Tuesday, May 29, 2012

Topcare Children's Ibuprofen




Generic Name: ibuprofen

Dosage Form: suspension
Topco Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)


Ibuprofen 100 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



Purpose


Pain reliever/fever reducer



Uses


temporarily:


  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

  • reduces fever


Warnings


Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:


  • hives

  • facial swelling

  • asthma (wheezing)

  • shock

  • skin reddening

  • rash

  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.


Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.


The chance is higher if your child


  • has had stomach ulcers or bleeding problems

  • takes a blood thinning (anticoagulant) or steroid drug

  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

  • takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.



Do not use


  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer

  • right before or after heart surgery


Ask a doctor before use if


  • the stomach bleeding warning applies to your child

  • child has a history of stomach problems, such as heartburn

  • child has not been drinking fluids

  • child has lost a lot of fluid due to vomiting or diarrhea

  • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease

  • child has asthma

  • child is taking a diuretic


Ask a doctor or pharmacist before use if the child is


  • under a doctor’s care for any serious condition

  • taking any other drug


When using this product


  • give with food or milk if stomach upset occurs

  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed


Stop use and ask a doctor if


  • child experiences any of the following signs of stomach bleeding:

  • feels faint

  • vomits blood

  • has bloody or black stools

  • has stomach pain that does not get better

  • the child does not get any relief within first day (24 hours) of treatment

  • fever or pain gets worse or lasts more than 3 days

  • redness or swelling is present in the painful area

  • any new symptoms appear


Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)



Directions


  • this product does not contain directions or complete warnings for adult use

  • do not give more than directed

  • do not give longer than 10 days, unless directed by a doctor (see Warnings)

  • shake well before using

  • find right dose on chart. If possible, use weight to dose; otherwise use age.

  • use only enclosed measuring cup

  • if needed, repeat dose every 6-8 hours

  • do not use more than 4 times a day

  • replace original bottle cap to maintain child resistance

  • wash dosage cup after each use























Dosing Chart
Weight (lb)Age(yrs)Dose (teaspoonful or mL)
under 2 yearsask a doctor
24-35 lbs2-3 years1 tsp or 5 mL
36-47 lbs4-5 years1 ½ tsp or 7.5 mL
48-59 lbs6-8 years2 tsp or 10 mL
60-71 lbs9-10 years2 ½ tsp or 12.5 mL
72-95 lbs11 years3 tsp or 15 mL

Other information


  • each teaspoon contains: sodium 2 mg

  • do not use if printed neckband is broken or missing

  • store at 20-25°C (68-77°F)

  • see bottom panel for lot number and expiration date


Inactive ingredients


anhydrous citric acid, butylparaben, FD&C red #40, flavors, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum



Questions or comments?


1-888-423-0139



Principal Display Panel


See New Warnings Information


For Ages 2 to 11


Children’s


Ibuprofen Oral Suspension


100 mg per 5 mL (teaspoonful)


Pain Reliever/Fever Reducer (NSAID)


Lasts Up to 8 Hours


Alcohol Free


Bubble Gum Flavor


Compare to Children’s Motrin® Bubble Gum Flavor active ingredient


Children's Ibuprofen Oral Suspension Carton










TOPCARE CHILDRENS IBUPROFEN 
ibuprofen  suspension










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-166
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN)IBUPROFEN100 mg  in 5 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorPINK (light)Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-166-261 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (36800-166-26)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493707/30/2002


Labeler - Topco Associates LLC (006935977)
Revised: 07/2009Topco Associates LLC




More Topcare Children's Ibuprofen resources


  • Topcare Children's Ibuprofen Side Effects (in more detail)
  • Topcare Children's Ibuprofen Use in Pregnancy & Breastfeeding
  • Drug Images
  • Topcare Children's Ibuprofen Drug Interactions
  • Topcare Children's Ibuprofen Support Group
  • 51 Reviews for Topcare Children's Ibuprofen - Add your own review/rating


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  • Frozen Shoulder
  • Gout, Acute
  • Headache
  • Muscle Pain
  • Osteoarthritis
  • Pain
  • Patent Ductus Arteriosus
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Monday, May 28, 2012

