ISOSORBIDE MONONITRATE (Page 4 of 4)

Methemoglobinemia

Methemoglobinemia has been reported in patients receiving other organic nitrates, and it probably could also occur as a side effect of isosorbide mononitrate. Certainly nitrate ions liberated during metabolism of isosorbide mononitrate can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moiety of isosorbide mononitrate is quantitatively applied to oxidation of hemoglobin, about 2 mg/kg of isosorbide mononitrate should be required before any of these patients manifest clinically significant (≥10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of isosorbide mononitrate. In one study in which 36 patients received 2-4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 7.8 to 11.1 mg of isosorbide mononitrate per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo.

Notwithstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible.

Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2 . Classically, methemoglobinemic blood is described as chocolate brown without color change on exposure to air. When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1 to 2 mg/kg intravenously.

DOSAGE AND ADMINISTRATION

The recommended starting dose of isosorbide mononitrate extended-release tablets is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of isosorbide mononitrate extended-release tablets should be taken in the morning on arising. Isosorbide mononitrate extended-release tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.

HOW SUPPLIED

Isosorbide mononitrate extended-release tablets, USP 30 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and debossed ‘3-0’ across breakline and ‘1104’ on other side. They are supplied as follows:

Bottles of 100 NDC 13668-104-01

Bottles of 500 NDC 13668-104-05

Bottles of 1000 NDC 13668-104-10

Bottles of 4000 NDC 13668-104-40

100 Unit dose tablets NDC 13668-104-74

Isosorbide mononitrate extended-release tablets, USP 60 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and ‘60-60’ debossing across breakline and ‘1105’ on the other side.

Bottles of 100 NDC 13668-105-01

Bottles of 500 NDC 13668-105-05

Bottles of 1000 NDC 13668-105-10

Bottles of 2000 NDC 13668-105-20

100 Unit dose tablets NDC 13668-105-74

Isosorbide mononitrate extended-release tablets, USP 120 mg are white to off-white, oval shaped, film coated tablets having debossed ‘120’ on one side and ‘1106’ on the other side.

Bottles of 100 NDC 13668-106-01

Bottles of 500 NDC 13668-106-05

Bottles of 1000 NDC 13668-106-10

100 Unit dose tablets NDC 13668-106-74

28 Unit dose tablets NDC 13668-106-59

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

torrent-logo

​30mg, 60mg & 120mg Manufactured by:

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For:

TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.

8053558 Revised February 2015

30mg Manufactured by:

TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

For:

TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.

8057361 Revised January 2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISMN 30 mg, 500s count – TPL, Indrad

30mg-500s-indrad
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISMN 60 mg, 500s count – TPL, Indrad

60mg-500s-indrad
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISMN 120 mg, 500s count – TPL, Indrad

120mg-500s-indrad
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISMN 30 mg, 100s count – TPL, Dahej

30mg-100s-dahej
(click image for full-size original)
ISOSORBIDE MONONITRATE
isosorbide mononitrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-104
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DIETHYL PHTHALATE
HYDROGENATED CASTOR OIL
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL (Oval) Size 9mm
Flavor Imprint Code 3;0;1104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-104-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-104-40 4000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-104-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-104-74 100 TABLET, EXTENDED RELEASE in 1 CARTON None
5 NDC:13668-104-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200270 06/03/2011
ISOSORBIDE MONONITRATE
isosorbide mononitrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE 60 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
DIETHYL PHTHALATE
HYDROGENATED CASTOR OIL
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL (Oval) Size 13mm
Flavor Imprint Code 60;60;1105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-105-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-105-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-105-20 2000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-105-74 100 TABLET, EXTENDED RELEASE in 1 CARTON None
5 NDC:13668-105-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200495 06/03/2011
ISOSORBIDE MONONITRATE
isosorbide mononitrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITRATE) ISOSORBIDE MONONITRATE 120 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
DIETHYL PHTHALATE
HYDROGENATED CASTOR OIL
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (oval) Size 20mm
Flavor Imprint Code 120;1106
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-106-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:13668-106-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:13668-106-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:13668-106-74 100 TABLET, EXTENDED RELEASE in 1 CARTON None
5 NDC:13668-106-59 28 TABLET, EXTENDED RELEASE in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200495 06/03/2011
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 864147745 manufacture (13668-104)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-104), manufacture (13668-105), manufacture (13668-106)

Revised: 04/2019 Torrent Pharmaceuticals Limited

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