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Friday, October 21, 2016

Camptosar

Generic Name: irinotecan (Intravenous route)

ir-in-oh-TEE-kan

Intravenous route(Solution)

Irinotecan can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms, and both forms of diarrhea may be severe. Early diarrhea may be accompanied by cholinergic symptoms that may be prevented or ameliorated by atropine. Late diarrhea (generally occurring more than 24 hours after administration of irinotecan) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide and administration of irinotecan should be interrupted and subsequent doses reduced if severe diarrhea occurs. Severe myelosuppression may occur with irinotecan administration .

Commonly used brand name(s)

In the U.S.

Camptosar

Novaplus Irinotecan Hydrochloride

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

Uses For Camptosar

Irinotecan injection is given together with other medicines to treat patients with metastatic cancer (a cancer that has already spread) of the colon or rectum.

Irinotecan belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with irinotecan has been stopped. Be sure that you have discussed with your doctor the possible side effects of this medicine as well as the good it can do.

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

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

Carcinoma, lung, non-small cell (treatment of non–small cell cancer of the lung).

Extensive-stage small-cell lung cancer, first-line treatment, in combination with cisplatin (treatment of small-cell lung cancer; used together with cisplatin [Platinol®]).

Ovarian cancer, platinum-refractory or platinum-resistant (treatment of ovarian cancer that does not respond to platinum-type medicines).

Malignant glioma, recurrent or progressive (treatment of brain cancer that has returned or is advancing).

Before Using Camptosar

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of irinotecan injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of irinotecan injection in the elderly. However, elderly patients are more likely to have severe diarrhea, which may require caution and an adjustment in the dose for patients receiving irinotecan.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

Atazanavir

Ketoconazole

Rotavirus Vaccine, Live

St John's Wort

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

Adenovirus Vaccine Type 4, Live

Adenovirus Vaccine Type 7, Live

Aprepitant

Bacillus of Calmette and Guerin Vaccine, Live

Carbamazepine

Fosaprepitant

Influenza Virus Vaccine, Live

Lopinavir

Measles Virus Vaccine, Live

Mumps Virus Vaccine, Live

Phenobarbital

Phenytoin

Rifabutin

Rifampin

Rotavirus Vaccine, Live

Rubella Virus Vaccine, Live

Smallpox Vaccine

Typhoid Vaccine

Varicella Virus Vaccine

Yellow Fever Vaccine

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

Citalopram

Sorafenib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Tobacco

Proper Use of irinotecan

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

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

Irinotecan often causes nausea and vomiting. However, it is very important that you continue to receive this medicine even if you begin to feel ill. You may receive other medicines to help with the nausea and vomiting. Ask your doctor for other ways to lessen these effects.

Precautions While Using Camptosar

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant before you receive this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have chills; fever; hives; hoarseness; itching; rash; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

While you are being treated with irinotecan, and after you stop treatment, do not have any immunizations (vaccinations) without your doctor's approval. Irinotecan may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal influenza or flu vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth.

Irinotecan may cause diarrhea, which can last long enough and be severe enough to cause serious medical problems. If diarrhea occurs while you are being treated with irinotecan:

Check with your doctor immediately. Be sure to let your doctor know if the diarrhea started during an irinotecan injection or less than 24 hours afterwards. Also, be sure to tell your doctor if you had any other symptoms, such as stomach cramps or sweating, before the diarrhea started. This means that you are having a certain kind of diarrhea that may need to be treated by your doctor.

If diarrhea first occurs more than 24 hours after a dose of irinotecan, start taking loperamide (Imodium A-D®) as soon as you notice that your bowel movements are occurring more often or are more loose than usual. Loperamide is available without a prescription. Buy some of it ahead of time, so that you will have it on hand in case it is needed. Unless otherwise directed by your doctor, take 4 milligrams (mg) of loperamide (2 capsules or tablets, or 4 teaspoonfuls of the oral solution dosage form) for the first dose, then 2 mg (1 capsule or tablet, or 2 teaspoonfuls of the oral solution dosage form) every two hours. To interrupt your sleep less often, you may take 4 mg of loperamide every four hours during the night. Continue taking loperamide, day and night, until you have not had any diarrhea for twelve hours. It is very important that you follow these (or your doctor's) directions, even though they are different from the directions on the nonprescription (over-the-counter [OTC]) loperamide package label. The largest amount of loperamide recommended on the package label for use in a twenty-four-hour period (8 mg) is not enough for treating diarrhea caused by irinotecan. Notify your doctor if the diarrhea is not controlled within 24 hours.

