Friday 29 June 2012

Twinject Auto-Injector



epinephrine

Dosage Form: injection
Twinject®

auto-injector

(epinephrine injection, USP 1:1000)

Available as:    0.3 mg    0.15 mg


each dose delivers 0.15 mg or 0.3 mg of epinephrine


PRESCRIBING INFORMATION



Twinject Auto-Injector Description


Twinject Auto-Injector contains 1.1 mL epinephrine injection, USP 1:1000 (1 mg/mL), from which two doses of either 0.15 mg (0.15 mL) or 0.3 mg (0.3 mL) each are available for use by injection. The first dose is administered by auto-injection after the patient prepares and fires Twinject as directed. A second dose can be manually administered following a partial disassembly of Twinject. The remaining volume is not available for use and should be discarded. See PATIENT DIRECTIONS FOR USE on the accompanying Patient Information Leaflet.


Each dose of epinephrine injection, USP 1:1000 contains either 0.15 mg or 0.3 mg l-epinephrine, sodium chloride, chlorobutanol and sodium bisulfite, all sealed under nitrogen.


Epinephrine is a sympathomimetic catecholamine. Its naturally occurring l-isomer, which is twenty times as active as the d-isomer, is obtained in pure form by separation from the synthetically produced racemate.


Chemically, epinephrine is 1-(3,4-dihydroxyphenyl)-2-(methylamino)ethanol with the following structure:



Epinephrine deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Epinephrine solutions that show evidence of discoloration should be discarded.


Twinject contains no latex.



Twinject Auto-Injector - Clinical Pharmacology


Epinephrine is the drug of choice for the emergency treatment of severe allergic reactions (Type I) to allergens, such as those present in certain insect venoms, foods, or drugs. It can also be used in the treatment of anaphylaxis of unknown cause (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Epinephrine, when given intramuscularly or subcutaneously, has a rapid onset and short duration of action. Epinephrine acts on both alpha and beta adrenergic receptors. Through its action on alpha adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during an anaphylactic reaction and can lead to loss of intravascular fluid volume and hypotension. Through its action on beta adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation that helps alleviate bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis. Epinephrine also helps alleviate pruritus, urticaria, and angioedema, and may be effective in relieving gastrointestinal and genitourinary symptoms of anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.



Indications and Usage for Twinject Auto-Injector


Twinject (epinephrine injection, USP 1:1000) is indicated in the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging insects (e.g. order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g. triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g. radiocontrast media), and other allergens, as well as anaphylaxis to unknown substances (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Twinject is intended for immediate administration in patients with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (See DOSAGE AND ADMINISTRATION section).


Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. Twinject is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.



Contraindications


There are no absolute contraindications to the use of epinephrine in a life-threatening allergic reaction.



Warnings


Twinject should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided. DO NOT INJECT INTO BUTTOCK. If there is an accidental injection into these areas, advise the patient to inform the healthcare provider of the accidental injection when he/she goes to the nearest emergency room for further treatment of anaphylaxis.


Avoid possible inadvertent intravascular administration. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.


Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations, even if the patient is sulfite-sensitive.


Epinephrine should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.


Epinephrine is light sensitive and should be stored in the carrying-case provided. Store at room temperature (20°-25°C/68°-77°F) with excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate; protect from freezing. Patients should periodically check the solution in Twinject for any discoloration and/or precipitates. If the solution is discolored or contains a precipitate, the patient should replace their Twinject.



Precautions



(1) General


Twinject is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek appropriate medical care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.


Twinject is not suitable for patients, or caregivers, with such disabilities as severe debilitating arthritis of the hands, because the use of this product requires some manual dexterity to administer. IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF Twinject.


Epinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions should be instructed about the circumstances under which epinephrine should be used (See INDICATIONS AND USAGE Section). It should be determined that the patient is at risk of future anaphylaxis, since there are some concerns in specific patients with epinephrine administration. (a) Epinephrine should be used with caution in patients with cardiac arrhythmias, coronary artery or organic heart disease, hypertension, or in patients who are on medications that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. (b) The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. (c) Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, and elderly individuals, and pregnant women. It must be noted that, despite these concerns, epinephrine is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, or any other person who might be in a position to administer epinephrine to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which epinephrine should be used.



(2) Information for Patients


Complete patient information, including dosage, directions for proper administration, and precautions, can be found inside each Twinject package within the Patient Information Leaflet.


Epinephrine may produce symptoms and signs that include an increase in pulse rate, the sensation of a more forceful heartbeat, palpitations, a throbbing headache, pallor, feelings of overstimulation, anxiety, weakness, shakiness, dizziness, or nausea. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency.


Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms.



(3) Drug Interactions


Patients who receive epinephrine while concomitantly taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.


The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.


The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive efffects are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids and phenothiazines may also reverse the pressor effects of epinephrine.



(4) Carcinogenesis, Mutagenesis, Impairment of Fertility


There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of epinephrine, and no studies have been conducted to determine its potential for the impairment of fertility. This should not prevent the use of epinephrine under the conditions noted under INDICATIONS AND USAGE section.



(5) Pregnancy


Pregnancy Category C

Epinephrine has been shown to have developmental effects in rabbits at a subcutaneous dose of 1.2 mg/kg (approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), in mice at a subcutaneous dose of 1 mg/kg (approximately 7 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), and in hamsters at a subcutaneous dose of 0.5 mg/kg (approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). Although there are no adequate and well-controlled studies in pregnant women, epinephrine crosses the placenta and could lead to fetal anoxia, spontaneous abortion or both. Therefore, epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.



Adverse Reactions


Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism. Large doses of epinephrine can cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see (3) Drug Interactions]. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for epinephrine to produce these types of adverse reactions does not contraindicate its use in an acute, life-threatening allergic reaction.



Overdosage


Epinephrine is rapidly inactivated in the body, and treatment following overdose with epinephrine is primarily supportive. If necessary, pressor effects may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.


Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients.


If an epinephrine overdose induces pulmonary edema that interferes with respiration, treatment consists of a rapidly acting alpha-adrenergic blocking drug and/or respiratory support.


Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.


Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.



Twinject Auto-Injector Dosage and Administration


The physician who prescribes Twinject should review this Prescribing Information insert in detail with the patient. This review should include the proper use of Twinject to ensure that subcutaneous or intramuscular injections are given into the anterolateral aspect of the thigh, through clothing if necessary. The accompanying Patient Information Leaflet and Wrap Label should also be reviewed with the patient.


Twinject is capable of delivering two doses of either 0.15 mg or 0.3 mg (0.15 mL or 0.3 mL of 1:1000 dilution of epinephrine) each. The first dose is available for auto-injection by the patient, and the second dose is available for manual injection by the patient following a partial disassembly of Twinject.


Selection of the appropriate Twinject dosage strength is determined according to patient body weight.






 Twinject 0.15 mg For use by patients who weigh 15 - 30 kilograms (approximately 33 - 66 pounds)
 Twinject 0.3 mg For use by patients who weigh 30 kilograms (approximately 66 pounds) or greater

The usual dose of epinephrine for allergic emergencies in patients who weigh 30 kilograms or greater is 0.3 mg (0.3 mL of 1:1000 dilution of epinephrine).


Since the doses of epinephrine delivered from Twinject are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Twinject are felt to be necessary. The prescribing physician should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is being prescribed.


Patients should be instructed to periodically visually inspect the epinephrine solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish color or becomes darker than slightly yellow, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.



How is Twinject Auto-Injector Supplied


Twinject is a patient (or caregiver) actuated, dual-dose product that contains 1.1 mL of epinephrine injection, USP (1:1000 or 1 mg/mL), of which an initial dose can be delivered by auto-injection, and a second dose is available by manual administration. THE REMAINING VOLUME THAT IS LEFT AFTER THESE TWO FIXED DOSES CANNOT BE FURTHER ADMINISTERED AND SHOULD BE DISCARDED WITH THE DEVICE AS OUTLINED IN THE PATIENT INFORMATION LEAFLET.


Twinject 0.15 mg is available in a single unit carton, NDC 59630-801-01, and in a Two-Pack, NDC 59630-801-02, containing two Twinject 0.15 mg auto-injectors and one Twinject Demonstrator.


Twinject 0.3 mg is available in a single unit carton, NDC 59630-802-01, and in a Two-Pack, NDC 59630-802-02, containing two Twinject 0.3 mg auto-injectors and one Twinject Demonstrator.



PROTECT FROM LIGHT. STORE AT ROOM TEMPERATURE, 20°-25°C (68°-77°F) WITH EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F). PROTECT FROM FREEZING. DO NOT REFRIGERATE.



Rx only.



Manufactured for and Distributed by: Shionogi Pharma, Inc., Atlanta, GA 30328


©2010 Shionogi Pharma, Inc., Atlanta, GA. All rights reserved. This product may be covered by some or all of the following patents, patent applications and foreign equivalents thereof: U.S. Patent Nos. 5,358,489; 5,540,664; 5,665,071; and 7,297,136 and other pending U.S. Patent applications.


