May 29, 2016
Recommended Topic Related To:

Rectiv

"The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opioids are a class of drugs that are used to treat and manage pain. A comm"...

A A A

Rectiv




Rectiv Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/8/2016

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. Common side effects of Rectiv Ointment include headache dizziness, lightheadedness, or faintness on standing.

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. 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. 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.

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

System Organ Class Preferred term RECTIV
N = 123
Placebo
N =124
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)

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.


GI Disorders

Get the latest treatment options.