Tuesday, 12 June 2012

Cenestin


Pronunciation: CON-ju-gate-ed ESS-tro-jenz
Generic Name: Conjugated Estrogens (Synthetic A)
Brand Name: Cenestin

Cenestin increases the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while using Cenestin. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.


Do not use Cenestin with or without progestins (eg, medroxyprogesterone) to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women 65 years of age or older. You and your health care provider should talk regularly about whether you still need treatment with Cenestin.





Cenestin is used for:

Treating a variety of symptoms due to menopause (hot flashes, vaginal itching, burning, dryness). It may also be used for other conditions as determined by your doctor.


Cenestin is a mixture of estrogen hormones. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.


Do NOT use Cenestin if:


  • you are allergic to any ingredient in Cenestin

  • you are pregnant or suspect you may be pregnant

  • you have known, suspected, or a history of breast cancer (unless directed by your doctor) or other cancers that are estrogen-dependent

  • you have abnormal vaginal bleeding of unknown cause

  • you have impaired liver function or liver disease, or the blood disease porphyria

  • you have recently (within the last year) had a stroke or heart attack

  • you have blood clots or circulation disorders

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



Before using Cenestin:


Some medical conditions may interact with Cenestin. 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

  • if you have an abnormal mammogram

  • if you have asthma (wheezing), a benign breast nodule, bone cancer, depression, diabetes, endometriosis or endometrial (uterine) cancer, epilepsy (seizures), gallbladder disease, heart problems, high blood pressure, kidney problems, liver problems or a history of yellowing of the skin or eyes, lupus, migraines, obesity, pancreatitis, uterine fibroids, thyroid problems or have high calcium levels in your blood

  • if you use tobacco, you are going to have surgery, or you will be on bed rest

  • if you have a family history of high cholesterol, lipid, calcium, or triglyceride levels; or breast cancer

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


  • Hydantoins (eg, phenytoin) and rifampin because they may decrease Cenestin's effectiveness

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


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


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

  • Take Cenestin by mouth with food or immediately after a meal to prevent stomach upset.

  • Take Cenestin at the same time each day.

  • Discuss with your doctor stopping Cenestin 4 to 6 weeks before surgery.

  • If you miss a dose of Cenestin, take it as soon as possible. If it is almost time for the 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 Cenestin.



Important safety information:


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

  • Smoking while taking Cenestin may increase your risk of blood clots (especially in women older than 35 years of age).

  • Before using Cenestin, you will need to have a complete medical and family history exam, which will include blood pressure, breast, stomach, and pelvic organ exams and a Pap smear.

  • You should have periodic mammograms as determined by your doctor. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.

  • Your doctor should reevaluate you every 3 to 6 months to determine whether or not you need to continue taking Cenestin.

  • If you are only being treated for vaginal menopause symptoms, products applied locally such as vaginal creams, tablets, or rings should be considered before products taken by mouth or absorbed through the skin. If you have other medical conditions and are prescribed estrogens for more than one condition, consult your doctor about your treatment plan and its options.

  • Non-drug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor of pharmacist for more details.

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

  • Cenestin may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.

  • If you wear contact lenses and you develop problems with them, contact your doctor.

  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Cenestin.

  • Cenestin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Cenestin.

  • Lab tests, including a lipid profile, may be performed while you use Cenestin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

  • Cenestin may affect growth in CHILDREN. They may need regular growth checks while they use Cenestin.

  • PREGNANCY and BREAST-FEEDING: Do not use Cenestin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Cenestin is found in breast milk. If you are or will be breast-feeding while you use Cenestin, check with your doctor. Discuss any possible risks to your baby..


Possible side effects of Cenestin:


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



Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes.



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); abnormal bleeding from the vagina; breast lumps; changes in vision or speech; chest pain; dizziness; fainting; mental/mood changes; pain or tenderness in the upper abdomen; pain in the calves; severe headache; sudden shortness of breath; swelling of the hands or feet; unusual vaginal discharge/itching/odor; vomiting; weakness or numbness of an arm or leg; 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: Cenestin 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 excessive vaginal bleeding 2 to 7 days following overdose; nausea and vomiting.


Proper storage of Cenestin:

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


General information:


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

  • Cenestin 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 Cenestin. Additionally, your doctor may have prescribed Cenestin for a use not mentioned above. 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 Cenestin resources


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


  • Cenestin Prescribing Information (FDA)

  • Cenestin Advanced Consumer (Micromedex) - Includes Dosage Information

  • conjugated estrogens Advanced Consumer (Micromedex) - Includes Dosage Information

  • Enjuvia Prescribing Information (FDA)

  • Enjuvia Consumer Overview

  • Premarin Prescribing Information (FDA)

  • Premarin Consumer Overview



Compare Cenestin with other medications


  • Abnormal Uterine Bleeding
  • Atrophic Urethritis
  • Atrophic Vaginitis
  • Breast Cancer, Palliative
  • Hypoestrogenism
  • Oophorectomy
  • Osteoporosis
  • Postmenopausal Symptoms
  • Primary Ovarian Failure
  • Prostate Cancer

Co-phenotrope 2.5 / 0.025 tablets





1. Name Of The Medicinal Product



Lomotil tablets (POM)



Dymotil tablets (P)



Co-phenotrope 2.5/0.025 tablets


2. Qualitative And Quantitative Composition



Each tablet contains 2.5mg of diphenoxylate hydrochloride BP and 0.025mg of atropine sulphate Ph.Eur



3. Pharmaceutical Form



White tablet with “GS10” engraved on one side



4. Clinical Particulars



4.1 Therapeutic Indications



POM product



Adults and children:



Adjunctive therapy to appropriate rehydration in acute diarrhoea



Control of stool formation after colostomy or ileostomy



Relief of symptoms in chronic and mild ulcerative colitis (see warning)



P product



Adults only (aged 16 years and over):



Adjunctive therapy to appropriate rehydration in acute diarrhoea



4.2 Posology And Method Of Administration



Route of administration



Oral



Caution: The recommended dosage should not be exceeded. Once satisfactory control is achieved, dosage should be reduced to suit the requirements of the individual patients.



POM product



Adults:



The recommended starting dosage is four tablets followed by two tablets every six hours.



Elderly:



Consideration should be given to the presence of other diseases and concomitant drug therapy ( see precautions)



Children:



Recommended dosage guide:



Under 4 years:- Not recommended



4-8 years:- 1 tablet three times daily



9-12 years:- 1 tablet four times daily



13-16 years:- 2 tablets three times daily



P product



Adults:



The recommended starting dose is four tablets followed by two tablets every six hours. The maximum dose is 10 tablets in the first 24 hours and 8 tablets in 24 hours thereafter. This should not be exceeded.



