Pariet 20 mg Uses, Dosage, Side Effects, Precautions & Warnings

Pariet 20 mg >> Generic drug of the Therapeutic class: Gastro-Entero–Hepatology
Active ingredients: Rabeprazole

what are pariet tablets used for?

Parallel importation drug. The information presented is that of the reference specialty.

PARIET, is indicated in the treatment:

•  Progressive duodenal ulcer,
•  Benign evolutionary gastric ulcer,
•  Erosive or ulcerative esophagitis symptomatic by gastroesophageal reflux,
•  Maintenance of oesophagitis by gastroesophageal reflux,
•  Symptomatic moderate to very severe gastro-oesophageal reflux,
• The eradication of Helicobacter pylori in peptic ulcer disease, in combination with appropriate antibiotic therapy,
• Zollinger Ellison syndrome

Pariet Dosage

Parallel importation drug. The information presented is that of the reference specialty.

Adult – Elderly:

Evolutionary duodenal ulcer, benign evolutionary gastric ulcer:

• The recommended daily dose for the treatment of active duodenal ulcer or benign progressive gastric ulcer is 20 mg once daily in the morning.
• Scarring is achieved in most patients with progressive duodenal ulcer within 4 weeks of treatment. However, in a small number of patients it may be necessary to continue treatment for an additional 4 weeks for complete healing. Scarring is achieved in most patients with benign progressive gastric ulcer within 6 weeks of treatment. However, in a small number of patients, it may be necessary to continue treatment for an additional 6 weeks for complete healing.

Erosive or ulcerative esophagitis by gastroesophageal reflux:

• The recommended daily dose for treatment of gastroesophageal reflux esophagitis is 20 mg once daily in the morning for 4 to 8 weeks.

Maintenance treatment of gastroesophageal reflux esophagitis:

• During long-term treatment, the maintenance dose is 20 or 10 mg once a day, in the morning, depending on the patient’s response.

Symptomatic treatment of moderate to very severe gastro-oesophageal reflux:

• 10 mg once daily, in patients without esophagitis. If symptoms persist after 4 weeks, additional tests should be performed.
• After resolution of symptoms, symptomatic recurrence can be controlled by taking PARIET 10 mg once daily as needed.

Eradication of Helicobacter pylori :

• A drug combination is recommended for 7 days according to the following dosing regimen.
• 20 mg PARIET 2 times daily with clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.

Treatment of Zollinger-Ellison syndrome:

• The recommended starting dose is 60 mg rabeprazole once daily. This can be increased to 120 mg per day depending on the needs of the patient.
• Single daily doses of 100 mg rabeprazole can be administered. Daily doses of 120 mg can be divided into 2 doses of 60 mg. Treatment should be continued as long as clinically necessary.
• In the indications where PARIET is administered once a day, PARIET should be taken in the morning before breakfast. Although neither time of intake nor diet influences rabeprazole sodium activity, this regimen facilitates adherence.
• Patients should be warned that PARIET tablets should not be chewed or chewed but should be swallowed whole.

Renal and hepatic insufficiency:

• Dosage adjustment is not required in patients with renal or hepatic impairment.
• See Special warnings and precautions for use of PARIET in patients with severe hepatic impairment.

Child:

• The use of PARIET is not recommended in children because of the lack of study in these patients.

Contraindications

How it works Pariet?

Pharmacotherapeutic group: Digestive system and metabolism, drugs for peptic ulcer and gastro-oesophageal reflux disease (GERD),

INHIBITORS OF THE PROTON PUMP

ATC Code: A02B C04

Mechanism of action :

• Rabeprazole sodium belongs to the class of antisecretory agents, derived from benzimidazoles, which do not possess anticholinergic properties or histamine H2 antagonists, but act by suppressing the secretion of gastric acid by specific inhibition of the enzyme H ⁺ / K ⁺-ATPase (the proton or acid pump). This effect is dose-dependent and leads, irrespective of the stimulus, to an inhibition of basal and stimulated secretions. Animal studies indicate that after administration, rabeprazole sodium rapidly disappears from both the bloodstream and the gastric mucosa. Like any weak base, rabeprazole is rapidly absorbed at any dose and is concentrated in the acid environment of parietal cells. Rabeprazole is converted to the active sulfonamide derivative by protonation, which reacts with the available cysteine ​​radicals at the proton pump.