Diarrhea causes loss of body fluid, which can lead to dehydration, a serious medical problem. To prevent this, it is very important that you replace the lost fluid. While you have diarrhea, and for a day or two after the diarrhea has stopped, drink plenty of clear liquids, such as ginger ale, caffeine-free cola, decaffeinated tea, and broth. Ask your doctor about the amount of liquid you should be drinking every day. Also, ask your doctor whether you should use a sports drink (e.g., Gatorade®), which contains other substances, such as sodium and potassium, that may be lost along with body fluid. Follow your doctor's directions very carefully.

Because alcohol and caffeine can increase fluid loss, you should not drink beverages or take any medicines that contain them while you have diarrhea. Also, avoid eating foods that may make diarrhea worse, such as bran, raw fruits or vegetables, or fatty, fried, or spicy foods.

Vomiting can also increase the amount of fluid lost by the body and increase the risk of dehydration. If vomiting occurs at the same time as diarrhea, check with your doctor right away.

Signs of too much fluid loss (dehydration) include decreased urination, dizziness or light-headedness, dryness of the mouth, fainting, increased thirst, and wrinkled skin. If any of these occur, check with your doctor immediately.

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

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

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

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

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

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

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

Call your doctor right away if you have an unexplained fever, cough, shortness of breath, trouble with breathing, or wheezing after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may increase your risk of having blood clots. Tell your doctor right away if you start having a sudden and severe headache, trouble with breathing, or problems with vision, speech, or walking.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. This medicine may also cause blurred vision or other vision problems. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well. If these reactions are especially bothersome, check with your doctor.

Ketoconazole (Nizoral®) and St. John's wort should not be used while you are receiving irinotecan. If you are using St. John's Wort, it should be discontinued at least 2 weeks before the first cycle of irinotecan. If you are using ketoconazole, it should be discontinued at least 1 week before starting irinotecan treatment.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Camptosar Side Effects

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

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

More common

Anxiety

black, tarry stools

blood in the urine or stools

blurred vision

changes in skin color

chest pain or discomfort

chest tightness or heaviness

chills

clay colored stools

cold hands and feet

confusion

constricted pupils

cough or hoarseness

dark urine

diarrhea with or without stomach cramps or sweating

dizziness

fainting

fast, slow, or irregular heartbeat

fever

full or bloated feeling or pressure in the stomach

headache

increased production of saliva

increased tear production

itching

lightheadedness when getting up suddenly from a lying or sitting position

loss of appetite

low blood pressure or pulse

lower back or side pain

nausea or vomiting

numbness or tingling in the face, arms, or legs

pain

pain in the chest, groin, or legs, especially calves of the legs

pain in the shoulders, arms, jaw, or neck

painful or difficult urination

pale skin

pinpoint red spots on the skin

redness or swelling of the leg

runny nose

severe headache of sudden onset

shortness of breath or troubled breathing

skin rash

slow breathing

slurred speech

sore throat

stomach pain

stopping of the heart

sudden and severe weakness in the arm or leg on one side of the body

sudden loss of coordination

sudden vision changes

sweating

swelling

swelling of the abdomen or stomach area

temporary blindness

tenderness, pain, or swelling of the arm, foot, or leg

trouble with speaking or walking

ulcers, sores, or white spots on the lips or in the mouth

unconsciousness

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

warm, red feeling over the body

yellow eyes or skin

Less common

Bleeding gums

coughing up blood

decreased urination

difficulty with swallowing

dryness of the mouth

increased menstrual flow or vaginal bleeding

increased thirst

nosebleeds

paralysis

prolonged bleeding from cuts

sneezing

wheezing

wrinkled skin

Rare

Decreased amount of urine

decreased frequency of urination

fast, irregular, or troubled breathing

hives

increased blood pressure

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

Incidence not known

Abdominal or stomach pain and tenderness

agitation

bloated or full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

coma

constipation

depression

heartburn or indigestion

hostility

irritability

lethargy

muscle pain and cramps

muscle twitching

pain in the stomach, side, or abdomen, possibly radiating to the back

pain or discomfort in the arms, jaw, back, or neck

rectal bleeding

severe abdominal or stomach cramping or burning

severe and continuing nausea

stupor

swelling of the face, lower legs, ankles, fingers, or hands

tightness in the chest

unusual tiredness or weakness

vomiting of material that looks like coffee grounds

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

More common

Acid or sour stomach

belching

blistering, peeling, redness, or swelling of the palms of hands or bottoms of the feet

cracked lips

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

numbness, pain, tingling, or unusual sensations in the palms of hands or bottoms of feet

passing gas

right upper abdominal or stomach pain and fullness

sensation of spinning

sleepiness or unusual drowsiness

sleeplessness

stomach discomfort, upset, or pain

trouble sleeping

unable to sleep

weight loss

Incidence not known

Hiccups

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

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

See also: Camptosar side effects (in more detail)

