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Thursday 27 September 2012

Zeel

Zeel 2.0 ml Injection

Zeel Description

Injection Solution Ingredient Information: Each 2.0 ml ampule contains: Arnica Montana, radix 4X 200 mcl, Rhus toxicodendron 2X 10 mcl, Dulcamara 3X 10 mcl, Symphytum officinale 6X 10 mcl, Sulphur 6X 3.6 mcl, Sanguinaria Canadensis 4X 3 mcl, Cartilago suis 6X 2 mcl, Embryo suis 6X 2 mcl, Funiculus umbillicalis suis 6X 2 mcl, Placenta suis 6X 2 mcl, α-Lipoicum acidum 8X 2 mcl, Coenzyme A 8X 2 mcl, Nadidum 8X 2 mcl, Natrum oxalaceticum 8X 2 mcl. Inactive ingredient: Sterile isotonic sodium chloride solution.

Indications and Usage for Zeel

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Zeel® Injection Solution is indicated for the temporary relief of mild to moderate arthritic pain, osteoarthritis and joint stiffness.

Zeel Dosage and Administration

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The dosage schedule listed below can be used as a general guide for the administration of Zeel® Injection Solution. Zeel® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response to therapy.

Adults and children 7 years and older: 1 ampule daily for acute disorders, or 1 ampule 1 to 3 times per week. Children ages 2 to 6 receive: ½ the adult dosage.

Discard unused solution.

Zeel® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Zeel® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Zeel® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Zeel® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Zeel® Injection Solution is a clear, colorless solution.

Discolored solutions should be discarded.

Warnings and Precautions

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Zeel® Injection Solution should not be administered for pain for more than 10 days for adults or five days for children. If new symptoms occur, or if redness, pain or swelling at the puncture site persists, the patient should be carefully re-evaluated because these could be signs of a more serious condition. Zeel® Injection Solution should not be administered to children for the pain of arthritis unless directed by a physician.

Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Overdosage

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Due to the low concentration of active ingredients in homeopathic preparations such as Zeel® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

Zeel - Clinical Pharmacology

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The exact mechanism of action of Zeel® Injection Solution is not fully understood. In-vitro data indicates that the ingredients in Zeel® Injection Solution may reduce pain, stiffness and inflammation in arthritic joints via immunomodulation. Hence, it has been shown that Zeel® Injection Solution inhibits activity of the leukocyte elastase. This enzyme is released during inflammatory reactions and attacks the articular cartilage which is rich in proteoglycans. A study of human whole blood cultures demonstrated that certain plant extracts contained in Zeel® Injection Solution (e.g. Rhus toxicodendron, Arnica montana) stimulates lymphocytes to release the transforming growth factor β. The protective effect of Zeel® Injection Solution upon cartilage has also been demonstrated by in-vitro and in-vivo studies. The clinical effectiveness and tolerance of Zeel® Injection Solution has also been demonstrated in a drug monitoring study.

