OMEPRAZOLE
Drugs in Pregnancy and Lactation.
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Name: OMEPRAZOLE
Class: Gastrointestinal Agent (Antisecretory)
Risk Factor: CM
Fetal Risk Summary
The antisecretory agent omeprazole, a proton pump inhibitor, suppresses gastric acid secretion by a direct inhibitory effect on the gastric parietal cell (1). It is used for the treatment of duodenal and gastric ulcers, erosive esophagitis, and pathologic hypersecretory conditions, such as Zollinger-Ellison syndrome.
In reproductive studies in pregnant rats and rabbits, doses up to approximately 345 and 172 times, respectively, the normal human dose produced no evidence of teratogenicity, but dose-related embryo and fetal mortality was observed (1). A dose-dependent increase in gastric cell carcinoid tumors has been observed in rats (1). The in vitro Ames mutagen assay was negative. Other tests for genotoxicity in mice and rats were either borderline or negative (1).
Omeprazole crosses the placenta to the fetus in sheep (2) and in humans (3). In sheep, the fetal:maternal ratio of total omeprazole, after both low and high dosage, was 0.2, but the ratio of unbound drug was 0.5 (2). Urinary clearance of the drug was low in both the mother and the fetus.
Placental passage of omeprazole in humans was demonstrated in a study published in 1989 (3). Twenty women were administered a single 80-mg oral dose of omeprazole the night before scheduled cesarean sections with a mean dosing-to–general anesthesia induction time interval of 853 minutes (range of 765–977 minutes) (3). At the time of surgery, maternal omeprazole levels ranged from 0 to 271 nmol/L. The drug concentration in 13 of the 20 infants (both arterial and venous umbilical samples were drawn in most cases) was either 0 or below the minimum detection limit (20 nmol/L). In the remaining 7 infants, omeprazole cord blood concentrations ranged from 21 to 109 nmol/L. No adverse effects attributable to the drug were observed either at birth or at follow-up in 7 days.
The FDA has received reports, following pregnancy exposure to omeprazole, of 11 specified birth defects, 4 of which were anencephaly and 1 of which was a hydranencephaly that developed de novo after starting omeprazole in the 13th gestational week (F. Rosa, personal communication, FDA, 1996).
A paper published in 1995 described the use of omeprazole, 20 mg daily for esophageal reflux, by a woman in two consecutive pregnancies that were terminated because of severe congenital anomalies—anencephaly in one and severe talipes in the other (4). The first pregnancy was the result of a gamete intrafallopian transfer (GIFT) procedure, and the second occurred after a natural conception. Both aborted fetuses had normal chromosomal patterns.
A woman with Zollinger-Ellison syndrome was treated in two of her three pregnancies with omeprazole (5). In her first pregnancy, she had been treated with ranitidine (300 mg/day) and other therapy during the 2nd and 3rd trimesters and delivered a healthy, 2560-g boy at 37 weeks' gestation. She then presented at 11 weeks' gestation in her second pregnancy, complaining of abdominal pain and vomiting. Her symptoms were controlled with omeprazole (120 mg/day), which was continued until delivery of a healthy, 2610-g girl. During the third pregnancy, she was treated throughout gestation with omeprazole (180 mg/day) and cimetidine (450 mg/day), delivering a healthy, term 2550-g male infant.
Data from the Swedish Medical Birth Registry were presented in 1998 (6). A total of 553 infants (6 sets of twins) were delivered from 547 women who had used acid-suppressing drugs early in pregnancy. A number of other pharmaceutical agents, identified only by drug category, were also used by these women. Seventeen infants with birth defects were identified (3.1%; 95% confidence interval [CI] 1.8–4.9) compared with the crude malformation rate of 3.9% in the Registry. The odds ration (OR) for a congenital malformation, stratified for birth year, maternal age, parity, and smoking was 0.72 (95% CI 0.41–1.24) (6). The OR for malformations after proton pump blocker exposure was 0.91 (95% CI 0.45–1.84) compared with 0.46 (95% CI 0.17–1.20) for H2-receptor antagonists (OR 0.86, 95% CI 0.33–2.23; p=0.13). Of the 17 infants with birth defects, 10 had been exposed to proton pump blockers, 6 to H2 antagonists, and 1 to both classes of drug. Six of the defects in the proton pump inhibitor group were cardiovascular defects (see also Lansoprazole), whereas only one such defect occurred in those exposed to H2 antagonists. Omeprazole was the only acid-suppressing drug exposure in 262 infants. Twenty other offspring were exposed in utero to omeprazole combined either with cimetidine (2 infants) or ranitidine (18 infants). Eight birth defects (3.1%) were observed in the group where omeprazole was the only acid-suppressing agent used. The defects were ventricular septum defect (N=3), and one each of patent ductus arteriosus, unspecified cardiac defect, urethral valve (detected at 1 month of age), facial anomaly (type not specified), and Down's syndrome. In addition, one infant with hypospadias was observed in a newborn exposed to a combination of omeprazole and ranitidine (6).
