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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- PROFENAL Ophthalmic Solution is indicated for inhibition of intraoperative miosis.
- On the day of surgery, instill two drops into the conjunctival sac at three, two and one hour prior to surgery. Two drops may be instilled into the conjunctival sac every four hours, while awake, the day preceding surgery.
Off-Label Use and Dosage (Adult)
There is limited information regarding Off-Label Guideline-Supported Use of Suprofen in adult patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Suprofen in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Suprofen in pediatric patients.
Off-Label Use and Dosage (Pediatric)
There is limited information regarding Off-Label Guideline-Supported Use of Suprofen in pediatric patients.
There is limited information regarding Off-Label Non–Guideline-Supported Use of Suprofen in pediatric patients.
- PROFENAL is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis) and in individuals hypersensitive to any component of the medication.
- The potential exists for cross sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
- With nonsteroidal anti-inflammatory drugs, the potential exists for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding tendency of ocular tissues in conjunction with ocular surgery.
- Use of oral suprofen has been associated with a syndrome of acute flank pain and generally reversible renal insufficiency, which may present as acute uric acid nephropathy. This syndrome occurs in approximately 1 in 3500 patients and has been reported with as few as one to two doses of a 200 mg capsule. If PROFENAL 1% Ophthalmic Solution is applied as two drops (1 mg suprofen) to one eye five times on the day prior to surgery and three times on the day of surgery, the total applied dose over the two days would be about 25 times less than a single 200 mg oral dose. Do not touch dropper tip to any surface, as this may contaminate the solution.
Clinical Trials Experience
- The most frequent adverse reactions reported are burning and stinging of short duration. Instances of discomfort, itching and redness have been reported. Other reactions occurring in less than 0.5% of patients include allergy, iritis, pain, chemosis, photophobia, irritation, and punctate epithelial staining.
- Systemic reactions related to therapy were not reported in the clinical studies. It is known that some systemic absorption does occur with ocularly applied drugs, and that nonsteroidal anti-inflammatory drugs have been shown to increase bleeding time by interference with thrombocyte aggregation. It is recommended that PROFENAL be used with caution in patients with bleeding tendencies and those taking anticoagulants.
There is limited information regarding Postmarketing Experience of Suprofen in the drug label.
- Clinical studies with acetylcholine chloride revealed no interference, and there is no known pharmacological basis for such an interaction. However, with other topical nonsteroidal anti-inflammatory products, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with these agents.
- Interaction of PROFENAL with other topical ophthalmic medications has not been fully investigated.
Use in Specific Populations
- Pregnancy Category C
- Reproductive studies have been performed in rabbits at doses up to 200 mg/kg/day and in rats at doses up to 80 mg/kg/day. In rats, doses of 40 mg/kg/day and above, and in rabbits, doses of 80 mg/kg/day and above, resulted in an increased incidence of fetal resorption associated with maternal toxicity. There was an increase in stillbirths and a decrease in postnatal survival in pregnant rats treated with suprofen at 2.5 mg/kg/day and above. An increased incidence of delayed parturition occurred in rats. As there are no adequate and well-controlled studies in pregnant women, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effect of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided.
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Suprofen in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Suprofen during labor and delivery.
- Suprofen is excreted in human milk after a single oral dose. Based on measurements of plasma and milk levels in women taking oral suprofen, the milk concentration is about 1% of the plasma level. Because systemic absorption may occur from topical ocular administration, a decision should be considered to discontinue nursing while receiving PROFENAL®, since the safety of suprofen in human neonates has not been established.
- Safety and effectiveness in pediatric patients have not been established.
There is no FDA guidance on the use of Suprofen with respect to geriatric patients.
There is no FDA guidance on the use of Suprofen with respect to specific gender populations.
There is no FDA guidance on the use of Suprofen with respect to specific racial populations.
There is no FDA guidance on the use of Suprofen in patients with renal impairment.
There is no FDA guidance on the use of Suprofen in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Suprofen in women of reproductive potentials and males.
There is no FDA guidance one the use of Suprofen in patients who are immunocompromised.
Administration and Monitoring
There is limited information regarding Monitoring of Suprofen in the drug label.
There is limited information regarding IV Compatibility of Suprofen in the drug label.
- Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
There is limited information regarding Chronic Overdose of Suprofen in the drug label.
|Systematic (IUPAC) name|
|Mol. mass||260.309 g/mol|
|Routes||Oral, eye drops|
Mechanism of Action
- Suprofen is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclooxygenase enzyme that is essential in the biosynthesis of prostaglandins.
- PROFENAL® (suprofen) 1% ophthalmic solution is a topical nonsteroidal anti-inflammatory product for ophthalmic use. Suprofen chemically is α -methyl-4-(2-thienylcarbonyl)benzeneacetic acid, with an empirical formula of C14H12O3S, and a molecular weight of 260.3. The chemical structure of suprofen is:
- PROFENAL Sterile Ophthalmic Solution contains suprofen 1.0% (10 mg/mL), thimerosal 0.005% (0.05 mg/mL), caffeine 2% (20 mg/mL), edetate disodium, dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH to 7.4) and purified water.
- Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
- Prostaglandins appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, PROFENAL has been shown to inhibit the miosis induced during the course of cataract surgery. PROFENAL could possibly interfere with the miotic effect of intraoperatively administered acetylcholine chloride.
There is limited information regarding Pharmacokinetics of Suprofen in the drug label.
- In an 18-month study in mice, an increased incidence of benign hepatomas occurred in females at a dose of 40 mg/kg/day. Male mice, treated at doses of 2, 5, 10 and 40 mg/kg/day, also had an increased incidence of hepatomas when compared to control animals. No evidence of carcinogenicity was found in long term studies in doses as high as 40 mg/kg/day in the rat and mouse. Based on a battery of mutagenicity tests (Ames, micronucleus, and dominant lethal), suprofen does not appear to have mutagenic potential. Reproductive studies in rats at a dose of up to 40 mg/kg/day revealed no impairment of fertility and only slight reductions of fertility at doses of 80 mg/kg/day. However, testicular atrophy/hypoplasia was observed in a six-month dog study (at 80 mg/kg/day) and a 12-month rat study (at 40 mg/kg/day).
There is limited information regarding Clinical Studies of Suprofen in the drug label.
- Sterile ophthalmic solution, 2.5 mL in plastic DROP-TAINER® dispensers.
- 2.5 mL NDC 0065-0348-25
- Store at room temperature.
There is limited information regarding Suprofen Storage in the drug label.
|This pill image is provided by the National Library of Medicine's PillBox.|
Package and Label Display Panel
|This image of the FDA label is provided by the National Library of Medicine.|
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Suprofen in the drug label.
Precautions with Alcohol
- Alcohol-Suprofen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Look-Alike Drug Names
There is limited information regarding Suprofen Look-Alike Drug Names in the drug label.
The contents of this FDA label are provided by the National Library of Medicine.