CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

[unable to retrieve full-text content]

Updated Date: Apr 25, 2016 EST CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

EQUALINE ANTACID (Calcium Carbonate) Tablet, Chewable [Supervalu Inc]

[unable to retrieve full-text content]

Updated Date: Apr 25, 2016 EST EQUALINE ANTACID (Calcium Carbonate) Tablet, Chewable [Supervalu Inc]

SIGNATURE CARE LICE TREATMENT (Piperonyl Butoxide, Pyrethrum Extract) Shampoo [Safeway]

[unable to retrieve full-text content]

Updated Date: Apr 25, 2016 EST SIGNATURE CARE LICE TREATMENT (Piperonyl Butoxide, Pyrethrum Extract) Shampoo [Safeway]

CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

Adverse Events Associated With Discontinuation of Treatment

Overall, the incidence of discontinuation due to adverse events was 17% in clonazepam compared to 9% for placebo in the combined data of two 6 to 9 week trials. The most common events (≥ 1%) associated with discontinuation and a dropout rate twice or greater for clonazepam than that of placebo included the following:

Adverse Events Occurring at an Incidence of 1% or More Among Clonazepam-Treated Patients

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6 to 9 week trials. Events reported in 1% or more of patients treated with clonazepam (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.

The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.

Treatment-Emergent Depressive Symptoms

In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term “depression” were reported in 7% of clonazepam-treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. In these same trials, adverse events classified under the preferred term “depression” were reported as leading to discontinuation in 4% of clonazepam-treated patients compared to 1% of placebo-treated patients. While these findings are noteworthy, Hamilton Depression Rating Scale (HAM-D) data collected in these trials revealed a larger decline in HAM-D scores in the clonazepam group than the placebo group suggesting that clonazepam-treated patients were not experiencing a worsening or emergence of clinical depression.

Other Adverse Events Observed During the Premarketing Evaluation of Clonazepam in Panic Disorder

Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with clonazepam at multiple doses during clinical trials. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and events reported only once and which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the events occurred during treatment with clonazepam, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency. These adverse events were reported infrequently, which is defined as occurring in 1/100 to 1/1000 patients.

Body as a Whole: weight increase, accident, weight decrease, wound, edema, fever, shivering, abrasions, ankle edema, edema foot, edema periorbital, injury, malaise, pain, cellulitis, inflammation localized

Cardiovascular Disorders: chest pain, hypotension postural

Central and Peripheral Nervous System Disorders: migraine, paresthesia, drunkenness, feeling of enuresis, paresis, tremor, burning skin, falling, head fullness, hoarseness, hyperactivity, hypoesthesia, tongue thick, twitching

Gastrointestinal System Disorders: abdominal discomfort, gastrointestinal inflammation, stomach upset, toothache, flatulence, pyrosis, saliva increased, tooth disorder, bowel movements frequent, pain pelvic, dyspepsia, hemorrhoids

Hearing and Vestibular Disorders: vertigo, otitis, earache, motion sickness

Heart Rate and Rhythm Disorders: palpitation

Metabolic and Nutritional Disorders: thirst, gout

Musculoskeletal System Disorders: back pain, fracture traumatic, sprains and strains, pain leg, pain nape, cramps muscle, cramps leg, pain ankle, pain shoulder, tendinitis, arthralgia, hypertonia, lumbago, pain feet, pain jaw, pain knee, swelling knee

Platelet, Bleeding and Clotting Disorders: bleeding dermal

Psychiatric Disorders: insomnia, organic disinhibition, anxiety, depersonalization, dreaming excessive, libido loss, appetite increased, libido increased, reactions decreased, aggressive reaction, apathy, attention lack, excitement, feeling mad, hunger abnormal, illusion, nightmares, sleep disorder, suicide ideation, yawning

Reproductive Disorders, Female: breast pain, menstrual irregularity

Reproductive Disorders, Male: ejaculation decreased

Resistance Mechanism Disorders: infection mycotic, infection viral, infection streptococcal, herpes simplex infection, infectious mononucleosis, moniliasis

Respiratory System Disorders: sneezing excessive, asthmatic attack, dyspnea, nosebleed, pneumonia, pleurisy

Skin and Appendages Disorders: acne flare, alopecia, xeroderma, dermatitis contact, flushing, pruritus, pustular reaction, skin burns, skin disorder

Special Senses Other, Disorders: taste loss

Urinary System Disorders: dysuria, cystitis, polyuria, urinary incontinence, bladder dysfunction, urinary retention, urinary tract bleeding, urine discoloration

Vascular (Extracardiac) Disorders: thrombophlebitis leg

Vision Disorders: eye irritation, visual disturbance, diplopia, eye twitching, styes, visual field defect, xerophthalmia

Let's block ads! (Why?)

CLONAZEPAM Tablet [NCS HealthCare Of KY, Inc Dba Vangard Labs]

EQUALINE ANTACID (Calcium Carbonate) Tablet, Chewable [Supervalu Inc]

To receive this label RSS feed

Copy the URL below and paste it into your RSS Reader application.

http://ift.tt/24qZnjk

To receive all DailyMed Updates for the last seven days

Copy the URL below and paste it into your RSS Reader application.

http://ift.tt/2111Ptd

What will I get with the DailyMed RSS feed?

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.

How to discontinue the RSS feed

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

Let's block ads! (Why?)

EQUALINE ANTACID (Calcium Carbonate) Tablet, Chewable [Supervalu Inc]

SIGNATURE CARE LICE TREATMENT (Piperonyl Butoxide, Pyrethrum Extract) Shampoo [Safeway]

Steps to Success

with 1-2-3 Lice Control System

Complete lice control for your family and home

Step 1: Treat

Lice Killing Shampoo

See Usage Guidelines to estimate how much product you will need.

Inspect

•

Check each household member with a magnifying glass in bright light for lice/nits (eggs).

•

Look for tiny nits near scalp, beginning at back of neck and behind ears.

•

Examine small sections of hair at a time.

•

Unlike dandruff which moves when touched, nits stick to the hair.

•

If either lice or nits are found, treat with this product.

NOTE:

•

Use towels to protect child's eyes from treatment and prevent clothes from getting wet.

•

Apply Lice Killing Shampoo thoroughly to DRY HAIR or other affected area.

•

Wetting the hair dilutes the treatment making it less effective.

•

Also, lice can hold their breath when immersed in water making it difficult for the active ingredient to penetrate the lice.

• For head lice, thoroughly massage shampoo into scalp, behind the ears and to the back of the neck. Lice can crawl up and down the shaft of the hair very quickly so it is important to apply the treatment from the roots to the ends of the hair.

• Allow product to remain on the hair (or other affected area) for 10 minutes, but no longer.

• Add warm water and massage to form a lather.

• Shampoo, then rinse thoroughly.

For head lice, towel dry hair and comb out tangles.

• Proceed to Step 2.

• A second treatment must be done in 7 to 10 days to kill any newly hatched lice.

Step 2: Remove

Lice & Egg Comb-Out Gel

This product should be used AFTER Lice Killing Shampoo (Step 1). Combing out eggs & nits* is an essential step to complete lice control.

See Usage Guidelines to estimate how much product you will need.

NOTE:

•

A fine-toothed comb or the special lice/nit removing comb (included) must be used to remove lice, eggs, and nits from hair.

•

Before starting have on hand:

-

Extra towels

-

Bobby pins or hair clips

-

Facial tissues or paper towels

-

Regular comb for parting and detangling hair

-

Throw-away gloves

•

Find a distraction for your child (e.g. books, TV, game).

•

Comb out damp hair with a regular wide-tooth comb to take out snarls and tangles.

• Apply Lice & Egg Comb-Out Gel to one section of hair. (Do not apply to entire head at once, since gel dries quickly.)

• Massage thoroughly until all strands of hair in this section are covered with the gel.

• When combing, use the fine-toothed lice/nit comb provided and make sure the teeth are facing you.

• Part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours.

• Lift a small strand of hair (about 1-2" wide) from the section with the gel.

