Pulcet 40mg Nobelfarma Treatment of gastroesophageal reflux (2 blisters x 14 tablets)

Dosage form Box of 2 blisters x 14 tablets
Specifications Pantoprazole

Ingredient

Composition information	Content
Pantoprazole	40mg

Uses

Indications

Pulcet 40 drugs are indicated in the following cases:

Gastroesophageal reflux.

Stomach and duodenal ulcer. The drug goes to the acid secretary tubes of the stomach into the stomach to be converted into activated sulfenamide, this form is not as opposed to the enzyme H+/K+ - ATPASE (also known as the proton pump) on the surface of the cell into the stomach wall, inhibiting this enzyme, preventing the final step of the acid secretion into the stomach heart. Therefore, it has the effect of inhibiting the stomach acid secretion and even when the stomach is irritated by any stimulant agent.

The effect of pantoprazole depends on the dose, the time to inhibit acid excretion due to gastric juice lasts more than 24 hours, although the half -life excreted of Pantoprazol is much shorter (0.7 - 1.9 hours). After the oral dose started 40 mg pantoprazole, excretion of gastric acid was inhibited an average of 51% after 2.5 hours. Take Pantoprazole once a day 40 mg in 7 days reduces 85% of gastric acid excretion.

Excretion of gastric acid becomes normal within 1 week after stopping pantoprazole and there is no phenomenon of reBound secretion. In addition, Pantoprazole can eliminate Helicobacter pylori in the stomach in people with duodenal ulcer and/or have reflux esophagitis. In vitro, pantoprazole reduces the number of Helicobacter pylori more than 4 times at pH = 4.

pharmacokinetic

absorption

Pantoprazole is quickly absorbed, reaching the highest concentration in the blood after drinking about 2 - 2.5 hours. Pantoprazole good absorption, less initial metabolism in the liver, oral use about 77%.

Distribution

Pantoprazole is strongly attached to plasma proteins (98%), the distribution of adults is 0.17 l/kg.

Metabolism

Pantoprazole metabolizes mainly in the liver thanks to CYP219 to convert it into Desmethylpantoprazole. A small part is metabolized by CYP3A4, CYD2P6, CYP2C9. In some people who lack the enzyme system CYP2P19 due to genetics (Asians are encountered by 17 - 23%, called slow metabolism) that slowed the metabolism of pantoprazole, leading to a plasma drug level may increase 5 times higher than normal people.

Elimination

The sale time of Pantoprazole is 0.7 - 1.9 hours, which can last in people with liver failure, cirrhosis (3-6 hours) or slow -metabolic metabolic people (3.5 - 10 hours). Mainly eliminated metabolites (about 80%), 18% through bile into feces.

Children

After taking a single dose of Pantoprazole 20 or 40 mg in children 5 - 16 years old, under the curve (AUC) and the maximum concentration of drugs in plasma (CMAX) is within the corresponding value in adults. After the single dose intravenous injection Pantoprazole 0.8 - 1.6 mg/kg in children 2 - 16 years old is not significantly related between clearance and age or weight.

Before taking Pulcet 40mg Nobelfarma Treatment of gastroesophageal reflux (2 blisters x 14 tablets)

How to use

Pulcet medicine is used once a day in the morning, before or after meals. Antacids can be taken simultaneously with this drug.

Because Pantoprazole is destroyed in the acidic environment, it must be used in the form of tablets in the intestine. When taking Pantoprazole, you have to swallow the whole tablet, not to break, chew or break the pill. Must fully follow the treatment.

Dosage

Treatment of gastroesophageal reflux disease - esophagus

Take 20 - 40 mg x 1 time/day in the morning for 4 weeks, can increase up to 8 weeks if necessary. In people with esophageal ulcer after 8 weeks of treatment, can prolong treatment for up to 16 weeks.

Maintain treatment: 20 - 40 mg per day. Safety and efficiency of maintenance dose for over 1 year has not been determined.

Treatment of benign stomach ulcers

Take 40 mg x 1 time/day, for 4 - 8 weeks.

duodenum ulcer

Take 40 mg x 1 time/day, for 2-4 weeks.

