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Thursday, October 20, 2016

Orphenadrine Citrate

Class: Skeletal Muscle Relaxants, Miscellaneous
VA Class: MS200
CAS Number: 341-69-5
Brands: Norflex, Norgesic

Introduction

Skeletal muscle relaxant; tertiary amine antimuscarinic.^a ^b ^c ^d ^k

Uses for Orphenadrine Citrate

Muscular Conditions

Used alone or in combination with aspirin and caffeine as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.^a ^b ^c ^k

For low back pain, generally reserve skeletal muscle relaxants for adjunctive treatment when pain is unresponsive to OTC analgesics (e.g., NSAIAs).^d ^e ^f ^g ^h ⁱ

Skeletal muscle relaxants less well tolerated than NSAIAs, and clinical superiority to NSAIAs not established for low back pain.^d ^e ^f ^g ^h ⁱ

Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief^j ^d and are more effective than placebo.^d ^f ^h

Initially, symptomatic control of acute low back pain focuses on providing sufficient comfort to allow maximum possible activity while awaiting spontaneous recovery; later, as an aid to overcome specific activity intolerance.^h

Because of rapid spontaneous recovery rate, efficacy of various therapies may be difficult to establish;^h improvement of low back pain usually occurs within 2 weeks, substantial improvement within 4 weeks.^g

Orphenadrine Citrate Dosage and Administration

Administration

Administer orally or by IV or IM injection.^a ^b ^c ^k

Switch from parenteral to oral therapy as soon as possible.^c

Oral Administration

Administer orphenadrine citrate extended-release tablets orally twice daily.^b ^c

Administer orphenadrine citrate fixed-combination tablets (with aspirin and caffeine) orally 3 or 4 times daily.^k

IV Administration

Place patient in supine position during and for 5–10 minutes following IV injection.^c (See CNS Effects under Cautions.) To minimize adverse reactions, assist patient from recumbent position.^c

Rate of Administration

Administer IV over about 5 minutes.^c

Dosage

Available as orphenadrine citrate; dosage expressed in terms of the salt.^a ^b

Adults

Muscular Conditions

Therapy with Extended-release Tablets

Oral

100 mg twice daily.^a ^b

Therapy with Orphenadrine Fixed-combination Tablets

Oral

25–50 mg (in combination with aspirin 385–770 mg and caffeine 30–60 mg) 3 or 4 times daily.^k

Parenteral Therapy

IV or IM

60 mg every 12 hours.^a ^b

Cautions for Orphenadrine Citrate

Contraindications

Glaucoma.^a ^b ^k

Pyloric or duodenal obstruction.^a ^b ^k

Stenosing peptic ulcers.^a ^b

Prostatic hypertrophy or obstruction of the bladder neck.^a ^b ^k

Cardiospasm (megaesophagus).^a ^b

Myasthenia gravis.^a ^b ^k

Known hypersensitivity to orphenadrine or any ingredient in the formulation.^a ^b ^k

Warnings/Precautions

Warnings

CNS Effects

Transient episodes of light-headedness, dizziness, or syncope reported.^a ^b ^k

Performance of activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) may be impaired.^a ^b ^k

Sensitivity Reactions

Sulfite Sensitivity

Injectable formulation contains sodium bisulfite, which can cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals.¹⁰⁰ ^a ^b

Overall prevalence of sulfite sensitivity in the general population unknown but probably low; such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.¹⁰⁰ ^a ^b

General Precautions

Adequate Patient Monitoring

Safety of continuous therapy not established.^a ^b ^k Perform periodic blood, urine, and liver function tests during prolonged orphenadrine therapy.^c ^k

Cardiac Effects

Possible tachycardia and palpitation; may be associated with increased dosages.^a ^b Use with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, or cardiac arrhythmias.^a ^b

Use of Fixed Combinations

When orphenadrine is used in fixed combination with aspirin and caffeine, consider the cautions, precautions, and contraindications associated with each agent in the combination.^k

Specific Populations

Pregnancy

Category C.^a ^b

Lactation

Not known whether orphenadrine is distributed into milk; use with caution.^c

Pediatric Use

Safety and efficacy not established in children <12 years of age.^c

Common Adverse Effects

Dry mouth,^a ^b ^d ^k tachycardia,^a ^b ^k palpitation,^a ^b ^k urinary hesitancy or retention,^a ^b ^k blurred vision,^a ^b ^k dilatation of pupils,^a ^b ^k increased intraocular pressure,^a ^b ^k weakness,^a ^b ^k nausea,^a ^b ^k vomiting,^a ^b ^k headache,^a ^b ^k diziness,^a ^b ^k constipation,^a ^b ^k drowsiness.^a ^b ^k