A prospective cohort study published in 1998 described the pregnancy outcomes of 113 women exposed to omeprazole (101 during organogenesis) matched to 113 disease-paired controls (exposed to H2-receptor antihistamines) and 113 controls who were exposed to nonteratogenic agents (e.g., dental radiation, acetaminophen) (7). All of the subjects and controls had contacted a teratogen information service to inquire about drug exposures during their pregnancy. Omeprazole-exposed women were from Canada (N=59), Italy (N=41), and France (N=13), whereas all of the 226 controls were from Canada (Motherisk Program in Toronto). There were no significant differences between the groups in alcohol use and smoking. However, omeprazole-exposed women used significantly more antipeptic and prokinetic agents (histamine blockers, antacids, sucralfate, bismuth subsalicylate, calcium carbonate, and cisapride) than women in the two control groups. Pregnancy outcomes were determined from information supplied by the women shortly after delivery. No significant differences between the three groups in terms of live births, spontaneous abortions, elective abortions, gestational age at delivery, preterm delivery, Cesarean section, and birth weight were observed (7). The incidence of major anomalies in live births exposed during the 1st trimester in the three groups were 4 of 78 (5.1%), 3 of 98 (3.1%), and 2 of 66 (3.0%), respectively. The four malformations in omeprazole-exposed infants were ventricular septal defect, polycystic kidneys, ureteropelvic junction stenosis, and patent ductus arteriosus. In disease-paired controls, the three defects were atrial septal defect and two cases of ventricular septal defect, whereas in nonteratogenic controls the two malformations were atrial septal defect with pulmonary stenosis and developmental delay. Although the study lacked the statistical power to detect a small increase in major malformations, the authors concluded that it was unlikely that omeprazole was a major teratogen (7).
A 1998 non-interventional observational cohort study described the outcomes of pregnancies in women who had been prescribed one or more of 34 newly marketed drugs by general practitioners in England (8). Data were obtained by questionnaires sent to the prescribing physicians one month after the expected or possible date of delivery. In 831 (78%) of the pregnancies, a newly marketed drug was thought to had been taken during the 1st trimester with birth defects noted in 14 (2.5%) singleton births of the 557 newborns (10 sets of twins). In addition, two birth defects were observed in aborted fetuses. However, few of the aborted fetuses were examined. Omeprazole was taken during the 1st trimester in five pregnancies. The outcomes of these pregnancies included one elective abortion and four normal, full-term infants (8).
The pregnancy outcomes of nine women who had taken omeprazole (20–60 mg/day) during gestation were described in 1998 publication (9). Four of the women took omeprazole during the 1st trimester and five started treatment in the 2nd or 3rd trimesters. No complications or congenital malformations were observed in the offspring or during subsequent follow-up periods ranging from 2 to 12 years (9).
In a study published in 1999, investigators linked data from a Danish prescription database to a birth registry to evaluate the risks of proton pump inhibitors for congenital malformations, low birth weight, and preterm delivery (<37 weeks') (10). From a total of 51 women who had filled a prescription for these drugs sometime during pregnancy, 38 (omeprazole N=35, lansoprazole N=3) had done so during the interval of 30 days before conception to the end of the 1st trimester. A control group, consisting of 13,327 pregnancies in which the mother had not obtained a prescription for reimbursed medication from 30 days before conception to the end of her pregnancy, was used for comparison. The prevalence of major congenital anomalies in the controls was 5.2%. Three major birth defects (7.9%), two of which were cardiovascular anomalies, were observed from the 38 pregnancies possibly exposed in the 1st trimester (specific drug exposure not given): ventricular septum defect; pyloric stenosis; and one case of patent ductus arteriosus, atrial septum defect, hydronephrosis, and agenesis of the iris. Compared with controls, the adjusted (for maternal age, birth order, gestational age, and smoking, but not for alcohol abuse) relative risks for the three outcomes were congenital malformations 1.6 (95% CI 0.5–5.2), low birth weight 1.8 (95% CI 0.2–13.1), and preterm delivery (not adjusted for gestational age) 2.3 (95% CI 0.9–6.0). Although the study found no elevated risks for the three outcomes, the investigators cautioned that more data were needed to assess the possible association between proton pump inhibitors and cardiac malformations or preterm delivery (10).