Antisecretory activity :

• After oral administration of a 20 mg dose of Rabeprazole Sodium the onset of antisecretory effect occurs within one hour and peaks within 2 to 4 hours. Twenty-three hours after the first dose of rabeprazole sodium, the inhibition of secretion, basal and stimulated by food intake, is 69% and 82%, respectively, and the effect is prolonged to 48 hours. The inhibitory activity of rabeprazole sodium on acid secretion increases slightly with repeated daily administration, reaching a state of inhibitory equilibrium after 3 days. At the end of treatment secretory activity is normalized in 2 to 3 days.
• Decreased gastric acidity, whatever the cause, including proton pump inhibitors such as rabeprazole, increases the number of bacteria normally present in the gastrointestinal tract. It is possible that treatment with proton pump inhibitors may increase the risk of gastrointestinal infections caused by bacteria such as Salmonella , Campylobacter and Clostridium difficile .

Effects on serum gastrin :

• In clinical studies, patients were treated with 10 to 20 mg of rabeprazole sodium once daily for up to 43 months. Serum gastrin concentrations increased during the first 2 to 8 weeks, reflecting inhibitory activity on acid secretion; they remained stable during maintenance treatment. Serum gastrin values ​​are returned to pre-treatment values, typically 1 to 2 weeks after stopping treatment.
• Human gastric biopsy specimens from the antrum and fundus in more than 500 patients treated with rabeprazole sodium or comparator for up to 8 weeks failed to detect changes in histology ECL cells, degree of gastritis, incidence of gastric atrophy, intestinal metaplasia, and distribution of H. pylori infections . In more than 250 patients, followed for 36 months in continuous treatment, no significant changes were noted compared to baseline data.

Other effects :

• No systemic effects of rabeprazole sodium on the CNS, cardiovascular or respiratory system have been identified to date. Rabeprazole sodium at 20 mg oral dose for 2 weeks has no effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid hormone, cortisol, estrogen, testosterone, prolactin, cholecystokinin, secretin, glucagon, FSH, LH, renin, aldosterone or somatotropic hormone.
• Studies in healthy subjects showed no clinically significant interaction between rabeprazole sodium and amoxicillin. Rabeprazole does not induce changes in plasma concentrations of amoxicillin or clarythromycin when administered for the purpose of eradicating a high gastrointestinal infection with Helicobacter pylori .

pariet drugs Side Effects

Like all medicines, PARIET can cause side effects, although not everybody gets them.

Adverse effects are usually mild and improve without you having to stop taking this medicine.

Stop taking PARIET and see a doctor immediately if you notice any of the following side effects you may need urgent medical treatment:

• · Allergic reactions Signs may include: Sudden swelling of your face, difficulty breathing, or low blood pressure that may cause fainting or falling.
• · Common signs of infection, such as sore throat, high temperature (fever), or ulcer in your mouth or throat.
• · Bruising or easy bleeding.
• These side effects are rare (affect less than 1 in 1,000 people).
• · Vesicular eruptions, pain or ulceration of your mouth and throat.

These side effects are very rare (affects less than 1 in 10,000 people).

Other possible side effects:

Frequent (affects less than 1 in 10 people)

• · Infections.
• · Difficult sleep
• · Headache, dizziness.
• · Cough, runny nose or sore throat (pharyngitis).
• · Effects on your stomach or intestine such as stomach pain, diarrhea, flatulence, nausea, vomiting or constipation.
• · Aches or backache.
• · Weakness or flu-like syndrome.
• · Benign polyps in the stomach.