Elderly:



The dose is as for adults. Consideration should be given to the presence of other disease and concomitant therapy (see precautions).



Children:



Not for use in children under 16 years of age.



4.3 Contraindications



POM product



Lomotil is contraindicated in patients with known hypersensitivity to diphenoxylate hydrochloride or atropine, in patients with jaundice, intestinal obstruction, acute ulcerative colitis, in the treatment of diarrhoea associated with pseudomembranous enterocolitis, and in patients with a raised intracranial pressure, and patients with head injury.



Contraindicated in myasthenia gravis, pyloric stenosis, paralytic ileus and prostatic enlargement.



P product



Dymotil is contraindicated in patients with a known hypersensitivity to diphenoxylate hydrochloride or atropine, in patients with jaundice, intestinal obstruction, any inflammatory bowel disease, including all forms of ulcerative colitis, and in the treatment of diarrhoea associated with pseudomembranous enterocolitis. Dymotil is also contraindicated in patients with Down's syndrome, and in patients with a raised intracranial pressure, and patients with head injury.



Contraindicated in myasthenia gravis, pyloric stenosis, paralytic ileus and prostatic enlargement.



4.4 Special Warnings And Precautions For Use



Appropriate fluid and electrolyte therapy should be given to protect against dehydration. If severe dehydration or electrolyte imbalance is present, the medicine should be withheld until appropriate corrective therapy has been initiated. In some patients with ulcerative colitis, agents which inhibit intestinal mobility or delay intestinal transit time have been reported to induce toxic megacolon. Patients with ulcerative colitis should be observed carefully and Lomotil therapy should be discontinued promptly if abdominal distension or other untoward symptoms develop.



The medicine should be used with extreme caution in patients with advanced hepatorenal disease, and in patients with abnormal liver function, since hepatic coma may be precipitated.



Because a subtherapeutic dose of atropine is added to the medicine, atropine effects may occur in susceptible individuals or in overdosage. Individuals with Down's syndrome appear to have increased susceptibility to the action of atropine.



Additionally for the P Product



If symptoms persist for more than 24 hours, the patient should consult a doctor. Dymotil is for the symptomatic relief of acute diarrhoea, and is not a substitute for rehydration therapy.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



The following interaction have to be considered in the use of Lomotil Tablets:-



Lomotil antagonises the effect of Domperidone, Metoclopramide, Bethanecol/Carbachol, Cisapride, Galantamine, Neostigmine/pyridostigmine, and Pilcarpine.



The amtimuscarinic side effects of Lomotil are increased by Amantadine, Anthihistamines (sedative and non-sedative), Clozapine, Disopyramide, Fluspiriline, Loxapine, MAOI's, Nefopam, Olanzapine, Phenothiazines, Quantiapine, Remoxipride, Terfenadine, Tricyclic antidepressasnts, and Zotepine.



Dry mouth prevents the dissolution of sublingual nitrate tablets, such as glyceryl trinitrate.



The effect of Lomotil is antagonised by Dompezil.



The effect of Lomotil is increased by Memantine.



Lomotil may reduce the plasma levels of Levodopa (in combination and sole products).



Lomotil reduces the absorption of Ketoconazole.



4.6 Pregnancy And Lactation



POM product



Pregnancy



Animal teratology and reproduction studies have demonstrated no adverse effects. The safety of Lomotil in human pregnancy has not been established. However, as with all drugs, caution is recommended when used in early pregnancy.



Lactation



Diphenoxylate hydrochloride and atropine sulphate may be excreted in human milk. If a nursing mother is taking Lomotil, the infant may exhibit some effects of the drug.



P product



Pregnancy and Lactation



Dymotil should not be used during pregnancy and in nursing mothers.



4.7 Effects On Ability To Drive And Use Machines



Some of the undesirable effects such as sedation, drowsiness or dizziness may affect the ability to drive or operate machines. If affected, patients should be advised not to drive or operate machinery.



4.8 Undesirable Effects



The side effects of Lomotil Tablets include malaise, lethargy, sedation, somnolence, confusion, dizziness, restlessness, depression, euphoria, hallucinations, headache, and fever.



Anaphylaxis, angioedema, urticaria and pruritus have been reported side effects.



Gastrointestinal side effects include paralytic ileus, toxic megacolon, nausea, vomiting, abdominal discomfort, constipation and anorexia.



The atropine side effects of Lomotil Tablets include flushing, dryness of the skin and mucous membranes (including dry mouth), cardiac irregularities such as arrhythmias, bradycardia, and palpitations, increased intra-ocular pressure, urinary retention and difficulty in micturition, and respiratory depression in children.



Dilation of pupils with loss of accommodation, photophobia and very rarely angle closure glaucoma can occur.



4.9 Overdose



Accidental overdose may produce narcosis with respiratory depression or atropine poisoning or both, particularly in children. Symptoms of overdose include dryness of the skin and mucous membranes, flushing, hypothermia and tachycardia, nystagmus, pinpoint pupils, hypotonic reflexes, lethargy, coma, and sever respiratory depression. The onset of symptoms of overdose may be considerably delayed and respiratory depression may not become evident until as late as 12-30 hours after ingestion, and may occur in spite of initial response to narcotic antagonists. Continuous observation should be maintained for at least 48 hours.



If respiratory depression develops, naloxone, a specific antidote, should be administered. The duration of action of naloxone hydrochloride is considerably shorter than that of diphenoxylate hydrochloride and repeated injections of the antidote may be required. Establishment of a patient airway and artificial ventilation may be needed. If the patient is not comatose, gastric ravage and administration of slurry of an activated charcoal may be indicated.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



The active ingredient diphenoxylate hydrochloride is a synthetic opioid derivative with selective effects on gastrointestinal smooth muscle. It is essentially devoid of “morphine type subjective effects” at therapeutic doses.



Atropine sulphate is included in the formulation as an anti-abusing agent contributing to the safe use of the product. The dose of atropine sulphate contained in each tablet is subtherapeutic therefore a pharmaceutical effect due to atropine should not be detected taken at normal therapeutic doses.



5.2 Pharmacokinetic Properties



Diphenoxylate hydrochloride is well absorbed from the gastrointestinal tract and extensively metabolised in the liver to diphenoxylic acid (diphenoxin), and hydroxydiphenoxylic acid. It is excreted mainly as metabolites in the urine and bile.



