Friday, 5 October 2012

CaviRinse Sodium Fluoride Oral Rinse





Dosage Form: oral mouthwash
CaviRinse™

0.2% Sodium Fluoride Oral Rinse

DESCRIPTION:


CaviRinse oral rinse is a prescription formulation for use in the prevention of dental caries. This formulation contains 0.2% sodium fluoride in a neutral pH base to help prevent caries and enhance remineralization.



ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.



INACTIVE INGREDIENTS: Water, Glycerine, Microdent® (Ultramulsion® of dimethicone and poloxamer), sodium saccharin, flavoring, cetylpyridinum chloride.



CLINICAL PHARMACOLOGY:


The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. CaviRinse oral rinse provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges.



INDICATIONS AND USAGE:


CaviRinse oral rinse is indicated for use as part of a professional program for the prevention and control of dental caries. CaviRinse oral rinse should be swished vigorously between your teeth once weekly after brushing with conventional toothpaste, unless otherwise instructed by a dental professional.



CONTRAINDICATIONS:


Do not use in children less than 6 years of age unless recommended by a dental professional.



WARNINGS:


DO NOT SWALLOW. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.



ADVERSE REACTIONS:


Allergic reactions and other idiosyncrasies have been rarely reported.



OVERDOSAGE:


Medical attention should be sought if more than a standard dose is accidentally swallowed. A single 10ml application of CaviRinse oral rinse contains approximately 9mg of fluoride ion.



DOSAGE AND ADMINISTRATION:


Follow these instructions unless otherwise instructed by a dental professional. Use once weekly after brushing your teeth with a toothpaste. Pour 10ml of CaviRinse oral rinse into the dosage cup, vigorously swish between your teeth for one minute and then spit out. Children 6 to 16 years of age should thoroughly rinse mouth with water.



HOW SUPPLIED:


8oz (236.59ml) of rinse in a plastic bottle with dosage cup.



STORAGE: Do not freeze or expose to extreme heat.


Rx Only


Vanilla Mint Flavor – NDC 48878-3223-8


Made in U.S.A. by

3M ESPE

Dental Products

St. Paul, MN 55144-1000 U.S.A.

1-800-634-2249


CaviRinse is a trademark of 3M or 3M ESPE AG. MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.


© 3M 2010. All rights reserved.



Principal Display Panel – Carton Label


NDC 48878-3223-8


Mint


3M ESPE


CaviRinse™


0.2 % Sodium Fluoride


Oral Rinse


Rx Only


Keep out of reach of children.


IMPORTANT: Read


directions thoroughly.


OMNI™


Contents:


8 fl oz


(236.59ml)




Principal Display Panel – Bottle Label


NDC 48878-3223-8


Mint


3M ESPE


CaviRinse™


0.2 % Sodium Fluoride


Oral Rinse


Rx Only


Keep out of reach of children.


IMPORTANT: Read


directions thoroughly.


OMNI™


Contents:


8 fl oz


(236.59ml)










CAVIRINSE 
sodium fluoride  mouthwash










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)48878-3223
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion)sodium fluoride2 mg  in 1 mL












Inactive Ingredients
Ingredient NameStrength
water 
glycerin 
saccharin sodium 
cetylpyridinium chloride anhydrous 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
148878-3223-81 BOTTLE In 1 BOXcontains a BOTTLE
1236.59 mL In 1 BOTTLEThis package is contained within the BOX (48878-3223-8)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2005


Labeler - 3M ESPE Dental Products (799975909)









Establishment
NameAddressID/FEIOperations
3M ESPE Dental Products799975909MANUFACTURE
Revised: 08/20093M ESPE Dental Products




More CaviRinse Sodium Fluoride Oral Rinse resources


  • CaviRinse Sodium Fluoride Oral Rinse Use in Pregnancy & Breastfeeding
  • CaviRinse Sodium Fluoride Oral Rinse Support Group
  • 3 Reviews for CaviRinse Sodium Fluoride Oral - Add your own review/rating


Compare CaviRinse Sodium Fluoride Oral Rinse with other medications


  • Prevention of Dental Caries

Thursday, 4 October 2012

Vimovo



Generic Name: naproxen and esomeprazole (Oral route)


na-PROX-en, es-oh-MEP-ra-zole mag-NEE-zee-um


Oral route(Tablet, Delayed Release)

Esomeprazole magnesium/naproxen 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 CABG surgery. Esomeprazole magnesium/naproxen contains an NSAID. NSAID-containing products 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.