• Begin combing in a "scooping" motion. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp, from the roots to the ends of the hair (newly-laid eggs are found near the roots of the hair so it is important to get the teeth very close to the scalp). Make sure the teeth are deeply embedded into the strands as you comb through.

• Always comb away from the head.

• Wipe eggs and nits from the teeth of the comb often with a tissue or paper towel.

• Remove any remaining nits by hand (using a throw-away glove).

• Pin back the strand you just finished combing with a bobby pin or hair clip.

• Lift up another 1-2 inch wide strand with gel and repeat the combing procedure.

• When one section with gel has been combed and pinned, apply Lice & Egg Comb-Out Gel to another section of hair. Continue to comb hair 1-2 inches at a time until entire head has been combed and pinned.

• Keep the hair damp during combing. If hair dries during combing, dampen slightly with water, and re-apply Lice & Egg Comb-Out Gel as needed.

• After you have combed and pinned the entire head, remove all bobby pins or hair clips and thoroughly recheck for lice/nits. Repeat combing if necessary. Rinse hair thoroughly with warm water. If desired, you may also wash with regular shampoo.

• Discard all the used tissues or cloths into a sealed plastic bag and dispose of immediately to prevent lice from coming back.

* Nits are empty eggshells left behind when lice hatch from eggs.

Step 3: Control

Home Lice, Bedbug & Dust Mite Spray

•

Use Home Lice, Bedbug & Dust Mite Spray to kill lice and their eggs on mattresses, furniture, car interiors and other non-washable items. A regular disinfectant spray will not kill lice and their eggs.

•

After spraying the infested area, vacuum rugs and carpets. Dispose of the vacuum cleaner bags after use.

•

Wash all clothes, towels, washable hats, scarves, coats and bed linens in hot water. Dry in high heat for at least 20 minutes.

•

Dry clean non-washables.

•

Personal combs and brushes may be disinfected by soaking in hot water (above 54°C (130°F)) for at least 10 minutes.

•

Place stuffed toys in plastic bags and seal them for 4 weeks.

Checklist

Daily Checking

TO PREVENT REINFESTATION:

• Carefully inspect infested family member daily for at least 2 weeks. If you see eggs or nits, repeat Step 2.

• Check other family members for Head Lice. If anyone in the family is infested, follow Step 1 and Step 2. Repeat Step 3 with any articles or items with which they have come into contact.

Second Application

Repeat the same procedures within 7-10 days for

Step 1: Treat and Step 2: Remove

There may be some eggs that were not combed out after the first treatment. These eggs will hatch and need to be killed with the second treatment.

If infestation continues, see a doctor for other treatments.

Did You Know?

Head Lice

•

Lay small white eggs (nits) on hair shaft close to scalp.

•

Nits are most easily found on back of neck or behind ears.

•

Disinfect hats, hair ribbons, scarves, coats, towels, and bed linens by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes.

•

Items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again.

•

Items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose.

•

Soak all combs and brushes in hot water (above 54°C (130°F)) for at least 10 minutes.

•

Vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people.

Pubic (Crab) Lice

•

May be transmitted by sexual contact. Sexual partners should be treated simultaneously to avoid reinfestation.

•

Lice are very small and look like brown or grey dots on skin.

•

Usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface.

•

May be present on the short hairs of groin, thighs, trunk, and underarms, and occasionally on the beard and mustache.

•

Disinfect underwear by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes.

Body Lice

•

Body lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area.

•

Body lice feed on skin then return to clothing to lay their eggs.

•

Disinfect clothing by machine washing in hot water (above 54°C (130°F)), then using hottest dryer cycle for at least 20 minutes.

•

Do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days.

Save this insert for future reference

DISTRIBUTED BY

PERRIGO

10100 00 J1

Keep carton for important product information.

Lice Killing Shampoo

Drug Facts

Active ingredients

Piperonyl butoxide 4%

Pyrethrum extract

(equivalent to 0.33% pyrethrins)

Purpose

Lice treatment

Uses

treats head, pubic (crab), and body lice

Warnings

For external use only

Do not use

•

near eyes

•

inside nose, mouth, or vagina

•

on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask a doctor before use if you are

•

allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

When using this product

•

keep eyes tightly closed and protect eyes with a washcloth or towel

•

if product gets in eyes, flush with water right away

•

scalp itching or redness may occur

Stop use and ask a doctor if

•

breathing difficulty occurs

•

eye irritation occurs

•

skin or scalp irritation continues or infection occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

•

Important: Read warnings before use

Other information

•

store at 20-25°C (68-77°F)

Inactive ingredients

benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, purified water, xanthan gum

Questions {or comments}?

Lice & Egg Comb-Out Gel

Product Information

Use

to make egg and nit removal from the hair faster and easier

Warnings

For external use only. Keep out of reach of children.

Ingredients

purified water, glycerin, hydroxyethylcellulose, PG-hydroxyethylcellulose cocodimonium chloride, polysorbate 20, DMDM hydantoin, fragrance, iodopropynyl butylcarbamate

Store at 20-25°C (68-77°F)

Home Lice, Bedbug & Dust Mite Spray

Not for use on humans

ACTIVE INGREDIENT:

†Cis/trans ratio: Max. 55% (+/-) cis and Min. 45% (+/-) trans.

††Contains petroleum distillate

FIRST AID

If on skin or clothing:

•

Take off contaminated clothing.

•

Rinse skin immediately with plenty of water for 15-20 minutes.

•

Call a poison control center or doctor for treatment advice.

If in eyes:

•

Hold eye open and rinse slowly and gently with water for 15-20 minutes.

•

Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.

•

Call a poison control center or doctor for treatment advice.

HOT LINE NUMBER

Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For additional information on this product (including health concerns, medical emergencies or pesticide incidents), you may call 1-800-222-1222.

NOTE TO PHYSICIAN

Contains petroleum distillate – vomiting may cause aspiration pneumonia.

PRECAUTIONARY STATEMENTS

Hazards To Humans & Domestic Animals

CAUTION: Harmful if absorbed through skin. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, or using tobacco or the toilet. Remove and wash contaminated clothing before reuse.

PHYSICAL OR CHEMICAL HAZARDS

Contents under pressure. Do not use or store near heat or open flame. Do not puncture or incinerate container. Exposure to temperatures above 130°F (54°C) may cause bursting.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Use Restrictions:

•

Do not allow adults, children, or pets to enter until vapors, mists and aerosols have dispersed, and the treated area has been thoroughly ventilated.

•

Do not allow adults, children, or pets to enter the treated area until sprays have dried.

•

In the home, all food processing surfaces and utensils should be covered during treatment or thoroughly washed before use. Exposed food should be covered or removed.

•

Remove pets, birds and cover any water inhabited by fish (such as aquariums and ornamental fish ponds) before application. Turnoff aquarium filtering systems before spraying and wait approximately 15 minutes after application before turning the filter back on.

•

This product is not for use on humans. If lice infestations should occur on humans, use a product labeled for use on humans.

•

Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application.

•

Not for broadcast use on indoor residential surfaces.

SHAKE WELL BEFORE USING

Remove protective cap. Hold container upright with nozzle away from you. Depress valve and spray from a distance of 8-10 inches (12 to 15 inches for baseboards, moldings and floors). Test product on an inconspicuous area before applying to check for possible staining or discoloration. Inspect again after drying. Spray to the point of dampness but not run-off. Over application may cause damage. Will not stain surfaces or fabrics where water alone causes no damage.

To kill Lice and Louse eggs: Clean home. Use this product for non-washable items. Washables should be washed in hot water and dried in high heat. Spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Hold container upright with nozzle away from you. Depress valve and spray from a distance of 8 to 10 inches. Spray each square foot for three seconds. Spray to the point of dampness but not run-off. Allow all sprayed articles to dry thoroughly before use. If lice infestation occurs on humans, use a product labeled for use on humans. Spray only those articles and parts of bedding including mattresses and furniture that cannot be either laundered or dry-cleaned. Do not use on sheets or pillowcases.