Atropine Ophthalmic Solution




Generic Name: atropine sulfate

Dosage Form: ophthalmic solution
ATROPINE SULFATE OPHTHALMIC SOLUTION 1%

STERI-UNITS®

STERILE OPHTHALMIC SOLUTION

FOR ONE TIME USE

Packaged in Pre-Sterilized Ready-to-Use Units—Sterile Unless Opened or Damaged


1. STERI-UNITS® Ophthalmic Solutions may be stored under ordinary conditions and handled freely prior to opening blister pack or vial without danger of contaminating the sterile surface of the enclosed DROP-TAINER® dispenser.

2. Open package using standard aseptic technique. The DROP-TAINER® dispenser may then be allowed to fall upon a sterile surface.

3. The entire outer surface of the DROP-TAINER® dispenser, as well as its contents, is sterile and thus may be safely handled by the surgeon or scrub nurse. The cap of the DROP-TAINER® dispenser is quickly and easily unscrewed; and the specially designed tip needs no puncturing before use.

4. Gentle pressure on the sides of the DROP-TAINER® dispenser will empty its contents in uniform drops.



Precautions



Carcinogenesis, Mutagenesis, Impairment of Fertility


There have been no long-term studies done using Atropine Sulfate in animals to evaluate carcinogenic potential.



Pregnancy


Pregnancy Category C. Animal reproduction studies have not been conducted with Atropine Sulfate. It is also not known whether these ingredients can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. STERI-UNITS® Solutions containing these ingredients should be given to a pregnant woman only if clearly needed.



Nursing Mothers


It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atropine Sulfate or Pilocarpine Hydrochloride is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


No overall differences in safety or effectiveness have been observed between elderly and younger patients.



STORAGE


Store Atropine Sulfate Ophthalmic Solution 1% at 46° - 80°F (8° -27°C). Protect from light.



Atropine Ophthalmic Solution Description


ATROPINE SULFATE OPHTHALMIC SOLUTION 1%


The active ingredient is represented by the chemical structure:


Established name: Atropine Sulfate

Chemical name: Benzeneacetic acid, α-(hydroxy-methyl)-, 8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester,endo-(±)-, sulfate (2:1) (salt), monohydrate.


Each mL Contains: Active: Atropine Sulfate 1%. Inactives: Boric Acid, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Water for Injection.



Atropine Ophthalmic Solution - Clinical Pharmacology


This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).



INDICATIONS & USAGE


For mydriasis and/or cycloplegia. For cycloplegic refraction; for papillary dilation desired in inflammatory conditions of the iris and uveal tract.



Contraindications


Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle; and in those persons showing hypersensitivity to any component of these preparations.



Warnings


For topical eye use only, not for injection. Use with extreme caution in infants, small children and geriatrics. Excessive use in children or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.



PATIENT WARNINGS


Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation.



Precautions


To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.



Adverse Reactions


Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in young children. Increase in IOP may occur in patients with open angle glaucoma. Photophobia may occur with a fixed and dilated pupil. Decreased lacrimation may aggravate a dry eye condition.



Overdosage


Systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distention in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination. Atropine poisoning, although distressing, is rarely fatal even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication discontinued. Treatment includes supportive measures including maintaining a patent airway and assisting respiration if needed. Treat hyperthermia, coma and seizures if they occur.1 In infants and children, the body surface must be kept moist. Excitement may be controlled by diazepam or a short acting barbiturate. For ingestion, activated charcoal can be used to prevent drug absorption. If necessary, ipecac or another cathartic may be useful for drug removal during initial treatment.1,2 Physostigmine is used as an antidote to the systemic effects of atropine and may be administered parenterally to provide more prompt relief of intoxication. Parenteral physostigmine may be particularly useful in cases of pronounced hallucinations, agitation in which a patient may be dangerous to himself or others, arrhythmias resulting in uncontrolled hemodynamic instability, and intractable seizures.