5.3 Preclinical Safety Data



Diphenoxylate hydrochloride is a well established pharmaceutical active and is the subject of a pharmacopoeial monograph. No specific preclinical studies have therefore been performed.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lomotil/Dymotil tablets contain:



Sucrose



Acacia



Sorbitol



Magnesium stearate



Talc



Light liquid paraffin



6.2 Incompatibilities



None known



6.3 Shelf Life



The shelf life of Lomotil/Dymotil tablets is 5 years when stored in blister packs.



6.4 Special Precautions For Storage



Store in a dry place below 30°C



6.5 Nature And Contents Of Container



POM



Lomotil tablets are supplied in PVC/PVDC/Aluminium foil blister packs of 100, 500, and 1000 tablets.



P



Dymotil tablets are supplied in PVC/PVDC/Aluminium foil blister packs of 20.



6.6 Special Precautions For Disposal And Other Handling



None



7. Marketing Authorisation Holder



Goldshield Pharmaceuticals Ltd



NLA Tower



12 - 16 Addiscombe Road



Croydon



Surrey



CR0 0XT



8. Marketing Authorisation Number(S)



PL 12762/0040



9. Date Of First Authorisation/Renewal Of The Authorisation



01/11/1999 / 12/05/2004



10. Date Of Revision Of The Text



17 August 2010




Monday, 11 June 2012

ioversol


Generic Name: ioversol (eye oh VERS ol)

Brand Names: Optiray 160, Optiray 240, Optiray 300, Optiray 320, Optiray 350


What is ioversol?

Ioversol is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Ioversol contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.


Ioversol is used to help diagnose certain disorders of the heart, brain, and blood vessels.


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


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


You should not receive ioversol if you have any type of active infection.

Tell your doctor if you have asthma, hay fever, or history of food or drug allergies, especially if you have had any type of reaction to another contrast agent.


Drink extra fluids before and after you receive ioversol. This medication can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

What should I discuss with my health care provider before receiving ioversol?


Tell your doctor if you have ever had any type of reaction to another contrast agent.


You should not receive ioversol if you have any type of active infection.

Before receiving ioversol, tell your doctor if you have:



  • a brain tumor or hematoma;




  • a recent head or brain injury;




  • epilepsy or other seizure disorder;




  • a bleeding or blood clotting disorder;




  • kidney disease;




  • liver disease;




  • diabetes;




  • heart disease, angina, or congestive heart failure;




  • homocysteinuria;




  • sickle cell disease;




  • a history of stroke, blood clots, or circulation problems;




  • asthma, hay fever, or a history of food or drug allergies;




  • multiple myeloma (bone cancer);




  • pheochromocytoma; or




  • a thyroid disorder.



If you have any of these conditions, you may not be able to receive ioversol, or you may need a dosage adjustment or special tests during treatment.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ioversol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may need special care in avoiding dehydration by drinking extra fluids before and after the radiologic test. Your kidney function may also need to be watched closely after you have received ioversol.


How is ioversol used?


Ioversol is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting during your radiologic test.


Drink extra fluids before and after you receive ioversol. This medication can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test. Your doctor or other healthcare provider may want to watch you for a short period of time after your injection. This is to make sure you do not have any unwanted side effects or delayed reactions.

This medication can cause you to have unusual results with certain thyroid tests. If you have such tests within 16 days after receiving ioversol, tell the doctor in charge that you have recently received ioversol.


What happens if I miss a dose?


Since ioversol is used only during your radiologic test, you will not be on a dosing schedule.


What happens if I overdose?


Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of an ioversol overdose may include chest pain, trouble breathing, and slow or uneven heartbeats.

What should I avoid while receiving ioversol?


Do not allow yourself to become dehydrated during the first few days after receiving ioversol. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

Ioversol side effects


Some of the side effects of ioversol can occur up to 24 hours after you have received the medication.


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. Call your doctor at once if you have any of these serious side effects:

  • urinating less than usual or not at all;




  • severe muscle pain or weakness;




  • seizure (convulsions);




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




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




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




  • feeling light-headed, fainting;




  • wheezing, trouble breathing;




  • fast or slow heartbeat;




  • easy bruising, unusual bleeding, or skin changes; or




  • swelling of your hands, ankles, or feet.



Other less serious side effects are more likely to occur, such as:



  • fever, warmth, or pain;




  • skin rash or redness;




  • headache; or




  • nausea.



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.


Ioversol Dosing Information


Usual Adult Dose for Cerebral Arteriography:

Either ioversol injection 51% (marketed as Optiray 240), ioversol injection 64% (marketed as Optiray 300), or ioversol injection 68% (marketed as Optiray 320) is recommended for cerebral arteriography

The usual individual injection for visualization of the carotid or vertebral arteries is 2 to 12 mL, repeated as necessary. Aortic arch injection for a simultaneous four vessel study requires 20 to 50 mL. Total procedural doses should not usually exceed 200 mL.

Extreme caution is advised in patients with advanced arteriosclerosis, severe hypertension, cardiac decompensation, senility, recent cerebral thrombosis or embolism, and migraine. Cardiovascular reactions that may occur with some frequency are bradycardia and either an increase or decrease in systemic blood pressure. Neurological reactions that may occur are: seizures, drowsiness, transient paresis, and mild disturbances in vision.

Central nervous system reactions with ioversol in controlled clinical studies in cerebral arteriography that were considered drug-related and occurred with frequencies greater than 1% were: headache, bradycardia, blood pressure fluctuation, disorientation, nausea, and vertigo.

Usual Adult Dose for Peripheral Arteriography:

Either ioversol injection 64% (marketed as Optiray 300), ioversol injection 68% (marketed as Optiray 320), or ioversol injection 74% (marketed as Optiray 350) is recommended for peripheral arteriography. The usual individual injection volumes for visualization of various peripheral arteries are as follows:

aorta-iliac runoff - 60 mL (range 20 to 90 mL)
common iliac, femoral - 40 mL (range 10 to 50 mL)
subclavian, brachial - 20 mL (range 15 to 30 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all.

Usual Adult Dose for Visceral Arteriography:

Ioversol injection 68% (marketed as Optiray 320) is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

aorta - 45 mL (range 10 to 80 mL)
celiac - 45 mL (range 12 to 60 mL)
superior mesenteric - 45 mL (range 15 to 60 mL)
renal or inferior mesenteric - 9 mL (range 6 to 15 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis. Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows.

Usual Adult Dose for Renal Arteriography:

Ioversol injection 68% (marketed as Optiray 320) is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

aorta - 45 mL (range 10 to 80 mL)
celiac - 45 mL (range 12 to 60 mL)
superior mesenteric - 45 mL (range 15 to 60 mL)
renal or inferior mesenteric - 9 mL (range 6 to 15 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis. Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows.

