Sample PLR Content Directory Idaho

Tuesday, 17 April 2012

Zacare

Generic Name: benzoyl peroxide and sodium hyaluronate topical kit (BEN zoe il per OX ide and SOE dee um HYE al ure ON ate)

Brand Names: Zacare

What is benzoyl peroxide and sodium hyaluronate topical?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Sodium hyaluronate is a lubricant that restores moisture to the skin.

Benzoyl peroxide and sodium hyaluronate topical are used together to treat severe acne along with dry or scaly skin.

Benzoyl peroxide and sodium hyaluronate topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about benzoyl peroxide and sodium hyaluronate topical?

This medication comes as a kit containing benzoyl peroxide lotion and sodium hyaluronate gel.

You should not use this medication if you are allergic to benzoyl peroxide or sodium hyaluronate. Do not use this medication on a child younger than 12 years old without the advice of a doctor. Avoid getting this medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take up to 3 weeks of using this medicine before your symptoms improve. Talk with your doctor if your symptoms do not improve. The best results may be seen after 8 to 12 weeks of use. Do not use other medicated skin products unless your doctor has told you to.

Stop using benzoyl peroxide and sodium hyaluronate and call your doctor at once if you have severe stinging or burning of your skin.

What should I discuss with my healthcare provider before using benzoyl peroxide and sodium hyaluronate topical?

You should not use this medication if you are allergic to benzoyl peroxide or sodium hyaluronate. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether benzoyl peroxide and sodium hyaluronate 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 medication on a child younger than 12 years old without the advice of a doctor.

How should I use benzoyl peroxide and sodium hyaluronate topical?

This medication comes as a kit containing benzoyl peroxide lotion and sodium hyaluronate gel.

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Shake the benzoyl peroxide lotion well just before each use. Wet the skin before applying the benzoyl peroxide cleansing lotion. Work the lotion into a lather and rinse thoroughly. Gently the skin dry.

During your first week of treatment, wash the affected skin with the benzoyl peroxide lotion once daily. After the first week, wash the skin twice daily.

The sodium hyaluronate gel may be applied 2 or 3 times daily. Follow your doctor's instructions. Apply a liberal amount of the gel and rub it in thoroughly.

Do not cover the treated skin area unless your doctor has told you to.

Store benzoyl peroxide and sodium hyaluronate at room temperature away from moisture and heat. Keep the lotion bottle and ointment tube tightly closed when not in use.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of benzoyl peroxide and sodium hyaluronate applied to the skin is not likely to cause life-threatening symptoms.

What should I avoid while using benzoyl peroxide and sodium hyaluronate topical?

Avoid getting this medication on your lips or in your mouth, nose, or eyes. If it does get into any of these areas, rinse with water.

Avoid using benzoyl peroxide and sodium hyaluronate topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

Do not use other medicated skin products unless your doctor has told you to.

Benzoyl peroxide and sodium hyaluronate topical side effects

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 benzoyl peroxide and sodium hyaluronate and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

redness or peeling of treated skin;

mild burning or stinging; or

dry skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect benzoyl peroxide and sodium hyaluronate topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide and sodium hyaluronate. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Zacare resources

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

Compare Zacare with other medications

Acne

Where can I get more information?

Your pharmacist can provide more information about benzoyl peroxide and sodium hyaluronate topical.

See also: Zacare side effects (in more detail)

Monday, 16 April 2012

Procaine Hydrochloride

Class: Local Anesthetics
ATC Class: N01BA52
VA Class: CN204
Chemical Name: 4-amino-, 2-(diethylamino) ethyl ester monohydrochloride
CAS Number: 51-05-8

Introduction

Short-acting local anesthetic (ester type).^a

Uses for Procaine Hydrochloride

Local or Regional Anesthesia

Local or regional analgesia or anesthesia^c ^d in surgical, dental, and diagnostic procedures.^a ^b

Procaine Hydrochloride Dosage and Administration

General

Determine dosage based on anesthetic procedure, area to be anesthetized, vascularity of tissues, number of neuronal segments to be blocked, depth and duration of anesthesia, degree of muscular relaxation, individual tolerance, and physical condition of the patient.^c ^d Use smallest dose and concentration required to produce the desired effect.^a ^c ^d

Administration

Injection

For solution and drug compatibility information, see Compatibility under Stability.

Administer by local infiltration, peripheral nerve block, or subarachnoid (spinal) block.^a ^c ^d Has been administered by continuous intra-articular infusion† (e.g., for control of postoperative pain); however, such use associated with chondrolysis.²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ (See Risk of Chondrolysis Associated with Intra-articular Infusions of Local Anesthetics under Cautions.)

Consult specialized references for specific techniques and procedures for administering local anesthetics.^a

For local infiltration or peripheral nerve block, inject slowly and avoid rapid injection of large volumes; when feasible, administer in fractional (incremental) doses.^d

For subarachnoid (spinal) block, use 2-mL single-dose ampuls containing procaine hydrochloride 10% only.^c ^d Position patient properly prior to spinal anesthesia.^a ^b

For disinfection of container surface, autoclave once at 15 PSI and 121°C for 15 minutes^a (diluent dextrose may show some brown discoloration due to caramelization); immersion in antiseptic solution not recommended.^c Reautoclaving not recommended because it increases likelihood of crystal formation.^a

Dilution

For local infiltration, dilute appropriate dose of 1% procaine hydrochloride injection with 0.9% sodium chloride to obtain final concentration of 0.25 or 0.5%.^a ^d May add 0.5–1 mL of epinephrine 0.1% to each 100 mL of anesthetic solution (to provide final epinephrine concentration of 1:200,000 to 1:100,000) for vasoconstrictive effect.^a

