Ethyol

Pronunciation: A-mi-FOS-teen
Generic Name: Amifostine
Brand Name: Ethyol

Ethyol is used for:

Reducing kidney damage due to cisplatin chemotherapy in patients with ovarian cancer. It is also used to reduce moderate to severe dry mouth associated with radiation treatment after surgery for head and neck cancer. It may also be used for other conditions as determined by your doctor.

Ethyol is a cytoprotective agent. It works by removing certain substances that cause damage to the kidneys. It also reduces some harmful effects of radiation on healthy tissues.

Do NOT use Ethyol if:

• you are allergic to any ingredient in Ethyol or to similar medicines


• you have low blood pressure or you are dehydrated

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

Before using Ethyol:

Some medical conditions may interact with Ethyol. 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 blood vessel problems, heart problems (eg, congestive heart failure, irregular heartbeat), stroke or transient ischemic attacks ("mini-strokes"), low blood calcium levels, or kidney problems (eg, nephrotic syndrome)


• if you are taking medicine to treat high blood pressure or you are receiving chemotherapy for other types of cancer

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

Ask your health care provider if Ethyol 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 Ethyol:

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

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


• Patients who take blood pressure medicines may need to avoid taking them within 24 hours before or after using Ethyol. If you take medicine for high blood pressure, ask your doctor how to take it along with Ethyol.


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


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


• If you miss a dose of Ethyol, contact your doctor right away.

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

Important safety information:

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


• Ethyol may cause low blood pressure. If you experience dizziness, shortness of breath, difficulty breathing, seizures, fainting, or decreased urination, contact your doctor immediately. Patients who take blood pressure medicines may need to avoid taking them within 24 hours before or after using Ethyol. If you take medicine for high blood pressure, ask your doctor how to take it along with Ethyol.


• Severe and sometimes fatal skin reactions have occurred with Ethyol. This reaction may develop even weeks after you start treatment. The risk may be greater in patients who use Ethyol to reduce dry mouth caused by radiation treatment. If you experience severe rash (eg, redness, scaling, swelling, peeling, or blistering of the skin), fever, mouth sores, or red and irritated eyes, contact your doctor right away.


• If you experience nausea or vomiting, talk to your doctor about how to avoid becoming dehydrated. Your doctor may prescribe medicine to help decrease nausea and vomiting that may occur while you are using Ethyol.


• Lab tests, including kidney function, blood calcium and electrolyte levels, and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Ethyol with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Ethyol can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ethyol while you are pregnant. It is not known if Ethyol is found in breast milk. Do not breast-feed while taking Ethyol.

Possible side effects of Ethyol:

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:

Drowsiness; feeling of coldness; flushing/feeling of warmth; hiccups; nausea; sneezing; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills or shaking; decreased urination; dizziness; fainting; fast, slow, or irregular heartbeat; fever; muscle twitching/cramping; numbness of an arm or leg; red, swollen, blistered, or peeling skin; seizures; severe or persistent nausea or vomiting; severe stomach pain; shortness of breath; sores on the lips, mouth, or tongue; sudden, severe headache; unusual fatigue or tiredness; vision changes.

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: Ethyol 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 seizures; severe or persistent dizziness; shortness of breath.

Proper storage of Ethyol:

Ethyol is usually handled and stored by a health care provider. If you are using Ethyol at home, store Ethyol as directed by your pharmacist or health care provider.

General information:

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


• Ethyol 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 Ethyol. 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 Ethyol resources

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

• Ethyol Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethyol Monograph (AHFS DI)


• Ethyol Prescribing Information (FDA)


• Amifostine Professional Patient Advice (Wolters Kluwer)


• Amifostine Prescribing Information (FDA)

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Pioglitazone 45mg Tablets

1. Name Of The Medicinal Product

Pioglitazone Sandoz 45 mg, Tablets

2. Qualitative And Quantitative Composition

Pioglitazone 45 mg

Each tablet contains 45 mg pioglitazone (as pioglitazone hydrochloride).