Interactions for Orphenadrine Citrate

Specific Drugs

Drug	Interaction	Comments
Propoxyphene	Potential additive CNS effects^a ^b ^c ^k	Reduce dosage and/or discontinue one or both agents if adverse CNS effects develop during concomitant therapy^a ^b ^c ^k

Orphenadrine Citrate Pharmacokinetics

Absorption

Bioavailability

Readily absorbed following oral administration.^c

Distribution

Extent

Distribution not fully characterized in humans.^c In animals, detected in all organs, especially those with greatest perfusion (e.g., lungs).^c

Orphenadrine may cross the placenta; not known whether distributed into milk.^c

Elimination

Metabolism

Almost completely metabolized to at least 8 metabolites; however, metabolic fate not fully determined.^c

Elimination Route

Eliminated principally in urine as metabolites and, in small amounts, as unchanged drug.^c

Half-life

Approximately 14 hours.^c

Stability

Storage

Oral

Tablets

15–30°C.^b ^c ^k

Parenteral

Injection

15–30°C.^a ^b ^c Do not freeze; protect from light.^c

ActionsActions

CNS depressant with skeletal muscle relaxant effects.^c

Precise mechanism of action not known.^a ^k Does not directly relax skeletal muscle;^a ^b ^c ^k therapeutic action may be related to analgesic properties.^a ^c ^k

May reduce skeletal muscle spasm, possibly through an atropine-like central action on cerebral motor centers or on the medulla.^c

Exhibits postganglionic anticholinergic,^a ^c antihistaminic^c , and local anesthetic properties.^c

Advice to Patients

Potential to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^a ^b ^k

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.^a ^b ^k

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a ^b ^k

Importance of informing patients of other important precautionary information.^a ^b ^k (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Orphenadrine Citrate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release	100 mg*	Norflex	3M
			Orphenadrine Citrate Tablets	Actavis, Global, Kiel, Sandoz
Parenteral	Injection	30 mg/mL*	Norflex (with sodium bisulfite)	3M
			Orphenadrine Citrate Injection	Akorn, Bedford, Watson

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Orphenadrine Citrate Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mg with Aspirin 385 mg and Caffeine 30 mg*	Norgesic (with povidone)	3M
			Orphenadrine Citrate, Aspirin, and Caffeine Tablets	Sandoz
		50 mg with Aspirin 770 mg and Caffeine 60 mg*	Norgesic Forte (with povidone; scored)	3M
			Orphenadrine Citrate, Aspirin, and Caffeine Tablets	Sandoz

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Orphenadrine Citrate CR 100MG 12-hr Tablets (GLOBAL PHARMACEUTICAL CORP): 30/$48.99 or 90/$141.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use; warning statements. [21 CFR Part 201] Fed Regist. 1986; 51:43900-5.

a. Hospira, Inc. Norflex (orphenadrine citrate) injection prescribing information. Lake Forest, IL; 2004 Jul.

b. 3M Pharmaceuticals. Norflex 9orphenadrine citrate) extended-release tablets and injection prescribing information. Northridge, CA; 2000 Jul.

c. AHFS drug information 2007. McEvoy GK, ed. Orphenadrine Citrate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1398-9.

d. van Tulder MW, Touray T, Furlan AD et al. Muscle relaxants for non-specific low back pain. Cochrane Database of Systematic Reviews. 2003, Issue 4. Art. No.: CD004252. DOIL 10.1002414651858. CD004252.

e. van Tulder MW, Scholten RJPM, Kowes BW, et al. Non-steroidal anti-inflammatory drugs for low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.

f. Department of Veterans Affairs Veterans Health Administration Office of Quality & Performance. Management of Person with Low Back Pain/Sciatica in Primary Care. From the web site (). Accessed 8/25/2003.

g. Agency for Healthcare Research and Quality. Adult low back pain. From the National Guideline Clearinghouse website. (). Accessed 8/25/2003.

h. U.S. Department of Health and Human Services. Public Health Service. Agency for Halath Care Policy and Research. Acute low back problems in adults. Clinical Practice Guideline.1994; No. 14

i. U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research. Acute low back problems in adults: Assessment and treatment. Clinical Practice Guideline. Quick Reference Guide for Clinicians.1994; No. 14

j. McNeil. Cyclobenzaprine hydrochloride (Flexeril) tablets prescribing information. Fort Washington, PA: 2003 Feb.

k. 3M Pharmaceuticals. Norgesic and Norgesic Forte tablets prescribing information. Northridge, CA; 1998 May.

