Minocycline Hydrochloride

MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride tablet, film coated, extended release
Bryant Ranch Prepack

mino-struc

1 INDICATIONS & USAGE

1.1 Indication

Minocycline hydrochloride extended-release tablets is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

1.2 Limitations of Use

Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline hydrochloride extended-release tablets 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)].To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Minocycline hydrochloride extended-release tablets should be used only as indicated [see Warnings and Precautions (5.11)].

2 DOSAGE & ADMINISTRATION

The recommended dosage of Minocycline hydrochloride extended-release tablets 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 tablet strength and body weight to achieve approximately 1 mg/kg.

Table 1: Dosing Table for Minocycline hydrochloride extended-release tablets

Patient’s Weight (lbs.)	Patient’s Weight (kg)	Tablet Strength (mg)	Actual mg/kg Dose
99 to 109	45 to 49	45	1 to 0.92
110 to 131	50 to 59	55	1.10 to 0.93
132 to 157	60 to 71	65	1.08 to 0.92
158 to 186	72 to 84	80	1.11 to 0.95
187 to 212	85 to 96	90	1.06 to 0.94
213 to 243	97 to 110	105	1.08 to 0.95
244 to 276	111 to 125	115	1.04 to 0.92
277 to 300	126 to 136	135	1.07 to 0.99

Minocycline hydrochloride extended-release tablets may be taken with or without food [see Clinical Pharmacology (12.3)]. Ingestion of food along with Minocycline hydrochloride extended-release tablets 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)].

3 DOSAGE FORMS & STRENGTHS

• 45 mg extended release tablets: grey coloured capsule shaped film coated tablets, debossed with “45”on one side, plain on other side.
• 55 mg extended release tablets:Pink coloured capsule shaped film coated tablets, debossed with “55” on one side,plain on other side.
• 65 mg extended release tablets: blue coloured capsule shaped film coated tablets, debossed with “65”on one side, plain on other side.
• 80 mg extended release tablets:Greyish brown coloured capsule shaped film coated tablets, debossed with “80”on one side, plain on other side.
• 90 mg extended release tablets: yellow coloured capsule shaped film coated tablets, debossed with “90”on one side, plain on other side.
• 105 mg extended release tablets:Purple coloured capsule shaped film coated tablets, debossed with “105” on one side, plain on other side.
• 115 mg extended release tablets: green coloured capsule shaped film coated tablets, debossed with “115”on one side, plain on other side.
• 135 mg extended release tablets: pink (orange-brown) coloured capsule shaped film coated tablets, debossed with “135”on one side, plain on other side

4 CONTRAINDICATIONS

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

5 WARNINGS AND PRECAUTIONS

5.1 Teratogenic Effects

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.
Minocycline hydrochloride extended-release tablets should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child [see Nonclinical Toxicology (13.1) & Use in Specific Populations (8.1)].
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).
This adverse reaction 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. This reaction 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)].

5.2 Pseudomembranous Colitis

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.

5.3 Hepatotoxicity

Post-marketing 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.

5.4 Metabolic Effects

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.