Printed in USA

Revised January, 2010


For inquiries call 1-888-TWIN-JCT



PRINCIPAL DISPLAY PANEL - 0.15 mg Carton Label


Rx Only

Contains One Twinject® 0.15mg Auto-Injector

NDC 59630-801-01


Two doses in each

Twinject® auto-injector


For Subcutaneous or

Intramuscular Use Only


Twinject®

auto-injector

(epinephrine injection, USP 1:1000)

each dose delivers 0.15 mg of epinephrine


Manufactured for and Distributed by:

Shionogi Pharma, Inc.

Atlanta, GA 30328 USA


SHIONOGI PHARMA, INC.


For Allergic Emergencies (Anaphylaxis)

Patient Reminder Program, See Details Inside




PRINCIPAL DISPLAY PANEL - 0.3 mg Carton Label


Rx Only

Contains One Twinject® 0.3mg Auto-Injector

NDC 59630-802-01


Two doses in each

Twinject® auto-injector


For Subcutaneous or

Intramuscular Use Only


Twinject®

auto-injector

(epinephrine injection, USP 1:1000)

each dose delivers 0.3 mg of epinephrine


Manufactured for and Distributed by:

Shionogi Pharma, Inc.

Atlanta, GA 30328 USA


SHIONOGI PHARMA, INC.


For Allergic Emergencies (Anaphylaxis)

Patient Reminder Program, See Details Inside










TWINJECT 
epinephrine  injection










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)59630-801
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (EPINEPHRINE)EPINEPHRINE1 mg  in 1 mL












Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
CHLOROBUTANOL 
SODIUM BISULFITE 
NITROGEN 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
159630-801-011 SYRINGE In 1 CARTONcontains a SYRINGE
10.15 mL In 1 SYRINGEThis package is contained within the CARTON (59630-801-01)
259630-801-022 SYRINGE In 1 CARTONcontains a SYRINGE
20.15 mL In 1 SYRINGEThis package is contained within the CARTON (59630-801-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080005/30/2003







TWINJECT 
epinephrine  injection










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)59630-802
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (EPINEPHRINE)EPINEPHRINE1 mg  in 1 mL












Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
CHLOROBUTANOL 
SODIUM BISULFITE 
NITROGEN 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
159630-802-011 SYRINGE In 1 CARTONcontains a SYRINGE
10.3 mL In 1 SYRINGEThis package is contained within the CARTON (59630-802-01)
259630-802-022 SYRINGE In 1 CARTONcontains a SYRINGE
20.3 mL In 1 SYRINGEThis package is contained within the CARTON (59630-802-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080005/30/2003


Labeler - Shionogi Pharma, Inc. (802728477)
Revised: 06/2010Shionogi Pharma, Inc.

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Saturday 23 June 2012

Eisai Corporation


Address


Eisai Corporation ,
100 Tice Blvd.

Woodcliff Lake, NJ 07677

Contact Details

Phone: (201) 692-1100
Website: http://www.eisai.com
Careers: http://us.eisai.com/section.asp?ID=128

Thursday 21 June 2012

Safyral


Pronunciation: droe-SPYE-re-none/ETH-i-nil ES-tra-DYE-ol/LEE-voe-me-FOE-late
Generic Name: Drospirenone/Ethinyl Estradiol/Levomefolate
Brand Name: Safyral

Cigarette smoking increases the risk of serious heart problems associated with use of Safyral. This risk increases with age and with heavy smoking. Women who are over 35 years old are at greater risk. Women who are over 35 years old and smoke should not use Safyral.





Safyral is used for:

Preventing pregnancy. It is also used to increase folate levels in order to decrease the risk of certain birth defects in women who become pregnant while taking Safyral or shortly after stopping Safyral. It may also be used for other conditions as determined by your doctor.


Safyral is a progesterone and estrogen combination birth control pill. It also contains a folate. It works by preventing ovulation. It may also change cervical mucus to prevent the sperm from reaching the egg, and change the lining of the uterus to prevent a fertilized egg from implanting in the uterus.


Do NOT use Safyral if:


  • you are allergic to any ingredient in Safyral

  • you are pregnant or think you may be pregnant

  • you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), or certain blood vessel problems (eg, in the brain or heart, bleeding in the brain, a heart attack, a stroke)

  • you have a history of breast cancer, or other estrogen- or progestin-dependent growths

  • you have certain heart problems (eg, heart valve problems, certain types of irregular heartbeat); certain types of headaches or migraines; endometrial, cervical, or vaginal cancer; undiagnosed abnormal vaginal bleeding; or uncontrolled high blood pressure

  • you have kidney disease; adrenal disease; diabetes that affects circulation, nerves, eyes, or kidneys; liver disease or liver tumors; or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use

  • you have had surgery and are or will be confined to a bed or a chair for an extended period of time

