Saturday, 11 August 2012

Principen


Pronunciation: AM-pi-SIL-in
Generic Name: Ampicillin
Brand Name: Principen


Principen is used for:

Treating infections caused by certain types of bacteria.


Principen is a penicillin antibiotic. It works by killing sensitive bacteria by interfering with formation of the bacteria's cell wall while it is growing. This weakens the cell wall and it ruptures, resulting in the death of the bacteria.


Do NOT use Principen if:


  • you are allergic to any ingredient in Principen or to any other penicillin antibiotic (eg, amoxicillin)

  • you are taking a tetracycline antibiotic (eg, doxycycline)

  • you have mononucleosis ("mono")

  • you have recently received or will be receiving live oral typhoid vaccine

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



Before using Principen:


Some medical conditions may interact with Principen. 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 stomach infection or diarrhea

  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a cephalosporin antibiotic (eg, cephalexin) or other beta-lactam antibiotic (eg, imipenem)

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


  • Tetracyclines (eg, doxycycline) because they may decrease Principen's effectiveness

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

  • Allopurinol because the risk of skin rash may be increased

  • Anticoagulants (heparin, warfarin) or methotrexate because the risk of their side effects may be increased by Principen

  • Aminoglycosides (eg, gentamicin), birth control pills, or live oral typhoid vaccine because their effectiveness may be decreased by Principen

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


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


  • Take Principen by mouth at least one-half hour before or 2 hours after eating.

  • Take Principen with a full glass of water (8 oz/240 mL).

  • Take Principen on a regular schedule to get the most benefit from it. Taking Principen at the same time each day will help you remember to take it.

  • To clear up your infection completely, use Principen for the full course of treatment. Keep using it even if you feel better in a few days.

  • If you miss a dose of Principen, 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 Principen.



Important safety information:


  • Principen only works against bacteria; it does not treat viral infections (eg, the common cold).

  • Be sure to use Principen for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • Long-term or repeated use of Principen may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Principen. To prevent pregnancy, use an extra form of birth control (eg, condoms).

  • Diabetes patients - Principen may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.

  • Lab tests, including white blood cell counts and kidney function tests, may be performed while you use Principen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Principen with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Principen while you are pregnant. Principen is found in breast milk. If you are or will be breast-feeding while you use Principen, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Principen:


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:



Inflammation and redness of the tongue; irritation of mouth or throat; mild diarrhea; nausea; second infection; 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); bloody stools; severe diarrhea; stomach pain/cramps; vaginal irritation or discharge .



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: Principen 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 diarrhea; nausea; seizures; vomiting.


Proper storage of Principen:

Store Principen at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Principen out of the reach of children and away from pets.


General information:


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

  • Principen 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 Principen. 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 Principen resources


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


  • Principen Concise Consumer Information (Cerner Multum)

  • Principen Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ampicillin Professional Patient Advice (Wolters Kluwer)

  • Ampicillin Monograph (AHFS DI)

  • Ampicillin Prescribing Information (FDA)

  • Ampicillin Sodium and Sulbactam Sodium Monograph (AHFS DI)



Compare Principen with other medications


  • Bacterial Endocarditis Prevention
  • Bronchitis
  • Endocarditis
  • Gastroenteritis
  • Intraabdominal Infection
  • Kidney Infections
  • Leptospirosis
  • Meningitis
  • Otitis Media
  • Peritonitis
  • Pharyngitis
  • Pneumonia
  • Prevention of Perinatal Group B Streptococcal Disease
  • Septicemia
  • Shigellosis
  • Sinusitis
  • Skin Infection
  • Surgical Prophylaxis
  • Typhoid Fever
  • Upper Respiratory Tract Infection
  • Urinary Tract Infection

Tuesday, 7 August 2012

Tinzaparin


Pronunciation: tin-ZAP-a-rin
Generic Name: Tinzaparin
Brand Name: Innohep

Tell your doctor you use Tinzaparin before you have any type of spinal puncture or epidural/spinal anesthesia. Patients who have these procedures while they use Tinzaparin are at risk for developing a blood clot on or near the spinal cord. This could result in long-term or permanent paralysis.


The risk is increased in patients who have an indwelling epidural catheter, or traumatic or repeated epidural or spinal puncture, a history of a deformed spine or spinal surgery, and in patients who use medicines that may affect blood clotting such as warfarin, aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen).