  • Vimovo

Available Dosage Forms:


  • Tablet, Delayed Release

Therapeutic Class: Antirheumatic


Pharmacologic Class: NSAID


Chemical Class: Propionic Acid (class)


Uses For Vimovo


Naproxen and esomeprazole combination is used to relieve the symptoms of ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. It is used for patients who have an increased risk for stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis or ankylosing spondylitis.


Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, inflammation, swelling, stiffness, and joint pain. Esomeprazole is a proton pump inhibitor (PPI) that is used to treat certain conditions where too much acid is produced in the stomach (e.g., duodenal and gastric ulcers).


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


Before Using Vimovo


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 and esomeprazole combination in the pediatric population. 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 and esomeprazole combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.


Pregnancy














Pregnancy CategoryExplanation
1st TrimesterCAnimal 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.
2nd TrimesterCAnimal 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.
3rd TrimesterDStudies 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.


  • Ketorolac

  • Pentoxifylline

  • Rilpivirine

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

  • Atazanavir

  • Beclamide

  • Beta Glucan

  • Bivalirudin

  • Caramiphen

  • Carbamazepine

  • Certoparin

  • Chlormethiazole

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Dasatinib

  • Desirudin

  • Diazepam

  • Dipyridamole

  • Enoxaparin

  • Erlotinib

  • Escitalopram

  • Ethotoin

  • Felbamate

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Fosphenytoin

  • Gabapentin

  • Ginkgo

  • Heparin

  • Lacosamide

  • Lepirudin

  • Mephenytoin

  • Mephobarbital

  • Methotrexate

  • Mycophenolate Mofetil

  • Nadroparin

  • Nefazodone

  • Nelfinavir

  • Nilotinib

  • 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

  • Cranberry

  • 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

  • Posaconazole

  • Propranolol

  • Quinapril

  • Ramipril

  • Sotalol

  • Spirapril

  • Spironolactone

  • Talinolol

  • Tasosartan

  • Telmisartan

  • Temocapril

  • Tertatolol

  • Timolol

  • Tolazamide

  • Tolbutamide

  • Torsemide

  • Trandolapril

  • Triamterene

  • Trichlormethiazide

  • Valsartan

  • Venlafaxine

  • Warfarin

  • 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

  • Congestive heart failure or

  • Crohn's disease, history of or

  • Edema (fluid retention or swelling) or

  • Heart attack, history of or

  • Heart or blood vessel disease or

  • Hypertension (high blood pressure) or

  • Hypomagnesemia (low magnesium in the blood), history of or

  • Kidney disease or

  • Liver disease or

  • Osteoporosis (weak bones) or

  • Stomach ulcers or bleeding, history of or

  • Stroke, history of or

  • Ulcerative colitis, 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 Vimovo


Use this medicine exactly as ordered 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 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.


It is best to take this medicine on an empty stomach about 30 minutes before a meal.


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


Your doctor may tell you to take vitamin D and calcium supplements while you are using this medicine.


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 rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
      • Adults—One tablet two times per day.

      • 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 Vimovo


It is very important that your doctor check your progress at regular visits while you are taking this medicine. 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.


Naproxen may increase 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.


Naproxen 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 steroids or a blood thinner).


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.


Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using 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.


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


Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.


This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.


Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.


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.