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

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

More Camptosar resources

Camptosar Side Effects (in more detail)
Camptosar Use in Pregnancy & Breastfeeding
Camptosar Drug Interactions
Camptosar Support Group
1 Review for Camptosar - Add your own review/rating

Camptosar Prescribing Information (FDA)

Camptosar Consumer Overview

Camptosar Monograph (AHFS DI)

Camptosar MedFacts Consumer Leaflet (Wolters Kluwer)

Irinotecan Prescribing Information (FDA)

Irinotecan Professional Patient Advice (Wolters Kluwer)

Compare Camptosar with other medications

Colorectal Cancer

Cortisporin Suspension

Pronunciation: HYE-droe-KOR-ti-sone/NEE-oh-MYE-sin/POL-ee-MIX-in
Generic Name: Hydrocortisone/Neomycin/Polymyxin B
Brand Name: Examples include Cortisporin and Cortomycin

Cortisporin Suspension is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cortisporin Suspension is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by slowing the growth of, or killing, sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Cortisporin Suspension if:

you are allergic to any ingredient in Cortisporin Suspension, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)

you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)

you have a perforated ear drum

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

Before using Cortisporin Suspension:

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

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

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

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

if you have asthma

Some MEDICINES MAY INTERACT with Cortisporin Suspension. Because little, if any, of Cortisporin Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cortisporin Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortisporin Suspension:

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

Cortisporin Suspension is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Cortisporin Suspension in your eyes, rinse immediately with cool tap water.

Wash your hands before and after using Cortisporin Suspension.

Wash and dry the outer ear with a sterile cotton applicator.

Shake well before each use.

Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.

To clear up your infection completely, use Cortisporin Suspension for the full course of treatment. Keep using it even if you feel better in a few days.

If you miss a dose of Cortisporin Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Cortisporin Suspension only works against bacteria; it does not treat fungal or viral infections.

Be sure to use Cortisporin Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Cortisporin Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

If your symptoms do not get better within 7 days or if they get worse, check with your doctor.

Do NOT take more than the recommended dose or use for longer than 7 days without checking with your doctor.

Do not use Cortisporin Suspension for other ear conditions at a later time.

Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

Tell your doctor or dentist that you take Cortisporin Suspension before you receive any medical or dental care, emergency care, or surgery.

Cortisporin Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortisporin Suspension while you are pregnant. It is not known if Cortisporin Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you use Cortisporin Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cortisporin Suspension:

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

Mild, temporary burning or stinging.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; muscle weakness; pain, redness, itching, irritation, or swelling not present when you began using Cortisporin Suspension; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cortisporin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cortisporin Suspension:

Store Cortisporin Suspension between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Cortisporin Suspension out of the reach of children and away from pets.

General information:

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

Cortisporin Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cortisporin Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Cortisporin resources

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

Compare Cortisporin with other medications

Otitis Externa
Otitis Media

Chlorpheniramine Tablets

Generic Name: chlorpheniramine maleate

Dosage Form: tablet
Chlorpheniramine maleate

ACTIVE INGREDIENT (IN EACH TABLET)

Chlorpheniramine Maleate 4 mg

PURPOSE

Antihistamine

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat

Warnings

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis, ■ glaucoma or ■ trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

■ marked drowsiness may occur ■ avoid alcoholic beverages ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur especially in children

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Directions

■ take every 4 to 6 hours ■ do not take more than 6 doses in 24 hours ■ adults and children 12 years and over: 1 tablet ■ children 6 to under 12 years: 1/2 tablet ■ children under 6 years: consult a doctor

Other information

■ save carton for full directions and warnings ■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

D.&C. Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.