If you have a spinal puncture or epidural/spinal anesthesia while you use Tinzaparin, tell your doctor immediately if you notice any signs or symptoms of nerve problems, such as numbness or tingling, muscle weakness, or paralysis.





Tinzaparin is used for:

Treating certain types of blood clots (deep vein thrombosis) when used along with warfarin.


Tinzaparin is a low molecular weight heparin (LMWH). It works by blocking the formation of blood clots, including fibrin clots.


Do NOT use Tinzaparin if:


  • you are allergic to any ingredient in Tinzaparin

  • you are allergic to heparin, sulfites, benzyl alcohol, or pork products

  • you have active severe high blood pressure, major bleeding, or a history of low platelets or bleeding problems due to the use of heparin

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



Before using Tinzaparin:


Some medical conditions may interact with Tinzaparin. 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 kidney problems, liver problems, or stomach or intestinal problems (eg, ulcers), stroke, asthma, or vision problems caused by diabetes

  • if you have inflammation of the heart due to a bacterial infection, severe, uncontrolled high blood pressure, or amyloidosis

  • if you have a history of stroke, asthma, or vision problems caused by diabetes

  • if you have a bleeding disorder or a history of brain bleeding or blood conditions

  • if you have recently had or are scheduled to have brain, spine, or eye surgery, an epidural catheter, or a spinal puncture

  • if you are taking medicines that affect platelets (eg, aspirin, clopidogrel, ticlopidine)

  • if you are 70 years old or older and have decreased kidney function

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


  • Activated protein C, anticoagulants (eg, warfarin), dextran, dipyridamole, direct factor XA inhibitors (eg, rivaroxaban), direct thrombin inhibitors (eg, dabigatran), injectable cephalosporins (eg, cephazolin), injectable penicillins (eg, ampicillin), NSAIDs (eg, ibuprofen, ketorolac, naproxen), platelet inhibitors (eg, clopidogrel, ticlopidine), salicylates (eg, aspirin), sulfinpyrazone, or thrombolytics (eg, streptokinase) because the risk of side effects, such as bleeding, may be increased

  • Nitrates (eg, nitroglycerin) because they may decrease the effectiveness of Tinzaparin

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


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


  • Tinzaparin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Tinzaparin at home, carefully follow the injection procedures taught to you by your health care provider.

  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into the muscle or a vein.

  • Do not use Tinzaparin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Tinzaparin, contact your doctor immediately.

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



Important safety information:


  • Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

  • Tinzaparin 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.

  • Tinzaparin may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.

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

  • Before you begin taking any new prescription or nonprescription medicine, check the label to see if it has aspirin or ibuprofen in it. If it does or you are not sure, contact your doctor or pharmacist.

  • Tinzaparin may affect certain lab tests, including liver enzyme. Be sure your doctor and lab personnel know you are using Tinzaparin.

  • Lab tests, including complete blood cell counts (eg, platelet counts), and tests for blood in the stool, may be performed while you use Tinzaparin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Tinzaparin with caution in the ELDERLY; the risk of death may be greater in patients 70 years old and older who have decreased kidney function. Discuss any concerns with your doctor.

  • Tinzaparin has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.

  • Tinzaparin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tinzaparin while you are pregnant. It is not known if Tinzaparin is found in breast milk. If you are or will be breast-feeding while you use Tinzaparin, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Tinzaparin:


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:



Mild bleeding, bruising, irritation, pain, redness or swelling at the injection site.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody, black, or tarry stools; chest pain; confusion; coughing up blood; difficult or painful urination; difficulty walking; fainting; fever, chills, or sore throat; irregular heartbeat; joint or muscle pain; nosebleed; tingling, numbness (especially in the legs and feet), and muscle weakness; one-sided weakness; pale skin; pink or red urine; prolonged, painful erection; red, swollen, blistered, or peeling skin; severe or persistent dizziness or weakness; severe or persistent headache, nausea, or stomach pain; shortness of breath; slurred speech; swelling; unusual bleeding or bruising, vomit that looks like coffee grounds.



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: Tinzaparin 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 unusual bleeding or bruising (eg, nosebleeds, easy bruising, bloody urine or stools).


Proper storage of Tinzaparin:

Store Tinzaparin 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 Tinzaparin out of the reach of children and away from pets.