For peripheral nerve block, dilute appropriate dose of 1% procaine hydrochloride injection with 0.9% sodium chloride to obtain final concentration of 0.5%.^a ^d Alternatively, may use 1% procaine hydrochloride injection without diluting.^d May add 0.5–1 mL of epinephrine 0.1% to each 100 mL of anesthetic solution (to provide a final epinephrine concentration of 1:200,000 to 1:100,000) for vasoconstrictive effect.^a

For subarachnoid (spinal) block, dilute appropriate dose of 10% procaine hydrochloride injection with sterile 0.9% sodium chloride injection, sterile water for injection, CSF, or, for hyperbaric technique, sterile dextrose injection.^a ^c For anesthesia of the perineum, dilute 0.5 mL of the 10% procaine hydrochloride injection (50 mg) with an equal volume of diluent.^a For anesthesia of the perineum and lower extremities, dilute 1 mL of the 10% injection (100 mg) with an equal volume of diluent.^a For anesthesia extending up to the costal margin, dilute 2 mL of the 10% injection (200 mg) with 1 mL of diluent.^a

Rate of Administration

For subarachnoid (spinal) block, usual rate of injection is 1 mL/5 seconds.^a

Dosage

Available as procaine hydrochloride; dosage expressed in terms of the salt.^c ^d

Pediatric Patients

Local or Regional Anesthesia

Local Infiltration

Up to 15 mg/kg as a 0.5% solution.^d

Adults

Local or Regional Anesthesia

Local Infiltration

Usually, 350–600 mg, administered as diluted solution (i.e., 140–240 mL of a 0.25% solution or 70–120 mL of a 0.5% solution).^a ^d

Peripheral Nerve Block

Up to 1 g, administered undiluted (i.e., 100 mL of a 1% injection) or as diluted solution (i.e., 200 mL of a 0.5% solution).^a ^d

Subarachnoid (Spinal) Block

Recommended Dosage for Spinal Anesthesia in Adultsac
Extent of Anesthesia	Total Dose of Procaine Hydrochloride (mg) (as 10% Injection)	Site of Injection (Lumbar Interspace)
Perineum	50	4th
Perineum and lower extremities	100	3rd or 4th
Up to costal margin	200	2nd, 3rd, or 4th

Prescribing Limits

Pediatric Patients

Local or Regional Anesthesia

Local Infiltration

Maximum 15 mg/kg as a 0.5% solution.^d

Adults

Local or Regional Anesthesia

Local Infiltration, Peripheral Nerve Block

Maximum 1 g per injection.^a

Special Populations

Hepatic Impairment

Reduce dosage in patients with hepatic disease.^a

Geriatric Patients

Reduce dosage based on age, weight, and physical status.^c ^d

Other Populations

Reduce dosage in patients with cardiac disease, debilitated patients, and acutely ill patients.^a ^d

Reduce dosage in obstetric patients and patients with increased intra-abdominal pressure.^a

Cautions for Procaine Hydrochloride

Contraindications

Contraindications to spinal anesthesia: generalized septicemia, sepsis at proposed injection site, and certain diseases of the cerebrospinal system (e.g., meningitis, syphilis, spinal fluid block, cranial or spinal hemorrhage, tumors, poliomyelitis, metastatic lesions of the spinal cord).^b ^c

Known hypersensitivity to procaine, drugs of a similar chemical configuration, aminobenzoic acid or its derivatives, or any ingredient in the formulation.^c ^d

Warnings/Precautions

Warnings

Experience of Supervising Clinician

Should be used only by clinicians who are sufficiently knowledgeable in the diagnosis and management of dose-related toxicity and other acute emergencies that might arise.^b ^c ^d Oxygen, resuscitative equipment, and drugs must be available for immediate use.^a ^b Delay in appropriate management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may result in acidosis, cardiac arrest, and, possibly, death.^b ^d

Risk of Chondrolysis Associated with Intra-articular Infusions of Local Anesthetics

Chondrolysis (necrosis and destruction of articular cartilage) reported in patients receiving continuous intra-articular infusions of local anesthetics, administered for 48–72 hours via elastomeric infusion devices, for treatment of postoperative pain.²⁰⁰ ²⁰¹ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ Primarily observed in the shoulder joint following arthroscopic or other shoulder surgery.²⁰⁰ May result in long-term disability; often requires intervention (e.g., debridement, arthroplasty).²⁰⁰ ²⁰² ²⁰³ ²⁰⁴ ²⁰⁵ ²⁰⁶ ²⁰⁹ Not known whether the drug, infusion device, and/or other factors contributed to the development of chondrolysis.²⁰⁰ ²⁰¹ Neither local anesthetics nor elastomeric infusion devices are approved for use for continuous intra-articular infusion therapy.²⁰⁰ ²⁰¹

Accidental Intravascular Injection

Accidental intravascular injection of local anesthetics may result in seizures, CNS or cardiorespiratory depression, coma, and/or respiratory arrest.^b

Aspirate prior to and during administration to guard against intravascular injection.^b ^d

Sensitivity Reactions

Hypersensitivity Reactions and Cross-sensitivity

Allergic reactions are rare.^b ^d

Possible urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and anaphylactoid reactions (including severe hypotension).^c ^d

Cross-sensitivity between ester-type local anesthetics reported.^b ^d

Use with caution in patients with known drug allergies and hypersensitivities.^c ^d