DISPLAY PANEL

CHLORPHENIRAMINE MALEATE
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	62211-246
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID
LACTOSE
STARCH, CORN
MAGNESIUM STEARATE
D&C YELLOW NO. 10
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	yellow	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AZ246
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	62211-246-93	24 TABLET In 1 PACKAGE	None
2	62211-246-99	75000 TABLET In 1 CARTON	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/12/2010

Labeler - A&Z Pharmaceutical, Inc. (926820705)

Registrant - A&Z Pharmaceutical, Inc. (926820705)

Revised: 10/2010A&Z Pharmaceutical, Inc.

More Chlorpheniramine Tablets resources

Chlorpheniramine Tablets Side Effects (in more detail)
Chlorpheniramine Tablets Dosage
Chlorpheniramine Tablets Use in Pregnancy & Breastfeeding
Drug Images
Chlorpheniramine Tablets Drug Interactions
Chlorpheniramine Tablets Support Group
18 Reviews for Chlorpheniramines - Add your own review/rating

Compare Chlorpheniramine Tablets with other medications

Allergic Reactions
Cold Symptoms
Hay Fever
Urticaria

Cialis

Generic Name: tadalafil (Oral route)

ta-DAL-a-fil

Commonly used brand name(s)

In the U.S.

Adcirca

Cialis

Available Dosage Forms:

Tablet

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Uses For Cialis

Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, tadalafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, tadalafil will not work to cause an erection.

Tadalafil is also used to treat men who have signs and symptoms of benign prostatic hyperplasia (BPH). BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Tadalafil will make these symptoms less severe and reduce the chance that prostate surgery will be needed. This medicine is also used to treat erectile dysfunction and signs and symptoms of BPH.

Tadalafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadalafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

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

Before Using Cialis

Allergies

Pediatric

Use of Cialis® tablet is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Adcirca™ tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving tadalafil.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

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

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

Boceprevir

Erythrityl Tetranitrate

Isosorbide Dinitrate

Isosorbide Mononitrate

Nitroglycerin

Pentaerythritol Tetranitrate

Telaprevir

Alfuzosin

Atazanavir

Bunazosin

Clarithromycin

Erythromycin

Indinavir

Itraconazole

Ketoconazole

Moxisylyte

Nefazodone

Nelfinavir

Phenoxybenzamine

Phentolamine

Prazosin

Saquinavir

Simvastatin

Tamsulosin

Telithromycin

Terazosin

Trimazosin

Urapidil

Doxazosin

Rifampin

Ritonavir

Silodosin

Tipranavir

Interactions with Food/Tobacco/Alcohol

Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of tadalafil

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

Use tadalafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with tadalafil. Read the directions carefully before you start using tadalafil and each time you get a refill of your medicine.

You may take this medicine with or without food.

Swallow the Cialis® tablet whole. Do not split, break, or crush it.

When using this medicine for erectile dysfunction, the ability to have sexual activity may be improved for up to 36 hours after taking the tablet.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

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

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

For oral dosage form (tablets):
- For treatment of benign prostatic hyperplasia (daily use):
  - Adults—5 milligrams (mg) as a single dose, no more than once a day, taken at the same time each day.
  - Children—Use is not recommended.
- For treatment of erectile dysfunction (as needed):
  - Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose if needed.
  - Children—Use is not recommended.
- For treatment of erectile dysfunction (daily use):
  - Adults—2.5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity. Your doctor may adjust your dose if needed.
  - Children—Use is not recommended.
- For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):
  - Adults—5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity.
  - Children—Use is not recommended.
- For treatment of pulmonary arterial hypertension:
  - Adults—40 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Cialis

It is important that you tell all of your doctors that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took tadalafil.

If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you take tadalafil for pulmonary arterial hypertension, do not take Cialis® or other PDE5 inhibitors, such as sildenafil (Revatio® or Viagra®) or vardenafil (Levitra®). Cialis® also contains tadalafil. If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

Do not use this medicine if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.

Do not drink excessive amounts of alcohol (e.g., 5 glasses of wine or 5 shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

If you experience sudden loss of vision in one or both eyes, stop using tadalafil and contact your doctor immediately.

