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Thursday, 14 June 2012

Trizivir

Pronunciation: a-BAK-a-vir/la-MIV-ue-deen/zye-DOE-vue-deen
Generic Name: Abacavir/Lamivudine/Zidovudine
Brand Name: Trizivir

Severe allergic reactions (achiness, cough, diarrhea, difficulty breathing, fever, nausea, rash, sore throat, stomach pain, tiredness, vomiting) have been associated with the use of abacavir. Stop using Trizivir and talk with your health care provider if any of these symptoms occur. Do not restart Trizivir if symptoms of a severe allergic reaction occur. Severe allergic reactions, including death, have occurred in patients who restart Trizivir, even if they have no history or unrecognized symptoms of an allergic reaction. Do not stop and restart Trizivir unless directed to do so by your doctor.

Patients who have a certain gene type called HLA-B^*5701 have an increased risk of an allergic reaction to abacavir. A lab test may be performed before you start Trizivir to see if you have this gene type. Discuss any questions or concerns with your doctor.

Zidovudine has been associated with certain blood disorders (eg, anemia, neutropenia), especially in patients with advanced HIV disease. Muscle disease, high levels of lactic acid in the blood, and severe liver problems that can cause death have also been associated with the use of Trizivir. Tell your doctor immediately if you have dark urine; fever; persistent sore throat; rapid breathing; unusual nausea, tiredness, or weakness; or yellowing of the eyes and skin. Severe worsening of hepatitis B has been reported in patients who are infected with both HIV and hepatitis B and have discontinued lamivudine. Liver function should be monitored closely for at least several months after discontinuing lamivudine. The long-term effects of Trizivir are not known at this time.

Trizivir is used for:

Treating HIV infection. Trizivir is used alone or in combination with other medicines.

Trizivir is a nucleoside reverse transcriptase inhibitor (NRTI) combination. It works by blocking HIV from reproducing.

Do NOT use Trizivir if:

you are allergic to any ingredient in Trizivir

you weigh less than 90 pounds

you have liver problems or the blood disorder lactic acidosis

you are taking emtricitabine, zalcitabine, or any medicine containing abacavir, lamivudine, or zidovudine

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

Before using Trizivir:

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

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

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

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

if you have a history of kidney problems, heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, pancreatitis, blood or bone marrow disorders, muscle disorders, smoking, alcohol dependence, hepatitis B infection, breathing difficulties, nerve disorders, obesity problems, or a weakened immune system

if you have abdominal pain, diarrhea, nausea, vomiting, cough, sore throat, fever, fatigue, or a rash

if you are taking any other medicine for HIV infection

if you have been tested and know whether or not you have a gene type called HLA-B^*5701

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

Bone marrow suppressors (eg, interferon alpha), cytotoxic agents (eg, cyclophosphamide), ganciclovir, probenecid, trimethoprim/sulfamethoxazole (TMP-SMZ), or valproic acid because they may increase the risk of Trizivir's side effects

Doxorubicin, ribavirin, stavudine, or zalcitabine because the effectiveness of both medicines may be decreased

Clarithromycin because it may decrease Trizivir's effectiveness

Methadone because its effectiveness may be decreased by Trizivir

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

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

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

Take Trizivir by mouth with or without food.

Taking Trizivir at the same time each day will help you remember to take it.

Continue to take Trizivir even if you feel well. Do not miss any doses.

If you miss a dose of Trizivir, 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. If you miss more than one dose of Trizivir, contact your doctor.

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

Important safety information:

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

Trizivir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.

When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Trizivir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

Trizivir does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.

Trizivir contains abacavir, lamivudine, and zidovudine. Before you start any new medicine, check the label to see if it has abacavir, lamivudine, or zidovudine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Carry an ID card at all times that says you take Trizivir.

Trizivir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Trizivir.

Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Trizivir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.

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

Patients who have a certain gene type called HLA-B^*5701 have an increased risk of a severe or even fatal allergic reaction to Trizivir. A lab test may be performed before you start Trizivir to see if you have this gene type. Discuss any questions or concerns with your doctor.

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

Trizivir 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 taking Trizivir while you are pregnant. Trizivir is found in breast milk. Do not breast-feed while taking Trizivir. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Trizivir to the baby.

Possible side effects of Trizivir:

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:

Decreased appetite; diarrhea; headache; joint or muscle pain; nausea; nervousness; tiredness; vomiting; weakness.

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

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression; excess hunger, thirst, or urination; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mouth ulcers; numbness, tingling, or pain in the hands and feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent muscle pain, weakness, or cramping; swollen lymph nodes; unusual tiredness or weakness; 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: Trizivir 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 confusion; dizziness; drowsiness; headache; nausea; seizures; tiredness; vomiting.

Proper storage of Trizivir:

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

General information:

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

Trizivir 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 Trizivir. 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

More Trizivir resources

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

Trizivir Prescribing Information (FDA)

Trizivir Advanced Consumer (Micromedex) - Includes Dosage Information

Trizivir Consumer Overview

Compare Trizivir with other medications

HIV Infection
Nonoccupational Exposure

Tuesday, 12 June 2012

Etravirine

Pronunciation: E-tra-VIR-een
Generic Name: Etravirine
Brand Name: Intelence

Etravirine is used for:

Treating HIV infection in certain patients. It is used in combination with other medicines.

Etravirine is a nonnucleoside reverse transcriptase inhibitor (NNRTI). It works by blocking the growth of HIV.