  • you are over 35 years old and you smoke

  • you have been through menopause

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



Before using Safyral:


Some medical conditions may interact with Safyral. 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 endometriosis, growths in the uterus, an abnormal mammogram, irregular menstrual periods, abnormal vaginal bleeding, a lump in the breast, fibrocystic breast disease, or if a family member has had breast cancer

  • if you have a history of diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems (eg, angina), high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems, mental or mood problems (eg, depression), thyroid problems, lupus, high blood calcium or potassium levels, chloasma (dark skin patches), chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, yellowing of the eyes or skin, pancreas problems, seizures, or a condition called hereditary angioedema

  • if you smoke, are very overweight, have not yet had your first menstrual period, have certain types of anemia (eg, pernicious anemia), have certain blood problems (eg, porphyria), or have fluid retention or swelling problems

  • if you will be having surgery or will be confined to a bed or a chair for a long period of time

  • if a family member has a history of high blood triglyceride levels

  • if you are taking a folate (folic acid) supplement

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


  • Aldosterone blockers (eg, eplerenone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin-receptor blockers (eg, losartan), heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, naproxen), potassium-sparing diuretics (eg, spironolactone), or potassium supplements because the risk of high blood potassium levels may be increased

  • Acetaminophen, ascorbic acid (vitamin C), atorvastatin, or tranexamic acid because they may increase the risk of Safyral's side effects

  • Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, efavirenz, nevirapine) because they may decrease Safyral's effectiveness, resulting in pregnancy or breakthrough bleeding, or they may increase the risk of Safyral's side effects

  • Aprepitant, armodafinil, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, oxcarbazepine, penicillins (eg, ampicillin), phenylbutazone, rifamycins (eg, rifampin), rufinamide, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Safyral's effectiveness, resulting in breakthrough bleeding or pregnancy

  • Certain antiseizure medicines, cholestyramine, methotrexate, or sulfasalazine because they may decrease the effectiveness of the folate in Safyral

  • Corticosteroids (eg, prednisolone), theophylline, tizanidine, or troleandomycin because the risk of their side effects may be increased by Safyral

  • Certain antiseizure medicines (eg, phenytoin, valproic acid), lamotrigine, methotrexate, pyrimethamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Safyral

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


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


  • An extra patient leaflet is available with Safyral. Talk to your pharmacist if you have questions about this information.

  • Take Safyral by mouth with or without food. It is preferable to take Safyral after the evening meal or at bedtime with liquid.

  • Talk with your doctor about how you should start to take your first pack of Safyral. If you begin to take Safyral during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take Safyral after the first 24 hours of your period or on the Sunday after your period starts, you will need to use an extra form of birth control (eg, condoms) for 7 days after you start taking Safyral.

  • If you are switching from another birth control pill to Safyral, start Safyral on the same day that you would have started a new pack of your previous birth control pills. If you are switching to Safyral from another type of hormonal birth control (eg, patch, vaginal ring), ask your doctor or pharmacist about when to start taking Safyral.

  • Take Safyral at the same time each day. After taking the last pill in the pack, start taking the first pill from the new pack the very next day.

  • Severe vomiting or diarrhea may decrease Safyral's effectiveness. Talk with your doctor about what to do if severe vomiting or diarrhea occurs while you take Safyral. If you vomit within 3 to 4 hours after you take Safyral, this should be considered a missed dose.

  • For Safyral to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.

  • If you miss 1 dose of Safyral, take it as soon as possible. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup form of birth control if you only miss 1 pill. If you miss more than 1 dose, read the extra patient leaflet that comes with Safyral or contact your doctor for instructions. You must use a backup form of birth control (eg, condom, spermicide) if you miss more than 1 dose. If you are not sure how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

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



Important safety information:


  • Safyral may increase the risk of a stroke, a heart attack, blood clots, high blood pressure, or similar problems. The risk is greater if you smoke. Do not smoke or use other tobacco products while taking Safyral.

  • Bleeding or spotting may occur while you are taking Safyral, especially during the first 3 months. Do not stop taking Safyral if this occurs. If bleeding or spotting is persistent, or if it occurs after menstrual cycles that were previously regular, contact your doctor.

  • If you miss more than 2 periods in a row or if you miss 1 period when you have not taken your pills correctly, contact your doctor. Also, if you have morning sickness or unusual breast tenderness, contact your doctor. You may be pregnant if any of these occur.

  • Certain antibiotics, anticonvulsants, and other medicines may decrease the effectiveness of Safyral. Ask your pharmacist if you have questions about which medicines may decrease Safyral's effectiveness. To prevent pregnancy while taking these medicines, use an extra form of birth control (eg, condoms). You may also need to use an extra form of birth control for a period of time after you stop taking these medicines. Check with your doctor for more information.

