Derek is a proton pump inhibitor that decreases the amount of acid produced in the stomach.
Derek is used to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.
Derek is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. Derek is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).
Derek may also be given with an antibiotic to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori).
Derek is not for immediate relief of heartburn symptoms.
Derek may also be used for purposes not listed in this medication guide.
Derek indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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1.1 Healing of Erosive or Ulcerative GERD in Adults
Derek delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Derek may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Derek delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Derek delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Derek delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Derek delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Derek delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Derek delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
How should I use Derek?
Use Derek delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Derek delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Derek delayed-release capsules refilled.
Take Derek delayed-release capsules 30 minutes before a meal.
Open the capsule and sprinkle the contents onto a small amount of soft food or liquid (eg, applesauce, apple juice, baby food, baby formula, yogurt). The food or liquid that you use should be at or below room temperature. Swallow the mixture right away. Do not crush or chew the granules before swallowing. Take the entire mixture within 15 minutes. Do not store the mixture for future use.
You may take antacids while you are taking Derek delayed-release capsules if you are directed to do so by your doctor.
Continue to take Derek delayed-release capsules even if you feel well. Do not miss any doses.
If you miss a dose of Derek delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Derek delayed-release capsules.
Uses of Derek in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Derek 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. Derek belongs to a class of drugs known as proton pump inhibitors (PPIs).
How to use Derek
Read the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking Derek and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
If you are using the tablets, take your dose by mouth with or without food as directed by your doctor, usually 1 to 2 times daily. Swallow the tablet whole with water. Do not crush, chew, or split the tablet. Doing so can release all of the drug at once, increasing the risk of side effects.
If you are using the capsules, take the dose 30 minutes before a meal as directed by your doctor, usually once daily. Do not swallow the capsule whole. Open the capsule and sprinkle the contents onto a small amount of soft food (such as applesauce or yogurt) or liquid. The food or liquid that you use should be at or below room temperature. Swallow the entire mixture within 15 minutes of preparing it. Do not chew or crush the prepared mixture.
The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight.
If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Derek at least 30 minutes before sucralfate.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.
Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.
Derek description
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NIKP-Derek enteric coated tablet 10 mg contains 10 mg of Derek sodium, equivalent to 9.42 mg Derek.
NIKP-Derek enteric coated tablet 20 mg contains 20 mg of Derek sodium, equivalent to 18.85 mg Derek.
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Table 1 shows the recommended dosage of Derek delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of Derek delayed-release tablets is not recommended for use in pediatric patients 1 year to less than 12 years of age because the lowest available tablet strength (20 mg) exceeds the recommended dose for these patients. Use another Derek formulation for pediatric patients 1 year to less than 12 years of age.
Table 1: Recommended Dosage and Duration of Derek Delayed-Release Tablets in Adults and Adolescents 12 Years of Age and Older
Indication
Dosage of Derek delayed-release tablets
Treatment Duration
Adults
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
20 mg once daily
4 to 8 weeks*
Maintenance of Healing of Erosive or Ulcerative GERD
20 mg once daily
Controlled studies do not extend beyond 12 months
Symptomatic GERD in Adults
20 mg once daily
Up to 4 weeks**
Healing of Duodenal Ulcers
20 mg once daily after the morning meal
Up to 4 weeks***
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Derek 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
Take all three medications twice daily with morning and evening meals; it is important that patients comply with the full 7-day regimen
7 days
Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
Starting dose 60 mg once daily then adjust to patient needs; some patients require divided doses
Dosages of 100 mg once daily and 60 mg twice daily have been administered
As long as clinically indicated
Some patients with Zollinger-Ellison syndrome have been treated continuously for up to one year
Adolescents 12 Years of Age and Older
Symptomatic GERD
20 mg once daily
Up to 8 weeks
* For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Derek may be considered.
** If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
*** Most patients heal within 4 weeks; some patients may require additional therapy to achieve healing.
Administration Instructions
Swallow Derek delayed-release tablets whole. Do not chew, crush, or split tablets.
For the treatment of duodenal ulcers take Derek delayed-release tablets after a meal.
For Helicobacter pylori eradication take Derek delayed-release tablets with food.
For all other indications Derek delayed-release tablets can be taken with or without food.
Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take two doses at the same time.