Do NOT use Etravirine if:

you are allergic to any ingredient in Etravirine

you are taking another NNRTI (eg, efavirenz)

you are taking certain protease inhibitors (eg, indinavir) without ritonavir

you are taking delavirdine, certain doses of ritonavir, or certain protease inhibitor and ritonavir combinations (eg, tipranavir/ritonavir, atazanavir/ritonavir)

you are taking a barbiturate (eg, phenobarbital), carbamazepine, a hydantoin (eg, phenytoin), rifampin, rifapentine, or St. John's wort

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

Before using Etravirine:

Some medical conditions may interact with Etravirine. 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 are of childbearing age

if you have a history of liver problems (eg, hepatitis), diabetes, or high blood cholesterol

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

Delavirdine because it may increase the risk of Etravirine's side effects

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), other NNRTIs (eg, efavirenz), protease inhibitor and ritonavir combinations (eg, tipranavir/ritonavir), protease inhibitors (eg, indinavir), rifamycins (eg, rifampin, rifapentine), certain doses of ritonavir, or St. John's wort because they may decrease Etravirine's effectiveness

Atazanavir/ritonavir because its effectiveness may be decreased by Etravirine and it may increase the risk of Etravirine's side effects

Fosamprenavir/ritonavir because the risk of its side effects may be increased by Etravirine

Many prescription and nonprescription medicines (eg, used for anxiety, erectile problems, irregular heartbeat, other heart problems, bacterial infections, fungal infections, immune suppression, inflammation, aches and pains, high cholesterol, HIV, narcotic or other substance dependence and withdrawal, seizures, thinning the blood), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Etravirine. This may decrease their effectiveness, increase the risk of their side effects, decrease Etravirine's effectiveness, or increase the risk of the medicine's side effects

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

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

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

Take Etravirine by mouth following a meal.

Swallow Etravirine whole with a liquid such as water. Do not chew before swallowing. If you cannot swallow the tablet whole, you may mix it in a glass of water. Stir well until the water looks milky, and then drink all of the liquid right away. Rinse the glass with water several times and completely swallow the rinse each time to ensure the entire dose is taken. Do not store the mixture for future use.

Taking Etravirine at the same time each day will help you remember to take it.

Continue to use Etravirine even if you feel well. Do not miss any doses.

If you miss a dose of Etravirine by less than 6 hours, take the missed dose as soon as possible following a meal, then go back to your regular dosing schedule. If you miss your dose by more than 6 hours, 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 Etravirine.

Important safety information:

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

Do not change your dose or stop taking Etravirine without talking to your doctor first.

Etravirine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.

When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Etravirine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.

Etravirine does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.

Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Etravirine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.

Etravirine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Etravirine.

Etravirine may cause serious, potentially life-threatening, and fatal skin reactions. The risk may be greater in women. Symptoms may include red, swollen, blistered, or peeling skin; severe rash or rash with fever, mouth sores, red and irritated eyes, or swelling of the face; muscle or joint pain; unusual tiredness; or unusual hoarseness. These reactions can sometimes be associated with organ failure (eg, liver failure). Contact your doctor at once if you develop a rash or any of these symptoms.

Lab tests, including liver function, CD4 count, complete blood cell counts, and blood cholesterol, may be performed while you use Etravirine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Etravirine should be used with extreme caution 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 Etravirine while you are pregnant. It is not known if Etravirine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing HIV infection or Etravirine to the baby.

Possible side effects of Etravirine:

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

Mild burning, numbness, or tingling of the arms, hands, legs, or feet.

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 eyes, mouth, face, lips, throat, or tongue; unusual hoarseness); bloody vomit or vomit that looks like coffee grounds; blurred vision or other vision changes; change in amount of urine; chest, jaw, or left arm pain; dark urine; fainting; fever or general feeling of being unwell; irregular heartbeat; joint pain; loss of appetite; mood or mental changes (eg, anxiety, confusion, memory loss); muscle pain, tenderness, or weakness; pale stools; persistent burning, numbness, pain, or tingling of the arms, legs, hands, or feet; reddened, blistered, swollen, or peeling skin; seizures; severe or persistent dizziness, drowsiness, or headache; severe rash or rash with fever, mouth sores, or red and irritated eyes; severe stomach pain with or without nausea and vomiting; shortness of breath; unusual tiredness or weakness; yellowing of the skin or eyes.

See also: Etravirine 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 Etravirine:

Store Etravirine between 59 and 86 degrees F (15 and 30 degrees C). Store in original bottle, away from heat, moisture, and light. Do not remove the desiccant pouches from the bottle. Do not store in the bathroom. Keep Etravirine out of the reach of children and away from pets.

General information:

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

Etravirine 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 Etravirine. 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

More Etravirine resources

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

Etravirine Professional Patient Advice (Wolters Kluwer)

Etravirine Monograph (AHFS DI)

etravirine Advanced Consumer (Micromedex) - Includes Dosage Information

Intelence Prescribing Information (FDA)

Intelence Consumer Overview

Compare Etravirine with other medications

HIV Infection

Monday, 11 June 2012

Metrogel

1. Name Of The Medicinal Product

Metrogel

2. Qualitative And Quantitative Composition

Metronidazole BP 0.75%.

3. Pharmaceutical Form

Aqueous gel for cutaneous use.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of acute inflammatory exacerbation of rosacea.

For the deodorisation of the smell associated with malodorous fungating tumours.

4.2 Posology And Method Of Administration

For the treatment of rosacea:

For topical administration only.

The average period of treatment is three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated, continued therapy for a further three to four months period may be considered by the prescribing physician depending on the severity of the condition. In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped.

Adults: Metrogel should be applied in a thin layer to the affected areas of the skin twice daily, morning and evening. Areas to be treated should be washed with a mild cleanser before application. Patients may use non-comedogenic and non-astringent cosmetics after application of Metrogel.

Elderly: The dosage recommended in the elderly is the same as that recommended in adults.

Children: Not recommended. Safety and efficacy have not been established.

4.3 Contraindications

Contraindicated in individuals with a history of hypersensitivity to Metronidazole, or other ingredients of the formulation.

4.4 Special Warnings And Precautions For Use

Contact with mucous membranes should be avoided.

Metrogel has been reported to cause lacrimation of the eyes, therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently or discontinue use temporarily and to seek medical advice if necessary. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. Exposure of treated sites to ultraviolet (e.g. solarium, sun-lamp) or strong sunlight (including sun-bathing) should be avoided during use of metronidazole.

Unnecessary and prolonged use of this medication should be avoided.

Evidence suggests that metronidazole is carcinogenic in certain animal species. There is no evidence to date of a carcinogenic effect in human.

This product contains propylene glycol that may cause skin irritation and hydroxybenzoic acid esters which may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Metrogel is low. Nevertheless, it should be mentioned that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol concomitantly. Oral metronidazole has been reported to potentiate the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin is not known. However, very rare cases of modification of the INR values have been reported with concomitant use of Metrogel and coumarin anticoagulants.