General information:


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

  • Tinzaparin 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 Tinzaparin. 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 Tinzaparin resources


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


  • tinzaparin Concise Consumer Information (Cerner Multum)

  • tinzaparin Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Innohep Prescribing Information (FDA)

  • Innohep Monograph (AHFS DI)



Compare Tinzaparin with other medications


  • Deep Vein Thrombosis

Sunday, 5 August 2012

Jext 300 micrograms Solution for Injection in pre-filled pen





1. Name Of The Medicinal Product



Jext 300 micrograms solution for injection in pre-filled pen


2. Qualitative And Quantitative Composition



Jext 300 micrograms: One pre-filled pen delivers one dose of 0.30ml solution for injection containing 300 micrograms of adrenaline (as tartrate).



1 ml solution contains 1mg adrenaline (as tartrate).



Excipients: Sodium metabisulphite (E223) and sodium chloride.



Jext contains less than 1 mmol sodium (23 mg) per dose.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Solution for injection in pre-filled pen.



Clear and colourless solution.



4. Clinical Particulars



4.1 Therapeutic Indications



Jext is indicated in the emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.



4.2 Posology And Method Of Administration



Posology:



Use in adults over 30 kg in weight:



The usual dose is 300 micrograms.



Larger adults may require more than one injection to reverse the effect of an allergic reaction.



Patients between 15 kg and 30 kg in weight should be prescribed a Jext 150 micrograms.



An initial dose should be administered as soon as symptoms of anaphylaxis are recognised.



The effective dose is typically in the range of 0.005-0.01 mg/kg but higher doses may be necessary in some cases.



In the absence of clinical improvement or if deterioration occurs, a second injection with an additional Jext may be administered 5 – 15 minutes after the first injection.



Method of administation:



For intramuscular use.



For single use.



Jext is for intramuscular administration into the anterolateral thigh.



It is designed to inject through clothing or directly through the skin.



Massage around the injection area is advised to accelerate absorption.



Please refer to section 6.6 for detailed instructions for use



4.3 Contraindications



There are no absolute contraindications to the use of Jext during an allergic emergency.



4.4 Special Warnings And Precautions For Use



Do not remove yellow cap until ready for use.



Jext should be administered into the anterolateral thigh. The injection is delivered immediately after the black needle shield of the auto-injector is pressed firmly against the skin or other surface. Patients should be advised not to inject Jext into the gluteus maximus due to the risk of accidental injection into a vein.



The patient should be instructed to seek emergency medical assistance immediately after administering the first dose in order to have close monitoring of the anaphylactic episode and further treatment as required.



Jext contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma. Patients with these conditions must be carefully instructed in regard to the circumstances under which Jext should be used.



Due to an increased risk of adverse reactions following administration of adrenaline special caution should be taken in patients with cardiovascular diseases including angina pectoris, obstructive cardiomyopathy, cardiac arrhythmia, cor pulmonale, atherosclerosis and hypertension.



Special caution should also be taken in patients with hyperthyroidism, phaeochromocytoma, narrow angle glaucoma, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcaemia, hypokalaemia and diabetes.



Caution should also be taken in elderly and pregnant patients.



Peripheral ischaemia following accidental injection into hands or feet may cause loss of blood flow to adjacent areas due to vasoconstriction.



All patients who are prescribed Jext should be thoroughly instructed to understand the indications for use and the correct method of administration.



There is often a prolonged period between supply of Jext and an allergic reaction requiring adrenaline. Patients should be advised to regularly check Jext and ensure it is replaced within the expiry period.



This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Caution is indicated in patients receiving drugs that may sensitise the heart to arrhythmias, including digitalis and quinidine. The effects of adrenaline may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors (MAO-inhibitors) and catechol-O-methyl transferase inhibitors (COMT inhibitors).



Adrenaline inhibits the secretion of insulin, thus increasing the blood glucose level. It may be necessary for diabetic patients receiving adrenaline to increase their dosage of insulin or oral hypoglycaemic drugs.



The alpha- and beta-stimulating effect can be inhibited by concomitant use of alpha- and beta-blocking drugs as well as parasympathomimetic drugs.



4.6 Pregnancy And Lactation



Clinical experience in the treatment of anaphylaxis during pregnancy is limited. Adrenaline should only be used during pregnancy if the potential benefit justifies the potential risk for the foetus.



