Nitroquick

Nitroquick® (Nitroquick) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

Nitroquick (Nitroquick sublingual spray) belongs to a group of drugs called nitrates. Nitroquick dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Nitroquick is used to treat or prevent attacks of chest pain (angina).

Nitroquick may also be used for purposes not listed in this medication guide.

Recommended Dosage

At the onset of an attack, one metered spray or two metered sprays should be administered on or under the tongue. A spray may be repeated approximately every 5 minutes as needed. If two sprays are used initially, the patient may only administer one more spray after waiting 5 minutes. No more than 3 metered sprays are recommended within a 15-minute period. If chest pain persists after a total of 3 sprays, prompt medical attention is recommended. Nitroquick may be used prophylactically 5 minutes to 10 minutes before engaging in activities that might precipitate an acute attack.

Priming The Container

After an initial priming of 10 sprays, each metered spray of Nitroquick delivers 33 mg of solution containing 400 mcg of Nitroquick. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks, it can be adequately re-primed with 2 sprays. Nitroquick is available in either 230 metered sprays or 90 metered sprays per container, but the total number of available doses depends on the number of sprays per use (1 spray or 2 sprays), and the frequency of priming.

Administration

During use the patient should rest, ideally in the sitting position. The container should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should preferably be sprayed into the mouth on or under the tongue by pressing the button firmly and the mouth should be closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. Patients should be instructed to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night.

1. Do not shake container.
2. Remove plastic cap.
3. If this is the first time using the bottle, press actuator button 10 times to ensure proper dose priming (holding unit away from yourself and others).
4. Hold container upright with forefinger on top of the actuator button.
5. Open mouth and bring the container as close as possible.
6. Press the actuator button firmly with forefinger to release spray(s) onto or under the tongue.
7. Release button and close mouth. The medication should not be spit out or the mouth rinsed for 5 minutes to 10 minutes following administration.
8. If a second administration is required to obtain relief, repeat steps 4, 5, and 6. No more than 3 metered sprays can be given within a 15-minute period.
9. Replace plastic cover.
10. If the product is not used for more than 6 weeks, then it can be adequately re-primed with 2 sprays.

The level of the liquid in the container should be periodically checked. While the container is in the upright position, if the liquid reaches the top or middle of the hole on the side of the container, one should order more. When the liquid reaches the bottom of the hole, the remaining doses will have less than label content.

How supplied

Dosage Forms And Strengths

Lingual aerosol, 400 mcg per spray, is available in either 230 metered sprays or 90 metered sprays per container.

Storage And Handling

Each box of Nitroquick contains one glass bottle coated with red/orange transparent plastic which assists in containing the glass and medication should the bottle be shattered. Nitroquick is available as an 8.5 g (Net Content) of Nitroquick lingual aerosol that will deliver 230 metered sprays containing 400 mcg of Nitroquick per actuation or as a 4.1 g (Net Content) of Nitroquick lingual aerosol that will deliver 90 metered sprays containing 400 mcg of Nitroquick per actuation.

230 metered sprays: NDC 76299-430-08

90 metered sprays: NDC 76299-430-04

Storage

Store at room temperature (25°C, 77°F); excursions permitted to 15°to30°C (59° to 85°F)

Handling

Nitroquick contains a highly flammable propellant (butane). Do not forcefully open a Nitroquick bottle, do not have the container burned after use, and do not spray directly toward flames.

Manufactured for Mist Pharmaceuticals, LLC Cranford, NJ 07016 by Dynamit Nobel GmbH, Leverkusen, Germany. Marketed and Distributed by: Mist Pharmaceuticals, LLC, Cranford, NJ 07016 USA. Revised June 2016

See also:
What is the most important information I should know about Nitroquick?

PDE-5-Inhibitors and sGC-Stimulators

Do not use Nitroquick Pumpspray in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.

Do not use Nitroquick Pumpspray in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.

Severe Anemia

Nitroquick Pumpspray is contraindicated in patients with severe anemia (large doses of Nitroquick may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia).

Increased Intracranial Pressure

Nitroquick Pumpspray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral hemorrhage or traumatic brain injury).

Hypersensitivity

Nitroquick Pumpspray is contraindicated in patients who are allergic to Nitroquick, other nitrates or nitrites or any excipient.

Circulatory Failure and Shock

Nitroquick Pumpspray is contraindicated in patients with acute circulatory failure or shock.

