Controloc tablets

Controloc

  • Active Ingredient: Pantoprazole
  • 40 mg, 20 mg
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What is Controloc?

The active ingredient of Controloc brand is pantoprazole. Pantoprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. Pantoprazole sodium USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium USP is supplied as a delayed-release tablet, available in two strengths 20 mg Pantoprazole (equivalent to 22.56 mg of Pantoprazole sodium USP) and 40 mg Pantoprazole (equivalent to 45.1 mg of Pantoprazole sodium USP). Pantoprazole sodium delayed-release tablets, USP contain the following inactive ingredients: calcium stearate, crospovidone, ferric oxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, sodium carbonate, and triethyl citrate. The tablets are imprinted with brown ink containing ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze in ethanol. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies USP dissolution test 3.

Used for

Controloc is used to treat diseases such as: Barrett's Esophagus, Dumping Syndrome, Duodenal Ulcer, Erosive Esophagitis, Gastritis/Duodenitis, GERD, Helicobacter Pylori Infection, Peptic Ulcer, Stomach Ulcer, Stress Ulcer Prophylaxis, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Controloc include: Abdominal or stomach pain; headache; decreased vision; passing gas; increased urination; joint pain.

How to Buy Controloc tablets online?

To get Controloc online - simply click on the "Buy Now" button in the top and follow along with our shop. Order and payment takes a couple of minutes, and all measures are obvious. We don't take a medical prescription plus we have many procedures of payment. Considering each detail of rapid delivery and confidentiality, you may read on the relevant pages on the links in the navigation menu.

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How to store Controloc

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

On this page

  1. About Controloc
  2. Key facts
  3. Who can and can't take Controloc
  4. How and when to take it
  5. Side effects
  6. How to cope with side effects
  7. Pregnancy and breastfeeding
  8. Cautions with other medicines
  9. Common questions

Michael Stewart, Reviewed by Sid Dajani | Last edited 15 Jun 2017 | Certified by The Information Standard

Controloc reduces the amount of acid produced in your stomach.

Swallow the tablet whole - do not chew or crush it before you swallow.

The most common side-effects are stomach upset and headache. These effects are generally mild and do not last long.

Side Effects

Headache or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea or opioid medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.

Rarely, proton pump inhibitors (such as Controloc) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Bacterial infections

Several studies have linked the use of Controloc with C. difficile diarrhea. This infective diarrhea can be fatal, particularly among older adults.

Doctors should prescribe the lowest effective dosage for the shortest time possible to prevent this infection.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Low magnesium levels. Using this drug for three months or longer can cause low magnesium levels. Symptoms can include:
    • seizures
    • abnormal or fast heart rate
    • tremors
    • jitteriness
    • muscle weakness
    • dizziness
    • spasms of your hands and feet
    • cramps or muscle aches
    • spasm of your voice box
  • nervousness
  • neuritis (inflammation of a nerve)
  • numbness or tingling in your hands and feet
  • poor muscular coordination
  • changes in menstruation
  • Severe diarrhea. This may be caused by a Clostr > Cutaneous lupus erythematosus on the back.
  • raised, red, scaly, red or purple rash on your body
  • fever
  • tiredness
  • weight loss
  • blood clots
  • heartburn
  • Fundic gland polyps (don’t usually cause symptoms)
  • Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Controloc oral tablet can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    Examples of drugs that can cause interactions with Controloc are listed below.

    8. Cautions with other medicines

    Some medicines can interfere with Controloc and make you more likely to have side effects.

    Tell your doctor if you're taking these medicines before you start Controloc treatment:

    • digoxin (a heart medicine)
    • antifungal medicines such as itraconazole, ketoconazole, posaconazole and voriconazole
    • methotrexate (a medicine used to treat cancer, psoriasis and rheumatoid arthritis)
    • HIV medicines
    • rifampicin (an antibiotic)
    • blood-thinning medicines, such as clopidogrel and warfarin

    Dictionary Entries near Controloc

    Cite this Entry

    “Controloc.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Controloc. Accessed 27 December 2019.

    Comments on Controloc

    What made you want to look up Controloc? Please tell us where you read or heard it (including the quote, if possible).

    What other drugs will affect Controloc (Protonix, Protonix IV)?

    Tell your doctor about all your other medicines, especially:

    This list is not complete. Other drugs may affect Controloc, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Pregnancy Category C

    Reproduction studies have been performed in rats at oral Controloc doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of Controloc sodium during organogenesis in pregnant animals. The studies have revealed no evidence of impaired fertility or harm to the fetus due to Controloc.

    A pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with Controloc sodium. Oral Controloc doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. On postnatal day (PND 4) through PND 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (AUC) in humans at a dose of 40 mg). There were no drug-related findings in maternal animals. During the preweaning dosing phase (PND 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (AUC) in humans receiving the 40 mg dose) and higher doses. On PND 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses. The femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. There were no microscopic changes in the distal femur, proximal tibia, or stifle joints. Changes in bone parameters were partially reversible following a recovery period, with findings on PND 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (AUC) in humans at the 40 mg dose) and higher doses.