PRINCIPAL DISPLAY PANEL

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Zeel_injectable box.jpg

Zeel
arnica montana and toxicodendron pubescens leaf and solanum dulcamara stem and symphytum tuberosum root and sulfur and sanguinaria canadensis root and sus scrofa cartilage and sus scrofa embryo and sus scrofa umbilical cord and sus scrofa placenta and alpha lipoic acid and coenzyme a and nadide and sodium diethyl oxalacetate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	52919-116
Route of Administration	INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (ARNICA MONTANA)	ARNICA MONTANA	4 [hp_X] in 2.0 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF)	TOXICODENDRON PUBESCENS LEAF	2 [hp_X] in 2.0 mL
SOLANUM DULCAMARA STEM (SOLANUM DULCAMARA STEM)	SOLANUM DULCAMARA STEM	3 [hp_X] in 2.0 mL
SYMPHYTUM TUBEROSUM ROOT (SYMPHYTUM TUBEROSUM ROOT)	SYMPHYTUM TUBEROSUM ROOT	6 [hp_X] in 2.0 mL
SULFUR (SULFUR)	SULFUR	6 [hp_X] in 2.0 mL
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT)	SANGUINARIA CANADENSIS ROOT	4 [hp_X] in 2.0 mL
SUS SCROFA CARTILAGE (SUS SCROFA CARTILAGE)	SUS SCROFA CARTILAGE	6 [hp_X] in 2.0 mL
SUS SCROFA EMBRYO (SUS SCROFA EMBRYO)	SUS SCROFA EMBRYO	6 [hp_X] in 2.0 mL
SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD)	SUS SCROFA UMBILICAL CORD	6 [hp_X] in 2.0 mL
SUS SCROFA PLACENTA (SUS SCROFA PLACENTA)	SUS SCROFA PLACENTA	6 [hp_X] in 2.0 mL
ALPHA LIPOIC ACID (ALPHA LIPOIC ACID)	ALPHA LIPOIC ACID	8 [hp_X] in 2.0 mL
COENZYME A (COENZYME A)	COENZYME A	8 [hp_X] in 2.0 mL
NADIDE (NADIDE)	NADIDE	8 [hp_X] in 2.0 mL
SODIUM DIETHYL OXALACETATE (SODIUM CATION)	SODIUM DIETHYL OXALACETATE	8 [hp_X] in 2.0 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	52919-116-10	2.0 mL In 1 AMPULE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/24/2011

Labeler - Hameln Pharma GmbH (315869123)

Revised: 01/2011Hameln Pharma GmbH

Wednesday 26 September 2012

Boots Pharmacy Anaesthetic Throat Spray

1. Name Of The Medicinal Product

Boots Anaesthetic Sore Throat Relief 2 % w/v Spray

2. Qualitative And Quantitative Composition

Active ingredient	%w/v
Lidocaine hydrochloride	2.0
(Lignocaine hydrochloride)

3. Pharmaceutical Form

Oromucosal spray

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of severe sore throats.

4.2 Posology And Method Of Administration

Adults and children over 12 years: Three sprays.

Aim nozzle at back of throat and spray on to the affected area. Repeat the dose every three hours as needed up to a maximum of six times in 24 hours.

Children under 12 years: Should not be given to children less than 12 years of age.

Elderly: There is no need for dose reduction in the elderly.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Patients suffering from asthma or bronchospasm. Children under 12 years.

4.4 Special Warnings And Precautions For Use

Do not use if you are sensitive to any of the ingredients.

Avoid contact with the eyes.

Children under 12 years of age should not be given this medicine.

Do not inhale whilst using the spray.

Do not exceed the stated dose.

Keep all medicines out of the reach of children.

Seek medical advice if symptoms persist or are accompanied by high fever, headache, nausea or vomiting.

Seek medical advice before using this product if you are pregnant, breastfeeding or receiving any medical treatment.

This product may cause numbness of the tongue and therefore care should be taken in eating and drinking hot foods.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions are known.

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established. Experimental animal studies are insufficient to assess the safety with respect to the development of the embryo or foetus, the course of gestation and peri- and post-natal development. The product is, therefore, not recommended during pregnancy and lactation except under medical supervision.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects are known.

4.8 Undesirable Effects

Occasional hypersensitivity reactions.

4.9 Overdose

Symptoms of overdose include yawning, restlessness, excitement, nervousness, dizziness, nystagmus, tinnitus, blurred vision, nausea, vomiting, muscle twitching, tremors and convulsions. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilatation, resulting in hypotension, arrhythmias and cardiac arrest. May also cause methaemoglobinaemia.

Treatment consists essentially of maintaining the circulation and respiration and controlling convulsions. The circulation may be maintained with infusions of plasma or suitable electrolyte solutions. Convulsions may be controlled by the intravenous administration of diazepam. If necessary, suxamethonium together with endotracheal intubation and artificial respiration may be used if convulsions persist. Methaemoglobinaemia may be treated by intravenous administration of 1-4 mg/kg methylene blue injection.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lidocaine is a local anaesthetic of the amide type.

5.2 Pharmacokinetic Properties

Lidocaine is readily absorbed from mucous membranes. The plasma elimination half-life is about two hours.

Lidocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol solution 70% (non-crystallising)

Levomenthol

Peppermint Flavour

Aniseed Flavour

Sodium Citrate

Saccharin

Alcohol 96%

Anstead 12401 Blue

Quinoline Yellow E104

Water Purified

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

A clear glass bottle fitted with metering valve spray pump with an extended polypropylene nozzle.

Pack size: 20, 30 millilitres.

6.6 Special Precautions For Disposal And Other Handling

On first use or after prolonged storage, spray 3 times away from the face into a sink.

Swing nozzle through 90° and spray on the back of the throat.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: Boots Pharmacy

Trading as: BCM

8. Marketing Authorisation Number(S)

PL 00014/0430

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 26 January 1996

Date of Last Renewal:

10. Date Of Revision Of The Text

October 2010

Prazosin Hydrochloride

Class: alpha-Adrenergic Blocking Agents
VA Class: CV150
CAS Number: 19237-84-4
Brands: Minipress

Introduction

Postsynaptic α₁-adrenergic blocking agent; quinazoline derivative.¹⁰¹ ^b

Uses for Prazosin Hydrochloride

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).¹⁰¹ ¹⁵³ ¹⁶¹

Current antihypertensive and urology guidelines (e.g., JNC 7) no longer recommend α₁-blockers as preferred first-line therapy for patients with hypertension.^b

Acute management of severe hypertension in patients with increased concentrations of circulating catecholamines.^b

Benign Prostatic Hyperplasia (BPH)

Has been used to reduce urinary obstruction and relieve associated manifestations in patients with symptomatic BPH†; efficacy relative to other α₁-adrenergic blockers remains to be established.¹¹² ¹¹³ ¹¹⁴ ¹¹⁵ ¹¹⁶ ¹¹⁷ ¹¹⁸ ¹¹⁹ ¹²⁰ ¹²¹ ¹²² ¹²³ ¹²⁴ ¹²⁵ ¹²⁶ ¹²⁷ ¹²⁸ ¹²⁹ ¹³⁰ ¹³¹ ¹³² ¹³³

Posttraumatic Stress Disorder (PTSD)

Has been used in the management of PTSD†, particularly in combat veterans and in patients experiencing nighttime PTSD symptoms (e.g., nightmares, sleep disturbances).²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹¹ ²¹² ²¹⁵ ²¹⁶ ²¹⁷ ²²¹ ²²² ²²⁵

Some clinicians currently recommend prazosin as first-line or alternative therapy when treating PTSD patients with prominent nighttime symptoms, particularly in combat veterans.²⁰¹ ²⁰⁴ ²¹² ²¹⁵ ²¹⁷ ²²² ²²⁵ Further studies necessary in civilians with noncombat trauma-related PTSD and in treatment of daytime PTSD symptoms.²⁰⁰ ²⁰¹ ²⁰³ ²⁰⁴ ²⁰⁸ ²¹⁶

Prazosin Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally in divided doses 2 or 3 times daily.¹⁰¹

Manufacturers make no specific recommendations regarding administration with meals.¹⁰¹ ²²¹

Dosage

Available as prazosin hydrochloride; dosage expressed in terms of prazosin.¹⁰¹ ^b

Individualize dosage according to patient response and tolerance.¹⁰¹ ^b Initiate at low dosage to minimize frequency of postural hypotension and syncope.¹⁰¹ ^b

Postural effects are most likely to occur 2–6 hours after a dose; monitor BP during this period after first dose and with any dosage increases.¹⁶¹ ¹⁷⁹

If therapy is interrupted for a few days, restart using initial dosage regimen.

Pediatric Patients

Hypertension†

Oral

Initially, 0.05–0.1 mg/kg daily given in 3 divided doses.¹⁹⁵ Increase dosage as necessary up to a maximum of 0.5 mg/kg daily given in 3 divided doses.¹⁹⁵

Adults

Hypertension

Monotherapy

Oral

Initially, 1 mg 2 or 3 times daily.¹⁰¹ ^b Do not initiate with higher dosages.¹⁰¹ ^b May increase dosage gradually to 20 mg daily given in divided doses.¹⁰¹ ^b