Usual Adult Dose for Coronary Arteriography:

Either ioversol injection 68% (marketed as Optiray 320) or ioversol injection 74% (marketed as Optiray 350) is recommended for this procedure. The usual individual injection volumes for visualization of the coronary arteries and left ventricle are:

left coronary - 8 mL (range 2 to 10 mL)
right coronary - 6 mL (range 1 to 10 mL)
left ventricle - 40 mL (range 30 to 50 mL)

These doses may be repeated as necessary. Total procedural dose for the combined procedures should not usually exceed 250 mL. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.

There were no cardiovascular system reactions with ioversol in controlled clinical studies in coronary arteriography with left ventriculography that were considered drug-related and occurred with a frequency greater than 1%.

Usual Adult Dose for Left Ventriculography:

Either ioversol injection 68% (marketed as Optiray 320) or ioversol injection 74% (marketed as Optiray 350) is recommended for this procedure. The usual individual injection volumes for visualization of the coronary arteries and left ventricle are:

left coronary - 8 mL (range 2 to 10 mL)
right coronary - 6 mL (range 1 to 10 mL)
left ventricle - 40 mL (range 30 to 50 mL)

These doses may be repeated as necessary. Total procedural dose for the combined procedures should not usually exceed 250 mL. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.

There were no cardiovascular system reactions with ioversol in controlled clinical studies in coronary arteriography with left ventriculography that were considered drug-related and occurred with a frequency greater than 1%.

Usual Adult Dose for Intra-arterial Digital Subtraction Angiography:

Ioversol injection 34% (marketed as Optiray 160) is recommended for intra-arterial digital subtraction angiography (IA-DSA). As a general rule, the volume and concentration used for IA-DSA is about 50% or less of that used for conventional procedures. The actual dosage and flow rate will vary depending on the selectivity of the injection site and the area being examined.
The following suggested volumes per injection are intended only as a guide. Injections may be repeated as necessary. It is advisable to inject at rates approximately equal to the flow of the vessel being injected.

Carotid Arteries 6 to 10 mL
Vertebral Arteries 4 to 8 mL
Aorta 25 to 50 mL
Subclavian or Brachial Arteries 2 to 10 mL
Major Branches of the Abdominal Aorta 2 to 20 mL

Dosage should not usually exceed 250 mL.

Usual Adult Dose for Venography:

Either ioversol injection 51% (marketed as Optiray 240), ioversol injection 64% (marketed as Optiray 300), ioversol injection 68% (marketed as Optiray 320), or ioversol injection 74% (marketed as Optiray 350), is recommended for venography.

Usual dose: 50 to 100 mL per extremity with smaller or larger volumes indicated in some cases.

Dosage should not usually exceed 250 mL.

Special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system. In order to minimize extravasation during injection, fluoroscopy is recommended.

Following the procedure, the venous system should be flushed with Sodium Chloride Injection U.S.P. or 5% Dextrose in Water (D5W). Massage and elevation are also helpful for clearing the contrast medium from the extremity.

Usual Adult Dose for Head Imaging:

Usual dosage is 50 to 150 mL of ioversol injection 74%, 68%, or 64% or 100 to 250 mL of ioversol injection 51%. Scanning may be performed immediately after completion of the intravenous administration. Dosage should not usually exceed 150 mL of ioversol injection 74%, 68%, or 64% or 250 mL of ioversol injection 51%.

Tumors: Ioversol may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of otherwise normal studies.

Nonneoplastic Conditions: Ioversol may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast medium is used. The use of iodinated contrast media results in enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement.

For these vascular lesions the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

Usual Adult Dose for Body Imaging:

Ioversol injection 74%, 68%, 64%, or 51% may be administered by bolus injection, by rapid infusion, or by a combination of both.

Usual doses:
ioversol injection 74% (marketed as Optiray 350) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 68% (marketed as Optiray 320) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 64% (marketed as Optiray 300) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 51% (marketed as Optiray 240) - bolus injection: 35 to 100 mL, infusion: 70 to 200 mL
Dosage should not usually exceed 150 mL of ioversol injection 74%, 68% or 64% or 250 mL of 51%.

Ioversol may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. Enhancement of computed tomography with ioversol may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Usual Adult Dose for Intravenous Digital Subtraction Angiography:

Usual dosage: Ioversol injection 74% (marketed as Optiray 350) may be injected centrally, in either the superior or inferior vena cava or right atrium; or peripherally into an appropriate arm vein. For central injections, catheters may be introduced at the antecubital fossa into either the basilic or cephalic vein or at the leg into the femoral vein and advanced to the distal segment of the corresponding vena cava. For peripheral injections, the catheter is introduced at the antecubital fossa into an appropriate size arm vein. In order to reduce the potential for extravasation during peripheral injection, a catheter of approximately 20 cm in length should be employed.
Depending on the area to be imaged, the usual dose range per injection is 30 to 50 mL. Injections may be repeated as necessary. The total procedural dose should not exceed 250 mL.
Injection rates will vary depending on the site of catheter placement and vessel size. Central catheter injections are usually made at a rate of between 10 and 30 mL/second. Peripheral injections are usually made at a rate of between 12 and 20 mL/second. Since the injected medium can sometimes remain in the arm vein for an extended period, it is advisable to flush the vein immediately following injection with an appropriate volume (20 to 25 mL) of sodium chloride injection U.S.P. or 5% dextrose in water (D5W).

Intravenous digital subtraction angiography (IV DSA) is a radiographic modality which allows dynamic imaging of the arterial system following intravenous injection of iodinated x-ray contrast media through the use of image intensification, enhancement of the iodine signal and digital processing of the image data. Temporal subtraction of the images obtained prior to and during the “first arterial pass” of the injected contrast medium yields images which are devoid of bone and soft tissue. IV DSA is most frequently used to examine the heart, including coronary by-pass grafts; the pulmonary arteries; arteries of the brachiocephalic circulation; the aortic arch; the abdominal aorta and its major branches; the iliac arteries; and the arteries of the extremities.

No special patient preparation is required for IV DSA. However, it is advisable to insure that patients are well hydrated prior to examination.

In addition to the general precautions previously described, the risks associated with IV DSA include those usually attendant with catheter procedures and include intramural injections, vessel dissection and tissue extravasation. The potential risk is reduced when small test injections of contrast medium are made under fluoroscopic observation to insure that the catheter tip is properly positioned and, in the case of peripheral placement, that the vein is of adequate size.
Patient motion, including respiration and swallowing, can result in misregistration leading to image degradation and non-diagnostic studies.