Two databases, one from England and the other from Italy, were combined in a study published in 1999 that was designed to assess the incidence of congenital malformations in women who had received a prescription for an acid-suppressing drug (omeprazole, cimetidine, or ranitidine) during the 1st trimester (11). Nonexposed women were selected from the same databases to form a control group. Spontaneous abortions and elective abortions (except two cases of prenatally diagnosed congenital anomalies that were grouped with stillbirths) were excluded from the analysis. Stillbirths were defined as any pregnancy loss occurring at 28 weeks' gestation or later. Omeprazole was taken in 134 pregnancies, resulting in 139 live births (11 [7.9%] premature), 5 (3.7%) of whom had a congenital malformation. There were no stillbirths or neonatal deaths. The malformations were (shown by system): head/face (tongue tie), heart (septal defects, N=2), muscle/skeleton (dysplastic hip/dislocation/clicking hip), and genital/urinary (congenital hydrocele/inguinal hernia). In addition, three newborns had a small head circumference for gestational age. In comparison, the outcomes of 1,547 nonexposed pregnancies included 1,560 live births (115 [7.4%] premature), 15 stillbirths (includes 2 elective abortions for anomalies), and 10 neonatal deaths. Sixty-four (4.1%) of the newborns had malformations, including defects of the central nervous system (N=2), head/face (N=13), eye (N=2), heart (N=7), muscle/skeleton (N=13), genital/urinary (N=18), gastrointestinal (N=2), and those that were polyformation (N=3) or known genetic anomalies (N=4). There were 21 newborns that were small for gestational age and 78 had a small head circumference for gestational age. The relative risk of malformation (adjusted for mother's age and prematurity) associated with omeprazole was 0.9 (95% CI 0.4–2.4), with cimetidine 1.3 (95% CI 0.7–2.6), and with ranitidine 1.5 (95% CI 0.9–2.6) (11).
A 1998 case report described a 41-year-old woman with refractory gastroesophageal reflux disease (GERD) who was treated with omeprazole (20 mg/day) starting at 29 weeks' gestation (12). Previous treatment with ranitidine (late 1st trimester), cisapride (2nd trimester), or a combination of the two had been unsuccessful. A slightly premature male child (birth weight not given) with fetal bradycardia was delivered in the 36th week with Apgar scores of 6 and 9 at 1 and 5 minutes, respectively. He was doing well at 1 year of age (12).
Several investigations have studied the effect of omeprazole for prophylaxis against aspiration pneumonitis in emergency cesarean section (13,14,15,16,17 and 18). No adverse effects were noted in the newborns.
In summary, the lack of teratogenicity in animals and the bulk of the human 1st-trimester exposure data indicate that omeprazole is not a major human teratogen. None of the cohort studies measured a significant increase in the rates of major birth defects, but they lacked the power to detect small increases in birth defects or rare malformations. The small cluster of cardiac defects observed in one study after omeprazole exposure appears to be an errant signal as it was not confirmed in other studies. Most likely, cardiac and other defects observed in all studies were the result of many factors, including possibly the severity of the disease and concurrent use of other drugs. The data, however, do warrant continued investigation. In addition, the studies lacked the sensitivity to detect minor anomalies because of the absence of standardized examinations. Late-appearing major defects may also have been missed due to the timing of some of the data collection. The gastric tumors observed in rats are a potential concern for human offspring, but the dose-related nature of the tumors and the limited in utero exposure during gestation probably indicates a negligible risk. However, as with all drug therapy, avoidance of omeprazole during pregnancy, especially during the 1st trimester, is the safest course. If omeprazole is required or if inadvertent exposure does occur early in gestation, the known risk to the embryo/fetus appears to be low. Long-term follow-up of offspring exposed during gestation is warranted.
