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Aptiom

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Overview

What is Aptiom?

The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is CHNO and its molecular weight is 296.32. The chemical structure is:

APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol.

Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.



What does Aptiom look like?



What are the available doses of Aptiom?

Tablets: 200 mg, 400 mg, 600 mg, 800 mg ()

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

Pregnancy: Based on animal data, may cause fetal harm. ()

How should I use Aptiom?


What interacts with Aptiom?

Sorry No Records found


What are the warnings of Aptiom?

Sorry No Records found


What are the precautions of Aptiom?

Sorry No Records found


What are the side effects of Aptiom?

Sorry No records found


What should I look out for while using Aptiom?

APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine


What might happen if I take too much Aptiom?


How should I store and handle Aptiom?

Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules.  Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 30 (NDC 16252-570-30)  Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100 (NDC 16252-571-01) bottles of 500 (NDC 16252-571-50)  Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap.  The body has “" and the cap has “” both printed in black:bottles of 100  (NDC 16252-572-01) bottles of 500 (NDC 16252-572-50) Ramipril 10 mg capsules are supplied as hard gelatin capsules with white opaque body and blue opaque cap.  The body has “" and the cap has “ ” both printed in black:bottles of 100 (NDC 16252-573-01) bottles of 500 (NDC 16252-573-50) Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

APTIOM is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.

Non-Clinical Toxicology
APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine

Centrally Acting Agents

Alcohol

Antacids

Compounds Which Inhibit Certain Hepatic Enzymes

Phenytoin

Antiepileptic drugs (AEDs), including APTIOM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% confidence interval [CI]: 1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number of events is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

Table 3

The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical trials in patients with psychiatric or other conditions, but the absolute risk differences were similar for epilepsy and psychiatric indications.

Anyone considering prescribing APTIOM or any other AED must balance this risk with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression; any unusual changes in mood or behavior; or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

The following adverse reactions are described in more detail in the section of the label:

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).