isosorbide

isosorbide dinitrate: eye-soe-SOR-bide dye-NYE-trate

isosorbide mononitrate: eye-soe-SOR-bide mo-noe-NYE-trate

Therapeutic Classification: antianginals

Pharmacologic Classification: nitrates

REMS

Prophylactic management of angina pectoris.

Unlabeled Use:

Treatment of chronic heart failure (unlabeled).

Produce vasodilation (venous greater than arterial).
Decrease left ventricular end-diastolic pressure and left ventricular end-diastolic volume (preload). Net effect is reduced myocardial oxygen consumption.
Increase coronary blood flow by dilating coronary arteries and improving collateral flow to ischemic regions.

Therapeutic effects:

Prevention of anginal attacks.

Absorption: Isosorbide dinitrate undergoes extensive first-pass metabolism by the liver, resulting in 25% bioavailability; isosorbide mononitrate has 100% bioavailability (does not undergo first-pass metabolism).

Distribution: Unknown.

Metabolism/Excretion: Isosorbide dinitrate is metabolized by the liver to 2 active metabolites (5-mononitrate and 2-mononitrate). Isosorbide mononitrate is primarily metabolized by the liver to inactive metabolites; primarily excreted in urine as metabolites.

Half-Life: Isosorbide dinitrate: 1 hr; isosorbide mononitrate: 5 hr.

(cardiovascular effects)

ROUTE	ONSET	PEAK	DURATION
ISDN-PO	45–60 min	unknown	4 hr
ISMN-PO	30–60 min	unknown	7 hr
ISMN-ER	unknown	unknown	12 hr

Contraindicated in:

Hypersensitivity;
Concurrent use of PDE-5 inhibitor or riociguat.

Use Cautiously in:

Volume depleted patients;
Right ventricular infarction;
Hypertrophic cardiomyopathy;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: Initial dose required in older adults due to potential for hypotension.

CV: hypotension, tachycardia, paradoxic bradycardia, syncope

Derm: flushing

GI: nausea, vomiting

Neuro: dizziness, headache

Misc: tolerance

Drug-drug:

Concurrent use of avanafil, sildenafil, tadalafil, or vardenafil may result in severe hypotension (do not use within 24 hr of isosorbide dinitrate or mononitrate); concurrent use contraindicated.
Concurrent use of riociguat may result in severe hypotension; concurrent use contraindicated.
Additive hypotension with antihypertensives, acute ingestion of alcohol, beta blockers, calcium channel blockers, and phenothiazines.

Isosorbide Dinitrate

PO (Adults ): Prophylaxis of angina pectoris: 5–20 mg 2–3 times daily; usual maintenance dose is 10–40 mg every 6 hr.

Isosorbide Mononitrate

PO (Adults ): ISMO, Monoket: 5–20 mg twice daily with the 2 doses given 7 hr apart. Imdur: 30–60 mg once daily; may ↑ to 120 mg once daily (maximum dose = 240 mg/day).

Isosorbide Dinitrate

Isosorbide Mononitrate

Tablets: 5 mg; 10 mg; 20 mg; 30 mg; 40 mg
In combination with: hydralazine (BiDil). See Appendix [not included in this PDA edition].
Tablets (Monoket): 10 mg; 20 mg
Extended-release tablets: 30 mg; 60 mg; 120 mg

Assess location, duration, intensity, and precipitating factors of anginal pain.
Monitor BP and pulse routinely during period of dose adjustment.

Lab Test Considerations:

Excessive doses may ↑ methemoglobin concentrations.

Isosorbide Dinitrate

PO: Do not administer around the clock to prevent tolerance to nitrate effect; allow nitrate-free interval for ≥14 hr. Twice-daily dosing may be administered at 8 am and 1 pm and 3 times daily dosing may be given at 8 am, 1 pm, and 6 pm.

Isosorbide Mononitrate

PO: Do not administer around the clock. Administer immediate release tablets twice daily with doses 7 hr apart (8 am and 3 pm); administer extended release tablet once daily in the morning upon rising with a half-glassful of fluid. DNC: Swallow extended-release tablets whole; do not break, crush, or chew. Extended release tablets that are scored may be split.