4.6 Pregnancy And Lactation

There has been no experience to date with the use of Metrogel in pregnant patients. In case of oral administration, metronidazole crosses the placental barrier and enters foetal circulation rapidly. No foetotoxicity was observed after oral metronidazole in either rats or mice. However because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents this drug should be used in pregnancy only if clearly needed.

After oral administration metronidazole is secreted in breast milk in concentration similar to those found in plasma. Even though blood levels are significantly lower with cutaneous application of Metrogel than those achieved after oral metronidazole in nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into importance of the drug to the mother.

4.7 Effects On Ability To Drive And Use Machines

Based upon the pharmacodynamic profile and clinical experience performance related to driving and using machines should not be affected.

4.8 Undesirable Effects

Because of the minimal absorption of metronidazole and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug have not been reported with Metrogel. Adverse reactions reported with Metrogel have been only local and mild.

The following spontaneous adverse experiences have been reported, and within each system

organ class, are ranked by frequency, using the following convention:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000), including isolated reports

Skin and subcutaneous tissue disorders:

Common: dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation, worsening of rosacea.

Unknown frequency: contact dermatitis

Nervous System disorders:

Uncommon: hypothesia, paraesthesia, dysgeusia (metallic taste)

Gastrointestinal disorders:

Uncommon: nausea

Watery eyes have been reported if applied too closely to this area.

4.9 Overdose

No data exists about overdosage in humans. Acute oral toxicity studies with a topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5 g of finished product per kilogram body weight, the highest dose used. This dose is equivalent to the oral intake of 12 tubes of 30g packaging Metrogel for an adult weighing 72 kg, and 2 tubes of Metrogel for a child weighing 12 kg.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The etiology of rosacea is unknown although a variety of hypotheses have been reported.

5.2 Pharmacokinetic Properties

The systemic concentration of Metronidazole following the topical administration of 1 g of a 0.75% Metronidazole gel to 10 patients with rosacea ranged from 25 ng/ml (limit of detection), to 66 mg/ml with a mean Cmax of 40.6 ng/ml.

The corresponding mean Cmax following the oral administration of a solution containing 30 mg of metronidazole was 850 ng/ml (equivalent to 212 ng/ml if dose corrected. The mean Tmax for the topical formulation was 6.0 hours compared to 0.97 hours for the oral solution.

5.3 Preclinical Safety Data

Metronidazole is a well established pharmaceutical active ingredient and to the subject of pharmacopoeial monograph in both the BP and Ph.Eur.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Bronopol BP,

Hydroxybenzoic acid esters HSE,

Hydroxyethylcellulose HSE,

Propylene glycol Ph.Eur,

Phosphoric acid Ph.Eur,

Purified water Ph.Eur.

6.2 Incompatibilities

None known

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store between 15°C and 25°C in a dry place.

6.5 Nature And Contents Of Container

Tube: Internally lacquered, membrane sealed aluminium.

Cap: low density polyethylene

Pack sizes available: 25 g and 40 g.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use/handling.

7. Marketing Authorisation Holder

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

8. Marketing Authorisation Number(S)

PL 10590/0035

9. Date Of First Authorisation/Renewal Of The Authorisation

27 February 1998

10. Date Of Revision Of The Text

December 2010

11 LEGAL CATEGORY

POM

Friday, 8 June 2012

Condylox Topical

Generic Name: podofilox (Topical route)

poe-DOF-il-lox

Commonly used brand name(s)

In the U.S.

Condylox

In Canada

Condyline

Available Dosage Forms:

Gel/Jelly

Solution

Therapeutic Class: Keratolytic

Uses For Condylox

Podofilox is used to remove certain types of warts on the outside skin of the genital areas (penis or vulva). The gel is used also to treat warts between the genitals and the rectum, the solution is not. Neither the gel nor the solution is used to treat warts that occur inside the rectum, vagina, or urine passageways inside the penis (male) or the vulva (female). Podofilox works by destroying the skin of the wart.

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

Before Using Condylox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of podofilox in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of podofilox

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

A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of podofilox. Read this paper carefully and ask your health care professional if you need additional information.

Also, keep podofilox away from the eyes and mucous membranes, such as the inside of the penis, rectum, or vagina. This medicine may cause severe irritation. If you get this medicine in your eyes or on one of these areas, immediately flush the area with water for 15 minutes.

Use podofilox only as directed, no more than 3 days a week and no more than 4 treatment cycles. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chances that this medicine is absorbed into the body and that side effects could occur.

Do not apply the medicine to any other wart until you discuss it with your doctor. The total dose of podofilox used on all warts should not exceed that which would cover an area measuring 1.6 square inches (10 square centimeters), about the size of a dollar coin.

To use:

To apply the solution, use the applicators that come with the solution or a cotton-tipped applicator. To apply the gel, use a cotton-tipped applicator or your finger. Never reuse an applicator or dip a used applicator into the bottle.

Apply podofilox only to the wart(s) discussed with your doctor.

Podofilox can cause severe irritation of normal skin. If you get medicine on normal skin, wash it off immediately.

Make sure the treated area is dry before allowing the treated skin to come in contact with normal, untreated skin.

Immediately after applying this medicine, wash your hands to remove any medicine. Properly discard used applicator(s).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (gel):
- For warts on penis or vulva (genitals) or on skin between genitals and rectum:
  - Adults—Apply to the wart(s) two times a day for three days in a row using an applicator tip or finger. Skip four days by not applying any medicine for four days in a row. If the wart can still be seen, this application cycle may be repeated each week for up to four weeks, until the wart is gone. No more than 0.5 grams of gel should be used each day of treatment.
  - Children—Use and dose must be determined by the doctor.

For topical dosage form (solution):
- For warts on penis or vulva (genitals) only:
  - Adults—Apply to the wart(s) two times a day (every twelve hours) for three days in a row using applicator tip. Skip four days by not applying any medicine for four days in a row. If the wart can still be seen, this application cycle may be repeated each week for up to four weeks, until the wart is gone. No more than 0.5 milliliters of solution should be used each day of treatment.
  - Children—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Condylox

Podofilox may not be able to prevent previously healed warts from reappearing or stop new warts from growing.