Excipient(s): Lactose monohydrate 231 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet

Pioglitazone 45 mg

white, round tablet, with imprint “PGT 45” on one side and with three-part score line on the other side The tablet can be divided into three equal parts.

4. Clinical Particulars

4.1 Therapeutic Indications

Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:

as monotherapy

- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance

Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).

After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).

4.2 Posology And Method Of Administration

Posology

Pioglitazone treatment may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily.

In combination with insulin, the current insulin dose can be continued upon initiation of pioglitazone therapy. If patients report hypoglycaemia, the dose of insulin should be decreased.

Special population

Elderly

No dosage adjustment is necessary for elderly patients (see section 5.2). Physicians should start treatment with the lowest available dose and increase the dose gradually, particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).

Renal impairment

No dosage adjustment is necessary in patients with impaired renal function (creatinine clearance> 4 ml/min) (see section 5.2). No information is available from dialysed patients therefore pioglitazone should not be used in such patients.

Hepatic impairment

Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4).

Paediatric population

The safety and efficacy of Pioglitazone in children and adolescents under 18 years of age have not been established. No data are available.

Method of administration

Pioglitazone tablets are taken orally once daily with or without food. Tablets should be swallowed with a glass of water.

4.3 Contraindications

Pioglitazone is contraindicated in patients with:

- hypersensitivity to the active substance or to any of the excipients

- cardiac failure or history of cardiac failure (NYHA stages I to IV)

- hepatic impairment

- diabetic ketoacidosis

- current bladder cancer or a history of bladder cancer

- uninvestigated macroscopic haematuria

4.4 Special Warnings And Precautions For Use

Fluid retention and cardiac failure:

Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure. When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually. Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve. There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure. Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin. Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema. Pioglitazone should be discontinued if any deterioration in cardiac status occurs.

A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease. Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years. This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.

Elderly

Combination use with insulin should be considered with caution in the elderly because of increased risk of serious heart failure.

In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.

Bladder Cancer

Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029). After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups. Available epidemiological data also suggest a small increased risk of bladder cancer in diabetic patients treated with pioglitazone in particular in patients treated for the longest durations and with the highest cumulative doses. A possible risk after short term treatment cannot be excluded.

Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment (risks include age, smoking history, exposure to some occupational or chemotherapy agents e.g. cyclophosphamide or prior radiation treatment in the pelvic region). Any macroscopic haematuria should be investigated before starting pioglitazone therapy.

Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.

Monitoring of liver function:

There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8). It is recommended, therefore, that patients treated with pioglitazone undergo periodic monitoring of liver enzymes. Liver enzymes should be checked prior to the initiation of therapy with pioglitazone in all patients. Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT> 2.5 X upper limit of normal) or with any other evidence of liver disease.

Following initiation of therapy with pioglitazone, it is recommended that liver enzymes be monitored periodically based on clinical judgement. If ALT levels are increased to 3 X upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible. If ALT levels remain> 3 X the upper limit of normal, therapy should be discontinued. If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with pioglitazone should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed, the medicinal product should be discontinued.

Weight gain:

In clinical trials with pioglitazone there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention. In some cases weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored. Part of the treatment of diabetes is dietary control. Patients should be advised to adhere strictly to a calorie-controlled diet.

Haematology:

There was a small reduction in mean haemoglobin (4 % relative reduction) and haematocrit (4.1 % relative reduction) during therapy with pioglitazone, consistent with haemodilution. Similar changes were seen in metformin (haemoglobin 3 - 4 % and haematocrit 3.6 – 4.1 % relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1 – 2 % and haematocrit 1 – 3.2 % relative reductions) treated patients in comparative controlled trials with pioglitazone.

Hypoglycaemia:

As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.

Eye disorders:

Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone. Many of these patients reported concurrent peripheral oedema. It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.

Others:

An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials in over 8100 pioglitazone and 7400 comparator treated patients, on treatment for up to 3.5 years.

Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).

The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator. The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.

In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).