DOSAGE & ADMINISTRATION


One drop topically in the eye(s) as required, with care to avoid overdosage. Discard unused portion. May be used during ocular surgery.



How is Atropine Ophthalmic Solution Supplied


2 mL in DROP-TAINER® dispenser in carton of 12.

NDC 0065-0702-12



REFERENCES


1Kirk M, Kulig K, Rumack BH. Anticholinergics. In: Clinical management of Poisoning and Drug Overdose, Second Edition. Edited by Haddad LM, Winchester JF. Philadelphia, W.B. Saunders Company, 1990, p861-867.

2Tani SA. Anticholinergics. In: Poisoning and Drug Overdose, Second Edition. Olson KR. Norwalk, CT, Appleton & Lange, 1994, p75-76.



PRINCIPAL DISPLAY PANEL


STERi-UNiTS®


Single Dose DROP-TAINER® dispensers for topical use only.

Not for internal use. See package insert for directions.

Rx Only

©1999, 2006 Alcon, Inc.


12 x 2mL

STERILE


Alcon®Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

Printed in USA









ATROPINE SULFATE  
atropine sulfate  solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0065-0702
Route of AdministrationOPHTHALMICDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atropine Sulfate (Atropine)Atropine Sulfate10 mg  in 1 mL












Inactive Ingredients
Ingredient NameStrength
Boric Acid 
Sodium Hydroxide 
Hydrochloric Acid 
Water 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10065-0702-122 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/12/2000


Labeler - Alcon Laboratories, Inc. (008018525)









Establishment
NameAddressID/FEIOperations
Alcon Laboratories, Inc.008018525MANUFACTURE
Revised: 09/2011Alcon Laboratories, Inc.

More Atropine Ophthalmic Solution resources


  • Atropine Ophthalmic Solution Dosage
  • Atropine Ophthalmic Solution Use in Pregnancy & Breastfeeding
  • Atropine Ophthalmic Solution Drug Interactions
  • Atropine Ophthalmic Solution Support Group
  • 0 Reviews for Atropine Ophthalmic - Add your own review/rating


Compare Atropine Ophthalmic Solution with other medications


  • Pupillary Dilation
  • Refraction, Assessment
  • Uveitis

Saturday, May 26, 2012

Testomar


Generic Name: yohimbine (yo HIM bean)

Brand Names: Erex, Testomar, Yocon, Yohimar, Yohimbe, Yohimex


What is Testomar (yohimbine)?

Yohimbine increases the amount of blood that is allowed to flow into the penis and prevents blood from flowing out of the penis. It can cause an erection.


Yohimbine is used to treat and diagnose some types of impotence.


Yohimbine may also be used for purposes other than those listed in this product guide.


What is the most important information I should know about Testomar (yohimbine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Yohimbine may cause dizziness. If you experience dizziness, avoid these activities.

Use caution when rising from a sitting or lying position. Yohimbine may be more likely to cause dizziness when changing positions.


What should I discuss with my healthcare provider before taking Testomar (yohimbine)?


Before taking this medication, tell your doctor if you


  • have kidney disease;


  • have peptic ulcer disease (stomach ulcers);




  • are suffering from depression;




  • are being treated for a psychiatric condition; or




  • have any type of heart disease.



You may not be able to take yohimbine, or you may require a lower dose or special monitoring during therapy if you have any of the conditions listed above.


Yohimbine should not be used by women. Do not take this medication if you are pregnant or are breast-feeding. Yohimbine should not be used by children.

How should I take Testomar (yohimbine)?


Take yohimbine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water.

Yohimbine is usually taken three times a day. Follow your doctor's instructions.


Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra yohimbine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Symptoms of a yohimbine overdose include increased blood pressure (severe headache, blurred vision, flushing); a fast heart rate; numbness or tingling; runny nose; tremor; anxiety; poor coordination; and confusion or abnormal behavior.


What should I avoid while taking Testomar (yohimbine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Yohimbine may cause dizziness. If you experience dizziness, avoid these activities.

Use caution when rising from a sitting or lying position. Yohimbine may be more likely to cause dizziness when you change positions.


