Wednesday, 25 July 2012

quinine


Generic Name: quinine (KWYE nine)

Brand names: Qualaquin, QM-260, Quinamm


What is quinine?

Quinine is used to treat malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.


Quinine will not treat severe forms of malaria, and it should not be taken to prevent malaria. Quinine also should not be taken to treat or prevent night-time leg cramps. Using this medication improperly or without the advice of a doctor can result in serious side effects or death. Quinine is approved for use only in treating malaria. Some people have used quinine to treat leg cramps, but this is not an FDA-approved use.

The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine. As of December 2006, Qualaquin is the only brand of quinine that is approved by the FDA.


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


What is the most important information I should know about quinine?


You should not take quinine if you have a heart rhythm disorder called Long QT syndrome, G-6-PD (an enzyme deficiency), a blood clotting disorder, myasthenia gravis, or optic neuritis (inflammation of the nerves in your eyes). Some people have used quinine to treat leg cramps, but this is not an FDA-approved use. Using this medication improperly or without the advice of a doctor can result in serious side effects or death. The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine. Do not purchase quinine on the Internet or from vendors outside of the United States.

Do not use this medication if you have ever had an allergic reaction to quinine or similar medicines such as mefloquine (Lariam) or quinidine (Cardioquin, Quinidex, Quinaglute, Quin-G).


Before taking quinine, tell your doctor if you have heart disease or a heart rhythm disorder, low potassium levels in your blood (hypokalemia), kidney disease, or liver disease.


Many drugs can interact with quinine and some should not be used at the same time. Tell your doctor about all medications you use. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking quinine?


Do not use this medication if you have ever had an allergic reaction to quinine or similar medicines such as mefloquine (Lariam) or quinidine (Cardioquin, Quinidex, Quinaglute, Quin-G), or if you have:

  • a heart rhythm disorder called Long QT syndrome;




  • an enzyme deficiency called glucose-6-phosphate dehydrogenase (G-6-PD) deficiency;




  • a blood clotting disorder;




  • myasthenia gravis; or




  • optic neuritis (inflammation of the optic nerve).



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



  • heart disease or a heart rhythm disorder;




  • low potassium levels in your blood (hypokalemia); or




  • kidney or liver disease.




FDA pregnancy category C. It is not known whether quinine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. Hypoglycemia (low blood sugar) may be more likely to occur in pregnant women who are taking quinine. Signs of low blood sugar include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Talk to your doctor about your specific risk for low blood sugar if you take quinine while you are pregnant. Quinine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 16 years old.

How should I take quinine?


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.


Take with food if quinine upsets your stomach.

Quinine is usually taken for 7 days. Call your doctor if your malaria symptoms do not improve after 2 days of taking quinine, or if your symptoms return after you have finished the medication. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.


Take this medication for the full prescribed length of time. Your symptoms may get better before your condition is completely cleared. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.

If you need surgery, tell the surgeon ahead of time that you are using quinine. You may need to stop using the medicine for a short time. This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using quinine.


Store at room temperature away from moisture and heat.

See also: Quinine dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. If you are more than 4 hours late for your dose, skip the missed dose and take the medicine at your next scheduled dose time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking quinine?


Avoid taking other anti-malaria medications without your doctor's advice. This includes chloroquine (Arelan), halofantrine (Halfan), and mefloquine (Lariam).


Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb quinine.


Quinine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Do not use quinine to treat any medical condition if your doctor did not prescribe quinine for that condition. Do not purchase quinine on the Internet or from vendors outside of the United States.

Quinine 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 quinine and call your doctor at once if you have any of these serious side effects:

  • fever, chills, confusion, weakness, sweating;




  • severe vomiting, stomach pain, diarrhea;




  • problems with vision or hearing;




  • chest pain, trouble breathing, severe dizziness, fainting, fast or pounding heartbeats;




  • severe flushing (warmth, redness, or tingly feeling);




  • urinating less than usual or not at all;




  • weak or shallow breathing, feeling like you might pass out;




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;




  • blood in your urine or stools;




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or




  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • headache, blurred vision, changes in color vision;




  • mild dizziness, spinning sensation, ringing in your ears;




  • upset stomach; or




  • muscle weakness.



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.


Quinine Dosing Information


Usual Adult Dose for Malaria:

Qualaquin (R):
Treatment of uncomplicated Plasmodium falciparum malaria: 648 mg orally every 8 hours for 7 days

Per Centers for Disease Control and Prevention (CDC) guidelines:
542 mg base (650 mg sulfate salt) orally 3 times a day for 3 to 7 days

Treatment of uncomplicated malaria due to chloroquine-resistant (or unknown resistance) P falciparum (or species not identified) infection should be in conjunction with one of the following: doxycycline, tetracycline, or clindamycin. In pregnant women, quinine sulfate plus clindamycin is recommended.