Usual Adult Dose for Intravenous Urography:

Either ioversol injection 74% (marketed as Optiray 350), ioversol injection 68% (marketed as Optiray 320), ioversol injection 64% (marketed as Optiray 300), or ioversol injection 51% (marketed as Optiray 240) is recommended for routine and high dose excretory urography. Preparatory dehydration is dangerous and may contribute to acute renal failure.

Usual dose for routine excretory urography: 50 to 75 mL of ioversol injection 74%, 68%, or 64% or 75 to 100 mL of ioversol injection 51%

Higher dosages may be indicated to achieve optimum results where poor visualization is anticipated (e.g., elderly patients or patients with impaired renal function). In these patients, high dose urography may be preferred, using ioversol injection 74% (marketed as Optiray 350) at a dose of 1.4 mL/kg (maximum 140 mL), ioversol injection 68% (marketed as Optiray 320) at a dose of 1.5 to 2 mL/kg (maximum 150 mL), ioversol injection 64% (marketed as Optiray 300) at a dose of 1.6 mL/kg (maximum 150 mL) or ioversol injection 51% (marketed as Optiray 240) at a dose of 2 mL/kg (maximum 200 mL).

Usual Pediatric Dose for Pediatric Angiocardiography:

Either ioversol injection 74% (marketed as Optiray 350) or ioversol injection 68% (marketed as Optiray 320) is recommended for this procedure. The usual single ventricular injection of ioversol injection 74% or ioversol injection 68% is 1.25 mL/kg of body weight with a range of 1 mL/kg to 1.5 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL.

Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus, and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure. Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL, or those less than 12 months of age.

Usual Pediatric Dose for Head Imaging:

Recommended dose: 1 mL/kg to 3 mL/kg of ioversol injection 68% (marketed as Optiray 320)

Tumors: Ioversol may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of otherwise normal studies.

Nonneoplastic Conditions: Ioversol may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast medium is used. The use of iodinated contrast media results in enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement.

For these vascular lesions the enhancement is probably dependent on the iodine content of the circulating blood pool. Hematomas and intraparenchymal bleeders seldom demonstrate contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

Usual Pediatric Dose for Body Imaging:

Recommended dose: 1 mL/kg to 3 mL/kg of ioversol injection 68% (marketed as Optiray 320), with a usual dose of 2 mL/kg.

Ioversol may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. Enhancement of computed tomography with ioversol may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Usual Pediatric Dose for Intravenous Urography:

Children: Ioversol injection 68% (marketed as Optiray 320) at doses of 0.5 mL/kg to 3 mL/kg of body weight has produced diagnostic opacification of the excretory tract.

Usual dose for children: 1 mL/kg to 1.5 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.

Preparatory dehydration is dangerous and may contribute to acute renal failure.


What other drugs will affect ioversol?


There may be other drugs that can affect ioversol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More ioversol resources


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


Compare ioversol with other medications


  • Body Imaging
  • Cerebral Arteriography
  • Coronary Arteriography
  • Head Imaging
  • Intra-arterial Digital Subtraction Angiography
  • Intravenous Digital Subtraction Angiography
  • Intravenous Urography
  • Left Ventriculography
  • Pediatric Angiocardiography
  • Peripheral Arteriography
  • Renal Arteriography
  • Venography
  • Visceral Arteriography


Where can I get more information?


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

See also: ioversol side effects (in more detail)


Mestranol/Norethindrone


Pronunciation: MES-tra-nole/nor-eth-IN-drone
Generic Name: Mestranol/Norethindrone
Brand Name: Examples include Norinyl 1 + 50 and Ortho-Novum 1/50

Cigarette smoking increases the risk of serious heart and blood vessel side effects from birth control pill use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite significant in women older than 35 years of age. Women who use birth control pills are strongly advised not to smoke.





Mestranol/Norethindrone is used for:

Prevention of pregnancy. It may also be used to regulate the menstrual cycle. It does NOT protect against HIV infection (AIDS) and other sexually transmitted diseases. It may also be used for other conditions as determined by your doctor.


Mestranol/Norethindrone is a combination of 2 female sex hormones, estrogen and progestin. Mestranol/Norethindrone works by preventing the ovaries from releasing eggs. When there is no egg to be fertilized, pregnancy cannot occur. It also thickens the cervical mucus, making it difficult for sperm to enter the uterus.


Do NOT use Mestranol/Norethindrone if:


  • you are allergic to any ingredient in Mestranol/Norethindrone

  • you are pregnant or think you may be pregnant

  • you have or have ever had abnormal growth or cancer of the breast, cervical or uterine cancer, or unexplained vaginal bleeding

  • you have or have ever had stoppage or rupture of blood vessels in the brain (stroke); blockage of blood vessels (blood clots) in the legs, lungs, heart (heart attack or angina/chest pain), or other parts of the body; heart valve problems; or severe high blood pressure

  • you have liver disease, liver tumors, or yellowing of the eyes or skin during pregnancy or during previous use of Mestranol/Norethindrone or a similar medicine

  • you are taking acitretin, aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin), St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone

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



Before using Mestranol/Norethindrone:


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


  • if you are breast-feeding

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

  • if you have allergies to medicines or other substances

  • if you smoke cigarettes or are 35 years of age or older

  • if you have breast nodules, disease of the breast, an abnormal breast x-ray or mammogram, or a strong family history of breast cancer

  • if you have vision problems, depression, diabetes, epilepsy (seizures), gallbladder or liver disease, heart problems, high blood pressure, kidney disease, or migraine headaches

  • if you have high cholesterol, triglycerides, or calcium in the blood; pancreas disease; obesity; or uterine fibroids or endometriosis

  • if you are going to have surgery or you will be on bed rest

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


  • Acitretin, aprepitant, azole antifungals (eg, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, penicillins (eg, amoxicillin), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin), St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Mestranol/Norethindrone's effectiveness. While on these medicines, you will need an alternative form of birth control (eg, condoms) until your next period after stopping these medicines.

  • Beta-blockers (eg, metoprolol), cyclosporine, theophyllines, or troleandomycin because the risk of their side effects or toxicity may be increased by Mestranol/Norethindrone

  • Corticosteroids (eg, prednisone) because their side effects, including rounding of the face, weight gain, fluid retention, elevated blood pressure, elevated blood sugar, or skin changes, may be increased by Mestranol/Norethindrone

  • Oral anticoagulants (eg, warfarin) because their side effects, including risk of bleeding, may be increased by Mestranol/Norethindrone; however, it is also possible that the effectiveness may also be decreased by Mestranol/Norethindrone

  • Lamotrigine because its effectiveness may be decreased by Mestranol/Norethindrone; stopping Mestranol/Norethindrone may lead to severe side effects

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


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


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

  • Take Mestranol/Norethindrone by mouth with food.