Usual maintenance dosage: 6–15 mg daily given in divided doses.¹⁰¹ ^b

Careful monitoring of BP is recommended during initial titration or subsequent upward dosage adjustment;¹⁶¹ avoid large or abrupt reductions in BP.¹⁶¹ ¹⁷⁹

For the acute management of severe hypertension, initially, 1–2 mg; dosage may be repeated after 1 hour, if necessary.^b

Combination Therapy

Oral

When other hypotensive agents or diuretics are added to existing prazosin therapy, reduce dosage to 1 or 2 mg 3 times daily; gradually increase according to patient's response and tolerance.¹⁰¹ ^b

Posttraumatic Stress Disorder†

Optimum dosage not established.²⁰⁰ ²⁰¹ ²¹² In clinical studies, usual initial dosage was 1 mg at bedtime; dosage was then gradually increased based on patient's response and tolerance.²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹¹ ²¹² ²¹⁷ ²²⁰ Maintenance dosages ranging from 1 to 25 mg daily (given once daily at bedtime or in 2 divided doses) have been use.²⁰⁰ ²⁰³ ²⁰⁶ ²¹⁰ ²¹² ²¹⁷ ²²⁰ ²²⁵ Some experts recommend a target maintenance dosage of 1–10 mg daily; others recommend a higher target dosage of 2–20 mg daily.²²⁴ ²²⁵

Prescribing Limits

Pediatric Patients

Hypertension†

Oral

Maximum 0.5 mg/kg daily.¹⁹⁵

Adults

Hypertension

Oral

Maximum 20 mg daily.¹⁰¹ ^b Although higher dosages usually do not increase efficacy, a few patients may benefit from ≤40 mg daily.¹⁰¹ ^b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.^b

Renal Impairment

Initially, 1 mg twice daily.^b Patients with chronic renal failure may require only small dosages.^b

Geriatric Patients

No specific dosage recommendations at this time;^b generally increase dosage more slowly in geriatric hypertensive patients than in younger adults.

Cautions for Prazosin Hydrochloride

Contraindications

Known hypersensitivity to prazosin, quinazolines (e.g., alfuzosin, doxazosin, terazosin), or any ingredient in the formulation.¹⁰¹

Warnings/Precautions

Warnings

Postural Hypotension

Like other α-adrenergic blocking agents, marked hypotension, especially in the upright position, can occur; may be accompanied by syncope, palpitations, and other postural effects (e.g., dizziness, lightheadedness, vertigo).¹⁰¹

Postural effects are most common after an initial dose, shortly after dosing (e.g., within 90 minutes), when dosage is rapidly increased, or when other antihypertensive agents are added to therapy.¹⁰¹ ^b

To decrease risk of excessive hypotension and syncope, initiate therapy at a low dosage (i.e., 1 mg) and titrate slowly; initiate concomitant antihypertensive agents with caution.¹⁰¹ ^b

If syncope or hypotension occurs, place patient in a recumbent position and institute supportive therapy as necessary.¹⁰¹ ^b

General Precautions

Intraoperative Floppy Iris Syndrome (IFIS)

IFIS observed during cataract surgery in some patients currently receiving or previously treated with α₁-adrenergic blocking agents.¹⁰¹ ²¹⁸

If patient has received α₁-blockers, ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, viscoelastic substances) to minimize complications of IFIS.¹⁰¹ ²¹⁸

Benefit of discontinuing α₁-blockers, including prazosin, prior to cataract surgery not established.¹⁰¹ ²¹⁸

Prostate Cancer

Exclude possibility of prostate cancer before initiation of therapy for BPH.¹⁵⁵ ¹⁵⁶

Specific Populations

Pregnancy

Category C.¹⁰¹

Lactation

Distributed into milk in small amounts.¹⁰¹ Caution if used in nursing women.¹⁰¹ ^b

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹⁰¹ ^b

Geriatric Use

Geriatric patients may be particularly susceptible to postural effects and other adverse effects.¹⁵³ ¹⁶¹

Common Adverse Effects

Dizziness, lightheadedness, headache, drowsiness, lack of energy, weakness, palpitation, nausea.¹⁰¹ ^b

Interactions for Prazosin Hydrochloride

Protein-bound Drugs

Potential pharmacokinetic interaction (displacement of prazosin or other protein-bound drug).^b