The risk of fractures should be considered in the long term care of women treated with pioglitazone.

As a consequence of enhancing insulin action, pioglitazone treatment in patients with polycystic ovarian syndrome may result in resumption of ovulation. These patients may be at risk of pregnancy. Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).

Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin). Glycaemic control should be monitored closely. Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).

Pioglitazone tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea. Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4. In vitro studies have shown no inhibition of any subtype of cytochrome P450. Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.

Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone. Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered. Close monitoring of glycaemic control should be considered (see section 4.4). Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone. The pioglitazone dose may need to be increased when rifampicin is concomitantly administered. Close monitoring of glycaemic control should be considered (see section 4.4).

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate human data to determine the safety of pioglitazone during pregnancy. Foetal growth restriction was apparent in animal studies with pioglitazone. This was attributable to the action of pioglitazone in diminishing the maternal hyperinsulinaemia and increased insulin resistance that occurs during pregnancy thereby reducing the availability of metabolic substrates for foetal growth. The relevance of such a mechanism in humans is unclear and pioglitazone should not be used in pregnancy.

Breastfeeding

Pioglitazone has been shown to be present in the milk of lactating rats. It is not known whether pioglitazone is secreted in human milk. Therefore, pioglitazone should not be administered to breast-feeding women.

Fertility

In animal fertility studies there was no effect on copulation, impregnation or fertility index.

4.7 Effects On Ability To Drive And Use Machines

Pioglitazone has no or negligible effect on the ability to drive and use machines. However patients who experience visual disturbance should be cautious when driving or using machines.

4.8 Undesirable Effects

Adverse reactions reported in excess (> 0.5 %) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency. Frequencies are defined as: very common (

Adverse reaction	Frequency of adverse reactions of pioglitazone by treatment regimen
Monotherapy	Combination
with metformin	with sulphonylurea	with metformin and sulphonylurea	with insulin
Infections and infestations
upper respiratory tract infection	common	common	common	common	common
bronchitis					common
sinusitis	uncommon	uncommon	uncommon	uncommon	uncommon
Blood and lymphatic system disorders
anaemia		common
Metabolism and nutrition disorders
hypo-glycaemia			uncommon	very common	common
appetite increased			uncommon
Nervous system disorders
hypo-aesthesia	common	common	common	common	common
headache		common	uncommon
dizziness			common
insomnia	uncommon	uncommon	uncommon	uncommon	uncommon
Eye disorders
visual disturbance1	common	common	uncommon
macular oedema2	not known	not known	not known	not known	not known
Ear and labyrinth disorders
vertigo			uncommon
Cardiac disorders
heart failure3					common
Neoplasms benign, malignant and unspecified (including cysts and polyps)
bladder cancer	uncommon	uncommon	uncommon	uncommon	uncommon
Respiratory, thoracic and mediastinal disorders
dyspnoea					common
Gastrointestinal disorders
flatulence		uncommon	common
Skin and subcutaneous tissue disorders
sweating			uncommon
Musculoskeletal and connective tissue disorders
fracture bone4	common	common	common	common	common
arthralgia		common		common	common
back pain					common
Renal and urinary disorders
haematuria		common
glycosuria			uncommon
proteinuria			uncommon
Reproductive system and breast disorders
erectile dysfunction		common
General disorders and administration site conditions
oedema					very common
fatigue			uncommon
Investigations
weight increased5	common	common	common	common	common
blood creatine phospho-kinase increased				common
increased lactic dehydro-genase			uncommon
alanine aminotransferase increased6	not known	not known	not known	not known	not known

¹ Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.

²Oedema was reported in 6 – 9 % of patients treated with pioglitazone over one year in controlled clinical trials. The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5 %. The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.

³ In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin. In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6 % higher with pioglitazone than with placebo, when added to therapy that included insulin. However, this did not lead to an increase in mortality in this study. Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.

⁴ A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%). No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).

In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator. No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).

⁵In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2 – 3 kg over one year. This is similar to that seen in a sulphonylurea active comparator group. In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg. In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.