Stop using this medicine and check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Cialis Side Effects

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

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

Less common

Arm, back, or jaw pain

blurred vision

chest pain or discomfort

chest tightness or heaviness

chills

cold sweats

confusion

dizziness

fainting

faintness or lightheadedness when getting up suddenly from a lying or sitting position

fast or irregular heartbeat

headache

hearing loss

nausea

nervousness

pain or discomfort in the arms, jaw, back, or neck

pounding in the ears

shortness of breath

slow or fast heartbeat

sweating

unusual tiredness or weakness

vomiting

Rare

Painful or prolonged erection of the penis

Incidence not known

Abdominal or stomach pain

blindness

blistering, peeling, or loosening of the skin

cough

cracks in the skin

decrease or change in vision

diarrhea

difficulty with speaking

double vision

fast, irregular, pounding, or racing heartbeat or pulse

headache, severe and throbbing

hives or welts

inability to move the arms, legs, or facial muscles

inability to speak

itching

joint or muscle pain

loss of heat from the body

numbness or tingling of the face, hands, or feet

red irritated eyes

red skin lesions, often with a purple center

red, swollen skin

redness of the skin

redness or soreness of the eyes

scaly skin

skin rash

slow speech

sores, ulcers, or white spots in the mouth or on the lips

sudden cardiac death

swelling of the feet or lower legs

More common

Acid or sour stomach

belching

heartburn

indigestion

stomach discomfort, upset, or pain

Less common

Bloody nose

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

burning feeling in the chest or stomach

congestion

difficulty with moving

difficulty with swallowing

dry mouth

dryness or soreness of the throat

excessive eye discharge

eye pain

feeling of constant movement of self or surroundings

feeling of warmth, redness of the face, neck, arms and occasionally, upper chest

fever

hoarseness

increased erection

lack or loss of strength

loose stools

muscle aching or cramping

muscle stiffness

nasal congestion

neck pain

pain

pain in the arms or legs

pain or burning in the throat

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

reduced sensitivity to touch

runny nose

sensation of spinning

sleepiness or unusual drowsiness

sleeplessness

spontaneous penile erection

stomach upset

swelling of the eyelids

swelling or puffiness of the eyes or face

swollen joints

tearing

tender, swollen glands in the neck

tenderness in the stomach area

trouble with sleeping

unable to sleep

upper abdominal or stomach pain

voice changes

watering of the eyes

Rare

Changes in color vision

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

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

See also: Cialis side effects (in more detail)

More Cialis resources

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

Cialis Prescribing Information (FDA)

Cialis Monograph (AHFS DI)

Cialis MedFacts Consumer Leaflet (Wolters Kluwer)

Cialis Consumer Overview

Tadalafil Professional Patient Advice (Wolters Kluwer)

Adcirca MedFacts Consumer Leaflet (Wolters Kluwer)

Adcirca Prescribing Information (FDA)

Adcirca Consumer Overview

Compare Cialis with other medications

Benign Prostatic Hyperplasia
Erectile Dysfunction

Complete Natal

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Complete Natal (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Complete Natal resources

Complete Natal Use in Pregnancy & Breastfeeding
Complete Natal Drug Interactions
0 Reviews for Complete Natal - Add your own review/rating

Compare Complete Natal with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

Cefobid

Dosage Form: Injection

Cefobid Description

Cefobid® (sterile cefoperazone), formerly known as sterile cefoperazone sodium, contains cefoperazone as cefoperazone sodium. It is a semisynthetic, broad-spectrum cephalosporin antibiotic. Chemically, cefoperazone sodium is sodium (6R,7R)-7-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-(p-hydroxyphenyl)- acetamido - 3 - [[(1 - methyl - 1H - tetrazol - 5 - yl)thio]methyl] - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylate. Its molecular formula is C25H26N9NaO8S2 with a molecular weight of 667.65. The structural formula is given below:

Cefobid (sterile cefoperazone) contains 34 mg sodium (1.5 mEq) per gram. Cefobid is a white powder which is freely soluble in water. The pH of a 25% (w/v) freshly reconstituted solution varies between 4.5–6.5 and the solution ranges from colorless to straw yellow depending on the concentration.

Cefobid (sterile cefoperazone) in crystalline form is supplied in vials containing 1 g or 2 g cefoperazone as cefoperazone sodium for intravenous or intramuscular administration.

Cefobid - Clinical Pharmacology

High serum and bile levels of Cefobid are attained after a single dose of the drug. Table 1 demonstrates the serum concentrations of Cefobid in normal volunteers following either a single 15-minute constant rate intravenous infusion of 1, 2, 3 or 4 grams of the drug, or a single intramuscular injection of 1 or 2 grams of the drug.

