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Uses
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with Parkinson's disease.
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Other Information
Rivastigmine tartrate 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 an empirical formula of C14H22N2O2 ∙ C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 (hta salt). Rivastigmine tartrate 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.
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 hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.
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Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 109 Manufacturers
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Laboratoires Clarins S.a.
Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 109 | Breckenridge Pharmaceutical, Inc
2.1 Dosing in Alzheimer's DiseaseRivastigmine 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 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 DementiaRivastigmine 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 TreatmentIf 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 PopulationsDosing 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.
2.5 Important Administration InstructionsRivastigmine tartrate oral solution and rivastigmine tartrate capsules may be interchanged at equal doses.
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