it is within 12 hours of your next dose in which case skip the missed dose and take the next one at the usual time
- twice a day, take the missed dose as soon as you remember, unless it is within 4 hours of your next dose in which case skip the missed dose and take the next one at the usual time.
How should I stop taking Protogut ?
Usually, you can stop taking Protogut without reducing the dose first. But if you've taken Protogut for a long time, speak to your doctor before you stop taking it.
What happens If I suddenly stop taking Protogut?
Stopping the medicine suddenly could make your stomach produce a lot more acid, and make your symptoms return.Reducing the dose gradually before stopping completely will prevent this happening.
Will Protogut affect my fertility?
There's no evidence to suggest that taking Protogut will reduce fertility in either men or women.
However, speak to a pharmacist or your doctor if you're trying to get pregnant as they may want to review your treatment.
When will I feel better?
You should start to feel better within 2 to 3 days. However, it may take up to 4 weeks for Protogut to work properly so you may still have some acid symptoms during this time.
Do I have to take Protogut on an empty stomach?
Protogut works best if taken on an empty stomach 30 to 60 minutes before food.
Does Protogut raise blood pressure?
Protogut had no effect on blood pressure and electrocardiogram of anesthetized rat.
Can Protogut affect my kidney?
Protogut may cause kidney damage, which can occur at any time during the treatment. Call your doctor if you have blood in your urine, flank pain or changes in urination during the treatment.
Can Protogut effects my liver?
Protogut therapy is associated with a low rate of transient and asymptomatic serum aminotransferase elevations and is a reported, but very rare cause of clinically apparent liver injury.
Who should not take Protogut?
Protogut is not recommended for use in children younger than 1 year due to an increased risk of serious side effects.
Can Protogut cause heart palpitations?
It's unlikely that acid reflux will cause heart palpitations directly.
