Overview:
Nitroglycerin ointment 0.4 % is a gastrointestinal agent used to treat chronic anal fissure pain. The drug is available in tube form as an ointment and on a doctor's prescription only. Nitroglycerin ointment of 0.4 % is safe and effective in adults, but its efficacy and safety in children have not been established. The drug may cause possible side effects, such as dizziness, headaches, and fainting during its administration, that may become tolerant over time. However, the doctor should be consulted immediately if the drugs cause severe side effects. Therefore, Nitroglycerin ointment 0.45 should be cautiously used by the patient as per the doctor's advice.
Uses of Nitroglycerin Ointment 0.4 %
Nitroglycerin ointment of 0.4 % is used to treat moderate to severe symptoms of pain caused by chronic anal fissures.
Dose and Administration
Nitroglycerin 0.4 % ointment is inserted up to 1 cm in the anal cavity with the help of an applicator. The dose is applied after every twelve hours intra-anally. The ointment is applied for at least eight weeks until the symptoms of pain resolve or become less strong.
Warning and Precautions
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Cardiovascular Disorders: Nitroglycerin ointment of 0.4 % can cause arterial and venous dilation by decreasing arterial vascular resistance and systolic pressure and reducing venous blood return to the heart. Patients treated for the conditions such as existing hypotension, congestive heart failures, cardiomyopathies, blood volume depletion, and acute myocardial infarction should be carefully monitored while prescribing Nitroglycerine ointment 0.4 %. The adverse effects of this drug are more likely to occur in older people.
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Headaches: Dose-related headaches are produced by Nitroglycerin ointment of 0.4 %, and they can be severe. A person develops tolerance to headaches over time.
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Severe Anemia: Nitroglycerin ointment of 0.4 % is contraindicated in people suffering from severe anemia.
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Hypersensitivity: People suffering from hypersensitivity reactions from nitrites or nitrates should not be treated with Nitroglycerin ointment 0.4 %.
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Increased Intracranial Pressure: Nitroglycerin ointment 0.4 % is also contraindicated in patients with increased intracranial pressure.
Use in Special Populations
Pediatric Use
The safety and effectiveness of Nitroglycerin ointment 0.4 % in pediatric patients (below 18 years) has not been established.
Geriatric Use
No clinical data on Nitroglycerin 0.4 % ointment suggests any different response from patients 65 and above. However, treatment with nitrates produces increased hypersensitivity in elderly patients. They frequently show severe symptoms of dizziness, hypotension, fainting, and reduced cardiac, renal, and hepatic function.
Pregnancy
There is no specific evidence or well-conducted studies on the adverse effects of Nitroglycerin ointment 0.4 % in pregnant women. But the drug shown is carefully prescribed during pregnancy if it does not affect the fetus and its potential benefits justify the potential risks. However, animal studies show no teratogenic effects.
Breastfeeding
No data shows Nitroglycerin excreted in human milk because many drugs are already present. Therefore, precautions are necessary before prescribing Nitroglycerine to a pregnant woman.
For Patients
What Is Nitroglycerin Ointment 0.4 %?
Nitroglycerin ointment 0.4 % is available in tube form as an intra-anal ointment for treating chronic anal fissure pain caused by a tear or split in the tissue of the rectum. The drug works by relaxing the muscles around the blood vessels and reduces pressure, thus causing pain relief.
Most Specific Information To Know About Nitroglycerin Ointment 0.4 %
The most specific information about Nitroglycerin ointment 0.4 % is that it causes dose-related side effects in a person, such as headaches, dizziness, or fainting. These symptoms usually indicate that the drug is working for a person, and tolerance to these symptoms develops over time. However, if these symptoms worsen, consult the doctor immediately.
How Should Nitroglycerin Ointment 0.4 % Be Used?
Nitroglycerin Ointment of 0.4 % is for intra-anal use only.
Topical Nitroglycerin or Nitroglycerin ointment 0.4 % is applied every 12 hours for at least three weeks on the skin when prescribed for treating anal fissures.
The rectal ointment indicated for anal fissures contains 0.4 % nitroglycerin. It is inserted into the anal cavity with the help of an applicator 12 hourly for at least three weeks.
What Should Be Avoided While Using Nitroglycerin Ointment 0.4 %?
The Nitroglycerin ointment of 0.4 % should be used per the doctor's advice. Any changes in the diet or anything that needs to be avoided should be followed as per the instructions given by the doctor. Else regular diet can be continued.
Who Should Not Use Nitroglycerin Ointment 0.4 %?
Nitroglycerin ointment of 0.4 % should not be taken by people having severe anemia, taking medications for erectile dysfunction, having an allergic reaction to Nitroglycerin, or having increased intracranial pressure due to head trauma or brain injury.
What Should Be Informed to the Doctor Before Using Nitroglycerin Ointment 0.4 %?
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Inform the doctor about any hypersensitivity reactions that a person may have or any allergy to Nitroglycerin ointment.
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A person should inform the doctor about any non-prescription or prescription drugs they are taking. This includes nutritional supplements, vitamins, or herbal products. In addition, inform the doctor if a person is taking beta-blockers, Aspirin, etc.
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Inform the doctor about the pregnancy, planning to get pregnant, or breastfeeding.
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If someone has anemia or any condition increasing intracranial pressure, inform the doctor, as they may ask to stop using Nitroglycerin ointment 0.4 %.
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Nitroglycerin ointment causes headache, dizziness, and fainting; therefore, avoid driving or operating heavy machines while using this drug.
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Do not change the drug dose or timings if a person experiences continuous headaches. Take proper advice from the doctor.
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Inform the doctor about any past or present medical conditions a person may have before using Nitroglycerin ointment 0.4 %. These conditions include heart failure, low blood pressure, migraines, recurrent headaches, and hypertrophic cardiomyopathies.