  • If you have trouble remembering to take Mestranol/Norethindrone, talk to your doctor about how to make pill-taking easier or about using another method of birth control.

  • Always have another kind of birth control (eg, condoms) to use as a backup in case you miss pills. Also, always keep an extra, full pack of pills.

  • Decide what time of day you want to take your medicine. It is important that you take it at about the same time every day.

  • Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).

  • Do not skip pills even if you do not have sex very often.

  • If you miss a dose of Mestranol/Norethindrone, take it as soon as your remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. If you miss more than 1 dose of Mestranol/Norethindrone, refer to the patient information that came with Mestranol/Norethindrone or contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Mestranol/Norethindrone.



Important safety information:


  • Mestranol/Norethindrone may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.

  • There may be times when you may not have regular menstrual periods after you have taken a pack of Mestranol/Norethindrone for a cycle. If you have taken Mestranol/Norethindrone regularly and missed 1 period, keep taking Mestranol/Norethindrone for the next cycle but be sure to tell your doctor first.

  • If you have not taken Mestranol/Norethindrone daily as instructed and missed a period, or if you missed 2 consecutive periods, you may be pregnant. You could get pregnant if you have sex in the 7 days after you miss pills. Do not continue to take Mestranol/Norethindrone until you are sure that you are not pregnant, but continue to use another method of birth control (eg, condoms).

  • Contact your doctor if you miss any menstrual periods so that the cause may be determined.

  • Follow your doctor's instructions to examine your breasts, and report any lumps to your doctor immediately.

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

  • If you will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor 3 to 4 weeks in advance. Special precautions may be needed.

  • Mestranol/Norethindrone does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.

  • Taking certain antibiotics or anticonvulsants while you are using Mestranol/Norethindrone may decrease the effectiveness of Mestranol/Norethindrone. To prevent pregnancy, use an additional form of birth control (eg, condoms) until your next menstrual period.

  • If you wear contact lenses and you develop problems with them, contact your doctor.

  • Mestranol/Norethindrone may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Mestranol/Norethindrone. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

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

  • Mestranol/Norethindrone may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Mestranol/Norethindrone.

  • Lab tests, including PAP tests, may be performed while you use Mestranol/Norethindrone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Mestranol/Norethindrone should not be used in CHILDREN or before the child's first menstrual period; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not use Mestranol/Norethindrone if you are pregnant. If you think you may be pregnant, contact your doctor right away. Mestranol/Norethindrone is found in breast milk. Do not breast-feed while taking Mestranol/Norethindrone.


Possible side effects of Mestranol/Norethindrone:


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 between menstrual periods; change in vaginal mucus; headache; nausea; nervousness; rash; spotty darkening of the skin (especially on the face); stomach cramps and bloating; vaginal infection; vomiting; weight or appetite change.



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); breast lumps; calf or leg pain or swelling; chest pain; coughing of blood; dark urine or light-colored bowel movements; depression; dizziness or fainting; fever; heaviness in the chest; lack of energy or fatigue; loss of appetite; loss of scalp hair; mood change; numbness in arm or leg; partial or complete loss of vision or other vision changes; sleeping problems; slurred speech; stomach pain or tenderness; sudden severe headache; sudden shortness of breath; swelling of the fingers or ankles; weakness on one side of the body; 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: Mestranol/Norethindrone 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 nausea; vaginal bleeding.


Proper storage of Mestranol/Norethindrone:

Store Mestranol/Norethindrone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store Mestranol/Norethindrone in the container it came in, tightly closed, away from heat, moisture, and light. Do not store in the bathroom. Keep Mestranol/Norethindrone out of the reach of children and away from pets.


General information:


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

  • Mestranol/Norethindrone 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 Mestranol/Norethindrone. 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 Mestranol/Norethindrone resources


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


Compare Mestranol/Norethindrone with other medications


  • Abnormal Uterine Bleeding
  • Birth Control
  • Endometriosis
  • Gonadotropin Inhibition

Saturday, 9 June 2012

Avonex Vials


Pronunciation: IN-ter-FEER-on BAY-ta
Generic Name: Interferon Beta-1a
Brand Name: Avonex


Avonex Vials are used for:

Treating relapsing forms of multiple sclerosis (MS) to reduce the number of flare-ups and to slow down the development of physical disability associated with MS.


Avonex Vials are a protein identical to one found in the body. Exactly how it works is not known. It is thought to interfere with other chemicals in the body that cause flare-ups of MS.


Do NOT use Avonex Vials if:


  • you are allergic to any ingredient in Avonex Vials

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



Before using Avonex Vials:


Some medical conditions may interact with Avonex Vials. 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 liver problems or high liver enzyme levels, blood problems (eg, anemia), thyroid problems, bone marrow depression, heart disease, seizures, alcohol abuse or dependence, depression, or suicidal thoughts or behaviors

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


  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of side effects on the liver may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

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


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


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

  • Avonex Vials are usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Avonex Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Avonex Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

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

  • Use Avonex Vials right away after mixing. It may be used for up to 6 hours after mixing if stored in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze.

  • Avonex Vials are for injection into a muscle. Use the proper technique taught to you by your doctor.

  • 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 Avonex Vials, use it as soon as possible and skip your dose the following day. Do not take Avonex Vials on 2 consecutive days. Return to your regular dosing schedule the following week. If you accidentally take Avonex Vials on 2 consecutive days or take more than your prescribed dose, contact your doctor right away.

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



Important safety information:


  • Some patients become depressed or suicidal while taking Avonex Vials. If you begin to feel depressed or suicidal, contact your doctor.

  • Avonex Vials may harm your liver. Your risk may be greater if you drink alcohol while you are using Avonex Vials. Talk to your doctor before drinking alcohol while you are using Avonex Vials.

  • Avonex Vials commonly causes flu-like symptoms. Talk to your doctor about whether you should take a nonprescription medicine for pain or fever reduction before or after taking Avonex Vials.

  • Avonex Vials contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Avonex Vials.

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

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

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

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


Possible side effects of Avonex Vials:


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:



Flu-like symptoms (eg, headache, tiredness, fever, chills, back pain, muscle aches, weakness); pain, redness, or swelling at the injection site; stomach pain.



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); change in vision; chest pain; dark urine; depression; easy bruising or bleeding; extreme tiredness or weakness; fast or irregular heartbeat; feeling cold or hot all the time; increased urination at night; infection at the injection site; seizures; shortness of breath; suicidal thoughts or behaviors; swollen ankles; unexplained change in weight; yellowing of the eyes or skin.