Bedbugs: Spray mattresses, particularly around tufts and seams. Take beds apart and spray into all joints. Treat baseboards, moldings and floors. Spray to the point of dampness but not run-off. After mattress is dry, cover with mattress cover and sheet. Do not use mattress without cover. Retreat if infestation occurs, but not more than once every two weeks.

To kill House Dust Mites (Dermatophagoides spp.) a multi-use lice spray controls house dust mites that may cause asthma, hay fever, rhinitis, watery eyes and sneezing. One treatment lasts for up to 8 weeks. On Upholstered Furniture – test fabric in an inconspicuous area to insure dyes will not bleed. Spray all fabric surfaces until damp. Do not use on delicate fabrics. Allow furniture to dry thoroughly before using. On Carpets – Spray over entire carpet until damp. Hold nozzle approximately 12 to 18 inches from the carpet surface and spray in a sweeping motion. Use an overlapping pattern to insure total coverage. After application, brush the surface of the carpet with a broom or brush to insure deep penetration. Allow carpet to dry thoroughly before reentering the treated area. Drying time can be accelerated by using a fan. On Mattresses – Spray the top, bottom and sides of mattresses until damp, paying particular attention to tufts and seams. Allow to dry thoroughly before using. After mattress is dry, cover with mattress cover and sheet. Do not use mattress without cover. Vacuum entire area once dry. Since vacuuming stirs dust up in the air those with allergies should have another person vacuum or should wear a dust mask and use vacuum with a high efficiency particulate (HEPA) filter.

STORAGE AND DISPOSAL

Do not contaminate water, food or feed by storage or disposal.

Storage: Store in a cool, dry area away from children and pets and away from heat, sparks and open flame. Do not transport or store below 32°F (0°C).

Pesticide Disposal and Container Handling: Do not puncture or incinerate.

If empty: Place in trash or offer for recycling if available.

If partly filled: Call your local solid waste agency or 1-800-CLEANUP (253-2687) for disposal instructions.

To the extent consistent with applicable law, purchaser assumes all responsibility for safety and use not in accordance with directions.

See carton for EPA numbers.

Close

Let's block ads! (Why?)

SIGNATURE CARE LICE TREATMENT (Piperonyl Butoxide, Pyrethrum Extract) Shampoo [Safeway]

MECLIZINE HYDROCHLORIDE Tablet [Unit Dose Services]

The Meclizine Hydrochloride Tablets, 25mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when meclizine is administered to a nursing woman.

Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetic of meclizine has not been evaluated. As meclizine undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with meclizine should be administered with caution in patients with hepatic impairment.

Renal Impairment

The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Due to a potential for drug/metabolite accumulation, meclizine should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age.

Drug Interactions

There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives. (see WARNINGS).

Based on evaluation, meclizine is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors. in-vitro

Close

Let's block ads! (Why?)

MECLIZINE HYDROCHLORIDE Tablet [Unit Dose Services]

FERROUS SULFATE (Iron Supplement) Tablet [A-S Medication Solutions]

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. . In case of accidental overdose, call a doctor or Poison Control Center immediately. Keep this product out of reach of children

The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. WARNINGS: Do not exceed recommended dosage.

As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.   

Close

Let's block ads! (Why?)

FERROUS SULFATE (Iron Supplement) Tablet [A-S Medication Solutions]

DOXYCYCLINE Capsule [Proficient Rx LP]

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Doxycycline is indicated for the treatment of the following infections:

    Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

    Respiratory tract infections caused by Mycoplasma pneumoniae.

    Lymphogranuloma venereum caused by Chlamydia trachomatis.

    Psittacosis (ornithosis) caused by Chlamydophila psittaci.

    Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.

    Inclusion conjunctivitis caused by Chlamydia trachomatis.

    Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.

    Nongonococcal urethritis caused by Ureaplasma urealyticum.

    Relapsing fever due to Borrelia recurrentis.

Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:

    Chancroid caused by Haemophilus ducreyi.

    Plague due to Yersinia pestis.

    Tularemia due to Francisella tularensis.

    Cholera caused by Vibrio cholerae.

    Campylobacter fetus infections caused by Campylobacter fetus.

    Brucellosis due to Brucella species (in conjunction with streptomycin).

    Bartonellosis due to Bartonella bacilliformis.

    Granuloma inguinale caused by Calymmatobacterium granulomatis.

Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.

Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

    Escherichia coli

    Enterobacter aerogenes

    Shigella species

    Acinetobacter species

    Respiratory tract infections caused by Haemophilus influenzae.

    Respiratory tract and urinary tract infections caused by Klebsiella species.

Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:

    Upper respiratory infections caused by Streptococcus pneumoniae.

    Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:

    Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

    Syphilis caused by Treponema pallidum.

    Yaws caused by Treponema pertenue.

    Listeriosis due to Listeria monocytogenes.

    Vincent's infection caused by Fusobacterium fusiforme.

    Actinomycosis caused by Actinomyces israelii.

    Infections caused by Clostridium species.

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.

In severe acne, doxycycline may be useful adjunctive therapy.

Close

Let's block ads! (Why?)

DOXYCYCLINE Capsule [Proficient Rx LP]

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Tablet [Unit Dose Services]

DIPHENOXYLATE HYDROCHLORIDE IS AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN. DIPHENOXYLATE HYDROCHLORIDE IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN. NOTOVERDOSAGE).

THE USE OF DIPHENOXYLATE HYDROCHLORIDE SHOULD BE ACCOMPANIED BY APPROPRIATE FLUID AND ELECTROLYTE THERAPY, WHEN INDICATED. IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS PRESENT, DIPHENOXYLATE HYDROCHLORIDE SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED. DRUG-INDUCED INHIBITION OF PERISTALSIS MAY RESULT IN FLUID RETENTION IN THE INTESTINE, WHICH MAY FURTHER AGGRAVATE DEHYDRATION AND ELECTROLYTE IMBALANCE.

DIPHENOXYLATE HYDROCHLORIDE SHOULD BE USED WITH SPECIAL CAUTION IN YOUNG CHILDREN BECAUSE THIS AGE GROUP MAY BE PREDISPOSED TO DELAYED DIPHENOXYLATE TOXICITY AND BECAUSE OF THE GREATER VARIABILITY OF RESPONSE IN THIS AGE GROUP.

Antiperistaltic agents may prolong and/or worsen diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic and pseudomembranous enterocolitis associated with broad-spectrum antibiotics. Antiperistaltic agents should not be used in these conditions. E. coli, Salmonella, Shigella),

In some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and diphenoxylate hydrochloride therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop.

Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of diphenoxylate hydrochloride with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.

Diphenoxylate hydrochloride should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated.

Diphenoxylate hydrochloride may potentiate the action of barbiturates, tranquilizers, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.

Close

Let's block ads! (Why?)

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Tablet [Unit Dose Services]

HEPARIN SODIUM Injection, Solution [Hospira, Inc.]

5.1 Fatal Medication Errors

Do not use this product as a “catheter lock flush” product. Heparin is supplied in various strengths. Fatal hemorrhages have occurred due to medication errors. Carefully examine all heparin products to confirm the correct container choice prior to administration of the drug.

5.2 Hemorrhage

Hemorrhage, including fatal events, has occurred in patients receiving HEPARIN SODIUM. Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks.

Hemorrhage can occur at virtually any site in patients receiving heparin. Adrenal hemorrhage (with resultant acute adrenal insufficiency), ovarian hemorrhage, and retroperitoneal hemorrhage have occurred during anticoagulant therapy with heparin [see Adverse Reactions (6.1)]. A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Clinical Pharmacology (12.3)]. An unexplained fall in hematocrit or fall in blood pressure should lead to serious consideration of a hemorrhagic event.

Use heparin sodium with caution in disease states in which there is increased risk of hemorrhage, including:

•

Cardiovascular — Subacute bacterial endocarditis. Severe hypertension.

•

Surgical — During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye.

•

Hematologic — Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.

•

Patients with hereditary antithrombin III deficiency receiving concurrent antithrombin III therapy – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, reduce the heparin dose during concomitant treatment with antithrombin III (human).

•

Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.