Treatment of uncomplicated malaria due to chloroquine-resistant P vivax infection should be in conjunction with either doxycycline or tetracycline plus primaquine phosphate. In pregnant women, quinine sulfate alone for 7 days is recommended.

Usual Pediatric Dose for Malaria:

Qualaquin (R):
Treatment of uncomplicated P falciparum malaria:
16 years or older: 648 mg orally every 8 hours for 7 days

Per CDC guidelines:
8.3 mg base/kg (10 mg sulfate salt/kg) orally 3 times a day for 3 to 7 days; pediatric dose should never exceed adult dose

Less than 8 years:
Treatment of uncomplicated malaria due to chloroquine-resistant (or unknown resistance) P falciparum (or species not identified) infection should be combined with clindamycin.

Treatment of uncomplicated malaria due to chloroquine-resistant P vivax infection should be combined with primaquine phosphate.

8 years or older:
Treatment of uncomplicated malaria due to chloroquine-resistant (or unknown resistance) P falciparum (or species not identified) infection should be in conjunction with one of the following: doxycycline, tetracycline, or clindamycin.

Treatment of uncomplicated malaria due to chloroquine-resistant P vivax infection should be in conjunction with either doxycycline or tetracycline plus primaquine phosphate.


What other drugs will affect quinine?


Many drugs can interact with quinine. Below is just a partial list. Tell your doctor if you are using:



  • acetazolamide (Diamox);




  • arsenic trioxide (Trisenox);




  • atorvastatin (Lipitor);




  • bosentan (Tracleer);




  • cimetidine (Tagamet) or ranitidine (Zantac);




  • dextromethorphan (cough medicine);




  • tacrolimus (Prograf);




  • aminophylline (Phyllocontin, Truphylline) or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);




  • St. John's wort;




  • an antibiotic, especially clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifampin (Rifadin, Rifater, Rifamate), or tetracycline (Brodspec, Tetracap);




  • an antidepressant, especially amitriptylline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), or paroxetine (Paxil);




  • ADHD medication;




  • antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);




  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • heart rhythm medicine, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);




  • heart or blood pressure medication, especially digoxin (digitalis, Lanoxin) or metoprolol (Toprol);




  • HIV medications, especially ritonavir (Norvir, Kaletra), or saquinavir (Invirase);




  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);




  • cancer medicine (chemotherapy);




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);




  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);




  • narcotic medication such as methadone (Methadose, Diskets, Dolophine);




  • sedatives or tranquilizers; or




  • seizure medication, especially carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton), or phenytoin (Dilantin).



This list is not complete and there are many other drugs that can interact with quinine. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.



More quinine resources


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


  • quinine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Qualaquin Prescribing Information (FDA)

  • Quinine Natural MedFacts for Professionals (Wolters Kluwer)

  • Quinine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Quinine Sulfate Monograph (AHFS DI)



Compare quinine with other medications


  • Malaria
  • Nocturnal Leg Cramps


Where can I get more information?


  • Your pharmacist can provide more information about quinine.

See also: quinine side effects (in more detail)


Serc-16mg





1. Name Of The Medicinal Product



Serc®-16/Betahistine Tablets 16 mg


2. Qualitative And Quantitative Composition



Each tablet contains 16 mg betahistine dihydrochloride.



3. Pharmaceutical Form



Tablet:



Round, biconvex, scored, white to almost white tablets imprinted '267' on one face and '



4. Clinical Particulars



4.1 Therapeutic Indications



Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.



4.2 Posology And Method Of Administration



Adults (including the elderly): initially 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.



Children: no dosage recommendations are made for children.



4.3 Contraindications



Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients.



4.4 Special Warnings And Precautions For Use



Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.



Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions have been reported.



4.6 Pregnancy And Lactation



Pregnancy:



There are no adequate data from the use of betahistine in pregnant women.



Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly necessary.



Lactation:



It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.



4.7 Effects On Ability To Drive And Use Machines



Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.



4.8 Undesirable Effects



The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials [very common (



Gastrointestinal disorders



Common: nausea and dyspepsia



In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.



Immune System disorders



Hypersensitivity reactions, e.g. anaphylaxis have been reported.



Gastrointestinal disorders



Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.



Nervous System disorders



Headache



Skin and subcutaneous tissue disorders



Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.



4.9 Overdose



A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. Treatment of overdose should include standard supportive measures.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



The active ingredient is a specific histamine agonist with virtually no H2-activity. It appears to act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space.



5.2 Pharmacokinetic Properties



Betahistine is rapidly and completely absorbed after oral administration of the drug in tablets. It is excreted almost quantitatively in urine as 2-pyridylacetic acid within 24 hours after administration. No unchanged betahistine has been detected.



5.3 Preclinical Safety Data



There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica and talc.



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



5 years.



6.4 Special Precautions For Storage



Do not store above 25°C. Store in the original package.



6.5 Nature And Contents Of Container



PVC/PVdC blister packs containing 84 tablets.



