Folgard OS

Pronunciation: VYE-ta-min/FOE-lik AS-id/MIN-er-als
Generic Name: Vitamin B6/Vitamin B12/Vitamin D/Folic Acid with Minerals
Brand Name: Examples include Folgard OS and TL G-Fol OS

Folgard OS is used for:

Treating or preventing calcium deficiency, bone weakness, and osteoporosis in certain patients. It may also be used for other conditions as determined by your doctor.

Folgard OS is a vitamin and mineral supplement. It works by providing extra calcium, certain vitamins, folic acid, and minerals to your body.

Do NOT use Folgard OS if:

• you are allergic to any ingredient in Folgard OS


• you have high blood calcium levels or severe kidney problems

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

Before using Folgard OS:

Some medical conditions may interact with Folgard OS. 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 (including soy)


• if you have anemia (eg, pernicious anemia), heart problems, high urine calcium levels, kidney problems, kidney stones, malabsorption problems, or sarcoidosis


• if you are dehydrated

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

• Fluorouracil, levodopa, or oral anticoagulants (eg, dicumarol) because the risk of their side effects may be increased by Folgard OS


• Hydantoins (eg, phenytoin), mycophenolate, penicillamine, or phenobarbital because their effectiveness may be decreased by Folgard OS

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

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

• Take Folgard OS by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


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


• Many medicines (eg, used for cancer, infection, high potassium levels, immune system suppression, iron supplements, low blood platelets, osteoporosis, thyroid problems) should not be taken at the same time as Folgard OS; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Folgard OS should be separated from your dose of any of your other medicines.


• If you miss a dose of Folgard OS, 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 Folgard OS.

Important safety information:

• Do not take large doses of vitamins while you use Folgard OS unless your doctor tells you to.


• Do NOT take more than the recommended dose without checking with your doctor.


• Before you start any new medicine, check the label to see if it has any of the same ingredients that are found in Folgard OS. If it does or if you are not sure, check with your doctor or pharmacist.


• Some brands of Folgard OS may contain soy. If you have had an allergic reaction to soy, ask your pharmacist if your brand contains soy.


• Folgard OS 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 Folgard OS while you are pregnant. It is not known if Folgard OS is found in breast milk. If you are or will be breast-feeding while you use Folgard OS, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Folgard OS:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Folgard OS. 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).

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: Folgard OS 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 Folgard OS:

Store Folgard OS at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Folgard OS out of the reach of children and away from pets.

General information:

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


• Folgard OS 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 Folgard OS. 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 Folgard OS resources

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

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Compare Folgard OS with other medications

• Vitamin/Mineral Supplementation and Deficiency

Bicalustad

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Bicalutamide

Bicalutamide is reported as an ingredient of Bicalustad in the following countries:

• Sweden

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Estramustine Sodium Phosphate

Estramustine Sodium Phosphate may be available in the countries listed below.

Ingredient matches for Estramustine Sodium Phosphate

Estramustine

Estramustine Sodium Phosphate (BANM) is known as Estramustine in the US.

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BANM	British Approved Name (Modified)

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DIAMOX Tablets 250mg (Goldshield Group Limited)

1. Name Of The Medicinal Product

DIAMOX* 250mg Tablets

Acetazolamide 250mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 250mg acetazolamide BP.

For excipients see 6.1.

3. Pharmaceutical Form

Tablet.

Round, convex, white tablets engraved with “FW 147” on one side and cored in quarters on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

DIAMOX Tablets are for oral administration.

DIAMOX is an enzyme inhibitor which acts specifically on carbonic anhydrase. It is indicated in the treatment of:

i) Glaucoma: DIAMOX is useful in glaucoma (chronic simple (open angle) glaucoma, secondary glaucoma, and perioperatively in acute angle closure glaucoma where delay of surgery is desired in order to lower intraocular pressure) because it acts on inflow, decreasing the amount of aqueous secretion.

ii) Abnormal retention of fluids: DIAMOX is a diuretic whose effect is due to the effect on the reversible hydration of carbon dioxide and dehydration of carbonic acid reaction in the kidney. The result is renal loss of HC03- ion which carries out sodium, water and potassium. DIAMOX can be used in conjunction with other diuretics when effects on several segments of the nepbron are desirable in the treatment of fluid retaining states.

iii) Epilepsy: In conjunction with other anticonvulsants best results with DIAMOX have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adults, with other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns etc.