Vimovo 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
  • Burning feeling in the chest or stomach

  • indigestion

  • loss of appetite

  • nausea

  • stomach bloating, cramping, or pain

  • tenderness in the stomach area

  • upper abdominal or stomach pain

  • upset stomach

  • vomiting

  • weight loss

Less common
  • Abdominal or stomach discomfort

  • black, tarry stools

  • bladder pain

  • bloating or swelling of the face, arms, hands, lower legs, or feet

  • bloody or cloudy urine

  • bloody stools

  • chest pain

  • difficult, burning, or painful urination

  • difficulty with moving

  • difficulty with swallowing

  • frequent urge to urinate

  • full or bloated feeling

  • heartburn

  • lower back or side pain

  • muscle pain or stiffness

  • pain in the joints

  • pain or burning in the throat

  • pressure in the stomach

  • rapid weight gain

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

  • swelling of the abdominal or stomach area

  • tingling of the hands or feet

  • unusual weight gain or loss

  • vomiting of blood or material that looks like coffee grounds

Incidence not known
  • Drowsiness

  • mood or mental changes

  • muscle spasms (tetany) or twitching seizures

  • trembling

  • unusual tiredness or weakness

  • vomiting

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
  • Acid or sour stomach

  • belching

  • diarrhea

Less common
  • Body aches or pain

  • change in taste

  • chills

  • cough

  • cough producing mucus

  • difficulty having a bowel movement (stool)

  • difficulty with breathing

  • ear congestion

  • excess air or gas in the stomach or intestines

  • fever

  • headache

  • loss of taste

  • loss of voice

  • nasal congestion

  • pain or tenderness around the eyes and cheekbones

  • passing gas

  • shortness of breath or troubled breathing

  • sneezing

  • sore throat

  • stuffy or runny nose

  • tightness of the chest or wheezing

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: Vimovo 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.


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More Vimovo resources


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


  • Vimovo Prescribing Information (FDA)

  • Vimovo Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vimovo Consumer Overview



Compare Vimovo with other medications


  • Ankylosing Spondylitis
  • NSAID-Induced Ulcer Prophylaxis
  • Osteoarthritis
  • Rheumatoid Arthritis

Wednesday, 3 October 2012

Ilana




Ilana may be available in the countries listed below.


Ingredient matches for Ilana



Isoconazole

Isoconazole nitrate (a derivative of Isoconazole) is reported as an ingredient of Ilana in the following countries:


  • Colombia

International Drug Name Search

Tuesday, 2 October 2012

gadoteridol Intravenous


gad-oh-TER-i-dol


Intravenous route(Solution)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .



Commonly used brand name(s)

In the U.S.


  • Prohance

Available Dosage Forms:


  • Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media


Uses For gadoteridol


Gadoteridol injection is a magnetic resonance imaging (MRI) contrast agent. Contrast agents are used to help create a clear picture of the body during MRI scans. MRI scans are a special kind of procedure that let a doctor look at the inside of the body, such as the brain. They use magnets and computers to create images or “pictures” of the body. Unlike x-rays, MRI scans do not involve radiation. Gadoteridol is a gadolinium-based contrast agent (GBCA) that is given by injection before the MRI to help diagnose problems in the brain, spine, head, or neck.


gadoteridol is to be used only by or under the direct supervision of a doctor.


Before Using gadoteridol


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 gadoteridol, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to gadoteridol 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadoteridol injection in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.


Geriatric


No information is available on the relationship of age to the effects of gadoteridol injection in geriatric patients.


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


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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 gadoteridol. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Asthma, history of or

  • Diabetes or

  • Hypertension (high blood pressure) or

  • Sickle cell anemia—Use with caution. May increase risk for side effects.

  • Kidney problems, severe, history of or

  • Liver disease or

  • Seizures (grand mal), history of—Use with caution. May cause side effects to become worse.

Proper Use of gadoteridol


A doctor or other trained health professional will give you gadoteridol. gadoteridol is given through a needle placed in one of your veins just before you have an MRI scan.


Precautions While Using gadoteridol


It is very important that your doctor check the progress of you or your child while you are receiving gadoteridol and during the MRI scan. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.