•

Other — Menstruation, liver disease with impaired hemostasis.

5.3 Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis)

HIT is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition known as HIT with thrombosis. Thrombotic events may also be the initial presentation for HIT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, thrombus formation on a prosthetic cardiac valve, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. Monitor thrombocytopenia of any degree closely. If the platelet count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT, and, if necessary, administer an alternative anticoagulant.

HIT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT.

5.4 Thrombocytopenia

Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%. It can occur 2 to 20 days (average 5 to 9) following the onset of heparin therapy. Obtain platelet counts before and periodically during heparin therapy. Monitor thrombocytopenia of any degree closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT, and, if necessary, administer an alternative anticoagulant [see Warnings and Precautions (5.3)].

5.5 Coagulation Testing and Monitoring

When using a full dose heparin regimen, adjust the heparin dose based on frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly [see Overdosage (10)]. Periodic platelet counts, hematocrits are recommended during the entire course of heparin therapy [see Dosage and Administration (2.2)].

5.6 Heparin Resistance

Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients, and patients with antithrombin III deficiency. Close monitoring of coagulation tests is recommended in these cases. Adjustment of heparin doses based on anti-Factor Xa levels may be warranted.

5.7 Hypersensitivity

Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations [see Adverse Reactions (6)]. Because heparin sodium is derived from animal tissue, monitor for signs and symptoms of hypersensitivity when it is used in patients with a history of allergy.

Close

Let's block ads! (Why?)

HEPARIN SODIUM Injection, Solution [Hospira, Inc.]

ALLERGY MEDICINE (Diphenhydramine Hcl) Tablet, Film Coated [LR Distributors, Inc.]

select brand®
the lower price name brand

NDC 15127-018-24

Allergy Medicine
Diphenhydramine HCl, 25 mg
Antihistamine

Allergy Relief for: 
Sneezing                          Runny Nose
Itchy, Watery Eyes           Itchy Throat

*Compare to the Active Ingredient of Benadryl® Allergy Ultratab®

10 MINI-TABS                                  Actual Size   Easy To Swallow  

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844      REV0512F32903

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603  USA
AC (870) 535-3635

Select Brand 44-329

Close

Let's block ads! (Why?)

ALLERGY MEDICINE (Diphenhydramine Hcl) Tablet, Film Coated [LR Distributors, Inc.]

ALENDRONATE SODIUM (Alendronate Sodium) Tablet [Jubilant Cadista Pharmaceuticals Inc.]

14.1 Treatment of Osteoporosis in Postmenopausal Women

Daily Dosing

     The efficacy of Alendronate 10 mg daily was assessed in four clinical trials. Study 1, a three-year, multicenter, double-blind, placebo-controlled, US clinical study enrolled 478 patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture; Study 2, a three-year, multicenter, double-blind, placebo-controlled Multinational clinical study enrolled 516 patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture; Study 3, the Three-Year Study of the Fracture Intervention Trial (FIT) a study which enrolled 2027 postmenopausal patients with at least one baseline vertebral fracture; and Study 4, the Four-Year Study of FIT: a study which enrolled 4432 postmenopausal patients with low bone mass but without a baseline vertebral fracture.

Effect on Fracture Incidence

     To assess the effects of Alendronate on the incidence of vertebral fractures (detected by digitized radiography; approximately one third of these were clinically symptomatic), the U.S. and Multinational studies were combined in an analysis that compared placebo to the pooled dosage groups of Alendronate (5 or 10 mg for three years or 20 mg for two years followed by 5 mg for one year). There was a statistically significant reduction in the proportion of patients treated with Alendronate experiencing one or more new vertebral fractures relative to those treated with placebo (3.2% vs. 6.2%; a 48% relative risk reduction). A reduction in the total number of new vertebral fractures (4.2 vs. 11.3 per 100 patients) was also observed. In the pooled analysis, patients who received Alendronate had a loss in stature that was statistically significantly less than was observed in those who received placebo (-3.0 mm vs. -4.6 mm).

     The Fracture Intervention Trial (FIT) consisted of two studies in postmenopausal women: the Three-Year Study of patients who had at least one baseline radiographic vertebral fracture and the Four-year Study of patients with low bone mass but without a baseline vertebral fracture. In both studies of FIT, 96% of randomized patients completed the studies (i.e., had a closeout visit at the scheduled end of the study); approximately 80% of patients were still taking study medication upon completion.

Fracture Intervention Trial: Three-Year Study (patients with at least one baseline radiographic vertebral fracture)

     This randomized, double-blind, placebo-controlled, 2027-patient study (Alendronate, n=1022; placebo, n=1005) demonstrated that treatment with Alendronate resulted in statistically significant reductions in fracture incidence at three years as shown in Table 6.

* Number evaluable for vertebral fractures: Alendronate, n=984; placebo, n=966

† p<0.001, ‡ p=0.007, § p<0.01, ¶ p<0.05

     Furthermore, in this population of patients with baseline vertebral fracture, treatment with Alendronate significantly reduced the incidence of hospitalizations (25.0% vs. 30.7%).

     In the Three-Year Study of FIT, fractures of the hip occurred in 22 (2.2%) of 1005 patients on placebo and 11 (1.1%) of 1022 patients on Alendronate, p=0.047. Figure 1 displays the cumulative incidence of hip fractures in this study.

Fracture Intervention Trial: Four-Year Study (patients with low bone mass but without a baseline radiographic vertebral fracture)

     This randomized, double-blind, placebo-controlled, 4432-patient study (Alendronate, n=2214; placebo, n=2218) further investigated the reduction in fracture incidence due to Alendronate. The intent of the study was to recruit women with osteoporosis, defined as a baseline femoral neck BMD at least two standard deviations below the mean for young adult women. However, due to subsequent revisions to the normative values for femoral neck BMD, 31% of patients were found not to meet this entry criterion and thus this study included both osteoporotic and non-osteoporotic women. The results are shown in table 7 for the patients with osteoporosis.

* Baseline femoral neck BMD at least 2 SD below the mean for young adult women

† Number evaluable for vertebral fractures: Alendronate, n=1426; placebo, n=1428

‡ p<0.001, § p=0.035, ¶ p=0.01,

# Not significant. This study was not powered to detect differences at these sites.

Fracture Results Across Studies

     In the Three-Year Study of FIT, Alendronate reduced the percentage of women experiencing at least one new radiographic vertebral fracture from 15.0% to 7.9% (47% relative risk reduction, p<0.001); in the Four-Year Study of FIT, the percentage was reduced from 3.8% to 2.1% (44% relative risk reduction, p=0.001); and in the combined U.S./Multinational studies, from 6.2% to 3.2% (48% relative risk reduction, p=0.034).

     Alendronate reduced the percentage of women experiencing multiple (two or more) new vertebral fractures from 4.2% to 0.6% (87% relative risk reduction, p<0.001) in the combined U.S./Multinational studies and from 4.9% to 0.5% (90% relative risk reduction, p<0.001) in the Three-Year Study of FIT. In the Four-Year Study of FIT, Alendronate reduced the percentage of osteoporotic women experiencing multiple vertebral fractures from 0.6% to 0.1% (78% relative risk reduction, p=0.035).

     Thus, Alendronate reduced the incidence of radiographic vertebral fractures in osteoporotic women whether or not they had a previous radiographic vertebral fracture.

Effect on Bone Mineral Density

     The bone mineral density efficacy of Alendronate 10 mg once daily in postmenopausal women, 44 to 84 years of age, with osteoporosis (lumbar spine bone mineral density [BMD] of at least 2 standard deviations below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration.

     Figure 2 shows the mean increases in BMD of the lumbar spine, femoral neck, and trochanter in patients receiving Alendronate 10 mg/day relative to placebo-treated patients at three years for each of these studies.