HDPE tablet containers containing 500 or 1000 tablets.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Solvay Healthcare Limited/Solvay Healthcare Limited T/A Mansbridge Pharmaceuticals Ltd



Mansbridge Road



West End



Southampton



SO18 3JD



8. Marketing Authorisation Number(S)



PL 00512/0088



9. Date Of First Authorisation/Renewal Of The Authorisation



15 October 1997/ 14 October 2002



10. Date Of Revision Of The Text



03/07/2009




Friday, 20 July 2012

thiethylperazine Oral, Intramuscular, Rectal


thye-eth-il-PER-a-zeen


Commonly used brand name(s)

In the U.S.


  • Torecan

Available Dosage Forms:


  • Suppository

  • Tablet

  • Solution

Therapeutic Class: Antiemetic


Pharmacologic Class: Phenothiazine


Chemical Class: Piperazine (class)


Uses For thiethylperazine


Thiethylperazine is a phenothiazine medicine. It is used to treat nausea and vomiting.


thiethylperazine is available only with your doctor's prescription.


Before Using thiethylperazine


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 thiethylperazine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to thiethylperazine 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


Children are usually more sensitive than adults to the effects of phenothiazine medicines such as thiethylperazine. Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration.


Geriatric


Elderly patients are usually more sensitive to the effects of phenothiazine medicines such as thiethylperazine. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, uncontrolled movements may be more likely to occur in elderly patients taking thiethylperazine.


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 thiethylperazine, 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 thiethylperazine 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.


  • Cisapride

  • Grepafloxacin

  • Sparfloxacin

Using thiethylperazine 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.


  • Fentanyl

  • Gatifloxacin

  • Ibutilide

  • Isradipine

  • Levorphanol

  • Methadone

  • Metrizamide

  • Morphine

  • Morphine Sulfate Liposome

  • Moxifloxacin

  • Octreotide

  • Oxycodone

  • Pentamidine

  • Procarbazine

  • Tramadol

Using thiethylperazine 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.


  • Belladonna

  • Belladonna Alkaloids

  • Betel Nut

  • Evening Primrose

  • Meperidine

  • Phenylalanine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using thiethylperazine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use thiethylperazine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


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


  • Alcohol abuse—thiethylperazine, if taken together with alcohol, may lower the blood pressure and cause CNS depressant effects, such as severe drowsiness

  • Asthma attack or

  • Other lung diseases—Thiethylperazine may cause secretions to become thick so that it might be difficult to cough them up, for example, during an asthma attack

  • Blood disease or

  • Heart or blood vessel disease—thiethylperazine may cause more serious conditions to develop

  • Difficult urination or

  • Enlarged prostate—thiethylperazine may cause urinary problems to get worse

  • Glaucoma—thiethylperazine may cause an increase in inner eye pressure

  • Liver disease—Thiethylperazine may accumulate in the body, increasing the chance of side effects, such as muscle spasms

  • Parkinson's disease or

  • Seizure disorders—The chance of thiethylperazine causing seizures or uncontrolled movements is greater when these conditions are present

Proper Use of thiethylperazine


Thiethylperazine is used only to relieve or prevent nausea and vomiting. Use it only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.


For patients taking thiethylperazine by mouth:


  • thiethylperazine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients using the suppository form of thiethylperazine :


  • To insert suppository: First, remove foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

  • Wash your hands with soap and water.

Dosing


The dose of thiethylperazine 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 thiethylperazine. 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 nausea and vomiting:
    • For oral dosage form (tablets):
      • Adults—10 milligrams (mg) one to three times a day.

      • Children—Use and dose must be determined by your doctor.


    • For injection dosage form:
      • Adults—10 mg one to three times a day, injected into a muscle.

      • Children—Use and dose must be determined by your doctor.


    • For rectal dosage form (suppositories):
      • Adults—10 mg one to three times a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of thiethylperazine, 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.


Precautions While Using thiethylperazine


If you are going to be taking thiethylperazine for a long time, your doctor should check your progress at regular visits, especially during the first few months of treatment with thiethylperazine. This will allow your dosage to be changed if necessary to meet your needs.


Thiethylperazine will add to the effects of alcohol and other CNS depressants (medicines that cause you to feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using thiethylperazine .


thiethylperazine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to thiethylperazine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well.


Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.


When using thiethylperazine on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin or other salicylates at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by thiethylperazine.


