Rectiv rectal

You should not use this medicine if you are allergic to:

• isosorbide dinitrate;

• isosorbide mononitrate; or

• other forms of nitroglycerin (pill, spray, or skin ointment, or skin patch).

Do not take erectile dysfunction medicine (Viagra, Cialis, Levitra, Stendra, Staxyn, sildenafil, avanafil, tadalafil, vardenafil) while you are using nitroglycerin rectal. Using erectile dysfunction medicine with nitroglycerin can cause a sudden and serious decrease in blood pressure.

You also should not use nitroglycerin rectal if you have:

• severe anemia (a lack of red blood cells); or

• a brain injury, hemorrhage, or tumor.

Do not use nitroglycerin rectal if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling). Seek emergency medical attention if you have symptoms of a heart attack.

To make sure nitroglycerin is safe for you, tell your doctor if you have:

• congestive heart failure;

• a history of heart attack, stroke, or circulation problems;

• low blood pressure;

• migraine headaches; or

• liver disease.

FDA pregnancy category C. It is not known whether nitroglycerin rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether nitroglycerin rectal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Nitroglycerin rectal is not approved for use by anyone younger than 18 years old.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), riociguat.

You should not use Rectiv if you are allergic to:

• isosorbide dinitrate;

• isosorbide mononitrate; or

• other forms of nitroglycerin (pill, spray, or skin ointment, or skin patch).

Do not take erectile dysfunction medicine (Viagra, Cialis, Levitra, Stendra, Staxyn, sildenafil, avanafil, tadalafil, vardenafil) while you are using Rectiv. Using erectile dysfunction medicine with nitroglycerin can cause a sudden and serious decrease in blood pressure.

You also should not use Rectiv if you have:

• severe anemia (a lack of red blood cells); or

• a brain injury, hemorrhage, or tumor.

Do not use Rectiv if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling). Seek emergency medical attention if you have symptoms of a heart attack.

To make sure Rectiv is safe for you, tell your doctor if you have:

• congestive heart failure;

• a history of heart attack, stroke, or circulation problems;

• low blood pressure;

• migraine headaches; or

• liver disease.

FDA pregnancy category C. It is not known whether Rectiv will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether nitroglycerin rectal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Rectiv is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Rectiv, especially:

• aspirin or heparin;

• blood pressure medication;

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine;

• medicine to treat a blood clot - alteplase, streptokinase, urokinase, tenecteplase); or

• nitroglycerin used in a pill form or spray under the tongue, or as a skin patch or skin ointment.

This list is not complete. Other drugs may interact with nitroglycerin rectal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to nitroglycerin: capsule extended release, packet, spray, tablet, tablet extended release

Other dosage forms:

• intravenous injectable, intravenous kit, intravenous solution
• rectal ointment
• transdermal ointment, transdermal patch extended release

Along with its needed effects, nitroglycerin (the active ingredient contained in Rectiv) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nitroglycerin:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficult or labored breathing
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• headache
• rapid weight gain
• sweating
• tightness in the chest
• tingling of the hands or feet
• unusual weight gain or loss

• Bluish-colored lips, fingernails, or palms
• dark urine
• fever
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• cough
• cracks in the skin
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• feeling of warmth
• hives, itching, or rash
• increased sweating
• loss of heat from the body
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, swollen skin
• redness of the face, neck, arms, and occasionally, upper chest
• scaly skin
• sensation of spinning
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking nitroglycerin:

• Bluish-colored lips, fingernails, or palms
• blurred or loss of vision
• bulging soft spot on the head of an infant
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• dark urine
• difficulty breathing
• disturbed color perception
• dizziness or lightheadedness
• double vision
• fever
• flushed skin
• halos around lights
• headache, severe and throbbing
• increased sweating
• loss of appetite
• loss of consciousness
• night blindness
• overbright appearance of lights
• pale skin
• paralysis
• slow or irregular heartbeat
• sore throat
• tunnel vision
• unusual bleeding or bruising
• unusual tiredness or weakness

Some side effects of nitroglycerin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• body aches or pain
• congestion
• hoarseness
• lack or loss of strength
• runny nose
• sneezing
• stuffy nose
• tender, swollen glands in the neck
• voice changes

Applies to nitroglycerin: buccal tablet extended release, intravenous solution, oral capsule extended release, rectal ointment, sublingual powder, sublingual spray, sublingual tablet, transdermal film extended release, transdermal ointment

General

The most common side effect is headache.[Ref]

Nervous system

Very common (10% or more): Headache (up to 64%)
Common (1% to 10%): Dizziness, lightheadedness, syncope, vertigo, drowsiness
Rare (0.1% to 0.01%): Severe and prolonged headache
Very rare (less than 0.01%): Cerebral ischemia
Frequency not reported: Faintness, somnolence[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, angina increased, paradoxical bradycardia, tachycardia, orthostatic hypotension, blood pressure decreased, facial flushing
Uncommon (0.1 to 1%): Circulatory collapse
Rare (less than 0.1%): Bradycardia, cyanosis, flushing, heart rate increase
Frequency not reported: Crescendo angina, rebound hypertension, palpitations, hypertension, decreased arterial oxygen tension, severe arterial hypotension with bradycardia, transient flushing[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting
Rare (0.01% to 0.1%): Dry mouth
Very rare (less than 0.01%): Heartburn, halitosis
Frequency not reported: Abdominal pain, retching, lip and tongue swelling[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dermatitis contact, erythema, pruritus, burning, irritation, eczema, urticaria
Rare (0.01 to 0.1%): Allergic skin reactions, rash
Very rare (less than 0.01%): Exfoliative dermatitis, drug rash
Frequency not reported: Cutaneous flushing, diaphoresis, angioedema
Postmarketing reports: Rash generalized[Ref]

Other

Common (1% to 10%): Asthenia, weakness
Frequency not reported: Retrosternal discomfort[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reactions, anaphylaxis
Frequency not reported: Allergic reaction, anaphylactoid reaction[Ref]

Psychiatric

Common (1% to 10%): Restlessness
Frequency not reported: Apprehension[Ref]

Respiratory

Very rare (less than 0.01%): Impairment of respiration
Frequency not reported: Hypoxemia, dyspnea[Ref]

Hematologic

Very rare (less than 0.01%): Methemoglobinemia[Ref]

Ocular

Rare (less than 0.1%): Blurred vision
Frequency not reported: Increased ocular pressure[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching[Ref]

Some side effects of Rectiv may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.