Breast Feeding Summary
Only one report describing the use of omeprazole during human lactation has been located. A woman with refractory GERD was treated with omeprazole (20 mg/day) for 7–8 weeks before delivering a premature male infant (birth weight not given) at 36 weeks' gestation (see above) (12). Treatment was continued after birth during breast feeding. During this time, she fed her infant son just before taking her dose at 8 AM, refrained from nursing for 4 hours, then expressed and discarded her milk at 12 noon. At 3 weeks postpartum, blood and milk samples were obtained at 8 AM and then every 30 minutes for 4 hours (i.e., until 12 noon). The milk was obtained by expressing but the volume of the samples was not specified. Maternal serum concentrations began to rise 90 minutes after the dose, reached 950 nM at 12 noon, and appeared to be still rising. Breast milk levels also began to rise at 90 minutes and peaked at 180 minutes at 58 nM. The infant was doing well at 1 year of age.
The above case report estimated a maximum daily omeprazole exposure of 4 µg, but the calculation was based on a consumption of only 200 mL of milk/day for a 5-kg infant (40 mL/kg/day). A more acceptable value is 150 mL/kg/day (19). Moreover, the milk samples were obtained by expression and the volumes expressed were not given. This is clinically relevant because hindmilk obtained at the end of a feeding is 4–5 times higher in fat than foremilk (20). For lipid-soluble drugs, such as omeprazole, hindmilk would be expected to contain most of the drug in milk.
In concurrence with the above case report, the relatively low molecular weight of omeprazole (about 345) predicts that it will be excreted into human milk. In rats, administration of omeprazole at a dose 35–345 times the human dose during late gestation and lactation resulted in decreased pup weight gain (1). The clinical significance of this for nursing human infants is unknown.
One source has stated that the safety of a drug during breast feeding can be arbitrarily defined as no more than 10% of the adult dose standardized by weight if a therapeutic dose for infants is not known (13). Until additional studies show that omeprazole meets this criterion, the use of omeprazole during breast feeding should probably be avoided. Other concerns, such as the carcinogenicity observed in animals and the potential for suppression of gastric acid secretion in the nursing infant, also warrant further study.
References
- Product information. Prilosec. AstraZeneca, 2001.
- Ching MS, Morgan DJ, Mihaly GW, Hardy KF, Smallwood RA. Placental transfer of omeprazole in maternal and fetal sheep. Dev Pharmacol Ther 1986;9:323–31.
- Moore J, Flynn RJ, Sampaio M, Wilson CM, Gillon KRW. Effect of single-dose omeprazole on intragastric acidity and volume during obstetric anaesthesia. Anaesthesia 1989;44:559–62.
- Tsirigotis M, Yazdani N, Craft I. Potential effects of omeprazole in pregnancy. Hum Reprod 1995;10:2177–8.
- Harper MA, McVeigh JE, Thompson W, Ardill JES, Buchanan KD. Successful pregnancy in association with Zollinger-Ellison syndrome. Am J Obstet Gynecol 1995;173:863–4.
- Kallen B. Delivery outcome after the use of acid-suppressing drugs in early pregnancy with special Reference to omeprazole. Br J Obstet Gynaecol 1998;105:877–81.
- Lalkin A, Loebstein R, Addis A, Ramezani-Namin F, Mastroiacovo P, Mazzone T, Vial T, Bonati M, Koren G. The safety of omeprazole during pregnancy: a multicenter prospective controlled study. Am J Obstet Gynecol 1998;179:727–30.
- Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 1998;105:882–9.
- Brunner G, Meyer H, Athmann C. Omeprazole for peptic ulcer disease in pregnancy. Digestion 1998;59:651–654.
- Nielsen GL, Sorensen HT, Thulstrup, Tage-Jensen U, Olesen C, Ekbom A. The safety of proton pump inhibitors in pregnancy. Aliment Pharmacol Ther 1999;13:1085–9.
- Ruigomez A, Rodriguez LAG, Cattaruzzi C, Troncon MG, Agostinis L, Wallander MA, Johansson S. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol 1999;150:476–81.
