Microsoft word - rectiv-pi-en-oint-0.4-20130703-v2-current.doc
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Most common adverse reactions are headache and dizziness. (6)
®(nitroglycerin) Ointment 0.4% safely and effectively. See full
prescribing information for RECTIV.
To report SUSPECTED ADVERSE REACTIONS, contact Aptalis
Pharma US, Inc. at 1-800-472-2634 or FDA at 1-800-FDA-1088 or
RECTIV (nitroglycerin) Ointment 0.4%, for intra-anal use
Initial U.S. Approval: 1955
----------------------------INDICATIONS AND USAGE---------------------------
PDE5 inhibitors: potentiation of hypotensive effects of organic nitrates;
RECTIV is a nitrate vasodilator indicated for the treatment of moderate to
concomitant use is contraindicated. (4.1, 7.1)
severe pain associated with chronic anal fissure (1).
Antihypertensives: possible additive hypotensive effects. (7.2)
Aspirin: increased nitroglycerin levels. (7.3)
----------------------DOSAGE AND ADMINISTRATION-----------------------
Tissue-type Plasminogen Activator (t-PA): decreased thrombolytic
Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of
nitroglycerin) intra-anally every 12 hours for up to 3 weeks (2).
Heparin: anticoagulant effect of heparin may be reduced. Monitor
RECTIV ointment is not for oral, ophthalmic, or intravaginal use (2)
Ergotamine: increased bioavailability of ergotamine. (7.6)
Alcohol: Additive vasodilatory effects to nitroglycerin. Consumption of
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Ointment 0.4% w/w (4 mg nitroglycerin/1 g ointment) (3)
See 17 for PATIENT COUNSELING INFORMATION and
Use of PDE5 inhibitors (e.g. sildenafil, vardenafil and tadalafil) as these
FDA-approved patient labeling.
are shown to potentiate the hypotensive effects of organic nitrates. (4.1).
Known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment. (4.4)
-----------------------WARNINGS AND PRECAUTIONS------------------------
Cardiovascular Disorders: Venous and arterial dilatation as a consequence of nitroglycerin treatment can result in hypotension. Exercise caution 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 (5.1).
Headache: Nitroglycerin produces dose-related headaches which may be severe (5.2)
FULL PRESCRIBING INFORMATION: CONTENTS*
USE IN SPECIFIC POPULATIONS
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
12 CLINICAL PHARMACOLOGY
WARNINGS AND PRECAUTIONS
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
7.4 Tissue-type Plasminogen Activator (t-PA)
*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
INDICATIONS AND USAGE
RECTIV® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain
associated with chronic anal fissure. 2
DOSAGE AND ADMINISTRATION
Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) intra-anally every 12 hours for up to 3 weeks. A finger covering, such as plastic-wrap, disposable surgical glove or a finger cot, should be placed on the finger to apply the ointment. To obtain a 1.5 mg dose of nitroglycerin, the covered finger is laid alongside the 1 inch dosing line on the carton.
Refer to carton for accurate dosage guide.
The tube is gently squeezed until a line of ointment the length of the measuring line is expressed
onto the covered finger. The ointment is gently inserted into the anal canal using the covered finger
no further than to the first finger joint and the ointment is applied around the side of the anal canal.
If this cannot be achieved due to pain, application of the ointment should be made directly to the
outside of the anus. Treatment may be continued for up to three weeks.
RECTIV ointment is not for oral, ophthalmic, or intravaginal use. Hands should be washed after
application of the ointment.
See Patients Instruction for Use. 3
DOSAGE FORMS AND STRENGTHS
Ointment, 0.4% w/w (4 mg /1 g) in 30 g tubes. 4
PDE5 inhibitor use
Administration of RECTIV is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), such as sildenafil, vardenafil, and tadalafil, as these are shown to potentiate the hypotensive effects of organic nitrates [see 7.1 DRUG INTERACTIONS].
RECTIV is contraindicated in patients with severe anemia. 4.3
Increased intracranial pressure
RECTIV is contraindicated in patients with increased intracranial pressure. 4.4 Hypersensitivity
RECTIV is contraindicated in patients who have shown hypersensitivity to it or to other nitrates or
nitrites. Skin reactions consistent with hypersensitivity have been observed with organic nitrates. 5
WARNINGS AND PRECAUTIONS
Venous and arterial dilatation as a consequence of nitroglycerin treatment including RECTIV, can
decrease venous blood returning to the heart and reduce arterial vascular resistance and systolic
pressure. Exercise caution 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, monitor cardiovascular status and clinical condition. The
adverse reactions of RECTIV are likely to be more pronounced in the elderly. 5.2
RECTIV produces dose-related headaches, which may be severe. Tolerance to headaches occurs. 6
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
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
Nervous system disorders
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.