  • Tell your doctor or dentist that you take Safyral before you receive any medical or dental care, emergency care, or surgery. If possible, Safyral should be stopped at least 4 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (eg, long plane flight, bedrest, lengthy illness).

  • You should usually not take Safyral within 4 weeks after giving birth or after a second-trimester abortion. Talk with your doctor about how to start taking Safyral in these instances.

  • If you start to take Safyral after giving birth and you have not yet had a period, use an extra form of birth control for 7 days after you start to take Safyral.

  • Safyral may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.

  • If you wear contact lenses and you develop problems with them or experience other vision changes, contact your doctor.

  • You may experience a delay in being able to become pregnant after stopping Safyral. This effect may be greater in patients who had irregular periods before starting Safyral. Discuss any concerns with your doctor or pharmacist.

  • Safyral does not stop the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.

  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not run out of medicine. Your chance of becoming pregnant may be increased if you do not take Safyral every day as directed.

  • Diabetes patients - Safyral may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Examine your breasts monthly as directed by your doctor. Report any lumps right away.

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

  • Safyral may interfere with certain lab tests, such as cholesterol or diabetes. Be sure your doctor and lab personnel know you are taking Safyral.

  • Lab tests, including breast exams, Pap, physicals, and blood pressure, may be performed while you use Safyral. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Safyral should not be used in CHILDREN who have not yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not take Safyral if you are pregnant. If you think you may become pregnant, contact your doctor right away. Safyral is found in breast milk. Do not breast-feed while you are taking Safyral.


Possible side effects of Safyral:


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:



Breast tenderness; bleeding or spotting between menstrual periods; headache; nausea; PMS-like symptoms (eg, irritability); vomiting.



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; unusual hoarseness); breast pain, lump, or discharge; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; fainting; irregular heartbeat; left-sided jaw, neck, shoulder, or arm pain; mental or mood changes (eg, depression); migraines; missed menstrual period; muscle cramps or weakness; numbness of an arm or leg; one-sided weakness; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; red, swollen, blistered, or peeling skin; severe or persistent trouble sleeping; severe stomach pain or tenderness; shortness of breath; slurred speech; sudden, severe vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation or discharge; vision changes (eg, sudden vision loss, double vision).



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: Safyral 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 severe nausea; unexplained vaginal bleeding.


Proper storage of Safyral:

Store Safyral at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Safyral out of the reach of children and away from pets.


General information:


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

  • Safyral 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 Safyral. 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 Safyral resources


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


  • Safyral Prescribing Information (FDA)

  • Safyral Advanced Consumer (Micromedex) - Includes Dosage Information

  • Safyral Consumer Overview

  • Beyaz Prescribing Information (FDA)

  • Beyaz Consumer Overview



Compare Safyral with other medications


  • Birth Control

Wednesday 20 June 2012

Sprycel


Pronunciation: da-SA-ti-nib
Generic Name: Dasatinib
Brand Name: Sprycel


Sprycel is used for:

Treating certain types of leukemia. It may also be used for other conditions as determined by your doctor.


Sprycel is a tyrosine kinase inhibitor. It works by blocking proteins that cause the rapid growth of certain types of leukemia cells. This helps the bone marrow to start making normal blood cells again.


Do NOT use Sprycel if:


  • you are allergic to any ingredient in Sprycel

  • you are taking an H2 blocker (eg, famotidine), a proton pump inhibitor (eg, omeprazole), or St. John's wort

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



Before using Sprycel:


Some medical conditions may interact with Sprycel. 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, other substances

  • if you are lactose intolerant. Sprycel contains lactose

  • if you have liver problems, lung problems (eg, pulmonary arterial hypertension [PAH]), blood problems (eg, anemia, low blood potassium or magnesium levels, low platelet levels, low white blood cell levels), immune system problems, heart problems, or irregular heartbeat (eg, prolonged QT interval, congenital long QT syndrome)

  • if you have not previously received treatment with imatinib or other therapies for leukemia

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


  • Anticoagulants (eg, heparin, warfarin), antiplatelet medicines (eg, clopidogrel), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding problems may be increased

  • Anthracyclines (eg, doxorubicin), antiarrhythmics (eg, amiodarone, quinidine), arsenic, astemizole, bepridil, chloroquine, citalopram, cisapride, crizotinib, dolasetron, domperidone, doxepin, droperidol, halofantrine, haloperidol, iloperidone, maprotiline, methadone, nortriptyline, ondansetron, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quetiapine, quinolone antibiotics (eg, levofloxacin), romidepsin, tacrolimus, terfenadine, toremifene, vandetanib, or ziprasidone because the risk of severe and possibly fatal irregular heartbeat may be increased

