EXENATIDE PACKAGE INSERT PDF

With each weekly dose, the amount of medicine in your body builds up until it reaches an optimal level after 10 weeks, to help give you consistent control of your blood sugar 7 days a week. Stomach With type 2 diabetes, the stomach moves food along faster than it should, and that sends sugar into the blood faster. Pancreas With type 2 diabetes, too little insulin is produced by the pancreas to keep blood sugar levels normal. Want help for your discussion?

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Serious bleeding, which may be fatal, from drug induced immune mediated thrombocytopenia has been reported with exenatide use [see Warnings and Precautions 5. Pen-sharing poses a risk for transmission of blood-borne pathogens. After initiation of BYETTA, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting. Therefore, patients receiving BYETTA and a sulfonylurea may require a lower dose of the sulfonylurea to reduce the risk of hypoglycemia.

In patients at increased risk of hypoglycemia consider reducing the dose of insulin [see Adverse Reactions 6. For additional information on glucose-dependent effects see Mechanism of Action Some of these events occurred in patients receiving one or more pharmacologic agents known to affect renal function or hydration status, such as angiotensin converting enzyme inhibitors, nonsteroidal anti-inflammatory drugs, or diuretics.

Some events occurred in patients who had been experiencing nausea, vomiting, or diarrhea, with or without dehydration. Reversibility of altered renal function has been observed in many cases with supportive treatment and discontinuation of potentially causative agents, including BYETTA.

Exenatide has not been found to be directly nephrotoxic in preclinical or clinical studies. If there is worsening glycemic control or failure to achieve targeted glycemic control, alternative antidiabetic therapy should be considered [see Adverse Reactions 6.

If a hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice. Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP 1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis with BYETTA [see Adverse Reactions 6. Drug-induced thrombocytopenia is an immune mediated reaction, with exenatide-dependent anti platelet antibodies.

In the presence of exenatide, these antibodies cause platelet destruction.

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BYETTA PACKAGE INSERT PDF

Serious bleeding, which may be fatal, from drug induced immune mediated thrombocytopenia has been reported with exenatide use [see Warnings and Precautions 5. Pen-sharing poses a risk for transmission of blood-borne pathogens. After initiation of BYETTA, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting. Therefore, patients receiving BYETTA and a sulfonylurea may require a lower dose of the sulfonylurea to reduce the risk of hypoglycemia.

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Got Stop taking BYETTA and packabe your healthcare provider byetta package insert away if you have pain in your stomach area abdomen that is severe, and will not go away, occurs with or without vomiting or is felt going from your abdomen through to your back. All other trademarks are property of their respective owners. Go to Patient Site. Beytta other trademarks are property of their respective owners. Based on animal data, BYETTA may cause fetal harm and should be used during pregnancy only if the potential byetta package insert justifies the potential risk to the fetus. Add BYETTA to insulin glargine as a complementary action to help improve glycemic control Postmarketing reports byetta package insert increased international normalized ratio INR sometimes associated with bleeding with concomitant use of warfarin.

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No placebo-treated patients withdrew due to nausea or vomiting. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Drug Interactions: International normalized ratio INR increased with concomitant warfarin use sometimes associated with bleeding [see Drug Interactions 7. Neurologic: dysgeusia; somnolence Renal and Urinary Disorders: altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure or acute renal failure sometimes requiring hemodialysis , kidney transplant and kidney transplant dysfunction [see Warnings and Precautions 5.

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BYETTA PACKAGE INSERT PDF DOWNLOAD

Volabar Exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Careful monitoring of blood glucose is recommended. Let the autoinjector come to room temperature for approximately 15 minutes before administration. The ijsert is not indicated in infants or neonates. The concurrent use of exenatide with prandial insulin has not been studied. This product information is intended for US Healthcare Professionals only.

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