This medicine contains alcohol and therefore may be flammable. Do not use near heat, near open flame, or while smoking.

Condylox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

Bad odor (solution only)

bleeding of treated skin

blistering, crusting, or scabbing of treated skin

bloody urine (solution only)

burning feeling of treated skin

dizziness (solution only)

headache (gel only)

itching of treated skin

pain during sexual intercourse (solution only)

pain of treated skin

problems with foreskin of penis (solution only)

redness or swelling of treated skin

scarring of treated skin (solution only)

skin ulcers of treated skin

vomiting (solution only)

Symptoms of overdose - in order of occurrence

Nausea

vomiting

diarrhea

chills

fever

sore throat

unusual bleeding or bruising

oral ulcers

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dryness of treated skin

peeling of treated skin

soreness or tenderness of treated skin

stinging or tingling of treated skin

trouble in sleeping (solution only)

Less common

Changes in color of treated skin (gel only)

skin rash (gel only)

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

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

See also: Condylox Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Condylomata Acuminata

Mydral Ophthalmic

Generic Name: tropicamide (Ophthalmic route)

troe-PIK-a-mide

Commonly used brand name(s)

In the U.S.

Mydral

Mydriacyl

Ocu-Tropic

Tropicacyl

Available Dosage Forms:

Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Antimuscarinic

Uses For Mydral

Tropicamide is used to dilate (enlarge) the pupil so that the doctor can see into the back of your eye. It is used before eye examinations, such as cycloplegic refraction and examination of the fundus of the eye. Tropicamide may also be used before and after eye surgery.

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

Before Using Mydral

Allergies

Pediatric

Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of tropicamide. This may increase the chance or severity of some of the side effects during treatment.

Geriatric

Elderly people are especially sensitive to the effects of tropicamide. This may increase the chance of side effects during treatment.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of tropicamide

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

To use:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye. This is especially important in infants.

Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. If you are using the eye drops for an infant or child, be sure to wash the infant's or child's hands also, and do not let any of the medicine get in the infant's or child's mouth.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing

For ophthalmic solution (eye drops) dosage form:
- For cycloplegic refraction (eye examination):
  - Adults—One drop of 1% solution, repeated once in five minutes.
  - Children—One drop of 0.5 to 1% solution, repeated once in five minutes.
- For examination of fundus of eye:
  - Adults and children—One drop of 0.5% solution fifteen to twenty minutes before examination.

Precautions While Using Mydral

After this medicine is applied to your eyes:

Your pupils will become unusually large and you will have blurring of vision, especially for close objects. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

Your eyes will become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor.

If these effects continue for longer than 24 hours after the medicine is used, check with your doctor.

Mydral Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Symptoms of too much medicine being absorbed into the body

Clumsiness or unsteadiness

confusion

fast heartbeat

flushing or redness of face

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

increased thirst or dryness of mouth

skin rash

slurred speech

swollen stomach in infants

unusual behavior, especially in children

unusual drowsiness, tiredness, or weakness

More common

Blurred vision

headache

sensitivity of eyes to light

stinging of the eye when the medicine is applied

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

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

See also: Mydral Ophthalmic side effects (in more detail)

More Mydral Ophthalmic resources

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

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Pupillary Dilation
Refraction, Assessment

Thursday, 24 May 2012

Xalatan

Generic Name: Latanoprost
Class: Prostaglandin Analogs
VA Class: OP109
Molecular Formula: C₂₆H₄₀O₅
CAS Number: 130209-82-4

Introduction

Ocular hypotensive agent; a synthetic analog of prostaglandin F_2α (PGF_2α).¹ ² ³ ³² ³³

Uses for Xalatan

Ocular Hypertension and Glaucoma

Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.¹ ³ ¹⁰ ¹¹ ¹² ¹³ ¹⁵ ³⁰ ³¹ ³² ³³ ⁴⁸ ⁵⁵ ⁶⁰ One of several first-line agents to reduce elevated IOP.⁷⁵

Safety and efficacy not established for the treatment of angle-closure, inflammatory, or neovascular glaucoma.¹

Appears to be more effective than unoprostone, as effective as travoprost, and slightly less effective than bimatoprost in reducing IOP in patients with open-angle glaucoma or ocular hypertension.⁷⁶ ⁷⁷ ⁷⁸ ⁷⁹ ⁸⁰ ⁸¹

May be more effective or at least as effective as twice daily administration of timolol 0.5% in reducing IOP in patients with open-angle glaucoma or ocular hypertension.¹ ³ ¹⁰ ¹¹ ¹² ³⁰ ³¹ ³² ³³ Appears to be more effective than thrice-daily administration of dorzolamide 2%.⁸⁶ ⁸⁷

May be used in conjunction with a topical β-adrenergic blocking agent (e.g., betaxolol, carteolol, levobunolol, metipranolol, timolol),³ ²⁸ ²⁹ ³² ³³ ³⁶ topical dipivefrin,³³ ⁵⁹ topical epinephrine, an oral carbonic anhydrase inhibitor (e.g., acetazolamide), ³³ or a topical carbonic anhydrase inhibitor (e.g., dorzolamide).¹ ⁴⁴ ⁵⁶

Tolerance does not occur, and reduction in mean IOP is maintained for up to at least 24 months of therapy after initial stabilization.¹ ³ ¹⁰ ¹¹ ¹² ¹⁵ ³⁶ ⁴⁴ ⁴⁸

Xalatan Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the affected eye(s).¹ ¹⁰ ¹¹ ¹² ³² ³³ ³⁶

Avoid contamination of the solution container.¹

If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.¹ (See Interactions.)