Thiethylperazine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


thiethylperazine 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 as soon as possible if any of the following side effects occur:


Less common or rare
  • Abdominal or stomach pains

  • aching muscles and joints

  • blurred vision, change in color vision, or difficulty in seeing at night

  • confusion (especially in the elderly)

  • convulsions (seizures)

  • difficulty in speaking or swallowing

  • fast heartbeat

  • fever and chills

  • inability to move eyes

  • lip smacking or puckering

  • loss of balance control

  • mask-like face

  • muscle spasms (especially of face, neck, and back)

  • nausea, vomiting, or diarrhea

  • nightmares (continuing)

  • nosebleeds

  • puffing of cheeks

  • rapid or fine, worm-like movements of tongue

  • shuffling walk

  • skin itching (severe)

  • sore throat and fever

  • stiffness of arms or legs

  • swelling of arms, hands, and face

  • tic-like or twitching movements

  • trembling and shaking of hands and fingers

  • twisting movements of body

  • uncontrolled chewing movements

  • uncontrolled movements of arms or legs

  • unusual bleeding or bruising

  • unusual excitement, nervousness, restlessness, or irritability

  • unusual tiredness or weakness

  • weakness of arms and legs

  • yellow eyes or skin

Symptoms of overdose
  • Confusion (severe)

  • convulsions (seizures)

  • dizziness (severe)

  • drowsiness (severe)

  • dry mouth (severe)

  • hyperextension of neck and trunk

  • inability to move eyes

  • loss of consciousness

  • spasms of face and neck

  • stuffy nose

  • troubled breathing

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
  • Dizziness

  • drowsiness

Less common or rare
  • Constipation

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

  • dryness of mouth, nose and throat

  • fainting

  • fever

  • headache

  • ringing or buzzing in ears

  • skin rash

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: thiethylperazine Oral, Intramuscular, Rectal 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 thiethylperazine Oral, Intramuscular, Rectal resources


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


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  • Nausea/Vomiting

Thursday, 19 July 2012

Saw Palmetto


Pronunciation: Not applicable.
Generic Name: Saw Palmetto
Brand Name: Generics only. No brands available.


Saw Palmetto is used for:

Urinary problems associated with benign prostatic hyperplasia (BPH). It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.


Saw Palmetto is an herbal product. It is thought to work by reducing inflammation.


Do NOT use Saw Palmetto if:


  • you are allergic to any ingredient in Saw Palmetto

  • you have a history of breast cancer

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



Before using Saw Palmetto:


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


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

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

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

Some MEDICINES MAY INTERACT with Saw Palmetto. However, no specific interactions are known at this time.


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


How to use Saw Palmetto:


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


  • Take this product with food or milk.

  • Dosing depends on the use and the source of the product.

  • Use as directed on the package, unless instructed otherwise by your doctor.

  • It may take 30 days for saw palmetto to work.

  • If you miss taking a dose of Saw Palmetto for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Saw Palmetto.



Important safety information:


  • Consult your doctor before taking this product.

  • Saw palmetto relieves only the symptoms associated with an enlarged prostate. It does not reduce enlargement.

  • Keep all doctor and laboratory appointments while you are taking Saw Palmetto.

  • This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.

  • This product is not recommended for use in CHILDREN.

  • PREGNANCY and BREAST-FEEDING: Do not take this product if you are pregnant. Do not breast-feed while taking this product.


Possible side effects of Saw Palmetto:


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



Back or stomach pain; change in sex drive; constipation; cramping; diarrhea (with large doses); difficulty urinating; headache; impotence; nausea.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.



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


See also: Saw Palmetto side effects (in more detail)


If OVERDOSE is suspected:


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


Proper storage of Saw Palmetto:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Saw Palmetto out of the reach of children and away from pets.


General information:


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

  • Saw Palmetto is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Saw Palmetto resources


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


  • Saw Palmetto Natural MedFacts for Professionals (Wolters Kluwer)

  • Saw Palmetto Natural MedFacts for Consumers (Wolters Kluwer)

  • saw palmetto Concise Consumer Information (Cerner Multum)



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  • Benign Prostatic Hyperplasia
  • Herbal Supplementation
  • Overactive Bladder

Sunday, 15 July 2012

Calcium Acetate Tablets




Calcium Acetate Tablets, USP

Description:


Each white to off-white, round, biconvex tablet (debossed with "P113" on one face) contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium; polyethylene glycol 8000; and magnesium stearate. Calcium Acetate Tablets, USP are administered orally for the control of hyperphosphatemia in end stage renal failure.



Clinical Pharmacology:


Patients with advanced renal insufficiency (creatinine clearance less than 30 mL/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate, when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium Acetate Tablets, USP are highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine.


Orally administered calcium acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.



Indications and Usage:


Calcium Acetate Tablets, USP are indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption.



Contraindications:


Patients with hypercalcemia.



Warnings:


Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with Calcium Acetate Tablets, USP.


Progressive hypercalcemia due to overdose of Calcium Acetate Tablets, USP may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period.


The serum calcium times phosphate (CaXP) product should not be allowed to exceed 66.Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft tissue calcification.



Precautions:



General:


Excessive dosage of Calcium Acetate Tablets, USP induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium Acetate Tablets, USP should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium Acetate Tablets, USP therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.



Information for the patient:


The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia (seeADVERSE REACTIONSsection).



Drug Interactions:


Calcium Acetate Tablets, USP may decrease the bioavailability of tetracyclines.