Instruct patient to take medication as directed, even if feeling better. Take missed doses as soon as remembered; doses of isosorbide dinitrate should be taken at least 2 hr apart; daily doses of isosorbide mononitrate should be taken 7 hr apart. Do not double doses. Do not discontinue abruptly.
Instruct patient to take last dose of day (when taking 2–4 doses/day) no later than 7 pm to prevent the development of tolerance.
Caution patient to make position changes slowly to minimize orthostatic hypotension.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to avoid concurrent use of alcohol with this medication. Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
Inform patient that headache is a common side effect that should decrease with continuing therapy. Aspirin or acetaminophen may be ordered to treat headache. Notify health care professional if headache is persistent or severe. Do not alter dose to avoid headache.
Advise patient to notify health care professional if dry mouth or blurred vision occurs.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.

Decrease in frequency and severity of anginal attacks.
- Increase in activity tolerance.

isosorbide dinitrate: ~~Dilatrate-SR,~~ Isordil,

isosorbide mononitrate: ~~Imdur,~~ ~~Ismo,~~ Monoket

isosorbide mononitrate: Imdur

NDC Code

0143- Hikma Pharmaceuticals USA Inc.
- 0143-1769- Isosorbide Dinitrate
  - 0143-1769-01- 100 TABLET in 1 BOTTLE, PLASTIC (0143-1769-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-1771- Isosorbide Dinitrate
  - 0143-1771-01- 100 TABLET in 1 BOTTLE, PLASTIC (0143-1771-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-1772- Isosorbide Dinitrate
  - 0143-1772-01- 100 TABLET in 1 BOTTLE, PLASTIC (0143-1772-01)

0187- Bausch Health Americas, Inc
- 0187-0152- Isordil Titradose
  - 0187-0152-01- 100 TABLET in 1 BOTTLE (0187-0152-01)

0187- Bausch Health Americas, Inc
- 0187-0192- Isordil Titradose
  - 0187-0192-01- 100 TABLET in 1 BOTTLE (0187-0192-01)

0615- NCS HealthCare of KY, Inc dba Vangard Labs
- 0615-8157- Isosorbide Dinitrate
  - 0615-8157-39- 30 TABLET in 1 BLISTER PACK (0615-8157-39)

0615- NCS HealthCare of KY, Inc dba Vangard Labs
- 0615-8193- Isosorbide Dinitrate
  - 0615-8193-39- 30 TABLET in 1 BLISTER PACK (0615-8193-39)

0615- NCS HealthCare of KY, Inc dba Vangard Labs
- 0615-8294- Isosorbide Dinitrate
  - 0615-8294-39- 30 TABLET in 1 BLISTER PACK (0615-8294-39)

0781- Sandoz Inc.
- 0781-1556- Isosorbide Dinitrate
  - 0781-1556-01- 100 TABLET in 1 BOTTLE (0781-1556-01)

0781- Sandoz Inc.
- 0781-1556- Isosorbide Dinitrate
  - 0781-1556-05- 500 TABLET in 1 BOTTLE (0781-1556-05)

0781- Sandoz Inc.
- 0781-1556- Isosorbide Dinitrate
  - 0781-1556-10- 1000 TABLET in 1 BOTTLE (0781-1556-10)

0781- Sandoz Inc.
- 0781-1556- Isosorbide Dinitrate
  - 0781-1556-13- 10 BLISTER PACK in 1 CARTON (0781-1556-13) > 10 TABLET in 1 BLISTER PACK

0781- Sandoz Inc.
- 0781-1635- Isosorbide Dinitrate
  - 0781-1635-01- 100 TABLET in 1 BOTTLE (0781-1635-01)

0781- Sandoz Inc.
- 0781-1635- Isosorbide Dinitrate
  - 0781-1635-10- 1000 TABLET in 1 BOTTLE (0781-1635-10)

0781- Sandoz Inc.
- 0781-1635- Isosorbide Dinitrate
  - 0781-1635-13- 10 BLISTER PACK in 1 CARTON (0781-1635-13) > 10 TABLET in 1 BLISTER PACK

0781- Sandoz Inc.
- 0781-1695- Isosorbide Dinitrate
  - 0781-1695-01- 100 TABLET in 1 BOTTLE (0781-1695-01)

0781- Sandoz Inc.
- 0781-1695- Isosorbide Dinitrate
  - 0781-1695-10- 1000 TABLET in 1 BOTTLE (0781-1695-10)

