XIMINO- minocycline hydrochloride capsule, extended release
Ranbaxy Laboratories Inc.
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)].
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.
|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 0.99|
Ximino 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)].
- 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.
- 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.
- 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.
A. Minocycline, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus.
B. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development.
C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. The decrease in fibula growth rate was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Use in Specific Populations (8.1)].
Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.