Testomar (yohimbine) side effects


If you experience any of the following serious side effects, stop taking yohimbine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • a very irregular or fast heartbeat; or




  • confusion or unusual behavior.



Other, less serious side effects are more likely to occur. Continue to take yohimbine and talk to your doctor if you experience



  • dizziness;




  • anxiety, irritability, or nervousness;




  • tremor (shaking);




  • headache; or




  • skin flushing.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Testomar (yohimbine)?


Before taking this medication, tell your doctor if you are taking a medicine for depression, mania, or another psychiatric condition. Generally, yohimbine should not be used with these medicines.


Drugs other than those listed here may also interact with yohimbine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More Testomar resources


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


  • yohimbine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Aphrodyne MedFacts Consumer Leaflet (Wolters Kluwer)

  • Yohimbe Natural MedFacts for Professionals (Wolters Kluwer)

  • Yohimbe Natural MedFacts for Consumers (Wolters Kluwer)



Compare Testomar with other medications


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Where can I get more information?


  • Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

See also: Testomar side effects (in more detail)


Friday, May 25, 2012

Naprelan


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 Naprelan


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 Naprelan


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 CategoryExplanation
All TrimestersCAnimal 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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Bleeding problems or

  • Blood clots or

  • Edema (fluid retention or body swelling) or

  • Heart attack, history of or

  • Heart disease (e.g., congestive heart failure) or

  • Hypertension (high blood pressure) or

  • Kidney disease or

  • Liver disease (e.g., hepatitis) or

  • Stomach or intestinal ulcers or bleeding, history of or

  • Stroke, history of—Use with caution. May make these conditions worse.

  • Aspirin-sensitive asthma or

  • Aspirin sensitivity, history of—Should not be used in patients with these conditions.

  • Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

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 Naprelan. 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 Naprelan


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.


Naprelan 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: Naprelan side effects (in more detail)



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.


More Naprelan resources


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


Compare Naprelan 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

Thursday, May 17, 2012

Sterets Unisept (Molnlycke Health Care )





1. Name Of The Medicinal Product



Sterets Unisept.


2. Qualitative And Quantitative Composition



Chlorhexidine Gluconate Solution 20% w/v BP 0.05% w/v.



3. Pharmaceutical Form



Sterile aqueous solution.



4. Clinical Particulars



4.1 Therapeutic Indications



Chlorhexidine gluconate is a potent antibacterial agent for general antiseptic purposes. It is bactericidal to a broad spectrum of organisms. Sterets Unisept is recommended for use in obstetrics and for swabbing burns and wounds.



4.2 Posology And Method Of Administration



There is no distinction between adults, the elderly and children. Sterets Unisept should be used without further dilution for topical administration only.



4.3 Contraindications



Sterets Unisept should not come into contact with the brain, eyes, meninges or middle ear. The use of Sterets Unisept is also contraindicated in patients who have shown hypersensitivity to chlorhexidine.



4.4 Special Warnings And Precautions For Use



For external use only. Not for injection. When Sterets Unisept is used in aseptic procedures, the outside of the sachet should be disinfected before opening. Discard any surplus immediately after use. Contact with eyes should be avoided. Do not use within body cavities.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with Sterets Unisept solution.



4.6 Pregnancy And Lactation



Although there are no adverse reports for this product in pregnant and lactating mothers, as with all medicines, care should be exercised when administering the product to pregnant or lactating women.



4.7 Effects On Ability To Drive And Use Machines



None known.



4.8 Undesirable Effects



Idiosyncratic skin reactions and generalised allergic reactions to chlorhexidine can occur, but these are rare.



4.9 Overdose



Treatment: Accidental ingestion - gastric lavage should be carried out with milk, egg white, gelatine or mild soap.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Chlorhexidine is a disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative bacteria: it is more effective against Gram-positive than Gram-negative bacteria, some species of Pseudomonas and Proteus being less susceptible. The wide range of organisms against which chlorhexidine is active explains the rationale for presenting it in a solution for swabbing wounds and burns and in obstetrics.