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


See also: Avonex 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 Avonex Vials:

Store Avonex Vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If refrigeration is not available, Avonex Vials can be stored at or below 77 degrees F (25 degrees C) for up to 30 days. Store away from heat, moisture, and light. Keep Avonex Vials, as well as needles and syringes, out of the reach of children and away from pets.


General information:


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

  • Avonex Vials are 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 Avonex Vials. 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.

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Gaviscon Cool Liquid





1. Name Of The Medicinal Product



Gaviscon Cool Liquid


2. Qualitative And Quantitative Composition



Gaviscon Cool Liquid contains 250mg sodium alginate BP, 133.5 mg sodium bicarbonate Ph. Eur. and 80 mg calcium carbonate Ph. Eur. per 5 ml.



3. Pharmaceutical Form



Oral suspension.



4. Clinical Particulars



4.1 Therapeutic Indications



Gastric reflux, hearburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.



4.2 Posology And Method Of Administration



For oral administration.



Adults and children over 12: 10-20 ml after meals and at bedtime.



Elderly: No dose modification is required in this age group.



Children 6-12 years: 5-10 ml after meals and at bedtime.



Children under 6 years: Not recommended.



If symptoms persist consult your doctor.



4.3 Contraindications



None known.



4.4 Special Warnings And Precautions For Use



The sodium content of a l0ml dose is 141mg (6.2mmol). This should be taken into account when a highly restricted salt diet is recommended as in some renal and cardiovascular conditions.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience this medicine may be used during pregnancy and lactation.



4.7 Effects On Ability To Drive And Use Machines



None.



4.8 Undesirable Effects



Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.



4.9 Overdose



In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



On ingestion Gaviscon Cool Liquid reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats (up to 4 hours) on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect.



5.2 Pharmacokinetic Properties



The mode of action of Gaviscon Cool Liquid is physical and does not depend on absorption into the systemic circulation.



5.3 Preclinical Safety Data



No preclinical findings of relevance to the prescriber have been reported



6. Pharmaceutical Particulars



6.1 List Of Excipients



Carbomer



E218 (Methyl parahydroxybenzoate)



E216 (Propyl parahydroxybenzoate)



Saccharin sodium



Mint flavour no. 4



Mint flavour no. 5



Sodium hydroxide



Purified water



6.2 Incompatibilities



None known.



6.3 Shelf Life



Two years.



6.4 Special Precautions For Storage



Do not store above 30°C. Do not refrigerate or freeze.



6.5 Nature And Contents Of Container



Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad and containing 100, 150, 200, 300, 500 or 600 ml.



6.6 Special Precautions For Disposal And Other Handling



To be taken orally. If desired the standard dose of Gaviscon Cool Liquid may be taken diluted with not more than an equal quantity of water well stirred.



ADMINISTRATIVE DATA


7. Marketing Authorisation Holder



Hamol Limited



103-105 Bath Road



Slough



Berkshire



SL1 3UH



United Kingdom



8. Marketing Authorisation Number(S)



PL 01839/0003



9. Date Of First Authorisation/Renewal Of The Authorisation



06/02/2006



10. Date Of Revision Of The Text



22/09/2009




Friday, 8 June 2012

Tetrahydrozoline Hydrochloride


Class: Vasoconstrictors
VA Class: NT100
CAS Number: 522-48-5
Brands: Murine Plus, Optigene 3, Tyzine, Visine, Visine A.C.

Introduction

Vasoconstrictor; an imidazoline-derivative sympathomimetic amine.101 a


Uses for Tetrahydrozoline Hydrochloride


Nasal Congestion


Temporary relief of nasal congestion.101 a


As effective as other topical vasoconstrictors.a


Nasal decongestants often preferred for short-term treatment; oral agents preferred for prolonged treatment.a (See Overuse under Cautions.)


Reduce swelling and facilitate visualization of nasal and pharyngeal membranes prior to surgery or diagnostic procedures.a


Open obstructed eustachian ostia in ear inflammation.a


Conjunctival Congestion


Temporary relief of conjunctival congestion, itching, and minor irritation.102 a


Used alone or in fixed combination with astringents (i.e., zinc sulfate).a c


Controls hyperemia in patients with superficial corneal vascularity.a


Ineffective in the treatment of delayed hypersensitivity reactions such as contact dermatoconjunctivitis.a


Used for vasoconstrictor effect during some ocular diagnostic procedures; phenylephrine may be preferred.a


Tetrahydrozoline Hydrochloride Dosage and Administration


Administration


Apply topically to nasal mucosa 101 a or to conjunctiva.102 a c


Avoid contamination of the dropper tip or spray dispenser.102 a c


Intranasal Administration


Apply topically to the nasal mucosa as drops or spray.101 a


Nasal sprays preferable due to a decreased risk of swallowing the drug and resultant systemic absorption; however, drops are easier to administer to young children.a


Apply nasal drops to the dependent (lower) nostril with the patient in a lateral, head-low position.101 a Remain in the same position for 5 minutes, then apply drops to the other nostril in a similar manner.a Alternatively, instill drops while in a reclining position, with head tilted back as far as possible.a


Administer nasal spray into each nostril while head is erect.101 a Squeeze bottle quickly and firmly and sniff briskly;101 blow nose thoroughly after 3–5 minutes.a


Rinse tips of dispensers or droppers thoroughly with hot water following use.a


Ophthalmic Administration


Apply ophthalmic solution topically to the conjunctiva.a


Remove contact lenses before administering ophthalmic solution;102 c wait ≥15 minutes to reinsert contact lenses.b


Do not administer discolored or cloudy solution.102 c


Dosage


Available as tetrahydrozoline hydrochloride; dosage expressed in terms of the salt.a


Pediatric Patients


Nasal Congestion

Intranasal

Children 2–5 years of age: 2–3 drops of a 0.05% solution in each nostril every 3–6 hours (typically 4–6 hours) as needed.101


Children ≥6 years of age: 2–4 drops or 3–4 sprays of a 0.1% solution in each nostril every 3–8 hours (typically 4–8 hours) as needed.101


Conjunctival Congestion

Ophthalmic

Children ≥6 years of age: 1–2 drops of a 0.05% ophthalmic solution in the affected eye(s) up to 4 times daily.102 a c


Adults


Nasal Congestion

Intranasal

2–4 drops or 3–4 sprays of 0.1% solution in each nostril every 3–8 hours (typically 4–8 hours) as needed.101 a


Conjunctival Congestion

Ophthalmic

1–2 drops of a 0.05% ophthalmic solution in the affected eye(s) up to 4 times daily.102 a c