More Orphenadrine Citrate resources

Orphenadrine Citrate Side Effects (in more detail)
Orphenadrine Citrate Use in Pregnancy & Breastfeeding
Drug Images
Orphenadrine Citrate Drug Interactions
Orphenadrine Citrate Support Group
8 Reviews for Orphenadrine Citrate - Add your own review/rating

Antiflex Advanced Consumer (Micromedex) - Includes Dosage Information

Norflex Prescribing Information (FDA)

Norflex Concise Consumer Information (Cerner Multum)

Norflex Advanced Consumer (Micromedex) - Includes Dosage Information

Norflex MedFacts Consumer Leaflet (Wolters Kluwer)

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Migraine
Muscle Spasm

Oral-B Minute Foam

Generic Name: sodium fluoride

Dosage Form: aerosol
Package.Label Principal Display Panel MINUTE-FOAM
Topical Fluoride Foaming Solution

(Acidulated Phosphate Fluoride Containing 1.23 % w/w Fluoride Ion)

FOR PROFESSIONAL USE ONLY

Active Ingredient:Acidulated Phosphate Fluoride (Sodium Fluoride and Hydrofluoric Acid) 1.23 % w/w fluoride ion.

DESCRIPTION:Oral-B Minute Foam is a flavored aqueous foaming solution of acidulated phosphate sodium fluoride with pH of 3.5 and a fluoride ion concentration of 1.23% w/w. Inactive Ingredients:Purified water, poloxamer 407, isobutane, poloxamer 234, phosphoric acid, sodium saccharin, flavor. CLINICAL PHARMACOLOGY: Acidulated Phosphate Fluoride inhibits caries formation by reducing enamel solubility and enhancing remineralization. INDICATION AND USE:A topically-applied foaming solution to aid in the prevention of dental caries. CONTRAINDICATIONS: Do not use in patients with hypersensitivity to fluoride.

Do not use in patients with dysphagia. WARNINGS: DO NOT SWALLOW

Accidental ingestion of the usual treatment dose (approx 12.4 mg of fluoride) is not harmful. In the event more than the treatment dose is swallowed, administer calcium (e.g. milk) and get medical or contact a Poison control Center right away. One bottle of Minute Foam contained 1.95 grams of fluoride ion which could be lethal for children adults.

Keep out of the reach of infants and children under 12 years.

Pediatric patients under age 12 should be supervised during use of this product.

Avoid spraying towards open flame.

Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures over 120 F (49 C).

PRECAUTIONS: FOR PROFESSIONAL USE ONLY

Laboratory studies have indicated that repeated use of Acidulated Phosphate Fluoride products may dull porcelain and composite restorations.

Safety and effectiveness below age 6 have not been established. There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential. Carcinogenesis, Mutagenesis, Impairment of Fertility:

No evidence of carcinogenicity was observed in female and male mice at doses ranging from 2.4 to 18.8 mg/kg sodium fluoride of body weight (3,4). Equivocal evidence of carcinogenicity was reported in male rats at doses ranging from 2.5 to 4.1 mg/kg fluoride, but no evidence of carcinogenicity was observed in female rates (3,4). In another study, no carcinogenicity was observed in rats treated with fluoride up to25 mg/kg of body weight (5). Overall, epidemiological studies do not show an association between fluoridated drinking water and increased cancer risks in humans (7).

Fluoride ion is not mutagenic in standard bacterial systems but has been associated with genetic aberrations in cultured human cells at doses much higher than expected for human exposure (6,8). Some in vivo studies report chromosomal aberrations in rodents while other studies using similar protocols report negative results (7).

Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse reproductive effects of fluoride have been reported in animal studies, but at high concentrations sufficient to produce other manifestations of toxicity (9). Pregnancy:Teratogenic Effects: Pregnancy Category B. Fluoride readily crosses the placenta (7,9). Animal studies (rats and rabbits) have shown that fluoride is not a teratogen (10,12,13). Maternal exposure to 18 mg Fluoride/kg of body weight did not affect maternal body weight, litter size or fetal weight and did not increase frequency of skeletal or visceral malformations (10). There are no adequate and well-controlled studies in pregnant women. Several epidemiological studies show no increase in birth defects in areas with fluoridated water compared to areas with low fluoridated water (7). However, caution should be exercised when fluoride is administered to pregnant women. Nursing Mothers: Due to the relative insensitivity of human milk fluoride levels to changes in maternal fluoride intake, and due to the low concentrations of fluoride in human milk, fluoride supplementation during lactation would not be expected to significantly affect fluoride intake by the nursing infant (11). However, caution should be exercised when fluoride is administered to nursing women. Pediatric Use: The use of fluoride solutions, gels, and foams containing up to 1.23 % fluoride ion as caries preventives in pediatric patients aged 6 to 16 years is supported by clinical studies in students aged 6 to 12 years (1,2). Safety and effectiveness in pediatric patients below the age of 6 years has not been established. Please refer to CONTRAINDICATIONS and WARNINGS sections. Geriatric Use: No overall differences in safety or effectiveness have been observed between geriatric and younger patients. This drug is known to be substantially excreted by the kidney, therefore the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ADVERSE REACTIONS: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache and weakness OVERDOSAGE: Accidental ingestion of large amounts of fluoride can result in acute irritation of the mouth and gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis epigastric cramping and abdominal pain. If large amounts of fluoride equal to or greater than 5mg fluoride/kg body weight (or 2.3 mg fluoride/lb body weight) are ingested, give calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) orally to relieve gastrointestinal symptoms and admit immediately to a hospital facility.

A standard treatment dose of Minute-Foam contains approximately 12.4 mg fluoride. One 165 g (5.8oz) bottle contains approximately 1.95 g of fluoride. DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over: Use foam 2 times a year.

This initial time you dispense from a new bottle, gently lift upward on the nozzle to break the protective seal (thin plastic located adjacent to trigger). If this seal is broken do not use the product.

Shake bottle vigorously for 3-4 seconds prior to dispensing.

Invert bottle 180 degree with nozzle tip pointed downward into tray.

Place nozzle tip close to the tray floor and at one end of the tray arch. Moving from one end of the tray to the other in one fluid motion, slowly press down on the trigger.

Dispense foam into applicator tray. (Note: foam will expand slightly to fill the tray.)

Immediately place trays in mouth. (Do not fill trays with foam too far in advance of treatment as the foam will collapse and not be as effective.)

Have patient bite down on the trays lightly but firmly for 4 minutes.

Remove trays and have patient expectorate excess.

Instruct patient not to eat, drink, or rinse for at least 30 minutes.

For optimal tooth coverage, use a fluoride applicator tray which is deep enough to reach the entire vertical height of all teeth (even the molars)

HOW SUPPLIED: Minute-Foam is available in a 165 g (5.8 oz) plastic aerosol container in six different flavors; NDC 0041-0340-06 Banana Splitz, NDC 0041-03141-06 Mellow Mint, NDC 0041-0342-06 Orang-a-Tangy, NDC 0041-0345-06 Bubblegum, NDC 0041-0346-06 Strawberry, NDC 0041-0347-06 Grape Punch.

REFERENCES:

(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, H et al.:J. Dent, 33, 469-473 (2005) (3.) National Toxicology Program: NTP TR 393, NIH Publication 91-2842, (1990) (4.) Bucker, J.R et al.L Int. J. Cancer 48, 1118-1126 (1990) (6.) Martin, G.R. et al.: Mutat. Res. 66, 159-167 (1979) (7.) Agency for toxic Substances and Disease Registry: Toxicological Profile for Fluorides (2003) (8.) Aardema, M.J. et al.: Mutat. Res. 331 (1), 171-172 (9.) National Research Council: Fluoride in Drinking Water (2006) (10.) Heindel, J.J. et al.: Fundam Appl Toxicol, 30, 162-177 (1996) (11.) Institute of Medicine, Food and Nutrition Board: Dietary Reference Intakes (1997) (12.) Collins, T.F et al.: Food Chem. Toxicol. 33 (11), 951-960 (13.) Collins, T.F. et al.: Food Chem Toxicol. 39 (8), 867-876