- Marshall JK, Thomson ABR, Armstrong D. Omeprazole for refractory gastroesophageal reflux disease during pregnancy and lactation. Can J Gastroenterol 1998;12:225–7.
- Yau G, Kan AF, Gin T, Oh TE. A comparison of omeprazole and ranitidine for prophylaxis against aspiration pneumonitis in emergency caesarean section. Anaesthesia 1992;47:101–4.
- Orr DA, Bill KM, Gillon KRW, Wilson CM, Fogarty DJ, Moore J. Effects of omeprazole, with and without metoclopramide, in elective obstetric anaesthesia. Anaesthesia 1993;48:114–9.
- Rocke DA, Rout CC, Gouws E. Intravenous administration of the proton pump inhibitor omeprazole reduces the risk of acid aspiration at emergency cesarean section. Anesth Analg 1994;78:1093–8.
- Gin T. Intravenous omeprazole before emergency cesarean section. Anesth Analg 1995;80:848.
- Rocke DA, Rout CC. Intravenous omeprazole before emergency cesarean section. Anesth Analg 1995;80:848–9.
- Stuart JC, Kan AF, Rowbottom SJ, Gin T. Acid aspiration prophylaxis for emergency caesarean section. Anaesthesia 1996;51:415–21.
- Ito S. Drug therapy for breast-feeding women. N Engl J Med 2000;343:118–26.
- Lawrence RA, Lawrence RM. Breastfeeding. A Guide for The Medical Profession. 5th ed. St. Louis, MO: Mosby, 1999:360.
Q&A about Omeprazole
I started taking 20MG of Omeprazole about two weeks ago and developed this rash. I googled it and found that i wasn't the only one with this problem. I decided to quit taking it today and monday I'll call the VA Hospital to see about changing it.
[Posted August 09, 2007] FDA issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, omeprazole (Prilosec) and esomeprazole (Nexium). The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD.
The results from the study of omeprazole and analyses from an ongoing study of esomeprazole raised concerns that long-term use of omeprazole or esomeprazole may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. After reviewing these and other data submitted by the company, FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.
Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Omeprazole is also sold over the counter for frequent heartburn. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/... and http://www.fda.gov/cder/drug/early_comm/...
Why is this medication prescribed? Return to top
Prescription omeprazole is used alone or with other medications to treat ulcers (sores in the lining of the stomach or small intestine), gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus (tube that connects the mouth and stomach), and erosive esophagitis (swelling and wearing away of the lining of the esophagus). Omeprazole delayed-release capsules are also used to treat conditions in which the stomach produces too much acid. Omeprazole delayed-release capsules are also used in combination with other medications to eliminate H. pylori(a bacteria that causes ulcers) and possibly prevent new ulcers from developing in patients who have or have had ulcers of the small intestine. Omeprazole powder for suspension (to be mixed with water) is also used to prevent bleeding from the esophagus, stomach, or the top of the small intestine in people who have life-threatening illnesses. Nonprescription omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 days a week). Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
How should this medicine be used? Return to top
Omeprazole comes as a delayed-release capsule (Prilosec), a nonprescription delayed-release tablet (Prilosec OTC), a powder for suspension (Zegerid) , and a regular capsule (Zegerid). The powder and regular capsule also contain sodium bicarbonate, a medication that decreases the amount of acid in the stomach and helps omeprazole to work quickly. The delayed-release capsules are usually taken once a day before a meal, but may be taken twice a day when used with other medications to eliminate H. pylori or up to three times a day when used to treat conditions in which the stomach produces too much acid. The capsules are usually taken once a day in the morning on an empty stomach one hour before a meal. The powder is usually taken once a day on an empty stomach one hour before a meal either in the morning or at bedtime. The nonprescription delayed-release tablets are usually taken once a day in the morning before eating. The nonprescription tablets should be taken for 14 days in a row, and additional 14-day treatments may be repeated once every 4 months if needed. To help you remember to take omeprazole, take it at around the same time(s) every day. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take omeprazole exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor or stated on the package.
Swallow the regular omeprazole capsules with water. Do not swallow the capsules with any other liquid.
Swallow the delayed-release omeprazole capsules, the regular capsules, and the nonprescription delayed-release tablets whole; do not split, open, chew or crush them. Do not crush the nonprescription delayed-release tablets in food and do not open the regular capsules and mix the contents with food.