     At three years significant increases in BMD, relative both to baseline and placebo, were seen at each measurement site in each study in patients who received Alendronate 10 mg/day. Total body BMD also increased significantly in each study, suggesting that the increases in bone mass of the spine and hip did not occur at the expense of other skeletal sites. Increases in BMD were evident as early as three months and continued throughout the three years of treatment. (See Figure 3 for lumbar spine results). In the two-year extension of these studies, treatment of 147 patients with Alendronate 10 mg/day resulted in continued increases in BMD at the lumbar spine and trochanter (absolute additional increases between years 3 and 5: lumbar spine, 0.94%; trochanter, 0.88%). BMD at the femoral neck, forearm and total body were maintained. Alendronate was similarly effective regardless of age, race, baseline rate of bone turnover, and baseline BMD in the range studied (at least 2 standard deviations below the premenopausal mean).

     In patients with postmenopausal osteoporosis treated with Alendronate 10 mg/day for one or two years, the effects of treatment withdrawal were assessed. Following discontinuation, there were no further increases in bone mass and the rates of bone loss were similar to those of the placebo groups.

Bone Histology

     Bone histology in 270 postmenopausal patients with osteoporosis treated with Alendronate at doses ranging from 1 to 20 mg alendronate/day for one, two, or three years revealed normal mineralization and structure, as well as the expected decrease in bone turnover relative to placebo. These data, together with the normal bone histology and increased bone strength observed in rats and baboons exposed to long-term alendronate treatment, support the conclusion that bone formed during therapy with Alendronate is of normal quality.

Effect on Height

     Alendronate, over a three- or four-year period, was associated with statistically significant reductions in loss of height vs. placebo in patients with and without baseline radiographic vertebral fractures. At the end of the FIT studies, the between-treatment group differences were 3.2 mm in the Three-Year Study and 1.3 mm in the Four-Year Study.

Weekly Dosing

     The therapeutic equivalence of once-weekly Alendronate 70 mg (n=519) and Alendronate 10 mg daily (n=370) was demonstrated in a one-year, double-blind, multicenter study of postmenopausal women with osteoporosis. In the primary analysis of completers, the mean increases from baseline in lumbar spine BMD at one year were 5.1% (4.8, 5.4%; 95% CI) in the 70 mg once-weekly group (n=440) and 5.4% (5.0, 5.8%; 95% CI) in the 10 mg daily group (n=330). The two treatment groups were also similar with regard to BMD increases at other skeletal sites. The results of the intention-to-treat analysis were consistent with the primary analysis of completers.

Concomitant Use with Estrogen/Hormone Replacement Therapy (HRT)

     The effects on BMD of treatment with Alendronate 10 mg once daily and conjugated estrogen (0.625 mg/day) either alone or in combination were assessed in a two-year, double-blind, placebo-controlled study of hysterectomized postmenopausal osteoporotic women (n=425). At two years, the increases in lumbar spine BMD from baseline were significantly greater with the combination (8.3%) than with either estrogen or Alendronate alone (both 6.0%).

     The effects on BMD when Alendronate was added to stable doses (for at least one year) of HRT (estrogen ± progestin) were assessed in a one-year, double-blind, placebo-controlled study in postmenopausal osteoporotic women (n=428). The addition of Alendronate 10 mg once daily to HRT produced, at one year, significantly greater increases in lumbar spine BMD (3.7%) vs. HRT alone (1.1%).

     In these studies, significant increases or favorable trends in BMD for combined therapy compared with HRT alone were seen at the total hip, femoral neck, and trochanter. No significant effect was seen for total body BMD.

     Histomorphometric studies of transiliac biopsies in 92 subjects showed normal bone architecture. Compared to placebo there was a 98% suppression of bone turnover (as assessed by mineralizing surface) after 18 months of combined treatment with Alendronate and HRT, 94% on Alendronate alone, and 78% on HRT alone. The long-term effects of combined Alendronate and HRT on fracture occurrence and fracture healing have not been studied.

14.3 Treatment to Increase Bone Mass in Men with Osteoporosis

     The efficacy of Alendronate in men with hypogonadal or idiopathic osteoporosis was demonstrated in two clinical studies.

Daily Dosing

     A two-year, double-blind, placebo-controlled, multicenter study of Alendronate 10 mg once daily enrolled a total of 241 men between the ages of 31 and 87 (mean, 63). All patients in the trial had either a BMD T-score less than or equal to -2 at the femoral neck and less than or equal to -1 at the lumbar spine, or a baseline osteoporotic fracture and a BMD T-score less than or equal to -1 at the femoral neck. At two years, the mean increases relative to placebo in BMD in men receiving Alendronate 10 mg/day were significant at the following sites: lumbar spine, 5.3%; femoral neck, 2.6%; trochanter, 3.1%; and total body, 1.6%. Treatment with Alendronate also reduced height loss (Alendronate, -0.6 mm vs. placebo, -2.4 mm).

Weekly Dosing

     A one-year, double-blind, placebo-controlled, multicenter study of once weekly Alendronate 70 mg enrolled a total of 167 men between the ages of 38 and 91 (mean, 66). Patients in the study had either a BMD T-score less than or equal to -2 at the femoral neck and less than or equal to -1 at the lumbar spine, or a BMD T-score less than or equal to -2 at the lumbar spine and less than or equal to -1 at the femoral neck, or a baseline osteoporotic fracture and a BMD T-score less than or equal to -1 at the femoral neck. At one year, the mean increases relative to placebo in BMD in men receiving Alendronate 70 mg once weekly were significant at the following sites: lumbar spine, 2.8%; femoral neck, 1.9%; trochanter, 2.0%; and total body, 1.2%. These increases in BMD were similar to those seen at one year in the 10 mg once-daily study.

     In both studies, BMD responses were similar regardless of age (greater than or equal to 65 years vs. less than 65 years), gonadal function (baseline testosterone less than 9 ng/dL vs. greater than or equal to 9 ng/dL), or baseline BMD (femoral neck and lumbar spine T-score less than or equal to -2.5 vs. greater than -2.5).

14.4 Treatment of Glucocorticoid-Induced Osteoporosis

     The efficacy of Alendronate 5 and 10 mg once daily in men and women receiving glucocorticoids (at least 7.5 mg/day of prednisone or equivalent) was demonstrated in two, one-year, double-blind, randomized, placebo-controlled, multicenter studies of virtually identical design, one performed in the United States and the other in 15 different countries (Multinational [which also included Alendronate 2.5 mg/day]). These studies enrolled 232 and 328 patients, respectively, between the ages of 17 and 83 with a variety of glucocorticoid-requiring diseases. Patients received supplemental calcium and vitamin D. Figure 5 shows the mean increases relative to placebo in BMD of the lumbar spine, femoral neck, and trochanter in patients receiving Alendronate 5 mg/day for each study.

     After one year, significant increases relative to placebo in BMD were seen in the combined studies at each of these sites in patients who received Alendronate 5 mg/day. In the placebo-treated patients, a significant decrease in BMD occurred at the femoral neck (-1.2%),  and smaller decreases were seen at the lumbar spine and trochanter. Total body BMD was maintained with Alendronate 5 mg/day. The increases in BMD with Alendronate 10 mg/day were similar to those with Alendronate 5 mg/day in all patients except for postmenopausal women not receiving estrogen therapy. In these women, the increases (relative to placebo) with Alendronate 10 mg/day were greater than those with Alendronate 5 mg/day at the lumbar spine (4.1% vs. 1.6%) and trochanter (2.8% vs. 1.7%), but not at other sites. Alendronate was effective regardless of dose or duration of glucocorticoid use. In addition, Alendronate was similarly effective regardless of age (less than 65 vs. greater than or equal to 65 years), race (Caucasian vs. other races), gender, underlying disease, baseline BMD, baseline bone turnover, and use with a variety of common medications.

     Bone histology was normal in the 49 patients biopsied at the end of one year who received Alendronate at doses of up to 10 mg/day.

     Of the original 560 patients in these studies, 208 patients who remained on at least 7.5 mg/day of prednisone or equivalent continued into a one-year double-blind extension. After two years of treatment, spine BMD increased by 3.7% and 5.0% relative to placebo with Alendronate 5 and 10 mg/day, respectively. Significant increases in BMD (relative to placebo) were also observed at the femoral neck, trochanter, and total body.