Minute Foam Label

ORAL-B MINUTE-FOAM STRAWBERRY
acidulated phosphate fluoride aerosol

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0041-0346
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (Fluoride ion)	Fluoride ion	10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (Strawberry Flavor)	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0041-0346-06	165 g In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/04/2000

Labeler - Oral-B Laboratories (183102243)

Revised: 09/2010Oral-B Laboratories

More Oral-B Minute Foam resources

Oral-B Minute Foam Use in Pregnancy & Breastfeeding
Oral-B Minute Foam Support Group
3 Reviews for Oral-B Minute - Add your own review/rating

Compare Oral-B Minute Foam with other medications

Prevention of Dental Caries

Oral Pain Relief

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Oral Pain Relief (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Oral Pain Relief (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Oral Pain Relief (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

asthma, bronchitis, emphysema, or other breathing disorder;

heart disease;

a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

if you smoke.

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Oral Pain Relief (benzocaine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Oral Pain Relief (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Oral Pain Relief (benzocaine topical) side effects

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

headache, tired feeling, confusion;

fast heart rate;

feeling light-headed or short of breath; and

pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzocaine topical and call your doctor at once if you have any of these other serious side effects:

headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

severe burning, stinging, or sensitivity where the medicine is applied;

swelling, warmth, or redness; or

oozing, blistering, or any signs of infection.

Less serious side effects may include:

mild stinging, burning, or itching where the medicine is applied;

skin tenderness or redness; or

dry white flakes where the medicine was applied.

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 other drugs will affect Oral Pain Relief (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Oral Pain Relief resources

Oral Pain Relief Use in Pregnancy & Breastfeeding
Oral Pain Relief Support Group
6 Reviews for Oral Pain Relief - Add your own review/rating

Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information

Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information

Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

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Anal Itching
Anesthesia
Aphthous Ulcer
Burns, External
Cold Sores
Hemorrhoids
Oral and Dental Conditions
Pain
Pruritus
Sunburn
Tonsillitis/Pharyngitis

Where can I get more information?

Your pharmacist can provide more information about benzocaine topical.

Orapred ODT

Pronunciation: pred-NIS-oh-lone
Generic Name: Prednisolone Sodium Phosphate
Brand Name: Orapred ODT

Orapred ODT is used for:

Treating severe inflammatory conditions including allergies, arthritis, asthma, or skin reactions. It may also be used to treat certain blood, adrenal gland, eye, respiratory, or bowel conditions. It may also be used for other conditions as determined by your doctor.

Orapred ODT is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation.

Do NOT use Orapred ODT if:

you are allergic to any ingredient in Orapred ODT

you have a systemic fungal infection, a malaria infection of the brain, inflammation of the optic nerve, or a herpes infection of the eye

you are scheduled to have a live or attenuated live vaccination (eg, smallpox)

you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Orapred ODT:

Some medical conditions may interact with Orapred ODT. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of heart problems (eg, congestive heart failure), heart attack, high blood pressure, kidney problems, liver problems (eg, cirrhosis), diabetes, seizures, an underactive or overactive thyroid, adrenal gland problems, or any mental or mood problems (eg, depression, psychosis)

if you have or have recently had a fungal or bacterial infection, viral infection (eg, chickenpox, measles, shingles), yeast infection, threadworm infection, or any other type of infection

if you have a herpes infection of the eye or increased pressure in the eye

if you have HIV infection or tuberculosis (TB) infection, or if you have had ever had a positive TB skin test

if you have any stomach problems (eg, ulcers), bowel problems (eg, blockage, perforation, or infection; diverticulitis; ulcerative colitis), recent intestinal surgery, or inflammation of the esophagus

if you are postmenopausal or have weak bones (eg, osteoporosis) or muscle problems (eg, myasthenia gravis)

if you have had a recent vaccination (eg, smallpox)

if you have unexplained diarrhea or have recently traveled out of the country (eg, tropical areas)

if you have low blood calcium or potassium levels or are experiencing stress (eg, illness, surgery)

Some MEDICINES MAY INTERACT with Orapred ODT. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, ephedrine, hydantoins (eg, phenytoin), or rifampin because they may decrease Orapred ODT's effectiveness