4.2 Posology And Method Of Administration

i) Glaucoma (simple acute congestive and secondary):

Adults: 250 - 1,000mg (1-4 tablets) per 24 hours, usually in divided doses for amounts over 250mg daily.

ii) Abnormal retention of fluid: Congestive heart failure, drug-induced oedema.

Adults: For diuresis, the starting dose is usually 250 - 375mg (1-1½ tablets) once daily in the morning. If, after an initial response, the patient fails to continue to lose oedema fluid, do not increase the dose but allow for kidney recovery by omitting a day. Best results are often obtained on a regime of 250 - 375mg (1-1½ tablets) daily for two days, rest a day, and repeat, or merely giving the DIAMOX every other day. The use of DIAMOX does not eliminate the need for other therapy, eg. digitalis, bed rest and salt restriction in congestive heart failure and proper supplementation with elements such as potassium in drug-induced oedema.

For cases of fluid retention associated with pre-menstrual tension, a daily dose (single) of 125 - 375mg is suggested.

iii) Epilepsy:

Adults: 250 - 1,000mg daily in divided doses.

Children: 8-30mg/kg in daily divided doses and not to exceed 750mg/day.

The change from other medication to DIAMOX should be gradual.

Elderly: DIAMOX should only be used with particular caution in elderly patients or those with potential obstruction in the urinary tract or with disorders rendering their electrolyte balance precarious or with liver dysfunction.

4.3 Contraindications

Acetazolamide is contra-indicated in situations in which sodium and/or potassium blood levels are depressed, in cases of marked kidney and liver disease or dysfunction, suprarenal gland failure, and hyperchloremic acidosis. DIAMOX should not be used in patients with hepatic cirrhosis as this may increase the risk of hepatic encephalopathy.

Long-term administration of DIAMOX is contra-indicated in patients with chronic non-congestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

DIAMOX should not be used in patients hypersensitive to sulphonamides.

4.4 Special Warnings And Precautions For Use

Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Acetazolamide.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia.

Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure diuresis in complete refractory failure.

When DIAMOX is prescribed for long-term therapy, special precautions are advisable. The patient should be cautioned to report any unusual skin rash. Periodic blood cell counts and electrolyte levels are recommended. Fatalities have occurred, although rarely, due to severe reactions to sulphonamides. A precipitous drop in formed blood cell elements or the appearance of toxic skin manifestations should call for immediate cessation of DIAMOX therapy.

In patients with pulmonary obstruction or emphysema where alveolar ventilation may be impaired, DIAMOX may aggravate acidosis and should be used with caution.

In patients with a past history of renal calculi, benefit should be balanced against the risks of precipitating further calculi.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

DIAMOX is a sulphonamide derivative. Sulphonamides may potentiate the effects of folic acid antagonists. Possible potentiation of the effects of folic acid antagonists, hypoglycaemics and oral anti-coagulants may occur. Concurrent administration of acetazolamide and aspirin may result in severe acidosis and increase central nervous system toxicity. Adjustment of dose may be required when DIAMOX is given with cardiac glycosides or hypertensive agents.

When given concomitantly, acetazolamide modifies the metabolism of phenytoin, leading to increased serum levels of phenytoin. Severe osteomalacia has been noted in a few patients taking acetazolamide in combination with other anticonvulsants. There have been isolated reports of reduced primidone and increased carbamazepine serum levels with concurrent administration of acetazolamide.

Because of possible additive effects, concomitant use with other carbonic anhydrase inhibitors is not advisable.

By increasing the pH of renal tubular urine, acetazolamide reduces the urinary excretion of amphetamine and quinidine and so may enhance the magnitude and the duration of effect of amphetamines and enhance the effect of quinidine.

Ciclosporin: Acetazolamide may elevate ciclosporin levels.

Methenamine: Acetazolamide may prevent the urinary antiseptic effect of methenamine.

Lithium: Acetazolamide increases lithium excretion and the blood lithium levels may be decreased.

Sodium bicarbonate: Acetazolamide and sodium bicarbonate used concurrently increases the risk of renal calculus formation.