Sulfite Sensitivity

Some procaine hydrochloride preparations contain acetone sodium bisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^a ^b

General Precautions

CNS Effects

Toxic plasma concentrations of local anesthetics (resulting from systemic absorption) associated with adverse CNS effects (e.g., anxiety, apprehension, restlessness, nervousness, disorientation, incoherent speech, confusion, dizziness, lightheadedness, blurred vision, tremors, twitching, shivering, numbness and tingling of the mouth and lips, metallic taste, tinnitus, seizures, depression, drowsiness, unconsciousness, respiratory arrest).^b ^c ^d

Carefully monitor level of consciousness after each local anesthetic administration.^c ^d

Cardiovascular Effects

Toxic plasma concentrations of local anesthetics (resulting from systemic absorption) associated with adverse cardiovascular effects (e.g., myocardial depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, cardiovascular collapse, cardiac arrest).^b ^c ^d Carefully monitor cardiovascular (e.g., BP) and respiratory vital signs after each local anesthetic injection.^a ^c ^d

Use with caution in patients with severe disturbances of cardiac rhythm, shock, heart block, or hypotension.^c ^d

Avoid use of large doses in patients with heart block.^c ^d

For solutions containing a vasoconstrictor (e.g., epinephrine), consider risk of exaggerated vasoconstrictor response in patients with peripheral or hypertensive vascular disease.^d Use with caution and in carefully restricted quantities in areas of the body supplied by end arteries or having otherwise compromised blood supply (e.g., digits, nose, external ear, penis).^d

Vasoconstrictor Administration

Concomitant use with a vasoconstrictor such as epinephrine may cause ischemic injury or necrosis.^d

Familial Malignant Hyperthermia

Many drugs used during the conduct of anesthesia may trigger familial malignant hyperthermia; not known whether ester-type local anesthetics trigger this reaction.^d However, standard protocol for management should be available.^d Early unexplained signs of tachycardia, tachypnea, labile BP, and metabolic acidosis may precede temperature elevation.^d If familial malignant hyperthermia is confirmed, discontinue triggering agent and initiate appropriate therapy (e.g., oxygen, dantrolene) and other supportive measures.^d

Preexisting Conditions

Employ anesthetic procedures with caution when there is inflammation and/or sepsis in the region of the proposed injection.^c ^d (See Contraindications under Cautions.)

Conditions that may preclude the use of spinal anesthesia (depending on the clinician’s evaluation of the situation and ability to manage potential complications) include cardiovascular disease (e.g., shock, hypertension, hypotension, arteriosclerosis, occlusive arterial disease); pulmonary disease; renal impairment; metabolic or endocrine disorders; GI disorder (e.g., intestinal obstruction, peritonitis); complicated obstetrical deliveries; spinal deformities that make spinal puncture inadvisable or difficult; bleeding resulting from traumatic lumbar puncture; severe anemia, cachexia, or moribund condition; chronic backache; preoperative headache or history of migraine; extremes of age; and emotional instability, hysteria, or nervous tension.^b ^c (See Contraindications under Cautions.)

Specific Populations

Pregnancy

Category C.^d

Labor and Delivery

Maternal hypotension reported.^b To prevent decreases in BP, elevate patient’s legs and position patient on her left side.^b Monitor fetal heart rate continuously; electronic fetal monitoring highly advisable.^b

Epidural, spinal, paracervical, or pudendal anesthesia may alter the forces of parturition through changes in uterine contractility or maternal expulsive efforts; may increase need for forceps assistance.^b

Possible diminished muscle strength and tone on neonate’s first or second day of life.^d

Lactation

Not known whether procaine is distributed into milk.^d Caution if used in nursing women.^d

Pediatric Use

Some manufacturers recommend reducing dosage of local anesthetics in proportion to age, weight, and physical condition.^b (See Pediatric Patients under Dosage and Administration.)

Geriatric Use

Reduce dosage based on age, weight, and physical status.^c ^d

Hepatic Impairment

Use with caution; patients with severe hepatic disease are at greater risk of developing toxic plasma concentrations.^d Dosage reduction recommended.^a

Renal Impairment

Weigh benefits against risks of spinal anesthesia in patients with renal impairment.^c

Common Adverse Effects

Adverse CNS and cardiovascular effects, underventilation, apnea.^d (See CNS Effects and also Cardiovascular Effects, under Cautions.)

Spinal anesthesia: Possible postspinal headache, meningismus, arachnoiditis, palsies, spinal nerve paralysis, hypotension, respiratory impairment or paralysis, nausea, vomiting.^c

Interactions for Procaine Hydrochloride

When used with epinephrine, consider usual drug interactions associated with epinephrine administration.^c ^d

Specific Drugs

Drug	Interaction	Comments
Aminosalicylic acid	Possible antagonism of aminosalicylic acid activity^a	Consider avoiding concomitant use^a ^b
Antidepressants, tricyclics	Possible severe, prolonged hypertension or disturbances of cardiac rhythm due to epinephrine component^d	Avoid concomitant use with epinephrine; if must be used concomitantly, careful monitoring is required^d
Butyrophenones	Possible reduction or reversal of pressor effect of epinephrine^d
Ergot alkaloid oxytocics (ergonovine, methylergonovine)	Possible severe, persistent hypertension or cerebrovascular accidents (e.g., rupture of cerebral blood vessel) due to epinephrine component^c ^d	Avoid concomitant use with epinephrine^d
MAO inhibitors	Possible severe, prolonged hypertension or disturbances of cardiac rhythm due to epinephrine component^d	Avoid concomitant use with epinephrine; if must be used concomitantly, careful monitoring is required^d
Phenothiazines	Possible reduction or reversal of pressor effect of epinephrine;^d severe sustained hypertension or hypotension also may occur^c	Use concomitantly with epinephrine with extreme caution^c
Succinylcholine	Possible increase in neuromuscular blocking effect with high IV doses of procaine^b
Sulfonamides	Possible antagonism of sulfonamide activity^b	Avoid concomitant use^a ^b