Derek sodium, as is the case with other members of the PPI class of compounds, is metabolized through the cytochrome P-450 (CYP450) hepatic drug metabolizing system. Studies in healthy subjects have shown that Derek sodium does not have clinically significant interactions with the drugs studied, including warfarin, phenytoin, theophylline or diazepam metabolized by the CYP450 system.
Derek sodium produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with compounds whose absorption is pH-dependent may occur, therefore, the potential for such interaction was investigated. Co-administration of Derek sodium results in a 33% decrease in ketoconazole levels and a 22% increase in trough digoxin levels in normal subjects. Therefore, individual patients may need to be monitored to determine if a dosage adjustment is necessary when such drugs are taken concomitantly with Derek. Derek does not adversely influence plasma concentrations of amoxicillin or clarithromycin when co-administered for the purpose of eradicating upper gastrointestinal H. pylori infection.
In clinical trials, antacids were used concomitantly with the administration of Derek and in a specific study designed to define this interaction, no interaction with liquid antacids was observed. There was no clinically relevant interaction with food.
Co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg once daily) to healthy volunteers resulted in a substantial reduction in atazanavir exposure. The absorption of atazanavir is pH-dependent. Although co-administration with Derek was not studied, similar results are expected with other PPIs. Therefore, PPIs including Derek sodium, should not be co-administered with atazanavir.
In vitro studies with human liver microsomes indicated that Derek sodium is metabolized by isoenzymes of CYP450 (CYP2C19 and CYP3A4). In these studies, at expected human plasma concentrations, Derek neither induces nor inhibits CYP3A4; and although in vitro studies may not always be predictive of in vivo status, these findings indicate that no interaction is expected between Derek and cyclosporin.
The following serious adverse reactions are described below and elsewhere in labeling:
Acute Interstitial Nephritis
Clostridium difficile-Associated Diarrhea
Bone Fracture
Cutaneous and Systemic Lupus Erythematosus
Cyanocobalamin (Vitamin B-12) Deficiency
Hypomagnesemia
Clinical Studies Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults
The data described below reflect exposure to Derek delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo-and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female. The racial distribution was 86% Caucasian, 8% African American, 2% Asian, and 5% other. Most patients received either 10 mg, 20 mg or 40 mg per day of Derek delayed-release tablets.
An analysis of adverse reactions appearing in ≥2% of patients treated with Derek delayed-release tablets (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs. 1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs. 1%), and constipation (2% vs. 1%).
Three long-term maintenance studies consisted of a total of 740 adult patients; at least 54% of adult patients were exposed to Derek delayed-release tablets for 6 months and at least 33% were exposed for 12 months. Of the 740 adult patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of Derek delayed-release tablets, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole.
The safety profile of Derek in the maintenance studies in adults was consistent with what was observed in the acute studies.
Less common adverse reactions seen in controlled clinical trials (<2% of patients treated with Derek delayed-release tablets and greater than placebo) and for which there is a possibility of a causal relationship to Derek, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.
Combination Treatment with Amoxicillin and Clarithromycin
In clinical trials using combination therapy with Derek plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively.
No clinically significant laboratory abnormalities particular to the drug combinations were observed.
For more information on adverse reactions or laboratory changes with amoxicillin or clarithromycin, refer to their respective prescribing information, Adverse Reactions section.
Pediatrics
In a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The adverse reactions reported without regard to relationship to Derek delayed-release tablets that occurred in ≥2% of 111 patients were headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%). The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in this study that were not previously observed in adults.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Derek. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: sudden death; coma; hyperammonemia; jaundice; rhabdomyolysis; disorientation and delirium; anaphylaxis; angioedema; systemic lupus erythematosus, bullous and other drug eruptions of the skin; severe dermatologic reactions, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme; interstitial pneumonia; interstitial nephritis; TSH elevations; bone fractures; hypomagnesemia and Clostridium difficile-associated diarrhea. In addition, agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia have been reported. Increases in prothrombin time/INR in patients treated with concomitant warfarin have been reported.
Patients with known hypersensitivity to Derek sodium, substituted benzimidazoles or to any excipients used in Derek.
Use in pregnancy: There are no data on the safety of Derek in human pregnancy.
Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to Derek sodium, although low feto-placental transfer occurs in rats. Derek is contraindicated during pregnancy.
Use in lactation: It is not known whether Derek sodium is excreted in human breast milk. No studies in lactating women have been performed. Derek sodium is, however, excreted in rat mammary secretions. Therefore, Derek should not be used during breastfeeding.
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