MINITRAN 10

Active substance: GLYCERYL TRINITRATE

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1

NAME OF THE MEDICINAL PRODUCT
Minitran 10 mg/ 24 h, transdermal patch

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Minitran 10 has a surface area of 13.3 sq cm and contains 36 mg of glyceryl trinitrate. The
average amount delivered in 24 hours is 10 mg.

3

PHARMACEUTICAL FORM
Adhesive transdermal patch.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Minitran 10 is indicated for:

Prophylaxis of angina pectoris either alone or in combination with other anti-anginal
therapy.

4.2

Posology and method of administration
ADULTS: Prophylaxis of angina pectoris.

The response to nitrates differs between individuals, and the minimum effective dose should
be prescribed in each case. It is therefore recommended that treatment is started with one
Minitran 5 patch per day, with upward dosage titration when necessary.

Application can either be for a continuous period of 24 hours or intermittently, incorporating
a patch free interval (usually at night). Attenuation of effect has occurred in some patients
being treated with sustained release nitrate preparations. On the basis of current clinical
studies it is recommended that in such cases Minitran should be applied daily with a patch
free interval of 8 - 12 hours.

Each Minitran patch is contained in a sealed sachet. The adhesive layer is covered by a
protective film, which should be removed before application. The Minitran patch should be
applied to a clean, dry healthy area of skin on the torso or the arms.

Subsequent patches should not be applied to the same area of skin until several days have
elapsed. The Minitran patch adheres easily to the skin, and also stays in place whilst bathing
or during physical exercise.

4.3

Contraindications
Minitran is contraindicated for patients with:


Known hypersensitivity to glyceryl trinitrate, and related organic nitrates or any excipient
of Minitran.





Acute circulatory failure associated with marked hypotension (shock).
Conditions associated with elevated intracranial and intra-ocular pressure.
Myocardial insufficiency due to obstruction, as in aortic or mitral stenosis or constrictive
pericarditis.
Concomitant use of Minitran and phosphodiesterase type 5 (PDE5) inhibitors such as
sildenafil (Viagra®) is contraindicated, because PDE5 inhibitors may amplify the
vasodilatory effects of Minitran resulting in severe hypotension.
Severe anaemia
Severe hypotension (systolic blood pressure less than 90 mmHg).
Severe hypovolemia






4.4

Special warnings and precautions for use
Minitran is not indicated for the treatment of acute angina attacks requiring rapid relief.
Minitran should be used only under strict medical supervision in recent myocardial infarction
or acute congestive cardiac insufficiency. Minitran should be used with caution in patients
with hypoxaemia or ventilation perfusion imbalance.
The appearance of cross-tolerance with other nitrates is possible.

The use of products for topical application, especially if prolonged, may give rise to
sensitisation phenomena, in which case treatment should be suspended, and suitable
therapeutic measures adopted.
Minitran does not contain any metal components, and therefore it is not considered necessary
to remove the patch prior to diathermy.
Removal of the patch should be considered as part of the management of patients who
develop significant hypotension.
Precautions
Hypoxaemia
Caution should be exercised in patients with arterial hypoxaemia due to severe anaemia
(including G6PD deficiency induced forms), because in such patients the biotransformation of
glyeryl trinitrate is reduced. Similarly, caution is called for in patients with hypoxaemia and
ventilation/perfusion imbalance due to lung disease or ischaemic heart failure. In Patients
with alveolar hypoventilation a vasoconstriction occurs within the lung to shift perfusion from
areas of alveolar hypoxia to better ventilated regions of the lung (Euler-Liljestrand
mechanism). Patients with angina pectoris, myocardial infarction, or cerebral ischaemia
frequently suffer from abnormalities of the small airways (especially alveolar hypoxia).
Under these circumstances vasoconstriction occurs within the lung to shift perfusion from
areas of alveolar hypoxia to better ventilated regions of the lung. As a potent vasodilator,
glyeryl trinitrate could reverse this protective vasoconstriction and thus result in increased
perfusion of poorly ventilated areas, worsening of the ventilation/perfusion imbalance, and a
further decrease in the arterial partial pressure of oxygen.
Hypertrophic cardiomyopathy
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
Increased angina
The possibility of increased frequency of angina during patch-off periods should be
considered. In such cases the use of concomitant anti-anginal therapy is desirable.
Tolerance to sublingual glyceryl trinitrate
As tolerance to glyceryl trinitrate patches develops, the effect of sublingual glyceryl trinitrate
on exercise tolerance may be partially diminished.
Use for maintenance of venous patency at peripheral infusion sites
The infusion site should be examined regularly. If phlebitis develops, it should be treated
accordingly

4.5

Interaction with other medicinal products and other forms of interaction
The hypotensive effects of nitrates are potentiated by concurrent administration of
phosphodiesterase type 5 inhibitors (eg. Sildenafil, Tadalafil. Vardenafil).
Concomitant use of Minitran and other vasodilatory agents, calcium antagonists, betablockers, ACE inhibitors, neuroleptics, diuretics, antihypertensives, tricyclic
antidepressants, and alcohol may decrease blood pressure. The effect of Minitran may
be weakened by acetylsalicylic acid or other NSAID’s. There is a risk of coronary
artery constriction with concurrent administration of dihydroergotamine.