Procaine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Readily absorbed following parenteral administration.^c

Rate of systemic absorption dependent upon total dose and concentration administered, route of administration, vascularity of administration site, and presence or absence of epinephrine in solution.^d

Onset

2–5 minutes.^a

Duration

1–1.5 hours.^a ^c ^d

Distribution

Extent

Local anesthetics are distributed to some extent to all body tissues, with high concentrations found in highly perfused organs (e.g., liver, lungs, heart, brain).^d

Local anesthetics generally cross blood-brain and placental barriers.^b ^d

Elimination

Metabolism

Rapidly and almost completely hydrolyzed by plasma cholinesterase to p-aminobenzoic acid and diethylaminoethanol.^a ^c ^d

Elimination Route

Approximately 90% of p-aminobenzoic acid and its conjugates and 33% of diethylaminoethanol are excreted in urine; <2% of administered dose is excreted in urine as unchanged drug.^d

Special Populations

Possible delayed metabolism in neonates, adults with liver disease, and adults with impaired renal function.^a

Stability

Storage

Parenteral

Injection

20–25°C.^c Protect from light.^c ^d Discard unused portion of solutions not containing preservatives.^d

Do not use if crystal formation, cloudiness, or discoloration is observed.^a

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose-Ringer's injection combinations
Dextrose-Ringer’s injection, lactated, combinations
Dextrose-saline combinations
Dextrose 2½, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer's injection
Ringer's injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M

Drug Compatibility

Do not mix with other local anesthetics (insufficient clinical data).^d

Admixture CompatibilityHID
Compatible
Ascorbic acid injection
Hydrocortisone sodium succinate
Penicillin G potassium
Penicillin G sodium
Vitamin B complex with C
Incompatible
Amobarbital sodium
Chlorothiazide sodium
Magnesium sulfate
Phenobarbital sodium
Phenytoin sodium
Sodium bicarbonate
Variable
Aminophylline

ActionsActions

Local anesthetics block the generation and conduction of nerve impulses by increasing the threshold for electrical excitation, slowing the propagation of the nerve impulse, and reducing the rate of rise of the action potential.^b ^c ^d

Produces vasodilation; may add a vasoconstrictor (e.g., epinephrine) to solutions of procaine to retard procaine’s absorption, prolong its duration of action, and maintain hemostasis.^a ^d

Has short duration of action.^a

Has little topical activity.^a

Advice to Patients

Prior to administration, advise patients of the possibility of temporary loss of sensation and motor activity following local or regional anesthesia.^d

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular or liver disease).^c ^d

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^c ^d

Importance of informing patients of other important precautionary information.^c ^d (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

Procaine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*

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

200. Food and Drug Administration. Information for healthcare professionals: Chondrolysis reported with continuously infused local anesthetics (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, and ropivacaine). Rockville, MD; Updated 2010 Feb 16. From FDA website ().

201. Todd JF. Chondrolysis linked to intra-articular infusions. Medical Devices Alerts and Notices. Silver Spring, MD: Food and Drug Administration; 2010 June. From FDA website ().

202. Hansen BP, Beck CL, Beck EP et al. Postarthroscopic glenohumeral chondrolysis. Am J Sports Med. 2007; 35:1628-34. [PubMed 17609526]

203. Bailie DS, Ellenbecker TS. Severe chondrolysis after shoulder arthroscopy: a case series. J Shoulder Elbow Surg. 2009 Sep-Oct; 18:742-7.

204. Anakwenze OA, Hosalkar H, Huffman GR. Case Reports: Two Cases of Glenohumeral Chondrolysis after Intraarticular Pain Pumps. Clin Orthop Relat Res. 2010; :.

205. Anderson SL, Buchko JZ, Taillon MR et al. Chondrolysis of the glenohumeral joint after infusion of bupivacaine through an intra-articular pain pump catheter: a report of 18 cases. Arthroscopy. 2010; 26:451-61. [PubMed 20362823]

206. Rapley JH, Beavis RC, Barber FA. Glenohumeral chondrolysis after shoulder arthroscopy associated with continuous bupivacaine infusion. Arthroscopy. 2009; 25:1367-73. [PubMed 19962061]

207. Scheffel PT, Clinton J, Lynch JR et al. Glenohumeral chondrolysis: A systematic review of 100 cases from the English language literature. J Shoulder Elbow Surg. 2010; :. [PubMed 20421168]

208. Ballieul RJ, Jacobs TF, Herregods S et al. The peri-operative use of intra-articular local anesthetics: a review. Acta Anaesthesiol Belg. 2009; 60:101-8. [PubMed 19594092]

209. Busfield BT, Romero DM. Pain pump use after shoulder arthroscopy as a cause of glenohumeral chondrolysis. Arthroscopy. 2009; 25:647-52. [PubMed 19501296]

a. AHFS drug information 2011. McEvoy GK, ed. Procaine Hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; e-pub ahead of print.

b. AHFS drug information 2011. McEvoy GK, ed. Local Anesthetics, Parenteral, General Statement. Bethesda, MD: American Society of Health-Systems Pharmacists; e-pub ahead of print.

c. Hospira, Inc. Novocain (procaine hydrochloride) injection 10% solution for spinal anesthesia prescribing information. Lake Forest, IL; 2005 Jul.

d. Hospira, Inc. Novocain (procaine hydrochloride) injection prescribing information. Lake Forest, IL; 2005 Jun.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1395-7.