Check with your doctor or nurse right away if you or your child have burning or itching of the skin; deep bone pain in the hips or ribs; joint stiffness; a limited range of motion in the arms and legs; muscle weakness; red or dark patches on the skin of the arms or legs; or skin swelling, hardening, or tightening within the first few days or weeks after you receive gadoteridol. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).


gadoteridol may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor or nurse right away if you or your child have chest pain; cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; or trouble with breathing after you receive the medicine.


gadoteridol 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 or nurse immediately if any of the following side effects occur:


Rare
  • Bluish color of the fingernails, lips, skin, palms, or nail beds

  • blurred vision

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

  • chest pain or discomfort

  • confusion

  • cough

  • decreased awareness or responsiveness

  • difficult or labored breathing

  • difficulty swallowing

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fainting

  • feeling of warmth

  • fever

  • general feeling of discomfort or illness

  • headache

  • hives

  • hoarseness

  • increased salivation

  • itching

  • loss of bladder control

  • loss of consciousness

  • low blood pressure or pulse

  • nervousness

  • pounding in the ears

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

  • redness of the face, neck, arms, and occasionally, upper chest

  • seizures

  • shakiness in the legs, arms, hands, or feet

  • shortness of breath

  • skin rash

  • slow, fast, or irregular breathing

  • spasm of the throat

  • sweating

  • tightness in the chest

  • trembling or shaking of the hands or feet

  • unconsciousness

  • unusual tiredness or weakness

  • wheezing

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:


Less common
  • Bad, unusual, or unpleasant (after) taste

  • nausea

Rare
  • Abdominal or stomach cramps

  • anxiety

  • bleeding gums

  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

  • continuing ringing or buzzing or other unexplained noise in the ears

  • diarrhea

  • dry mouth

  • hearing loss

  • irritation in the mouth

  • loss of coordination in the arms

  • mouth ulcers

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

  • redness and swelling of the gums

  • runny nose

  • sneezing

  • stuffy nose

  • tingling sensation in the throat

  • voice changes

  • vomiting

  • watery eyes

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: gadoteridol Intravenous 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 gadoteridol Intravenous resources


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


Compare gadoteridol Intravenous with other medications


  • CNS Magnetic Resonance Imaging

Detrunorm XL 30 mg Modified Release Capsules





1. Name Of The Medicinal Product



Detrunorm XL 30 mg Modified Release Capsules


2. Qualitative And Quantitative Composition



Each capsule contains 30 mg propiverine hydrochloride (equivalent to 27.28 mg propiverine).



Excipient(s): Lactose monohydrate.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Modified-release capsules, hard.



Orange and white size 3 capsules containing white to off-white pellets.



4. Clinical Particulars



4.1 Therapeutic Indications



The treatment of urinary incontinence, as well as urgency and frequency in patients who have idiopathic detrusor overactivity (overactive bladder).



4.2 Posology And Method Of Administration



Capsules for oral use.



The recommended daily doses are as follows:



Adults: As a standard dose one capsule (= 30 mg propiverine hydrochloride) once a day is recommended.



Elderly: Generally there is no special dosage regimen for the elderly (see 5.2).



Children: Due to a lack of data, this product should not be used in children.



There is no clinically relevant effect of food on the pharmacokinetics of propiverine (see 5.2). Accordingly, there is no particular recommendation for the intake of propiverine in relation to food.



4.3 Contraindications



The drug is contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients and in patients suffering from one of the following disorders:



- obstruction of the bowel



- significant degree of bladder outflow obstruction where urinary retention may be anticipated



- myasthenia gravis



- intestinal atony



- severe ulcerative colitis



- toxic megacolon



- uncontrolled angle closure glaucoma



- moderate or severe hepatic impairment



- tachyarrhythmias.



This drug is also contraindicated in women who are pregnant or breast-feeding an infant.



4.4 Special Warnings And Precautions For Use



The drug should be used with caution in patients suffering from:



autonomic neuropathy.



Symptoms of the following diseases may be aggravated following administration of the drug:



severe congestive heart failure (NYHA IV)



prostatic hypertrophy



hiatus hernia with reflux oesophagitis



cardiac arrhythmia



tachycardia.



Propiverine, like other anticholinergics, induces mydriasis. Therefore, the risk to induce acute angle-closure glaucoma in individuals predisposed with narrow angles of the anterior chamber may be increased.



Drugs of this class have been reported to induce or precipitate acute angle-closure glaucoma.



Pollakiuria and nocturia due to renal disease or congestive heart failure as well as organic bladder diseases (e.g. urinary tract infections, malignancy) should be ruled out prior to treatment.



Due to a lack of data Detrunorm XL 30 mg Capsules should not be used in children.