Flushing, allergic reactions and application site reactions (including drug rash and exfoliative dermatitis) have been reported rarely.
In rare cases, therapeutic doses of organic nitrates have caused methemoglobinemia (see 10
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. 7.2 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
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.
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. 7.4 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. 7.5 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. 7.6 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. 7.7 Alcohol
The vasodilating effects of nitroglycerin have been shown to be additive to the effects observed with
USE IN SPECIFIC POPULATIONS
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been conducted with RECTIV.
Nitroglycerin was not teratogenic when administered by topical or dietary route. 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.
Teratology studies in rats and rabbits were conducted with topically applied nitroglycerin ointment
at doses up to 80 mg/kg/day and 240 mg/kg/day, respectively. No toxic effects on dams or fetuses
were seen at any dose tested.
A teratogenicity study was conducted in rats with nitroglycerin administered in the diet at levels up
to 1% content (approximately 430 mg/kg/day) on days 6 to 15 of gestation. In offspring of the high-
dose group, an increased but not statistically significant incidence of diaphragmatic hernias was
noted together with decreased hyoid bone ossification. The latter finding probably reflects delayed
development, thus indicating no clear evidence of a potential teratogenic effect of nitroglycerin. 8.3 Nursing
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. 8.4 Pediatric
The safety and effectiveness of RECTIV in pediatric patients under 18 years of age have not been
established. 8.5 Geriatric
Clinical studies of RECTIV did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Clinical data from the published
literature indicate that the elderly demonstrate increased sensitivity to nitrates, which may be
therapeutic but also manifest by more frequent or severe hypotension and related dizziness or
fainting. Increased sensitivity may reflect the greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or other drug therapy. 10 OVERDOSAGE
Nitroglycerin toxicity is generally mild. The estimated adult oral lethal dose of nitroglycerin is 200
mg to 1,200 mg. Infants may be more susceptible to toxicity from nitroglycerin. Consultation with a
poison center should be considered.
Laboratory determinations of serum levels of nitroglycerin and its metabolites are not widely
available, and such determinations have, in any event, no established role in the management of
No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the
urine) that might accelerate elimination of nitroglycerin and its active metabolites. Similarly, it is not
known which if any of these substances can usefully be removed from the body by hemodialysis.
No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention has
been subject to controlled study as a therapy of nitroglycerin overdose. Because the hypotension
associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia,
prudent therapy in this situation should be directed toward increase in central fluid volume. Passive
elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline or similar
fluid may also be necessary.
The use of epinephrine or other arterial vasoconstrictors in this setting is not recommended.
In patients with renal disease or congestive heart failure, therapy resulting in central volume
expansion is not without hazard. Treatment of RECTIV overdose in these patients may be subtle and
difficult, and invasive monitoring may be required. Methemoglobinemia
Methemoglobinemia has been rarely reported with organic nitrates. The diagnosis should be
suspected in patients who exhibit signs of impaired oxygen delivery despite adequate arterial PO2.
Classically, methemoglobinemic blood is described as chocolate brown, without color change on
exposure to air.
If methemoglobinemia is present, intravenous administration of methylene blue, 1 to 2 mg/kg of
body weight, may be required. 11 DESCRIPTION
Nitroglycerin is 1,2,3,-propanetriol trinitrate, an organic nitrate whose structural formula is as
and whose molecular weight is 227.09. RECTIV (nitroglycerin) Ointment 0.4% contains 0.4%
nitroglycerin w/w (4 mg nitroglycerin/1 g ointment), propylene glycol, lanolin, sorbitan sesquioleate,
paraffin wax, and white petrolatum. RECTIV (nitroglycerin) Ointment 0.4% is available in tubes
with a one-inch dosing line on the carton allowing the measurement of approximately 375 mg of
nitroglycerin ointment 0.4% (1.5 mg nitroglycerin) for application. 12
Mechanism of Action
Nitroglycerin forms free radical nitric oxide (NO), which activates guanylate cyclase, resulting in an
increase of guanosine 3’,5’-monophosphate (cyclic GMP) in smooth muscle and other tissues. This
leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth
muscle and results in vasodilatation. 12.2
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Intra-anal application of nitroglycerin reduces sphincter tone and resting intra-anal pressure.
In six healthy subjects, the average absolute bioavailability of nitroglycerin applied to
the anal canal as a 0.2% w/w ointment was approximately 50% of the 0.75 mg nitroglycerin dose. Distribution:
The volume of distribution of nitroglycerin following intravenous administration is
about 3 L/kg. At plasma concentrations between 50 and 500 ng/mL, the binding of nitroglycerin to
plasma proteins is approximately 60%, while that of 1,2- and 1,3-dinitroglycerin is 60% and 30%,
Nitroglycerin is metabolized by a liver reductase enzyme to glycerol di- and
mononitrate metabolites and ultimately to glycerol and organic nitrate. Known sites of extrahepatic
metabolism include red blood cells and vascular walls. In addition to nitroglycerin, the two major
metabolites, 1,2- and 1,3- dinitroglycerols are found in plasma. The contribution of metabolites to
the relaxation of the internal anal sphincter is unknown. The dinitrates are further metabolized to
nonvasoactive mononitrates and ultimately to glycerol and carbon dioxide.