More Procaine Hydrochloride resources

Procaine Hydrochloride Drug Interactions
Procaine Hydrochloride Support Group
0 Reviews for Procaine Hydrochloride - Add your own review/rating

Novocain Prescribing Information (FDA)

Novocain Concise Consumer Information (Cerner Multum)

Compare Procaine Hydrochloride with other medications

Local Anesthesia

neomycin and polymyxin b Topical

nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate

Commonly used brand name(s)

In the U.S.

Antibiotic Cream

Available Dosage Forms:

Powder

Cream

Therapeutic Class: Antibacterial Combination

Chemical Class: Neomycin

Uses For neomycin and polymyxin b

Neomycin and polymyxin B combination is used to prevent bacterial infections. It works by killing bacteria.

Neomycin and polymyxin B cream is applied to the skin to prevent minor bacterial skin infections. It may also be used for other problems as determined by your doctor.

neomycin and polymyxin b is available without a prescription.

Before Using neomycin and polymyxin b

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 neomycin and polymyxin b, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to neomycin and polymyxin b 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

Although there is no specific information comparing use of neomycin and polymyxin B combination in children with use in other age groups, neomycin and polymyxin b is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of neomycin and polymyxin B combination in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 neomycin and polymyxin b, 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 neomycin and polymyxin b 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.

Alcuronium

Atracurium

Cidofovir

Cisatracurium

Colistimethate Sodium

Decamethonium

Doxacurium

Ethacrynic Acid

Fazadinium

Furosemide

Gallamine

Hexafluorenium

Metocurine

Mivacurium

Pancuronium

Pipecuronium

Rapacuronium

Rocuronium

Sorafenib

Tacrolimus

Tubocurarine

Vecuronium

Using neomycin and polymyxin b 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.

Alcuronium

Atracurium

Bumetanide

Cisatracurium

Doxacurium

Fazadinium

Gallamine

Hexafluorenium

Metocurine

Mivacurium

Pancuronium

Pipecuronium

Rapacuronium

Rocuronium

Tubocurarine

Vecuronium

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 neomycin and polymyxin b

If you are using neomycin and polymyxin b without a prescription, do not use it to treat deep wounds, puncture wounds, animal bites, serious burns, or raw areas without first checking with your health care professional.

Do not use neomycin and polymyxin b in the eyes.

To use:

Before applying neomycin and polymyxin b, wash the affected area(s) with soap and water, and dry thoroughly.

Apply a small amount of neomycin and polymyxin b to the affected area(s) and rub in gently.

After applying neomycin and polymyxin b, the treated area(s) may be covered with a gauze dressing if desired.

Do not use neomycin and polymyxin b for longer than 1 week or on large areas of the skin, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

To help clear up your skin infection completely, keep using neomycin and polymyxin b for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of neomycin and polymyxin b 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 neomycin and polymyxin b. 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 topical dosage form (cream):
- For prevention of minor bacterial infections:
  - Adults and children 2 years of age and older—Apply to the affected area(s) of the skin one to three times a day.
  - Children up to 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of neomycin and polymyxin b, apply 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.

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.

Precautions While Using neomycin and polymyxin b

If your skin infection does not improve within 1 week, or if it becomes worse, check with your health care professional.

neomycin and polymyxin b 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

Itching, pain, skin rash, swelling, redness, or other sign of skin irritation not present before use of neomycin and polymyxin b

Rare

Loss of hearing

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Pergolide Mesylate is used for:

Treating Parkinson disease when used with levodopa/carbidopa.

Pergolide Mesylate is dopamine agonist. It works by stimulating dopamine receptors in the brain.

Do NOT use Pergolide Mesylate if:

you are allergic to any ingredient in Pergolide Mesylate

you are allergic to ergot-type medicines (eg, ergotamine)

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

Before using Pergolide Mesylate:

Some medical conditions may interact with Pergolide Mesylate. 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 or kidney problems, irregular heartbeat, lung problems, low blood pressure, or hallucinations

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

Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, thioridazine), or thioxanthenes (eg, thiothixene) because the effectiveness of Pergolide Mesylate may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pergolide Mesylate 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 Pergolide Mesylate:

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

Pergolide Mesylate may be taken with or without food.

If Pergolide Mesylate needs to be stopped or if a different medicine is added to therapy by your doctor, this will be done gradually. The risk of side effects may be increased if Pergolide Mesylate is suddenly stopped.

If you miss a dose of Pergolide Mesylate, 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 Pergolide Mesylate.

Important safety information:

Pergolide Mesylate may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Pergolide Mesylate. Using Pergolide Mesylate alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Pergolide Mesylate may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Pergolide Mesylate. Pergolide Mesylate will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Pergolide Mesylate if you suddenly stop taking it or if your dose is lowered too quickly. Symptoms may include increased body heat; rigid muscles; altered mental abilities, including lack of response to your surroundings; fast or irregular heartbeat; sweating. Contact your doctor at once if any of these symptoms occur. Do not stop taking Pergolide Mesylate without first talking with your doctor.

Use Pergolide Mesylate with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion.