  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Sprycel's side effects

  • Carbamazepine, dexamethasone, H2 blockers (eg, famotidine), hydantoins (eg, phenytoin), nevirapine, phenobarbital, primidone, proton pump inhibitors (eg, omeprazole), rifamycins (eg, rifabutin, rifampin), or St. John's wort because they may decrease Sprycel's effectiveness

  • Alfentanil, cyclosporine, ergot derivatives (eg, ergotamine), fentanyl, or sirolimus because the risk of their side effects may be increased by Sprycel

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


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


  • An extra patient leaflet is available with Sprycel. Talk to your pharmacist if you have questions about this information.

  • Take Sprycel by mouth with or without food.

  • Swallow Sprycel whole. Do not break, crush, or chew before swallowing.

  • Do not eat grapefruit or drink grapefruit juice while you use Sprycel.

  • Do not take an antacid within 2 hours before or 2 hours after you take Sprycel.

  • Take Sprycel at the same time each day.

  • Do not change your dose or stop taking Sprycel without first talking with your doctor.

  • If you miss a dose of Sprycel, take your next scheduled dose at its regular time. Do not take 2 doses at once. Contact your doctor or pharmacist if you are unsure of what to do.

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



Important safety information:


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

  • Women who may become pregnant should use effective birth control while taking Sprycel. Check with your doctor if you have questions about using birth control.

  • Women who are pregnant should avoid exposure to Sprycel if the tablet is accidentally crushed or broken.

  • If you experience nausea, vomiting, diarrhea, or loss of appetite, talk with your doctor about ways to lessen these effects.

  • Sprycel 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.

  • Sprycel 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.

  • Sprycel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sprycel. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Sprycel may increase the risk of developing high blood pressure in your lungs (pulmonary arterial hypertension [PAH]). This may occur at anytime after starting Sprycel, including after more than 1 year of treatment. Discuss any questions or concerns with your doctor. Contact your doctor right away if you experience shortness of breath or trouble breathing, unusual tiredness, or unusual swelling.

  • Tell your doctor or dentist that you take Sprycel before you receive any medical or dental care, emergency care, or surgery.

  • Lab tests, including liver, lung, and heart function; blood electrolytes; and complete blood cell counts, may be performed while you use Sprycel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Sprycel with caution in the ELDERLY; they may be more sensitive to its effects.

  • Sprycel should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Sprycel may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Sprycel is found in breast milk. Do not breast-feed while taking Sprycel.


Possible side effects of Sprycel:


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:



Constipation; diarrhea; dizziness; drowsiness; dry eyes; fatigue; hair loss; headache; joint or muscle pain; loss of appetite; nausea; stomach pain; taste changes; trouble sleeping; upset stomach; vomiting; weakness.



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); black, tarry, or bright red stools; blood in the vomit; burning, numbness, or tingling; calf or leg pain, tenderness, or swelling; change in the amount of urine produced; chest, jaw, or left arm pain; confusion; dark urine; dry cough; fainting; irregular heartbeat; irritation or sores in the mouth; mood or mental changes (eg, depression); numbness of an arm or leg; red, swollen, peeling, or blistered skin; ringing in the ears; seizures; severe or persistent diarrhea, headache, muscle or bone pain, nausea, stomach pain, or vomiting; severe or persistent tiredness or weakness; shortness of breath; signs of bleeding in the brain (eg, slurred speech, one-sided weakness, muscle weakness, loss of consciousness); signs of infection (eg, fever, chills, sore throat); unusual bruising or bleeding; unusual swelling or weight gain; vision changes (eg, blurred vision, decreased vision clearness); vomit that looks like coffee grounds; yellowing of the skin or eyes.



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


See also: Sprycel 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 Sprycel:

Store Sprycel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sprycel out of the reach of children and away from pets.


General information:


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

  • Sprycel 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 Sprycel. 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 Sprycel resources


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


  • Sprycel Prescribing Information (FDA)

  • Sprycel Consumer Overview

  • Sprycel Monograph (AHFS DI)

  • Sprycel Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dasatinib Professional Patient Advice (Wolters Kluwer)



Compare Sprycel with other medications


  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Leukemia

Saturday 16 June 2012

tinidazole


tye-NYE-da-zole


Oral route(Tablet)

Carcinogenicity has been seen in mice and rats treated chronically with another agent in the nitroimidazole class (metronidazole). Although such data have not been reported for tinidazole, unnecessary use of tinidazole should be avoided .



Commonly used brand name(s)

In the U.S.