0781- Sandoz Inc.
- 0781-1695- Isosorbide Dinitrate
  - 0781-1695-13- 10 BLISTER PACK in 1 CARTON (0781-1695-13) > 10 TABLET in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6619- Isosorbide Dinitrate
  - 0904-6619-61- 100 BLISTER PACK in 1 CARTON (0904-6619-61) > 1 TABLET in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6620- Isosorbide Dinitrate
  - 0904-6620-61- 100 BLISTER PACK in 1 CARTON (0904-6620-61) > 1 TABLET in 1 BLISTER PACK

42291- AvKARE, Inc.
- 42291-350- Isosorbide Dinitrate
  - 42291-350-01- 100 TABLET in 1 BOTTLE (42291-350-01)

43353- Aphena Pharma Solutions - Tennessee, LLC
- 43353-139- Isosorbide Dinitrate
  - 43353-139-60- 90 TABLET in 1 BOTTLE (43353-139-60)

43353- Aphena Pharma Solutions - Tennessee, LLC
- 43353-141- Isosorbide Dinitrate
  - 43353-141-60- 90 TABLET in 1 BOTTLE (43353-141-60)

49884- Par Pharmaceutical, Inc.
- 49884-009- Isosorbide Dinitrate
  - 49884-009-01- 100 TABLET in 1 BOTTLE (49884-009-01)

49884- Par Pharmaceutical, Inc.
- 49884-009- Isosorbide Dinitrate
  - 49884-009-10- 1000 TABLET in 1 BOTTLE (49884-009-10)

49884- Par Pharmaceutical, Inc.
- 49884-020- Isosorbide Dinitrate
  - 49884-020-01- 100 TABLET in 1 BOTTLE (49884-020-01)

49884- Par Pharmaceutical, Inc.
- 49884-020- Isosorbide Dinitrate
  - 49884-020-10- 1000 TABLET in 1 BOTTLE (49884-020-10)

49884- Par Pharmaceutical, Inc.
- 49884-021- Isosorbide Dinitrate
  - 49884-021-01- 100 TABLET in 1 BOTTLE (49884-021-01)

49884- Par Pharmaceutical, Inc.
- 49884-021- Isosorbide Dinitrate
  - 49884-021-10- 1000 TABLET in 1 BOTTLE (49884-021-10)

49884- Par Pharmaceutical, Inc.
- 49884-022- Isosorbide Dinitrate
  - 49884-022-01- 100 TABLET in 1 BOTTLE (49884-022-01)

49884- Par Pharmaceutical, Inc.
- 49884-022- Isosorbide Dinitrate
  - 49884-022-10- 1000 TABLET in 1 BOTTLE (49884-022-10)

50268- AvPAK
- 50268-447- Isosorbide Dinitrate
  - 50268-447-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-447-15) > 1 TABLET in 1 BLISTER PACK (50268-447-11)

50268- AvPAK
- 50268-448- Isosorbide Dinitrate
  - 50268-448-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-448-15) > 1 TABLET in 1 BLISTER PACK (50268-448-11)

50268- AvPAK
- 50268-449- Isosorbide Dinitrate
  - 50268-449-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-449-15) > 1 TABLET in 1 BLISTER PACK (50268-449-11)

51407- Golden State Medical Supply Inc.
- 51407-147- Isosorbide Dinitrate
  - 51407-147-01- 100 TABLET in 1 BOTTLE, PLASTIC (51407-147-01)

51407- Golden State Medical Supply Inc.
- 51407-147- Isosorbide Dinitrate
  - 51407-147-10- 1000 TABLET in 1 BOTTLE, PLASTIC (51407-147-10)

51407- Golden State Medical Supply Inc.
- 51407-148- Isosorbide Dinitrate
  - 51407-148-01- 100 TABLET in 1 BOTTLE, PLASTIC (51407-148-01)

51407- Golden State Medical Supply Inc.
- 51407-148- Isosorbide Dinitrate
  - 51407-148-10- 1000 TABLET in 1 BOTTLE, PLASTIC (51407-148-10)

51407- Golden State Medical Supply Inc.
- 51407-149- Isosorbide Dinitrate
  - 51407-149-01- 100 TABLET in 1 BOTTLE, PLASTIC (51407-149-01)

51407- Golden State Medical Supply Inc.
- 51407-149- Isosorbide Dinitrate
  - 51407-149-10- 1000 TABLET in 1 BOTTLE, PLASTIC (51407-149-10)