Metabolism is the primary route of drug elimination. Nitroglycerin plasma
concentrations decrease rapidly with a mean elimination half-life of two to three minutes. Half-life
values range from 1.5 to 7.5 minutes. Clearance (13.6 L/min) greatly exceeds hepatic blood flow. 13
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal carcinogenicity studies with topically applied nitroglycerin have not been performed.
Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related
fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes.
At the highest dose, the incidence of hepatocellular carcinomas was 52% compared to 0% in
untreated controls. Incidence of testicular tumors were 52% vs. 8% in controls. Lifetime dietary
administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.
Nitroglycerin was mutagenic in the in vitro
bacterial reverse mutation (Ames) assay with Salmonella
. A similar mutation in this S. typhimurium
was also reported with other NO donors.
There was no evidence of clastogenic potential in multiple assays including a rodent dominant lethal
assay, an in vitro
Chinese Hamster Ovary assay that was conducted in the absence of metabolic
activation, and several in vivo
chromosomal aberration assays conducted in rats and dogs.
In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to approximately 434 mg/kg/day for 6 months prior to mating of the F0 generation with treatment
continuing through successive F1 and F2 generations. The high dose was associated with decreased
feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of
the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to
increased interstitial cell tissue and aspermatogenesis in the high-dose males.
RECTIV ointment was evaluated in a 3-week double-blind, randomized, multi-center, placebo-
controlled study. Patients with a painful chronic anal fissure for at least 6 weeks and moderate or
severe pain prior to treatment (≥ 50 mm on the 100mm visual analog scale, VAS) were randomized
to receive 0.4% (1.5mg) nitroglycerin or placebo ointment applied to the anal canal every 12 hours.
Pain as assessed by the change in VAS from baseline to Days 14-18 was lower in patients receiving
0.4% ointment compared to placebo. The mean change from baseline was 44mm for RECTIV and
37mm for placebo. The difference in the mean change in pain between RECTIV and placebo was
-7.0mm (95% Confidence Interval: -13.6 to -0.4mm).
HOW SUPPLIED/STORAGE AND HANDLING
RECTIV (nitroglycerin) Ointment 0.4%
is available in 30 g (NDC 58914-301-80) aluminum
tubes with polyethylene screw caps.
Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP
Controlled Room Temperature].
Keep the tube tightly closed. Use within 8 weeks of first opening. 17
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information and Instructions for Use)
17.1 Interaction with PDE5 inhibitors
Advise patient not to use RECTIV with medications for erectile dysfunction such as Viagra
(sildenafil), Levitra (vardenafil), and Cialis (tadalafil). These products have been shown to increase
the hypotensive effects of RECTIV and other nitrate drugs. 17.2 Hypotension
Advise patients that treatment with RECTIV may be associated with light-headedness on standing,
especially just after rising from a lying or seated position. The effect may be more frequent in
patients who have also consumed alcohol, since alcohol use contributes to hypotension. Advise
patients to stand up from the supine or sitting position slowly. 17.3 Headaches
Advise patients that headaches sometimes accompany treatment with RECTIV. For patients who
get these headaches, the headaches may indicate the activity of the drug. Tolerance to headaches
develops. Advise patients that if they experience headache they should not alter the schedule of their
RECTIV treatment to avoid the occurrence of headache. An analgesic, such as acetaminophen, may
be used to prevent or relieve the headaches.
Advise patients that dizziness has been reported as a side-effect of treatment with RECTIV.
Advise patients not to drive or operate machinery immediately after applying RECTIV.
17.5 FDA-Approved Patient Labeling
IMPORTANT: For intra-anal use only
Read the Patient Information that comes with RECTIV before you start using the product and each
time you get a refill because there may be new information. This information does not take the place
of talking to your healthcare provider about your medical condition or your treatment. If you have
any questions about RECTIV, ask your healthcare provider.
What is RECTIV?
RECTIV is a prescription medicine used to treat moderate to severe pain caused by chronic anal
fissures. An anal fissure is a tear in the skin lining the anal canal.
RECTIV is not suitable for children and adolescents under the age of 18 years because it has not
been assessed in people in this age group. Who should not use RECTIV?
Do not use RECTIV if you:
are taking a medicine for erectile dysfunction (male impotence), for example Viagra
(sildenafil), Cialis (tadalafil) or Levitra (vardenafil).
have been told by your doctor that you have severe anemia (low numbers of red blood cells
have increased intracranial pressure or high pressure within your skull e.g. following head
are allergic to any of the ingredients in RECTIV or if you have had allergic reactions to
similar medicines in the past. See the end of this leaflet for a list of ingredients in RECTIV.