Adrenaline is not orally bioavailable; any adrenaline excreted in breast milk would not be expected to have any effect on the nursing infant.



4.7 Effects On Ability To Drive And Use Machines



Jext has no or negligible influence on the ability to drive and use machines, however,patients are not recommended to drive or use machines following administration of adrenaline, since they will be affected by the anaphylactic reaction.



4.8 Undesirable Effects



Side effects associated with adrenaline's alpha and beta receptor activity may include cardiovascular effects as well as undesirable effects on the central nervous system.



The following table is based upon post marketing experience with the use of adrenaline. The frequency cannot be estimated from the available data.






















System Organ Class




Adverse Drug Reaction




Metabolism and nutrition disorders




Hyperglycaemia, hypokalaemia, metabolic acidosis




Psychiatric disorders




Anxiety, hallucination




Nervous system disorders




Headache, dizziness, tremor, syncope




Cardiac disorders




Tachycardia, arrhythmia, palpitations, angina pectoris, stress cardiomyopathy




Vascular disorders




Hypertension, vasoconstriction, peripheral ischaemia




Respiratory, thoracic and mediastinal disorders




Bronchospasm




Gastrointestinal disorders




Nausea, vomiting




General disorders and administration site conditions




Hyperhidrosis, asthenia



Peripheral ischaemia following accidental injection of adrenaline in the hands or feet has been reported.



Jext contains sodium metabisulphite which may rarely cause severe hypersensitivity reactions including anaphylactic symptoms and bronchospasm (see section 4.4. Special warning and precautions for use).



4.9 Overdose



Overdose or inadvertent intravascular injection of adrenaline may cause cerebral haemorrhage and ventricular arrhythmias resulting from a sharp rise in blood pressure. Myocardial ischaemias and necroses as well as renal impairment may occur. Fatalities may also result from pulmonary oedema because of peripheral vascular constriction together with cardiac stimulation.



Pulmonary oedema may be treated with alpha-blocking agents such as phentolamine. In case of arrhythmias these may be treated with beta-blocking agents.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Cardiac stimulants excl. cardiac glycosides, adrenergic and dopaminergic agents.



ATC code: C01CA24.



Adrenaline is a catecholamine which stimulates the sympathetic nervous system (both alpha and beta receptors) by which cardiac rate, cardiac output and coronary circulation is raised. Adrenaline through its action on beta receptors on bronchial smooth muscles causes bronchial smooth muscle relaxation which alleviates wheezing and dyspnoea.



5.2 Pharmacokinetic Properties



Adrenaline is a naturally occurring substance produced by the adrenal medulla and secreted in response to exertion or stress. It is rapidly inactivated in the body mostly by the enzymes COMT and MAO. The liver is rich in these enzymes and is an important, although not essential, tissue in the degradation process. Much of the dose of adrenaline is accounted for by excretion of metabolites in the urine.



The plasma half-life of adrenaline is about 2.5 min. However local vasoconstriction may retard absorption, so that the effects can last longer than the half-life would predict. Massage around the injection area is advised to accelerate absorption.



5.3 Preclinical Safety Data



Adrenaline has been utilised in the treatment of allergic emergencies for many years. There is no preclinical data of relevance available.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium Chloride



Sodium Metabisulphite (E223)



Hydrochloric Acid (for pH adjustment)



Water for Injections



6.2 Incompatibilities



In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.



6.3 Shelf Life



2 years



6.4 Special Precautions For Storage



Do not freeze.



6.5 Nature And Contents Of Container



Pre-filled pen (single dose pen) comprising an auto-injector with a cartridge. The cartridge is made of glass (type 1), sealed with a latex free grey rubber plunger and a latex free bromobutyl rubber seal within an anodised aluminium cap. The auto-injector is made of plastic.



Pack-size: 1 pre-filled pen



6.6 Special Precautions For Disposal And Other Handling



Jext is a single-use pre-filled pen designed for easy use.



The pre-filled pen is operated by simply pressing the black injector tip against the outer thigh. This will activate a plunger, which pushes a concealed needle through the membrane on the black injector tip into the muscle and injects a dose of adrenaline. This can be done through clothing.



Jext 300 micrograms contains 1.4 ml of adrenaline injection 1 mg/ml which is designed to deliver a single dose (0.30 ml) of 300 micrograms adrenaline when activated. After activation of the auto-injector 1.1 ml remains in the pre-filled pen. Discard any unused solution.