⁶ In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups. Mean levels of liver enzymes decreased with treatment with pioglitazone. Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience. Although in very rare cases fatal outcome has been reported, causal relationship has not been established.

4.9 Overdose

In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily. The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.

Hypoglycaemia may occur in combination with sulphonylureas or insulin. Symptomatic and general supportive measures should be taken in case of overdose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10 BG 03.

Pioglitazone effects may be mediated by a reduction of insulin resistance. Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals. Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.

Fasting and postprandial glycaemic control is improved in patients with type 2 diabetes mellitus. The improved glycaemic control is associated with a reduction in both fasting and postprandial plasma insulin concentrations. A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA_1c1c < 8.0 %) was sustained in 69 % of patients treated with pioglitazone, compared with 50 % of patients on gliclazide. In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA_1c was similar between treatment groups after one year. The rate of deterioration of HbA_1c during the second year was less with pioglitazone than with gliclazide.

In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months. Patients receiving pioglitazone had a mean reduction in HbA_1c of 0.45 % compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.

HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity. Two-year clinical studies have shown maintenance of this effect.

In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.

The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics. Pioglitazone was associated with significant weight gain. Visceral fat was significantly decreased, while there was an increase in extra-abdominal fat mass. Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity. In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.

In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide. Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide. In a 20-week study, as well as reducing fasting triglycerides, pioglitazone reduced post prandial hypertriglyceridaemia through an effect on both absorbed and hepatically synthesised triglycerides. These effects were independent of pioglitazone's effects on glycaemia and were statistically significant different to glibenclamide.

In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years. The study population had an average age of 62 years; the average duration of diabetes was 9.5 years. Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea. To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease. Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke. Approximately half of the study population had at least two of the cardiovascular history entry criteria. Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).

Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone. However, the incidences of oedema, weight gain and heart failure were increased. No increase in mortality from heart failure was observed.

5.2 Pharmacokinetic Properties

Absorption:

Following oral administration, pioglitazone is rapidly absorbed, and peak plasma concentrations of unchanged pioglitazone are usually achieved 2 hours after administration. Proportional increases of the plasma concentration were observed for doses from 2 – 60 mg. Steady state is achieved after 4–7 days of dosing. Repeated dosing does not result in accumulation of the compound or metabolites. Absorption is not influenced by food intake. Absolute bioavailability is greater than 80 %.

Distribution:

The estimated volume of distribution in humans is 0.25 l/kg.

Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99 %).

Biotransformation:

Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups. This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree. Three of the six identified metabolites are active (M-II, M-III, and M-IV). When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy. On this basis M-IV contribution to efficacy is approximately three-fold that of pioglitazone, whilst the relative efficacy of M-II is minimal.

In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450. There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.

Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin. Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).

Elimination:

Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45 %). In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces. The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.

Elderly:

Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.

Patients with renal impairment:

In patients with renal impairment, plasma concentrations of pioglitazone and its metabolites are lower than those seen in subjec

Cytoxan

Generic Name: cyclophosphamide (Oral route, Intravenous route)

sye-kloe-FOS-fa-mide

Commonly used brand name(s)

In the U.S.

• Cytoxan


• Cytoxan Lyophilized

Available Dosage Forms:

• Powder for Solution


• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

Uses For Cytoxan

Cyclophosphamide belongs to the group of medicines called alkylating agents. It is used to treat cancer of the ovaries, breast, blood and lymph system, nerves (found primarily in children), retinoblastoma (a cancer of the eye found primarily in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin).

Cyclophosphamide is also used for treatment of some kinds of kidney disease.

Cyclophosphamide may also be used for other conditions as determined by your doctor.