If you have difficulty swallowing the delayed-release capsules, you may add the contents of a delayed-release capsule to applesauce. Place one tablespoon of soft, cool applesauce in an empty bowl. Open the delayed-release capsule and carefully empty all the pellets inside the capsule onto the applesauce. Mix the pellets with the applesauce and swallow the mixture immediately with a glass of cool water. Do not chew or crush the pellets. Do not store the applesauce/pellet mixture for future use.
If you are taking the powder, you must mix it with water before use. Place 1-2 tablespoons of water into a small cup and add the contents of one powder packet. Mix well and drink the mixture immediately. Refill the cup with water and drink the water to be sure that you swallow all of the medication. Do not mix the medication with any other liquid or with food.
If you are taking the powder or the regular capsules, be sure that you are taking the strength and the number of capsules or powder packets that your doctor prescribed. If you were told to take one 40-mg capsule or powder packet, do not take two 20-mg capsules or powder packets instead. They do not contain the same amount of medication as one 40-mg capsule or packet.Ask your doctor or pharmacist if you have any questions about how many capsules or packets you should take.
Do not take nonprescription omeprazole for immediate relief of heartburn symptoms. It may take 1-4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment Do not take nonprescription omeprazole for longer than 14 days or more often than once every 4 months without talking to your doctor.
Your doctor may prescribe omeprazole for 10-14 days to eliminate H. pylori or for 4-8 weeks or longer to treat other conditions. Continue to take omeprazole even if you feel well. Do not stop taking prescription omeprazole without talking to your doctor.
Other uses for this medicine Return to top
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow? Return to top
Before taking omeprazole,
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
tell your doctor and pharmacist if you are allergic to omeprazole, esomeprazole (Nexium), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex), any other medications, or any of the ingredients in the type of omeprazole you will be taking. Ask your pharmacist or check the package label for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: ampicillin (in Principen, in Unasyn); anticoagulants ('blood thinners') such as warfarin (Coumadin); atazanavir (Reyataz); cyclosporine (Neoral, Sandimmune); diazepam (Valium); digoxin (Lanoxicaps, Lanoxin) disulfiram (Antabuse); ketoconazole (Nizoral); medications for anxiety and seizures; phenytoin (Dilantin); sedatives; sleeping pills; tacrolimus (Prograf); tranquilizers; and vitamins or supplements containing iron. If you will be taking the regular capsules or powder, tell your doctor if you are taking any antacids or calcium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
if you will be taking the regular capsules or the powder, tell your doctor if you have or have ever had low levels of calcium or potassium in your blood or excessive vomiting. Your doctor may tell you not to take omeprazole capsules or powder.
if you plan to take nonprescription omeprazole, first tell your doctor if your heartburn has lasted 3 months or longer or if you have experienced any of the following symptoms: lightheadedness, sweating, or dizziness along with your heartburn; chest pain or shoulder pain; shortness of breath or wheezing; pain that spreads to your arms, neck, or shoulders; unexplained weight loss; nausea; vomiting, especially vomiting blood; stomach pain; difficulty swallowing or pain when you swallow; or black or bloody stools. You may have a more serious condition that cannot be treated with nonprescription medication.
tell your doctor if you have or have ever had liver disease. If you will be taking the regular capsules or the powder, also tell your doctor if you have been told to limit the amount of sodium in your diet, if you have or have ever had low levels of potassium in your blood, or if you have or have ever had Bartter's syndrome (condition in which the kidneys cannot absorb potassium from the blood properly).
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking omeprazole, call your doctor.
What special dietary instructions should I follow? Return to top
If you will be taking the regular capsules or the powder, your doctor may tell you to limit the amount of milk and other foods and drinks that are high in calcium that you eat and drink during your treatment. Follow these instructions carefully.
If you will be taking any other form of omeprazole, continue your normal diet unless your doctor tells you otherwise.
What should I do if I forget a dose? Return to top
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause? Return to top
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Omeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
stomach pain
diarrhea
constipation
dizziness
cough
back pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
rash
hives
itching
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
hoarseness
seizures
muscle spasms, tightening, aching, or cramping
burning or tingling of the lips, tongue, hands, or feet
Omeprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions are needed for this medicine? Return to top
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light,excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose Return to top
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
confusion
drowsiness
blurred vision
fast or pounding heartbeat
nausea
vomiting
sweating
flushing (feeling of warmth)
headache
dry mouth
What other information should I know? Return to top
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor.