Dosage

Adults

Ocular Hypertension and Glaucoma

Ophthalmic

One drop of a 0.005% solution (1.5 mcg) in the affected eye(s) once daily in the evening.¹ ¹⁰ ¹¹ ¹² ³² ³³ ³⁶ More frequent dosing may paradoxically diminish the IOP-lowering effect of the drug.¹ ¹⁵ ²⁹ ³⁹ If a dose is missed, omit the dose and apply the next dose the following evening.¹⁵

Cautions for Xalatan

Contraindications

Known hypersensitivity to latanoprost, benzalkonium chloride, or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Ocular Effects

Increases in brown pigmentation of the iris and periorbital tissue (eyelid) or increases in length, thickness, and pigmentation of eyelashes or vellus hair in the treated eye reported;¹ ³ ¹⁰ ¹¹ ¹² ¹⁵ ³¹ ³² ³³ ³⁶ misdirected growth of eyelashes also may occur.¹ Pigmentation is expected to increase throughout the treatment period.¹ Increased pigmentation of the iris may be permanent, while pigmentation of the periorbital tissue and eyelash changes reportedly are reversible in some patients.¹ Long-term effects (i.e., beyond 5 years) of increased pigmentation are unknown.¹

Increased pigmentation of iris develops slowly; may not be evident until after several months to years of latanoprost therapy.¹ In clinical studies, noticeable increased pigmentation of the iris generally occurred within the first year of therapy.¹ Therapy generally may be continued in the presence of increased iris pigmentation;¹ patients should be examined regularly.¹ ³³ ³⁶

General Precautions

Ocular Precautions

Macular edema, including cystoid macular edema, reported in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema; use with caution in such patients.¹ ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁸ ⁶¹ ⁶² ⁶³ ⁶⁴ ⁶⁵

Use with caution in patients with a history of intraocular inflammation (e.g., iritis, uveitis); use generally not recommended in patients with active intraocular inflammation.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known if distributed into milk; use with caution.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.¹ ¹⁵

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹ ¹⁰ ¹¹ ¹²

Common Adverse Effects

Blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, pruritus, increased pigmentation of the iris, punctate epithelial keratopathy.¹

Interactions for Xalatan

Ocular Hypotensive Agents

Potential for additive IOP-lowering effects when used concomitantly with another ocular hypotensive agent (e.g., topical β-adrenergic blocking agent, oral or topical carbonic anhydrase inhibitor).¹ ³ ¹⁹ ²⁸ ²⁹ ³² ³³ ³⁶ ⁵⁶ ⁵⁹ Additive effect may be used to therapeutic advantage.¹ ³ ¹⁹ ²⁸ ²⁹ ³² ³³ ³⁶

Thimerosal

Precipitation occurs when ophthalmic solutions containing thimerosal are admixed with latanoprost ophthalmic solution.¹ If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.¹

Xalatan Pharmacokinetics

Absorption

Bioavailability

Approximately 1% of a topically applied dose penetrates the human eye;¹⁵ remaining portion is absorbed into systemic circulation through blood vessels in the conjunctiva and mucous membranes of the nose, pharynx, esophagus, and GI tract.⁶ ¹⁵

Prodrug; absorbed through the cornea following ocular instillation and rapidly hydrolyzed to active form (latanoprost acid).¹ ⁶ ¹⁴ ¹⁵ ¹⁶ ¹⁸ Peak plasma concentrations of latanoprost acid occur within 2 hours.¹ ¹⁵

Onset

Reduction in IOP generally occurs within 3–4 hours after topical application and peaks within 8–12 hours.

Duration

Effects on IOP generally persist for up to 24 hours or longer.¹ ¹⁰ ¹¹ ¹² ¹³ ¹⁵ ¹⁷

Following long-term therapy (i.e., 6 months), pharmacologic effects may persist for at least 14 days after the drug is discontinued.¹⁵

Distribution

Extent

The volume of distribution of latanoprost acid in humans following ocular or IV administration is 0.36 or 0.16 L/kg, respectively.¹ ¹⁵ Latanoprost acid can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after ocular instillation.¹

Not known whether the drug or its metabolites distribute into milk in humans.¹

Elimination

Metabolism

Rapidly hydrolyzed by esterases in the cornea and plasma to biologically active form (latanoprost acid).¹ ¹⁵ ¹⁶ ³³

Systemically absorbed latanoprost acid is metabolized in the liver.¹ ¹⁵

Elimination Route

Metabolites are excreted principally in urine; however, biliary excretion also may occur.¹ ⁶ ¹⁵ Unchanged latanoprost or latanoprost acid generally are not recovered in urine or feces.¹⁵ Following topical administration of radiolabeled latanoprost to the eye, 88% of the dose was eliminated in urine.¹⁵

Half-life

The elimination half-life of latanoprost acid from aqueous humor is approximately 3 hours.¹⁵

Following topical application to the eye, the plasma elimination half-life of latanoprost acid is approximately 17 minutes.¹⁵

Stability

Storage

Ophthalmic

Solution

Unopened bottles: refrigerate at 2–8°C and protect from light.¹ ¹⁵

Opened bottles: room temperature (not exceeding 25°C) for up to 6 weeks.¹

ActionsActions

Selective prostanoid agonist.¹ ² ³ ⁵ ⁶ ⁷ ⁸ ⁹ ³³ ⁴⁰

Appears to reduce IOP by increasing uveoscleral outflow of aqueous humor.¹ ² ³ ⁵ ⁶ ⁷ ⁹ ³¹ ³² ³³

Advice to Patients

Risk of changes in eyelashes and permanent darkening of iris, eyelashes, or skin around the eyes associated with therapy.¹ Potential for disparity between eyes if only one eye is treated.¹ ³⁶

Importance of learning and adhering to proper administration techniques to avoid contamination of the solution with common bacteria that can cause ocular infections.¹ Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.¹

Importance of informing clinicians if intercurrent ocular condition (e.g., trauma, infection) develops or ocular surgery is planned.¹ Importance of immediately reporting ocular reactions, particularly conjunctivitis and eyelid reactions.¹

Importance of delaying insertion of contact lenses for at least 15 minutes after latanoprost instillation, since benzalkonium chloride preservative may be absorbed by soft lenses.¹

Importance of administering different topical ophthalmic preparations at least 5 minutes apart.¹

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

Importance of women informing clinicians if they are or intend to become pregnant or plan to breast-feed.¹

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.

Latanoprost
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Solution	0.005%	Xalatan (with benzalkonium chloride)	Pharmacia

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Xalatan 0.005% Solution (PFIZER U.S.): 2/$104.99 or 7/$295.97

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.

References

1. Pharmacia & Upjohn Inc. Xalatan (latanoprost) sterile ophthalmic solution 0.005% (50 mcg/mL) prescribing information. Kalamazoo, MI; 2003 Sep.

