RABEPRAZOLE

Drugs in Pregnancy and Lactation.

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Name: RABEPRAZOLE
Class: Gastrointestinal Agent (Antisecretory)
Risk Factor:    BM

Fetal Risk Summary

Rabeprazole is a proton pump inhibitor that blocks gastric acid secretion by a direct inhibitory effect on the gastric parietal cell (1). It is used for the treatment of duodenal ulcer, erosive or ulcerative gastroesophageal reflux disease (GERD), and the long-term treatment of pathologic hypersecretory conditions, such as Zollinger-Ellison syndrome.

Reproductive studies have been conducted in rats and rabbits at IV doses up to 13 and 8 times, respectively, the recommended human dose based on area under the plasma concentration curve (1). No evidence was found at these doses of impaired fertility or fetal harm. In male and female rats, rabeprazole caused gastric cell hyperplasia and, in female rats, gastric cell tumors, at all doses tested (1). In addition, positive results with the drug and its inactive metabolite were demonstrated in hamsters and mice with the in vitro Ames mutation assay and in some other mutagenicity tests (1).

It is not known if rabeprazole crosses the human placenta. The molecular weight (about 381 for the sodium salt) is low enough, however, that passage to the fetus should be expected. Another proton pump inhibitor, omeprazole, has a similar molecular weight and chemical structure and it is known to cross the human placenta (see Omeprazole).

No reports describing the use of rabeprazole during human pregnancy have been located. Human pregnancy experience with two other proton pump inhibitors (see Lansoprazole and Omeprazole) have not shown a causal relationship with congenital malformations. In some cases, for both agents, malformations may have been missed because of the design and size of the studies. The carcinogenic and mutagenic data are a potential concern, but the absence of follow-up studies prevents a risk assessment for exposed offspring. As with all drug therapy, avoidance of rabeprazole during pregnancy, especially during the 1st trimester, is the safest course. If rabeprazole is required or if inadvertent exposure does occur early in gestation, the known risk to the embryo/fetus for congenital defects, based on animal data for rabeprazole and the published experience with other proton pump inhibitors, appears to be low. Long-term follow-up of offspring exposed during gestation is warranted.

Breast Feeding Summary

No reports describing the use of rabeprazole during human lactation have been located. The drug is excreted into the milk of lactating rats (1). Moreover, the drug concentrated in rat milk, reaching levels 2–7 times the concentrations found in the plasma. Decreased body weight gain of pups was observed when the drug was administered to rats in late gestation and during lactation at a dose 195 times the recommended human dose based on body surface area. The clinical significance of this in humans is unknown. The animal data and the relatively low molecular weight (about 381 for the sodium salt) suggests that rabeprazole will be excreted into human milk. Because of the mutagenicity shown in some animal tests, the carcinogenicity observed in female rats, and the potential for suppression of gastric acid secretion in the nursing infant, the use of rabeprazole during lactation should probably be avoided until clinical data are available.

Reference

  • Product information. Rabeprazole. Eisai, 2001.

    Index

    Q&A about Rabeprazole

    sabir a
    Is it ok to take Rabeprazole Sodium & Domperidone for more than 2 years?
    I've been taking this now for more than 2 yrs for gastritis.Is that ok?any side effects?
    noah > U
    Do you really trust your life with individuals here in Y/A?

    I suggest you talk to your personal physician regarding your digestive diseases.

    Good god...
    gingerjo...
    Why do I need to take Rabeprazole?
    I had a sprain in the MCL(right knee). I had nearly recovered when I had a fall again. Doctor advised me to wear braces for 2 weeks and prescribed Diclofenac Sodium tablets and Serratiopeptidase tablets. Perhaps these are pain killers? Are they? I was also prescribed Rabeloc 20 ( Rabeprazole ). I looked it up and found it is used to reduce production of stomach acids. Why would I be prescribed these?
    Bardic
    Diclofenac is used to relieve pain and inflammation in a wide range of conditions, including arthritis, gout, sprains, fractures, back pain and following minor surgery.

    Serratiopeptidase is a powerful anti-inflammatory.