52244- Endo Pharmaceuticals, Inc.
- 52244-920- Dilatrate SR
  - 52244-920-10- 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-920-10)

53808- State of Florida DOH Central Pharmacy
- 53808-0626- Isosorbide Dinitrate
  - 53808-0626-2- 60 TABLET in 1 BLISTER PACK (53808-0626-2)

55154- Cardinal Health
- 55154-5406- Isosorbide Dinitrate
  - 55154-5406-0- 10 BLISTER PACK in 1 BAG (55154-5406-0) > 1 TABLET in 1 BLISTER PACK

55154- Cardinal Health
- 55154-5407- Isosorbide Dinitrate
  - 55154-5407-0- 10 BLISTER PACK in 1 BAG (55154-5407-0) > 1 TABLET in 1 BLISTER PACK

55154- Cardinal Health
- 55154-7990- Isosorbide Dinitrate
  - 55154-7990-0- 10 BLISTER PACK in 1 BAG (55154-7990-0) > 1 TABLET in 1 BLISTER PACK

55154- Cardinal Health
- 55154-7991- Isosorbide Dinitrate
  - 55154-7991-0- 10 BLISTER PACK in 1 BAG (55154-7991-0) > 1 TABLET in 1 BLISTER PACK

60429- Golden State Medical Supply, Inc.
- 60429-440- Isosorbide Dinitrate
  - 60429-440-01- 100 TABLET in 1 BOTTLE (60429-440-01)

60429- Golden State Medical Supply, Inc.
- 60429-440- Isosorbide Dinitrate
  - 60429-440-10- 1000 TABLET in 1 BOTTLE (60429-440-10)

60429- Golden State Medical Supply, Inc.
- 60429-441- Isosorbide Dinitrate
  - 60429-441-01- 100 TABLET in 1 BOTTLE (60429-441-01)

60429- Golden State Medical Supply, Inc.
- 60429-441- Isosorbide Dinitrate
  - 60429-441-10- 1000 TABLET in 1 BOTTLE (60429-441-10)

60429- Golden State Medical Supply, Inc.
- 60429-442- Isosorbide Dinitrate
  - 60429-442-01- 100 TABLET in 1 BOTTLE (60429-442-01)

60429- Golden State Medical Supply, Inc.
- 60429-442- Isosorbide Dinitrate
  - 60429-442-10- 1000 TABLET in 1 BOTTLE (60429-442-10)

63739- McKesson Corporation dba SKY Packaging
- 63739-367- Isosorbide Dinitrate
  - 63739-367-10- 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-367-10) > 10 TABLET in 1 BLISTER PACK

63739- McKesson Corporation dba SKY Packaging
- 63739-569- Isosorbide Dinitrate
  - 63739-569-10- 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-569-10) > 10 TABLET in 1 BLISTER PACK

68001- BluePoint Laboratories
- 68001-222- Isosorbide Dinitrate
  - 68001-222-00- 100 TABLET in 1 BOTTLE (68001-222-00)

68001- BluePoint Laboratories
- 68001-222- Isosorbide Dinitrate
  - 68001-222-08- 1000 TABLET in 1 BOTTLE (68001-222-08)

68001- BluePoint Laboratories
- 68001-223- Isosorbide Dinitrate
  - 68001-223-00- 100 TABLET in 1 BOTTLE (68001-223-00)

68001- BluePoint Laboratories
- 68001-223- Isosorbide Dinitrate
  - 68001-223-08- 1000 TABLET in 1 BOTTLE (68001-223-08)

68001- BluePoint Laboratories
- 68001-225- Isosorbide Dinitrate
  - 68001-225-00- 100 TABLET in 1 BOTTLE (68001-225-00)

68001- BluePoint Laboratories
- 68001-225- Isosorbide Dinitrate
  - 68001-225-08- 1000 TABLET in 1 BOTTLE (68001-225-08)

68001- BluePoint Laboratories
- 68001-373- Isosorbide
  - 68001-373-00- 100 TABLET in 1 BOTTLE, PLASTIC (68001-373-00)

68001- BluePoint Laboratories
- 68001-374- Isosorbide
  - 68001-374-00- 100 TABLET in 1 BOTTLE, PLASTIC (68001-374-00)