Uncommon (affects less than 1 in 100 people)

• · Nervousness or drowsiness.
• · Infection in the lungs (bronchitis).
• · Sinus painful and blocked (sinusitis).
• · Dry mouth.
• · Indigestion or burping (belching).
• · Rash or redness of the skin.
• · Pain in the muscles, legs or joints.
• · Fracture of the hip, wrist or vertebrae.
• · Infection of the bladder (urinary tract infection).
• · Chest pain.
• · Chills or fever.
• · Changes in the functioning of your liver (measurable by blood tests).

Rare (affect less than 1 in 1,000 people)

• · Loss of appetite (anorexia).
• · Depression.
• · Hypersensitivity (including allergic reactions).
• · Visual disturbances
• · Pain in the mouth (stomatitis) or disturbances of taste.
• · Irritation or stomach pain.
• · Liver disorders resulting in yellowing of your skin and the whites of your eyes (jaundice).
• · Rash with itching or blistering on your skin.
• · Sudation.
• · Kidney disorders.
• · Weight gain.
• · Changes in white blood cells (measurable by blood tests) that can lead to frequent infections.
• · Decreased platelets in the blood causing bleeding or bruising more easily than usual.

Other possible side effects (frequency not known)

• · Increased breast size in humans.
• · Water retention.
• · Low sodium level in the blood can cause tiredness and confusion, muscle spasms, convulsions and coma.
• · Patients with previous liver problems can very rarely develop encephalopathy (brain disease).
• · Rash, possibly with joint pain.

If you take PARIET for more than three months, it is possible that the level of magnesium in your blood will decrease. Low levels of magnesium can result in fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. If you have any of these symptoms, please inform your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may decide to have regular blood tests to monitor your magnesium levels.

Do not be worried about this list of unwanted effects. You may not be presenting any of them.

pariet drugs Interactions

• Rabeprazole sodium produces strong and lasting inhibition of gastric acid secretion. Interaction with products whose absorption is dependent on gastric pH may occur. Concomitant administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in plasma levels of these antifungals. As a result, patient monitoring may be necessary when concomitant use of ketoconazole or itraconazole is used.
• In clinical studies, antacids were used concomitantly with PARIET and a specific study did not show any interaction with antacids in solution.
• Atazanavir 300 mg and ritonavir 100 mg in combination with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg daily) in healthy volunteers significant decrease in exposure to atazanavir. The absorption of atazanavir is pH dependent. Although not studied, similar results are expected with other proton pump inhibitors. IPPs, including rabeprazole, should not be used in combination with atazanavir

Warnings and Precautions

•  An improvement in symptoms during treatment with rabeprazole sodium does not exclude the presence of a malignant pathology of the esophagus or stomach; therefore, any possibility of lesion malignancy should be ruled out before the start of treatment with PARIET.
• Regular monitoring should be exercised during long-term treatment (especially in patients treated for more than one year).
• A cross-hypersensitivity reaction with other proton pump inhibitors or benzimidazole derivatives can not be ruled out.
• Patients should be warned that PARIET tablets should not be chewed or chewed but should be swallowed whole.
• The use of PARIET is not recommended in children, in the absence of study in these patients.
• Blood abnormalities (thrombocytopenia and neutropenia) have been reported since marketing. In most cases where no etiology was identified, these abnormalities were uncomplicated and normalized upon discontinuation of rabeprazole.
• Hepatic enzyme abnormalities have been observed in clinical trials and reported from the time of marketing. In most cases where no other etiology was identified, these increases were uncomplicated and normalized upon discontinuation of rabeprazole.
• Studies in patients with mild to moderate hepatic impairment did not reveal any significant drug-related adverse events compared to healthy subjects of the same age and sex. However, in the absence of clinical data on the use of PARIET in patients with severe hepatic impairment, the prescriber should be especially vigilant when initiating PARIET therapy in these patients.
• Administration of PARIET with latazanavir is not recommended  .
• Proton Pump Inhibitor therapy, including PARIET, may increase the risk of gastrointestinal infections caused by bacteria such as Salmonella, Campylobacter and Clostridium difficile .
• Proton pump inhibitors, particularly if they are used in high doses over a prolonged period (> 1 year), may moderately increase the risk of fracture of the hip, wrist and vertebrae, mainly in elderly patients or in the presence of other identified risk factors. Observational studies suggest that proton pump inhibitors can increase the overall risk of fracture by 10-40%. This increase may be due in part to other risk factors. Patients at risk of osteoporosis should be managed according to clinical guidelines and receive appropriate vitamin D and calcium intake.
• Severe hypomagnesemia has been reported in patients treated with proton pump inhibitors such as PARIET for at least 3 months, and in most cases for one year. Hypomagnesemia can manifest itself in serious clinical signs such as fatigue, tetany, delirious flushes, convulsions, dizziness, ventricular arrhythmia, but it can start insidiously and go unnoticed. In most patients, hypomagnesemia improved after magnesium supplementation and proton pump inhibitor discontinuation.
• In patients requiring prolonged therapy or in combination with proton pump inhibitors with digoxin or with treatments that may induce hypomagnesaemia (eg diuretics), a determination of blood magnesium level should be considered by professionals before starting treatment with proton pump inhibitor and then regularly during treatment.

