Examples of Outcome Reporting Bias in Vaccine Studies: Illustrating ...
Side Effect(s) Of Pantoprazole And Domperidone
Review the side-effects of Pantoprazole and Domperidone as documented in medical literature. The term "side effects" refers to unintended effects that can occur as a result of taking the medication. In majority of the instances these side-effects are mild and easily tolerable, however sometimes they can be more severe and can be detrimental.If the side effects are not tolerable adjusting the dosage or switching to a different medication can help to manage or overcome side effects. If you have any doubts or questions, we recommend seeking advice from your doctor or pharmacist. Headache, dizziness, diarrhea, rash, swelling. Other Precautions : Avoid excess dosage. Drug Name : Pantoprazole and Domperidone Pantoprazole and Domperidone generic contains proton pump inhibitor and an antidopaminergic agent, prescribed for dyspepsia and gastro-esophageal reflux disease. It is not for treating type 1 diabetes. More info about Pantoprazole and DomperidoneBiktarvy Side Effects: What You Should Know
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) is a brand-name tablet prescribed for HIV-1. As with other drugs, Biktarvy can cause side effects, such as diarrhea, nausea, and headache.
For a general overview of Biktarvy, including details about what it's used for, see this article.
Biktarvy has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the "Side effect specifics" section.
Biktarvy can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Biktarvy in clinical trials:
Mild side effects can occur with Biktarvy use. This list doesn't include all possible mild side effects reported with the drug. For more information, you can refer to Biktarvy's prescribing information.
Mild side effects of Biktarvy can include:
These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Biktarvy and want to tell the FDA about it, visit MedWatch.
Biktarvy may cause serious side effects. The list below may not include all possible reported serious side effects of the drug. For more information, you can refer to the Biktarvy prescribing information.
If you develop serious side effects while taking Biktarvy, call your doctor right away. If the side effects seem life threatening or if you think you're having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects and their symptoms can include:
* See "Side effect specifics" below for more information about this side effect.† Biktarvy has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).‡ An allergic reaction is possible after using Biktarvy. But this side effect wasn't reported in clinical trials.
Biktarvy may cause several side effects. Here are some frequently asked questions about the drug's side effects and their answers.
Does Biktarvy cause skin side effects?It's possible. Rash was reported in Biktarvy's clinical trials, and some other skin side effects have been reported since the drug was approved. These include:
Biktarvy can also cause allergic reaction, which can sometimes cause a skin rash, hives, or flushing.
If you think you may be experiencing skin side effects with Biktarvy, be sure to contact your doctor.
Does Biktarvy cause weight gain?No, weight gain hasn't been reported in clinical trials of Biktarvy. Weight gain has been reported since Biktarvy was approved, but it's not clear whether the drug may have caused this weight gain.
However, Biktarvy contains active ingredients from a class of medications* called nucleoside reverse transcriptase inhibitors. It also contains an active ingredient from a class of medications called integrase inhibitors. And drugs in these classes have been reported to cause weight gain.
If you notice unintended weight gain while taking Biktarvy, tell your doctor. They can recommend ways to handle this side effect.
* A class of medications is a group of drugs that work in a similar way. Biktarvy specifically contains the active drugs emtricitabine and tenofovir alafenamide, which are nucleoside reverse transcriptase inhibitors. It also contains the active drug bictegravir sodium, which is an integrase inhibitor.
How long does Biktarvy stay in your system and how long do side effects last?It isn't known how long it may take for side effects to go away after stopping Biktarvy treatment. None of the active ingredients in Biktarvy typically stay in the body longer than a couple of days after the last dose. But this can vary by individual.
Some side effects, especially mild ones, may go away within a few days or weeks as your body gets used to Biktarvy. Others may last longer (see the following section, "What are the long-term side effects of Biktarvy?").
Do not stop taking Biktarvy unless your doctor gives you permission to do so. Stopping Biktarvy can sometimes cause serious side effects in people who have certain conditions.* Your doctor may want to monitor you for these side effects if you're going to stop taking the drug.
If you have side effects that bother you or last a long time, be sure to talk with your doctor.
* If you have hepatitis B, stopping Biktarvy could worsen your hepatitis B. Biktarvy has a boxed warning for this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). See "Side effect specifics" below for details.