Do not let anyone else take your medication. If you are taking prescription omeprazole, ask your pharmacist any questions you have about refilling your prescription.
Brand names Return to top
Prilosec®
Prilosec® OTC
Zegerid®
Last Revised - 01/01/2008
Is anyone else taking this for hiatus hernia or any other stomach problem?
If so did you notice that nobody seems to know if it safe to be taken in pregnancy?
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. ie, dosage as recommended by your doctor.
You can safely take it, ive dispensed this to many pregnant women, so please dont worry. You are not harming the baby.
If you are worried, talk to your doctor, he will be able to reassure you that all is well. Omeprazole is a fairly gentle drug, it doesnt react badly with much at all, certain allergies can cause problems with it, but your doctor would be aware of these anyway.
The reason it says to check with doctor first is simply the same with any other medications, to make sure its not going to interact with any ongoing conditions or meds you are taking. If you had a problematic pregnancy he may chose another medication, but if he has already prescribed it, im sure he has checked.
Hope ive put your mind at rest a bit.
xx
I have been taking Losec (omeprazole) a PPI for 8 years at 20mg a day until recently when I reduced it to 10mg. For the last 3 weeks I have gone off it completely and wondered how long it might take to get it right out of my system. Also, if it has now caused low acid production, how would I know and how could I restore normal stomach acidity?
the second question is almost impossible to answer, it is case particular. as long as no symptoms present themselves, you will normalize in several days.
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I have been prescribed omeprazole for my stomach, and I currently have a headache. Is it okay to take them both?
I need to find a place on the net where I can buy omeprazole at a cheap price., this stuff is expensive!
It's an Indian Generic pharmaceutical mfgr,,,an established & reputable company.
Their prices seem VERY Inexpensive compared to most places I saw while checking.
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,...
https://purpleoutlet.com/index.cfm
corporate website is
http://www.intaspharma.com/
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Something I'd like to mention about Switching to Generic Drugs--just "In General"
#1 is the standard,,"Always Check with your Dr first"
#2 is something that's seldom discussed and just an observation as more folks try Generics and other sources .
It seems that;
a)Some generic medications seem to work "for Everybody" as effectively as the Name Brand,Original drugs.
b)Some Generics work fine for Some People,,,but not for Other people.
c)Some Generics simply dont work the same as NameBrand,not for anyone.
My opinion is,,,all a person can do is TRY and see how it goes,,,
while keeping in mind there's a Possibility that the Replacement Drug MIGHT not work the same as what the Person is used to.
I think it would be wise to keep a few doses of "Original Drugs" on hand during the " trial-period".
Just in case the Generics happen to not work well.
Best Wishes,,Hope ya find something Cheap & Effective
I want to know about the long term side effects of the medicine, omeprazole.
Before taking omeprazole, tell your doctor if you have ever had any type of liver disease. You may not be able to take omeprazole, or you may require a dosage adjustment or special monitoring.
Do not use over-the-counter omeprazole (Prilosec OTC) without first talking to your healthcare provider if you have
· trouble or pain with swallowing;
· vomiting blood;
· bloody or black stools;
· had heartburn for over 3 months;
· heartburn with sweating, lightheadedness, dizziness, chest, shoulder, neck, jaw, or arm pain;
· frequent chest pain;
· heartburn with wheezing;
· unexplained weight loss;
· nausea or vomiting; or
· stomach pain.
Your doctor should evaluate your condition before taking over-the-counter omeprazole (Prilosec OTC) if you have any of the conditions listed above.
Omeprazole is in the FDA pregnancy category C. This means that it is not known whether omeprazole will be harmful to an unborn baby. Do not take omeprazole without first talking to your doctor if you (female) are pregnant or could become pregnant during treatment.
It is not known whether omeprazole passes into breast milk.
If you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives), stop taking omeprazole and seek emergency medical attention.
