What happens if I overdose Nitromak Retard?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Nitromak Retard ointment:
Store Nitromak Retard ointment at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep the tube tightly closed. Use within 8 weeks of first opening. Keep Nitromak Retard ointment out of the reach of children and away from pets.
Overdose of Nitromak Retard in details
Nitromak Retard toxicity is generally mild. The estimated adult oral lethal dose of Nitromak Retard is 200 mg to 1,200 mg. Infants may be more susceptible to toxicity from Nitromak Retard. Consultation with a poison center should be considered.
Laboratory determinations of serum levels of Nitromak Retard and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of Nitromak Retard overdose.
No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of Nitromak Retard and its active metabolites. Similarly, it is not known which if any of these substances can usefully be removed from the body by hemodialysis. No specific antagonist to the vasodilator effects of Nitromak Retard is known, and no intervention has been subject to controlled study as a therapy of Nitromak Retard overdose. Because the hypotension associated with Nitromak Retard overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. Passive elevation of the patient's legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.
The use of epinephrine or other arterial vasoconstrictors in this setting is not recommended.
In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of Nitromak Retard overdose in these patients may be subtle and difficult, and invasive monitoring may be required.
Methemoglobinemia
Methemoglobinemia has been rarely reported with organic nitrates. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate arterial PO2. Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.
If methemoglobinemia is present, intravenous administration of methylene blue, 1 to 2 mg/kg of body weight, may be required.
What should I avoid while taking Nitromak Retard?
Avoid using Nitromak Retard topical on irritated or broken skin.
Nitromak Retard can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Avoid drinking alcohol. It can increase some of the side effects of Nitromak Retard topical.
Nitromak Retard warnings
Amplification of the vasodilatory effects of Nitromak Retard by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with volume expansion.
Nitromak Retard readily migrates into many plastics, including the polyvinyl chloride (PVC) plastics commonly used for intravenous administration sets. Nitromak Retard absorption by PVC tubing is increased when the tubing is long, the flow rates are low, and the Nitromak Retard concentration of the solution is high. The delivered fraction of the solution's original Nitromak Retard content has been 20-60% in published studies using PVC tubing; the fraction varies with time during a single infusion, and no simple correction factor can be used. PVC tubing has been used in most published studies of intravenous Nitromak Retard, but the reported doses have been calculated by simply multiplying the flow rate of the solution by the solution's original concentration of Nitromak Retard. The actual doses delivered have been less, sometimes much less, than those reported.
Some in-line intravenous filters also absorb Nitromak Retard; these filters should be avoided.
Because of the problem of Nitromak Retard absorption by polyvinyl chloride (PVC) tubing, Nitromak Retard Injection should be used with the least absorptive infusion tubing (i.e., non-PVC tubing) available.
DOSING INSTRUCTIONS MUST BE FOLLOWED WITH CARE. WHEN THE APPROPRIATE INFUSION SETS ARE USED, THE CALCULATED DOSE WILL BE DELIVERED TO THE PATIENT, BECAUSE THE LOSS OF Nitromak Retard Injection SEEN WITH STANDARD PVC TUBING WILL BE AVOIDED. THE DOSAGES REPORTED IN PUBLISHED STUDIES UTILIZED GENERAL-USE PVC ADMINISTRATION SETS, AND RECOMMENDED DOSES BASED ON THIS EXPERIENCE WILL BE TOO HIGH WHEN THE LOW-ABSORBING INFUSION SETS ARE USED.
What should I discuss with my healthcare provider before taking Nitromak Retard?
Some medical conditions may interact with Nitromak Retard spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of other heart problems (eg, heart failure, enlarged heart, heart attack), overactive thyroid, stroke or other bleeding in the brain, or recent head injury
- if you have anemia, low blood pressure, dehydration, or low blood volume
- if you drink alcoholic beverages
Some MEDICINES MAY INTERACT with Nitromak Retard spray. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Avanafil, beta-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem), diuretics (eg, furosemide, hydrochlorothiazide), medicines for high blood pressure, phenothiazines (eg, thioridazine), riociguat, sildenafil, tadalafil, or vardenafil because the risk of low blood pressure and dizziness on standing may be increased
- Salicylates (eg, aspirin) because they may increase the risk of Nitromak Retard spray's side effects
- Long-acting nitrates (eg, Nitromak Retard patch) because they may decrease Nitromak Retard spray's effectiveness
- Ergot derivatives (eg, ergotamine, dihydroergotamine) because the risk of their side effects may be increased by Nitromak Retard spray
- Alteplase because its effectiveness may be decreased by Nitromak Retard spray
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nitromak Retard spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Nitromak Retard precautions
General
Only the smallest dose required for effective relief of the acute anginal attack should be used. Excessive use may lead to the development of tolerance. Nitromak Retard USP tablets are intended for sublingual or buccal administration and should not be swallowed. Severe hypotension, particularly with upright posture, may occur even with small doses of Nitromak Retard. The drug should be used cautiously in patients with volume depletion or low systolic blood pressure.
Paradoxical bradycardia and increased angina pectoris may accompany Nitromak Retard-induced hypotension.
Nitrate therapy may aggravate angina caused by hypertrophic cardiomyopathy.
Tolerance to the vascular and antianginal effects of Nitromak Retard and cross-tolerance to other nitrates and nitrites may occur.
The drug should be discontinued if blurring of vision or drying of the mouth occurs. Excessive dosage of Nitromak Retard may produce severe headaches.
Information for patients
If possible, patients should sit down when taking Nitromak Retard tablets USP. This eliminates the possibility of falling due to lightheadedness or dizziness.
Nitromak Retard may produce a burning or tingling sensation when administered sublingually; however, the ability to produce a burning or tingling sensation should not be considered a reliable method for determining the potency of the tablets.
Nitromak Retard should be kept in the original glass container, tightly capped. The cotton should be discarded once the bottle is opened.
Administration of Nitromak Retard tablets USP is contraindicated in patients who are using Viagra® (sildenafil citrate). Viagra® has been shown to potentiate the hypotensive effects of organic nitrates.
Interactions
Drug interactionsConcomitant use of nitrates and alcohol may cause hypotension. Patients receiving antihypertensive drugs, beta-adrenergic blockers or phenothiazines and nitrates should be observed for possible additive hypotensive effects. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Dose adjustment of either class of agent may be necessary.
Aspirin may decrease the clearance and enhance the hemodynamic effects of sublingual Nitromak Retard. A decrease in the therapeutic effect of sublingual Nitromak Retard may result from use of long-acting nitrates.
Drug/laboratory test interactions
Nitrates may interfere with the Ziatkis-Zak color reaction causing a false report of decreased serum cholesterol.
Carcinogenesis, mutagenesis, impairment of fertility
No long-term studies in animals were performed to evaluate the carcinogenic potential of Nitromak Retard.
Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with Nitromak Retard. It is also not known whether Nitromak Retard can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nitromak Retard should be given to apregnant woman only if clearly needed.
Nursing mothers
It is not known whether Nitromak Retard is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when intravenous Nitromak Retard is administered to a nursing woman.
Pediatric use
The safety and effectiveness of Nitromak Retard in pediatric patients have not been established.
What happens if I miss a dose of Nitromak Retard?
Since Nitromak Retard is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "NITROGLYCERIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "nitroglycerin". http://www.drugbank.ca/drugs/DB00727 (accessed September 17, 2018).
- MeSH. "Explosive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