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Analgesic agents (aspirin, indomethacin, phenylbutazone [no longer commercially available in the US], propoxyphene)	No interaction observed¹⁰¹
Antiarrhythmic agents (procainamide, quinidine)	No interaction observed¹⁰¹
Antigout agents (allopurinol, colchicine, probenecid)	No interaction observed¹⁰¹
Antihypertensive agents (e.g., propranolol)	Possible additive hypotensive effects and symptomatic hypotension¹⁰¹	Initiate additional antihypertensive agents with caution; may reduce prazosin dosage and gradually increase dosage based on clinical response¹⁰¹
Benzodiazepines (chlordiazepoxide, diazepam)	No interaction observed¹⁰¹
Digoxin	No interaction observed¹⁰¹
Diuretics	Possible additive hypotensive effects and symptomatic hypotension¹⁰¹ ^b	Effect usually used to therapeutic advantage^b Initiate diuretics with caution; may reduce prazosin dosage and gradually increase dosage based on clinical response¹⁰¹
Hypoglycemic agents (insulin, chlorpropramide, phenformin [no longer commercially available in the US], tolazamide, tolbutamide)	No interaction observed¹⁰¹
Phenobarbital	No interaction observed¹⁰¹
Phosphodiesterase (PDE) type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)	Possible additive hypotensive effects and symptomatic hypotension¹⁰¹	Initiate PDE type 5 inhibitor at lowest possible dosage¹⁰¹
Test for pheochromocytoma	Possible increase in urinary metabolite of norepinephrine and VMA; false positive results may occur in pheochromocytoma screening tests¹⁰¹	If elevated VMA is observed, discontinue prazosin and repeat test after 1 month¹⁰¹

Prazosin Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations attained within about 2–3 hours.^b

Bioavailability is approximately 60%.^b

Onset

In patients with hypertension, maximum reduction in BP usually occurs 2–4 hours after administration.^b

Food

Food does not affect the extent of absorption; however, absorption may be delayed.^b

Distribution

Extent

Not known whether prazosin crosses the placenta;^b distributed into milk in small amounts.^b Crosses the blood-brain barrier.²⁰⁰ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁸ ²¹⁰

Plasma Protein Binding

Approximately 97%.^b

Elimination

Metabolism

Extensively metabolized, principally in the liver by demethylation and conjugation.¹⁰¹ ^b

Elimination Route

Excreted principally in feces via biliary excretion and to a lesser extent in urine (6–10%).¹⁰¹ ^b

Half-life

2–4 hours.^b

Stability

Storage

Oral

Capsules

20-25°C; protect from moisture and light.²²¹

ActionsActions

Reduces peripheral vascular resistance and BP as a result of vasodilating effects;¹⁰¹ ^b produces both arterial and venous dilation.¹⁰¹

Effects appear to result from selective, competitive inhibition of α₁-adrenergic receptors.^b

Generally causes no change in heart rate, cardiac output, renal blood flow, and GFR.¹⁰¹ ^b

Binds to α-adrenergic receptors on the prostate capsule, prostate adenoma, and bladder trigone, resulting in decreased urinary outflow resistance in men.

May improve to limited extent the serum lipid profile (e.g., small increases in HDL and HDL/total cholesterol ratio; small decreases in LDL, total cholesterol, and triglyceride concentrations).¹⁵³ ¹⁶¹ ^c

Precise mechanism of action in PTSD not fully elucidated; however, norepinephrine and α₁-adrenergic receptors play an important role in the pathophysiology of PTSD-associated nightmares, arousal, selective attention and vigilance.²⁰⁰ ²⁰¹ ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹⁶ ²¹⁷ ²²⁰ Prazosin is believed to help correct the effects of α₁-adrenergic receptor hyperstimulation in PTSD and has also been shown to normalize the sleep cycle.²⁰⁰ ²⁰³ ²⁰⁵ ²⁰⁶ ²¹¹ ²²⁰

Advice to Patients

Possible dizziness, lightheadedness or fainting, especially at initiation of therapy;¹⁰¹ ^b importance of avoiding driving or other hazardous tasks where injury could occur for 24 hours after the first dose or when dosage is increased.¹⁰¹