This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Increased effects due to concomitant medication with tricyclic antidepressants (e.g. imipramine), tranquillisers (e.g. benzodiazepines), anticholinergics (if applied systemically), amantadine, neuroleptics (e.g. phenothiazines) and beta-adrenoceptor agonists (beta-sympathomimetics). Decreased effects due to concomitant medication with cholinergic drugs. Reduced blood pressure in patients treated with isoniazid. The effect of prokinetics such as metoclopramide may be decreased.



Pharmacokinetic interactions are possible with other drugs metabolised by cytochrome P450 3A4 (CYP 3A4). However, a very pronounced increase of concentrations for such drugs is not expected as the effects of propiverine are small compared to classical enzyme inhibitors (e.g. ketoconazole or grapefruit juice). Propiverine may be considered as weak inhibitor of cytochrome P450 3A4. Pharmacokinetic studies with patients concomitantly receiving potent CYP 3A4 inhibitors such as azole antifungals (e.g. ketoconazole, itraconazole) or macrolide antibiotics (e.g. erythromycin, clarithromycin) have not been performed.



4.6 Pregnancy And Lactation



In animal studies, skeletal retardation in the offspring occurred when the drug was administered orally at high doses to pregnant females. The drug was also secreted into the milk of lactating mammals.



Propiverine hydrochloride should therefore not be administered to pregnant or nursing women.



4.7 Effects On Ability To Drive And Use Machines



Propiverine hydrochloride may produce drowsiness and blurred vision. This may impair the patient's ability to exert activities that require mental alertness such as operating a motor vehicle or other machinery, or to exert hazardous work while taking this drug.



Sedative drugs may enhance the drowsiness caused by propiverine hydrochloride.



4.8 Undesirable Effects














































Adverse reactions




System organ class (Disorders according to MedDRA)




Very common (>1/10)




 




- dry mouth




Gastrointestinal




Common (>1/100, <1/10)



 


- accommodation abnormal, accommodation disturbances, vision abnormal




Eye




- constipation




Gastrointestinal




Uncommon (>1/1,000, <1/100)



 


- fatigue




General disorders and administration site conditions




- nausea/vomiting




Gastrointestinal




- dizziness




Nervous system




- tremor




Nervous system




- urinary retention




Urinary system




- flushing




Vascular




- decreased blood pressure with drowsiness




Vascular




Rare (>1/10,000, <1/1,000)



 


- rash due to idiosyncrasy (propiverine hydrochloride) or hypersensitivity (excipients, e.g. colorant)




Skin and subcutaneous tissue



Very rare (<1/10,000, including isolated reports)

 


- palpitation




Cardiac




- restlessness, confusion




Psychiatric




1 Not known (cannot be estimated from the available data)



 


- hallucination




Psychiatric



All undesirable effects are transient and recede after a dose reduction or termination of the therapy after maximum 1-4 days.



During long-term therapy hepatic enzymes should be monitored, because reversible changes of liver enzymes might occur in rare cases. Monitoring of intraocular pressure is recommended in patients at risk of developing glaucoma.



Particular attention should be paid to the residual urine volume in cases of urinary tract infections.



1 PL20072/0016-0009; 27/08/2008



4.9 Overdose



Overdose with the muscarinic receptor antagonist propiverine hydrochloride can potentially result in central anticholinergic effects, e.g. restlessness, dizziness, vertigo, disorders in speech and vision and muscular weakness.



Moreover, severe dryness of mucosa, tachycardia and urinary retention may occur.



Treatment should be symptomatic and supportive. Management of overdose may include initiation of vomiting or gastric lavage using an oiled tube (attention: dryness of mucosa!), followed by symptomatic and supportive treatment as for atropine overdose (e.g. physostigmine) with a dosage of 1.0 to 2.0 mg in adults by slow intravenous injection (may be repeated as necessary to a total of 5 mg).



A 14-years old girl who ingested 450 mg propiverine hydrochloride presented with confabulation. The adolescent fully recovered.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC code: G04B D06



Pharmacotherapeutic group: spasmolytic, anticholinergic.