Table 1. Cefoperazone Serum Concentrations
	Mean Serum Concentrations (mcg/mL)
Dose/Route	0*	0.5 hr	1 hr	2 hr	4 hr	8 hr	12 hr
* Hours post-administration, with 0 time being the end of the infusion. † Values obtained 15 minutes post-injection.
1 g IV	153	114	73	38	16	4	0.5
2 g IV	252	153	114	70	32	8	2
3 g IV	340	210	142	89	41	9	2
4 g IV	506	325	251	161	71	19	6
1 g IM	32†	52	65	57	33	7	1
2 g IM	40†	69	93	97	58	14	4

The mean serum half-life of Cefobid is approximately 2.0 hours, independent of the route of administration.

In vitro studies with human serum indicate that the degree of Cefobid reversible protein binding varies with the serum concentration from 93% at 25 mcg/mL of Cefobid to 90% at 250 mcg/mL and 82% at 500 mcg/mL.

Cefobid achieves therapeutic concentrations in the following body tissues and fluids:

Tissue or Fluid	Dose	Concentration
Ascitic Fluid	2 g	64 mcg/mL
Cerebrospinal Fluid (in patients with inflamed meninges)	50 mg/kg	1.8 mcg/mL to 8.0 mcg/mL
Urine	2 g	3,286 mcg/mL
Sputum	3 g	6.0 mcg/mL
Endometrium	2 g	74 mcg/g
Myometrium	2 g	54 mcg/g
Palatine Tonsil	1 g	8 mcg/g
Sinus Mucous Membrane	1 g	8 mcg/g
Umbilical Cord Blood	1 g	25 mcg/mL
Amniotic Fluid	1 g	4.8 mcg/mL
Lung	1 g	28 mcg/g
Bone	2 g	40 mcg/g

Cefobid is excreted mainly in the bile. Maximum bile concentrations are generally obtained between one and three hours following drug administration and exceed concurrent serum concentrations by up to 100 times. Reported biliary concentrations of Cefobid range from 66 mcg/mL at 30 minutes to as high as 6000 mcg/mL at 3 hours after an intravenous bolus injection of 2 grams.

Following a single intramuscular or intravenous dose, the urinary recovery of Cefobid over a 12-hour period averages 20–30%. No significant quantity of metabolites has been found in the urine. Urinary concentrations greater than 2200 mcg/mL have been obtained following a 15-minute infusion of a 2 g dose. After an IM injection of 2 g, peak urine concentrations of almost 1000 mcg/mL have been obtained, and therapeutic levels are maintained for 12 hours.

Repeated administration of Cefobid at 12-hour intervals does not result in accumulation of the drug in normal subjects. Peak serum concentrations, areas under the curve (AUC's), and serum half-lives in patients with severe renal insufficiency are not significantly different from those in normal volunteers. In patients with hepatic dysfunction, the serum half life is prolonged and urinary excretion is increased. In patients with combined renal and hepatic insufficiencies, Cefobid may accumulate in the serum.

Cefobid has been used in pediatrics, but the safety and effectiveness in children have not been established. The half-life of Cefobid in serum is 6–10 hours in low birth-weight neonates.

Microbiology

Cefobid is active in vitro against a wide range of aerobic and anaerobic, gram-positive and gram-negative pathogens. The bactericidal action of Cefobid results from the inhibition of bacterial cell wall synthesis. Cefobid has a high degree of stability in the presence of beta-lactamases produced by most gram-negative pathogens. Cefobid is usually active against organisms which are resistant to other beta-lactam antibiotics because of beta-lactamase production. Cefobid is usually active against the following organisms in vitro and in clinical infections:

Gram-Positive Aerobes

Staphylococcus aureus, penicillinase and non-penicillinase-producing strains

Staphylococcus epidermidis

Streptococcus pneumoniae (formerly Diplococcus pneumoniae)

Streptococcus pyogenes (Group A beta-hemolytic streptococci)

Streptococcus agalactiae (Group B beta-hemolytic streptococci)

Enterococcus (Streptococcus faecalis, S. faecium and S. durans)

Gram-Negative Aerobes

Escherichia coli

Klebsiella species (including K. pneumoniae)

Enterobacter species

Citrobacter species

Haemophilus influenzae

Proteus mirabilis

Proteus vulgaris

Morganella morganii (formerly Proteus morganii)

Providencia stuartii

Providencia rettgeri (formerly Proteus rettgeri)

Serratia marcescens

Pseudomonas aeruginosa

Pseudomonas species

Some strains of Acinetobacter calcoaceticus

Neisseria gonorrhoeae

Anaerobic Organisms

Gram positive cocci (including Peptococcus and Peptostreptococcus)

Clostridium species

Bacteroides fragilis

Other Bacteroides species

Cefobid is also active in vitro against a wide variety of other pathogens although the clinical significance is unknown. These organisms include: Salmonella and Shigella species, Serratia liquefaciens, N. meningitidis, Bordetella pertussis, Yersinia enterocolitica, Clostridium difficile, Fusobacterium species, Eubacterium species and beta-lactamase producing strains of H. influenzae and N. gonorrhoeae.

