nitroglycerin rectal ointment

(redirected from Rectiv)

nitroglycerin rectal ointment

(nye-tro-gli-ser-in) ,

Rectiv

(trade name)

Classification

Therapeutic: vasodilators
Pharmacologic: nitrates
Pregnancy Category: C

Indications

Moderate to severe pain associated with chronic anal fissure.

Action

Forms nitric oxide which activates the enzyme guanylate cyclase causing increased guanosine 3', 5' monophospahte (cyclic GMP). This produces vasodilation. Also reduces sphincter tone and resting intra-anal pressure.

Therapeutic effects

Decreased pain associated with chronic anal fissure.

Pharmacokinetics

Absorption: 50% absorbed following intra-anal applications.
Distribution: Unk.
Metabolism and Excretion: Mostly metabolized by the liver; some extra-hepatic metabolism (red blood cells, vascular walls).
Half-life: 2–3 min.

Time/action profile

ROUTEONSETPEAKDURATION
Rectunkunk12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to nitrates, nitrites, nitroglycerin or any other ointment components ;Increased intracranial pressure;Concurrent use of sildenafil, tadalafil or varndenafil;Severe anemia.
Use Cautiously in: Volume depletion, hypotension, cardiomyopathy, HF, acute MI, or poor cardiac function due to other causes (may ↓ venous return, arterial resistance and BP);Concurrent use of tissue plasminogen activator (t-PA) therapy; Geriatric: ↑ sensitivity to nitrates and ↑ risk of hypotension; Obstetric: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; Lactation: Effects are not known, use cautiously; Pediatric: Safe and effective use in children <18 yr not established.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • dizziness

Cardiovascular

  • hypotension

Hematologic

  • methemoglobinemia (rare)

Miscellaneous

  • allergic reactions (rare)

Interactions

Drug-Drug interaction

Concurrent use with sildenafil, tadalafil, or vardenafil ↑ risk of hypotension and is contraindicated.Concurrent use with antihypertensives, beta blockers, other nitrates, alcohol or aspirin (500–1000 mg) may ↑ risk of hypotension.Beta blockers may ↓ reflex tachycardia from nitroglycerin.May ↓ levels and effectiveness of t-PA.May ↓ effectiveness of heparin.May ↑ levels and risk of adverse cardiovascular reactions with ergotamine.

Route/Dosage

Rectal (Adults) Apply one inch of ointment intra-anally every 12 hr for up to three weeks.

Availability

Ointment: 0.4% in 30 g tubes

Nursing implications

Nursing assessment

  • Assess anal fissure and amount of pain periodically during therapy.

Potential Nursing Diagnoses

Chronic pain (Indications)

Implementation

  • Topical: Using plastic wrap, a disposable surgical glove, or finger cot, apply 1 inch of ointment intra-anally every 12 hrs. Dose is determined by laying covered finger alongside 1 inch dosing line on carton. Gently insert covered finger into anal canal no further than first finger joint and apply ointment around the side of the anal canal. If not possible due to pain, apply ointment directly to outside of anus. May continue treatment for up to 3 wks. Close tube tightly. Use within 8 wks of opening. Wash hands after application.
    • Not for oral, ophthalmic, or intravaginal use.

Patient/Family Teaching

  • Instruct patient to use nitroglycerin ointment as directed. Notify health care professional if anal pain does not improve.
  • Inform patient that nitroglycerin ointment may cause headache. Advise patient not to alter schedule due to headache; tolerance develops. May take an analgesic, such as acetaminophen to treat headache.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to stop medication and notify health care professional immediately if signs of allergic reaction (swelling of face, lips, tongue, or throat, difficulty breathing) occur.
  • Caution patient to change positions slowly to prevent orthostatic hypotension. Avoid drinking alcohol; may increase orthostatic hypotension.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially medications for erectile dysfunction; may increase hypotensive effects.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • ↓ pain associated with chronic anal fissure.
References in periodicals archive ?
If successful in development, relamorelin could provide a significant addition to our GI family, which currently includes Linzess, Delzicol/Asacol, Carafate, Canasa, Pylera and Rectiv, and for which we are currently developing eluxadoline, the product opportunity acquired earlier this year with our acquisition of Furiex Pharmaceuticals.
Under the agreement Aptalis will gain exclusive rights to market ProStrakan's drug Rectiv (nitroglycerin) ointment in the US.
Although Rectiv is effective in reducing pain, an oft-cited side effect is moderate to severe headaches stemming from the drug's active ingredient - nitroglycerin.
Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP, CANASA, CARAFATE, PYLERA, RECTIV, VIOKACE (TM), ULTRESA, LACTEOL, DELURSAN, PANZYTRAT, and SALOFALK.
Rectiv will be the only FDA approved prescription product for patients with this condition.