What should I tell my healthcare provider before using RECTIV?
Tell your healthcare provider about all your medical conditions, including if you:
have low blood pressure have recently had a heart attack have heart or blood vessel disorders suffer from migraine or recurrent headaches are pregnant or plan to become pregnant. It is not known if RECTIV will harm your unborn
are breast-feeding or plan to breast-feed. It is not known if the components of RECTIV will
RECTIV may lower your blood pressure. When getting up from a lying or sitting position, you
should get up slowly, otherwise you might feel faint.
Tell your healthcare provider about all the medicines you take
, including prescription and non-
prescription medicines, vitamins and herbal supplements. Other medicines may affect how RECTIV
works. RECTIV may also affect how other medicines work.
Specifically, tell your doctor if you are taking any of the following:
other nitroglycerin containing products a medicine for erectile dysfunction (male impotence), for example sildenafil, tadalafil or
vardenafil (see the section above ‘Who should not use RECTIV’)
medicines used to treat high blood pressure are taking aspirin, ergotamine (used to treat migraine) or are receiving tissue-type
plasminogen activator (used to help dissolve blood clots formed in blood vessels in the heart, lungs and brain)
are to be given heparin. If so, close monitoring of your blood will be required as your dose
of heparin may need to be altered. Please discuss with your doctor before stopping RECTIV.
How should RECTIV be used?
Use RECTIV exactly as prescribed
. See detailed Patient Instructions for Applying RECTIV at the
end of this Patient Information leaflet.
Treatment may be continued for up to 3 weeks. If your anal pain does not get better after using
RECTIV you should talk to your doctor. What should I avoid while using RECTIV?
Do not drive or operate machinery immediately after applying RECTIV. If you feel dizzy or light-
headed after applying the ointment do not drive or operate machinery until the dizziness has stopped.
Avoid consuming alcohol while you are being treated with RECTIV as your blood pressure is more
likely to be affected if you consume alcoholic beverages.
What are the possible side effects of RECTIV?
RECTIV can cause serious side-effects: Stop using the ointment and seek medical attention immediately if you have an allergic reaction. You may have swelling of the face, lips, tongue or throat, or difficulty breathing. Common side-effects of RECTIV are:
Headaches, which can be severe. You could take painkillers for this (such as acetaminophen). If
the headaches are unpleasant, you may need to ask your doctor whether you should stop using RECTIV.
Dizziness, faintness on standing, or light-headedness
These are not all the possible side effects of RECTIV. Tell your healthcare provider if you have any
side effect that bothers you or that does not go away. For more information, ask your healthcare
provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-
How should I store RECTIV?
Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP
Keep the tube tightly closed. Use within 8 weeks of first opening.
Keep RECTIV out of the reach of children.
Do not use RECTIV after the expiry date which is stated on the label and carton after ‘EXP.’ The
expiry date refers to the last day of that month.
General information about RECTIV
Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information
leaflets. Do not use RECTIV for a condition for which it is not prescribed. Do not give RECTIV to
other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about RECTIV. If you
would like more information, talk to your healthcare provider. You can ask your pharmacist or
healthcare provider for information about RECTIV that is written for health professionals.
For more information call 1-800-472-2634 or visit www.RECTIV.com. Patient Instructions for Use
When do I apply the ointment?
Apply the ointment every 12 hours exactly as your doctor has told you to.
How do I apply the ointment?
Cover your finger with plastic-wrap, a disposable surgical glove or a finger cot.
Lay the covered finger alongside the 1 inch dosing line marked on the side of the medicine box (see
figure below) so that the tip of your finger is at one end of the dosing line. Starting at the tip of the
finger, squeeze the ointment onto your finger for the same length marked on the box.
Refer to carton for accurate dosage guide.
Gently insert the finger with the ointment into the anal canal, up to the first finger joint. Carefully
smear the ointment around the inner sides of the anal canal. If this cannot be achieved due to pain,
application of the ointment should be made directly to the outside of the anus. What do I do after I have applied the ointment?
Throw away the finger covering in the garbage, out of the reach of children and pets. Wash your
What are the ingredients in RECTIV?
Active ingredient: nitroglycerin
Inactive ingredients: propylene glycol, lanolin, sorbitan sesquioleate, paraffin wax and white
PHARBIL Waltrop GmbH
Im Wirrigen 25
Aptalis Pharma US, Inc.
100 Somerset Corporate Boulevard
Bridgewater, NJ 08807
RECTIV® is a registered trademark of Aptalis Pharma US, Inc.
U.S. Patent No. 7,189,761 Revised: July 2013
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