Dinex EC (Didanosine Delayed - Release 250mg Capsules)

What is Dinex EC (Didanosine Delayed - Release 250mg Capsules)?

Dinex EC (Didanosine Delayed - Release 250mg Capsules) is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body. Dinex EC (Didanosine Delayed - Release 250mg Capsules) is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Dinex EC (Didanosine Delayed - Release 250mg Capsules) is not a cure for HIV or AIDS. Dinex EC (Didanosine Delayed - Release 250mg Capsules) may also be used for purposes not listed in Dinex EC (Didanosine Delayed - Release 250mg Capsules) guide. Overdose symptoms may include some of the serious side effects listed in Dinex EC (Didanosine Delayed - Release 250mg Capsules) guide.

Pancreatitis

Fatal and non-fatal pancreatitis has occurred during therapy with did anosine used alone or in combination regimens in both treatment-naïve and treatment-experienced patients, regardless of degree of immunosuppression.  Dinex EC (Didanosine Delayed - Release 250mg Capsules)should be suspended in patients with signs or symptoms of pancreatitis. Patients treated with Dinex EC (Didanosine Delayed - Release 250mg Capsules) in combination with stavudine, with or without hydroxyurea, may be at increased risk for pancreatitits.

When treatment with life-sustaining drugs known to cause pancreatic toxicity is required, suspension of didanosine therapy is recommended. In patients with risk factors for pancreatitis, Dinex EC (Didanosine Delayed - Release 250mg Capsules) should be used with extreme caution and only if clearly indicated.  Patients with advanced hiv-1 infection, especially the elderly, are at increased risk of pancreatitis and should be followed closely. Patients with renal impairment may be at greater risk for pancreatitis if treated without dose adjustment.the frequency of pancreatitis is dose-related.

Lactic acidosis/Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. A majority of these have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk (see warnings and precautions, pregnancy).particular caution should be exercised when administering didanosine to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with Dinex EC (Didanosine Delayed - Release 250mg Capsules) should be suspended in any patient who develops clinical signs or symptoms with or without laboratory findings consistent with symptomatic hyperlactatemia, lactic acidosis, or pronounced hepatoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Hepatic Toxicity

The safety and efficacy of Dinex EC (Didanosine Delayed - Release 250mg Capsules) have not been established in hiv-infected patients with significant underlying liver disease. During combination antiretroviral therapy, patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities, including severe and potentially fatal hepatic adverse events, and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in hiv-infected patients treated with hydroxyurea and other antiretroviral agents.  Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine and stavudine. This combination should be avoided.

Non-cirrhotic Portal Hypertension

Postmarketing cases of non-cirrhotic portal hypertension have been reported, including cases leading to liver transplantation or death. Cases of didanosine-associated non-cirrhotic portal hypertension were confirmed by liver biopsy in patients with no evidence of viral hepatitis.  Onset of signs and symptoms ranged from months to years after start of didanosine therapy. Common presenting features included elevated liver enzymes, esophageal varices, hematemesis, ascites, and splenomegaly.

Patients receiving Dinex EC (Didanosine Delayed - Release 250mg Capsules) should be monitored for early signs of portal hypertension (eg, thrombocytopenia and splenomegaly) during routine medical visits. Appropriate laboratory testing including liver enzymes, serum bilirubin, albumin, complete blood count, and international normalized ratio (inr) and ultrasonography should be considered. Dinex EC (Didanosine Delayed - Release 250mg Capsules)(Didanosine Delayed - Release 250mg Capsules)should be discontinued in patients with evidence of non-cirrhotic portal hypertension.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Dinex EC (Didanosine Delayed - Release 250mg Capsules). During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as mycobacterium avium infection, cytomegalovirus, pneumocystis jirovecii pneumonia , or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as graves’ disease, polymyositis, and guillain-barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Pregnancy

Pregnancy Category B:

Reproduction studies have been performed in rats and rabbits at doses up to 12 and 14.2 times the estimated human exposure (based upon plasma levels), respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to didanosine. At approximately 12 times the estimated human exposure, didanosine was slightly toxic to female rats and their pups during mid- and late-lactation. These rats showed reduced food intake and body weight gains but the physical and functional development of the offspring was not impaired and there were no major changes in the f2 generation. A study in rats showed that didanosine and/or its metabolites are transferred to the fetus through the placenta. Animal reproduction studies are not always predictive of human response.

There are no adequate and well-controlled studies of didanosine in pregnant women. Didanosine should be used during pregnancy only if the potential benefit justifies the potential risk.

Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis syndrome reported in non-pregnant individuals receiving nucleoside analogs (see warnings and precautions). The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Healthcare providers caring for hiv-infected pregnant women receiving didanosine should be alert for an early diagnosis of lactic acidosis/hepatic steatosis syndrome.

Pediatric Use

Use of didanosine in pediatric patients from 2 weeks of age through adolescence is supported by evidence from adequate and well-controlled studies of didanosine in adult and pediatric patients (seedosage and administration; undesirable effects; pharmacology). Additional pharmacokinetic studies in pediatric patients support the use of didanosinein pediatric patients who weigh at least 20 kg.

Geriatric Use

In an expanded access program using a buffered formulation of didanosine for the treatment of advanced hiv infection, patients aged 65 years and older had a higher frequency of pancreatitis (10%) than younger patients (5%) (see warnings and precautions). Clinical studies of didanosine, including those for Dinex EC (Didanosine Delayed - Release 250mg Capsules), did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects. Didanosine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly (see dosage and administration).

Overdosage

There is no known antidote for didanosine overdosage.  In phase 1 studies, in which buffered formulations of didanosine were initially administered at doses ten times the currently recommended dose, toxicities included:pancreatitis, peripheral neuropathy, diarrhea, hyperuricemia, and hepatic dysfunction. Didanosine is not dialyzable by peritoneal dialysis, although there is some clearance by hemodialysis

Dinex EC (Didanosine Delayed - Release 250mg Capsules) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Dinex EC (Didanosine Delayed - Release 250mg Capsules) may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• Muscle pain or weakness.
• Numb or cold feeling in your arms and legs.
• Trouble breathing; feeling dizzy, light-headed, tired, or very weak.
• Stomach pain, nausea with vomiting.
• Fast or uneven heart rate.

Stop using Dinex EC (Didanosine Delayed - Release 250mg Capsules) and call your doctor at once if you have any of these other serious side effects:

• Signs of a new infection such as flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores.
• Severe pain in your upper stomach spreading to your back, nausea and vomiting; itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• Swelling around your stomach, feeling of fullness, feeling short of breath, coughing up blood;
• Numbness, tingling, or pain in your hands or feet.
• Pain in one or both eyes, vision problems, seeing flashes of light.
• Pale skin, easy bruising or bleeding, feeling light-headed, rapid heart rate, trouble concentrating.
• Increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia).
• Diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex.
• Swelling in your neck or throat (enlarged thyroid).
• weakness or prickly feeling in your fingers or toes.
• Problems with walking, breathing, speech, swallowing, or eye movement.
• severe lower back pain, loss of bladder or bowel control.

 Less serious side effects  may include:

• Mild skin rash;
• Diarrhea; headache;
• Changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

• Availability: In Stock
• Model: Dinex EC 250
• Brand: Cipla