Other, less serious side effects may be more likely to occur. Continue to take omeprazole and talk to your doctor if you experience
· drowsiness, dizziness, or headache;
· diarrhea, increased gas, or bloating; or
· itching.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Before taking omeprazole, tell your doctor if you are taking any of the following medicines
· warfarin (Coumadin);
· digoxin (Lanoxin, Lanoxicaps);
· a medicine for insomnia or anxiety such as diazepam (Valium), alprazolam (Xanax), lorazepam (Ativan), temazepam (Restoril), clorazepate (Tranxene), chlordiazepoxide (Librium), and others;
· cyclosporine (Neoral, Sandimmune);
· phenytoin (Dilantin);
· theophylline (Theo-Dur, Theochron, Theolair, Elixophyllin, Slo-Phyllin, others);
· itraconazole (Sporanox) or ketoconazole (Nizoral);
· ampicillin (Omnipen, Principen); or
· iron (Feosol, Mol-Iron, Fergon, Femiron, others).
You may not be able to take omeprazole, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with omeprazole. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
ADRAC (Australian Adverse Drug Reactions - Therapeutic Goods Administration) has received 19 reports (13 female) describing musculoskeletal problems associated with omeprazole. Ages ranged from 43 to 91 (median 55) years. Of the 16 patients for whom the information is available, 14 took 20 mg daily, 2 took 40 mg and the onset of symptoms occurred as early as one day and as late as 12 months after starting omeprazole. Eight reports documented joint pain and/or swelling including gout in two cases (one of which was confirmed by rechallenge). Nine reports described muscle pain and/or atrophy and symptoms recurred on rechallenge in two of these. Two reports documented both myalgia and arthralgia occurring simultaneously. One report documented a marked elevation of plasma creatine phosphokinase. Ten reports documented recovery, usually within a few days, 4 patients had not recovered a few months after the drug was stopped, and except for an elderly man who died from an unrelated cause, the outcome is unknown in the 4 other cases. Recent overseas reports1 have also documented similar problems and the product information has been updated to include mention of arthralgia, myalgia and muscular weakness.
Recently the Committee received a report of a 51 year old man who developed interstitial nephritis several months after commencing omeprazole (Losec) 20 mg daily as treatment for reflux oesophagitis. He had tolerated omeprazole well for the first two months but then developed marked fatigue and rigors. Urine microscopy revealed over 40,000 red cells and 8,000 white cells per mL. His serum creatinine peaked at 0.19 mmol/L and a peripheral eosinophilia of 4.7% was noted. Renal biopsy revealed a marked interstitial infiltrate with prominent eosinophils consistent with acute interstitial nephritis. Omeprazole was withdrawn, he was treated with prednisone and improved rapidly.
Two other Australian1,2 and four overseas3 case reports have similarly described interstitial nephritis in association with omeprazole therapy. In these 6 patients who ranged in age from 58 to 86 (median: 75) years, onset occurred from a few weeks to 6 months after commencement of omeprazole therapy and for 3 patients, the reaction recurred on rechallenge. The triad of fever, rash and eosinophilia, is described as the classical presentation of drug-induced interstitial nephritis, but this was observed in only one of these 7 cases. Prescribers should be aware that interstitial nephritis can occur within the first few months after starting omeprazole.
I started taking Omeprazole 2 days ago and I haven't had any noticeable differences in my acid reflux. Food and liquids still go up my throat.. though it's not acidic. Can this be a sign of anything else besides GERD?
Wondering if there are any side effects or things to watch out for when taking this medicine and any tips from people suffering from Gastritis. I've never had any real stomach complaints until recently because of my pain medication. I now know not to have acidic foods or milk (lactose intorelant). Anything else to watch out for?
Alternatively ur Dr may try one of the other Proton Pump Inhibitors e.g. Nexium, Zoton or Protium.
Lifestyle advice is:-
Lose weight if necessary,
Stop smoking
Avoid Fatty, greasy & spicy food
Avoid Acidic foods such as citric fruits, tomatoes etc
Avoid fruit juice, diluting juice & fizzy drinks (stick with milk, water)
Avoid Alcohol
Sleep with you head raised e.g. 2 -3 pillows
Eat little & often
Also Alka-Seltzer is quite good.
Best to see your Dr, He may send you for a OGD (camera) to see if there is an obvious cause e.g. ulcer, hernia, gall stones etc. & / or test your blood for Helicobacter, an easily treated infection.
Good Luck xx