A small air bubble may occur in Jext. It has no influence on either the use or the efficacy of the product.



The prescriber may use a “Jext Simulator” during patient instruction. This is a pen without needle or adrenaline, which is also available for patients or carers who may wish to practise at home.



Note: the yellow cap prevents the device from activating, and should not be removed before injection is required. The black injector tip should be kept away from the hand.


















 




1. Grasp the Jext injector in your dominant hand (the one you use to write with) with your thumb closest to the yellow cap.






 




2. Pull off the yellow cap with your other hand.






 




3. Place the black injector tip against your outer thigh, holding the injector at a right angle (approx 90°) to the thigh.






 




4. Push the black tip firmly into your outer thigh until you hear a 'click' confirming the injection has started, then keep it pushed in. Hold the injector firmly in place against the thigh for 10 seconds (a slow count to 10) then remove. The black tip will extend automatically and hide the needle.






 




5. Massage the injection area for 10 seconds. Seek immediate medical help.



Any expired products should be disposed of in accordance with local requirements.



Check the solution periodically through the viewing window of the unit to make sure the solution is clear and colourless.



The solution darkens in colour upon exposure to air or light.



Replace and discard the pre-filled pen if the solution is discoloured or contains a precipitate, or at the latest before the expiry date.



The expiry date is indicated on the label and Jext should not be used after this date.



7. Marketing Authorisation Holder



ALK-Abelló A/S



Bøge Allé 6-8



DK-2970 Hørsholm



8. Marketing Authorisation Number(S)



PL 10085/0053



9. Date Of First Authorisation/Renewal Of The Authorisation



12-11-2010



10. Date Of Revision Of The Text



12-11-2010




Saturday, 4 August 2012

Esoterica Cream


Pronunciation: hye-droe-KWIN-own
Generic Name: Hydroquinone
Brand Name: Examples include Esoterica and Melquin


Esoterica Cream is used for:

Lightening freckles, age spots, and other skin discolorations associated with pregnancy, skin trauma, birth control pills, or hormone replacement therapy. It may also be used for other conditions as determined by your doctor.


Esoterica Cream is a skin-bleaching agent. It works by inhibiting an enzyme reaction in skin cells.


Do NOT use Esoterica Cream if:


  • you are allergic to any ingredient in Esoterica Cream

  • you are pregnant

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



Before using Esoterica Cream:


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


  • if you are 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

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


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


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


  • Before using Esoterica Cream for the first time, apply a small amount to an unbroken patch of skin and check in 24 hours for itching, blistering, or excessive redness or irritation. If these effects develop, contact your doctor as soon as possible and do not use Esoterica Cream on other areas.

  • Wash and completely dry the affected areas. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after using Esoterica Cream, unless your hands are part of the treated area.

  • If you miss a dose of Esoterica Cream, use 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 use 2 doses at once.

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



Important safety information:


  • Protect your skin from the sun during and after the use of Esoterica Cream. Limit sun exposure, use a sunscreen, and wear protective clothing to cover the treated areas.

  • Esoterica Cream is for external use only. Avoid getting Esoterica Cream in your eyes, nose, or mouth, or on your lips. If you get Esoterica Cream in your eyes, wash them out with water and contact your doctor. If you get Esoterica Cream on your lips or in your nose or mouth, rinse with water.

  • Do not use Esoterica Cream on irritated or injured skin.

  • Do not use Esoterica Cream with products that contain hydrogen peroxide or benzoyl peroxide. This may cause a dark staining of your skin. The staining can be removed by stopping use of the peroxide and washing your skin with soap and water.

  • Do not use Esoterica Cream with other medicines containing resorcinol, phenol, or salicylic acid unless otherwise directed by your doctor.

  • Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.

  • Esoterica Cream is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Esoterica Cream during pregnancy. It is unknown if Esoterica Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Esoterica Cream, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Esoterica Cream:


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:



Dryness or cracking of the skin if applied around eyes or nose; minor redness or mild burning sensation at application site.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; blue-black darkening of the skin; excessive redness, stinging, or irritation.



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: Esoterica 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 Esoterica Cream:

Store Esoterica Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Esoterica Cream out of the reach of children and away from pets.