SUSCEPTIBILITY TESTING

Diffusion Technique

For the disk diffusion method of susceptibility testing, a 75 mcg Cefobid diffusion disk should be used. Organisms should be tested with the Cefobid 75 mcg disk since Cefobid has been shown in vitro to be active against organisms which are found to be resistant to other beta-lactam antibiotics.Tests should be interpreted by the following criteria:

Zone diameter	Interpretation
Greater than or equal to 21 mm	Susceptible
16–20 mm	Moderately Susceptible
Less than or equal to 15 mm	Resistant

Quantitative procedures that require measurement of zone diameters give the most precise estimate of susceptibility. One such method which has been recommended for use with the Cefobid 75 mcg disk is the NCCLS approved standard. (Performance Standards for Antimicrobial Disk Susceptibility Tests. Second Information Supplement Vol. 2 No. 2 pp. 49–69. Publisher–National Committee for Clinical Laboratory Standards, Villanova, Pennsylvania.)

A report of "susceptible" indicates that the infecting organism is likely to respond to Cefobid therapy and a report of "resistant" indicates that the infecting organism is not likely to respond to therapy. A "moderately susceptible" report suggests that the infecting organism will be susceptible to Cefobid if a higher than usual dosage is used or if the infection is confined to tissues and fluids (e.g., urine or bile) in which high antibiotic levels are attained.

Dilution Techniques

Broth or agar dilution methods may be used to determine the minimal inhibitory concentration (MIC) of Cefobid. Serial twofold dilutions of Cefobid should be prepared in either broth or agar. Broth should be inoculated to contain 5 × 105 organism/mL and agar "spotted" with 104 organisms.

MIC test results should be interpreted in light of serum, tissue, and body fluid concentrations of Cefobid. Organisms inhibited by Cefobid at 16 mcg/mL or less are considered susceptible, while organisms with MICs of 17–63 mcg/mL are moderately susceptible. Organisms inhibited at Cefobid concentrations of greater than or equal to 64 mcg/mL are considered resistant, although clinical cures have been obtained in some patients infected by such organisms.

Indications and Usage for Cefobid

Cefobid is indicated for the treatment of the following infections when caused by susceptible organisms:

Respiratory Tract Infections caused by S. pneumoniae, H. influenzae, S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes1 (Group A beta-hemolytic streptococci), P. aeruginosa, Klebsiella pneumoniae, E. coli, Proteus mirabilis, and Enterobacter species.

Peritonitis and Other Intra-abdominal Infections caused by E. coli, P. aeruginosa,1 and anaerobic gram-negative bacilli (including Bacteroides fragilis).

Bacterial Septicemia caused by S. pneumoniae, S. agalactiae,1 S. aureus, Pseudomonas aeruginosa,1 E. coli, Klebsiella spp.,1Klebsiella pneumoniae,1 Proteus species1 (indole-positive and indole-negative), Clostridium spp.1 and anaerobic gram-positive cocci.1

Infections of the Skin and Skin Structures caused by S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes,1 and P. aeruginosa.

Pelvic Inflammatory Disease, Endometritis, and Other Infections of the Female Genital Tract caused by N. gonorrhoeae, S. epidermidis,1 S. agalactiae, E. coli, Clostridium spp.,1Bacteroides species (including Bacteroides fragilis), and anaerobic gram-positive cocci.

Urinary Tract Infections caused by Escherichia coli and Pseudomonas aeruginosa.

Enterococcal Infections: Although cefoperazone has been shown to be clinically effective in the treatment of infections caused by enterococci in cases of peritonitis and other intra-abdominal infections, infections of the skin and skin structures, pelvic inflammatory disease, endometritis and other infections of the female genital tract, and urinary tract infections,1 the majority of clinical isolates of enterococci tested are not susceptible to cefoperazone but fall just at or in the intermediate zone of susceptibility, and are moderately resistant to cefoperazone. However, in vitro susceptibility testing may not correlate directly with in vivo results. Despite this, cefoperazone therapy has resulted in clinical cures of enterococcal infections, chiefly in polymicrobial infections. Cefoperazone should be used in enterococcal infections with care and at doses that achieve satisfactory serum levels of cefoperazone.

