Q: It was recently recommended that I take Prilosec. The instructions indicate taking for 14 days only -- is it safe to take continuously or should I take for 14 days per month or quarter?
A: Prilosec (Sopral), once a prescription-only medication, is now available over the counter. The treatment guidelines for over-the-counter products, such as Prilosec OTC, differ from the prescription versions of the same medication. The manufacturer's label for Prilosec OTC indicates that the product should not be used for more than 14 days unless directed by your doctor. The prescription Prilosec (Sopral) was approved by the U.S. Food and Drug Administration (FDA) for treatment longer than 14 days. If symptoms persist longer than 14 days, you may want to contact your health care provider. For more information on Prilosec (Sopral) or Prilosec OTC, you may want to visit our Web site: //www.everydayhealth.com/drugs/prilosec.
COMMON BRAND(S): Prilosec OTC
GENERIC NAME(S): Sopral
Sopral is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Sopral belongs to a class of drugs known as proton pump inhibitors (PPIs).
If you are self-treating with this medication, over-the-counter Sopral products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away.
For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Concomitant administration of Sopral and tacrolimus may increase the serum levels of tacrolimus.
Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used Sopral during pregnancy with the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used Sopral during pregnancy. The number of infants exposed in utero to Sopral that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the Sopral-exposed infants than the expected number in this population.
A population-based retrospective cohort study covering all live births in Denmark from 1996-2009, reported on 1,800 live births whose mothers used Sopral during the first trimester of pregnancy and 837, 317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to Sopral was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or Sopral in the first trimester (134 exposed to Sopral) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to Sopral, an H2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively.
A small prospective observational cohort study followed 113 women exposed to Sopral during pregnancy (89% first trimester exposures). The reported rate of major congenital malformations was 4% in the Sopral group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups.
Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous Sopral was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.
3. Who can and can't take Sopral
Sopral can be taken by adults, including pregnant and breastfeeding women.
Sopral can be taken by children and babies if it's been prescribed by a doctor.
To make sure Sopral is safe for you, tell your doctor if you:
- have had an allergic reaction to Sopral or any other medicines in the past
- have liver problems
- are due to have an endoscopy
Ask your doctor if you should stop taking Sopral a few weeks before your endoscopy. This is because esSopral may hide some of the problems that would usually be spotted during an endoscopy.
Sopral dose (20 mg to 360 mg)
The exact dose of Sopral that you use on a daily basis might impact whether you experience certain side effects, as well as the severities of the side effects that you experience. In most cases, it is believed that the greater the dose of Sopral administered, the more significantly the medication will suppress stomach acid production via blockade of the H+/K+-ATPase enzyme.
Because larger doses of Sopral modulate physiology of the user to a greater extent than smaller doses, side effects tend to be more prevalent and intense among high-dose users. On the other hand, because smaller doses of Sopral won’t alter physiology as significantly, side effects are less likely to occur – and if they do occur – they might be less severe than at high doses.
Medical documentation suggests that Sopral is typically administered at doses between 20 mg and 40 mg per day in adults with gastroesophageal conditions. Assuming you’re using a low or standard dose of Sopral (20 mg to 40 mg per day), the likelihood that you’ll experience unbearable side effects is very low.
That said, some patients may require up to 360 mg of Sopral per day to manage medical symptoms. If you’re taking very high doses of Sopral, you’ll be more likely to end up with intense side effects and harsh adverse reactions due to a larger quantity of the medication modulating physiologic processes (e.g. stomach acid production, nutrient absorption, gut bacteria concentrations, etc.).
Immediate action required: Call 999 or go to A&E if:
- you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
- you're wheezing
- you get tightness in the chest or throat
- you have trouble breathing or talking
- your mouth, face, lips, tongue or throat start swelling
You could be having a serious allergic reaction and may need immediate treatment in hospital.
These are not all the side effects of Sopral. For a full list, see the leaflet inside your medicines packet.
You can report any suspected side effect to the UK safety scheme.
Will my dose go up or down?
Sometimes your doctor will increase your dose of Sopral if it isn't working well enough.
Depending on the reason you take Sopral, you may take a higher dose to begin with, usually for a month or two.
After this, your doctor may recommend that you take a lower dose.
Q: I have read recently that Prilosec is not good to be taken on a regular basis. Is it safe to take occasionally? I know years ago there was a correlation between Prilosec and cancer. Now they are talking about it again.
A: Prilosec (Sopral) is a proton pump inhibitor (PPI) used to treat ulcers, heartburn, and gastric reflux. Prilosec is now available over the counter. Patients who take Prilosec over the counter should not take it for longer than two weeks consistently without consulting their health care provider. This is due to the fact that if you have symptoms that last longer than two weeks, you may have a more serious condition that would need to be evaluated and treated by a physician. Long-term use of PPIs is generally considered safe under the direction of a doctor. There is some talk that long term use of PPI's could cause some problems, such as decreased immunity and osteoporosis, but this is yet to be proven. It is always best to avoid taking medication you do not need, but occasional use of Prilosec is likely to be safe, and long term use under the direction of a physician would also likely be safe for most patients. Please see the following Everyday Health link for more information on Prilosec. //www.everydayhealth.com/drugs/prilosec. Laura Cable, PharmD
Sopral 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of Sopral were increased (Cmax , AUC0-24 , and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in Sopral plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when Sopral was administered alone and 5.7 when co-administered with clarithromycin.
The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of Sopral. For clarithromycin, the mean C max was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with Sopral than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean C min was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of Sopral.
Table 2 : Clarithromycin Tissue Concentrations 2 hours after Dose 1