Pergolide Mesylate is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is unknown if Pergolide Mesylate can cause harm to the fetus. If you become pregnant while taking Pergolide Mesylate, discuss with your doctor the benefits and risks of using Pergolide Mesylate during pregnancy. It is unknown if Pergolide Mesylate is excreted in breast milk. Do not breast-feed while taking Pergolide Mesylate.

If you suddenly stop taking Pergolide Mesylate, you may experience WITHDRAWAL symptoms, including anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Pergolide Mesylate:

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:

Anxiety; constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; dry mouth; lightheadedness; loss of appetite; nausea; pain; runny nose; stomach pain; stomach upset.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; increased jerking movements; leg or foot swelling; seeing or hearing strange things (hallucinations); severe dizziness or lightheadedness; trouble breathing; unusual weakness; unusually slow, fast, or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Pergolide Mesylate 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 (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include agitation; fast or irregular heartbeat; hallucinations; nausea; seizures; tingling or uncontrolled movement of the arms and legs; unusual dizziness or fainting; vomiting

Proper storage of Pergolide Mesylate:

Store Pergolide Mesylate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pergolide Mesylate out of the reach of children and away from pets.

General information:

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

Pergolide Mesylate 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.

This information is a summary only. It does not contain all information about Pergolide Mesylate. 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 Pergolide Mesylate resources

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

Pergolide Mesylate Monograph (AHFS DI)

Pergolide Prescribing Information (FDA)

pergolide Concise Consumer Information (Cerner Multum)

pergolide Advanced Consumer (Micromedex) - Includes Dosage Information

Permax Prescribing Information (FDA)

Compare Pergolide Mesylate with other medications

Hyperprolactinemia
Parkinson's Disease
Tourette's Syndrome

Wednesday, 11 April 2012

IBU

Pronunciation: EYE-bue-PROE-fen
Generic Name: Ibuprofen
Brand Name: Examples include IBU and Motrin

IBU is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take IBU for a long time. Do not use IBU right before or after bypass heart surgery.

IBU may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

IBU is used for:

Treating rheumatoid arthritis, osteoarthritis, menstrual cramps, or mild to moderate pain. It may also be used for other conditions as determined by your doctor.

IBU is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use IBU if:

you are allergic to any ingredient in IBU

you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)

you have recently had or will be having bypass heart surgery

you are in the last 3 months of pregnancy

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

Before using IBU:

Some medical conditions may interact with IBU. 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 product, or dietary supplement

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

if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

if you have a history of swelling or fluid buildup, lupus, asthma, or growths in the nose (nasal polyps), or mouth inflammation

if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

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

Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

Probenecid because it may increase the risk of IBU's side effects

Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by IBU

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by IBU

This may not be a complete list of all interactions that may occur. Ask your health care provider if IBU 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 IBU:

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

IBU comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get IBU refilled.

Take IBU by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

Take IBU with a full glass of water (8 oz/240 mL) as directed by your doctor.

If you miss a dose of IBU and you are taking it regularly, 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 the proper use of IBU.

Important safety information:

IBU may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use IBU with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Serious stomach ulcers or bleeding can occur with the use of IBU. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking IBU with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

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

Do not take aspirin while you are using IBU unless your doctor tells you to.

Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be done to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use IBU with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.

IBU should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: IBU may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking IBU while you are pregnant. It is not known if IBU is found in breast milk. Do not breast-feed while taking IBU.

Possible side effects of IBU:

All medicines can 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; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset.

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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

See also: IBU 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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of IBU:

Store IBU at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep IBU out of the reach of children and away from pets.

General information:

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

IBU 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 IBU. 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 IBU resources

IBU Side Effects (in more detail)
IBU Dosage
IBU Use in Pregnancy & Breastfeeding
IBU Drug Interactions
0 Reviews for IBU - Add your own review/rating

Ibuprofen Prescribing Information (FDA)

Ibuprofen Monograph (AHFS DI)

Ibuprofen Professional Patient Advice (Wolters Kluwer)

Advil Prescribing Information (FDA)

Advil Advanced Consumer (Micromedex) - Includes Dosage Information

Advil Consumer Overview

Advil Childrens Prescribing Information (FDA)

Advil Migraine Prescribing Information (FDA)

Caldolor Consumer Overview

Caldolor Prescribing Information (FDA)

Caldolor Advanced Consumer (Micromedex) - Includes Dosage Information

Ibutilide Fumarate Monograph (AHFS DI)

Motrin Prescribing Information (FDA)

Motrin Consumer Overview

Motrin IB Prescribing Information (FDA)

NeoProfen Prescribing Information (FDA)

Compare IBU with other medications

Aseptic Necrosis
Back Pain
Costochondritis
Cystic Fibrosis
Diffuse Idiopathic Skeletal Hyperostosis
Dysautonomia
Fever
Frozen Shoulder
Gout, Acute
Headache
Muscle Pain
Osteoarthritis
Pain
Patent Ductus Arteriosus
Period Pain
Rheumatoid Arthritis
Sciatica
Spondylolisthesis
Temporomandibular Joint Disorder

Monday, 9 April 2012

Chlorothiazide Suspension

Pronunciation: klor-oh-THYE-a-zide
Generic Name: Chlorothiazide
Brand Name: Diuril

Chlorothiazide Suspension is used for:

Treating excess fluid buildup in the body caused by certain conditions or medicines. It may also be used to treat high blood pressure or other conditions as determined by your doctor.

Chlorothiazide Suspension is a thiazide diuretic. It works by helping the kidneys eliminate fluid from your body. Exactly how Chlorothiazide Suspension works to treat high blood pressure is unknown.