5.2 Pharmacokinetic Properties



The British Pharmacopoeia 1993 contains a monograph for Chlorhexidine Gluconate Solution 20% w/v. The pharmacokinetics of the compound when applied to the skin as a topical antiseptic are well understood and described in the literature.



5.3 Preclinical Safety Data



Not applicable.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Nonoxynol 10; sodium hydroxide; Carmoisine Red E122; purified water.



6.2 Incompatibilities



Sterets Unisept is incompatible with anionic agents.



6.3 Shelf Life



36 months.



6.4 Special Precautions For Storage



Store in a cool dark place. Store sachets in the outer containers.



6.5 Nature And Contents Of Container



Nylon-ethylene-propylene copolymer laminate sachets containing either 25 ml or 100 ml of product overwrapped in heat sealed polythene/nylon and / or polythene/polyester pouches.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS.



8. Marketing Authorisation Number(S)



PL: 21248/0037.



9. Date Of First Authorisation/Renewal Of The Authorisation



10th April 2006.



10. Date Of Revision Of The Text



April 2006.




Monday, May 14, 2012

Adoxa TT


Generic Name: doxycycline (Oral route)

dox-i-SYE-kleen

Commonly used brand name(s)

In the U.S.


  • Adoxa

  • Adoxa CK

  • Adoxa Pak

  • Adoxa TT

  • Alodox

  • Doryx

  • Monodox

  • Oracea

  • Periostat

  • Vibramycin Calcium

  • Vibramycin Hyclate

  • Vibramycin Monohydrate

  • Vibra-Tabs

Available Dosage Forms:


  • Tablet

  • Powder for Suspension

  • Capsule

  • Capsule, Extended Release

  • Tablet, Delayed Release

  • Capsule, Delayed Release

  • Syrup

Therapeutic Class: Antibiotic


Chemical Class: Tetracycline (class)


Uses For Adoxa TT


Doxycycline is used to treat bacterial infections in many different parts of the body. It is also used to treat pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne.


Doxycycline delayed-release tablets are also used to prevent malaria and treat anthrax infection after possible exposure and other problems as determined by your doctor.


Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.


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


Before Using Adoxa TT


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


Doxycycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger (except for treatment of exposure to inhalational anthrax), unless directed by the child's doctor.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxycycline in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving doxycycline.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies 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 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.


  • Acitretin

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.


  • Digoxin

  • Isotretinoin

  • Methotrexate

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.


  • Aluminum Carbonate, Basic

  • Aluminum Hydroxide

  • Aluminum Phosphate

  • Bismuth Subsalicylate

  • Calcium

  • Desogestrel

  • Dienogest

  • Dihydroxyaluminum Aminoacetate

  • Dihydroxyaluminum Sodium Carbonate

  • Drospirenone

  • Estradiol Cypionate

  • Estradiol Valerate

  • Ethinyl Estradiol

  • Ethynodiol Diacetate

  • Etonogestrel

  • Fosphenytoin

  • Iron

  • Levonorgestrel

  • Magaldrate

  • Magnesium Carbonate

  • Magnesium Hydroxide

  • Magnesium Oxide

  • Magnesium Trisilicate

  • Medroxyprogesterone Acetate

  • Mestranol

  • Norelgestromin

  • Norethindrone

  • Norgestimate

  • Norgestrel

  • Penicillin G

  • Penicillin G Procaine

  • Penicillin V

  • Rifampin

  • Rifapentine

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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Diarrhea or

  • Vaginal candidiasis (yeast) infections—Use with caution. May make these conditions worse.

  • Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of doxycycline

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


Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.


To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.


If you are using Doryx® delayed-release tablets:


  • It may be taken with food or milk, if it upsets your stomach.

  • You may take this medicine by breaking the tablets. Hold the tablet between your thumb and index fingers close to the appropriate score (separation) line. Then, apply enough pressure to snap the tablet segments apart. Do not use the tablet if it does not break on the scored lines.

  • You may also take this medicine by sprinkling the equally broken tablets onto cold, soft food such as an applesauce. This mixture must be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not store the mixture for later use.