     After one year, 2.3% of patients treated with Alendronate 5 or 10 mg/day (pooled) vs. 3.7% of those treated with placebo experienced a new vertebral fracture (not significant). However, in the population studied for two years, treatment with Alendronate (pooled dosage groups: 5 or 10 mg for two years or 2.5 mg for one year followed by 10 mg for one year) significantly reduced the incidence of patients with a new vertebral fracture (Alendronate 0.7% vs. placebo 6.8%).

Let's block ads! (Why?)

ALENDRONATE SODIUM (Alendronate Sodium) Tablet [Jubilant Cadista Pharmaceuticals Inc.]

AUNT KS (Oatmeal, Colloidal) Powder AUNT KS (Oatmeal Colloidal) Powder AUNT KS (Oatmeal, Collodial) Powder [Comfy Bottoms, LLC]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

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.

Let's block ads! (Why?)

AUNT KS (Oatmeal, Colloidal) Powder AUNT KS (Oatmeal Colloidal) Powder AUNT KS (Oatmeal, Collodial) Powder [Comfy Bottoms, LLC]

DR. SHEFFIELD VAPOR CREAM (Vapor Cream) Cream [Sheffield Pharmaceuticals LLC]

Carbomer, Cedarleaf oil, Cetyl Alcohol, Cetyl Palmitate, Cyclomethicone, Dimethicone, Disodium EDTA, Glycerin, Imidazolldnyl Urea, Isopropyl Palmitiate, Methylparaben , Nutmeg oil, PEG-100 Sterate, PEG/PPG- 18/18 Dimethicone, Propylparaben, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Thymol, Titantium Dioxide, Purfied Water

Close

Let's block ads! (Why?)

DR. SHEFFIELD VAPOR CREAM (Vapor Cream) Cream [Sheffield Pharmaceuticals LLC]

TRANEXAMIC ACID Tablet [Amring Pharmaceuticals, Inc.]

TRANEXAMIC ACID TABLETS

Read the Patient Information that comes with Tranexamic Acid Tablets before you start using the drug and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Tranexamic Acid Tablets?

Tranexamic Acid Tablets is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. Tranexamic Acid Tablets does not contain any hormones. On average, Tranexamic Acid Tablets has been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period.

Tranexamic Acid Tablets is taken only during your period and is not meant to treat pre-menstrual symptoms (symptoms that occur before your bleeding starts). Tranexamic Acid Tablets does not affect your fertility and cannot be used as birth control. Tranexamic Acid Tablets does not protect you against diseases that you may get if you have unprotected sex.

Tranexamic Acid Tablets has not been studied in adolescents younger than 18 years of age.

Tranexamic Acid is not for women who have already gone through menopause (post-menopausal).

Who should not take Tranexamic Acid Tablets?

Do not take Tranexamic Acid Tablets if you:

• Are using a form of birth control that contains estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Ask your healthcare provider before taking Tranexamic Acid Tablets if you are not sure if your birth control method contains estrogen and a progestin.
• Currently have a blood clot
• Have ever had a blood clot
• Have been told that you are at risk of having a blood clot
• Are allergic to tranexamic acid

What should I tell my healthcare provider before taking Tranexamic Acid Tablets?

Before taking Tranexamic Acid Tablets, tell your healthcare provider about all of your medical conditions, including whether:

• You have ever had a blood clot or been told that you are at risk of having a blood clot
• You are using a form of birth control that contains estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Using hormonal birth control along with Tranexamic Acid Tablets may increase your chance of having a serious blood clot, stroke, or heart attack. For this reason, do not use Tranexamic Acid Tablets if you use a form of birth control that contains estrogen and a progestin.
• You are pregnant or think you may be pregnant
• You are breastfeeding or plan to breast-feed. Tranexamic Acid Tablets can pass into your milk. Talk to your healthcare provider about the best way to feed your baby if you take Tranexamic Acid Tablets.
• The time between the start of your periods is less than 21 days or more than 35 days
• You have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tranexamic Acid Tablets and other medicines can affect each other, causing side effects. Tranexamic Acid Tablets can affect the way other medicines work and other medicines can affect how Tranexamic Acid Tablets works.

Especially tell your healthcare provider if you take:

• Birth control pills or other hormonal birth control
• Medicines used to help your blood form clots
• Medicines used to break up blood clots
• Any medicines to treat leukemia

Ask your healthcare provider if you are not sure if your medicine is one that is described above.

How should I take Tranexamic Acid Tablets?

• Take Tranexamic Acid Tablets exactly as your healthcare provider tells you.
• Do not take Tranexamic Acid Tablets until your period has started.
• Do not take Tranexamic Acid Tablets for more than 5 days in a row.
• Do not take Tranexamic Acid Tablets when you do not have your period.
• Once your period has started, take 2 tablets of Tranexamic Acid Tablets three times per day (e.g., in the morning, afternoon, and evening).
• Tranexamic Acid Tablets should be swallowed whole and not chewed or broken apart.
• Tranexamic Acid Tablets may be taken with or without food.
• Do not take more than 6 tablets of Tranexamic Acid Tablets in a day. If you take more than 6 tablets, call your healthcare provider.
• If you miss a dose, take it when you remember, and then take your next dose at least six hours later. Do not take more than two tablets at a time to make up for missed doses.
• If Tranexamic Acid Tablets does not help to lessen bleeding with your periods after 2 cycles or seems to stop working, talk to your healthcare provider.

What are the possible side effects of Tranexamic Acid Tablets? Tranexamic Acid Tablets can cause serious side effects, including:

• Blood clots. You may have a higher risk of having serious blood clots if you take Tranexamic Acid Tablets with:
  • medicines used to help your blood form clots
  • some medicines used to treat leukemia
• Eye changes. Stop taking Tranexamic Acid Tablets and promptly report any eye problems you have while taking Tranexamic Acid Tablets. Your doctor will refer you to an eye doctor who will examine your eyes.
• Allergic reaction. If you have severe shortness of breath and your throat feels tight, stop taking Tranexamic Acid Tablets and get medical care right away.

The most common side effects of Tranexamic Acid Tablets include:

• Headaches
• Sinus and nasal problems
• Back pain
• Pain in your abdomen
• Pain in your muscles or joints
• Anemia
• Fatigue

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of Tranexamic Acid Tablets. For more information, ask your healthcare provider or pharmacist.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641).

How should I store Tranexamic Acid Tablets?

Store Tranexamic Acid Tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep Tranexamic Acid Tablets and all medicines out of the reach of children.

General information about Tranexamic Acid Tablets

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use Tranexamic Acid Tablets for a condition for which it was not prescribed. Do not give Tranexamic Acid Tablets to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Tranexamic Acid Tablets. If you would like more information about Tranexamic Acid Tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Tranexamic Acid Tablets that is written for healthcare professionals. For more information, call 1-844-Amring1 (1-844-267-4641).

What are the ingredients of Tranexamic Acid Tablets?

Active ingredient: tranexamic acid

Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Close

Let's block ads! (Why?)

TRANEXAMIC ACID Tablet [Amring Pharmaceuticals, Inc.]

TRECATOR (Ethionamide) Tablet, Film Coated [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]

In the treatment of tuberculosis, a major cause of the emergence of drug-resistant organisms, and thus treatment failure, is patient nonadherence to prescribed treatment. Treatment failure and drug-resistant organisms can be life-threatening and may result in other serious health risks. It is, therefore, important that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended when patients are receiving treatment for tuberculosis. Consultation with an expert in the treatment of drug-resistant tuberculosis is advised for patients in whom drug-resistant tuberculosis is suspected or likely. Ethionamide should be administered with at least one, sometimes two, other drugs to which the organism is known to be susceptible (see INDICATIONS AND USAGE).

Trecator is administered orally. The usual adult dose is 15 to 20 mg/kg/day, administered once daily or, if patient exhibits poor gastrointestinal tolerance, in divided doses, with a maximum daily dosage of 1 gram.

Trecator tablets have been reformulated from a sugar-coated tablet to a film-coated tablet. Patients should be monitored and have their dosage retitrated when switching from the sugar-coated tablet to the film-coated tablet (see CLINICAL PHARMACOLOGY).