Concomitant use of rabeprazole and methotrexate

• Data from the literature suggest that concomitant use of IPP and methotrexate (especially at high dose, refer to methotrexate product information) may increase and prolong plasma levels of methotrexate and / or its metabolite, and lead to methotrexate-associated toxicity. . When methotrexate is given in high doses, temporary interruption of IPP may be considered in some patients.

Influence on the absorption of vitamin B12

• Rabeprazole sodium, like all antacids, may decrease the absorption of vitamin B12 (cyanocobalamin) due to hypo or achlorhydria. This should be taken into account in case of long-term treatment in patients with reduced vitamin B12 stores or risk factors for decreased absorption of vitamin B12, or when corresponding clinical symptoms are observed.

Subacute cutaneous lupus erythematosus (LECS)

• Inhibitors of the proton pump are associated with very occasional cases of LECS. If lesions develop, especially on sun-exposed skin areas, and if accompanied by arthralgia, the patient should seek medical attention promptly and the health care provider should consider discontinuing PARIET. The occurrence of LECS after treatment with a proton pump inhibitor may increase the risk of LECS with other proton pump inhibitors.

Interference with laboratory tests

• Increased levels of Chromogranin A (CgA) may interfere with tests performed for the exploration of neuroendocrine tumors. To avoid this interference, treatment with PARIET should be discontinued at least 5 days before measuring the CgA level (see section 5.1). If the levels of CgA and gastrin have not normalized after the initial measurement, the measurements should be repeated 14 days after discontinuation of proton pump inhibitor therapy.

Drive and use machines

• Because of its pharmacodynamic properties and side effect profile, it is unlikely that PARIET will change the ability to drive or use machines.
• However, if the patient’s attention is reduced due to drowsiness it is recommended to avoid driving or the use of complex machines.

PREGNANCY / BREAST FEEDING / FERTILITY

Parallel importation drug. The information presented is that of the reference specialty.

Pregnancy

• There are no clinical data on the safety of rabéprazole during pregnancy. Reproductive studies in rats and rabbits provided no evidence of decreased fertility or fetal risk attributable to rabeprazole sodium, despite poor foeto-placental passage in rats. PARIET is contraindicated during pregnancy.

feeding

• The excretion of rabeprazole sodium in human milk is not documented. There is no study in lactating women. Rabeprazole sodium is excreted in milk in the spleen. As a result, PARIET should not be used during breastfeeding.

What happens if I overdose from Pariet ?

Parallel importation drug. The information presented is that of the reference specialty.

Experience with intentional or accidental overdose is limited to date. Maximum ingested doses did not exceed 60 mg twice daily or 160 mg once daily. The effects are generally minimal, in agreement with the profile of known secondary events, and are reversible without specific intervention.

There is no known specific antidote. Rabeprazole sodium is highly bound to plasma proteins and is therefore not readily dialyzable. In case of overdose, the treatment will be symptomatic and will aim at preserving the vital functions.

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.