    There are no adequate and well-controlled studies in pregnant women. Advise pregnant women of the potential risk of fetal harm. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Controloc and Pregnancy

    Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding before taking Controloc.

    Although there is no evidence suggesting that Controloc use is harmful during pregnancy, it's recommended that the drug only be used during pregnancy as needed, when no other options are available.

    Research indicates that Controloc and its metabolites are excreted in the milk of rats, and that they may be excreted in human breast milk as well.

    The manufacturer recommends that due to the potential for serious adverse reactions in breastfeeding infants, mothers using Controloc may want to discontinue breastfeeding or discontinue use of the drug.

    Controloc dosing information

    Usual Adult Dose for Erosive Esophagitis:

    Treatment of Erosive Esophagitis: 40 mg orally once a day for up to 8 weeks; however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

    Maintenance of Healing of Erosive Esophagitis: 40 mg orally once a day. Controlled studies have been limited to 12 months of Controloc therapy.

    Usual Adult Dose for Gastroesophageal Reflux Disease:

    Parenteral: 40 mg once a day for 7 to 10 days, administered via intravenous infusion over a period of 15 minutes. Intravenous therapy should be discontinued as soon as the patient is able to resume oral therapy.

    Oral: 40 mg orally once a day, for short-term administration (up to 8 weeks); however an additional 8 weeks may be considered for patients who have not healed after the initial treatment. Safety and efficacy beyond 16 weeks of therapy have not been established.

    Usual Adult Dose for Duodenal Ulcer:

    Study (n=54) 40 mg orally once a day, dose was increased every 12 weeks by 40 mg increments to a maximum of 120 mg per day, for 28 weeks. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete duodenal ulcer healing in up to 87% and 94% of patients after 4 weeks and 8 weeks respectively.

    Usual Adult Dose for Gastric Ulcer:

    40 mg orally once a day. Data have revealed that monotherapy with daily doses of 40 mg have been associated with complete gastric ulcer healing in up to 87% and 97% of patients after 4 weeks and 8 weeks respectively.

    Usual Adult Dose for Helicobacter pylori Infection:

    Study (n=242) - Triple therapy: 40 mg orally twice daily for 7 days, commonly in conjunction with clarithromycin and either amoxicillin or metronidazole to eradicate Helicobacter pylori, followed with 40 mg Controloc orally once daily until day 28. Triple therapy has resulted in eradication rates of greater than 95%.

    The QUADRATE Study (n=405) - Quadruple therapy: 40 mg orally twice daily for 7 days, concomitantly with bismuth subcitrate and tetracycline, both four times daily, and metronidazole 200 mg three times daily and 400 mg at bedtime. Helicobacter Pylori eradication was achieved in 82% of patients.

    Usual Adult Dose for Zollinger-Ellison Syndrome:

    Parenteral: 80 mg every 12 hours, administered by 15-minute infusion. Daily doses higher than 240 mg administered in equally divided doses by 15-minute infusion, or administered for more than 6 days have not been studied.

    Oral: 40 mg twice daily, to a maximum of 240 mg per day. Some patients have received treatment with Controloc for more than 2 years.

    Usual Adult Dose for Stress Ulcer Prophylaxis:

    Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting: 80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

    Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting: 80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

    Usual Adult Dose for Peptic Ulcer:

    Study (n=21) - Stress Ulcer bleeding prophylaxis in the Critical Care Setting: 80 mg twice daily, as a bolus infusion over a period of 15 minutes, to a maximum daily dose of 240 mg, divided into three equal doses.

    Study (n=20 ) - Peptic Ulcer rebleeding prophylaxis after hemostasis in the Critical Care Setting: 80 mg IV bolus, followed by continuous infusion of 8 mg/hr for 3 days, after which therapy may be continued with an oral PPI.

    How should I use Controloc?

    Take Controloc exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

    Use the lowest dose for the shortest amount of time needed to treat your condition.

    Controloc is taken by mouth (oral) or given as an infusion into a vein (injection). A healthcare provider may teach you how to properly use the injection by yourself.

    Controloc tablets are taken by mouth, with or without food. The oral granules should be taken 30 minutes before a meal.

    Do not crush, chew, or break the tablet. Swallow it whole.

    The oral granules should be mixed with applesauce or apple juice and given either by mouth or through a nasogastric (NG) tube.

    Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have any questions.

    Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

    Call your doctor if your symptoms do not improve or if they get worse while you are using this medicine.

    Controloc can cause false results with certain medical tests. Tell the doctor or laboratory staff that you are using this medicine.

    Controloc may also affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use this medicine.

    Store this medicine at room temperature away from moisture, heat, and light.

    Why it’s used

    Controloc oral tablet is used to reduce the amount of stomach acid your body makes. It helps treat painful symptoms caused by conditions such as gastroesophageal reflux disease (GERD). With GERD, gastric juices flow upward from your stomach and into the esophagus.

    Controloc oral tablet is also used to treat other conditions in which the stomach makes excess acid, such as Zollinger-Ellison syndrome.


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