Importance of advising patient that alcohol use, hot weather, exercise, and standing for long periods of time may precipitate or exacerbate symptoms of dizziness, lightheadedness, or fainting, and to use caution during these situations.¹⁰¹

Importance of sitting or lying down when symptoms of lowered BP occur, and of rising carefully from a sitting or lying position.¹⁰¹ ^b

Possible drowsiness or somnolence; use caution when operating machinery or driving a motor vehicle until effects on individual are known.^b

Importance of advising patients being considered for cataract surgery that they should inform their ophthalmologist of current or prior α₁-blocker therapy, including prazosin.¹⁰¹ ²¹⁸

Importance of advising patients receiving prazosin for PTSD† that the drug may help reduce nightmares and improve sleep and other symptoms; however, it does not cure PTSD and their nightmares, anxiety, and other PTSD-related symptoms may return if therapy is stopped.²⁰¹ ²⁰³ ²¹⁹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹⁰¹

Importance of informing patients of other important precautionary information.¹⁰¹ (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

Prazosin Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	1 mg (of prazosin)*	Minipress	Pfizer
			Prazosin Hydrochloride Capsules
		2 mg (of prazosin)*	Minipress	Pfizer
			Prazosin Hydrochloride Capsules
		5 mg (of prazosin)*	Minipress	Pfizer
			Prazosin Hydrochloride Capsules

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.

Minipress 1MG Capsules (PFIZER U.S.): 60/$51.99 or 180/$149.97

Minipress 2MG Capsules (PFIZER U.S.): 60/$69.99 or 180/$199.98

Minipress 5MG Capsules (PFIZER U.S.): 60/$123.99 or 180/$347.96

Prazosin HCl 1MG Capsules (MYLAN): 60/$17.99 or 180/$37.97

Prazosin HCl 2MG Capsules (TEVA PHARMACEUTICALS USA): 60/$22.99 or 180/$49.97

Prazosin HCl 5MG Capsules (TEVA PHARMACEUTICALS USA): 60/$33.99 or 180/$93.97

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 February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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

100. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

101. Pfizer Labs. Minipress (prazosin hydrochloride) capsules prescribing information. New York, NY; 2009 Jul.

102. Waldo R. Prazosin relieves Raynaud’s vasospasm. JAMA. 1979; 241:1037. [IDIS 101504] [PubMed 762741]

103. Nielsen SL, Vitting K, Rasmussen K. Prazosin treatment of primary Raynaud’s phenomenon. Eur J Clin Pharmacol. 1983; 24:421-3. [IDIS 170153] [PubMed 6345178]

104. Wollersheim H, Thien T, Fennis J et al. Double-blind, placebo-controlled study of prazosin in Raynaud’s phenomenon. Clin Pharmacol Ther. 1986; 40:219-25. [IDIS 219933] [PubMed 3731684]

105. Cobaugh DS. Prazosin treatment of ergotamine-induced peripheral ischemia. JAMA. 1980; 244:1360. [IDIS 125518] [PubMed 7411811]

106. 1988 Joint National Committee. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

107. Guilleminault C, Mignot E, Aldrich M et al. Prazosin contraindicated in patients with narcolepsy. Lancet. 1988; 2:511. [IDIS 245751] [PubMed 2900433]

108. Aldrich MS, Rogers AE. Exacerbation of human cataplexy by prazosin. Sleep. 1989; 12:254-6. [PubMed 2740697]

109. Mignot E, Guilleminault C, Bowersox S et al. Central alpha 1 adrenoceptor subtypes in narcolepsy-cataplexy: a disorder of REM sleep. Brain Res. 1989; 490:186-91. [PubMed 2569353]

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114. Aoki H, Ohninata M, Tsuzuki T et al. Clinical studies on the effectiveness of prazosin HCl (Minipress tablets) in the treatment of dysuria accompanying benign prostatic hyperplasia. Urol Int. 1990; 45(Suppl 1):18-25. [PubMed 1690476]

115. Kohama Y, Watanabe H, Sen Y et al. Effects of prazosin HCl on micturition disturbance associated with benign prostatic hypertrophy and bladder neck contracture. Urol Int. 1990; 45(Suppl 1):26-9. [PubMed 1690477]