What are the long-term side effects of Biktarvy?Biktarvy may cause some long-term side effects. These aren't common, but they can occur.
Potential long-term side effects of Biktarvy can include:
If you notice symptoms of long-term side effects while taking Biktarvy, call your doctor. (See the "Serious side effects" section above for examples of symptoms.) Your doctor can help determine how to handle any side effects you have. This may include trying an HIV medication other than Biktarvy.
Does Biktarvy cause hair loss?No, hair loss wasn't a side effect of Biktarvy in clinical trials.
However, Biktarvy contains active drugs from a class of medications called nucleoside reverse transcriptase inhibitors and an active drug from a class of medications called integrase inhibitors. And drugs in these classes have been reported to cause hair loss.
If you notice hair loss while taking Biktarvy, contact your doctor. They'll be able to help you decide how to manage this side effect.
Learn more about some of the side effects Biktarvy may cause.
Worsening of hepatitis BBiktarvy has a boxed warning for worsening of existing hepatitis B. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
If you have hepatitis B and HIV and you stop taking Biktarvy, your hepatitis B may get worse. There have been reports of worsening hepatitis B in people who stop taking the medications emtricitabine, tenofovir disoproxil fumarate, or both. Biktarvy contains emtricitabine and a form of tenofovir called tenofovir alafenamide.
Specifically, severe side effects such as liver failure have occurred in people with hepatitis B who stop taking drugs such as Biktarvy.
For more information, see Biktarvy's prescribing information. You can also talk with your doctor.
What you can doBefore you start treatment with Biktarvy, your doctor will order a test to check if you have hepatitis B. If you have hepatitis B, make sure to talk with your doctor before you start Biktarvy.
It's important that you don't run out of Biktarvy tablets. You also shouldn't stop taking Biktarvy unless your doctor recommends that you do so. Stopping Biktarvy could cause serious side effects in people with hepatitis B.
If you have hepatitis B and your doctor decides to have you stop taking Biktarvy, they'll monitor your liver function for several months. This is to make sure your hepatitis B doesn't get worse. If your hepatitis B does get worse, your doctor may have you take medications to treat it.
DepressionAlthough rare, it's possible to experience depression as a side effect of Biktarvy.
Most people in clinical trials didn't report depression as a side effect of the drug. Of those who did, most experienced depression that was mild. A few people experienced serious depression, including suicidal thoughts. Serious depression was only reported in people taking Biktarvy who also had an existing mental health condition.
What you can doWhile taking Biktarvy, be aware of any changes in your mood, emotions, or thinking. Specific symptoms can include:
If you have these symptoms, call your doctor right away. If you have thoughts of harming yourself, call 911 or your local emergency number.
Immune reconstitution syndromeImmune reconstitution syndrome can be a side effect of Biktarvy. This may also be called immune reconstitution inflammatory syndrome.
With this condition, your immune system starts to get stronger after you start HIV treatment. And it may react to infections that may already be present in your body. This may cause symptoms that develop unexpectedly. They could be from an infection that hasn't been diagnosed or an infection that was previously treated.
Immune reconstitution syndrome may also cause certain autoimmune diseases. Graves' disease is one example. An autoimmune disorder means your immune system mistakenly attacks your own tissues.
Immune reconstitution syndrome is most likely to occur when you first start treatment with Biktarvy. Symptoms vary depending on the condition that develops, which can include:
Watch for possible symptoms of immune reconstitution syndrome while you're taking Biktarvy. Make sure to call your doctor right away if you notice new symptoms after you start Biktarvy treatment.
Allergic reactionAs with most drugs, Biktarvy can cause an allergic reaction. However, this side effect wasn't reported in clinical studies of the drug.
Symptoms can be mild or serious and can include:
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Biktarvy. But if your symptoms are serious and you think you're having a medical emergency, immediately call 911 or your local emergency number.
Below is important information you should consider before taking Biktarvy.
Biktarvy has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the "Side effect specifics" section.
Other precautionsBefore taking Biktarvy, discuss your health history with your doctor. Biktarvy may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Protonix For Oral Susp
Protonix For Oral Susp Generic Name & Formulations General DescriptionPantoprazole (as sodium) 40mg; per pkt; e-c del-rel granules.
