Venlafaxine 37.5 mg sevrage


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Venlafaxine er capsules dosage form and orally disintegrating tablets may contain one or more of (a) quaternary ammonium compounds (b) aluminum salts (c) iron salts (d) phosphorus salts or (e) sucrose salts in a concentration that is greater than 25% by weight of the active substance in capsule, tablet and the entire formulation (see list 4). Except in the case of quaternary ammonium compounds and aluminum salts, excluding the case of aluminum salts: (a) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 4.5% by weight of the capsule, tablet and entire formulation, (ii) 250 mg per 10 kg of body weight the capsules or tablets, (iii) 0.15% by weight of the formulation as a whole, or (iv) 50 mg per 10 kg of body weight the formulation as a whole (see Table 3); (b) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 4.0% by weight of the capsule, tablet and entire formulation, (ii) 50 mg per 10 kg of body weight the capsules or tablets and entire formulation as a whole, or (iii) 0.1% by weight of the formulation as a whole, or (iv) 25 mg per 10 kg of body weight the formulation as a whole (see Table 3); (c) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 3.25% by weight of the capsule, tablet and entire formulation 100 mg per capsule, (ii) 1 mg per 10 kg of body weight the capsule or tablets and entire formulation as a whole, or (iii) 20 mg per 10 kg of body weight the capsule or tablets and entire formulation as a whole (see Table 3); (d) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 3.0% by weight of the capsule, tablet and entire formulation 50 mg per 10 kg of body weight the capsules or tablets, (ii) 1 mg per 10 kg of body weight the capsule or tablets and entire formulation as a whole (see Table 3); (e) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 2.0% by weight of the capsule, tablet and entire formulation 1.25 mg per 10 kg of body weight the capsules or tablets and entire formulation as a whole (see Table 3); (f) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 1.5% by weight of the capsule, tablet and entire formulation 1.25 mg per 10 kg of body weight the capsules or tablets and entire formulation as a whole (see Table 3); and (i) 25 mg per 10 kg of body weight the capsules or tablets (see Table 3); (g) quaternary ammonium compounds or aluminum salts can be present in amounts that are not more than: (i) 1.25% by weight of the capsule, tablet and entire formulation 0.4 mg per 10 kg of body weight the capsules or tablets, (ii) 0.5% by weight of the formulation and whole, or (iii) 0.2% by weight of the formulation and whole, or (iv) 20 mg per 10 kg of body weight the capsules or tablets (see Table 3). (2) The amount of aluminum salts and quaternary ammonium compounds in an oral disintegrating tablet of the present invention is controlled in a venlafaxine hcl 37.5 mg hot flashes manner that does not allow for any quantity of the aluminum salts to be present in a powder form that would alter the pharmacokinetic profile of disintegrating tablet, nor could it allow a quantity of the quaternary ammonium compounds to be present in a powder form that would alter the oral disintegrating tablet's chemical stability to cause a pharmacological effect. (3) The amount of quaternary ammonium compounds in the final formulation can vary from 2.0 mg per 10 kg to 100 mg per 10 kg. The amount of quaternary ammonium compounds can then be adjusted to have a range of approximately 0.6% to 50% by weight of the total dosage form.

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