Use Nitroquick exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. If you use too much Nitroquick, the medicine might stop working as well in controlling your symptoms.

If possible, try to rest or stay seated when you use this medication. Nitroquick can cause dizziness or fainting.

How to use Nitroquick sublingual spray to treat an angina attack: At the first sign of an attack, apply the spray directly on or under your tongue. Close your mouth after each spray. Do not inhale the spray. Do not shake the spray before or during use. You may use additional sprays every 5 minutes, but not more than 3 sprays in 15 minutes.

You may use Nitroquick spray within 5 to 10 minutes before an activity you think might cause chest pain. Follow your doctor's instructions.

Seek emergency medical attention if your chest pain gets worse or lasts more than 5 minutes, especially if you have trouble breathing or feel weak, dizzy, or nauseated, or lightheaded. You may feel a slight burning or stinging in your mouth when you use Nitroquick. However, this sensation is not a sign of how well the medication is working. Do not use more medication just because you do not feel a burning or stinging.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Nitroquick.

Keep this medicine on hand at all times in case of an angina attack. Get your prescription refilled before you run out of medicine completely.

If you take Nitroquick on a regular schedule to prevent angina, do not stop taking it suddenly or you could have a severe attack of angina. Keep this medicine on hand at all times in case of an angina attack. Get your prescription refilled before you run out of medicine completely.

Keep the spray away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot.

See also:
What other drugs will affect Nitroquick?

PDE5 inhibitors

Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.

The time course of the interaction appears to be related to the half-life of the PDE5 inhibitor, however, the dose dependence of this interaction has not been studied. Use of Nitroquick within a few days of PDE5 inhibitors is contraindicated.

Antihypertensives

Patients receiving antihypertensive drugs, beta-adrenergic blockers, and other nitrates should be observed for possible additive hypotensive effects when using Nitroquick. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly.

Beta-blockers blunt the reflex tachycardia produced by Nitroquick without preventing its hypotensive effects. If beta-blockers are used with Nitroquick in patients with angina pectoris, additional hypotensive effects may occur.

Aspirin

Coadministration of aspirin (at doses between 500 mg and 1000 mg) and Nitroquick has been reported to result in increased Nitroquick maximum concentrations by as much as 67% and AUC by 73% when administered as a single dose. The pharmacological effects of Nitroquick may be enhanced by concomitant administration of aspirin.

Tissue-type Plasminogen Activator (t-PA)

Intravenous administration of Nitroquick decreases the thrombolytic effect of tissue-type plasminogen activator (t-PA). Plasma levels of t-PA are reduced when coadministered with Nitroquick. Therefore, caution should be observed in patients receiving Nitroquick during t-PA therapy.

Heparin

Although an interaction has been reported between intravenous heparin and intravenous Nitroquick (resulting in a decrease in the anticoagulant effect of heparin), the data are not consistent. If patients are to receive intravenous heparin and Nitroquick concurrently, the anticoagulation status of the patient must be checked.

Ergotamine

Oral administration of Nitroquick markedly decreases the first-pass metabolism of dihydroergotamine and consequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore the possibility of ergotism in patients receiving Nitroquick should be considered.

Alcohol

The vasodilating effects of Nitroquick have been shown to be additive to the effects observed with alcohol.

See also:
What are the possible side effects of Nitroquick?

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 most common adverse reaction of Nitroquick (Nitroquick) Ointment 0.4% applied to the anal canal is headache.

Headache may be recurrent following each dose. Headaches are typically of short duration and can be treated with an analgesic, e.g. acetaminophen, and are reversible upon discontinuation of treatment.

In Study REC-C-001, a double-blind, placebo-controlled trial in patients with a painful chronic anal fissure, the most frequent ( ≥ 2%) adverse reactions reported were as follows (Table 1):

Table 1: Incidence of Adverse Reactions ( ≥ 2%) in Study REC-C-001

Hypotension

Transient episodes of light-headedness, occasionally related to blood pressure changes, also may occur. Hypotension (including orthostatic hypotension) occurs infrequently, but in some patients may be severe enough to warrant discontinuation of therapy.

Allergic Reactions

Flushing, allergic reactions and application site reactions (including drug rash and exfoliative dermatitis) have been reported rarely.

Methemoglobinemia

In rare cases, therapeutic doses of organic nitrates have caused methemoglobinemia.

A volatile vasodilator which relieves angina pectoris by stimulating guanylate cyclase and lowering cytosolic calcium.