Pharmacological ClassProton pump inhibitor.
How SuppliedTabs—90; Susp—30 packets; Vials—1, 10, 25
How SuppliedProtonix for Delayed-Release Oral Suspension
StorageStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Mechanism of ActionPantoprazole suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell.
Protonix For Oral Susp Indications IndicationsShort-term treatment (up to 8 weeks) and maintenance of healing of erosive esophagitis (EE). Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).
Protonix For Oral Susp Dosage and Administration AdultSwallow whole. Do not crush or chew granules. Susp: Take 30mins before a meal. Mix contents of packet in 5mL of apple juice or applesauce (do not mix in water, other liquids or foods); then swallow. May give via NG or gastrostomy tube (see full labeling). Treatment of EE: 40mg once daily for ≤8 weeks; if not healed, may repeat for 8 more weeks. Maintenance of EE healing: 40mg once daily. Hypersecretory conditions: initially 40mg twice daily; max 240mg/day.
ChildrenSwallow whole. Do not crush or chew granules. Susp: Take 30mins before a meal. Mix contents of packet in 5mL of apple juice or applesauce (do not mix in water, other liquids or foods); then swallow. May give via NG or gastrostomy tube (see full labeling). <5yrs: not recommended. Treatment of EE: Give once daily for up to 8 weeks. ≥5yrs: (≥15kg to <40kg): 20mg; (≥40kg): 40mg.
AdministrationAdminister in 1 teaspoonful of applesauce or apple juice approx. 30 minutes prior to meal. Do not crush or chew granules. Granules will not dissolve in apple juice. Take within 10mins of preparation. Packets cannot be divided to make a smaller dose. NG or gastrostomy tube: add 10mL of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10mL) each time. No granules should remain in the syringe.
Nursing ConsiderationsAdminister in 1 teaspoonful of applesauce or apple juice approx. 30 minutes prior to meal. Do not crush or chew granules. Granules will not dissolve in apple juice. Take within 10 minutes of preparation. Packets cannot be divided to make a smaller dose. NG or gastrostomy tube: add 10mL of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10mL) each time. No granules should remain in the syringe. May use concomitant antacids.
Protonix For Oral Susp Contraindications ContraindicationsConcomitant rilpivirine-containing products.
Protonix For Oral Susp Boxed WarningsNot Applicable
Protonix For Oral Susp Warnings/Precautions Warnings/PrecautionsSymptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Reevaluate periodically. IV: consider zinc supplementation in those prone to zinc deficiency. Pregnancy. Nursing mothers.
Warnings/PrecautionsPresence of Gastric Malignancy
Symptomatic response does not preclude gastric malignancy. Consider additional follow-up and diagnostic testing in adults with suboptimal response or an early symptomatic relapse after completing treatment.
Consider endoscopy in older patients.
Acute Tubulointerstitial Nephritis
Acute tubulointerstitial nephritis (TIN) may occur at any point during PPI therapy.
Signs and symptoms may vary from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function.
Discontinue and evaluate patients with suspected acute TIN.
Clostridium difficile-Associated Diarrhea
Protonix may be associated with a greater risk of Clostridium difficile associated diarrhea, especially in hospitalized patients.
Consider diagnosis of Clostridium difficile for diarrhea does not improve.
Use the lowest dose of Protonix and for the shortest duration of PPI therapy appropriate to the condition.
Bone Fracture
PPI therapy may be associated with a greater risk of osteoporosis-related fractures of the hip, wrist, or spine.
Higher risk in patients who receive high-dose (multiply daily doses) and long-term PPI therapy (1 year or longer).
Use the lowest dose of Protonix and for the shortest duration of PPI therapy appropriate to the condition.
Severe Cutaneous Adverse Reactions
PPI therapy have been associated with severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Discontinue at the first sign or symptoms of SCARs or other signs of hypersensitivity and consider further evaluation.
Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)
Cutaneous and systemic lupus erythematosus have been reported with PPI therapy; a majority of cases were CLE.
The most common form of CLE was subacute.
Avoid administering PPI therapy for longer than medically indicated.