4.6 Pregnancy And Lactation

Use in pregnancy: Acetazolamide has been reported to be teratogenic and embryotoxic in rats, mice, hamsters and rabbits at oral or parenteral doses in excess of ten times those recommended in human beings. Although there is no evidence of these effects in human beings, there are no adequate and well-controlled studies in pregnant women. Therefore, DIAMOX should not be used in pregnancy, especially during the first trimester.

Use in lactation: DIAMOX has been detected in low levels in the milk of lactating women who have taken DIAMOX. Although it is unlikely that this will lead to any harmful effects in the infant, extreme caution should be exercised when DIAMOX is administered to lactating women.

4.7 Effects On Ability To Drive And Use Machines

Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia. Less commonly, fatigue, dizziness and ataxia have been reported. Disorientation has been observed in a few patients with oedema due to hepatic cirrhosis. Such cases should be under close supervision. Transient myopia has been reported.

These conditions invariably subside upon diminution or discontinuance of the medication.

4.8 Undesirable Effects

Adverse reactions during short-term therapy are usually non-serious. Those effects which have been noted include: paraesthesia, particularly a “tingling” feeling in the extremities; some loss of appetite; taste disturbance, polyuria, flushing, thirst, headache, dizziness, fatigue, irritability, depression, reduced libido and occasional instances of drowsiness and confusion. Rarely, photosensitivity has been reported.

During long-term therapy, metabolic acidosis and electrolyte imbalance may occasionally occur. This can usually be corrected by the administration of bicarbonate.

Transient myopia has been reported. This condition invariably subsides upon diminution or withdrawal of the medication.

Gastro-intestinal disturbances such as nausea, vomiting and diarrhoea.

DIAMOX is a sulphonamide derivative and therefore some side-effects similar to those caused by sulphonamides have occasionally been reported. These include fever, agranulocytosis, thrombocytopenia, thrombocytic purpura, leukopenia, and aplastic anaemia, bone marrow depression, pancytopenia, rash (including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis), anaphylaxis, crystalluria, calculus formation, renal and ureteral colic, and renal lesions. Rarely, fulminant hepatic necrosis has been reported.

Other occasional adverse reactions include: urticaria, melaena, haematuria, glycosuria, impaired hearing and tinnitus, abnormal liver function, renal failure and rarely, hepatitis or cholestatic jaundice, flaccid paralysis, and convulsions.

4.9 Overdose

No specific antidote. Supportive measures with correction of electrolyte and fluid balance. Force fluids.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalysed by this enzyme in the renal tubules, acetazolamide increases the excretion of bicarbonate and of cations, chiefly sodium and potassium, and so promotes alkaline diuresis.

Continuous administration of acetazolamide is associated with metabolic acidosis and resultant loss of diuretic activity. Therefore, the effectiveness of DIAMOX in diuresis diminishes with continuous use.

By inhibiting carbonic anhydrase in the eye, acetazolamide decreases intraocular pressure and is therefore useful in the treatment of glaucoma.

5.2 Pharmacokinetic Properties

Acetazolamide is fairly rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 2 hours after administration by mouth. It has been estimated to have a plasma half-life of about 4 hours. It is tightly bound to carbonic anhydrase and accumulates in tissues containing this enzyme, particularly red blood cells and the renal cortex. It is also bound to plasma proteins. It is excreted unchanged in the urine; renal clearance being enhanced in alkaline urine.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dicalcium phosphate BP

Corn starch BP

Magnesium stearate BP

Sodium starch glycolate NF

Povidone USP

6.2 Incompatibilities

None.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

Do not store above 25ºC. Store in the original pack or in containers which prevent the access of moisture.

6.5 Nature And Contents Of Container

Amber glass bottles with metal screw-on caps.

Polypropylene bottles with plastic screw-on caps.

The product is supplied in bottles of 112 and 1000 tablets.

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

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0147

9. Date Of First Authorisation/Renewal Of The Authorisation

12 December 2003

10. Date Of Revision Of The Text

29 December 2009

Norethindrone

Pronunciation: nor-ETH-in-drone
Generic Name: Norethindrone
Brand Name: Aygestin

Norethindrone is used for:

Treating certain menstrual problems or uterine problems (eg, abnormal bleeding, endometriosis). It may also be used for other conditions as determined by your doctor.