Carcinogenesis, Mutagenesis, Impairment of Fertility:


Long term animal studies have not been performed to evaluate the carcinogenic potential, mutagenicity, or effect on fertility of Calcium Acetate Tablets.



Pregnancy:


Teratogenic Effects:

Category C.


Animal reproduction studies have not been conducted with Calcium Acetate Tablets. It is not known whether Calcium Acetate Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium Acetate Tablets should be given to a pregnant woman only if clearly needed.



Pediatric Use:


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use:


Of the total number of subjects in clinical studies of Calcium Acetate Tablets (n= 91), 25 percent were 65 and over, while 7 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.



Adverse Reactions:


In clinical studies, patients have occasionally experienced nausea during calcium acetate tablet therapy. Hypercalcemia may occur during treatment with Calcium Acetate Tablets, USP. Mild hypercalcemia (Ca >10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca >12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the Calcium Acetate Tablets, USP dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium Acetate Tablets therapy.


Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium Acetate Tablets, USP induced hypercalcemia. The long-term effect of Calcium Acetate Tablets on the progression of vascular or soft tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.



Overdosage:


Administration of Calcium Acetate Tablets, USP in excess of the appropriate daily dosage can cause severe hypercalcemia (SeeADVERSE REACTIONS).



Dosage and Administration:


The recommended initial dose of Calcium Acetate Tablets, USP for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3 to 4 tablets with each meal.



How Supplied:


In tablet form with "P113" debossed on one side and plain on the other, for oral administration. Each white round tablet contains 667 mg calcium acetate (anhydrous; Ca(CH3COO)2; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium; polyethylene glycol 8000; and magnesium stearate.


Tablets, NDC 0574-0113-02, bottles of 200.



Storage:


Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]



Paddock Laboratories, Inc.

Minneapolis, MN 55427

(02-10)



PRINCIPAL DISPLAY PANEL - 667 mg Bottle Label


NDC 0574-0113-02


CALCIUM ACETATE

TABLETS, USP


667 mg*


Rx ONLY


Take as directed by your physician.


200 TABLETS


Paddock

Laboratories, Inc.










CALCIUM ACETATE 
calcium acetate  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0574-0113
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ACETATE (CALCIUM CATION)CALCIUM ACETATE667 mg








Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 8000 
MAGNESIUM STEARATE 


















Product Characteristics
ColorWHITE (White to off-white)Scoreno score
ShapeROUND (Biconvex)Size13mm
FlavorImprint CodeP113
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10574-0113-02200 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09156109/13/2011


Labeler - Paddock Laboratories, LLC (967694121)









Establishment
NameAddressID/FEIOperations
Paddock Laboratories, LLC967694121MANUFACTURE, LABEL
Revised: 09/2011Paddock Laboratories, LLC




More Calcium Acetate Tablets resources


  • Calcium Acetate Tablets Side Effects (in more detail)
  • Calcium Acetate Tablets Dosage
  • Calcium Acetate Tablets Use in Pregnancy & Breastfeeding
  • Drug Images
  • Calcium Acetate Tablets Drug Interactions
  • Calcium Acetate Tablets Support Group
  • 0 Reviews for Calcium Acetates - Add your own review/rating


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  • Hyperphosphatemia

Saturday, 14 July 2012

Sympt-X


Generic Name: glutamine (Oral route)

GLOO-ta-meen

Commonly used brand name(s)

In the U.S.


  • Enterex Glutapak-10

  • Resource Glutasolve

  • Sympt-X

  • Sympt-X G.I.

Available Dosage Forms:


  • Powder for Solution

  • Powder for Suspension

  • Tablet

  • Capsule

  • Powder

  • Packet

Therapeutic Class: Amino Acid Supplement


Uses For Sympt-X


Glutamine is a substance naturally produced in the body to help regulate cell growth and function. There may also be man-made versions of these substances. Glutamine is used along with human growth hormone and a specialized diet to treat short bowel syndrome


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


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


Before Using Sympt-X


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


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of glutamine in children with use in other age groups.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of glutamine in the elderly with use in other age groups. However, elderly patients are more likely to be sensitive requiring the need for dosage adjustment.


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


  • Liver disease—May be worsened by glutamine.

Proper Use of glutamine

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


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 (powder for oral solution):
    • For short bowel syndrome
      • Adults—30 grams per day in divided doses (5 grams taken 6 times a day) for up to 16 weeks. Taken with meals or snacks, 2 to 3 hours apart while awake.

      • 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 Sympt-X


It is very important that your doctor check you at regular visits.


