Diclegis

Diclegis

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 Epilepsy

Adjunctive Therapy

Lamotrigine tablets, USP are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:

• partial-onset seizures.

• primary generalized tonic-clonic (PGTC) seizures.

• generalized seizures of Lennox-Gastaut syndrome. 

Monotherapy

Lamotrigine tablets, USP are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).  

Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

1.2 Bipolar Disorder

Lamotrigine tablets, USP are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (aged 18 years and older) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.  

The effectiveness of lamotrigine as maintenance treatment was established in 2 placebo-controlled trials in patients with bipolar I disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe lamotrigine for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

1.1 Epilepsy

Adjunctive Therapy

Lamotrigine tablets, USP are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:

• partial-onset seizures.

• primary generalized tonic-clonic (PGTC) seizures.

• generalized seizures of Lennox-Gastaut syndrome. 

Monotherapy

Lamotrigine tablets, USP are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).  

Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

1.2 Bipolar Disorder

Lamotrigine tablets, USP are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (aged 18 years and older) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.  

The effectiveness of lamotrigine as maintenance treatment was established in 2 placebo-controlled trials in patients with bipolar I disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe lamotrigine for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

History

There is currently no drug history available for this drug.

Other Information

Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:

Structure

Lamotrigine tablets are supplied for oral administration as 25 mg (white), 100 mg (peach), 150 mg (cream), and 200 mg (blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: magnesium stearate; microcrystalline cellulose; colloidal silicon dioxide; sodium starch glycolate; Sunset Yellow Aluminum Lake (100 mg tablet only); ferric oxide, yellow (150 mg tablet only); and Indigotine Al Lake (200 mg tablet only).

Diclegis Manufacturers


  • Duchesnay Usa, Inc.
    Diclegis (Doxylamine Succinate And Pyridoxine Hydrochloride) Tablet, Delayed Release [Duchesnay Usa, Inc.]

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