4.6

Fertility, pregnancy and lactation
Fertility
There is no data available on the effect of Minitran on fertility in humans.
Pregnancy
As with all drugs Minitran should not be prescribed during pregnancy, particularly during the
first trimester, unless there are compelling reasons for doing so. It is not known whether the
active substance passes into the breast milk. The benefits for the mother must be weighed
against the risks for the child.
Lactation
There is limited information on the excretion of the active substance in human or animal
breast milk. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from
Minitran therapy taking into account the benefit of breast feeding for the child and the benefit
of therapy for the woman.

4.7

Effects on ability to drive and use machines

Minitran, especially at the start of treatment or dose adjustments, may impair the reactions or
might rarely cause orthostatic hypotension and dizziness (as well as exceptionally syncope
after overdosing). Patients experiencing these effects should refrain from driving or using
machines.

Undesirable effects
Within the system organ classes, adverse reactions are listed under headings of frequency
(number of patients expected to experience the reaction), using the following categories:
Very common ( 1/10)



Common ( 1/100 to <1/10)



Uncommon ( 1/1,000 to <1/100)



Rare ( 1/10,000 to <1/1,000)



4.8

Very rare (<1/10,000)
Not known (The adverse drug reactions have been derived from post-marketing experience
with Minitran via spontaneous case reports and literature cases. Because these reactions are
reported voluntarily from a population of uncertain size, it is not possible to reliably estimate
their frequency)
Nervous system disorders
Common: Headache1
Very rare: Dizziness
Cardiac disorders
Rare: Tachycardia2

Not known: Palpitation, fainting
Vascular disorders
Rare: Orthostatic hypotension, flushing2
Gastrointestinal disorders
Very common: Nausea, vomiting
Skin and subcutaneous tissue disorders
Uncommon: Dermatitis contact
Not known: Rash generalized
General disorders and administration site conditions
Uncommon: Application site erythema, pruritus, burning, irritation3
Investigations
Rare: Heart rate increase
1

Like other nitrate preparations, Minitran commonly causes dose-dependent headaches due to
cerebral vasodilatation. These often regress after a few days despite the maintenance of
therapy. If headaches persist during intermittent therapy, they should be treated with mild
analgesics. Unresponsive headaches are an indication for reducing the dosage of glyceryl
trinitrate or discontinuing treatment.

2

A slight reflex-induced increase in heart rate can be avoided by resorting, if necessary, to
combined treatment with a beta-blocker.

3

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.

4.9

Overdose
Signs
High doses of glyceryl trinitrate may lead to severe hypotension and reflex tachycardia or to
collapse and syncope. Methaemoglobinaemia has also been reported following accidental
overdosage.
Management
The nitrate effect of Minitran can be rapidly terminated simply by removing the system(s).
Hypotension or collapse can be treated by elevation or, if necessary, compression bandaging
of the patient’s legs.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Nitroglycerin, the active constituent of Minitran is a dilator of smooth muscle, producing
relaxation by an unknown mechanism. It has no direct effects on the inotropic or
chronotropic state of the heart. It affects cardiac output only as a consequence of its effect on
venous capacitance and arteriolar resistance vessels. These effects on preload and afterload

reduce myocardial oxygen consumption and are primarily responsible for the mechanism by
which nitroglycerin relieves the symptoms of angina pectoris. The drug’s principal side
effects (headache, flushing, dizziness, postural hypotension and tachycardia) are also a result
of its smooth muscle relaxing effects.

5.2

Pharmacokinetic properties
When Minitran is applied to the skin, nitroglycerin is absorbed continuously through the skin
into the systemic circulation and thus reaches the target organs (heart, vascular system) before
deactivation by the liver. Minitran gives continuous release of nitroglycerin over 24 hours
maintaining constant plasma levels. Nitroglycerin is metabolised by hydrolysis to dinitrates
and the mononitrate.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Isooctyl Acrylate/Acrylamide Copolymer (93:7)
Ethyl Oleate BP
Glyceryl Monolaurate

Low Density Polyethylene Film
One Side Silicone Coated Polyester Film

6.2

Incompatibilities
None known.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Minitran must be stored at room temperature (below 25°C) under exclusion of light and
moisture.

6.5

Nature and contents of container

Each patch is individually packed in a heat sealed foil sachet. Cartons contain 30 patches.

6.6

Special precautions for disposal and other handling

The patch is covered by a protective polyester film, which is detached and discarded
before use.

7. MARKETING AUTHORISATION HOLDER

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU

8

MARKETING AUTHORISATION NUMBER(S)
PL 15142/0086

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/12/2005

10

DATE OF REVISION OF THE TEXT

04/07/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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