Do NOT use Chlorothiazide Suspension if:

you are allergic to any ingredient in Chlorothiazide Suspension or to any other sulfonamide medicine (eg sulfamethoxazole, glyburide, acetazolamide)

you are unable to urinate

you are taking dofetilide or ketanserin

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

Before using Chlorothiazide Suspension:

Some medical conditions may interact with Chlorothiazide Suspension. 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 gout, kidney or liver problems, lupus, diabetes, asthma, parathyroid problems, high blood cholesterol or lipid levels, or low blood pressure

if you have low blood sodium, chloride, potassium, or magnesium levels; or high blood calcium levels

if you have recently had nerve surgery

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

Nonsteroidal anti-inflammatory medicines (NSAIDs) (eg, ibuprofen) because they decrease the effectiveness of Chlorothiazide Suspension

Barbiturates (eg, phenobarbital), narcotic pain medicines (eg, codeine, morphine, fentanyl), or medicines for high blood pressure because side effects of Chlorothiazide Suspension may be increased

Diazoxide or nondepolarizing muscle relaxants (eg, tubocurarine) because side effects may be increased by Chlorothiazide Suspension

Lithium because risk of toxicity may be increased by Chlorothiazide Suspension

Digoxin, dofetilide, or ketanserin because risk of irregular heartbeat may be increased by Chlorothiazide Suspension

Diabetes medicines (eg, glipizide, metformin) or insulin because their effectiveness may be decreased by Chlorothiazide Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorothiazide Suspension 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 Chlorothiazide Suspension:

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

Chlorothiazide Suspension may be taken with or without food.

Shake well before using.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

When you first start taking Chlorothiazide Suspension, it may cause an increase in urine or in frequency of urination. To prevent this from affecting sleep, try not to take any dose later than 6 pm.

Continue to use Chlorothiazide Suspension even if you feel well. Do not miss any doses.

If you miss a dose of Chlorothiazide Suspension, 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 Chlorothiazide Suspension.

Important safety information:

Chlorothiazide Suspension may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Chlorothiazide Suspension. Using Chlorothiazide Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Chlorothiazide Suspension may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Chlorothiazide Suspension.

Chlorothiazide Suspension may cause high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor). If these symptoms occur, tell your doctor immediately.

Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.

Chlorothiazide Suspension may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Chlorothiazide Suspension. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

Patients being treated for high blood pressure often feel tired or run down for a few weeks after beginning therapy. Continue taking your medication even though you may not feel quite "normal." Contact your doctor or pharmacist about any new symptoms.

LAB TESTS, including kidney function, blood pressure, and blood electrolyte levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Chlorothiazide Suspension with caution in the ELDERLY because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Chlorothiazide Suspension during pregnancy. Chlorothiazide Suspension is excreted in breast milk. Do not breast-feed while taking Chlorothiazide Suspension.

Possible side effects of Chlorothiazide Suspension:

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:

Blurred vision; dizziness; headache; lightheadedness, especially when sitting up or standing; numbness or tingling of skin.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decrease in amount of urine; drowsiness; gout; inability to keep an erection; inflammation of the pancreas; muscle pain or cramps; rapid or irregular heartbeat; red, swollen, blistered, or peeling skin; restlessness; seizures; shortness of breath; unusual thirst; unusual tiredness or weakness; unusually dry mouth; vomiting.

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: Chlorothiazide 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include dry mouth; excessive urination followed by a decrease in amount of urine; muscle cramps; severe lightheadedness, especially upon standing; weak or irregular heartbeat.

Proper storage of Chlorothiazide Suspension:

Store Chlorothiazide Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorothiazide Suspension out of the reach of children and away from pets.

General information:

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

Chlorothiazide Suspension 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 Chlorothiazide Suspension. 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 Chlorothiazide resources

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

Compare Chlorothiazide with other medications

Edema
High Blood Pressure

Saturday, 7 April 2012

Loprazolam 1mg tablets

1. Name Of The Medicinal Product

Loprazolam 1mg Tablets

Dormonoct

2. Qualitative And Quantitative Composition

Each tablet contains loprazolam mesylate equivalent to 1mg loprazolam.

3. Pharmaceutical Form

Light yellow, biconvex, round tablets, 7mm in diameter marked with an 'A' and '026' separated by a score line on one side. The other side is blank.

4. Clinical Particulars

4.1 Therapeutic Indications

Loprazolam is indicated for the short-term treatment of insomnia including difficulty in falling asleep and/or frequent nocturnal awakenings. Benzodiazepines should be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme distress. An underlying cause of insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.

4.2 Posology And Method Of Administration

Adults: The recommended dose is 1mg at bedtime. This may be increased to 1.5mg or 2mg if necessary.

Elderly: Dosage in the elderly should be limited to 1mg at bedtime.

Frail, debilitated or aged patients: A starting dose of a half tablet may be appropriate. Dosage should not exceed 1mg.

Treatment should if possible be intermittent.

The lowest dose to control symptoms should be used. Treatment should not normally be continued beyond 4 weeks.

Long term chronic use is not recommended.

Treatment should always be tapered off gradually.

Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.

Children: There is insufficient evidence to recommend the use of Loprazolam in children.

4.3 Contraindications

Sensitivity to benzodiazepines, acute pulmonary insufficiency, severe respiratory insufficiency, myasthenia gravis, phobic or obsessional states and sleep apnoea syndrome. Monotherapy in depression or anxiety associated with depression and chronic psychosis and alcohol intake.

4.4 Special Warnings And Precautions For Use

Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients who are depressed and who exhibit aggressive behaviour towards self and others. Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.