Prescribing Limits


Pediatric Patients


Nasal Congestion

Intranasal

Maximum of every 3 hours;101 a maximum duration of 3–5 days.a


Conjunctival Congestion

Ophthalmic

For self-medication: Maximum of 4 times daily; maximum duration of 3–4 days, unless directed by a clinician.102 a


Adults


Nasal Congestion

Intranasal

Maximum of every 3 hours;101 a maximum duration 3–5 days.a


Conjunctival Congestion

Ophthalmic

For self-medication: Maximum of 4 times daily; maximum duration of 3–4 days, unless directed by a clinician.102 a


Special Populations


No special population dosage recommendations at this time.a


Cautions for Tetrahydrozoline Hydrochloride


Contraindications



  • Known hypersensitivity to tetrahydrozoline or any ingredient in the formulation.101 a




  • Nasal solution: Use in infants <2 years of age.101 a




  • Nasal solution: Use of 0.1% solution in children <6 years of age.101 a




  • Nasal solution: Concomitant use of MAO inhibitors.101 (See Specific Drugs under Interactions.)



Warnings/Precautions


Warnings


Glaucoma

Patients with narrow-angle glaucoma or other serious eye disease should consult a clinician before using ophthalmic solution.102 a c


General Precautions


Overuse

Possible irritation of nasal mucosa or conjunctiva and adverse systemic effects (particularly in children) with excessive dosage and/or prolonged or too frequent use.a Possible rebound congestion (rhinitis, chronic redness, and swelling of the nasal mucosa) or ocular hyperemia (redness); avoid prolonged use.101 102 a c (See Advice to Patients.)


Overdose in children may produce profound sedation, profuse sweating, hypotension, and/or shock.101


High concentrations of ophthalmic solution may liberate pigment granules; more common in the elderly.a


Sympathomimetic Effects

Possible headache, hypertension, weakness, sweating, cardiac irregularities (e.g., palpitations), tremors, drowsiness, lightheadedness, and insomnia.101 a Use with caution in patients with thyroid disease (e.g., hyperthyroidism), heart disease (e.g., coronary artery disease), hypertension, or diabetes mellitus.101 a


Use of Fixed Combinations

When used in fixed combination with astringents (i.e., zinc sulfate), consider the cautions, precautions, and contraindications associated with the concomitant drug.c


Specific Populations


Pregnancy

Category C.101


Lactation

Not known whether tetrahydrozoline is distributed into milk.101 a Caution if used in nursing women.101 a


Pediatric Use

Safety and efficacy of 0.05% nasal solution not established in children <2 years of age;101 safety and efficacy of 0.1% nasal solution not established in children <6 years of age.101


Safety and efficacy of ophthalmic solution not established in children <6 years of age.102


Common Adverse Effects


Intranasal: Mucosal burning, stinging, dryness, sneezing.101 a


Ophthalmic: Blurred vision, irritation, mydriasis.a


Interactions for Tetrahydrozoline Hydrochloride


Specific Drugs









Drug



Interaction



Comments



MAO Inhibitors



Nasal solution: possible severe hypertensive reaction101



Concomitant use contraindicated101


Tetrahydrozoline Hydrochloride Pharmacokinetics


Absorption


Bioavailability


Absorption may occasionally be sufficient to produce systemic effects.a


Onset


Following intranasal or ocular administration, local vasoconstriction usually occurs within minutes.a


Duration


Local vasoconstriction may persist for 4–8 hours.a


Stability


Storage


Nasal


Solution

Tight containersa at <30°C.101


Ophthalmic


Solution

Tight containersa at 15–25°C.102 a c


ActionsActions



  • Structurally and pharmacologically related to naphazoline, oxymetazoline, and xylometazoline.a




  • Directly stimulates α-adrenergic receptors; exerts little or no effect on β-adrenergic receptors.a




  • Intranasal application constricts dilated arterioles, reduces nasal blood flow and congestion, and may open obstructed eustachian ostia.101 a Temporarily improves nasal ventilation.a




  • Conjunctival application constricts small arterioles and temporarily relieves conjunctival congestion.a



Advice to Patients



  • With intranasal use, importance of discontinuing drug and consulting a clinician if nasal congestion worsens or persists for >3–5 days.a




  • With ophthalmic use, importance of discontinuing drug and consulting a clinician if ocular pain or visual changes occur or if ocular redness or irritation worsens or persists for >72 hours.102 a c




  • Overuse of nasal solution may cause recurrence or exacerbation of nasal congestion; overuse of ophthalmic solution may produce increased redness of the eye. 101 a




  • Importance of removing contact lenses prior to administration of ophthalmic solution; wait ≥15 minutes after instillation to replace lenses.102 b




  • Importance of avoiding contamination of the dropper or spray dispenser.102 a c Do not touch dropper tip to any surface;102 c rinse nasal spray dispenser tip with hot water.a To minimize risk of spreading infections, do not share dropper or spray dispenser with other individuals.a




  • Advise patients not to use ophthalmic solution if solution is cloudy.102 c




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.101




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.101 102 c




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name











































Tetrahydrozoline Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Nasal



Solution



0.05%



Tyzine (with benzalkonium chloride; drops)



Kenwood



0.1%



Tyzine (with benzalkonium chloride; drops and spray)



Kenwood



Ophthalmic



Solution



0.05%*



Murine Plus (with benzalkonium chloride and povidone)



Prestige Brands



Optigene 3 (with benzalkonium chloride and glycerin)



Pfeiffer



Tetrahydrozoline Hydrochloride Eye Drops (with benzalkonium chloride)



Rugby



Visine (with benzalkonium chloride)



McNeil



Visine Advanced Relief (with benzalkonium chloride and povidone)



McNeil













Tetrahydrozoline Hydrochloride Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Ophthalmic



Solution



0.05% with Zinc Sulfate 0.25%



Visine A.C. (with benzalkonium chloride)



McNeil



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References


Only references cited for selected revisions after 1984 are available electronically.



101. Tyzine (tetrahydrozoline hydrochloride) nasal solution prescribing information. Fairfield, NJ; 1999 Apr.



102. Pfizer. Visine (tetrahydrozoline hydrochloride 0.05%) product information. From Pfizer Visine website (). Accessed 2006 Oct 25.



a. AHFS drug information 2007. McEvoy GK, ed. Tetrahydrozoline hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2868-9.



b. McNeil-PPC, Inc. Frequently asked questions. Available at: . Accessed 2007 Nov 29.



c. McNeil-PPC, Inc. Visine A.C. (tetrahydrozoline hydrochloride 0.05% and zinc sulfate 0.25%) product information. From McNeil Visine website (. Accessed 2007 Nov 21.



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