Kapidex
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Uses
1.1 Healing of Erosive Esophagitis
KAPIDEX is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
1.2 Maintenance of Healed Erosive EsophagitisKAPIDEX is indicated to maintain healing of EE for up to 6 months.
1.3 Symptomatic Non-Erosive Gastroesophageal Reflux DiseaseKAPIDEX is indicated for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in KAPIDEX (dexlansoprazole) delayed release capsules is (+)-2-[( R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl} sulfinyl]- 1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its empirical formula is: C 16H 14F 3N 3O 2S, with a molecular weight of 369.36. The structural formula is:
Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane.
Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions.
KAPIDEX is supplied as a dual delayed release formulation in capsules for oral administration. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)].
KAPIDEX is available in two dosage strengths: 30 mg and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymer, polyethylene glycol 8000, triethyl citrate, polysorbate 80, and colloidal silicon dioxide. The components of the capsule shell include the following inactive ingredients: hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 and aluminum lake; gray contains ferric oxide and aluminum lake; and both contain titanium dioxide.
Sources
Kapidex Manufacturers
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Physicians Total Care, Inc.
![Kapidex (Dexlansoprazole) Capsule, Delayed Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kapidex | Physicians Total Care, Inc.
2.1 Recommended DoseKAPIDEX is available as capsules in 30 mg and 60 mg strengths for adult use. Directions for use in each indication are summarized in Table 1.
Table 1: KAPIDEX Dosing Recommendations Indication Recommended Dose Frequency Healing of EE 60 mg
Once daily for up to 8 weeks Maintenance of Healed EE 30 mg
Once daily* Symptomatic Non-Erosive GERD 30 mg
Once daily for 4 weeks * Controlled studies did not extend beyond 6 months.
2.2 Special PopulationsNo adjustment for KAPIDEX is necessary for patients with mild hepatic impairment (Child-Pugh Class A). Consider a maximum daily dose of 30 mg for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.5)].
No dosage adjustment is necessary for elderly patients or for patients with renal impairment [see Clinical Pharmacology (12.5)].
2.3 Important Administration InformationKAPIDEX can be taken without regard to food.
KAPIDEX should be swallowed whole.
Alternatively, KAPIDEX capsules can be opened and administered as follows: – Open capsule; – Sprinkle intact granules on one tablespoon of applesauce; – Swallow immediately.
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