Mechanism of action



Inhibition of calcium influx and modulation of intracellular calcium in urinary bladder smooth muscle cells causing musculotropic spasmolysis.



Inhibition of the efferent connection of the nervus pelvicus due to anticholinergic action.



Pharmacodynamic effects



In animal models propiverine hydrochloride causes a dose-dependent decrease of the intravesical pressure and an increase in bladder capacity.



The effect is based on the sum of the pharmacological properties of propiverine and three active urinary metabolites as shown in isolated detrusor strips of human and animal origin.



5.2 Pharmacokinetic Properties



General characteristics of the active substance



Propiverine is nearly completely absorbed from the gastrointestinal tract. It undergoes extensive first pass metabolism. Effects on urinary bladder smooth muscle cells are due to the parent compound and three active metabolites as well, which are rapidly excreted into the urine.



Absorption



After oral administration of Detrunorm XL 30 mg Capsules propiverine is absorbed from the gastrointestinal tract with maximal plasma concentrations reached after 9.9 hours. The mean absolute bioavailability of Detrunorm XL 30 mg Capsules is 60.8 ± 17.3% (arithmetic mean value ± SD for AUC0-(p.o.) / AUC0- (i.v.)).



In comparison with administration under fasting conditions, when a propiverine hydrochloride 45 mg modified release capsule is administered after a meal absorption is delayed by 1 hour, but the bioavailability of propiverine is 99%, Cmax is 3% lower and tmax is identical. Food intake therefore has no significant effect on the pharmacokinetics of propiverine hydrochloride modified release capsules.



Distribution



After administration of Detrunorm XL 30 mg Capsules, steady state is reached after four to five days at a higher concentration level than after single dose application (C average = 71 ng/ml).



The volume of distribution was estimated in 21 healthy volunteers after intravenous administration of propiverine hydrochloride to range from 125 to 473 l (mean 279l) indicating that a large amount of available propiverine is distributed to peripheral compartments. The binding to plasma proteins is 90 - 95 % for the parent compound and about 60 % for the main metabolite.



Pharmacokinetic characteristics (geometric mean, ± SD, range) of propiverine in 10 healthy volunteers after single dose administration of Detrunorm XL 30 mg Capsules and propiverine hydrochloride modified release capsules 45 mg:






















Dose [mg]




30




45




AUC0- [ng




1378



(903, 2104)




1909



(1002, 3639)




Cmax [ng/ml]




60.6



(41.5, 88.6)




80.0



(41.8, 152.1)




t1/2 [h]




14.2



(10.8, 18.6)




16.3



(13.9, 19.2)




tmax [h]




9.9



± 2.4




9.9



± 2.4



 
  


Plasma concentrations of propiverine in 10 healthy volunteers after single dose administration of Detrunorm XL 30 mg Capsules and propiverine hydrochloride modified release capsules 45 mg:





Steady state characteristics of propiverine following multiple-dose administration to 24 healthy volunteers of propiverine hydrochloride modified release capsules 45 mg once daily for 7 days:



























 


geometric mean




range or ±SD




AUC 0-24h [ng




1711




1079, 2713




PTF [%]




109.4




81.2, 147.5




Cav [ng/ml]




71




45.0, 113.0




Cmax [ng/ml]




105




71, 155




Cmin [ng/ml]




29




20, 42




t1/2 [h]




20.4




12.8, 32.3




tmax [h]




7.3




± 2.5



PTF: peak-trough fluctuation



Plasma concentrations of propiverine on day 7 and trough levels during treatment following multiple-dose administration of propiverine hydrochloride modified release capsules 45 mg to 24 healthy volunteers once daily for 7 days:





Biotransformation



Propiverine is extensively metabolised by intestinal and hepatic enzymes. The primary metabolic route involves the oxidation of the Piperidyl-N and is mediated by CYP 3A4 and Flavin-monoxygenases (FMO) 1 and 3 and leads to the formation of the much less active N-oxide, the plasma concentration of which greatly exceeds that of the parent substance. Four metabolites were identified in urine; three of them are pharmacologically active and may contribute to the therapeutic efficacy.



In vitro there is a slight inhibition of CYP 3A4 and CYP 2D6 detectable which occurs at concentrations exceeding therapeutic plasma concentrations 10- to 100-fold (see section 4.5).