2. Stjernschantz J, Resul B. Phenyl substituted prostaglandin analogs for glaucoma treatment. Drugs Future. 1992; 17:691-704.

3. Camras CB. Prostaglandins. In: Ritch R, Shields MB, Krupin T eds. The glaucomas. 2nd ed. St. Louis: Mosby-Year Book, Inc; 1996:1449-61.

4. Campbell WB, Halushka PV. Lipid-derived autacoids: eicosanoids and platelet-activating factor. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: McGraw-Hill; 1996:601-16.

5. Toris CB, Camras CB, Yablonski ME. Effects of PhXA41, a new prostaglandin F_2α analog, on aqueous humor dynamics in human eyes. Ophthalmology. 1993; 100:1297-304. [PubMed 8371915]

6. Stjernschantz J, Selén G, Sjöquist B et al. Preclinical pharmacology of latanoprost, a phenyl-substituted PGF_2α analogue. Adv Prostaglandin Thromboxane Leukotriene Res. 1995; 23:513-8.

7. True Gabelt B, Kaufman PL. Prostaglandin F_2α increases uveoscleral outflow in the cynomolgus monkey. Exp Eye Res. 1989; 49:389-402. [PubMed 2792235]

8. Nilsson SFE, Samuelsson M, Bill A et al. Increased uveoscleral outflow as a possible mechanism of ocular hypotension caused by prostaglandin F_2α-1-isopropylester in the cynomolgus monkey. Exp Eye Res. 1989; 48:707-16. [PubMed 2737263]

9. Ziai N, Dolan JW, Kacere RD et al. The effects on aqueous dynamics of PhXA41, a new prostaglandin F_2α analogue, after topical application in normal and ocular hypertensive human eyes. Arch Ophthalmol. 1993; 111:1351-8. [IDIS 320631] [PubMed 8216015]

10. Alm A, Stjernschantz J, and the Scandinavian Latanoprost Study Group. Effects on intraocular pressure and side effects of 0.005% latanoprost applied once daily, evening or morning: a comparison with timolol. Ophthalmology. 1995; 102:1743-52. [IDIS 358006] [PubMed 9098273]

11. Camras CB, and the United States Latanoprost Study Group. Comparison of latanoprost and timolol in patients with ocular hypertension and glaucoma: a six-month, masked, multicenter trial in the United States. Ophthalmology. 1996; 103:138-47. [IDIS 359594] [PubMed 8628544]

12. Watson P, Stjernschantz J, and the Latanoprost Study Group. A six-month, randomized, double-masked study comparing latanoprost with timolol in open-angle glaucoma and ocular hypertension. Ophthalmology. 1996; 103:126-37. [IDIS 359593] [PubMed 8628543]

13. Rácz P, Ruzsonyi MR, Nagy ZT et al. Around-the-clock intraocular pressure reduction with once-daily application of latanoprost by itself or in combination with timolol. Arch Ophthalmol. 1996; 114:268-73. [IDIS 364525] [PubMed 8600885]

14. Bito LZ, Baroody RA. The ocular pharmacokinetics of eicosanoids and their derivatives. 1. Comparison of ocular eicosanoid penetration and distribution following the topical application of PGF_2α, PGF_2α-1-methyl ester, and PGF_2α-1-isopropyl ester. Exp Eye Res. 1987; 44:217-26. [PubMed 3472899]

15. Pharmacia & Upjohn Inc, Kalamazoo, MI: Personal communication.

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17. Rácz P, Ruzsonyi MR, Nagy ZT et al. Maintained intraocular pressure reduction with once-a-day application of a new prostaglandin F_2α analogue (PhXA41): an in-hospital, placebo-controlled study. Arch Ophthalmol. 1993; 111:657-61. [IDIS 313809] [PubMed 8489449]

18. Bito LZ, Stjernschantz J, Resul B et al. The ocular effects of prostaglandins and the therapeutic potential of a new PGF_2α analog, PhXA41 (latanoprost), for glaucoma management. J Lipid Mediators. 1993; 6:535-43.

19. Friström B, Nilsson SEG. Interaction of PhXA41, a new prostaglandin analogue, with pilocarpine: a study on patients with elevated intraocular pressure. Arch Ophthalmol. 1993; 111:662-5. [IDIS 313810] [PubMed 8489450]

20. Alm A, Villumsen J, Törnquist P et al. Intraocular pressure-reducing effect of PhXA41 in patients with increased eye pressure: a one-month study. Ophthalmology. 1993; 100:1312-7. [PubMed 8371917]

21. Lichter PR. Another blockbuster glaucoma drug? Ophthalmology. 1993; 100:1281-2. Editorial.

22. Serle JB. Pharmacological advances in the treatment of glaucoma. Drugs Aging. 1994; 5:156-70. [PubMed 7803944]

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24. Cotton P. Glaucoma: detection before damage, fewer side effects may be possible. JAMA. 1990; 264:1793. [PubMed 2402030]

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26. Chaudhry I, Wong S. Recognizing glaucoma. A guide for the primary care physician. Postgrad Med. 1996; 99:247-8,251-2,257-9. [IDIS 367760] [PubMed 8650090]

27. Hayreh SS, Zimmerman MB, Podhajsky P et al. Nocturnal arterial hypotension and its role in optic nerve head and ocular ischemic disorders. Am J Ophthalmol. 1994; 117: 603-24.

28. Rulo AH, Greve EL, Hoyng PF. Additive effect of latanoprost, a prostaglandin F_2α analogue, and timolol in patients with elevated intraocular pressure. Br J Ophthalmol. 1994; 78:899-902. [PubMed 7819171]

29. Alm A, Widengard I, Kjellgren D et al. Latanoprost administered once daily caused a maintained reduction of intraocular pressure in glaucoma patients treated concomitantly with timolol. Br J Ophthalmol. 1995; 79:12-6. [PubMed 7880782]

30. Mishima HK, Masuda K, Kitazawa Y et al. A comparison of latanoprost and timolol in primary open-angle glaucoma and ocular hypertension. Arch Ophthalmol. 1996; 114: 929-932. [IDIS 370988] [PubMed 8694726]

31. Higginbotham EJ. Will latanoprost be the “wonder” drug of the ’90s for the treatment of glaucoma? Arch Ophthalmol. 1996; 114:998-999.