Sympt-X 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:


Less common
  • Blood in urine

  • changes in skin color

  • chills

  • cold hands and feet

  • confusion

  • cough

  • difficulty swallowing

  • dizziness

  • fainting

  • fast heartbeat

  • fever

  • frequent and painful urination

  • headache

  • hives

  • itching

  • lightheadedness

  • lower back or side pain

  • pain, redness, or swelling in arm or leg

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

  • rapid, shallow breathing

  • shortness of breath

  • skin rash

  • stomach pain

  • sudden decrease in amount of urine

  • tightness in chest

  • 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:


More common
  • Cough or hoarseness

  • frequent urge to defecate

  • straining while passing stool

Less common
  • Abnormal or decreased touch sensation

  • back pain

  • bacterial infection

  • bleeding after defecation

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

  • bloated full feeling

  • body aches or pain

  • breast pain, female

  • chest pain

  • change in the color, amount, or odor of vaginal discharge

  • congestion

  • constipation

  • Crohn's disease, aggravated

  • dark urine

  • decreased urination

  • diarrhea

  • difficulty having a bowel movement (stool)

  • difficulty in moving

  • discoloration of fingernails or toenails

  • discouragement

  • dry mouth

  • dryness or soreness of throat

  • ear or hearing symptoms

  • excess air or gas in stomach or intestines

  • feeling sad or empty

  • feeling unusually cold shivering

  • flatulence

  • full or bloated feeling

  • general feeling of discomfort or illness

  • increase in heart rate

  • indigestion

  • irritability

  • joint pain;

  • lack of appetite

  • light-colored stools

  • loss of appetite

  • loss of interest or pleasure

  • muscle aches and pains

  • muscle pain or stiffness

  • nausea

  • pain in joints

  • pain or burning while urinating

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

  • passing gas

  • pressure in the stomach

  • rash

  • rectal bleeding

  • runny nose

  • shivering

  • sleeplessness

  • sneezing

  • sore throat

  • stomach bloating, burning, cramping, or pain

  • stuffy nose

  • sunken eyes

  • sweating

  • swelling of abdominal or stomach area

  • swelling of face

  • swelling of hands, ankles, feet, or lower legs

  • swollen joints

  • tender, swollen glands in neck;

  • thirst

  • trouble concentrating

  • trouble sleeping

  • trouble in swallowing

  • unable to sleep

  • uncomfortable swelling around anus

  • unpleasant breath odor

  • unusual tiredness or weakness

  • voice changes

  • vomiting

  • vomiting of blood

  • weight loss

  • wrinkled skin

  • yellow eyes or skin

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: Sympt-X 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 Sympt-X resources


  • Sympt-X Side Effects (in more detail)
  • Sympt-X Use in Pregnancy & Breastfeeding
  • 0 Reviews for Sympt-X - Add your own review/rating


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  • Anemia, Sickle Cell
  • Dietary Supplementation
  • Short Bowel Syndrome

Tuesday, 10 July 2012

Soltamox Solution


Generic Name: Tamoxifen (ta-MOX-i-fen)
Brand Name: Soltamox

Women taking Soltamox Solution to decrease the risk of developing breast cancer have developed cancer of the uterus, stroke, and blood clots in the lung. Some of these events have been fatal. Contact your doctor right away if you develop any of the following: unusual vaginal bleeding or discharge; abnormal menstrual period; groin pressure or pain; chest pain; shortness of breath; coughing up blood; confusion; one-sided weakness; vision or speech problems.


Women at high risk of breast cancer or with ductal carcinoma in situ (DCIS) should discuss the use of Soltamox Solution with their doctor. Decide if the possible benefits (reducing the risk of breast cancer) outweigh the risk of these events. The benefits of Soltamox Solution outweigh the risks in women who already have breast cancer.





Soltamox Solution is used for:

Treating breast cancer that has spread to other sites in the body.It is also used along with other medicines to treat other types of breast cancer. It is used in women who are at high risk for breast cancer and in women with DCIS (after surgery and radiation) to decrease the risk of developing breast cancer. It may also be used for other conditions as determined by your doctor.


Soltamox Solution is an antiestrogen. It works by blocking the effect of estrogen on certain tumors. This may prevent the growth of tumors that are activated by estrogen.


Do NOT use Soltamox Solution if:


  • you are allergic to any ingredient in Soltamox Solution

  • you are using Soltamox Solution to reduce your risk of breast cancer and you have a history of blood clots in the lung or leg

  • you are using Soltamox Solution to reduce your risk of breast cancer and you also take certain anticoagulants (eg, warfarin)

  • you are taking anastrozole

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



Before using Soltamox Solution:


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


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

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

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

  • if you have a history of blood clots in the legs or lungs

  • if you have high levels of calcium in your blood, a weakened immune system, or low levels of white blood cells or platelets in your blood

  • if you have high cholesterol or lipid levels

  • if you have cataracts or other vision problems

  • if you are using cytotoxic cancer medicines

  • if you are confined to a bed or chair

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


  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased

  • Cytotoxic cancer medicines (eg, cisplatin) because the risk of developing blood clots may be increased

  • Rifampin because it may decrease Soltamox Solution's effectiveness

  • Fluorouracil or mitomycin C because they may increase the risk of Soltamox Solution's side effects

  • Aromatase inhibitors (eg, anastrozole, letrozole) because their effectiveness may be decreased by Soltamox Solution

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


How to use Soltamox Solution:


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


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

  • Soltamox Solution may be taken by mouth with or without food.