    The absorption of certain drugs may be affected by changes in stomach acidity, I'd guess the Rabeprazole is to tailor your stomach acid to complement the other two drugs and protect you from the indigestion they may cause (especially the Diclofenac).
    ruth me
    can I drink a cocktail when I take rabeprazole sodium tablets?
    This product is for heart burn
    Stephen K
    NEVER take medication with alcohol
    ruth me
    What Herb is most likely to interact with prescription drugs such as Rabeprazole Sodium (Pariet) orFenofibrate
    dremadag...
    rabeprazole is extensively metabolized in liver so any drug affect liver metabolizing enzyme exactly is cytochrome p-450 will either increase or decrease efficacy but aim sorry that i do not know the herb that affect this enzymes so look at the contraindication if buy the herb from the OTC in pharmacy and buy from recommended source only since the unstudied formulas is very toxic
    manoharp...
    Does anyone have access to clinical trials with Intravenous Rabeprazole?
    IV Rabeprazole is marketed in India since 2004. Rabeloc IV, Rabicip IV, Rablelet IV...
    Michelle...
    marg_gag...
    what is the precription medication in canada "rabeprazole sodium" used for?
    Nurse Annie
    This medication is used to treat duodenal (intestinal) ulcers, as well as conditions that cause extreme increases in stomach acid production (such as Zollinger-Ellison syndrome), erosive esophagitis (severe, chronic inflammation or ulceration of the esophagus), and heartburn--both due to gastroesophageal reflux (backwash of stomach acid into the esophagus).
    Johann B
    can cummadin and orphenadrine citrate 100mg andnaproxen andaciphex rabeprazole sodium cause limp dick?
    i have been usig the acid flex drug for three days and now im on mussle relaxer drugs
    cdsfhc20...
    Those medications should not be causing that, none of them have effects on erection, the coumadin works on blood clotting, the orphenadrine relaxes skeletal muscle(none of that in your penis), naproxen is an antiinflammatory, and aciphex only works in your stomach, so i dont think its related
    Kind G
    Rabeprazole sodium?
    Rabeprazole sodium?

    doctor prescribed me it, and im 17 is it ok to take it?

    my doc is on vacation and im having liver pains from taking it, and joint pains.
    Kate from Drugs.com
    Although these are not noted side effects of rabeprazole (see source link below), I would suggest you stop taking it and see some other doctor as soon as possible. Don't wait till your doctor comes back.

    If you can tolerate the heartburn or indigestion symptoms, it's fine to stop taking rabeprazole.
    katietig...
    rabeprazole sodium 10 mg?
    Hey everyone, well about a week or 2 ago i got prescribed this pill called rabeprazole sodium 10mg because i have acid reflux and it seems to be helping. The thing is though that everytime i have startch like potatoes or fries i always get really nauses and have a burning stomach. Well today i forgot and went ahaed and had a poutin, not a good thing. Well now my stomach is killing me i have diaraha and my stomauch is nauses and burning and i'm a bit bloated. I took my pill before i ate and it didn't help. I'm only supposed to take it once a day but would it hurt taking another one since i feel like crap? Or should I not and wait till i get back home to go see the doctor's. I'm on vacation right now and won't be back till Sunday.

    Please give me some advice and let me know what to do i'm in pain and don't want to go home just yet!!
    cheryl s
    No, do not take more than the doc prescribed. Those are all possible side effects of the medicine so talk with your doc when u get home. If the pain is real severe, go to nearest ER could be food poisioning.
    Utopia
    Which proton pump acid inhibitor (Nexium, Prevacid, etc.) do you think is the best? anyone tried Rabeprazole?
    found out my insurance doesn't pay for Nexium, but may others, anybody have that problem with their insurance? why u think the reason? I always get in a battle with them for paying for Viagra (10-20 $/ pill) like Medicare was paying but not for other drugs, politicians felt even though age in 70's and 80's very important drug Viagra, shows what our gov officials spend a lot of time doing on our salary with our money
    double_k...
    Nexium is the best I've tried. Have you tried Prilosec? It's Over-the-counter and works quite well. Ask your doctor for a close generic to Nexium. The insurance companies most always will cover the generic scripts. If it involves the male of our species nothing is too good or expensive for them. WHY? Because most of our government is run by a bunch a OLD, FAT MALE B- - - - - -s that should have retired years ago and had to live on Medicare