Elimination



Following administration of 30 mg oral dose of 14C-propiverine hydrochloride to healthy volunteers, 60 % of radioactivity was recovered in urine and 21 % was recovered in faeces within 12 days. Less than 1% of an oral dose is excreted unchanged in the urine. Mean total clearance after single dose administration of 30 mg is 371 ml/min (191 – 870 ml/min).



Linearity/non-linearity



Pharmacokinetic parameters of propiverine following oral administration of 10 – 45 mg of propiverine hydrochloride are linearly related to dose.



Correlation between the oral dose of extended release propiverine and the resulting AUC0-:





Correlation between the oral dose of extended release propiverine and the resulting Cmax:





Characteristics in patients



Renal impairment



Severe renal impairment does not significantly alter the disposition of propiverine and its main metabolite, propiverine-N-oxide, as deduced from a single dose study in 12 patients with creatinine clearance < 30 ml/min. No dose adjustment is to be recommended.



Hepatic insufficiency



There were similar steady state pharmacokinetics in 12 patients with mild to moderate impairment of liver function due to fatty liver disease as compared to 12 healthy controls. No data are available for severe hepatic impairment.



Age



The comparison of trough plasma concentrations during steady state reveals no difference between older patients (60 – 85 years; mean 68) and young healthy subjects. The ratio of parent drug to metabolite remains unchanged in older patients indicating the metabolic conversion of propiverine to its main metabolite, propiverine-N-oxide, not to be an age-related or limiting step in the overall excretion. As bioequivalence of Detrunorm 15 mg Coated Tablets t.i.d. and propiverine hydrochloride modified release capsules 45 mg s.i.d. was established in a GCP compliant study the same can be concluded for Detrunorm XL 30 mg Capsules.



Patients with glaucoma



The treatment with Detrunorm XL 30 mg Capsules will not lead to an increase of intraocular pressure in patients with open angle glaucoma and in patients with treated (controlled) angle closure glaucoma.



5.3 Preclinical Safety Data



In long term oral dose studies in two mammalian species the main treatment related effect were changes in the liver (including elevation of hepatic enzymes). These were characterised by hepatic hypertrophy and fatty degeneration. The fatty degeneration was reversible upon cessation of treatment.



In animal studies, skeletal retardation in the offspring occurred when the drug was administered orally at high doses to pregnant females. In lactating mammals propiverine hydrochloride was excreted into the milk.



There was no evidence of mutagenicity. Carcinogenicity studies in rodents revealed three types of tumours which were considered to be species specific and therefore not of clinical relevance.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Pellets



Citric acid (anhydrous)



Povidone



Lactose monohydrate



Talc



Triethyl citrate



Magnesium stearate



Methacrylic acid-methyl methacrylate copolymer (1:1)



Methacrylic acid-methyl methacrylate copolymer (1:2)



Ammonio methacrylate copolymer type A



Ammonio methacrylate copolymer type B



Capsule



Gelatin



Titanium dioxide E171



Red iron oxide E172



Yellow iron oxide E172



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



3 years.



6.4 Special Precautions For Storage



Blister



Store in the original package.



Do not store above 25°C.



6.5 Nature And Contents Of Container



2Blisters of standard 200 μm and 250 μm Ineos AquaBa 130 and 20μm aluminium foil in cartons with 7 or 10 or 14 capsules per blister:


































Blisters:


  


7 per blister




10 per blister




14 per blister



 

 

 


14 (2 blisters per carton)




20 (2 blisters per carton)




14 (1 blister per carton)




28 (4 blisters per carton)




30 (3 blisters per carton)




28 (2 blisters per carton)




49 (7 blisters per carton)



 


56 (4 blisters per carton)




56 (8 blisters per carton)




50 (5 blisters per carton)




84 (6 blisters per carton)




98 (14 blisters per carton)




60 (6 blisters per carton)




98 (7 blisters per carton)




112 (16 blisters per carton)




100 (10 blisters per carton)




112 (8 blisters per carton)




10 x 28 (2 blister with 14 capsules per carton)


  


2 PL 20072/0016 – 0012; 05/09/2010



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Amdipharm Plc



Regency House



Miles Gray Road



Basildon



Essex



SS14 3AF



United Kingdom



8. Marketing Authorisation Number(S)



PL 20072/0016



9. Date Of First Authorisation/Renewal Of The Authorisation



03/04/2006



10. Date Of Revision Of The Text



August 2010




Monday, 1 October 2012

Axert


Generic Name: almotriptan (AL moe TRIP tan)

Brand Names: Axert


What is Axert (almotriptan)?