In general, the dependence potential of benzodiazepines is low but this increases when high doses are attained, especially when given over long periods and particularly in patients with a history of alcoholism or drug abuse. However, withdrawal symptoms occur even with normal therapeutic doses given for short periods of time. Withdrawal from benzodiazepines may be associated with physiological and psychological symptoms of withdrawal including depression, anxiety, tension, restlessness, confusion, irritability and headaches. Patients receiving benzodiazepines should be regularly monitored.

Rebound insomnia may also occur. It may be accompanied by other reactions such as changes in mood, anxiety, sleep disturbances and restlessness.

Loprazolam should be used with caution in chronic pulmonary insufficiency, cerebrovascular disease and chronic renal or hepatic impairment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Loprazolam may be potentiated by alcohol or other drugs acting on the CNS or with Cisapride. Additive synergy has been observed with neuromuscular depressants (curare-like drugs and muscle relaxants).

Combination with CNS depressants e.g. antipsychotics, hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines, causes enhancement of the central depressive effects of Loprazolam.

Concommitant intake with alcohol is not recommended. The sedative effects may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machinery.

The risk of a withdrawal syndrome occurring is increased when loprazolam is combined with other benzodiazepines prescribed as anxiolytics or hypnotics.

4.6 Pregnancy And Lactation

If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant.

If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression can be expected due to the pharmacological action of the compound.

Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependency and may be at some risk for developing withdrawal symptoms in the postnatal period.

Since benzodiazepines are found in the breast milk, they should not be given to breast feeding mothers.

4.7 Effects On Ability To Drive And Use Machines

Attention should be drawn to the risk of drowsiness, sedation, amnesia, impaired concentration and muscular weakness, especially in drivers of vehicles and operators of machines, when taking the product (see also “Interactions”).

4.8 Undesirable Effects

In general, Loprazolam is very well tolerated. However, the common side effects of benzodiazepines, including headaches, nausea, drowsiness, hypotonia, blurring of vision, dizziness and ataxia may occur on the following day, particularly in unusually sensitive patients or when dosage has been excessive.

Rare behavioural adverse effects of benzodiazepines include paradoxical aggressive outbursts, excitement, confusion and the uncovering of depression with suicidal tendencies. If these reactions should occur, use of the drug should be discontinued. Even more rare side effects reported with some benzodiazepines have been hypotension, gastro-intestinal and visual disturbances, skin rashes, urinary retention, changes in libido, blood dyscrasias and jaundice.

Benzodiazepines may induce anterograde amnesia. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

4.9 Overdose

As with other benzodiazepines, overdosage does not usually present a threat to life. Treatment is symptomatic and gastric lavage may be of use if performed shortly after ingestion. Use of a specific antidote such as flumazenil in association with symptomatic treatment in hospital should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benzodiazepines have a widespread action as a result of their enhancing the release of gamma-aminobutyric acid (GABA). They are effective as anti-convulsants, muscle relaxants, anti-anxiety agents, pre-medications and sedative hypnotics.

5.2 Pharmacokinetic Properties

The pharmacokinetics of oral Loprazolam given in a single dose or in repeated doses on 7 consecutive nights were studied in a balanced cross-over trial in six healthy male subjects aged 22-37 years. The subjects were allocated randomly to the treatment phases which were separated by 2-week drug-free intervals. Loprazolam was administered as 1mg tablets.

On the night of administration of the single dose and the seventh repeated dose, venous blood samples were taken before and at intervals after treatment. Serum Loprazolam concentrations were measured using both a radioimmunoassay (RIA) and the more specific high pressure liquid chromatography and gas chromatography (HPLC/GC) technique. Maximum serum levels (C_max) and the time taken to achieve them (T_max) were measured, and the half-life (t_1/2) was calculated. The area under the serum concentration-time curve (AUC) was determined using the trapezoidal rule. The ratios of AUC and C_max after repeated doses to AUC and C_max after single doses were used to assess possible accumulation of Loprazolam.

	MEAN (SD)
SINGLE DOSES	RIA data	HPLC/GC data
C_max (mcg/litre)	4.0 (1.2)	4.1 (2.2)
t_max (hours)	4.0 (2.1)	5.0 (3.6)
t_1/2 (hours)	11.7 (4.7)	8.0 (3.4)*
AUC (mcg/litre hour)	60.0 (20.9)	35.5 (22.2)

REPEATED DOSES	RIA data	HPLC/GC data
C_max (mcg/litre)	5.1 (1.2)	4.6 (2.1)
t_max (hours)	5.3 (3.7)	5.5 (2.7)
t_1/2 (hours)	12.8 (4.9)	3.5 (0.2)**
AUC (mcg/litre hour)	75.6 (21.1)	50.0 (26.9)

n = 6 subjects, except for *n = 5, **n = 3.

5.3 Preclinical Safety Data

No additional data of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Povidone, Lactose, Colloidal silicon dioxide, Maize starch, Microcrystalline cellulose and Magnesium stearate.

6.2 Incompatibilities

None.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25^oC in a dry place. Protect from light.

6.5 Nature And Contents Of Container

UPVC/aluminium foil blisters, packaged in cartons of 10, 28 or 30 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

Trading as: Winthrop Pharmaceuticals, P.O. Box 611, Guildford GU1 4YS.

8. Marketing Authorisation Number(S)

PL 17780/0306

9. Date Of First Authorisation/Renewal Of The Authorisation

17^th March 2009

10. Date Of Revision Of The Text

15 July 2010

LEGAL CLASSIFICATION

POM