  • Tindamax

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antibiotic


Uses For tinidazole


Tinidazole is used to treat infections caused by protozoa (tiny, one-celled animals). It works by killing the protozoa.


tinidazole is also used to treat vaginal infections caused by bacteria .


Tinidazole is available only with your doctor's prescription.


Before Using tinidazole


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 tinidazole, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to tinidazole 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 tinidazole in children below 3 years of age. Safety and efficacy have not been established. It is only used in children three years of age and older for the treatment of giardiasis and amebiasis .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of tinidazole in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require adjustment of dosage in patients receiving tinidazole .


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. When you are taking tinidazole, 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 tinidazole 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.


  • Disulfiram

  • Fluorouracil

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 tinidazole with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tinidazole, 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 tinidazole. Make sure you tell your doctor if you have any other medical problems, especially:


  • Blood disease or a history of blood disease—Tinidazole may make this condition worse.

  • Central nervous system (CNS) disease, including epilepsy—Tinidazole may increase the chance of seizures (convulsions) or other CNS side effects.

  • Liver disease, severe—Patients with severe liver disease may have an increase in side effects.

  • Oral thrush or vaginal yeast infection—Tinidazole may make yeast infections worse.

Proper Use of tinidazole


If tinidazole upsets your stomach, it may be taken with meals or a snack. If stomach upset (nausea, vomiting, stomach pain, or diarrhea) continues, check with your doctor.


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


In some kinds of infections, tinidazole works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, the doses should be spaced about 24 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.


Some types of infections are treated with one dose of tinidazole.


If you cannot swallow the tablet, it may be crushed in artificial cherry syrup. Shake this mixture well before drinking .


Dosing


The dose of tinidazole 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 tinidazole. 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 (tablets):
    • For intestinal amebiasis:
      • Adults—2 grams per day for three days.

      • Children 3 years of age and older—50 milligrams per kilogram of body weight per day (up to to 2 grams per day) for three days.

      • Children below 3 years old—Use and dose must be determined by your doctor .


    • For amebic liver abscess:
      • Adults—2 grams per day for 3 to 5 days.

      • Children 3 years of age and older—50 milligrams per kilogram of body weight per day (up to to 2 grams per day) for 3 to 5 days.

      • Children below 3 years old—Use and dose must be determined by your doctor .


    • For bacterial vaginosis:
      • Adults— 2 grams per day for two days or 1 gram per day for five days.

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


    • For giardiasis:
      • Adults—2 grams given once as a single dose.

      • Children 3 years of age and older—50 milligrams per kilogram of body weight (up to to 2 grams) given once as a single dose.

      • Children below 3 years old—Use and dose must be determined by your doctor .


    • For trichomoniasis:
      • Adults— 2 grams given once as a single dose.

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



Missed Dose


If you miss a dose of tinidazole, 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 tinidazole


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


You should not take tinidazole during the first trimester (3 months) of pregnancy. Using tinidazole while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Also, do not breastfeed while using tinidazole. Wait at least three days after you stop taking tinidazole before you breastfeed .


Tinidazole may cause a vaginal yeast infection. Check with your doctor right away if you are having itching of the vagina or outside genitals; pain during sexual intercourse; or thick, white curd-like vaginal discharge without odor or with mild odor .


Drinking alcoholic beverages or using preparations that contain propylene glycol while taking tinidazole may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least 3 days after you stop taking tinidazole. Also, tinidazole may cause alcoholic beverages to taste different. Therefore, you should not drink alcoholic beverages or use other alcohol or propylene glycol-containing preparations while you are taking tinidazole and for at least 3 days after stopping it.


If you are taking tinidazole for trichomoniasis (an infection of the sex organs in males and females), your doctor may want to treat your sexual partner at the same time you are being treated, even if he or she has no symptoms. Also, it may be desirable to use a condom (prophylactic) during intercourse. These measures will help keep you from getting the infection back again from your partner. If you have any questions about this, check with your doctor.


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


tinidazole 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:


Rare
  • Change in consciousness

  • cough

  • difficulty breathing

  • loss of consciousness

  • noisy breathing

  • shortness of breath

  • tightness in chest

  • wheezing

Incidence unknown
  • Black, tarry stools

  • bleeding gums

  • blood in urine or stools

  • burning, numbness, tingling, or painful sensations

  • chest pain

  • chills

  • difficulty swallowing

  • fast, irregular, pounding, or racing heartbeat or pulse

  • fever

  • hives

  • increased transaminase levels

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

  • lower back or side pain

  • nausea

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on skin

  • reddening of the skin, especially around ears

  • seizures

  • sore throat

  • sores, ulcers, or white spots on lips or in mouth

  • swelling of eyes, face, or inside of nose

  • swollen glands

  • ulcers

  • unsteadiness or awkwardness

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • weakness in arms, hands, legs, or feet