  • Drink plenty of fluids to avoid throat irritation and ulceration.

If you are using this medicine to prevent malaria while traveling, start taking the medicine 1 or 2 days before you travel. Take the medicine every day during your trip and continue taking it for 4 weeks after you return. However, do not use the medicine for longer than 4 months.


If you are using For Oracea™ delayed-release capsules:


  • You should take this medicine on an empty stomach, preferably at least 1 hour before or 2 hours after meals.

  • You should take this medicine with a full glass of water while sitting or standing.

  • To prevent throat irritation, do not lay down right after taking this medicine.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.


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 oral dosage form (delayed-release tablets):
    • For infections:
      • Adults—100 milligrams (mg) every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.

      • Children older than 8 years of age who weigh 45 kg or less—Dose is based on body weight and must be determined by your doctor. The dose is usually 4.4 milligrams (mg) per kilogram (kg) of body weight per day and divided into two doses on the first day of treatment. This is followed by 2.2 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days.

      • Children up to 8 years of age—Use is not recommended.


    • For the prevention of malaria:
      • Adults—100 milligrams (mg) once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.

      • Children older than 8 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.

      • Children up to 8 years of age—Use is not recommended.



  • For oral dosage form (delayed-release capsules):
    • For the treatment of pimples from rosacea:
      • Adults—40 milligrams (mg) or one capsule once a day, in the morning.

      • 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 Adoxa TT


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


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.


This medicine may darken the color of your skin, nails, eyes, teeth, gums, or scars. Talk with your doctor if you have any concerns.


Doxycycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


Birth control pills (containing estrogen) may not work properly while you are using doxycycline. To keep from getting pregnant, use other forms of birth control. These include condoms, diaphragms, or contraceptive foams or jellies.


Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:


  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

  • Wear protective clothing, including a hat. Also, wear sunglasses.

  • Apply a sunblock product that has a skin protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

  • Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.

  • Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.


Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.


You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron such as vitamin or mineral supplements.


If you are using this medicine to prevent malaria, take extra care not to get bitten by mosquitoes. Use protective clothing, mosquito netting or screens, and an insect repellent.


Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.


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.


Adoxa TT 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:


Incidence not known
  • Abdominal or stomach tenderness

  • bloating

  • clay-colored stools

  • cough

  • dark urine

  • decreased appetite

  • diarrhea

  • diarrhea, watery and severe, which may also be bloody

  • difficulty with swallowing

  • dizziness

  • fast heartbeat

  • feeling of discomfort

  • fever

  • headache

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

  • hives or welts

  • increased thirst

  • inflammation of the joints

  • itching

  • joint or muscle pain

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

  • loss of appetite

  • nausea and vomiting

  • numbness or tingling of the face, hands, or feet

  • pain

  • rash

  • redness and soreness of the eyes

  • redness of the skin

  • shortness of breath

  • sore throat

  • sores in the mouth

  • stomach cramps

  • stomach pain or tenderness

  • swelling of the feet or lower legs

  • swollen lymph glands

  • tightness in the chest

  • unusual tiredness or weakness

  • unusual weight loss

  • wheezing

  • yellow eyes or skin

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:


Incidence not known
  • Back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • blurred vision

  • bulging soft spot on the head of an infant

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

  • chest pain, discomfort, or burning

  • chills

  • cracks in the skin

  • decrease in vision

  • difficulty breathing

  • discoloration of the thyroid glands

  • double vision

  • general body swelling

  • heartburn

  • increased sensitivity of the skin to sunlight

  • loss of heat from the body

  • lower back or side pain

  • nosebleeds

  • pain or burning in the throat

  • pain with swallowing

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

  • rash with flat lesions or small raised lesions on the skin

  • red, swollen skin

  • redness or other discoloration of the skin

  • redness, swelling, or soreness of the tongue

  • scaly skin

  • severe nausea

  • severe stomach pain

  • severe sunburn

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

  • unusual bleeding or bruising

  • vomiting blood

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: Adoxa TT side effects (in more detail)



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