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If a person is alcoholic, inform the doctor before using Nitroglycerine ointment 0.4 %. Alcohol can make the condition even worse if taken along with nitroglycerin.
Side Effects of Nitroglycerine Ointment 0.4 %
Common Side Effects:
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Dizziness.
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Flushing.
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Lightheadedness.
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Irritation or readiness at the skin area covered with ointment.
Severe Side Effects:
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Fainting.
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Slow heart rate.
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Hives.
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Breathing and swallowing difficulties.
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Severe chest pain.
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Itching.
What Happens With the Overdose of Nitroglycerin?
In case of an overdose of Nitroglycerin ointment 0.4 %, contact the poison control helpline 911.
What Should Be Done if the Nitroglycerin Ointment of 0.4 % Is Missed?
The missed dose of the ointment should be applied as soon as the person remembers it. The dose should be missed if the timing clashes with the next regular dose. Avoid double dose application of Nitroglycerin ointment 0.4 %.
Drug Storage and Disposal
The ointment should be kept away from children, and the cap must be tightly closed after use. Nitroglycerin ointment should be stored at room temperature and away from moisture and excessive heat. Also, Nitroglycerin ointment 0.4 % used for treating annal fissure pain should be discarded after eight weeks from the date of opening the ointment, and no leftovers should be stored for a longer duration. Discarded as per the FDA guidelines for the disposal of waste products.
For Doctors
Clinical Pharmacology
Mechanism of Action:
Nitroglycerin ointment 0.4 % forms NO that is free radicals of nitric oxide, which increases cyclic GMP or guanosine 3, 5- monophosphate by activating guanylate cyclase. It further causes dephosphorylation of the myosin light chain. Thus, Nitroglycerin ointment of 0.4 % initiates vasodilation by regulating the contractile state in the smooth muscles.
Pharmacodynamics:
The principal pharmacological action of Nitroglycerin ointment 0.4 % is the relaxation of vascular smooth muscles. The ointment application in chronic anal fissure pain relaxes intra-anal pressure by reducing the sphincter tone.
Pharmacokinetics:
Topical Bioavailability: 72 %
Ingredients
Active Ingredients:
Nitroglycerin
Inactive Ingredients:
Lanolin, propylene glycol, paraffin wax, sorbitan sesquiplane, white petrolatum.
Warning and Precautions
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The doctor should take the patient's medical and drug history before prescribing this medication.
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Patients should be appropriately guided about using the ointment cautiously and making them aware of the possible side effects that usually occur with Nitroglycerin ointment 0.4 %.
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Necessary precautions should be observed in cases where the drug can cause adverse effects, such as if a person is already suffering from any medical condition that can cause potential risk with Nitroglycerin treatment.
Dosage and Forms
No specific dosage of Nitroglycerin ointment is 0.4 % for rectal fissure pain is determined. However, the frequency of application of the ointment is prescribed by the doctor depending on the patient's condition.:
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Children: As determined by the doctor.
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Adults: The ointment is applied 1 cm into the anal canal after every 12 hours for three weeks. The ointment can be used for four to eight weeks in case of severe symptoms.
The product or drug is available in the following dose form.
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Ointment
Administration of the Drug
The patient administers the ointment of 0.4 % Nitroglycerin as per the doctor's advice.
Consideration for Administration
Nitroglycerin ointment of 0.4 % for treating chronic anal fissure pain is applied every 12 hours for three weeks or as prescribed by the doctor. The dose can differ for each patient. Therefore, consult the doctor before making any changes. No other specific dose titration has been suggested for Nitroglycerin ointment 0.4 %.
Contraindications
Nitroglycerin ointment of 0.4 % is usually contraindicated in patients with any known hypersensitivity to Nitroglycerin or some other ingredients of this formulation.
Adverse Effects
Nitroglycerin ointment 0.4 % causes adverse effects such as dizziness and headache. In addition, it may also cause rare side effects such as leakage of bowel motions and loss of control over bowel movements.
Drug Interactions
Antihypertensives:
Nitroglycerin ointment for chronic fissure pain should be cautiously prescribed to patients using beta-blockers, antihypertensive drugs, and other nitrates, as the drug can cause hypotensive effects. The use of organic nitrates and Beta-blockers can cause orthostatic hypotension, as reported. Beta-blockers used with antihypertensive drugs in angina pectoris cases can cause additional hypotensive effects.
PDE5 Inhibitors:
Nitroglycerin ointment 0.4 % is contraindicated in people using selective inhibitors such as vardenafil, sildenafil tadalafil as they cause hypotensive effects of nitrates.
Heparin:
Intravenous heparin causes drug interaction with intravenous Nitroglycerin and leads to reduced anticoagulation effects of the heparin. The drug interaction of heparin and intra-anal ointment of Nitroglycerin should be cautiously monitored and reconsidered.
Aspirin:
Co-administration of aspirin and Nitroglycerin increases the concentration of Nitroglycerin by 67 %. Therefore, Nitroglycerin ointment's pharmacological effects of Nitroglycerin ointment 0.4 % may be enhanced with aspirin administration.
Ergotamine:
Ergotamine can cause angina pectoris in a person. Therefore, patients receiving both Nitroglycerin ointments and ergotamine should be reconsidered.
Tissue-type Plasminogen Activator (t-PA):
Co-administration of t-PA with Nitroglycerin can cause a reduction in plasma levels of t-PA. The thrombolytic effects of t-PA are decreased with intravenous administration of Nitroglycerin and t-PA. Therefore, the doctor should take necessary precautions in patients using Nitroglycerin ointment for rectal fissures during t-PA therapy.
Alcohol:
Nitroglycerin produces vasodilating effects, which are additive to the ones produced by alcohol.