Discontinue Protonix and refer to a specialist for evaluation if signs or symptoms consistent with CLE or SLE are observed. Most patients improved after discontinuing PPI in 4 to 12 weeks.
Cyanocobalamin (Vitamin B-12) Deficiency
Hypomagnesemia and Mineral Metabolism
Consider monitoring magnesium levels prior to initiation and periodically during treatment in patients expected to be on prolonged treatment, in patients who take concomitant medications (eg, digoxin) that may cause hypomagnesemia, and in patients with a preexisting risk of hypocalcemia (eg, hypoparathyroidism).
Patients with preexisting risk of hypocalcemia will need magnesium and/or calcium supplementation. Consider discontinuing PPI therapy if hypocalcemia is refractory to treatment.
Tumorigenicity
Prolonged administration of Protonix may be carcinogenic and cause rare types of GI tumors, according to long-term rodent studies.
The relevance of these findings to tumor development in humans is unknown.
Fundic Gland Polyps
Increased risk of fundic gland polyps which increases with long-term use (especially beyond 1 year).
Patients were mostly asymptomatic and the fundic gland polyps were identified incidentally on endoscopy.
Use the shortest duration of PPI therapy.
Interference with Investigations for Neuroendocrine Tumors
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity.
May cause false (+) results in diagnostic investigations for neuroendocrine tumors.
Temporarily discontinue Protonix at least 14 days prior to CgA level assessment and consider repeating the test if initial CgA levels are high.
Interference with Urine Screen for THC
Concomitant Use of Protonix with Methotrexate
Concomitant use of PPI with high-dose methotrexate may potentiate serum levels of methotrexate and/or its metabolites and lead to toxicities.
Consider temporarily withdrawing the PPI therapy in patients receiving high-dose methotrexate.
The efficacy and safety of Protonix for short-term treatment EE associated with GERD has been established in patients 1 year through 16 years of age. Efficacy of Protonix for EE associated with GERD in patients less than 1 year of age has not been established. There is also no appropriate dosage strength in an age-appropriate formulation available for patients less than 5 years of age.
The safety and effectiveness of Protonix for pediatric uses other than EE have not been established.
1 year through 16 years of age: The effectiveness of Protonix for treating symptomatic GERD in pediatric patients has not been established.
The use of Protonix for treatment of symptomatic GERD in infants less than 1 year of age is not indicated.
Peak plasma concentration after an oral 40 mg dose of Protonix tablet was reached in approximately 2.5 hours and the maximum concentration was 2.5 μg/mL.
Absolute bioavailability was 77%.
Food may delay absorption of Protonix tablets by up to 2 hours or longer; but this did not change the maximum concentration and the area under the curve for Protonix.
Apparent volume of distribution is approximately 11 to 23.6 L, mainly distributed in extracellular fluid.
~98% serum protein bound, primarily to albumin.
Renal (71%), fecal (18%).
Protonix For Oral Susp Interactions InteractionsSee Contraindications. May antagonize atazanavir, nelfinavir (avoid). May potentiate saquinavir, methotrexate (at high doses, consider temporary withdrawal of the PPI); monitor. May alter absorption of gastric pH-dependent drugs (eg, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Caution with digoxin or drugs that may cause hypomagnesemia (eg, diuretics); monitor. Monitor warfarin. May cause false (+) results in diagnostic investigations for neuroendocrine tumors; discontinue pantoprazole 14 days prior to CgA level assessment. May cause false (+) urine THC test. IV: caution with concomitant other EDTA-containing products.
Protonix For Oral Susp Adverse Reactions Adverse ReactionsHeadache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, arthralgia; possible C. Difficile-associated diarrhea, inj site reactions (IV); rare: hypomagnesemia and mineral metabolism. Also children: URI, fever, rash.
Protonix For Oral Susp Clinical Trials Clinical TrialsErosive Esophagitis (EE) Associated with GERD
Adult Patients (Trial 1)
The approval was based on data from a US multicenter, double-blind, placebo-controlled study which evaluated the efficacy and safety of Protonix in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale). Patients received either Protonix 10 mg, 20 mg, or 40 mg once daily, or placebo.
At week 4, 45.6%, 58.4% and 75.0% of patients treated with Protonix 10 mg, 20 mg, and 40 mg, respectively, achieved greater EE healing rates compared with 14.3% of those treated with placebo (all P <.001 vs placebo).