68001- BluePoint Laboratories
- 68001-375- Isosorbide
  - 68001-375-00- 100 TABLET in 1 BOTTLE, PLASTIC (68001-375-00)

68084- American Health Packaging
- 68084-082- Isosorbide Dinitrate
  - 68084-082-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-082-01) > 1 TABLET in 1 BLISTER PACK (68084-082-11)

68084- American Health Packaging
- 68084-083- Isosorbide Dinitrate
  - 68084-083-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-083-01) > 1 TABLET in 1 BLISTER PACK (68084-083-11)

68084- American Health Packaging
- 68084-894- Isosorbide Dinitrate
  - 68084-894-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-894-25) > 1 TABLET in 1 BLISTER PACK (68084-894-95)

70518- REMEDYREPACK INC.
- 70518-0063- Isosorbide Dinitrate
  - 70518-0063-0- 30 TABLET in 1 BLISTER PACK (70518-0063-0)

70518- REMEDYREPACK INC.
- 70518-0063- Isosorbide Dinitrate
  - 70518-0063-1- 90 TABLET in 1 BOTTLE, PLASTIC (70518-0063-1)

70518- REMEDYREPACK INC.
- 70518-1435- Isosorbide Dinitrate
  - 70518-1435-0- 30 TABLET in 1 BLISTER PACK (70518-1435-0)

70518- REMEDYREPACK INC.
- 70518-2306- Isosorbide Dinitrate
  - 70518-2306-0- 30 TABLET in 1 BLISTER PACK (70518-2306-0)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1148- Isosorbide dinitrate
  - 70710-1148-0- 1000 TABLET in 1 BOTTLE (70710-1148-0)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1148- Isosorbide dinitrate
  - 70710-1148-1- 100 TABLET in 1 BOTTLE (70710-1148-1)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1149- Isosorbide dinitrate
  - 70710-1149-0- 1000 TABLET in 1 BOTTLE (70710-1149-0)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1149- Isosorbide dinitrate
  - 70710-1149-1- 100 TABLET in 1 BOTTLE (70710-1149-1)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1150- Isosorbide dinitrate
  - 70710-1150-0- 1000 TABLET in 1 BOTTLE (70710-1150-0)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1150- Isosorbide dinitrate
  - 70710-1150-1- 100 TABLET in 1 BOTTLE (70710-1150-1)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1151- Isosorbide dinitrate
  - 70710-1151-0- 1000 TABLET in 1 BOTTLE (70710-1151-0)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1151- Isosorbide dinitrate
  - 70710-1151-1- 100 TABLET in 1 BOTTLE (70710-1151-1)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1152- Isosorbide dinitrate
  - 70710-1152-1- 100 TABLET in 1 BOTTLE (70710-1152-1)

70771- Cadila Healthcare Limited
- 70771-1501- Isosorbide dinitrate
  - 70771-1501-0- 1000 TABLET in 1 BOTTLE (70771-1501-0)

70771- Cadila Healthcare Limited
- 70771-1501- Isosorbide dinitrate
  - 70771-1501-1- 100 TABLET in 1 BOTTLE (70771-1501-1)

70771- Cadila Healthcare Limited
- 70771-1502- Isosorbide dinitrate
  - 70771-1502-0- 1000 TABLET in 1 BOTTLE (70771-1502-0)

70771- Cadila Healthcare Limited
- 70771-1502- Isosorbide dinitrate
  - 70771-1502-1- 100 TABLET in 1 BOTTLE (70771-1502-1)

70771- Cadila Healthcare Limited
- 70771-1503- Isosorbide dinitrate
  - 70771-1503-0- 1000 TABLET in 1 BOTTLE (70771-1503-0)

70771- Cadila Healthcare Limited
- 70771-1503- Isosorbide dinitrate
  - 70771-1503-1- 100 TABLET in 1 BOTTLE (70771-1503-1)

70771- Cadila Healthcare Limited
- 70771-1504- Isosorbide dinitrate
  - 70771-1504-0- 1000 TABLET in 1 BOTTLE (70771-1504-0)

70771- Cadila Healthcare Limited
- 70771-1504- Isosorbide dinitrate
  - 70771-1504-1- 100 TABLET in 1 BOTTLE (70771-1504-1)

70771- Cadila Healthcare Limited
- 70771-1505- Isosorbide dinitrate
  - 70771-1505-1- 100 TABLET in 1 BOTTLE (70771-1505-1)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

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