116. Nakamura K, Kawashita E, Osumi Y et al. Effects of prazosin HCl on the urethral pressure profile in patients with benign prostatic hyperplasia. Urol Int. 1990; 45(Suppl 1):30-5. [PubMed 1690478]

117. Shimizu K, Nakai K, Imai K et al. Effects of an alpha 1-adrenergic blocker (prazosin HCl) on micturition disturbances associated with benign prostatic hypertrophy. Urol Int. 1990; 45(Suppl 1):36-9. [PubMed 1690479]

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207.

Naprosyn

Generic Name: naproxen (Oral route)

na-PROX-en

Oral route(Tablet;Tablet, Enteric Coated;Suspension)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Aflaxen

Aleve

Aleve Arthritis

Anaprox

Anaprox DS

EC Naprosyn

Naprelan

Naprelan 500

Naprelan Dose Card

Naprosyn

In Canada

Naxen

Available Dosage Forms:

Tablet

Suspension

Tablet, Enteric Coated

Tablet, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Naprosyn

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.

This medicine is available only with your doctor's prescription.

Before Using Naprosyn

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Ardeparin

Argatroban

Aspirin

Beclamide

Beta Glucan

Bivalirudin

Caramiphen

Carbamazepine

Certoparin

Chlormethiazole

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desirudin

Diazepam

Dipyridamole

Enoxaparin

Escitalopram

Ethotoin

Felbamate

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Fosphenytoin

Gabapentin

Ginkgo

Heparin

Lacosamide

Lepirudin

Mephenytoin

Mephobarbital

Methotrexate

Nadroparin

Nefazodone

Oxcarbazepine

Paraldehyde

Paramethadione

Parnaparin

Paroxetine

Pemetrexed

Phenacemide

Phenobarbital

Phenytoin

Piracetam

Pregabalin

Protein C

Reviparin

Rivaroxaban

Rufinamide

Sertraline

Sibutramine

Stiripentol

Tacrolimus

Tiagabine

Ticlopidine

Tinzaparin

Tirofiban

Topiramate

Trimethadione

Valproic Acid

Vigabatrin

Vilazodone

Warfarin

Zimeldine

Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Acetohexamide

Alacepril

Alprenolol

Amiloride

Arotinolol

Atenolol

Azilsartan Medoxomil

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Candesartan Cilexetil

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Clopamide

Cyclopenthiazide

Cyclosporine

Delapril

Desvenlafaxine

Dilevalol

Duloxetine

Enalaprilat

Enalapril Maleate

Eprosartan

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Irbesartan

Labetalol

Landiolol

Levobetaxolol

Levobunolol

Lisinopril

Lithium

Losartan

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Milnacipran

Moexipril

Nadolol

Nebivolol

Nipradilol

Olmesartan Medoxomil

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Tasosartan

Telmisartan

Temocapril

Tertatolol

Timolol

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Valsartan

Venlafaxine

Xipamide

Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of naproxen

This section provides information on the proper use of a number of products that contain naproxen. It may not be specific to Naprosyn. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day.
  - Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

For naproxen controlled-release tablet (e.g., Naprelan®) dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day.
  - Children—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
  - Children—Use and dose must be determined by your doctor.

For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Naprosyn

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Naprosyn Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Belching

bruising

difficult or labored breathing

feeling of indigestion

headache

itching skin

large, flat, blue, or purplish patches in the skin

pain in the chest below the breastbone

shortness of breath

skin eruptions

stomach pain

swelling

tightness in the chest

wheezing

Less common

Bloating

bloody or black, tarry stools

blurred or loss of vision

burning upper abdominal or stomach pain

cloudy urine

constipation

decrease in urine output or decrease in urine-concentrating ability

disturbed color perception

double vision

fast, irregular, pounding, or racing heartbeat or pulse

halos around lights

indigestion

loss of appetite

nausea or vomiting

night blindness

overbright appearance of lights

pale skin

pinpoint red or purple spots on the skin

severe and continuing nausea

severe stomach burning, cramping, or pain

skin rash

swelling or inflammation of the mouth

troubled breathing with exertion

tunnel vision

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of material that looks like coffee grounds

