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Pariet®

Indications

Pariet® (generic name: rabeprazole) is a proton-pump inhibitor (PPI) which suppresses gastric acid production. It indicates for the treatment of:

  • Duodenal Ulcer
  • Gastric Ulcer
  • Stomal Ulcer
  • Reflux Esophagitis
  • GERD long term management
  • Symptomatic treatment of GERD
  • Zollinger-Ellison Syndrome
  • H.pylori eradication in combination with antibiotics

Pariet®

Dosage & Administration

There are two doses of Pariet®: 10mg and 20mg tablets. DO NOT chew or crush the tablet when you are taking Pariet®.

Indication Recommended Dosage Duration
Reflux Esophagitis 10mg or 20mg QD 8 weeks
10mg or 20mg BD for patients who have not healed after 8 weeks of PPI treatment 8 weeks
GERD Maintenance 10mg or 20mg QD As long as clinically necessary
Symptomatic GERD 10mg QD 4 weeks
On-Demand Maintenance for Symptomatic GERD 10mg QD When needed
H. pylori Eradication 20mg + amoxicillin 1g + clarithromycin 500mg, all BD 7 days
10mg + amoxicillin 750mg + clarithromycin 200mg, all BD 7 days
10mg +metronidazole 250mg + amoxicillin 750mg, all BD 7 days
Gastric Ulcer 10mg or 20mg QD 8 weeks
Duodenal Ulcer 10mg or 20mg QD 6 weeks
Stomal Ulcer 10mg or 20mg QD 8 weeks
Zollinger-Ellison Syndrome 60-120mg daily As long as clinically necessary

Contraindications

Pariet® is contraindicated in patients with known hypersensitivity to rabeprazole sodium or substituted benzimidazoles or to any excipient used in the formulation. Patients in pregnancy or breast feeding are contraindicated to take Pariet®.

Precautions

Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or esophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Pariet®.

Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.

In some rare cases, patients taking PPIs including rabeprazole, for at least 3 months, in most cases after a year of therapy, may suffer from hypomagnesemia (low concentration of magnesium in blood). Serious adverse events include tetany, arrhythmias, and seizure. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g, diuretics), healthcare professionals may consider monitoring magnesium level prior to initiation of PPI treatment and periodically.

Pariet® is not recommended for use in children, as there is no clinical evidence of its use in this group.

No evidence of significant drug related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However, because there are no clinical data on the use of Pariet® in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Pariet® is first initiated in such patients.

Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly clostridium difficile.

Fractures: Observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy, appropriate to the condition being treated.

Concomitant use of Rabeprazole with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.

Drug Interactions: It has been reported that the hepatic enzyme cytochromes P450 2C19 (CYP2C19) and 3A4 (CYP3A4) are involved in the metabolism of Pariet®. Studies in healthy subjects have shown that rabeprazole sodium does not have clinically significant interactions with the drugs studied including warfarin, phenytoin, theophylline or diazepam metabolized by the CYP450 system.

Undesirable Effects

The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache (10%), diarrhea (8%), abdominal pain (4%), asthenia (4%), flatulence (3%), rash (1%) and dry mouth (1%). The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature. The following adverse events have been reported from clinical trial and post-marketed experience. Frequencies are defined as: common (=1/100, <1/10), uncommon (=1/1000, <1/100), rare(=1/10,000, <1/1,000) and very rare (<1/10,000).

System Organ Class Common Uncommon Rare Very Rare Not Known
Infections and infestations Infection
Blood and the lympatic system disorders Neutropenia

Leucopenia

Thrombocytopenia

Leucocytosis

Immune system disorders Hypersensitivity*,**
Metabolism and nutrition disorders Anorexia

Hypomagesemia

Hyponatremia
Psychiatric disorders Insomnia Nervousness Depression Confusion
Nervous system disorders Headache

Dizziness

Somnolence
Eye disorders Visual disturbance
Vascular disorder Peripheral oedema
Respiratory, thoracic and mediastinal disorders Cough

Pharyngitis

Rhinitis

Bronchitis

Sinusitis

Gastrointestinal disorders Diarrhoea

Vomiting

Nausea

Abdominal pain

Constipation

Flatulence

Dyspepsia

Dry mouth

Eructation

Gastritis

Stomatitis

Taste disturbance

Hepato-billary disorder Hepatitis

Jaundice

Hepatic encephalopathy***

Skin and subcutaneous tissue disorders Rash

Erythema**

Pruritus

Sweating

Bullous reactions**

Erythema multiforme

Toxic epidermal necrolysis (TEN)

Stevens-Johnson syndrome (SJS)

Musculoskeletal, connective tissue and bone disorders Non-specific pain Back pain Myalgia

Leg cramps

Arthralgia

Renal and urinary disorders Urinary tract infection Interstitial nephritis
Reproductive system and breast disorders Gynaecomastia
General disorders and administration site conditions Asthenia Influenza like illness Chest pain

Chills

Pyrexia

Investigations Increased hepatic enzymes*** Weight increased

*Includes facial swelling, hypotension and dyspnea.

**Erythema, bullous reactions and hypersensitivity reactions have usually resolved after discontinuation of therapy.

***Rare reports of hepatic encephalopathy have been received in patients with underlying cirrhosis. In treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Pariet® is first initiated in such patients.

For further product information kindly refer to the prescribing information.

Reference of Pariet® website

Pariet® package insert