Drug Catalog - Product Detail
RIVASTIGMINE TARTRATE 3MG CAP 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-3209-60 | ACTAVIS PHARMA | 60 | 3MG | CAPSULE |
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Description
11 DESCRIPTION Rivastigmine Tartrate Capsules USP are a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate, USP is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has a molecular formula of C 14 H 22 N 2 O 2 • C 4 H 6 O 6 (hydrogen tartrate salt-hta salt) and a molecular weight of 400.43 (hta salt). Rivastigmine tartrate, USP is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate USP, equivalent to 1.5 mg, 3 mg, 4.5 mg, and 6 mg of rivastigmine base for oral administration. Inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, and microcrystalline cellulose. The capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 1.5 mg capsule shell also contains red iron oxide. The 4.5 and 6 mg capsule shell also contains red iron oxide and black iron oxide. The imprinting ink, common for all strengths, contains: black iron oxide, D&C yellow #10 aluminum lake, FD&C blue #1 brilliant blue FCF aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, shellac and may contain propylene glycol. Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Rivastigmine Tartrate Capsules USP equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base are available as follows: 1.5 mg – Hard gelatin capsules with orange opaque cap and body printed with WATSON over 3208 on both cap and body in black ink. Capsules are supplied in bottles of 60 (NDC 0591-3208-60). 3 mg - Hard gelatin capsules with yellow opaque cap and body printed with WATSON over 3209 on both cap and body in black ink. Capsules are supplied in bottles of 60 (NDC 0591-3209-60). 4.5 mg - Hard gelatin capsules with light brown opaque cap and body printed with WATSON over 3210 on both cap and body in black ink. Capsules are supplied in bottles of 60 (NDC 0591-3210-60). 6 mg - Hard gelatin capsules with light brown opaque cap and orange opaque body printed with WATSON over 3211 on both cap and body in black ink.Capsules are supplied in bottles of 60 (NDC 0591-3211-60). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Indications & Usage
1 INDICATIONS AND USAGE Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: Mild-to-moderate dementia of the Alzheimer’s type (AD) ( 1.1 ) Mild-to-moderate dementia associated with Parkinson’s disease (PD) ( 1.2 ) 1.1 Alzheimer’s Disease Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD). 1.2 Parkinson’s Disease Dementia Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinson’s disease (PD).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Alzheimer’s Disease ( 2.1 ) : Initial Dose: Initiate treatment with 1.5 mg twice a day Dose Titration: After a minimum of 2 weeks, if tolerated, increase dose to 3 mg twice a day and further to 4.5 mg twice a day and 6 mg twice a day if tolerated with a minimum of 2 weeks at each dose Parkinson’s Disease Dementia (PDD) ( 2.2 ) : Initial Dose: Initiate treatment with 1.5 mg twice a day Dose Titration: After a minimum of 4 weeks, if tolerated, increase dose to 3 mg twice a day and further to 4.5 mg twice a day and 6 mg twice a day if tolerated with a minimum of 4 weeks at each dose Rivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening. ( 2.1 , 2.2 ) 2.1 Dosing in Alzheimer’s Disease Rivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening. The recommended dosage of rivastigmine tartrate capsules in Alzheimer’s disease (AD) is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial. Initial Dose Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules. Dose Titration After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day). 2.2 Dosing in Parkinson’s Disease Dementia Rivastigmine tartrate capsules should be taken with meals in divided doses in the morning and evening. The dosage of rivastigmine tartrate capsules shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day). Initial Dose Initiate treatment with the 1.5 mg twice a day with rivastigmine tartrate capsules. Dose Titration After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day). 2.3 Interruption of Treatment If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of rivastigmine tartrate capsules. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1) ] . 2.4 Dosing in Specific Populations Dosing Modifications in Patients with Renal Impairment Patients with moderate and severe renal impairment may be able to only tolerate lower doses. Dosing Modifications in Patients with Hepatic Impairment Patients with mild (Child-Pugh score 5 to 6) and moderate (Child-Pugh score 7 to 9) hepatic impairment may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment. Dosing Modifications in Patients with Low Body Weight Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.