weight loss

Rare

Anxiety

back or leg pains

bleeding gums

blindness

blistering, peeling, or loosening of the skin

blood in the urine or stools

blue lips and fingernails

canker sores

change in the ability to see colors, especially blue or yellow

chest pain or discomfort

clay-colored stools

cold sweats

coma

confusion

cool, pale skin

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

cracks in the skin

darkened urine

decreased vision

depression

diarrhea

difficult, burning, or painful urination

difficult, fast, or noisy breathing

difficulty with swallowing

dilated neck veins

dizziness

dry cough

dry mouth

early appearance of redness, or swelling of the skin

excess air or gas in the stomach

extreme fatigue

eye pain

fainting

fever with or without chills

fluid-filled skin blisters

flushed, dry skin

frequent urination

fruit-like breath odor

greatly decreased frequency of urination or amount of urine

hair loss

high fever

hives

increased hunger

increased sensitivity of the skin to sunlight

increased sweating

increased thirst

increased urination

increased volume of pale, dilute urine

irregular breathing

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas

light-colored stools

lightheadedness

loss of heat from the body

lower back or side pain

nervousness

nightmares

no blood pressure

no breathing

no pulse

nosebleeds

numbness or tingling in the hands, feet, or lips

pain in the ankles or knees

pain or burning in the throat

pain or discomfort in the arms, jaw, back, or neck

painful, red lumps under the skin, mostly on the legs

pains in the stomach, side, or abdomen, possibly radiating to the back

pale or blue lips, fingernails, or skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, shallow breathing

red, irritated eyes

red skin lesions, often with a purple center

red-green color blindness

redness or other discoloration of the skin

redness, swelling, or soreness of the tongue

scaly skin

seizures

severe sunburn

shakiness

skin thinness

slurred speech

sneezing

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sores, welting, or blisters

spots on your skin resembling a blister or pimple

stiff neck or back

stomach cramps or tenderness

stomach upset

swelling in the legs and ankles

swelling of the face, fingers, feet, or lower legs

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tiny bumps on the inner lining of the eyelid

unexplained weight loss

unpleasant breath odor

watery or bloody diarrhea

weakness or heaviness of the legs

weight gain

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bleeding under the skin

confusion about identity, place, and time

muscle tremors

restlessness

sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Continuing ringing or buzzing or other unexplained noise in the ears

hearing loss

Less common

Acid or sour stomach

change in hearing

feeling of constant movement of self or surroundings

passing gas

sensation of spinning

stomach soreness or discomfort

Rare

Appetite changes

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

difficulty with moving

discharge, excessive tearing

general feeling of discomfort or illness

lack or loss of strength

menstrual changes

muscle aching, cramping, stiffness, or weakness

not able to concentrate

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

seeing, hearing, or feeling things that are not there

shakiness in the legs, arms, hands, or feet

sleeplessness

swollen joints

trembling or shaking of the hands or feet

trouble getting pregnant

trouble performing routine tasks

trouble sleeping

unable to sleep

unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Naprosyn side effects (in more detail)

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More Naprosyn resources

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

Naprosyn Prescribing Information (FDA)

Naprosyn MedFacts Consumer Leaflet (Wolters Kluwer)

Naprosyn Consumer Overview

Naproxen Prescribing Information (FDA)

Naproxen Professional Patient Advice (Wolters Kluwer)

Naproxen Monograph (AHFS DI)

Aleve MedFacts Consumer Leaflet (Wolters Kluwer)

Aleve Consumer Overview

EC-Naprosyn Enteric-Coated Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Naprosyn with other medications

Ankylosing Spondylitis
Aseptic Necrosis
Back Pain
Bursitis
Costochondritis
Diffuse Idiopathic Skeletal Hyperostosis
Dysautonomia
Fever
Frozen Shoulder
Gout, Acute
Headache
Juvenile Rheumatoid Arthritis
Muscle Pain
Osteoarthritis
Pain
Period Pain
Rheumatoid Arthritis
Sciatica
Spondylolisthesis
Tendonitis