Drug Catalog - Product Detail
RIVASTIGMINE TARTRATE CP 6MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0355-05 | DR.REDDY'S LABORATORIES, INC. | 500 | 6MG | CAPSULE |
PACKAGE FILES
Generic Name
RIVASTIGMINE TARTRATE
Substance Name
RIVASTIGMINE TARTRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA077130
Description
11 DESCRIPTION Rivastigmine tartrate USP is 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 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 g/mol (hta salt). Rivastigmine tartrate is a white to off-white powder, that is very soluble in water and in methanol, very slightly soluble in ethyl acetate and soluble in ethanol. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine tartrate capsules, USP contain rivastigmine tartrate, 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 5 cps, magnesium Stearate and microcrystalline cellulose. Each hard-gelatin capsule contains gelatin, titanium dioxide and black, red and yellow iron oxides (1.5 mg), red and yellow iron oxides (3 mg and 6 mg) and red iron oxide (4.5 mg).
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: Rivastigmine tartrate capsules USP, 1.5 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with light tan opaque color cap and light tan opaque color body, imprinted ‘RDY” on cap and ‘352’ on body with black ink and are supplied in bottles of 30, 60, 100 and 500. Bottles of 30 NDC 55111-352-30 Bottles of 60 NDC 55111-352-60 Bottles of 100 NDC 55111-352-01 Bottles of 500 NDC 55111-352-05 Rivastigmine tartrate capsules USP, 3 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with brown opaque color cap and brown opaque color body, imprinted ‘RDY’ on cap and ‘353’ on body with black ink and are supplied in bottles of 30, 60, 100 and 500. Bottles of 30 NDC 55111-353-30 Bottles of 60 NDC 55111-353-60 Bottles of 100 NDC 55111-353-01 Bottles of 500 NDC 55111-353-05 Rivastigmine tartrate capsules USP, 4.5 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with swedish orange opaque color cap and swedish orange opaque color body, imprinted 'RDY' on cap and '354' on body with black ink and are supplied in bottles of 30, 60, 100 and 500. Bottles of 30 NDC 55111-354-30 Bottles of 60 NDC 55111-354-60 Bottles of 100 NDC 55111-354-01 Bottles of 500 NDC 55111-354-05 Rivastigmine tartrate capsules USP, 6 mg are white to off-white powder filled in size ‘2’ hard gelatin capsules with swedish orange opaque color cap and brown opaque color body, imprinted ‘RDY’ on cap and ‘355’ on body with black ink and are supplied in bottles of 30, 60, 100 and 500. Bottles of 30 NDC 55111-355-30 Bottles of 60 NDC 55111-355-60 Bottles of 100 NDC 55111-355-01 Bottles of 500 NDC 55111-355-05 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Rivastigmine tartrate capsule is 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 capsule 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.