Reviews Didanosine Delayed-Release Capsules - Enteric-Coated Beadlets


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Videx EC Drug Description
VIDEX EC
(didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with
STEATOSIS
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. VIDEX EC should be suspended
in patients with suspected pancreatitis and discontinued in patients with
confirmed pancreatitis [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION



What are the possible side effects of didanosine (Videx, Videx EC)?

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.
Stop using didanosine and call your doctor at once if you have any of these serious side effects:

liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms...
Read All Potential Side Effects for Videx EC »




VIDEX® EC is the brand name for an enteric-coated formulation of didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine. The inactive ingredients in the beadlets include carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc. The capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible inks.
Didanosine is also available in a powder formulation. Please consult the prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for additional information.
The chemical name for didanosine is 2',3'-dideoxyinosine. The structural
formula is:








Didanosine is a white crystalline powder with the molecular formula C10H12N4O3
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 VIDEX EC, an enteric coating is used
to protect didanosine from degradation by stomach acid.
Last reviewed on RxList: 2/19/2010




Videx EC Drug Description
VIDEX EC
(didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with
STEATOSIS
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. VIDEX EC should be suspended
in patients with suspected pancreatitis and discontinued in patients with
confirmed pancreatitis [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION



What are the possible side effects of didanosine (Videx, Videx EC)?

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.
Stop using didanosine and call your doctor at once if you have any of these serious side effects:

liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms...
Read All Potential Side Effects for Videx EC »




VIDEX® EC is the brand name for an enteric-coated formulation of didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine. The inactive ingredients in the beadlets include carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc. The capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible inks.
Didanosine is also available in a powder formulation. Please consult the prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for additional information.
The chemical name for didanosine is 2',3'-dideoxyinosine. The structural
formula is:








Didanosine is a white crystalline powder with the molecular formula C10H12N4O3
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 VIDEX EC, an enteric coating is used
to protect didanosine from degradation by stomach acid.
Last reviewed on RxList: 2/19/2010




Videx EC Drug Description
VIDEX EC
(didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with
STEATOSIS
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. VIDEX EC should be suspended
in patients with suspected pancreatitis and discontinued in patients with
confirmed pancreatitis [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION



What are the possible side effects of didanosine (Videx, Videx EC)?

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.
Stop using didanosine and call your doctor at once if you have any of these serious side effects:

liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms...
Read All Potential Side Effects for Videx EC »




VIDEX® EC is the brand name for an enteric-coated formulation of didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine. The inactive ingredients in the beadlets include carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc. The capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible inks.
Didanosine is also available in a powder formulation. Please consult the prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for additional information.
The chemical name for didanosine is 2',3'-dideoxyinosine. The structural
formula is:








Didanosine is a white crystalline powder with the molecular formula C10H12N4O3
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 VIDEX EC, an enteric coating is used
to protect didanosine from degradation by stomach acid.
Last reviewed on RxList: 2/19/2010




Videx EC Drug Description
VIDEX EC
(didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with
STEATOSIS
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. VIDEX EC should be suspended
in patients with suspected pancreatitis and discontinued in patients with
confirmed pancreatitis [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION



What are the possible side effects of didanosine (Videx, Videx EC)?

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.
Stop using didanosine and call your doctor at once if you have any of these serious side effects:

liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms...
Read All Potential Side Effects for Videx EC »




VIDEX® EC is the brand name for an enteric-coated formulation of didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine. The inactive ingredients in the beadlets include carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc. The capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible inks.
Didanosine is also available in a powder formulation. Please consult the prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for additional information.
The chemical name for didanosine is 2',3'-dideoxyinosine. The structural
formula is:








Didanosine is a white crystalline powder with the molecular formula C10H12N4O3
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 VIDEX EC, an enteric coating is used
to protect didanosine from degradation by stomach acid.
Last reviewed on RxList: 2/19/2010




Videx EC Drug Description
VIDEX EC
(didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with
STEATOSIS
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. VIDEX EC should be suspended
in patients with suspected pancreatitis and discontinued in patients with
confirmed pancreatitis [see WARNINGS AND PRECAUTIONS].
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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION



What are the possible side effects of didanosine (Videx, Videx EC)?

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.
Stop using didanosine and call your doctor at once if you have any of these serious side effects:

liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms...
Read All Potential Side Effects for Videx EC »




VIDEX® EC is the brand name for an enteric-coated formulation of didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine. The inactive ingredients in the beadlets include carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc. The capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible inks.
Didanosine is also available in a powder formulation. Please consult the prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for additional information.
The chemical name for didanosine is 2',3'-dideoxyinosine. The structural
formula is:








Didanosine is a white crystalline powder with the molecular formula C10H12N4O3
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 VIDEX EC, an enteric coating is used
to protect didanosine from degradation by stomach acid.
Last reviewed on RxList: 2/19/2010





Other reviews about Didanosine Delayed-Release Capsules - Enteric-Coated Beadlets on web:

Learn about the prescription medication Videx EC (Didanosine Delayed-Release Capsules - Enteric-Coated Beadlets), drug uses, dosage, side effects, drug interactions, warnings ... Videx EC (Didanosine Delayed-Release Capsules - Enteric-Coated ...


Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric-Coated Beadlets) September 2008 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and ... Videx EC (didanosine, USP) Delayed-Release Capsules (Enteric ...


... Dinex EC : Didanosine delayed-release Capsules Enteric-coated beadlets CIPLADOC - Cipla Therapeutic Index


VIDEX ® EC (didanosine) Delayed-Release Capsules Enteric-Coated Beadlets (Patient Information Leaflet Included) DESCRIPTION VIDEX ® EC is the brand name for an enteric-coated ... VIDEX®EC (didanosine) Delayed-Release Capsules Enteric-Coated ...


Pediatric powder for oral solution in 4- or 8-ounce bottles containing didanosine 2 or 4 g, respectively. Delayed-release capsules of enteric-coated beadlets containing didanosine ... AIDSinfo - HIV/AIDS Drug Information - Didanosine


Learn about Videx EC (Didanosine Delayed-Release Capsules - Enteric-Coated Beadlets) - Side Effects, Drug Interactions, Pictures, Patient Information on RxList Videx EC (Didanosine Delayed-Release Capsules - Enteric-Coated ...


VIDEX EC (didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets Initial U.S. Approval: 1991 WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS See full ... Final pdf sent to KW 8/5/10. Web version no FSClogo


Didanosine delayed-release Capsules Enteric-coated beadlets DINEX EC WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS FATAL AND NON-FATAL PANCREATITIS HAS OCCURRED ... WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS


Didanosine Delayed-Release Capsules (Enteric-Coated Beadlets) Initial U.S. Approval: 1991----- RECENT MAJOR CHANGES ----- ... DIDANOSINE DELAYED-RELEASE CAPSULES, 125 MG, 200 MG, 250 MG AND ...


... would like to make HIV clinicians aware of new pharmacoki-netic (PK) data concerning the co-administration of VIDEX EC (didanosine) Delayed-Release Capsules Enteric Coated Beadlets ... Letter From Bristol Myers Squibb About DDI and Tenofovir Interaction





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