32. Anon. A topical prostaglandin for glaucoma. Med Lett Drugs Ther. 1996; 38:100-1. [PubMed 8914508]

33. Patel SS, Spencer CM. Latanoprost: a review of its pharmacological properties, clinical efficacy and tolerability in the management of primary open-angle glaucoma and ocular hypertension. Drugs Aging. 1996; 9:363-78. [PubMed 8922563]

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35. Prostaglandin. Dorland’s illustrated medical dictionary. 28th ed. Philadelphia: WB Saunders Company; 1994:1366.

36. Camras CB, Alm A, Watson P et al et al. Latanoprost, a prostaglandin analog, for glaucoma therapy. Ophthalmology. 1996; 103:1916-24. [IDIS 377481] [PubMed 8942890]

37. Rulo AH, Greve EL, Geijssen HC et al. Reduction of intraocular pressure with treatment of latanoprost once daily in patients with normal-pressure glaucoma. Ophthalmology. 1996; 103:1276-82. [IDIS 372462] [PubMed 8764799]

38. Nicolela MT, Buckley AR, Walman BE et al. A comparative study of the effects of timolol and latanoprost on blood flow velocity of the retrobulbar vessels. Am J Ophthalmol. 1996; 122:784-9. [IDIS 376778] [PubMed 8956632]

39. Nagasubramanian S, Sheth GP, Hitchings RA et al. Intraocular pressure-reducing effect of PhXA41 in ocular hypertension: comparison of dose regimens. Ophthalmology. 1993; 100:1305-11. [PubMed 8371916]

40. Coleman RA, Smith WL, Narumiya S. International union of pharmacology classification of prostanoid receptors: properties, distribution, and structure of the receptors and their subtypes. Pharmacol Rev. 1994; 46:205-29. [PubMed 7938166]

41. Johnstone MA. Hypertrichosis and increased pigmentation of lashes and adjacent hair in the region of the eye in patients treated with unilateral topical latanoprost. Am J Ophthalmol. (in press)

42. Lindsey JD, Kashiwagi K, Boyle D et al. Prostaglandins increase proMMP-1 and proMMP-3 secretion by human ciliary smooth muscle cells. Curr Eye Res. 1996; 15: 869-75.

43. Lindsey JD, Kashiwagi K, Kashiwagi F et al. Prostaglandin action on ciliary smooth muscle extracellular matrix metabolism: implications for uveoscleral outflow. Surv Ophthalmol. 1997; 42(Suppl 2):S53-9.

44. Reviewers’ comments (personal observations).

46. Alward WLM. Medical management of glaucoma. N Engl J Med. 1998; 339:1298-307. [IDIS 414110] [PubMed 9791148]

47. Crawford K, Kaufman PL. Pilocarpine antagonizes prostaglandin F2 alpha-induced ocular hypotension in monkeys. Evidence for enhancement of uveoscleral outflow by prostaglandin F2 alpha. Arch Ophthalmol. 1987; 105:1112-6. [PubMed 3477218]

48. Watson PG, and the Latanoprost Study Group. Latanoprost: two years’ experience of its use in the United Kingdom. Ophthalmology. 1998; 105:82-7. [IDIS 399628] [PubMed 9442782]

49. Peak AS, Sutton BM. Systmic adverse effects associated with topically applied latanoprost. Ann Pharmacother. 1998; 32:504-5. [IDIS 403361] [PubMed 9562149]

50. Reynolds A, Murray PI, Colloby PS. Darkening of eyelashes in a patient treated with latanoprost. Eye. 1998; 12:741-3. [PubMed 9850277]

51. Ayyala RS, Cruz DA, Margo CE et al. Cystoid macular edema associated with latanoprost in aphakic and pseudophakic eyes. Am J Ophthalmol. 1998; 126:602-4. [PubMed 9780112]

52. Thorne JE, Maguire AM, Lanciano R. CME and anterior uveitis with latanoprost use. Ophthalmology. 1998; 105:1981-3. [IDIS 423347] [PubMed 9818590]

53. Camras CB. CME and anterior uveitis with latanoprost use. Ophthalmology. 1998; 105:1978-81. [IDIS 423345] [PubMed 9818589]

54. Eisenberg D. CME and anterior uveitis with latanoprost use. Ophthalmology. 1998; 105:1978. [IDIS 423344] [PubMed 9818588]

55. Camras CB, Wax MB, Ritch R et al and the United States Latanoprost Study Group. Latanoprost treatment for glaucoma: effects of treating for 1 year and of switching from timolol. Am J Ophthalmol. 1998; 126:390-9. [IDIS 414482] [PubMed 9744372]

56. Vanlandigham BD, Brubaker RF. Combined effect of dorzolamide and latanoprost on the rate of aqueous humor flow. Am J Ophthalmol. 1998; 126:191-6. [IDIS 418945] [PubMed 9727512]

57. Fechtner RD, Khouri AS, Zimmerman TJ et al. Anterior uveitis associated with latanoprost. Am J Ophthalmol. 1998; 126:37-41. [IDIS 410266] [PubMed 9683147]

58. Callanan D, Fellman RL, Savage JA. Latanoprost-associated cystoid macular edema. Am J Ophthalmol. 1998; 126:134-5. [PubMed 9683162]

59. Widengard I, Maepea O, Alm A. Effects of latanoprost and dipivefrin, alone or combined, on intraocular pressure and on blood-aqueous barrier permeability. Br J Ophthalmol. 1998; 82:404-6. [PubMed 9640189]

60. Drance SM, Crichton A, Mills RP. Comparison of the effect of latanoprost 0.005% and timolol 0.5% on the calculated ocular perfusion pressure in patients with normal-tension glaucoma. Am J Ophthalmol. 1998; 125:585-92. [IDIS 408145] [PubMed 9625541]

61. Heier JS, Steinert RF, Frederick AR Jr. Cystoid macular edema associated with latanoprost use. Arch Ophthalmol. 1998; 116:680-2. [IDIS 406366] [PubMed 9596510]

62. Avakian A, Renier SA, Butler PJ. Adverse effects of latanaprost on patients with medically resistant glaucoma. Arch Ophthalmol. 1998; 116:679-80. [IDIS 406365] [PubMed 9596509]