General information:


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

  • Esoterica Cream 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 Esoterica Cream. 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 Esoterica resources


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


Compare Esoterica with other medications


  • Dermatological Disorders

Thursday, 2 August 2012

antihistamine, decongestant, and anticholinergic combination


Class Name: antihistamine, decongestant, and anticholinergic combination (Oral route)


Commonly used brand name(s)

In the U.S.


  • Allerx-D

  • Dallergy

  • Extendryl JR

  • Extendryl SR

  • Phenylephrine CM

  • Rescon ER

  • Stahist

Available Dosage Forms:


  • Syrup

  • Tablet, Extended Release

  • Capsule, Extended Release

  • Tablet

  • Solution

  • Suspension

  • Tablet, Chewable

Uses For This Medicine


In November 2000, the Food and Drug Administration (FDA) issued a public health warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by results of a research program, requested that manufacturers voluntarily discontinue marketing products that contain PPA and that consumers work with their healthcare providers to select alternative products.


Antihistamine, decongestant, and anticholinergic combinations are used to treat the nasal congestion (stuffy nose) and runny nose caused by allergies and/or the common cold.


Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. The antihistamine contained in these combinations is chlorpheniramine.


The decongestants in these combinations, phenylephrine, and pseudoephedrine produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.


Anticholinergics, such as atropine, hyoscyamine, methscopolamine, and scopolamine may help produce a drying effect in the nose and chest.


Some of these medicines are available without a prescription.


Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Before Using This Medicine


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Very young children are usually more sensitive than adults to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Also, when anticholinergics are given to children during hot weather, a rapid increase in body temperature may occur, which may lead to heat stroke. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be especially likely to cause severe side effects.


Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Geriatric


Confusion or memory loss, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, eye pain may occur, which may be a sign of glaucoma.


Pregnancy


For the individual ingredients of these combinations, the following apply:


  • Antihistamines—Antihistamines have not been shown to cause problems in humans.

  • Atropine—Studies on effects in pregnancy have not been done in humans. Atropine has not been shown to cause birth defects or other problems in animals.

  • Hyoscyamine—Studies on effects in pregnancy have not been done in either humans or animals.

  • Methscopolamine—Studies on effects in pregnancy have not been done in either humans or animals.

  • Phenylephrine—Studies on birth defects have not been done in either humans or animals.

  • Pseudoephedrine—Studies on birth defects have not been done in humans. Pseudoephedrine has not been shown to cause birth defects in animal studies. However, studies in animals have shown that pseudoephedrine causes a reduction in average weight, length, and rate of bone formation in the animal fetus.

  • Scopolamine—Studies on effects in pregnancy have not been done in pregnant women. However, studies in animals at doses many times the human dose have shown that scopolamine causes a small increase in the number of fetal deaths.

Breast Feeding


Small amounts of antihistamines, decongestants, and anticholinergics may pass into the breast milk. Use is not recommended since this medicine may cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since this medicine tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some women.


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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Potassium

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


  • Brain damage in children or

  • Down syndrome or

  • Dryness of mouth (severe and continuing) or

  • Enlarged prostate or

  • Fever or

  • Glaucoma or

  • Intestinal blockage or other intestinal problems or

  • Kidney disease or

  • Liver disease or

  • Lung disease or

  • Mental or emotional problems or

  • Myasthenia gravis or

  • Toxemia of pregnancy or

  • Urinary tract blockage or difficult urination—These medicines may make these conditions worse.

  • Type 2 diabetes mellitus—The decongestant in this medicine may put diabetic patients at greater risk of having heart or blood vessel disease.

  • Heart or blood vessel disease or

  • High blood pressure—The decongestant and anticholinergic in this medicine may cause the blood pressure to increase and may also speed up the heart rate.

  • Overactive thyroid—If the overactive thyroid has caused a fast heartbeat, the decongestant and anticholinergic in this medicine may cause the heart rate to speed up further.

Proper Use of This Medicine


Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.


If this medicine irritates your stomach, you may take it with food or a glass of water or milk, to lessen the irritation.


For patients taking the extended-release capsule or extended-release tablet form of this medicine:


  • Swallow the capsule or tablet whole.

  • Do not crush, break, or chew before swallowing.

