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Rectiv

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Rectiv

Rectiv Side Effects Center

Medical Editor: William C. Shiel Jr., MD, FACP, FACR

Rectiv (nitroglycerin) Ointment 0.4%, for intra-anal use is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. The most common adverse reaction of Rectiv Ointment 0.4% applied to the anal canal is headache. Headache may be recurrent following each dose. Headaches from Rectiv are typically of short duration, reversible upon discontinuation of treatment, and can be treated with an over-the-counter analgesic, such as acetaminophen. Caution should be used when taking Rectiv with aspirin and alcohol.

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. Caution should be exercised when treating patients with any of the following conditions: blood volume depletion, existing hypotension, cardiomyopathies, congestive heart failure, acute myocardial infarction, or poor cardiac function for other reasons. If patients with any of these conditions are treated with Rectiv, they should be monitored for cardiovascular status and clinical condition. The adverse reactions of Rectiv are likely to be more pronounced in the elderly.

There are no adequate and well-controlled studies in pregnant women. Rectiv should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Rectiv is administered to a nursing woman.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rectiv in Detail - Patient Information: Side Effects

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

Nitroglycerin rectal can cause severe headaches, which may occur each time you use the medication. Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol). Follow the label directions or your doctor's instructions about how much of this medicine to use.

Less serious side effects may include:

  • dizziness; or
  • mild headache.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rectiv FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 OVERDOSAGE).

Read the entire FDA prescribing information for Rectiv (Nitroglycerin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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