Certain anticholinesterases (eg, neostigmine) because severe muscle weakness in patients who have myasthenia gravis could occur

Clarithromycin, cyclosporine, estrogens (eg, estradiol), oral contraceptives (eg, birth control pills), or pancuronium because they may increase the risk of Orapred ODT's side effects

Amphotericin B, anticholinesterases (eg, pyridostigmine), digitalis glycosides (eg, digoxin), diuretics, (eg, hydrochlorothiazide), furosemide, live or attenuated live vaccines, methotrexate, mifepristone, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), ritodrine, or salicylates (eg, aspirin) because the risk of their side effects may be increased by Orapred ODT

Anticoagulants (eg, warfarin) or killed or inactivated vaccines because their effectiveness may be decreased by Orapred ODT

This may not be a complete list of all interactions that may occur. Ask your health care provider if Orapred ODT may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Orapred ODT:

Use Orapred ODT as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Orapred ODT by mouth with food.

Swallow Orapred ODT whole. Do not break, crush, or chew before swallowing. Do not use partial tablets.

Do not remove the blister from the outer pouch until you are ready to take Orapred ODT. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. The medicine may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.

If you miss a dose of Orapred ODT, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Orapred ODT.

Important safety information:

Orapred ODT may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

Orapred ODT may interfere with skin allergy tests. If you are scheduled for a skin test, talk to you doctor. You may need to stop taking Orapred ODT for a few days before the tests.

Do not receive a live vaccine (eg, measles, mumps) while you are taking Orapred ODT. Talk with your doctor before you receive any vaccine.

Tell your doctor or dentist that you take Orapred ODT before you receive any medical or dental care, emergency care, or surgery.

Orapred ODT is a corticosteroid. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Diabetes patients - Orapred ODT may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests, including adrenal function tests, may be performed while you use Orapred ODT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Orapred ODT with caution in the ELDERLY; they may be more sensitive to its effects, especially an increased risk of bone weakness or fracture.

Caution is advised when using Orapred ODT in CHILDREN; they may be more sensitive to its effects.

Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Orapred ODT.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Orapred ODT while you are pregnant. Orapred ODT is found in breast milk. If you are or will be breast-feeding while you use Orapred ODT, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Orapred ODT suddenly, you may have WITHDRAWAL symptoms. These may include fever, vomiting, appetite loss, diarrhea, nausea, dizziness, weight loss, weakness, general body discomfort, or joint or muscle pain.

Possible side effects of Orapred ODT:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; facial flushing; headache; increased appetite; increased sweating; lightheadedness; nausea; nervousness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual period; changes in skin color; depression; fever, chills, or sore throat; lesions in the mouth or throat; mental or mood changes; muscle pain or weakness; seizures; severe nausea or vomiting; severe stomach or back pain; sudden severe dizziness or headache; swelling of the ankles, feet, or hands; tendon or bone pain; thinning of skin; trouble sleeping; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Orapred ODT side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Orapred ODT:

Store Orapred ODT at room temperature, between 68 and 77 degrees F (20 to 25 degrees C). Store in the original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Orapred ODT out of the reach of children and away from pets.

General information:

If you have any questions about Orapred ODT, please talk with your doctor, pharmacist, or other health care provider.

Orapred ODT is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Orapred ODT. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Orapred ODT resources

Orapred ODT Side Effects (in more detail)
Orapred ODT Use in Pregnancy & Breastfeeding
Orapred ODT Drug Interactions
Orapred ODT Support Group
0 Reviews for Orapred ODT - Add your own review/rating

Orapred ODT Prescribing Information (FDA)

Orapred ODT Advanced Consumer (Micromedex) - Includes Dosage Information

Flo-Pred Consumer Overview

Flo-Pred Prescribing Information (FDA)

Millipred Prescribing Information (FDA)

Orapred Prescribing Information (FDA)

Orapred Consumer Overview

Prednisolone tablets Prescribing Information (FDA)

Prednisolone Professional Patient Advice (Wolters Kluwer)

Prednisolone Monograph (AHFS DI)

Prednisolone Acetate eent Monograph (AHFS DI)

Veripred 20 Prescribing Information (FDA)

Compare Orapred ODT with other medications

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Oramorph SR Sustained-Release Tablets

Pronunciation: MOR-feen
Generic Name: Morphine
Brand Name: Examples include MS Contin and Oramorph SR

Oramorph SR Sustained-Release Tablets are a narcotic pain reliever used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain.