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

  • Continue to take Soltamox Solution even if you feel well. Do not miss any doses. Taking Soltamox Solution at the same time each day will help you to remember to take it.

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

Ask your health care provider any questions you may have about how to use Soltamox Solution.



Important safety information:


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

  • Soltamox Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

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

  • New tumors have occurred in body sites other than the uterus in patients taking Soltamox Solution. It is unknown if Soltamox Solution may be the cause. Discuss any questions or concerns with your doctor.

  • Women who take Soltamox Solution to reduce the risk of breast cancer should have a breast exam, mammogram, and gynecological exam before starting and during treatment with Soltamox Solution.

  • Women who may become pregnant should begin taking Soltamox Solution during a menstrual period. Women who have irregular menstrual periods should have a pregnancy test immediately before starting Soltamox Solution. Talk to your doctor if you have any questions about how to begin taking Soltamox Solution.

  • Women who may become pregnant must use effective nonhormonal birth control (eg, condoms, diaphragm) during sexual intercourse while they are taking Soltamox Solution and for 2 months after they stop taking it. Do not use hormonal birth control (eg, birth control pills); it may not work as well while you are taking Soltamox Solution. Discuss any questions about effective nonhormonal birth control with your doctor.

  • Soltamox Solution will not prevent you from becoming pregnant.

  • Lab tests, including breast exams, mammograms, gynecologic exams,complete blood counts, and liver function tests, may be performed while you use Soltamox Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

  • PREGNANCY and BREAST-FEEDING: Soltamox Solution may cause harm to the fetus. Do not become pregnant while you are using it and for 2 months after you stop using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Soltamox Solution while you are pregnant. It is not known if Soltamox Solution is found in breast milk. Do not breast-feed while taking Soltamox Solution.


Possible side effects of Soltamox Solution:


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



Bone pain; constipation; coughing; hot flashes; muscle pain; nausea; tiredness; vaginal discharge; weight loss.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); abnormal menstrual periods; abnormal vaginal bleeding or bloody discharge; chest pain; coughing up blood; dark urine; decreased sexual desire or ability; depression; fever, chills, or persistent sore throat; groin or pelvic pain or pressure; loss of appetite; loss of balance or coordination; missed menstrual period; new or increased breast tumor or pain; new or unusual lumps; one-sided weakness; pain or swelling in one or both legs; red, swollen, blistered, or peeling skin; severe or persistent tiredness or weakness; shortness of breath; skin changes; stomach pain; sudden severe headache; swelling of the arms or the legs; unusual bleeding or bruising; vision or speech problems; yellowing of the eyes or skin.



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


See also: Soltamox side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include exaggerated reflexes; seizures; severe or persistent dizziness; tremor; trouble breathing; trouble walking.


Proper storage of Soltamox Solution:

Store Soltamox Solution at room temperature, below 77 degrees F (25 degrees C), in the original container. Do NOT refrigerate or freeze. Store away from moisture, heat, and light. Do not store in the bathroom. Throw away any unused medicine 3 months after the bottle is opened. Keep Soltamox Solution out of the reach of children and away from pets.


General information:


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

  • Soltamox Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Soltamox resources


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


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Heritage Pharmaceuticals


Address


Heritage Pharmaceuticals,
105 Fieldcrest Avenue, Suite 100

Edison

New Jersey 08837

Contact Details

Phone: (732) 429-1000
Website: http://www.heritagepharma.com/
Careers: http://www.heritagepharma.com/about-us...

Monday, 9 July 2012

Inigrin




Inigrin may be available in the countries listed below.


Ingredient matches for Inigrin



Loratadine

Loratadine is reported as an ingredient of Inigrin in the following countries:


  • Mexico

International Drug Name Search

carbidopa


Generic Name: carbidopa (kar bi DOE pa)

Brand Names: Lodosyn


What is carbidopa?

Carbidopa is used with levodopa to treat Parkinson's disease. Parkinson's disease is believed to be related to low levels of a chemical called dopamine (DOE pa meen) in the brain. Levodopa (Dopar, Larodopa) is turned into dopamine in the body. Carbidopa is used with levodopa to prevent the breakdown (metabolism) of levodopa before it can reach the brain and take effect. Carbidopa is only effective if it is taken with levodopa. It has no effect if it is used alone.


Carbidopa is used with levodopa to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. These medications are also used to treat the same muscular conditions when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.


Carbidopa may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about carbidopa?


Carbidopa is only used in combination with levodopa. It has no effect if it is used on its own.


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

What should I discuss with my healthcare provider before taking carbidopa?


