Ximino
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Ximino is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Ximino should be used only as indicated [see Warnings and Precautions (5.11)].
Ximino did not demonstrate any effect on non-inflammatory acne lesions. Safety of Ximino has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)].
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Ximino Extended-Release Capsules is minocycline hydrochloride, a semi synthetic derivative of tetracycline. Ximino is a tetracycline-class drug. Ximino is known chemically as [4S(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride.
The structural formula is represented below:
Minocycline hydrochloride, USP is a yellow crystalline powder, sparingly soluble in water, soluble in solutions of alkali hydroxides and carbonates, slightly soluble in alcohol, practically insoluble in chloroform and in ether.
Ximino (minocycline hydrochloride) Extended-Release Capsules for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 90 mg, or 135 mg of minocycline. The Extended-Release Capsules contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow #10 (in 45 mg strength), FD&C Blue #1, FD&C Yellow #6 (in 45 mg and 135 mg strength), gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, and titanium dioxide.
The 45 mg, 90 mg, and 135 mg capsules also contain Opadry Clear which contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000, and talc.
Ximino Extended-Release Capsules also contain black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.
Sources
Ximino Manufacturers
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Ranbaxy Laboratories Inc.
![Ximino (Minocycline Hydrochloride) Capsule, Extended Release [Ranbaxy Laboratories Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ximino | Ranbaxy Laboratories Inc.
The recommended dosage of Ximino is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.
The following table shows capsule strength and body weight to achieve approximately 1 mg/kg.
Table 1: Dosing Table for Ximino Patient’s Weight (lbs.) Patient’s Weight (kg) Capsule Strength (mg) Actual mg/kg Dose 99 to 122 45 to 55 45 1 to 0.82 123 to 164 56 to 74 67.5 1.21 to 0.91 165 to 212 75 to 96 90 1.20 to 0.94 213 to 276 97 to 125 112.5 1.16 to 0.90 277 to 300 126 to 136 135 1.07 to 0.99Ximino may be taken with or without food [see Clinical Pharmacology (12)]. The capsules should be swallowed whole without chewing, crushing or splitting. Ingestion of food along with Ximino may help reduce the risk of esophageal irritation and ulceration.
In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.4)].
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