Cyclophosphamide interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by cyclophosphamide, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with cyclophosphamide, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Cyclophosphamide is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, cyclophosphamide is used in certain patients with the following medical conditions:

• Cancer of the bladder


• Cancer in the bones


• Cancer of the cervix


• Cancer of the endometrium


• Cancers of the lungs


• Cancer of the prostate


• Cancer of the testicles


• Cancer of the adrenal cortex (the outside layer of the adrenal gland)


• Ewing's sarcoma (a certain type of bone cancer)


• Germ cell tumors in the ovaries (a cancer in the egg-making cells in the ovary)


• Gestational trophoblastic tumors (a certain type of tumor in the uterus/womb)


• Soft tissue sarcomas (a cancer of the muscles, tendons, vessels that carry blood or lymph, joints, and fat)


• Thymoma (a cancer in the thymus, a small organ beneath the breastbone)


• Tumors in the brain


• Waldenström's macroglobulinemia (a certain type of cancer of the blood)


• Wilms' tumor (a cancer of the kidney found primarily in children)


• Histiocytosis X (a certain type of cancer found primarily in children)


• Organ transplant rejection (prevention)


• Rheumatoid arthritis


• Wegener's granulomatosis


• Systemic lupus erythematosus


• Systemic dermatomyositis or


• Multiple sclerosis (a disease of the nervous system)

Before Using Cytoxan

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

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults.

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. Although there is no specific information comparing use of cyclophosphamide in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Allopurinol


• Bacillus of Calmette and Guerin Vaccine, Live


• Cyclosporine


• Etanercept


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Nevirapine


• Pentostatin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• St John's Wort


• Tamoxifen


• Trastuzumab


• Typhoid Vaccine


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hydrochlorothiazide


• Ondansetron

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or


• Kidney stones (history of)—Cyclophosphamide may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infection—Cyclophosphamide can decrease your body's ability to fight infection

• Kidney disease—Effects of cyclophosphamide may be increased because of slower removal from the body

• Liver disease—The effect of cyclophosphamide may be decreased

• Prior removal of adrenal gland(s)—Toxic effects of cyclophosphamide may be increased, dosage adjustment may be necessary

• Tumor cell accumulation—Increased risk of tumor cells entering the bone marrow, due to bone marrow depression from high doses of cyclophosphamide

Proper Use of cyclophosphamide

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

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Cyclophosphamide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

While you are using cyclophosphamide, it is important that you drink extra fluids so that you will pass more urine. Also, empty your bladder frequently, including at least once during the night. This will help prevent kidney and bladder problems and keep your kidneys working well. Cyclophosphamide passes from the body in the urine. If too much of it appears in the urine or if the urine stays in the bladder too long, it can cause dangerous irritation. Follow your doctor's instructions carefully about how much fluid to drink every day. Some patients may have to drink up to 7 to 12 cups (3 quarts) of fluid a day.

Usually it is best to take cyclophosphamide first thing in the morning, to reduce the risk of bladder problems. However, your doctor may want you to take it with food in smaller doses over the day, to lessen stomach upset or help the medicine work better. Follow your doctor's instructions carefully about when to take cyclophosphamide.

Cyclophosphamide often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to use the medicine even if you begin to feel ill. Do not stop taking this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of cyclophosphamide, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

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.

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.

Call your doctor or pharmacist for instructions.

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.

Store the oral solution form of this medicine in the refrigerator. Keep it from freezing.

Precautions While Using Cytoxan

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with cyclophosphamide, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Cyclophosphamide may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Before having any kind of surgery, including dental surgery, or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking this medicine, especially if you have taken it within the last 10 days.

Cyclophosphamide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

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

Cytoxan Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Cough or hoarseness


• fever or chills


• lower back or side pain


• missing menstrual periods


• painful or difficult urination

With high doses and/or long-term treatment

• Blood in urine


• dizziness, confusion, or agitation


• fast heartbeat


• joint pain


• shortness of breath


• swelling of feet or lower legs


• unusual tiredness or weakness

Less common

• Black, tarry stools or blood in stools


• pinpoint red spots on skin


• unusual bleeding or bruising

Rare

• Frequent urination


• redness, swelling, or pain at site of injection


• sores in mouth and on lips


• sudden shortness of breath


• unusual thirst


• yellow eyes or skin

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

• Darkening of skin and fingernails


• loss of appetite


• nausea or vomiting

Less common

• Diarrhea or stomach pain


• flushing or redness of face


• headache


• increased sweating


• skin rash, hives, or itching


• swollen lips

Cyclophosphamide may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although the new hair may be a slightly different color or texture.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Blood in urine

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: Cytoxan side effects (in more detail)

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

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

More Cytoxan resources

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

• Cytoxan Prescribing Information (FDA)


• Cytoxan MedFacts Consumer Leaflet (Wolters Kluwer)


• Cytoxan oral/injection Concise Consumer Information (Cerner Multum)


• Cytoxan Monograph (AHFS DI)


• Cyclophosphamide Prescribing Information (FDA)


• Cyclophosphamide Professional Patient Advice (Wolters Kluwer)

Compare Cytoxan with other medications

• Acute Lymphocytic Leukemia
• Acute Nonlymphocytic Leukemia
• Bladder Cancer
• Brain Tumor
• Breast Cancer
• Bullous Pemphigoid
• Cancer
• Cervical Cancer
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Cogan's Syndrome
• Dermatomyositis
• Endometrial Cancer
• Ewing's Sarcoma
• Histiocytosis
• Hodgkin's Lymphoma
• IgA Nephropathy
• Multiple Myeloma
• Multiple Sclerosis
• Mycosis Fungoides
• Nephrotic Syndrome
• Neuroblastoma
• Non-Hodgkin's Lymphoma
• Non-Small Cell Lung Cancer
• Organ Transplant, Rejection Prophylaxis
• Osteosarcoma
• Ovarian Cancer
• Pemphigoid
• Pemphigus
• Prostate Cancer
• Rheumatoid Arthritis
• Small Cell Lung Cancer
• Systemic Lupus Erythematosus
• Systemic Sclerosis
• Testicular Cancer
• Wegener's Granulomatosus
• Wilms' Tumor

Nasin

Generic Name: oxymetazoline (Nasal route)

ox-i-me-TAZ-oh-leen

Commonly used brand name(s)

In the U.S.

• 4-Way Long Lasting


• Afrin


• Duramist Plus


• Duration


• Genasal


• Mucinex Full Force


• Mucinex Moisture Smart


• Nasacon


• Nasin


• Neo-Synephrine 12 Hour


• Nostrilla


• NRS-Nasal Relief


• Sinarest Nasal


• Vicks Sinex 12 Hour

Available Dosage Forms:

• Solution


• Spray

Therapeutic Class: Decongestant

Chemical Class: Imidazoline

Uses For Nasin

Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Before Using Nasin

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

Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment.

Geriatric

Many medicines have not been tested 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 about the use of oxymetazoline in the elderly.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus

• Dry membranes in nose

• Enlarged prostate—Difficulty urinating may worsen

• Glaucoma

• Heart or blood vessel disease or


• High blood pressure—Oxymetazoline may make the condition worse

• Overactive thyroid

Proper Use of oxymetazoline

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

To use the nose drops:

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.


• Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.


• To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

• Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.


• Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.


• To avoid spreading the infection, do not use the container for more than one person.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

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 nasal dosage form (nose drops or spray):
  
  • For nasal congestion or stuffiness:
    
    • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
    
    
    • Children up to 6 years of age—Use and dose must be determined by your 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.

Nasin 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

• Blurred vision


• fast, irregular, or pounding heartbeat


• headache, dizziness, drowsiness, or lightheadedness


• high blood pressure


• nervousness


• trembling


• trouble in sleeping


• weakness.

• Increase in runny or stuffy nose

The above side effects are more likely to occur in children because there is a greater chance in children that too much of this medicine may be absorbed into the body.

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:

• Burning, dryness, or stinging inside of nose


• increase in nasal discharge


• sneezing

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

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

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

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

More Nasin resources

• Nasin Use in Pregnancy & Breastfeeding
• Nasin Drug Interactions
• Nasin Support Group
• 12 Reviews for Nasin - Add your own review/rating

Compare Nasin with other medications

• Nasal Congestion