Therapy should be initiated at a dose of 250 mg daily, with gradual titration to optimal doses as tolerated by the patient. A regimen of 250 mg daily for 1 or 2 days, followed by 250 mg twice daily for 1 or 2 days with a subsequent increase to 1 gm in 3 or 4 divided doses has been reported.4,5 Thus far, there is insufficient evidence to indicate the lowest effective dosage levels. Therefore, in order to minimize the risk of resistance developing to the drug or to the companion drug, the principle of giving the highest tolerated dose (based on gastrointestinal intolerance) has been followed. In the adult this would seem to be between 0.5 and 1.0 gm daily, with an average of 0.75 gm daily.

The optimum dosage for pediatric patients has not been established. However, pediatric dosages of 10 to 20 mg/kg p.o. daily in 2 or 3 divided doses given after meals or 15 mg/kg/24 hrs as a single daily dose have been recommended.1,2 As with adults, ethionamide may be administered to pediatric patients once daily. It should be noted that in patients with concomitant tuberculosis and HIV infection, malabsorption syndrome may be present. Drug malabsorption should be suspected in patients who adhere to therapy, but who fail to respond appropriately. In such cases, consideration should be given to therapeutic drug monitoring (see CLINICAL PHARMACOLOGY).

The best times of administration are those which the individual patient finds most suitable in order to avoid or minimize gastrointestinal intolerance, which is usually at mealtimes. Every effort should be made to encourage patients to persevere with treatment when gastrointestinal side effects appear, since they may diminish in severity as treatment proceeds.

Concomitant administration of pyridoxine is recommended.

Duration of treatment should be based on individual clinical response. In general, continue therapy until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

Close

Let's block ads! (Why?)

TRECATOR (Ethionamide) Tablet, Film Coated [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]

Newly identified molecular pathway could lead to new treatments for reflux, incontinence disorders

Researchers at UMass Medical School have identified a new molecular pathway critical for maintaining the smooth muscle tone that allows the passage of materials through the digestive system. Newly identified molecular pathway could lead to new treatments for reflux, incontinence disorders

LINZESS (Linaclotide) Capsule, Gelatin Coated [Forest Laboratories, Inc.]

14.1 Irritable Bowel Syndrome with Constipation (IBS-C)

The efficacy of LINZESS for the management of symptoms of IBS-C was established in two double-blind, placebo-controlled, randomized, multicenter trials in adult patients (Trials 1 and 2). A total of 800 patients in Trial 1 and 804 patients in Trial 2 [overall mean age of 44 years (range 18 - 87 years with 5% at least 65 years of age), 90% female, 77% white, 19% black, and 12% Hispanic] received treatment with LINZESS 290 mcg or placebo once daily and were evaluated for efficacy. All patients met Rome II criteria for IBS and were required, during the 2-week baseline period, to meet the following criteria:

• a mean abdominal pain score of at least 3 on a 0-to-10-point numeric rating scale
• less than 3 complete spontaneous bowel movements (CSBMs) per week [a CSBM is a spontaneous bowel movement (SBM) that is associated with a sense of complete evacuation; a SBM is a bowel movement occurring in the absence of laxative use], and
• less than or equal to 5 SBMs per week.

The trial designs were identical through the first 12 weeks, and thereafter differed only in that Trial 1 included a 4-week randomized withdrawal (RW) period, and Trial 2 continued for 14 additional weeks (total of 26 weeks) of double-blind treatment. During the trials, patients were allowed to continue stable doses of bulk laxatives or stool softeners but were not allowed to take laxatives, bismuth, prokinetic agents, or other drugs to treat IBS-C or chronic constipation.

Efficacy of LINZESS was assessed using overall responder analyses and change-from-baseline endpoints. Results for endpoints were based on information provided daily by patients in diaries.

The 4 primary efficacy responder endpoints were based on a patient being a weekly responder for either at least 9 out of the first 12 weeks of treatment or at least 6 out of the first 12 weeks of treatment. For the 9 out of 12 weeks combined primary responder endpoint, a patient had to have at least a 30% reduction from baseline in mean abdominal pain, at least 3 CSBMs and an increase of at least 1 CSBM from baseline, all in the same week, for at least 9 out of the first 12 weeks of treatment. Each of the 2 components of the 9 out of 12 weeks combined responder endpoint, abdominal pain and CSBMs, was also a primary endpoint.

For the 6 out of 12 weeks combined primary responder endpoint, a patient had to have at least a 30% reduction from baseline in mean abdominal pain and an increase of at least 1 CSBM from baseline, all in the same week, for at least 6 out of the first 12 weeks of treatment. To be considered a responder for this analysis, patients did not have to have at least 3 CSBMs per week.

The efficacy results for the 9 out of 12 weeks and the 6 out of 12 weeks responder endpoints are shown in Tables 3 and 4, respectively. In both trials, the proportion of patients who were responders to LINZESS 290 mcg was statistically significantly higher than with placebo.

In each trial, improvement from baseline in abdominal pain and CSBM frequency was seen over the first 12-weeks of the treatment periods. For change from baseline in the 11-point abdominal pain scale, LINZESS 290 mcg began to separate from placebo in the first week. Maximum effects were seen at weeks 6 - 9 and were maintained until the end of the study. The mean treatment difference from placebo at week 12 was a decrease in pain score of approximately 1.0 point in both trials (using an 11-point scale). Maximum effect on CSBM frequency occurred within the first week, and for change from baseline in CSBM frequency at week 12, the difference between placebo and LINZESS was approximately 1.5 CSBMs per week in both trials.

In each trial, in addition to improvements in abdominal pain and CSBM frequency over the first 12 weeks of the treatment period, improvements were observed in the following when LINZESS was compared to placebo: SBM frequency [SBMs/week], stool consistency [as measured by the Bristol Stool Form Scale (BSFS)], and amount of straining with bowel movements [amount of time pushing or physical effort to pass stool].

During the 4-week randomized withdrawal period in Trial 1, patients who received LINZESS during the 12-week treatment period were re-randomized to receive placebo or continue treatment on LINZESS 290 mcg. In LINZESS-treated patients re-randomized to placebo, CSBM frequency and abdominal-pain severity returned toward baseline within 1 week and did not result in worsening compared to baseline. Patients who continued on LINZESS maintained their response to therapy over the additional 4 weeks. Patients on placebo who were allocated to LINZESS had an increase in CSBM frequency and a decrease in abdominal pain levels that were similar to the levels observed in patients taking LINZESS during the treatment period.

14.2 Chronic Idiopathic Constipation (CIC)

The efficacy of LINZESS for the management of symptoms of CIC was established in two double-blind, placebo-controlled, randomized, multicenter clinical trials in adult patients (Trials 3 and 4). A total of 642 patients in Trial 3 and 630 patients in Trial 4 [overall mean age of 48 years (range 18 - 85 years with 12% at least 65 years of age), 89% female, 76% white, 22% black, 10% Hispanic] received treatment with LINZESS 145 mcg, 290 mcg, or placebo once daily and were evaluated for efficacy. All patients met modified Rome II criteria for functional constipation. Modified Rome II criteria were less than 3 Spontaneous Bowel Movements (SBMs) per week and 1 of the following symptoms for at least 12 weeks, which need not be consecutive, in the preceding 12 months:

• Straining during greater than 25% of bowel movements
• Lumpy or hard stools during greater than 25% of bowel movements
• Sensation of incomplete evacuation during greater than 25% of bowel movements

Patients were also required to have less than 3 CSBMs per week and less than or equal to 6 SBMs per week during a 2-week baseline period. Patients were excluded if they met criteria for IBS-C or had fecal impaction that required emergency room treatment.

The trial designs were identical through the first 12 weeks. Trial 3 also included an additional 4-week randomized withdrawal (RW) period. During the trials, patients were allowed to continue stable doses of bulk laxatives or stool softeners but were not allowed to take laxatives, bismuth, prokinetic agents, or other drugs to treat chronic constipation.