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
  • Bitter taste

  • metallic taste

Less common
  • Acid or sour stomach

  • belching

  • cramps

  • difficulty having a bowel movement (stool)

  • dizziness

  • general feeling of discomfort or illness

  • headache

  • heartburn

  • indigestion

  • loss of appetite

  • pain or discomfort in chest, upper stomach, or throat

  • vomiting

  • weight loss

Rare
  • Body aches or pain

  • coating on tongue

  • congestion

  • depression

  • dryness or soreness of throat

  • hoarseness

  • mood or mental changes

  • runny nose

  • tender, swollen glands in neck

  • voice changes

Incidence unknown
  • Abnormal liver

  • darkened urine

  • diarrhea

  • difficulty in moving

  • feeling of constant movement of self or surroundings

  • giddiness

  • lightheadedness

  • muscle pain or stiffness

  • pain, swelling, or redness in joints

  • sensation of spinning

  • shakiness and unsteady walk

  • sleepiness

  • sleeplessness

  • swelling or inflammation of the mouth

  • tongue discoloration

  • trembling, or other problems with muscle control or coordination

  • trouble sleeping

  • unable to sleep

  • white or brownish vaginal discharge

  • white patches in the mouth or throat or on the tongue

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: tinidazole 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 tinidazole resources


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


  • Tinidazole Professional Patient Advice (Wolters Kluwer)

  • Tinidazole Monograph (AHFS DI)

  • Tinidazole MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tindamax Prescribing Information (FDA)

  • Tindamax Consumer Overview



Compare tinidazole with other medications


  • Amebiasis
  • Bacterial Vaginitis
  • Giardiasis
  • Trichomoniasis

Friday 15 June 2012

Alka-Seltzer Plus Cough and Cold Liquigel


Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)

Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Children's Tylenol Flu, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Cold and Flu Maximum Strength Tablet, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Triaminic Flu, Cough & Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M


What is Alka-Seltzer Plus Cough and Cold Liquigel (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.


Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.


Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about this medication?


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking this medication?


Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use a cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:



  • liver disease, cirrhosis, or a history of alcoholism;




  • a blockage in your digestive tract (stomach or intestines);




  • diabetes;




  • kidney disease;




  • epilepsy or other seizure disorder;




  • cough with mucus, or cough caused by emphysema or chronic bronchitis;




  • enlarged prostate or urination problems;




  • pheochromocytoma (an adrenal gland tumor); or




  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).




It is not known whether acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.

How should I take Alka-Seltzer Plus Cough and Cold Liquigel (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


The chewable tablet must be chewed thoroughly before you swallow it.


Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.


If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?


Since cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. 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. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


What should I avoid while taking this medication?


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medication 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 this medication and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats, severe restless feeling or nervousness;




  • mood changes, confusion, hallucinations, unusual thoughts or behavior;




  • tremor, seizure (convulsions);




  • easy bruising or bleeding, unusual weakness;




  • urinating less than usual or not at all;




  • feeling short of breath;




  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • dizziness, drowsiness;




  • dry mouth, nose, or throat;




  • constipation or diarrhea;




  • blurred vision; or




  • feeling nervous or restless.



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 Alka-Seltzer Plus Cough and Cold Liquigel (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?


Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.

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



  • leflunomide (Arava);




  • topiramate (Topamax);




  • zonisamide (Zonegran);




  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;




  • an antidepressant;




  • birth control pills or hormone replacement therapy;




  • bladder or urinary medications;




  • blood pressure medication;




  • a bronchodilator;




  • cancer medicine;




  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;




  • gout or arthritis medications (including gold injections);




  • HIV/AIDS medication;




  • medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;




  • medicines to treat psychiatric disorders;




  • an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or




  • seizure medication.



This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. 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 Alka-Seltzer Plus Cough and Cold Liquigel resources


  • Alka-Seltzer Plus Cough and Cold Liquigel Side Effects (in more detail)
  • Alka-Seltzer Plus Cough and Cold Liquigel Use in Pregnancy & Breastfeeding
  • Alka-Seltzer Plus Cough and Cold Liquigel Drug Interactions
  • Alka-Seltzer Plus Cough and Cold Liquigel Support Group
  • 1 Review for Alka-Seltzer Plus Cough and Cold Liquigel - Add your own review/rating


  • Vicks Formula 44M Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Alka-Seltzer Plus Cough and Cold Liquigel with other medications


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  • Influenza


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Alka-Seltzer Plus Cough and Cold Liquigel side effects (in more detail)