Rectiv Side Effects Center

Last updated on RxList: 7/18/2021
Rectiv Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Rectiv?

Rectiv (nitroglycerin) Ointment 0.4%, for intra-anal use is an organic nitrate that dilates (widens) blood vessels indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

What Are Side Effects of Rectiv?

Common side effects of Rectiv Ointment include:

  • headache,
  • dizziness,
  • lightheadedness, or
  • faintness on standing
  • Dosage for Rectiv

    Apply 1 inch of Rectiv ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) intra-anally every 12 hours for up to 3 weeks.

    What Drugs, Substances, or Supplements Interact with Rectiv?

    Rectiv may interact with alcohol, alteplase, aspirin, heparin, dihydroergotamine or ergotamine, heart or blood pressure medications, or nitroglycerin used in a pill form or spray under the tongue, or as a skin patch or skin ointment. Tell your doctor all medications and supplements you use.

    Rectiv During Pregnancy or Breastfeeding

    Tell your doctor if you are pregnant or plan to become pregnant while using Rectiv. It is unknown how it could affect a fetus. It is unknown if Rectiv passes into breast milk. Consult your doctor before breastfeeding.

    Additional Information

    Our Rectiv Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Rectiv Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;
  • slow heart rate;
  • a light-headed feeling, like you might pass out; or
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Nitroglycerin can cause severe headaches. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop using this medicine. Ask your doctor before using any headache pain medication.

Common side effects may include:

  • headache; or
  • dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rectiv (Nitroglycerin)

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Rectiv Professional Information

SIDE EFFECTS

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 RECTIV (nitroglycerin) 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

RECTIV
N = 123
Placebo
N = 124
System Organ Class
  Preferred term
Patients
n (%)
Events
n
Patients
n (%)
Events
n
Nervous system disorders
  Headache 79 (64) 938 51 (41) 225
  Dizziness 6 (5) 26 0 0

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 (see OVERDOSE).

DRUG INTERACTIONS

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 RECTIV 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 RECTIV. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly.

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

Aspirin

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

Tissue-Type Plasminogen Activator (t-PA)

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

Heparin

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

Ergotamine

Oral administration of nitroglycerin 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 RECTIV should be considered.

Alcohol

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

Read the entire FDA prescribing information for Rectiv (Nitroglycerin)

© Rectiv Patient Information is supplied by Cerner Multum, Inc. and Rectiv Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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