Efficacy of LINZESS was assessed using overall responder analysis and change-from-baseline endpoints. Results for endpoints were based on information provided daily by patients in diaries.

A CSBM overall responder in the CIC trials was defined as a patient who had at least 3 CSBMs and an increase of at least 1 CSBM from baseline in a given week for at least 9 weeks out of the 12-week treatment period. The CSBM responder rates are shown in Table 5. During the individual double-blind placebo-controlled trials, LINZESS 290 mcg did not consistently offer additional clinically meaningful treatment benefit over placebo than that observed with the LINZESS 145 mcg dose. Therefore, the 145 mcg dose is the recommended dose. Only the data for the approved 145 mcg dose of LINZESS are presented in Table 5.

In Trials 3 and 4, the proportion of patients who were CSBM responders was statistically significantly greater with the LINZESS 145 mcg dose than with placebo.

CSBM frequency reached maximum level during week 1 and was also demonstrated over the remainder of the 12-week treatment period in Trial 3 and Trial 4. For the mean change from baseline in CSBM frequency at week 12, the difference between placebo and LINZESS was approximately 1.5 CSBMs.

On average, patients who received LINZESS across the 2 trials had significantly greater improvements compared with patients receiving placebo in stool frequency (CSBMs/week and SBMs/week), and stool consistency (as measured by the BSFS).

In each trial, in addition to improvements in CSBM frequency over the first 12 weeks of the treatment period, improvements were observed in each of the following when LINZESS was compared to placebo: SBM frequency [SBMs/week], stool consistency [as measured by the BSFS], and amount of straining with bowel movements [amount of time pushing or physical effort to pass stool].

During the 4-week randomized withdrawal period in Trial 3, patients who received LINZESS during the 12-week treatment period were re-randomized to receive placebo or continue treatment on the same dose of LINZESS taken during the treatment period. In LINZESS-treated patients re-randomized to placebo, CSBM and SBM frequency returned toward baseline within 1 week and did not result in worsening compared to baseline. Patients who continued on LINZESS maintained their response to therapy over the additional 4 weeks. Patients on placebo who were allocated to LINZESS had an increase in CSBM and SBM frequency similar to the levels observed in patients taking LINZESS during the treatment period.

Close

Let's block ads! (Why?)

LINZESS (Linaclotide) Capsule, Gelatin Coated [Forest Laboratories, Inc.]

ESZOPICLONE Tablet, Film Coated [Teva Pharmaceuticals USA Inc]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The premarketing development program for eszopiclone included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with eszopiclone varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.

6.1 Clinical Trials Experience

Adverse Reactions Resulting in Discontinuation of Treatment

In placebo-controlled, parallel-group clinical trials in the elderly, 3.8% of 208 patients who received placebo, 2.3% of 215 patients who received 2 mg eszopiclone, and 1.4% of 72 patients who received 1 mg eszopiclone discontinued treatment due to an adverse reaction. In the 6 week parallel-group study in adults, no patients in the 3 mg arm discontinued because of an adverse reaction. In the long-term 6 month study in adult insomnia patients, 7.2% of 195 patients who received placebo and 12.8% of 593 patients who received 3 mg eszopiclone discontinued due to an adverse reaction. No reaction that resulted in discontinuation occurred at a rate of greater than 2%.

Adverse Reactions Observed at an Incidence of ≥ 2% in Controlled Trials

Table 1 shows the incidence of adverse reactions from a Phase 3 placebo-controlled study of eszopiclone at doses of 2 or 3 mg in non-elderly adults. Treatment duration in this trial was 44 days. The table includes only reactions that occurred in 2% or more of patients treated with eszopiclone 2 mg or 3 mg in which the incidence in patients treated with eszopiclone was greater than the incidence in placebo-treated patients.

Adverse reactions from Table 1 that suggest a dose-response relationship in adults include viral infection, dry mouth, dizziness, hallucinations, infection, rash, and unpleasant taste, with this relationship clearest for unpleasant taste.

Table 2 shows the incidence of adverse reactions from combined Phase 3 placebo-controlled studies of eszopiclone at doses of 1 or 2 mg in elderly adults (ages 65 to 86). Treatment duration in these trials was 14 days. The table includes only reactions that occurred in 2% or more of patients treated with eszopiclone 1 mg or 2 mg in which the incidence in patients treated with eszopiclone was greater than the incidence in placebo-treated patients.

Adverse reactions from Table 2 that suggest a dose-response relationship in elderly adults include pain, dry mouth, and unpleasant taste, with this relationship again clearest for unpleasant taste.

These figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice because patient characteristics and other factors may differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contributions of drug and non-drug factors to the adverse reaction incidence rate in the population studied.

Other Reactions Observed During the Premarketing Evaluation of Eszopiclone

Following is a list of modified COSTART terms that reflect adverse reactions as defined in the introduction to the Adverse Reactions section and reported by approximately 1550 subjects treated with eszopiclone at doses in the range of 1 to 3.5 mg/day during Phase 2 and 3 clinical trials throughout the United States and Canada. All reported reactions are included except those already listed in Tables 1 and 2 or elsewhere in labeling, minor reactions common in the general population, and reactions unlikely to be drug-related. Although the reactions reported occurred during treatment with eszopiclone, they were not necessarily caused by it.

Reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those that occurred on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those that occurred in fewer than 1/100 patients but in at least 1/1,000 patients; rare adverse reactions are those that occurred in fewer than 1/1,000 patients. Gender-specific reactions are categorized based on their incidence for the appropriate gender.

Body as a Whole:Frequent: chest pain; Infrequent: allergic reaction, cellulitis, face edema, fever, halitosis, heat stroke, hernia, malaise, neck rigidity, photosensitivity.

Cardiovascular System:Frequent: migraine; Infrequent: hypertension; Rare: thrombophlebitis.

Digestive System:Infrequent: anorexia, cholelithiasis, increased appetite, melena, mouth ulceration, thirst, ulcerative stomatitis; Rare: colitis, dysphagia, gastritis, hepatitis, hepatomegaly, liver damage, stomach ulcer, stomatitis, tongue edema, rectal hemorrhage.

Hemic and Lymphatic System:Infrequent: anemia, lymphadenopathy.

Metabolic and Nutritional:Frequent: peripheral edema; Infrequent: hypercholesteremia, weight gain, weight loss; Rare: dehydration, gout, hyperlipemia, hypokalemia.

Musculoskeletal System:Infrequent: arthritis, bursitis, joint disorder (mainly swelling, stiffness, and pain), leg cramps, myasthenia, twitching; Rare: arthrosis, myopathy, ptosis.

Nervous System:Infrequent: agitation, apathy, ataxia, emotional lability, hostility, hypertonia, hypesthesia, incoordination, insomnia, memory impairment, neurosis, nystagmus, paresthesia, reflexes decreased, thinking abnormal (mainly difficulty concentrating), vertigo; Rare: abnormal gait, euphoria, hyperesthesia, hypokinesia, neuritis, neuropathy, stupor, tremor.

Respiratory System:Infrequent: asthma, bronchitis, dyspnea, epistaxis, hiccup, laryngitis.

Skin and Appendages:Infrequent: acne, alopecia, contact dermatitis, dry skin, eczema, skin discoloration, sweating, urticaria; Rare: erythema multiforme, furunculosis, herpes zoster, hirsutism, maculopapular rash, vesiculobullous rash.

Special Senses:Infrequent: conjunctivitis, dry eyes, ear pain, otitis externa, otitis media, tinnitus, vestibular disorder; Rare: hyperacusis, iritis, mydriasis, photophobia.

Urogenital System:Infrequent: amenorrhea, breast engorgement, breast enlargement, breast neoplasm, breast pain, cystitis, dysuria, female lactation, hematuria, kidney calculus, kidney pain, mastitis, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, uterine hemorrhage, vaginal hemorrhage, vaginitis; Rare: oliguria, pyelonephritis, urethritis.

Let's block ads! (Why?)

ESZOPICLONE Tablet, Film Coated [Teva Pharmaceuticals USA Inc]