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TRINIPATCH is a brand name for Nitroglycerin, supplied as a patch. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TRINIPATCH (nitroglycerin) used intermittently (see 10 CLINICAL PHARMACOLOGY) is indicated for the prevention of anginal attacks in patients with stable angina pectoris associated with coronary artery disease. It can be used in conjunction with other antianginal agents such as beta-blockers and/or calcium antagonists.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The daily dosage schedule is based on intermittent therapy to prevent the development of tolerance to nitroglycerin. The optimal dose should be selected based upon the clinical response, side effects, and the effects of therapy on blood pressure (see 7 WARNINGS AND PRECAUTIONS).
2 patch (7 cm2), usually applied in the morning. 4 mg/hour (14 cm2) if required. 8 mg/hour may be used.
Considerations for Special Populations Pediatric (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatric (>65 years of age):
No special information is available on the use of TRINIPATCH in geriatric population. However, there is no evidence suggesting that dosage should be adapted in these patients. 4 Administration TRINIPATCH can be applied to any area of skin except the distal extremities.
Many patients prefer the chest. Each successive application should be to a different site. The area should be clean, dry, and preferably hairless. If hair is likely to interfere with patch adhesion or removal, clipping may be necessary prior to application.
Take care to avoid areas with cuts or irritations. TRINIPATCH should be applied for 12-14 hours and taken off for 10-12 hours. 8 mg/hour. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion.
5 Missed Dose If the patient has forgotten to apply TRINIPATCH at the scheduled time then they should apply it as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the patient should go back to their regular dosing schedule.
The patient should not apply extra patches to make up for a missed dose. 6 (Nitroglycerin Transdermal Delivery System) Page 6 of 27
1 Adverse Reaction Overview Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses of nitroglycerin. Headaches may be treated with concomitant administration of mild analgesics.
If such headaches are unresponsive to treatment, the nitroglycerin dosage should be reduced or the product discontinued. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy.
Reddening of the skin (erythema), with or without a mild local itching (pruritus) or burning sensation, as well as allergic contact dermatitis may occasionally occur. Upon removal of the patch, any slight reddening of the skin will usually disappear within a few hours.
The application site should be changed regularly to prevent local irritation. Less frequently reported adverse reactions include dizziness, faintness, facial flushing, postural hypotension which may be associated with reflex tachycardia.
Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon. Rarely nausea, and vomiting. 5 Post-Market Adverse Reactions The most common adverse drug reaction reported post-market is localized skin reaction (local erythema, pruritus, rash).
6 (Nitroglycerin Transdermal Delivery System) Page 12 of 27
and 9 DRUG INTERACTIONS. 6 (Nitroglycerin Transdermal Delivery System) Page 5 of 27 pulmonary arterial hypertension. Concomitant use can cause hypotension. See 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS. 1 Dosing Considerations The daily dosage schedule is based on intermittent therapy to prevent the development of tolerance to nitroglycerin.
The optimal dose should be selected based upon the clinical response, side effects, and the effects of therapy on blood pressure (see 7 WARNINGS AND PRECAUTIONS). 2 patch (7 cm2), usually applied in the morning. 4 mg/hour (14 cm2) if required.
8 mg/hour may be used.
Considerations for Special Populations Pediatric (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatric (>65 years of age):
No special information is available on the use of TRINIPATCH in geriatric population. However, there is no evidence suggesting that dosage should be adapted in these patients. 4 Administration TRINIPATCH can be applied to any area of skin except the distal extremities.
Many patients prefer the chest. Each successive application should be to a different site. The area should be clean, dry, and preferably hairless. If hair is likely to interfere with patch adhesion or removal, clipping may be necessary prior to application.
Take care to avoid areas with cuts or irritations. TRINIPATCH should be applied for 12-14 hours and taken off for 10-12 hours. 8 mg/hour. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion.
5 Missed Dose If the patient has forgotten to apply TRINIPATCH at the scheduled time then they should apply it as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the patient should go back to their regular dosing schedule.
• TRINIPATCH (nitroglycerin) is contraindicated in patients who are hypersensitive to this drug and related organic nitrate compounds or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the patch.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • TRINIPATCH (nitroglycerin) is contraindicated in patients with: o Acute circulatory failure associated with marked hypotension (shock and states of collapse).
o Postural hypotension. o Left ventricular dysfunction due to obstruction as in aortic or mitral stenosis or of constrictive pericarditis. o Increased intracranial pressure. o Increased intraocular pressure. o Severe anemia. • Concomitant use of TRINIPATCH (nitroglycerin) either regularly and/or intermittently, with phosphodiesterase type 5 (PDE5) inhibitors such as VIAGRA (sildenafil), CIALIS (tadalafil) and LEVITRA (vardenafil) is absolutely contraindicated, because PDE5 inhibitors amplify the vasodilatory effects of TRINIPATCH which can lead to severe hypotension.
See 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS. 6 (Nitroglycerin Transdermal Delivery System) Page 5 of 27 pulmonary arterial hypertension. Concomitant use can cause hypotension. See 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nitroglycerin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The patient should not apply extra patches to make up for a missed dose. 6 (Nitroglycerin Transdermal Delivery System) Page 6 of 27 5 OVERDOSAGE Symptoms Nitroglycerin overdose may result in severe hypotension, persistent throbbing headache, vertigo, palpitations, visual disturbances, flushing and perspiring skin (later becoming cold and cyanotic), anorexia, nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis, hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block and bradycardia, increased intracranial pressure with cerebral symptoms of fever, confusion, and coma possibly followed by paralysis, clonic convulsions and death due to circulatory collapse.
Treatment Keep the patient recumbent in a shock position and comfortably warm. Remove the TRINIPATCH. Passive movement of the extremities may aid venous return. Administer oxygen and artificial ventilation if necessary. Intravenous infusion of normal saline or similar fluid may also be required to produce sufficient central volume expansion.
However, in patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of nitroglycerin overdose in these patients may be subtle and difficult, and invasive monitoring may be required.
Epinephrine is ineffective in reversing the severe hypotensive events associated with overdose; it and related compounds are contraindicated in this situation. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764- 7669).
2 mg/hour, 7 cm2. 2 mg of nitroglycerin per hour. 4 mg/hour, 14 cm2. 8 mg of Duro Tak 87-2196 and sorbitan mono-oleate. 6 (Nitroglycerin Transdermal Delivery System) Page 7 of 27 Composition The TRINIPATCH (nitroglycerin) transdermal system is a flat unit designed to provide continuous controlled release of nitroglycerin through intact skin.
03 mg of nitroglycerin per hour. 6 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered approximately 10% of its original content of nitroglycerin.
The TRINIPATCH system comprises three layers: 1. a thin, occlusive, low density polyethylene (LDPE) backing film layer, 2. an acrylic adhesive matrix/drug reservoir layer, 3. a layer of siliconized polyester release liner comprised of overlapped liner strips that form an easy- opening tab.
Prior to use, a protective peel strip is removed from the adhesive surface. Cross-section of the system. 1. Low density polyethylene (LDPE) Backing Film 2. Matrix Adhesive Layer 3. 4 mg of nitroglycerin and delivers […]