Norethindrone is a progestin hormone. It works by altering the lining of the uterus.

Do NOT use Norethindrone if:

• you are allergic to any ingredient in Norethindrone


• you are pregnant or think you may be pregnant


• you have undiagnosed abnormal vaginal bleeding or are postmenopausal


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


• you have decreased liver function or active liver disease

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

Before using Norethindrone:

Tell your health care provider 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 seizures (eg, epilepsy), migraines, heart problems, kidney problems, or a history of depression


• if you have a history of high blood pressure, diabetes, high blood cholesterol, lupus, or blood clots, or if a member of your family has had these problems


• if you smoke or are very overweight

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

• Aprepitant, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, rifampin, St. John's wort, or tetracyclines because they may decrease Norethindrone's effectiveness


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


• Beta-adrenergic blockers (eg, propranolol), lamotrigine, or thyroid medicines because their effectiveness may be decreased by Norethindrone

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

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

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


• Take Norethindrone by mouth with or without food.


• Take Norethindrone at the same time every day, with doses not more than 24 hours apart.


• If you miss a dose of Norethindrone, 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 Norethindrone.

Important safety information:

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


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


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


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


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


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

Possible side effects of 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:

Acne; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain; rash; stomach pain; trouble sleeping; weakness; weight gain or loss.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; lumps in the breast or under the armpits; migraine headache; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache; sudden severe headache, dizziness, vomiting, or fainting; swelling of fingers or ankles; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; 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: 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.

Proper storage of Norethindrone:

Store Norethindrone in a tightly closed container at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Norethindrone out of the reach of children and away from pets.

General information:

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


• 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 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 Norethindrone resources

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

• norethindrone Concise Consumer Information (Cerner Multum)


• Aygestin Prescribing Information (FDA)


• Aygestin Monograph (AHFS DI)


• Aygestin Oral, Implantation, Parenteral Advanced Consumer (Micromedex) - Includes Dosage Information


• Camila Prescribing Information (FDA)


• Errin Prescribing Information (FDA)


• Jolivette Prescribing Information (FDA)


• Nor-QD Prescribing Information (FDA)


• Nora-BE Prescribing Information (FDA)


• Ortho Micronor Prescribing Information (FDA)

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FreshKote Drops

Pronunciation: loo-BRIH-kant
Generic Name: Lubricant
Brand Name: Examples include FreshKote and Puralube Tears

FreshKote Drops are used for:

Temporarily relieving burning and irritation caused by dry eyes. It may also be used for other conditions as determined by your doctor.

FreshKote Drops are an eye lubricant. It works by coating the eye, which relieves dryness.

Do NOT use FreshKote Drops if:

• you are allergic to any ingredient in FreshKote Drops

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

Before using FreshKote Drops:

Some medical conditions may interact with FreshKote Drops. 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

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

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

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

• FreshKote Drops are for use in the eye only. Avoid contact with your nose, mouth, or other mucous membranes.


• To use FreshKote Drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.


• If you miss a dose of FreshKote Drops and you are using it regularly, 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.

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

Important safety information:

• Remove contact lenses before using FreshKote Drops.


• Do not use FreshKote Drops if it becomes cloudy or changes color.


• Contact your doctor if you experience changes in your vision, eye pain, irritation, soreness, or continued redness or if your condition does not improve after 3 days.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking FreshKote Drops, discuss with your doctor the benefits and risks of using FreshKote Drops during pregnancy. If you are or will be breast-feeding while you are using FreshKote Drops, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of FreshKote Drops:

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:

Blurred vision.

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); changes in vision; eye irritation, pain, or redness; worsening of your condition.

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: FreshKote 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 FreshKote Drops:

Store FreshKote Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep FreshKote Drops out of the reach of children and away from pets.

General information:

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


• FreshKote Drops 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 FreshKote Drops. 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 FreshKote resources

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

Compare FreshKote with other medications

• Eye Dryness/Redness

Ketotifen Teva

Ketotifen Teva may be available in the countries listed below.

Ingredient matches for Ketotifen Teva

Ketotifen

Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Ketotifen Teva in the following countries:

• Belgium

International Drug Name Search