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Didanosine Granules

Function and Efficacy

Didanosine is a synthetic nucleoside drug. Compared with natural adenosine, the latter's 3'-hydroxyl group is converted to hydrogen. Didanosine is phosphorylated by cellular kinases to form the active metabolite 5'-dideoxyadenosine triphosphate. 5'-dideoxyadenosine triphosphate inhibits HIV reverse transcriptase, and its mechanism includes competition with the natural substrate deoxyadenosine triphosphate and incorporation into viral DNA to terminate the extension of the DNA chain.

Ingredients

The main ingredients of this product are: Didanosine

Name Description Content CAS NO. Manufacturer
DideoxyinosineIngredients

Didanosine is a synthetic nucleoside drug. Compared with natural adenosine, the latter's 3'-hydroxyl group is converted to hydrogen. Didanosine is phosphorylated by cellular kinases to form the active metabolite 5'-dideoxyadenosine triphosphate. 5'-dideoxyadenosine triphosphate inhibits HIV reverse transcriptase, and its mechanism includes competition with the natural substrate deoxyadenosine triphosphate and incorporation into viral DNA to terminate DNA chain extension.

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69655-05-6 13

Appearance

This product is off-white granules with fruity aroma and sweet taste.

Indication

This product is used in combination with other antiviral drugs to treat type 1 HIV (human immunodeficiency virus) infection.

Usage and Dosage

Dosage: This product should be administered at least 30 minutes before meals, or 2 hours after meals, on an empty stomach. Place this product in a small amount of water, stir well and then take it. This product is suitable for children, but not for adults due to dosage reasons. The recommended dose for children is 120 mg/m2 twice a day. There is no data for once-daily treatment. Dose adjustment: Once clinical signs of pancreatitis and abnormal laboratory tests occur, patients should immediately suspend medication and determine whether pancreatitis has occurred. After pancreatitis is diagnosed, use should be stopped. If patients develop symptoms of peripheral neuropathy, they can still tolerate reduced doses of this product after the symptoms of poisoning subside. After repeated use, if peripheral neuropathy recurs, complete cessation of treatment with this product should be considered. Given that urinary excretion is also the main way to eliminate didanosine in children, if children have renal impairment, the clearance rate of didanosine will also change accordingly. Although there is no experimental data to show that the dosage of such patients needs to be adjusted, it is still possible to consider reducing the dose or lengthening the medication interval.

Adverse Reactions

1. Pancreatitis: Regardless of whether the patient has received treatment or the degree of immunosuppression, this product, when used alone or in combination, will cause fatal or non-fatal pancreatitis. If the patient is suspected of having pancreatitis, use of the product should be suspended. Once pancreatitis is confirmed, use should be discontinued. Patients taking stavudine are more likely to develop pancreatitis, regardless of whether they are taking hydroxyurea at the same time. 2. Lactic acidosis and severe hepatomegaly with fatty degeneration. 3. Retinal changes and optic neuritis: Retinal changes and optic neuritis have occurred in both adult and pediatric patients. Patients taking this product should undergo regular retinal examinations. 4. Systemic reactions: hair loss, allergic-like reactions, weakness, pain, chills and fever. 5. Digestive system: anorexia, indigestion and abdominal distension. 6. Exocrine glands: salivary glands

Precautions

Patients with significant hypersensitivity to didanosine or other formulation ingredients are contraindicated.

Drug Interactions

1. Drug interaction studies have shown that this product has no clinical pharmacokinetic interactions with daspone, loperamide, metoclopramide, nevirapine, ranitidine, rifabutin, ritonavir, stavudine, sulfamethoxazole, trimethoprim and zidovudine. Among them, the interaction studies with dapsone, nevirapine, rifabutin, ritonavir, stavudine and zidovudine are multiple-dose studies; the interaction studies with loperamide, metoclopramide, ranitidine, sulfamethoxazole and trimethoprim are single-dose studies, and their steady-state kinetic interactions are unknown. 2. This product can increase pancreatic toxicity when used in combination with drugs known to be toxic to the pancreas. It should be used with extreme caution. This treatment option can only be used when there is no other treatment option or it must be used. Patients with a history of neuropathy and those who use neurotoxic drugs such as stavudine at the same time are more likely to develop peripheral neuropathy. 3 Allopurinol: In two patients with impaired renal function (creatinine clearance of 15 and 18 ml/min, respectively), a single dose of 200 mg of this product was used simultaneously with allopurinol (300 mg/day), resulting in a four-fold increase in the AUC of didanosine. As for patients with normal renal function, the effect of allopurinol on the pharmacokinetics of didanosine is unknown. 4 Antacids: When taking this product, taking magnesium and aluminum-containing antacids at the same time, the antacid components of both will aggravate adverse reactions. 5 Drugs whose absorption is affected by gastric acidity: Such as ketoconazole and itraconazole, should be taken at least two hours before taking this product. 6 Ganciclovir: Taking this product two hours before or at the same time as taking ganciclovir will increase the steady-state AUC of the latter to 111 (plusmn; 14%) (n=12). Taking this product two hours before taking ganciclovir, the steady-state AUC of the former decreased by 21 (plusmn; 17%), while taking it at the same time had no effect on the AUC of ganciclovir (n=12). 7 Quinolone antibiotics: Because antacid components such as magnesium and calcium can reduce the plasma concentration of ciprofloxacin, this product should be taken 2 hours after or 6 hours before taking ciprofloxacin. In 8 HIV-infected patients, when ciprofloxacin was taken two hours before taking this product, the steady-state AUC of ciprofloxacin decreased by 26% (95% confidence interval was 14%, 37%). In 12 healthy subjects, ciprofloxacin and didanosine placebo were given at the same time, and the AUC of the former decreased by 15 times. One subject took ciprofloxacin before taking didanosine placebo, and the AUC of the latter decreased by more than 50%. Antacid components such as magnesium and calcium can reduce the plasma concentration of quinolone antibiotics. If you need to take this product, refer to the instructions in the corresponding quinolone package to determine the interval between the use of the two drugs. 8 Interaction with other antiviral drugs: Taking this product at the same time will significantly reduce the AUC of delaviridine (20%) and indinavir (84%). To avoid this drug interaction, delaviridine and indinavir should be administered 1 hour before taking this product. Nelfinavir is administered one hour after taking this product, and a small amount of food is taken at the same time, and the pharmacokinetics of the former are not affected.

Storage

Keep tightly closed in a dry place.

Packaging Specification

50 mg

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