Oramorph SR Sustained-Release Tablets should only be used by patients who have already been taking a narcotic pain medicine and are tolerant to its effects. Use of Oramorph SR Sustained-Release Tablets by people who are not used to taking narcotic pain medicines may cause severe and sometimes fatal breathing problems.

Swallow Oramorph SR Sustained-Release Tablets whole. Do NOT break, crush, chew, dissolve, or split Oramorph SR Sustained-Release Tablets. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal.

Oramorph SR Sustained-Release Tablets are used for:

Treating moderate to severe pain when around-the-clock pain medicine is needed for more than a few days. Oramorph SR Sustained-Release Tablets should only be used by patients who have already been taking a narcotic pain medicine and are tolerant to its effects.

Oramorph SR Sustained-Release Tablets are a narcotic pain reliever. It works in the brain and nervous system to reduce pain.

Do NOT use Oramorph SR Sustained-Release Tablets if:

you are allergic to any ingredient in Oramorph SR Sustained-Release Tablets

you have known or suspected bowel blockage (eg, paralytic ileus)

you have severe or persistent diarrhea associated with antibiotic use (pseudomembranous colitis)

you have slow or difficult breathing, severe asthma, severe hypercarbia or hypercapnia (high blood levels of carbon dioxide), or you are having an asthma attack

you are taking sodium oxybate (GHB) or you drink alcohol

you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken one within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Oramorph SR Sustained-Release Tablets:

Some medical conditions may interact with Oramorph SR Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, especially other narcotic pain relievers (eg, codeine, hydromorphone); foods; or other substances

if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems

if you have increased pressure in the head, a recent head injury, or growths in the brain (eg, tumors, lesions)

if you have a history of adrenal gland problems (eg, Addison disease), curvature of the spine, heart problems (eg, cor pulmonale), stomach or bowel problems (eg, constipation, blockage, inflammation), kidney or liver problems, gallbladder or pancreas problems, prostate problems, seizures, thyroid problems, trouble urinating, hypoxia (not enough oxygen in your body), hypercapnia or hypercarbia, or if you are unable to swallow

if you have severe drowsiness; low blood volume; stomach pain; very poor health; have had stomach or intestinal surgery; you are in shock caused by heart problems, blood vessel problems, or severe bleeding; or if you are very overweight

if you will be having surgery or you are currently having alcohol withdrawal

if you have a history of mood or mental problems (eg, depression), hallucinations, suicidal thoughts or behavior, or alcohol or other substance abuse or dependence

Some MEDICINES MAY INTERACT with Oramorph SR Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Mixed narcotic agonists/antagonists (eg, buprenorphine, butorphanol, pentazocine) or naltrexone because they may decrease Oramorph SR Sustained-Release Tablets's effectiveness and withdrawal symptoms may occur

Cimetidine, ketorolac, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as severe drowsiness, slow or difficult breathing, confusion, and seizures, may be increased

Fluoxetine, rifamycins (eg, rifampin), or risperidone because they may decrease Oramorph SR Sustained-Release Tablets's effectiveness

Anticholinergics (eg, scopolamine, oxybutynin), antihistamines (eg, diphenhydramine), antinausea medicines (eg, ondansetron), benzodiazepines (eg, lorazepam), MAOIs (eg, phenelzine), other narcotic pain medicines (eg, hydrocodone) phenothiazines (eg, chlorpromazine), quinidine, sleep medicines (eg, zolpidem), sodium oxybate (GHB) because they may increase the risk of Oramorph SR Sustained-Release Tablets's side effects

Skeletal muscle relaxants (eg, cyclobenzaprine) because the risk of their side effects may be increased

Mexiletine or trovafloxacin because their effectiveness may be decreased by Oramorph SR Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oramorph SR Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Oramorph SR Sustained-Release Tablets:

Use Oramorph SR Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Oramorph SR Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Swallow Oramorph SR Sustained-Release Tablets whole. Do not break, crush, chew, dissolve, or split before swallowing.

Take Oramorph SR Sustained-Release Tablets on a regular schedule to get the most benefit from it.

If Oramorph SR Sustained-Release Tablets are no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Oramorph SR Sustained-Release Tablets properly.

If you miss a dose of Oramorph SR Sustained-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Oramorph SR Sustained-Release Tablets.