At week 8, 66.0%, 83.5%, and 92.6% of patients treated with Protonix 10 mg, 20 mg, and 40 mg, respectively, achieved greater EE healing rates compared with 39.7% of those treated with placebo (all P <.001 vs placebo).
At both weeks 4 and 8, treatment with Protonix 40 mg had significantly greater healing rates vs Protonix 10 mg or 20 mg (P <.05), and Protonix 20 mg had significantly greater healing rates vs Protonix 10 mg (P <.05).
A significantly greater proportion of patients who received Protonix 40 mg experienced complete relief of daytime and nighttime heartburn and the absence of regurgitation, starting from the first day of treatment, compared with placebo.
There were fewer antacid tablets per day consumed among patients who received Protonix compared with those who received placebo.
Adult Patients (Trial 2)
In a US multicenter, double-blind study, Protonix 20 mg and 40 mg once daily were compared with nizatidine 150 mg twice daily in 243 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above.
At week 4, 61.4% and 64.0% of patients treated with Protonix 20 mg and 40 mg, respectively, achieved superior EE healing rates compared with 22.2% of those treated with nizatidine 150 mg (both P <.001).
At week 8, 79.2% and 82.9% of patients treated with Protonix 20 mg and 40 mg, respectively, achieved superior EE healing rates compared with 41.4% of those treated with nizatidine 150 mg (both P <.001).
A significantly greater proportion of patients who received Protonix 40 mg experienced complete relief of nighttime heartburn and regurgitation, starting on the first day and of daytime heartburn on the second day, compared with those taking nizatidine 150 mg twice daily.
There were fewer antacid tablets per day consumed among patients who received Protonix compared with those who received nizatidine.
Pediatric Patients Aged 5 Years through 16 Years
The efficacy of Protonix in pediatric patients 5 to 16 years of age was extrapolated from adequate and well-controlled trials in adults.
There were 4 pediatric patients with endoscopically diagnosed EE who were evaluated in multicenter, randomized, double-blind, parallel-treatment trials. Patients were treated with Protonix 20 mg or 40 mg once daily for 8 weeks. All 4 patients with EE were healed at 8 weeks, defined as a Hetzel-Dent score of 9 or 1.
Long-Term Maintenance of Healing of Erosive Esophagitis
Approval was based on 2 US independent, multicenter, randomized, double-blind, comparator-controlled trials (386 and 404 patients, respectively) in adult GERD patients with endoscopically confirmed healed EE.
Patients received either Protonix 10 mg, 20 mg, or 40 mg delayed-release tablets once daily or ranitidine 150 mg twice daily.
Protonix 20 mg and 40 mg was significantly superior to ranitidine at every time point (Month 1, 3, 6, and 12) for the maintenance of healing
Protonix 40 mg achieved superiority to ranitidine in reducing the number of daytime and nighttime heartburn episodes from Month 1 to 12 of treatment.
Protonix 20 mg was also effective in reducing episodes of daytime and nighttime heartburn in one trial.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Approval was based on a multicenter, open-label trial which included 35 patients with pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, with or without multiple endocrine neoplasia-type I.
Treatment with Protonix ranging from 80 mg to 240 mg daily successfully controlled gastric acid secretion and maintained gastric acid output below 10 mEq/h in patients without prior acid-reducing surgery and below 5 mEq/h in patients with prior acid-reducing surgery.
Not Applicable
Protonix For Oral Susp Patient Counseling Patient CounselingGastric Malignancy
Acute Tubulointerstitial Nephritis
Clostridium difficile-Associated Diarrhea
Bone Fracture
Report any fractures, especially of the hip, wrist or spine, to their healthcare provider.
Severe Cutaneous Adverse Reactions
Cutaneous and Systemic Lupus Erythematosus
Cyanocobalamin (Vitamin B-12) Deficiency
Hypomagnesemia and Mineral Metabolism
Report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia, to a healthcare provider, if you have been receiving Protonix for at least 3 months.
Drug Interactions
Inform healthcare provider of any other medications if you are currently taking, including rilpivirine-containing products, digoxin and high dose methotrexate.
Pregnancy
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