Ximino

INDICATIONS

Indication

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].

Limitations of Use

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].

DOSAGE AND ADMINISTRATION

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 (Ibs.) 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 0.99

Ximino may be taken with or without food [see CLINICAL PHARMACOLOGY]. 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].

HOW SUPPLIED

Dosage Forms and Strengths

  • 45 mg Extended-Release Capsules: Opaque bluish green cap and opaque yellow body hard gelatin capsule with 'RI18' imprinted on both cap and body in black ink containing one yellow to grayish yellow colored film-coated, round tablet plain on both sides.
  • 67.5 mg Extended-Release Capsules: Opaque bluish green cap and white body hard gelatin capsule imprinted with 'RI92' on both cap and body in black ink containing one yellow to grayish yellow colored film-coated, round tablet plain on both sides.
  • 90 mg Extended-Release Capsules: Opaque light blue cap and body hard gelatin capsule with 'RI19' imprinted on both cap and body in black ink containing two yellow to grayish yellow colored film-coated, round tablets plain on both sides.
  • 112.5 mg Extended-Release Capsules: Opaque light blue cap and white body hard gelatin capsule imprinted with 'RI93' on both cap and body in black ink containing two yellow to grayish yellow colored film-coated, round tablets debossed with 'X' on one side and plain on the other side.
  • 135 mg Extended-Release Capsules: Opaque bluish green cap and opaque light blue body hard gelatin capsule with 'RI20' imprinted on both cap and body in black ink containing three yellow to grayish yellow colored film-coated, round tablets plain on both sides.

Ximino (minocycline hydrochloride) Extended-Release Capsules are hard-gelatin capsules containing minocycline hydrochloride, USP equivalent to 45 mg, 67.5 mg, 90 mg, 112.5 mg or 135 mg minocycline. The Extended-Release Capsules are supplied as follows:

Ximino (minocycline hydrochloride) Extended-Release Capsules 45 mg: Opaque bluish green cap and opaque yellow body hard gelatin capsule with 'RI18' imprinted on both cap and body in black ink containing one yellow to grayish yellow colored film-coated, round tablet plain on both sides and are supplied as follows:

NDC 10631-330-30 Bottle of 30
NDC 10631-330-05 Bottle of 500
NDC 10631-330-69 Blister pack of 10

Ximino (minocycline hydrochloride) Extended-Release Capsules 67.5 mg: Opaque bluish green cap and white body hard gelatin capsule imprinted with 'RI92' on both cap and body in black ink containing one yellow to grayish yellow colored film-coated, round tablet plain on both sides and are supplied as follows:

NDC 10631-230-30 Bottle of 30
NDC 10631-230-05 Bottle of 500
NDC 10631-230-69 Blister pack of 10

Ximino (minocycline hydrochloride) Extended-Release Capsules 90 mg: Opaque light blue cap and body hard gelatin capsule with 'RI19' imprinted on both cap and body in black ink containing two yellow to grayish yellow colored film-coated, round tablets plain on both sides and are supplied as follows:

NDC 10631-331-30 Bottle of 30
NDC 10631-331-05 Bottle of 500
NDC 10631-331-69 Blister pack of 10

Ximino (minocycline hydrochloride) Extended-Release Capsules 112.5 mg: Opaque light blue cap and white body hard gelatin capsule imprinted with 'RI93' on both cap and body in black ink containing two yellow to grayish yellow colored film-coated, round tablets debossed with 'X' on one side and plain on the other side and are supplied as follows:

NDC 10631-231-30 Bottle of 30
NDC 10631 -231 -05 Bottle of 500
NDC 10631 -231 -69 Blister pack of 10

Ximino (minocycline hydrochloride) Extended-Release Capsules 135 mg: Opaque bluish green cap and opaque light blue body hard gelatin capsule with 'RI20' imprinted on both cap and body in black ink containing three yellow to grayish yellow colored film-coated, round tablets plain on both sides and are supplied as follows:

NDC 10631-332-30 Bottle of 30
NDC 10631-332-05 Bottle of 500
NDC 10631-332-69 Blister pack of 10

Storage

Store at 20° C - 25°C (68° F - 77°F); excursions are permitted to 15° C - 30°C (59° F - 86°F) [See USP Controlled Room Temperature].

Handling

Protect from light, moisture, and excessive heat.

Dispense in tight, light-resistant container with child-resistant closure.

Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Ltd. New Delhi -110 019, India.

Last reviewed on RxList: 7/30/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations