Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.
Desmopressin acetate tablets contain as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin.
Dose response studies in patients with diabetes insipidus have demonstrated that oral doses of 0.025 mg to 0.4 mg produced clinically significant antidiuretic effects. In most patients, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic effects lasting up to eight hours. With doses of 0.4 mg, antidiuretic effects were observed for up to 12 hours; measurements beyond 12 hours were not recorded. Increasing oral doses produced dose dependent increases in the plasma levels of desmopressin acetate.
The plasma half-life of desmopressin acetate followed a monoexponential time course with t 1/2values of 1.5 to 2.5 hours which was independent of dose.
The bioavailability of desmopressin acetate oral tablets is about 5% compared to intranasal desmopressin acetate, and about 0.16% compared to intravenous desmopressin acetate. The time to reach maximum plasma desmopressin acetate levels ranged from 0.9 to 1.5 hours following oral or intranasal administration, respectively. Following administration of desmopressin acetate tablets, the onset of antidiuretic effect occurs at around 1 hour, and it reaches a maximum at about 4 to 7 hours based on the measurement of increased urine osmolality.
The use of desmopressin acetate tablets in patients with an established diagnosis will result in a reduction in urinary output with an accompanying increase in urine osmolality. These effects usually will allow resumption of a more normal life style, with a decrease in urinary frequency and nocturia.
There are reports of an occasional change in response to the intranasal formulations of desmopressin acetate (desmopressin acetate Nasal Spray and desmopressin acetate Rhinal Tube). Usually, the change occurred over a period of time greater than six months. This change may be due to decreased responsiveness, or to shortened duration of effect. There is no evidence that this effect is due to the development of binding antibodies, but may be due to a local inactivation of the peptide. No lessening of effect was observed in the 46 patients who were treated with desmopressin acetate tablets for 12 to 44 months and no serum antibodies to desmopressin were detected.
The change in structure of arginine vasopressin to desmopressin acetate resulted in less vasopressor activity and decreased action on visceral smooth muscle relative to enhanced antidiuretic activity. Consequently, clinically effective antidiuretic doses are usually below the threshold for effects on vascular or visceral smooth muscle. In the four long-term studies of desmopressin acetate tablets, no increases in blood pressure in 46 patients receiving desmopressin acetate tablets for periods of 12 to 44 months were reported.
In one study, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulation were compared during an 8-hour dosing interval at steady state. The doses administered to 36 hydrated (water loaded) healthy male adult volunteers every 8 hours were 0.1, 0.2, 0.4 mg orally and 0.01 mg intranasally by rhinal tube. The results are shown in the following table:
With respect to the mean values of total urine volume decrease and maximum urine osmolality increase from baseline, the 90% confidence limits estimated that the 0.4 mg and 0.2 mg oral dose produced between 95% and 110% and 84% to 99% of pharmacodynamic activity, respectively, when compared to the 0.01 mg intranasal dose.
While both the 0.2 mg and 0.4 mg oral doses are considered pharmacodynamically similar to the 0.01 mg intranasal dose, the pharmacodynamic data on an inter-subject basis was highly variable and, therefore, individual dosing is recommended.
In another study in diabetes insipidus patients, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulations were compared over a 12-hour period. Ten fluid-controlled patients under age 18 were administered tablet doses of 0.2 mg and 0.4 mg, and intranasal doses of 0.01 mg and 0.02 mg.
All four dose formulations (0.01 mg IN, 0.02 mg IN, 0.2 mg PO and 0.4 mg PO) have a similar, pronounced pharmacodynamic effect on urine volume and urine osmolality. At two hours after study drug administration, mean urine volume was 4 mL/min and urine osmolality was >500 mOsm/kg. Mean plasma osmolality remained relatively constant over the time course recorded (0 to 12 hours). A statistical separation from baseline did not occur at any dose or time point. In these patients, the 0.2 mg tablets and the 0.01 mg intranasal spray exhibited similar pharmacodynamic profiles as did the 0.4 mg tablets and the 0.02 mg intranasal spray formulation. In another study of adult diabetes insipidus patients previously controlled on desmopressin acetate intranasal spray, after one week of self-titration from spray to tablets, patients’ diuresis was controlled with 0.1 mg desmopressin acetate tablets three times a day.
Two double-blind, randomized, placebo-controlled studies were conducted in 340 patients with primary nocturnal enuresis. Patients were 5-17 years old, and 72% were males. A total of 329 patients were evaluated for efficacy. Patients were evaluated over a two-week baseline period in which the average number of wet nights was 10 (range 4-14). Patients were then randomized to receive 0.2, 0.4, or 0.6 mg of desmopressin acetate or placebo. The pooled results after two weeks are shown in the following table:
Patients treated with desmopressin acetate tablets showed a statistically significant reduction in the number of wet nights compared to placebo-treated patients. A greater response was observed with increasing doses up to 0.6 mg.
In a six month, open-label extension study, patients completing the placebo-controlled studies were started on 0.2 mg/day desmopressin acetate tablets, and the dose was progressively increased until the optimal response was achieved (maximum dose 0.6 mg/day). A total of 230 patients were evaluated for efficacy; the average number of wet nights/2 weeks during the untreated baseline period was 10 (range 4-14), and the average duration (SD) of treatment was 4.2 (1.8) months. Twenty-five (25) patients (11%) achieved a complete or near complete response (≤2 wet nights/2 weeks) and did not require titration to the 0.6 mg/day dose. The majority of patients (198 of 230, 86%) were titrated to the highest dose. When all dose groups were combined, 128 (56%) showed at least a 50% reduction from baseline in the number of wet nights/2 weeks, while 87 (38%) patients achieved a complete or near complete response.
Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose desmopressin acetate (2mcg) injection demonstrated a difference in desmopressin acetate terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. (See CONTRAINDICATIONS.)
Methocarbamol tablets USP 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘114’ on other side . They are supplied as follows:
Bottles of 20 NDC 63187-087-20
Bottles of 30 NDC 63187-087-30
Bottles of 60 NDC 63187-087-60
Bottles of 90 NDC 63187-087-90
Bottles of 100 NDC 63187-087-00
Methocarbamol tablets USP 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side . They are supplied as follows:
Bottles of 20 NDC 63187-019-20
Bottles of 30 NDC 63187-019-30
Bottles of 40 NDC 63187-019-40
Bottles of 60 NDC 63187-019-60
Bottles of 90 NDC 63187-019-90
Bottles of 100 NDC 63187-019-00
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By: Hetero Labs Limited 2012754
Jeedimetla, Hyderabad- 500 055, India
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
Copy the URL below and paste it into your RSS Reader application.
Copy the URL below and paste it into your RSS Reader application.
DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.
If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
More about getting RSS News & Updates from DailyMed LEGATRIN PM (Acetaminophen, Diphenhydramine Hci) Tablet [Church Dwight Co., Inc.]
NDC 68084-764-25
Phospha 250 TM
Neutral
phosphorus supplement which supplies
250 mg
per tablet
30 Tablets (5 x 6)
DESCRIPTION: Each tablet contains 852 mg dibasic
sodium phosphate anhydrous, 155 mg monobasic
potassium phosphate, and 130 mg monobasic sodium
phosphate monohydrate. Each tablet yields approximately
250 mg of phosphorus, 298 mg sodium (13.0 mEq), and 45 mg
of potassium (1 .1 mEq).
OTHER INGREDIENTS: Purified Water, Lactose,
Monohydrate, Sodium Starch Glycolate, Polyvinyl
Pyrrolidone, Magnesium Stearate, Hydroxypropyl
methylcellulose, Polyethylene Glycol 400, Titanium dioxide.
DOSAGE AND ADMINISTRATION: Phospha 250™
Neutral tablets should be taken with a full glass of water,
with meals and at bedtime. Adults: One or two tablets four
times daily; Pediatric Patients over 4 years of age: One
tablet four times daily. For Pediatric Patients under 4 years of
age, use only as directed by a physician.
STORAGE: Store at controlled room temperature, 20° to
25°C (68° to 77°F).
IDENTITY: Phospha 250™ Neutral is an orally administered
medical food for use only under medical supervision for the
dietary management of hypophosphatemia.
To report a serious adverse event contact American Health
Packaging at: 1-800-707-4621.
Keep this and all drugs out of reach of children.
Rx Only
FOR YOUR PROTECTION: Do not use if blister
is torn or broken.
The drug product contained in this
package is from NDC # 64980-104,
Rising Pharmaceuticals, Inc.
Distributed by:
American Health Packaging
Columbus, Ohio 43217
076425
0276425/1115OS
NDC 49035-102-54
equate™
Compare to Tums® Extra Strength Active Ingredient*
Extra Strength
Antacid
Calcium Carbonate
Starts Working in Seconds to Relieve:
Wintergreen
750 mg
96 CHEWABLE TABLETS
Gluten-Free
Satisfaction guaranteed-
For questions or comments, please call
1-888-287-1915.
Distributed by: Wal-Mart Stores, Inc.,
Bentonville,AR 72716
*This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Tums®.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
taking the blood thinning drug warfarin
do not use more than directed
ask a health professional before use.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which nonselectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the alpha1/alpha5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses.
Absorption
Zolpidem Tartrate Sublingual Tablets disintegrates in the sublingual cavity after administration. On average, Zolpidem Tartrate Sublingual Tablets are rapidly absorbed in both genders, with a mean Tmax across studies of about 35 minutes to about 75 minutes.
In healthy normal volunteers (age 21 to 45 years) dosed with 3.5 mg Zolpidem Tartrate Sublingual Tablets, the average Cmax and AUC were 77 ng/mL and 296 ng·h/mL, respectively in women. The average Cmax and AUC were 53 ng/mL and 198 ng·h/mL, respectively in men. In women, the average Cmax and AUC of the 1.75 mg Zolpidem Tartrate Sublingual Tablets dose were 37 ng/mL and 151 ng·h/mL, respectively.
Food decreased the overall Cmax and AUC of Zolpidem Tartrate Sublingual Tablets 3.5 mg by 42% and 19%, respectively, and increased the time to peak exposure (Tmax) to nearly 3 hours. For optimal effect, Zolpidem Tartrate Sublingual Tablets should not be administered with or immediately after a meal.
Distribution
Based on data obtained with oral zolpidem, the total protein binding was found to be 93% ± 0.1% and remained constant independent of concentration between 40 ng/mL and 790 ng/mL.
Metabolism
Based on data obtained with oral zolpidem, zolpidem tartrate is converted to inactive metabolites that are eliminated primarily by renal excretion.
Elimination
The elimination half-life of a single dose of a 3.5 mg Zolpidem Tartrate Sublingual Tablet is approximately 2.5 hours (range 1.4 to 3.6 hours).
Special Populations
Elderly: The recommended dose for Zolpidem Tartrate Sublingual Tablets is 1.75 mg. A pharmacokinetic study of 1.75 mg and 3.5 mg doses of Zolpidem Tartrate Sublingual Tablets showed that the plasma Cmax and AUC0-4hr in elderly subjects following the 3.5 mg dose was higher by 34% and 30%, respectively, than the non-elderly subjects. The Cmax and AUC of 1.75 mg in elderly subjects were consistently lower than those observed for the 3.5 mg dose in non-elderly subjects but consistently higher than the 1.75 mg dose in non-elderly subjects. The elimination half-life remained unchanged.
Hepatic Impairment: The pharmacokinetics of oral zolpidem tartrate in eight patients with chronic hepatic insufficiency were compared to results in subjects with normal hepatic function. Following a single 20 mg oral zolpidem tartrate dose, mean Cmax and AUC were found to be two times (250 ng/mL vs. 499 ng/mL) and five times (788 ng·hr/mL vs. 4203 ng·hr/mL) higher, respectively, in hepatically compromised patients compared to subjects with normal hepatic function. Tmax did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in subjects with normal hepatic function of 2.2 hr (range: 1.6 to 2.4 hr). Dosing should be modified accordingly in patients with hepatic insufficiency [see Dosage and
Administration (2.5)].
Renal Impairment: The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage renal failure (mean ClCr = 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for Cmax, Tmax, half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally-impaired patients. No dosage adjustment is necessary in patients with renal impairment.
Drug Interactions
CNS-depressants
Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1)]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration.
An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1)].
Following five consecutive nightly doses at bedtime of oral zolpidem tartrate 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem Cmax was significantly higher (43%) and Tmax was significantly decreased (-53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem.
A single-dose interaction study with zolpidem tartrate 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine were given at steady state and the concentrations evaluated in healthy females, an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance.
Drugs that Affect Drug Metabolism via Cytochrome P450
Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes on the pharmacokinetics of zolpidem is unknown.
A single-dose interaction study with zolpidem tartrate 10 mg and itraconazole 200 mg at steady-state levels in male volunteers resulted in a 34% increase in AUC0-∞ of zolpidem tartrate. There were no pharmacodynamic effects of zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance.
A single-dose interaction study with zolpidem tartrate 10 mg and rifampin 600 mg at steady-state levels in female subjects showed significant reductions of the AUC (-73%), Cmax (-58%), and T1/2 (-36 %) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem tartrate. Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem.
A single-dose interaction study with zolpidem tartrate 5 mg and ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem (30%) and the total AUC of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30 %) along with an increase in the pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.
Other Drugs with No Interactions with Zolpidem
A study involving cimetidine/zolpidem tartrate and ranitidine/zolpidem tartrate combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.
Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects.
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
water, propylene glycol, cocamidopropyl betaine, PEG-7 glyceryl cocoate, fragrance, benzyl alcohol, methylchloroisothiazolinine, methylisothiazolinone, tetrasodium EDTA, PEG-40 hydrogenated castor oil, cetrimonium chloride, citric acid, aloe vera extract, tocopherol acetate
Close LUCKY SUPERSOFT WET WIPES (Benzalkonium Chloride) Cloth [Delta Brands, Inc]In case of overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children.
Other Information
Store in cool, dry place out of direct sunlight.
Do not use if neck wrap is broken or missing.
Close RELIEF-TONE (Arnica Montana, Belladonna, Cortisone Aceticum, Hypericum Perforatum, Symphytum Officinale) Liquid [Energetix Corp]MEDICATION GUIDE
Raloxifene Hydrochloride (ral-OX-i-FEEN HYE-droe-KLOR-ide) Tablets USP for Oral Use
Read the Medication Guide that comes with raloxifene hydrochloride tablets before you start taking them and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene hydrochloride tablets when you start taking them and at regular checkups.
What is the most important information I should know about raloxifene hydrochloride tablets?
Serious and life-threatening side effects can occur while taking raloxifene hydrochloride tablets. These include blood clots and dying from stroke:
What are raloxifene hydrochloride tablets?
Raloxifene hydrochloride tablets are a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Raloxifene hydrochloride tablets are for women after menopause, and has more than one use:
Raloxifene hydrochloride tablets are not for use in premenopausal women (women who have not passed menopause).
Who should not take raloxifene hydrochloride tablets?
Do not take raloxifene hydrochloride tablets if you:
What should I tell my doctor before taking raloxifene hydrochloride tablets?
Raloxifene hydrochloride tablets may not be right for you. Before taking raloxifene hydrochloride tablets, tell your doctor about all your medical conditions, including if you:
Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. Especially tell your doctor if you take:
Raloxifene hydrochloride tablets should not be taken with cholestyramine or estrogens.
How should I take raloxifene hydrochloride tablets?
What should I avoid while taking raloxifene hydrochloride tablets?
What are the possible side effects of raloxifene hydrochloride tablets?
Serious and life-threatening side effects can occur while taking raloxifene hydrochloride tablets. These include blood clots and dying from stroke:
See “What is the most important information I should know about raloxifene hydrochloride tablets?”
The most common side effects of raloxifene hydrochloride tablets are hot flashes, leg cramps, swelling of the feet, ankles, and legs, flu syndrome, joint pain, and sweating. Hot flashes are more common during the first 6 months after starting treatment.
These are not all the side effects of raloxifene hydrochloride tablets. Tell your doctor about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking raloxifene hydrochloride tablets, ask your doctor or pharmacist for more information.
What else should I know about raloxifene hydrochloride tablets?
How should I store raloxifene hydrochloride tablets?
General Information about the safe and effective use of raloxifene hydrochloride tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use raloxifene hydrochloride tablets for a condition for which they were not prescribed. Do not give your raloxifene hydrochloride tablets to other people, even if they have the same symptoms you have. They may harm them.
This Medication Guide is a summary of the most important information about raloxifene hydrochloride tablets. If you would like more information about raloxifene hydrochloride tablets, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene hydrochloride tablets that is written for health professionals. For more information, call the AvKARE Customer Response Line at 1-855-361-3993.
What are the ingredients in raloxifene hydrochloride tablets?
Active Ingredient: raloxifene hydrochloride
Inactive Ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of AvKARE, Inc.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. C 06/12
AV 10/14 (P)
Rev. D 8/2014
Close RALOXIFENE HYDROCHLORIDE (Raloxifene Hydrochloride) Tablet, Film Coated [AvKARE, Inc.]croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Close PAIN RELIEF EXTRA STRENGTH (Acetaminophen) Tablet [VALUE MERCHANDISERS COMPANY, INC.]
Frovatriptan Succinate Tablets
Read this Patient Information before you start taking frovatriptan succinate and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor. You and your doctor should discuss frovatriptan succinate when you start taking your medication and at regular check-ups.
What is frovatriptan succinate?
Frovatriptan succinate is a prescription medicine used to treat migraine headaches with or without aura in adults.
Frovatriptan succinate is not used to treat other types of headaches.
Frovatriptan succinate is not used to prevent or decrease the number of migraine headaches.
It is not known if frovatriptan succinate is safe and effective to treat cluster headaches.
It is not known if frovatriptan succinate is safe and effective in children under 18 years of age.
Who should not take frovatriptan succinate?
Do not take frovatriptan succinate if you have:
What should I tell my doctor before taking frovatriptan succinate?
Before you take frovatriptan succinate, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take:
These medicines may affect how frovatriptan succinate works, or frovatriptan succinate may affect how these medicines work.
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I take frovatriptan succinate?
What should I avoid while taking frovatriptan succinate?
Frovatriptan succinate can cause dizziness, weakness, or drowsiness. If you have these symptoms do not drive a car, use machinery, or do anything where you need to be alert.
What are the possible side effects of frovatriptan succinate?
Frovatriptan succinate can cause serious side effects.
Call your doctor right away if you have any of the following symptoms after taking frovatriptan succinate:
The most common side effects of frovatriptan succinate are:
Tell your doctor about any symptoms that you develop while taking frovatriptan succinate.
This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.
How should I store frovatriptan succinate?
Store frovatriptan succinate at 68° to 77°F (20° to 25°C). Protect frovatriptan succinate from moisture. Discard after expiration date printed on package.
Keep frovatriptan succinate and all medicines out of the reach of children.
General advice about the safe and effective use of frovatriptan succinate.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use frovatriptan succinate for a condition for which it was not prescribed. Do not give frovatriptan succinate to other people, even if they have the same symptoms as you. People may be harmed if they take medicines that have not been prescribed for them.
This leaflet summarizes the most important information about frovatriptan succinate. If you would like more information about frovatriptan succinate, talk to your doctor. You can ask your doctor or pharmacist for information on frovatriptan succinate that is written for healthcare professionals. You can also call Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115.
What are the Ingredients in frovatriptan succinate?
Active ingredient: frovatriptan succinate
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (potato), talc, titanium dioxide and triacetin.
Manufactured by:
Glenmark Pharmaceuticals Ltd.
Plot No. 2, Phase-2, Pharma Zone SEZ
Pithampur, Dist.-Dhar
Madhya Pradesh 454775, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1(888)721-7115
http://ift.tt/1RAu82r
July 2015
Trademarks are the property of their respective owners.
Close FROVATRIPTAN SUCCINATE Tablet, Film Coated [Glenmark Pharmaceuticals Inc., USA]This product contains acetaminophen. Severe liver damage may occur if you take:
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Alcohol warning: if the user consumes 3 or more alcoholic drinks every day, ask your doctor whether the user should take acetaminophen or other pain reliever/fever reducers.
Do not use
Ask a doctor before use if the user has liver disease.
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
iIn case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms.
Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
ANTISEPTIC TOWELETTE (Benzalkonium Chloride) Liquid [Med-Nap LLC]exchange✓select™
Compare To The Active Ingredients
of Tylenol® Cold Multi-Symptom
Daytime & Nighttime*
Pseudoephedrine Free
COLD
MULTI-SYMPTOM
DAYTIME Non-Drowsy
Acetaminophen {Pain reliever
Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
12 Caplets
Actual Size
NIGHTTIME
Acetaminophen {Pain reliever
Fever Reducer
Chlorpheniramine maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
12 Caplets
Actual Size
Cool Blast Flavor
24 Total Cool Caplets
✓quality
value
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare,
owner of the registered trademark Tylenol® Cold Multi-Symptom Daytime and
Nighttime.
50844 REV0213.470/0113.473H08
Exchange Select 44-470C473
Close COLD MULTI-SYMPTOM (Acetaminophen, Chlorpehniramine Hcl, Dextromethorphan Hbr, Phenylephrine Hcl) Kit [ARMY AND AIR FORCE EXCHANGE SERVICE]Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Benazepril hydrochloride has been evaluated for safety in over 6,000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in benazepril hydrochloride and placebo patients.
The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 mg to 80 mg.
Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with benazepril hydrochloride and in 3% of patients treated with placebo. The most common reasons for discontinuation were headache (0.6%) and cough (0.5%).
Adverse reactions seen in at least 1% greater frequency in patients treated with benazepril hydrochloride than placebo were headache (6% vs 4%), dizziness (4% vs 2%), somnolence (2% vs 0%) and postural dizziness (2% vs 0%). Adverse reactions reported in controlled clinical trials (less than 1% more on benazepril than on placebo), and rarer events seen in post-marketing experience, include the following (in some, a causal relationship to drug use is uncertain):
Dermatologic
Stevens-Johnson syndrome, pemphigus, apparent hypersensitivity reactions (manifested by dermatitis, pruritus, or rash), photosensitivity, and flushing.
Gastrointestial
Nausea, pancreatitis, constipation, gastritis, vomiting, and melena.
Hematologic
Thrombocytopenia and hemolytic anemia.
Neurologic/Psychiatric
Anxiety, decreased libido, hypertonia, insomnia, nervousness, and paresthesia.
Other
Fatigue, asthma, bronchitis, dyspnea, sinusitis, urinary tract infection, frequent urination, infection, arthritis, impotence, alopecia, arthralgia, myalgia, asthenia, sweating.
Laboratory Abnormalities
Elevations of uric acid, blood glucose, serum bilirubin, and liver enzymes [see WARNINGS AND PRECAUTIONS (5)] have been reported, as have incidents of hyponatremia, electrocardiographic changes, eosinophilia, and proteinuria.
Close BENAZEPRIL HYDROCHLORIDE Tablet, Film Coated [Preferred Pharmaceuticals Inc.]1. Gupta N, Ahmed I, Nissel-Horowitz S, Patel D, Mehrotra B. Intravenous gammaglobulin-associated acute renal failure. Am J Hematol 2001; 66:151-152.
2. Cayco, A.V., M.A. Perazella, and J.P. Hayslett. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-1794.
3. Steinberger BA, Ford SM, Coleman TA. Intravenous immune globulin therapy results in post-infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia. Am J Hematol 2003; 73:97-100.
4. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994; 44:223-226.
5. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986; 2:217-218.
6. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000; 65:30-34.
7. Casteels-Van Daele, M., et al. Intravenous immune globulin and acute aseptic meningitis [letter]. N Engl J Med 1990; 323:614-615.
8. Kato, E., et al. Administration of immune globulin associated with aseptic meningitis [letter]. Jama 1988; 259:3269-3271.
9. Scribner, C.L., et al. Aseptic meningitis and intravenous immunoglobulin therapy [editorial, comment]. Ann Intern Med 1994; 121:305-306.
10. Copelan EA, Stohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986; 26:410-412.
11. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig. Blood 1993; 15:3789.
12. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle and Nerve 1997; 20:1142-1145.
13. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmune 1999; 13:129-135.
14. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 41:264-268.
15. Siber GA, Werner BG, Halsey NA, et al. Interference of immune globulin with measles and rubella immunization. J Pediatr 1993; 122:204-211.
16. Salisbury D, Ramsay M, Noakes K, eds. Immunisation against infectious disease. The Stationery Office (TSO), London: UK Department of Health; 2009:426.
17. Hammarstrom L, Smith CIE. Placental transfer of intravenous immunoglobulin. Lancet 1986; 1:681.
18. Sidiropoulos D, Herrmann U, Morell A, von Muralt G, Barandun S. Transplacental passage of intravenous immunoglobulin in the last trimester of pregnancy. J Pediatr 1986; 109:505-508.
19. Skvaril F. Qualitative and quantitative aspects of IgG subclasses in i.v. immunoglobulin preparations. In: Nydegger UE, ed. Immunotherapy. London: Academic Press; 1981:118-122.
20. French M. Serum IgG subclasses in normal adults. Monogr Allergy 1986, 19:100-107.
Close BIVIGAM (Human Immunoglobulin G) Injection, Solution [KEDRION BIOPHARMA, INC.]For External Use Only.
Do not use:
On wounds or damaged skin
With a heating pad
On children under 12 years of age with arthritis-like conditions
Ask a doctor before use if:
You have redness over the affected area
When using this product:
Avoid contact eith eyes or mucous membranes
Do not bandage tightly
Stop use and ask a Doctor if:
Contiditon worsens or symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Excessive skin irritation occurs
Close CAREALL MUSLE AND JOINT (Menthol) Gel [New World Imports, Inc]cyclopentasiloxane, stearyl alcohol, C12-15 alkyl benzoate, PPG-14 butyl ether, cyclodextrin, petrolatum, phenyl trimethicone, hydrogenated castor oil, talc, fragrance, ozokerite, behenyl alcohol, panthenyl triacetate, tocopheryl acetate, acetyl glucosamine
Close SECRET OUTLAST INVISIBLE SPORT FRESH (Aluminum Zirconium Tetrachlorohydrex Gly) Stick [Procter Gamble Manufacturing Company]General view of box content of labeling
Caja con cambios Keractil Plus.jpg
Representative sample image of carton/container label
Keractil Fondo gris.jpg
Information shown both on container label and package
Active Ingredients- Keractil plus.jpg
Infiomaion shown both on content of label and package
Inactive ingredients.jpg
Information shown both on container label and package
Purpose.jpg
Ibformation shown both on container label and package
Directions.jpg
Information shown both on container label and package
Dosage and administration.jpg
Information shown both on cintainer label and package
Warnings.jpg
Information shown both on cobtainer label and package
Keep out of reach of children.jpg
Information shown both on container label and package
Questions Keractil Plus.jpg
Ibformation shown both on container label and package
Other information Keractil plus.jpg
| Patient Information IMBRUVICA (im-BRU-vih-kuh) (ibrutinib) capsules |
|||
| What is IMBRUVICA? | |||
| IMBRUVICA is a prescription medicine used to treat people with: | |||
|
|||
| It is not known if IMBRUVICA is safe and effective in children. | |||
| What should I tell my healthcare provider before taking IMBRUVICA? | |||
| Before you take IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you: | |||
|
|||
|
|||
|
|||
| Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects. | |||
| How should I take IMBRUVICA? | |||
|
|||
| What should I avoid while taking IMBRUVICA? | |||
|
|||
| What are the possible side effects of IMBRUVICA? | |||
| IMBRUVICA may cause serious side effects, including: | |||
|
|||
|
|
||
|
|||
| The most common side effects of IMBRUVICA include: | |||
|
|
||
| Diarrhea is a common side effect in people who take IMBRUVICA. Drink plenty of fluids during treatment with IMBRUVICA to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away. | |||
| These are not all the possible side effects of IMBRUVICA. | |||
| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
| How should I store IMBRUVICA? | |||
|
|||
| Keep IMBRUVICA and all medicines out of the reach of children. | |||
| General information about the safe and effective use of IMBRUVICA | |||
| Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals. | |||
| What are the ingredients in IMBRUVICA? | |||
| Active ingredient: ibrutinib | |||
| Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, and black ink. | |||
| Distributed and Marketed by: Pharmacyclics LLC Sunnyvale, CA USA 94085 | |||
| Marketed by: Janssen Biotech, Inc. Horsham, PA USA 19044. For more information call 1-877-877-3536. | |||
| © Pharmacyclics LLC 2015 | |||
| © Janssen Biotech, Inc. 2015 | |||
| This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 03/2016 | ||
water, dicaprylyl ether, cetearyl alcohol, glycerin, neopentyl glycol diethylhexanoate, dimethicone, methyl gluceth-20, aluminum starch octenylsuccinate, ceteth-10 phosphate, dicetyl phosphate, steareth-20, steareth-2, neopentyl glycol diisostearate, sodium benzoate, fragrance, sodium hydroxide, disodium EDTA, xanthan gum, magnesium aluminum silicate, BHT, citrus grandis (grapefruit) fruit extract
Close NEUTROGENA OIL FREE ACNE MOISTURIZER PINK GRAPEFRUIT (Salicylic Acid) Lotion [Johnson Johnson Consumer Inc.]Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
liver disease
taking the blood thinning drug warfarin
do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc
Close COMPLETE DUAL ACTION (Famotidine, Calcium Carbonate And Magnesium Hydroxide) Tablet, Chewable [HyVee Inc]When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
Patients with Major Depressive Disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with Major Depressive Disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 2.
Table 2: Suicidality per 1000 Patients Treated
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for Major Depressive Disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms [see Warnings and Precautions (5.15)].
Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for fluoxetine should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
It should be noted that fluoxetine is approved in the pediatric population for Major Depressive Disorder and Obsessive Compulsive Disorder.
Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules. However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including fluoxetine, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St.John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of fluoxetine with MAOIs intended to treat psychiatric disorders is contraindicated. Fluoxetine should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking fluoxetine. Fluoxetine should be discontinued before initiating treatment with the MAOI [see Contraindications (4.1) andDosage and Administration (2.9, 2.10)].
If concomitant use of fluoxetine with other serotonergic drugs, i.e., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with fluoxetine and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
In US fluoxetine clinical trials, 7% of 10,782 patients developed various types of rashes and/or urticaria. Among the cases of rash and/or urticaria reported in premarketing clinical trials, almost a third were withdrawn from treatment because of the rash and/or systemic signs or symptoms associated with the rash. Clinical findings reported in association with rash include fever, leukocytosis, arthralgias, edema, carpal tunnel syndrome, respiratory distress, lymphadenopathy, proteinuria, and mild transaminase elevation. Most patients improved promptly with discontinuation of fluoxetine and/or adjunctive treatment with antihistamines or steroids, and all patients experiencing these reactions were reported to recover completely.
In premarketing clinical trials, 2 patients are known to have developed a serious cutaneous systemic illness. In neither patient was there an unequivocal diagnosis, but one was considered to have a leukocytoclastic vasculitis, and the other, a severe desquamating syndrome that was considered variously to be a vasculitis or erythema multiforme. Other patients have had systemic syndromes suggestive of serum sickness.
Since the introduction of fluoxetine, systemic reactions, possibly related to vasculitis and including lupus-like syndrome, have developed in patients with rash. Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions.
Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported.
Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom.
Whether these systemic reactions and rash have a common underlying cause or are due to different etiologies or pathogenic processes is not known. Furthermore, a specific underlying immunologic basis for these reactions has not been identified. Upon the appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified, fluoxetine should be discontinued.
A major depressive episode may be the initial presentation of Bipolar Disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for Bipolar Disorder. Whether any of the symptoms described for clinical worsening and suicide risk represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder; such screening should include a detailed psychiatric history, including a family history of suicide, Bipolar Disorder, and depression. It should be noted that fluoxetine and olanzapine in combination is approved for the acute treatment of depressive episodes associated with Bipolar I Disorder [see Warnings and Precautions section of the package insert for Symbyax]. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
In US placebo-controlled clinical trials for Major Depressive Disorder, mania/hypomania was reported in 0.1% of patients treated with fluoxetine and 0.1% of patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with Major Affective Disorder treated with other marketed drugs effective in the treatment of Major Depressive Disorder [see Usein Specific Populations (8.4)].
In US placebo-controlled clinical trials for OCD, mania/hypomania was reported in 0.8% of patients treated with fluoxetine and no patients treated with placebo. No patients reported mania/hypomania in US placebo-controlled clinical trials for bulimia. In US fluoxetine clinical trials, 0.7% of 10,782 patients reported mania/hypomania [see Use in Specific Populations (8.4)].
In US placebo-controlled clinical trials for Major Depressive Disorder, convulsions (or reactions described as possibly having been seizures) were reported in 0.1% of patients treated with fluoxetine and 0.2% of patients treated with placebo. No patients reported convulsions in US placebo-controlled clinical trials for either OCD or bulimia. In US fluoxetine clinical trials, 0.2% of 10,782 patients reported convulsions. The percentage appears to be similar to that associated with other marketed drugs effective in the treatment of Major Depressive Disorder. Fluoxetine should be introduced with care in patients with a history of seizures.
Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with fluoxetine.
In US placebo-controlled clinical trials for Major Depressive Disorder, 11% of patients treated with fluoxetine and 2% of patients treated with placebo reported anorexia (decreased appetite). Weight loss was reported in 1.4% of patients treated with fluoxetine and in 0.5% of patients treated with placebo. However, only rarely have patients discontinued treatment with fluoxetine because of anorexia or weight loss [see Use in Specific Populations (8.4)].
In US placebo-controlled clinical trials for OCD, 17% of patients treated with fluoxetine and 10% of patients treated with placebo reported anorexia (decreased appetite). One patient discontinued treatment with fluoxetine because of anorexia [see Use in Specific Populations (8.4)].
In US placebo-controlled clinical trials for Bulimia Nervosa, 8% of patients treated with fluoxetine 60 mg and 4% of patients treated with placebo reported anorexia (decreased appetite). Patients treated with fluoxetine 60 mg on average lost 0.45 kg compared with a gain of 0.16 kg by patients treated with placebo in the 16-week double-blind trial. Weight change should be monitored during therapy.
SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants may add to this risk. Case reports and epidemiological studies (case control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding reactions related to SNRIs and SSRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation [see Drug Interactions (7.4)].
Angle-Closure Glaucoma — The pupillary dilation that occurs following use of many antidepressant drugs including fluoxetine may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hyponatremia has been reported during treatment with SNRIs and SSRIs, including fluoxetine. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported and appeared to be reversible when fluoxetine was discontinued. Elderly patients may be at greater risk of developing hyponatremia with SNRIs and SSRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk [see Use in Specific Populations (8.5)]. Discontinuation of fluoxetine should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death.
In US placebo-controlled clinical trials for Major Depressive Disorder, 12% to 16% of patients treated with fluoxetine and 7% to 9% of patients treated with placebo reported anxiety, nervousness, or insomnia.
In US placebo-controlled clinical trials for OCD, insomnia was reported in 28% of patients treated with fluoxetine and in 22% of patients treated with placebo. Anxiety was reported in 14% of patients treated with fluoxetine and in 7% of patients treated with placebo.
In US placebo-controlled clinical trials for Bulimia Nervosa, insomnia was reported in 33% of patients treated with fluoxetine 60 mg, and 13% of patients treated with placebo. Anxiety and nervousness were reported, respectively, in 15% and 11% of patients treated with fluoxetine 60 mg and in 9% and 5% of patients treated with placebo.
Among the most common adverse reactions associated with discontinuation (incidence at least twice that for placebo and at least 1% for fluoxetine in clinical trials collecting only a primary reaction associated with discontinuation) in US placebo-controlled fluoxetine clinical trials were anxiety (2% in OCD), insomnia (1% in combined indications and 2% in bulimia), and nervousness (1% in Major Depressive Disorder) [see Table 5].
Post-marketing cases of QT interval prolongation and ventricular arrhythmia including Torsades dePointes have been reported in patients treated with fluoxetine. Fluoxetine should be used with caution in patients with congenital long QT syndrome; a previous history of QT prolongation; a family history of long QT syndrome or sudden cardiac death; and other conditions that predispose to QT prolongation and ventricular arrhythmia. Such conditions include concomitant use of drugs that prolong the QT interval; hypokalemia or hypomagnesemia; recent myocardial infarction, uncompensated heart failure, bradyarrhythmias, and other significant arrhythmias; and conditions that predispose to increased fluoxetine exposure (overdose, hepatic impairment, use of CYP2D6 inhibitors, CYP2D6 poor metabolizer status, or use of other highly protein-bound drugs). Fluoxetine is primarily metabolized by CYP2D6 [see Contraindications (4.2), Drug Interactions (7.7, 7.8), Overdose (10.1), and Clinical Pharmacology (12.3)].
Pimozide and thioridazine are contraindicated for use with fluoxetine. Avoid the concomitant use of drugs known to prolong the QT interval. These include specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol,); specific antibiotics (e.g.,erythromycin, gatifloxacin, moxifloxacin, sparfloxacin); Class 1A antiarrhythmic medications (e.g., quinidine, procainamide); Class III antiarrhythmics (e.g., amiodarone, sotalol); and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus) [see Drug Interactions (7.7, 7.8) and Clinical Pharmacology (12.3)].
Consider ECG assessment and periodic ECG monitoring if initiating treatment with fluoxetine in patients with risk factors for QT prolongation and ventricular arrhythmia. Consider discontinuing fluoxetine and obtaining a cardiac evaluation if patients develop signs or symptoms consistent with ventricular arrhythmia.
Clinical experience with fluoxetine in patients with concomitant systemic illness is limited. Caution is advisable in using fluoxetine in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
Cardiovascular — Fluoxetine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were systematically excluded from clinical studies during the product’s premarket testing. However, the electrocardiograms of 312 patients who received fluoxetine in double-blind trials were retrospectively evaluated; no conduction abnormalities that resulted in heart block were observed. The mean heart rate was reduced by approximately 3 beats/min.
Glycemic Control — In patients with diabetes, fluoxetine may alter glycemic control. Hypoglycemia has occurred during therapy with fluoxetine, and hyperglycemia has developed following discontinuation of the drug. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic, dosage may need to be adjusted when therapy with fluoxetine is instituted or discontinued.
As with any CNS-active drug, fluoxetine has the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma for several weeks, affecting both strategies for titration to final dose and withdrawal from treatment. This is of potential consequence when drug discontinuation is required or when drugs are prescribed that might interact with fluoxetine and norfluoxetine following the discontinuation of fluoxetine [see Clinical Pharmacology (12.3)].
During marketing of fluoxetine, SNRIs, and SSRIs, there have been spontaneous reports of adverse reactions occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these reactions are generally self-limiting, there have been reports of serious discontinuation symptoms. Patients should be monitored for these symptoms when discontinuing treatment with fluoxetine. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. Plasma fluoxetine and norfluoxetine concentration decrease gradually at the conclusion of therapy which may minimize the risk of discontinuation symptoms with this drug.
When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