Important safety information:

Oramorph SR Sustained-Release Tablets may cause dizziness, drowsiness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Oramorph SR Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol while you are taking Oramorph SR Sustained-Release Tablets.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Oramorph SR Sustained-Release Tablets; they may add to Oramorph SR Sustained-Release Tabletss effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Oramorph SR Sustained-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Oramorph SR Sustained-Release Tablets may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using fiber laxatives or stool softeners to prevent or treat constipation while you take Oramorph SR Sustained-Release Tablets.

The risk of Oramorph SR Sustained-Release Tablets becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the prescribed dose or use for longer than prescribed without checking with your doctor. Do NOT change your dose or use more often than prescribed without checking with your doctor.

Do NOT suddenly stop taking Oramorph SR Sustained-Release Tablets without checking with your doctor. If you have been taking Oramorph SR Sustained-Release Tablets for more than a few weeks and your doctor tells you to stop taking it, your dose may need to be gradually lowered as directed by your doctor to avoid side effects.

Tell your doctor or dentist that you take Oramorph SR Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

You may notice the tablet shell in your stool after taking Oramorph SR Sustained-Release Tablets. This is normal and not a cause for concern.

Lab tests, including liver, kidney, or lung function and complete blood cell counts, may be performed while you use Oramorph SR Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Oramorph SR Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially severe drowsiness, or slow or shallow breathing.

Oramorph SR Sustained-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Oramorph SR Sustained-Release Tablets while you are pregnant. Oramorph SR Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Oramorph SR Sustained-Release Tablets.

When used for long periods of time or at high doses, Oramorph SR Sustained-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Oramorph SR Sustained-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Oramorph SR Sustained-Release Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

Do not suddenly stop taking Oramorph SR Sustained-Release Tablets. If you do, you may experience WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Oramorph SR Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; restless mood; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); confusion; disorientation; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes (eg, agitation, exaggerated sense of well-being); seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, or headache; shortness of breath; slow or shallow breathing; sudden chest pain; swelling of the hands, ankles, or feet; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

See also: Oramorph SR side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; confusion; decreased muscle tone; decreased pupil size; loss of consciousness; low body temperature; seizures; severe dizziness, drowsiness, or lightheadedness; severe muscle pain or weakness; shortness of breath; slow heartbeat; slow or shallow breathing.

Proper storage of Oramorph SR Sustained-Release Tablets:

Store Oramorph SR Sustained-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oramorph SR Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Oramorph SR Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Oramorph SR Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Oramorph SR Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Oramorph SR resources

Oramorph SR Side Effects (in more detail)
Oramorph SR Use in Pregnancy & Breastfeeding
Drug Images
Oramorph SR Drug Interactions
Oramorph SR Support Group
3 Reviews for Oramorph SR - Add your own review/rating

Compare Oramorph SR with other medications

Pain

Orajel Maximum Strength

What is Orajel Maximum Strength (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Orajel Maximum Strength (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

What should I discuss with my health care provider before using Orajel Maximum Strength (benzocaine topical)?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

asthma, bronchitis, emphysema, or other breathing disorder;

heart disease;

a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

if you smoke.

How should I use Orajel Maximum Strength (benzocaine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Orajel Maximum Strength (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Orajel Maximum Strength (benzocaine topical) side effects

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

headache, tired feeling, confusion;

fast heart rate;

feeling light-headed or short of breath; and

pale, blue, or gray appearance of your skin, lips, or fingernails.

headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

severe burning, stinging, or sensitivity where the medicine is applied;

swelling, warmth, or redness; or

oozing, blistering, or any signs of infection.

Less serious side effects may include:

mild stinging, burning, or itching where the medicine is applied;

skin tenderness or redness; or

dry white flakes where the medicine was applied.

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 other drugs will affect Orajel Maximum Strength (benzocaine topical)?

More Orajel Maximum Strength resources

Orajel Maximum Strength Side Effects (in more detail)
Orajel Maximum Strength Use in Pregnancy & Breastfeeding
Orajel Maximum Strength Support Group
0 Reviews for Orajel Maximum Strength - Add your own review/rating

Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information

Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information

Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Orajel Maximum Strength with other medications

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Where can I get more information?

Your pharmacist can provide more information about benzocaine topical.

See also: Orajel Maximum Strength side effects (in more detail)