  • If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

Dosing


The dose medicines in this class 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 these medicines. 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 regular (short-acting) dosage forms (syrup, tablets, or chewable tablets):
    • For allergy and cold symptoms:
      • Adults and children 12 years of age and older—1 or 2 tablets or chewable tablets, or 1 to 2 teaspoonfuls of syrup every four to six hours.

      • Children 6 to 12 years of age—1 chewable tablet or 1 teaspoonful of syrup every four hours.

      • Children 4 to 6 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .



  • For long-acting dosage forms (extended-release capsules or tablets):
    • For allergy and cold symptoms:
      • Adults and children 12 years of age and older—1 capsule or tablet every twelve hours.

      • Children 4 to 12 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .



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


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using This Medicine


Check with your doctor if your symptoms do not improve or become worse, or if you have a high fever


Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.


These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also hot baths or saunas may make you dizzy or faint while you are taking this medicine.


The anticholinergic contained in this medicine may cause some people to have blurred vision. Make sure your vision is clear before you drive or do anything else that could be dangerous if you are not able to see well. These medicines may also cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.


These medicines may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.


The decongestant in this medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.


Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.


This medicine may cause dryness of the mouth, nose, and throat. For temporary relief, 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 dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


If you think you or someone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine or taking this medicine with alcohol or other CNS depressants may lead to unconsciousness and possibly death.


Side Effects of This Medicine


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.


Get emergency help immediately if any of the following symptoms of overdose occur:


For pseudoephedrine only
  • Unusual nervousness, restlessness, or excitement

  • Clumsiness or unsteadiness

  • convulsions (seizures)

  • drowsiness (severe)

  • dryness of mouth, nose, or throat (severe)

  • fast heartbeat

  • flushing or redness of face

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • headache (continuing)

  • shortness of breath or troubled breathing

  • trouble in sleeping

Check with your doctor as soon as possible if any of the following side effects occur:


Rare
  • Irregular or slow heartbeat

  • mood or mental changes

  • skin rash, hives, or itching

  • sore throat and fever

  • tightness in chest

  • unusual bleeding or bruising

  • unusual tiredness or weakness

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
  • Drowsiness

  • nervousness

  • restlessness

  • thickening of mucus

  • trouble in sleeping

Less common - more common with high doses
  • Blurred vision

  • confusion

  • difficult or painful urination

  • dizziness

  • dryness of mouth, nose, or throat

  • fast or pounding heartbeat

  • headache

  • increased sweating

  • loss of appetite

  • nausea or vomiting

  • nightmares

  • ringing or buzzing in ears

  • trembling

  • unusual excitement, nervousness, restlessness, or irritability

  • unusual paleness

  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

pilocarpine


Generic Name: pilocarpine (pie low CAR peen)

Brand Names: Salagen


What is pilocarpine?

Pilocarpine is an agent that affects the nervous system. Pilocarpine increases saliva secretion in the mouth.


Pilocarpine is used in the treatment of dry mouth.


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


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


Pilocarpine may cause changes in vision, especially at night. Use caution when driving, operating machinery, or performing other hazardous activities. If you experience changes in vision, avoid these activities. Dehydration may be more likely to occur during treatment with pilocarpine, due to increased sweating. Use caution when exercising and when exposed to hot weather. Drink plenty of fluid to maintain adequate hydration.

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


Before taking pilocarpine, talk to your doctor if you have:



  • glaucoma or other eye problems




  • asthma, chronic bronchitis, emphysema, or other breathing or lung problems;




  • heart problems;




  • gallbladder problems;




  • mental problems;




  • stomach problems;




  • abnormal blood pressure or blood vessel problems;



  • kidney problems; or

  • liver problems.

You may not be able to take pilocarpine or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Pilocarpine is in the FDA pregnancy category C. This means that it is not known whether pilocarpine will be harmful to an unborn baby. Do not take pilocarpine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether pilocarpine passes into breast milk. Do not take pilocarpine without first talking to your doctor if you are breast-feeding a baby.

How should I take pilocarpine?


Take pilocarpine 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.

Pilocarpine can be taken with or without food.


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


Store pilocarpine at room temperature away from moisture and heat.

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 regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of pilocarpine unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a pilocarpine overdose may include headache, hallucinations, visual disturbances, sweating, chest pain, abnormal heart rate, abnormal blood pressure, vomiting, nausea, diarrhea, tremors, or confusion.


What should I avoid while taking pilocarpine?