Do not take this medication without first talking to your doctor if you have

  • taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the past 2 weeks;




  • narrow-angle glaucoma (angle closure glaucoma); or




  • malignant melanoma (a type of skin cancer).



Before taking this medication, tell your doctor if you have



  • heart disease, high blood pressure, arteriosclerosis, hardening of the arteries, a previous heart attack, or an irregular heartbeat;




  • respiratory disease, including asthma and chronic obstructive pulmonary disease (COPD);



  • liver disease;

  • kidney disease;


  • an endocrine (hormonal) disease;




  • a stomach or intestinal ulcer;




  • wide-angle glaucoma; or




  • depression or any other psychiatric disorder.



You may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


It is not known whether carbidopa will be harmful to an unborn baby. Do not take carbidopa without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is also not known whether carbidopa will be harmful to a nursing infant. Do not take carbidopa without first talking to your doctor if you are breast-feeding a baby.

How should I take carbidopa?


Take carbidopa exactly as directed by your doctor. 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.

Carbidopa must be taken with levodopa to have an effect.


It is important to take carbidopa regularly to get the most benefit.


Your doctor may want you to have blood tests or other medical evaluations during treatment with carbidopa to monitor progress and side effects.


Store carbidopa at room temperature away from moisture and heat.

See also: Carbidopa dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a carbidopa overdose include muscle spasms or weakness, spasms of the eyelid, nausea, vomiting, diarrhea, an irregular heartbeat, confusion, agitation, hallucinations, and unconsciousness.


What should I avoid while taking carbidopa?


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

Carbidopa side effects


Carbidopa alone is not associated with side effects. The following side effects are generally associated with carbidopa and levodopa therapy.


If you experience any of the following serious side effects, stop taking carbidopa and levodopa and seek emergency medical attention or contact your doctor immediately:

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




  • uncontrolled movements of a part of the body;




  • seizures;




  • persistent nausea, vomiting, or diarrhea;




  • an irregular heartbeat or fluttering in your chest;




  • unusual changes in mood or behavior; or




  • depression or suicidal thoughts.



Other, less serious side effects may be more likely to occur. Continue to take carbidopa and levodopa and talk to your doctor if you experience



  • mild nausea, vomiting, or decreased appetite;




  • constipation, dry mouth, or blurred vision;




  • hand tremor;




  • muscle twitches;




  • dizziness or drowsiness;




  • insomnia, confusion, or nightmares;




  • agitation or anxiety;




  • darkening of urine or sweat; or




  • fatigue.



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.


Carbidopa Dosing Information


Usual Adult Dose for Parkinsonian Tremor:

Initial:
25 mg three to four times a day. Give at the same time with levodopa, at 2% to 25% of the previous or recommended daily dosage of levodopa when taken alone.

In patients already on levodopa, allow 12 hours between the last dose of levodopa and the initiation of therapy with carbidopa and levodopa.

Maximum daily dosage should not exceed 200 mg.

Usual Adult Dose for Neuroleptic Malignant Syndrome:

Case Report:
Carbidopa 25 mg/levodopa 250 mg three times daily via nasogastric tube for 2 days.

Usual Pediatric Dose for GTP-CH Deficiency:

Case Reports:
>1 year:
Initial: 5 mg/kg/day of carbidopa/levodopa, then titrated slowly downward with the aim of maintaining control of extrapyramidal syndrome.


What other drugs will affect carbidopa?


Do not take carbidopa and levodopa if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the past 14 days.

Antacids may increase the effectiveness of carbidopa and levodopa and lead to side effects. Ask your doctor about the use of antacids.


Before taking carbidopa, tell your doctor if you are taking any of the following medicines:



  • a medicine to treat high blood pressure (hypertension);




  • a medicine used to treat seizures, such as phenytoin (Dilantin), ethotoin (Peganone), or mephenytoin (Mesantoin);




  • papaverine (Pavabid, Cerespan, others);




  • pyridoxine or vitamin B6;




  • an antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), desipramine (Norpramin), and amoxapine (Asendin); or




  • a medicine used to treat a psychiatric condition (or nausea and vomiting), such as chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), thioridazine (Mellaril), trifluoperazine (Stelazine), and haloperidol (Haldol).



You may not be able to take carbidopa, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.


Levodopa may interfere with urine tests for sugar and ketones. If you have diabetes and notice changes in urine test results, talk to your doctor before making any changes in your diabetes medication.


Drugs other than those listed here may also interact with carbidopa. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More carbidopa resources


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


  • Carbidopa Professional Patient Advice (Wolters Kluwer)

  • Carbidopa MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lodosyn Prescribing Information (FDA)

  • Lodosyn Monograph (AHFS DI)



Compare carbidopa with other medications


  • GTP-CH Deficiency
  • Neuroleptic Malignant Syndrome
  • Parkinsonian Tremor


Where can I get more information?


  • Your pharmacist can provide more information about carbidopa.

See also: carbidopa side effects (in more detail)