Almotriptan is a headache medicine that narrows blood vessels around the brain. Almotriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.


Almotriptan is used to treat migraine headaches in adults and in adolescents who are at least 12 years old. Almotriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.


Almotriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

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


What is the most important information I should know about Axert (almotriptan)?


You should not take this medication if you are allergic to almotriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches. Do not take almotriptan within 24 hours before or after using another migraine headache medicine, including eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Before taking almotriptan, tell your doctor if you have liver or kidney disease, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).


Also tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).


Almotriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.


After taking an almotriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than two (2) almotriptan tablets in 24 hours.


What should I discuss with my healthcare provider before using Axert (almotriptan)?


You should not take this medication if you are allergic to almotriptan, or if you have:

  • coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;




  • a history of heart disease, heart attack, or stroke, including "mini-stroke";




  • severe or uncontrolled high blood pressure;




  • ischemic bowel disease; or




  • a headache that seems different from your usual migraine headaches.



To make sure you can safely take almotriptan, tell your doctor if you have any of these other conditions:


  • liver disease;

  • kidney disease;


  • high blood pressure, a heart rhythm disorder; or




  • coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).




FDA pregnancy category C. It is not known whether almotriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether almotriptan 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 give this medicine to anyone under 12 years old.

How should I take Axert (almotriptan)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse. Follow the instructions on your prescription label.


Take almotriptan as soon as you notice headache symptoms, or after an attack has already begun.


Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.


Take one almotriptan tablet whole with a full glass of water.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet two (2) hours after the first. Do not take more than two (2) almotriptan tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.


Contact your doctor if you have more than four headaches in one month (30 days).


If you use almotriptan long-term, your doctor may want to check your heart function using an electrocardiograph or ECG (sometimes called an EKG), a machine that measures electrical activity of the heart. This will help your doctor determine if it is still safe for you to use this medication. Visit your doctor regularly.


Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?


Since almotriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using almotriptan.


After taking a almotriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than two (2) almotriptan tablets in 24 hours.


What happens if I overdose?


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

Overdose could cause high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, or seizure).


What should I avoid while using Axert (almotriptan)?


Do not take almotriptan within 24 hours before or after using another migraine headache medicine, including:

  • eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig); or




  • ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).




Almotriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Axert (almotriptan) 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 almotriptan and call your doctor at once if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with vision, speech, or balance;




  • sudden and severe stomach pain and bloody diarrhea;




  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or




  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.



Less serious side effects may include:



  • dry mouth, nausea, vomiting;




  • pressure or heavy feeling in any part of your body;




  • mild headache (not a migraine);




  • dizziness, drowsiness; or




  • warmth, redness, or mild tingling under your skin.



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 Axert (almotriptan)?


Tell your doctor about all other medicines you use, especially:



  • conivaptan (Vaprisol);




  • imatinib (Gleevec);




  • isoniazid (for treating tuberculosis);




  • nefazodone;




  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);




  • an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor);




  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend);




  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra).



This list is not complete and other drugs may interact with almotriptan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Axert resources


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


  • Axert Prescribing Information (FDA)

  • Axert Monograph (AHFS DI)

  • Axert Advanced Consumer (Micromedex) - Includes Dosage Information

  • Axert MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Axert with other medications


  • Migraine


Where can I get more information?


  • Your pharmacist can provide more information about almotriptan.

See also: Axert side effects (in more detail)


Sunday, 30 September 2012

Inhavir




Inhavir may be available in the countries listed below.


Ingredient matches for Inhavir



Lamivudine

Lamivudine is reported as an ingredient of Inhavir in the following countries:


  • Colombia

  • Peru

International Drug Name Search