63. Gaddie IB, Bennett DW. Cystoid macular edema associated with the use of latanoprost. J Am Optom Assoc. 1998; 69:122-8. [PubMed 9549261]

64. Warwar RE, Bullock JD, Ballal D. Cystoid macular edema and anterior uveitis associated with latanoprost use: experience and incidence in a retrospective review of 94 patients. Ophthalmology. 1998; 105:263-8. [IDIS 401387] [PubMed 9479285]

65. Rowe JA, Hattenhauer MG, Herman DC. Adverse side effects associated with latanoprost. Am J Ophthalmol. 1997; 124:683-5. [IDIS 396198] [PubMed 9372723]

66. Wand M. Latanoprost and hyperpigmentation of eyelashes. Arch Ophthalmol. 1997; 115:1206-8. [IDIS 392336] [PubMed 9298071]

67. Hedner J, Everts B, Moller CS. Latanoprost and respiratory function in asthmatic patients: randomized, double-masked, placebo-controlled crossover evaluation. Arch Ophthalmol. 1999; 117:1305-9. [IDIS 436687] [PubMed 10532438]

68. Kent AR, Vroman DT, Thomas TJ et al. Interaction of pilocarpine with latanoprost in patients with glaucoma and ocular hypertension. J Glaucoma. 1999; 8:257-62. [PubMed 10464735]

69. Moroi SE, Gottfredsdottir MS, Schteingart MT et al. Cystoid macular edema associated with latanoprost therapy in a case series of patients with glaucoma and ocular hypertension. Ophthalmology. 1999; 106:1024-9. [IDIS 427941] [PubMed 10328408]

70. Wand M, Gilbert CM, Liesegang TJ. Latanoprost and herpes simplex keratitis. Am J Ophthalmol. 1999; 127:602-4. [IDIS 428960] [PubMed 10334356]

71. Weston BC. Migraine headache associated with latanoprost. Arch Ophthalmol. 2001; 119:300-1. [IDIS 459054] [PubMed 11176999]

72. Wand M, Ritch R, Isbey EK et al. Latanoprost and periocular skin color changes. Arch Ophthalmol. 2001; 119:614-5. [IDIS 462463] [PubMed 11296032]

73. Demitsu T, Manabe M, Harima N et al. Hypertrichosis induced by latanoprost. J Am Acad Dermatol. 2001; 44:721-3. [IDIS 461970] [PubMed 11260563]

74. Johnstone MA, Albert DM. Prostaglandin-induced hair growth. Surv Ophthalmol. 2002; 47(suppl 1):S185-202.

75. Distelhorst JS and Hughes GM. Open-angle glaucoma. Am Fam Physician. 2003; 67: 1937-44.

76. Noecker RS, Dirks MS, Choplin NT et al. A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma. Am J Ophthalmol. 2003; 135:55-63. [IDIS 491912] [PubMed 12504698]

77. Choplin N, Bernstein P, Batoosingh AL et al. A randomized, investigator-masked comparison of diurnal responder rates with bimatoprost and latanoprost in the lowering of intraocular pressure. Surv Ophthalmol. 2004; 49(suppl 1):S19-25. [PubMed 15016558]

78. Gandolfi S, Simmons ST, Sturm R et al. Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension. Adv Ther. 2001; 18:110-21. [PubMed 11571823]

79. Dubiner H, Cooke D, Dirks M et al. Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost. Surv Ophthalmol. 2001; 45(suppl 4):S353-60. [PubMed 11434938]

80. Dubiner HB, Sircy MD, Landry T et al. Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure. Clin Ther. 2004; 26:84-91. [PubMed 14996520]

81. Perry CM, McGavin JK,, Culy CR et al. Latanoprost: an update of its use in glaucoma and ocular hypertension. Drugs Aging. 2003; 20:597-630. [PubMed 12795627]

82. Jampel HD, Bacharach J, Sheu WP et al. Randomized clinical trial of latanoprost and unoprostone in patients with elevated intraocular pressure. Am J Ophthalmol. 2002; 134:863-71. [IDIS 491312] [PubMed 12470755]

83. Sponsel WE, Paris G, Trigo Y et al. Comparative effects of latanoprost (Xalatan) and unoprostone (Rescula) in patients with open-angle glaucoma and suspected glaucoma. Am J Ophthalmol. 2002; 134:552-9. [IDIS 487694] [PubMed 12383812]

84. Aung T, Chew PT, Yip CC et al. A randomized double-masked crossover study comparing latanoprost 0.005% with unoprostone 0.12% in patients with primary open-angle glaucoma and ocular hypertension. Am J Ophthalmol. 2001; 131:636-42. [IDIS 465245] [PubMed 11336940]

85. Susanna R Jr, Giampani J Jr, Borges AS et al. A double-masked, randomized clinical trial comparing latanoprost with unoprostone in patients with open-angle glaucoma or ocular hypertension. Ophthalmology. 2001; 108:259-63. [IDIS 459094] [PubMed 11158796]

86. Niazi MK and Raja N. Comparison of latanoprost and dorzolamide in the treatment of patients with open angle glaucoma. J Ayub Med Coll Abbottabad. 2004; 16:50-3.

87. O’Donoghue EP for the Ireland Latanoprost Study Group. A comparison of latanoprost and dorzolamide in patients with glaucoma and ocular hypertension: a 3 month, randomised study. Br J Ophthalmol. 2000; 84:579-82. [PubMed 10837379]

88. Shin DH, McCracken MS, Bendel RE et al. The additive effect of latanoprost to maximum-tolerated medications with low-dose, high-dose, or no pilocarpine therapy. Ophthalmology. 1999; 106:386-90. [IDIS 422864] [PubMed 9951495]

89. Toris CB, Zhan GL, Zhao J et al. Potential mechanism for the additivity of pilocarpine and latanoprost. Am J Ophthalmol. 2001; 131:722-8. [IDIS 464258] [PubMed 11384567]

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Thursday, 14 June 2012

Trizivir

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Tuesday, 12 June 2012

Etravirine

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Monday, 11 June 2012

Metrogel

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6. Pharmaceutical Particulars

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Friday, 8 June 2012

Condylox Topical

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Mydral Ophthalmic

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