صيدلية اونلاين
  • DEXILANT 30 caps 30mg

    $300.00 $265.00


    DEXILANT

    Alimentary System

    Antacids and Defrothicants

    ACTIVE INGREDIENTS


    Dexlansoprazole 30, 60 mg.  

    Dexlansoprazole

    PRESENTATION AND DOSSAGE

    CAPS.: 14, 28.

    RELATED INFORMATION


    INDICATIONS

    Dexilant 30mg is indicated in adults for the following: Maintenance of healed erosive reflux oesophagitis and maintenance  of relief of heartburn. Short-term treatment of heartburn and acid regurgitation associated with symptomatic nonerosive gastro-oesophageal reflux disease (GERD).

    Dexilant 60mg is indicated in adults for the following: Treatment of erosive reflux oesophagitis


    DRUG INTERACTION

    Effect of Dexlansoprazole on Other Drugs

    Cytochrome P 450 Interactions: Dexlansoprazole is metabolized, in part, by CYP2C19 and CYP3A4.

    Clopidogrel: Clopidogrel is metabolized to its active metabolite in part by CYP2C19. A study of healthy subjects who were CYP2C19 extensive metabolizers, receiving once daily administration of clopidogrel 75 mg alone or concomitantly with DEXILANT 60 mg capsules (n=40), for nine days was conducted.

    See prescribing information for full details.


    CONTRAINDICATIONS

    Patients with known hypersensitivity to active substance or to any component of the formulation. Concomitant use with  rilpivirine-containing products.


    SPECIAL PRECAUTIONS

    Presence of Gastric Malignancy: Symptomatic response with Dexlansoprazole does not preclude the presence of gastric malignancy.

    Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue  Dexlansoprazole  if acute interstitial nephritis develops.

    Cyanocobalamin (Vitamin B-12) Deficiency: Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Dexlansoprazole.

    Clostridium Difficile Associated Diarrhea: Published observational studies suggest that PPI therapy like Dexlansoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

    Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.

    Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

    For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

    Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

    Interaction with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.

    Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the healthcare professional should consider stopping dexlansoprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

    See prescribing information for full details.


    SIDE EFFECTS

    Acute interstitial nephritis, cyanocobalamin (vitamin b-12) deficiency, clostridium difficile associated diarrhea, bone fracture, hypomagnesemia.

    See prescribing information for full details.


    DOSAGE

    Treatment of erosive reflux esophagitis: One 60 mg capsule once daily for up to 8 weeks.

    Maintenance of healed erosive reflux esophagitis and maintenance of relief of heartburn: One 30 mg capsule once daily*.

    Symptomatic non-erosive gastro-esophageal reflux disease (GERD): One 30 mg capsule once daily for 4 weeks. *Controlled studies did not extend beyond 6 months.

    Important Administration Information

    Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose. Take without regard to food. Swallow whole. Do not chew.

    The drug  capsules can be opened and administered with applesauce as follows:

    1. Place one tablespoonful of applesauce into a clean container.

    2. Open capsule.

    3. Sprinkle intact granules on applesauce.

    4. Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.

    For patients who have trouble swallowing capsules: The capsules can be opened and administered with applesauce as follows:

    1. Place one tablespoonful of applesauce into a clean container.

    2. Open capsule.

    3. Sprinkle intact granules on applesauce.

    4. Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.

    Alternatively, the capsule can be administered with water via oral syringe or nasogastric (NG) tube.

    Administration with Water in an Oral Syringe:

    1. Open the capsule and empty the granules into a clean container with 20 mL of water.

    2. Withdraw the entire mixture into a syringe.

    3. Gently swirl the syringe in order to keep granules from settling.

    4. Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use.

    5. Refill the syringe with 10 mL of water, swirl gently, and administer.

    6. Refill the syringe again with 10 mL of water, swirl gently, and administer.

    Administration with Water via a NG Tube (≥16 French):

    1. Open the capsule and empty the granules into a clean container with 20 mL of water.

    2. Withdraw the entire mixture into a catheter-tip syringe.

    3. Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and granule mixture for later use.

    4. Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube.

    5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.


    OVERDOSE

    There have been no reports of significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events. However, serious adverse events of hypertension have been reported in association with twice daily doses of Dexlansoprazole 60 mg. Non-serious adverse reactions observed with twice daily doses of Dexlansoprazole 60 mg include hot flashes, contusion, oropharyngeal pain, and weight loss. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis. In the event of over-exposure, treatment should be symptomatic and supportive.  If over-exposure occurs, call your poson control center for current information on the management of poisoning or over-exposure.


    PREGNANCY & LACTATION

    Pregnancy: There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk.

    Lactation: There is no information regarding the presence of dexlansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production.

    See prescribing information for full details.


    IMPORTANT NOTES

    Storage: Do not store above 25°C.


    MANUFACTURER & DISTRIBUTER:

    Manufacturer: TAKEDA Pharma, Denmark

    License Holder: TAKEDA ISRAEL LTD.

    دواء  Dexilant يحتوى على المادة الفعالة Dexlansoprazole , و هو من مجموعة (مثبطات مضخة البروتون), و يستخدم لعلاج مشاكل لمعدة  المريء (مثل إرتجاع المرىء), بعض حالات الحموضة نتيجة زيادة حمضية المعدة, و بعض حالات التهابات اغشية المعدة كعلاج مساعد مع علاجات اخرى.
    و يعمل الدواء عن طريق خفض كمية حمض الهيدروكلوريك التى تفرزها المعدة. لذلك يساعد على تخفيف الاعراض المتمثلة في الشعور بالحرقة، وصعوبة في البلع، والسعال المستمر نتيجة مشاكل المرىء. ويساعد على منع تكون القرح المعدية، و يمكن أن يساعد في منع الإصابة بسرطان المريء. 

    الدواء امن إذا استخدم في الدواعي المخصص له, ووفقا لاشراف طبيب متابع للحالة, لانه يمكن ان يسبب اعراض جانبية تشمل الحساسية, و الاسهال, و اضطربات الجهاز الهضمي و مشاكل الكلي إذا استخدم من قبل شخص يعاني من مرض مزمن أو قصور بالكلي.


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