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Didanosine

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Overview

What is Didanosine?

Didanosine delayed-release capsules are an enteric-coated formulation of didanosine, (ddl), a synthetic purine nucleoside analogue active against HIV-1. Didanosine delayed-release capsules, containing enteric-coated pellets, are available for oral administration in the strengths of 200, 250, and 400 mg of didanosine. The inactive ingredients include croscarmellose sodium, hydroxypropyl cellulose, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, sodium hydroxide, talc, titanium dioxide, triacetin and triethyl citrate.The capsule shell contains FD&C blue no.1, gelatin, and titanium dioxide.The 200 mg capsule shell also contains D&C red no. 33, and FD&C yellow no. 6. The 250 mg capsule shell also contains D&C red no. 28. The 400 mg capsule shell also contains D&C red no.33, and FD&C yellow no. 6. The edible imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide, propylene glycol and shellac glaze.

The chemical name for didanosine is 2', 3'-dideoxyinosine. The structural formula is:

Didanosine is a white crystalline powder with the molecular formula CHNO and a molecular weight of 236.2. The aqueous solubility of didanosine at 25° C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic solutions. For example, at pH less than 3 and 37° C, 10% of didanosine decomposes to hypoxanthine in less than 2 minutes. In didanosine delayed-release capsules, an enteric coating is used to protect didanosine from degradation by stomach acid.



What does Didanosine look like?



What are the available doses of Didanosine?

Capsules: 200 mg, 250 mg, 400 mg ()

What should I talk to my health care provider before I take Didanosine?

Pregnancy: Fatal lactic acidosis has been reported in pregnant women who received both didanosine and stavudine with other agents. This combination should be used with caution during pregnancy and only if the potential benefit clearly outweighs the potential risk. (, ) Physicians are encouraged to register patients in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263.

How should I use Didanosine?

Didanosine delayed-release capsules, also known as ddI, in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [].

Didanosine delayed-release capsules should be administered on an empty stomach. Didanosine delayed-release capsules should be swallowed intact.


What interacts with Didanosine?

Sorry No Records found


What are the warnings of Didanosine?

Sorry No Records found


What are the precautions of Didanosine?

Sorry No Records found


What are the side effects of Didanosine?

Sorry No records found


What should I look out for while using Didanosine?

These recommendations are based on either drug interaction studies or observed clinical toxicities.

Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine delayed-release capsules should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis []

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. 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 []


What might happen if I take too much Didanosine?

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 [].


How should I store and handle Didanosine?

ZERIT Capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature). ZERIT for Oral Solution should be protected from excessive moisture and stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature). After constitution, store tightly closed containers of ZERIT for Oral Solution in a refrigerator, 2° C to 8° C (36° F to 46° F). Discard any unused portion after 30 days. ZERIT Capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature). ZERIT for Oral Solution should be protected from excessive moisture and stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature). After constitution, store tightly closed containers of ZERIT for Oral Solution in a refrigerator, 2° C to 8° C (36° F to 46° F). Discard any unused portion after 30 days. Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Didanosine Delayed-Release Capsules are available as:200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 588 over 200 mg.250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 589 over 250 mg. 400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink stylized barr 590 over 400 mg. They are supplied by as follows:Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Didanosine is an antiviral agent [].

Non-Clinical Toxicology
These recommendations are based on either drug interaction studies or observed clinical toxicities.

Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine delayed-release capsules should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis []

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. 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 []

Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine should be suspended in patients with signs or symptoms of pancreatitis and discontinued in patients with confirmed pancreatitis. Patients treated with didanosine in combination with stavudine may be at increased risk for pancreatitis.

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, didanosine 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 [].

The following adverse reactions are discussed in greater detail in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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