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Minolira

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Overview

What is Minolira?

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [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:

MINOLIRA (minocycline hydrochloride) extended-release tablets for oral administration contain 105 mg or 135 mg of minocycline, equivalent to 113.4 mg or 145.8 mg of minocycline hydrochloride, respectively. MINOLIRA extended-release tablets, 105 mg and 135 mg, contain 25% of minocycline as immediate release beads and 75% of minocycline as extended release beads.

In addition, 105 mg and 135 mg tablets contain the following inactive ingredients: ethyl cellulose NF, hypromellose USP, isopropyl alcohol USP, microcrystalline cellulose NF, polyethylene glycol 400 NF, purified water USP, silicified microcrystalline cellulose NF, sodium stearyl fumarate NF, talc USP, triethyl citrate NF.

Both 105 mg and 135 mg tablets also contain Opadry clear which contains hydroxyl propyl cellulose NF and hypromellose USP.



What does Minolira look like?



What are the available doses of Minolira?

Extended- release tablets: 105 mg and 135 mg of minocycline, functionally scored ()

What should I talk to my health care provider before I take Minolira?

How should I use Minolira?

MINOLIRA is indicated to treat the inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.  

Limitations of Use

This formulation of minocycline has not been evaluated in the treatment of infections.  

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, MINOLIRA should be used only as indicated 

The recommended dosage of MINOLIRA 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 105 mg and 135 mg tablets may be split on the score line for dosing of patient weight ranges of 45-59 kg and 60-89 kg, respectively (see Table 1).

Table 1: Dosing Table for MINOLIRA

MINOLIRA may be taken with or without food . Ingestion of food along with MINOLIRA may help reduce the risk of esophageal irritation and ulceration. MINOLIRA tablets should not be chewed or crushed.  

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


What interacts with Minolira?

Sorry No Records found


What are the warnings of Minolira?

Sorry No Records found


What are the precautions of Minolira?

Sorry No Records found


What are the side effects of Minolira?

Sorry No records found


What should I look out for while using Minolira?

MINOLIRA is contraindicated in patients who have shown hypersensitivity to any of the tetracyclines .


What might happen if I take too much Minolira?

In case of over dosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.


How should I store and handle Minolira?

How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline.   The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface. On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows:   NDC 43598-540-30 Bottle of 30   The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 mg of minocycline as extended release beads. The 135 mg tablets are supplied as follows:   NDC 43598-539-30 Bottle of 30 Storage Store at 20ºC - 25ºC (68ºF - 77ºF); excursions are permitted to 15ºC-30ºC (59º-86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of MINOLIRA for the treatment of acne is unknown.

Non-Clinical Toxicology
MINOLIRA is contraindicated in patients who have shown hypersensitivity to any of the tetracyclines .

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.  

The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended release tablets.

Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial

6.2 Postmarketing Experience

Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include:  

Skin and hypersensitivity reactions:

[see Warnings and Precautions (

)].

Autoimmune conditions:

Central nervous system:

Endocrine:

Oncology:

Oral:

,

Gastrointestinal:

Genitourinary:

[see Nonclinical Toxicology (

)]

Renal:

Hematology:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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