Pilocarpine may cause changes in vision, especially at night. Use caution when driving, operating machinery, or performing other hazardous activities. If you experience changes in vision, avoid these activities. Dehydration may be more likely to occur during treatment with pilocarpine, due to increased sweating. Use caution when exercising and when exposed to hot weather. Drink plenty of fluid to maintain adequate hydration.

Pilocarpine side effects


Stop taking pilocarpine and seek emergency medical attention if you experience any of the following uncommon but serious side effects:

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




  • difficulty breathing;




  • irregular heartbeats;




  • eye pain; or




  • confusion or changes in mental status or behavior.



Other, less serious side effects may also occur. Continue to take pilocarpine and talk to your doctor if you experience



  • changes in vision;




  • increased sweating;




  • dizziness;




  • headache;




  • runny nose;




  • nausea;




  • redness of the face and neck;




  • chills; or




  • an increased urge to urinate.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Pilocarpine Dosing Information


Usual Adult Dose for Xerostomia:

Initial - Head and Neck cancer patients:
5 mg three times a day. Titrate upwards, not to exceed 10 mg per dose, to a maximum of 30 mg per day.

Sjögren's syndrome patients:
5 mg four times a day.


What other drugs will affect pilocarpine?


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



  • a heart or blood pressure medication;




  • a seizure medication;




  • a medication for Parkinson's disease or other medications for muscle control;




  • an antihistamine or allergy medications;




  • a medication for motion sickness;




  • an antidepressant or antipsychotic medication; or




  • a medication for stomach problems.



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


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



More pilocarpine resources


  • Pilocarpine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Pilocarpine Drug Interactions
  • Pilocarpine Support Group
  • 0 Reviews for Pilocarpine - Add your own review/rating


  • pilocarpine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Pilocarpine Prescribing Information (FDA)

  • Pilocarpine Professional Patient Advice (Wolters Kluwer)

  • Pilocarpine Monograph (AHFS DI)

  • Pilocarpine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Salagen Prescribing Information (FDA)



Compare pilocarpine with other medications


  • Xerostomia


Where can I get more information?


  • Your pharmacist has more information about pilocarpine written for health professionals that you may read.


Wednesday, 1 August 2012

Teat Dip HP 5





Dosage Form: FOR ANIMAL USE ONLY

FOR COMMERCIAL USE ONLY


KEEP OUT OF REACH OF CHILDREN


NOT FOR HUMAN USE



CAUTION


CAUTION


Harmful if swallowed, eye irritant.



FIRST AID :


Avoid contact with skin and eyes. Contact can cause severe irritation. Get medical attention. If ingested, drink large amounts of water or milk. DO NOT induce vomiting. Get immediate attention. Avoid repeated contact with skin and hands. Use rubber gloves to avoid skin irritation. If contact occurs, wash thoroughly with clean water.


EMERGENCY : CHEMTREC 800-424-9300



Prior to milking, dip teats in undiluted Teat Dip HP 5. Wipe off with a clean towel after 15-30 seconds. After milking reapply Teat Dip HP 5. Do not rinse or wash off. Allow teats to dry before letting cows outdoors in cold weather to guard against.



PRINCIPAL DISPLAY PANEL/REPRESENTATIVE LABEL


Teat Dip HP 5


Non-Iodine Teat Dip


An Aid Reducing the Spread of Organisms


Which May Cause Mastitis


ACTIVE INGREDIENTS:


Hydrogen Peroxide........................0.5%


INACTIVE INGREDIENTS............99.5%


Wausau Chemical Corporation


2001 North River Drive


Wausau, WI 54403-0953 U.S.A.










Teat Dip HP 5 
hydrogen peroxide  solution










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)64892-006
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen Peroxide (Hydrogen Peroxide)Hydrogen Peroxide0.5 L  in 100 L





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


























Packaging
#NDCPackage DescriptionMultilevel Packaging
164892-006-1618.9 L In 1 DRUMNone
264892-006-1756.78 L In 1 DRUMNone
364892-006-18113.6 L In 1 DRUMNone
464892-006-21208.2 L In 1 DRUMNone
564892-006-881040 L In 1 CONTAINERNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2010


Labeler - Wausau Chemical Corporation (006136220)









Establishment
NameAddressID/FEIOperations
Wausau Chemical Corporation006136220manufacture
Revised: 06/2010Wausau Chemical Corporation