To eradicate Helicobacter pylori, it is necessary to combine Pantoprazole with 2 antibiotics in the treatment mode using 3 drugs in a week. An effective regimen includes oral pantoprazole 40 mg 2 times/day (in the morning and evening) + Clarithromycin 500 mg x 2 times/day + Amoxicillin 1 g x 2 times/day or Metronidazole 400 mg x 2 times/day.

Preventive treatment for gastrointestinal ulcers caused by nonsteroidal anti -inflammatory drugs

Take 20 mg x 1 time/day.

Treatment of pathological acid secretion in Zollinger - Ellison syndrome

The dose starts 80 mg once a day, then adjusts to the patient's response (the elderly is maximum doses of 40 mg/day). May be up to 240 mg daily. If the daily dose is greater than 80 mg, then divide 2 times a day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? The signs and symptoms of the overdose may be: fast heartbeat, vasodilation, sleep, confusion, headache, blurred vision, abdominal pain, nausea and vomiting.

Handling

Gastric lavage, activated carbon, symptomatic treatment and support. Monitor the activity of the heart, blood pressure. If vomiting is prolonged, water and electrolytes must be monitored.

Do pantoprazole is strongly attached to plasma proteins, the method of separation does not eliminate the drug.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Pulcet 40, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Body: Tired, dizzy, headache.

Skin: skin, urticaria, itching.

Digestive: dry mouth, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea.

musculoskeletal: muscle pain, joint pain.

Uncommon, 1/1000

Body: weakness, dizziness, dizziness, insomnia.

Skin: itching.

Liver: Increase liver enzyme.

Instructions on how to handle ADR

Pantoprazole is often used well. ADRs such as abdominal pain, diarrhea, headache, fatigue often go away when continuing to treat, rarely have to stop the drug. It is necessary to monitor symptoms such as blurred vision, depression, hepatitis, bleeding, rash, impotence. If prolonged to stop the drug or transfer to other drugs.

Notice an unwanted effect when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Pulcet 40 contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Be cautious when using

Before using Pantoprazole as well as other drugs inhibiting proton pump for people with stomach ulcers, eliminating stomach cancer because the drug can cover symptoms or slow down the diagnosis of cancer.

Be careful when used in people with liver disease (acute, chronic, or a history). The serum concentration of the drug may increase slightly or mitigate the exhaust, but do not need to adjust the dose. Avoid use in patients with cirrhosis, or severe liver failure. If used, the dose should be reduced or given 1 time a day. Monitor regular liver function.

Use carefully in people with kidney failure, the elderly.

Children

Pantoprazole 40 mg is not recommended for use in children under 12 years old because there is no adequate data on safety and efficiency in this age group.

The ability to drive and operate machinery

Caution when driving and operating machinery because the drug can cause dizziness or headache.

Pregnancy

There is no adequate study when using Pantoprazole in pregnant women. Animal studies have shown Pantoprazole through the placenta fence. However, it has not been observed that the effect causes teratogenicity. The dose of 15 mg/kg may slow down the bone development in fetus. Therefore, only using pantoprazole when really necessary during pregnancy.

Breastfeeding period

Not enough data to prove whether pantoprazole is excreted in human milk or not. However, Pantoprazole and its metabolites are excreted into mouse milk. Pantoprazole has the ability to cause cancer in mice, so it is necessary to consider whether to stop breastfeeding or stopping the drug, depending on the benefit of Pantoprazole with the mother.

Drug interaction

Although Pantoprazole is transformed through the cytochrome P450 enzyme system in the liver, but does not inhibit or activate the enzyme activity. There is no clinical interaction that is noticeable about the interaction between pantoprazole and common drugs such as diazepam, phenytoin, theophyllline, digoxin, warfarin or oral contraceptive pills.

Like other proton pump inhibitors, Pantoprazole can reduce the absorption of some drugs that their absorption depends on the stomach pH such as Ketoconazole, Itraconazole. Severe muscle pain and bone pain can occur when using methotrexate along with pantoprazole.

Storage

Store at temperatures below 30 ° C, in closed boxes.

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