1: Efficacy of this organism in this organ system was studied in fewer than 10 infections.

Susceptibility Testing

Before instituting treatment with Cefobid, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Treatment may be started before results of susceptibility testing are available.

Combination Therapy

Synergy between Cefobid and aminoglycosides has been demonstrated with many gram-negative bacilli. However, such enhanced activity of these combinations is not predictable. If such therapy is considered, in vitro susceptibility tests should be performed to determine the activity of the drugs in combination, and renal function should be monitored carefully. (See PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections.)

Contraindications

Cefobid is contraindicated in patients with known allergy to the cephalosporin-class of antibiotics.

Warnings

BEFORE THERAPY WITH Cefobid IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE THE USE OF SUBCUTANEOUS EPINEPHRINE AND OTHER EMERGENCY MEASURES.

PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH THE USE OF CEPHALOSPORINS (AND OTHER BROAD-SPECTRUM ANTIBIOTICS); THEREFORE, IT IS IMPORTANT TO CONSIDER ITS DIAGNOSIS IN PATIENTS WHO DEVELOP DIARRHEA IN ASSOCIATION WITH ANTIBIOTIC USE.

Treatment with broad-spectrum antibiotics alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis. Cholestyramine and colestipol resins have been shown to bind the toxin in vitro.

Mild cases of colitis may respond to drug discontinuance alone.

Moderate to severe cases should be managed with fluid, electrolyte, and protein supplementation as indicated.

When the colitis is not relieved by drug discontinuance or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should also be considered.

Precautions

Although transient elevations of the BUN and serum creatinine have been observed, Cefobid alone does not appear to cause significant nephrotoxicity. However, concomitant administration of aminoglycosides and other cephalosporins has caused nephrotoxicity.

Cefobid is extensively excreted in bile. The serum half-life of Cefobid is increased 2–4 fold in patients with hepatic disease and/or biliary obstruction. In general, total daily dosage above 4 g should not be necessary in such patients. If higher dosages are used, serum concentrations should be monitored.

Because renal excretion is not the main route of elimination of Cefobid (see CLINICAL PHARMACOLOGY), patients with renal failure require no adjustment in dosage when usual doses are administered. When high doses of Cefobid are used, concentrations of drug in the serum should be monitored periodically. If evidence of accumulation exists, dosage should be decreased accordingly.

The half-life of Cefobid is reduced slightly during hemodialysis. Thus, dosing should be scheduled to follow a dialysis period. In patients with both hepatic dysfunction and significant renal disease, Cefobid dosage should not exceed 1–2 g daily without close monitoring of serum concentrations.

As with other antibiotics, vitamin K deficiency has occurred rarely in patients treated with Cefobid. The mechanism is most probably related to the suppression of gut flora which normally synthesize this vitamin. Those at risk include patients with a poor nutritional status, malabsorption states (e.g., cystic fibrosis), alcoholism, and patients on prolonged hyper- alimentation regimens (administered either intravenously or via a naso-gastric tube). Prothrombin time should be monitored in these patients and exogenous vitamin K administered as indicated.

A disulfiram-like reaction characterized by flushing, sweating, headache, and tachycardia has been reported when alcohol (beer, wine) was ingested within 72 hours after Cefobid administration. Patients should be cautioned about the ingestion of alcoholic beverages following the administration of Cefobid. A similar reaction has been reported with other cephalosporins.

Prolonged use of Cefobid may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Cefobid should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Drug/Laboratory Test Interactions

A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate carcinogenic potential. The maximum duration of Cefobid animal toxicity studies is six months. In none of the in vivo or in vitro genetic toxicology studies did Cefobid show any mutagenic potential at either the chromosomal or subchromosomal level. Cefobid produced no impairment of fertility and had no effects on general reproductive performance or fetal development when administered subcutaneously at daily doses up to 500 to 1000 mg/kg prior to and during mating, and to pregnant female rats during gestation. These doses are 10 to 20 times the estimated usual single clinical dose. Cefobid had adverse effects on the testes of prepubertal rats at all doses tested. Subcutaneous administration of 1000 mg/kg per day (approximately 16 times the average adult human dose) resulted in reduced testicular weight, arrested spermatogenesis, reduced germinal cell population and vacuolation of Sertoli cell cytoplasm. The severity of lesions was dose dependent in the 100 to 1000 mg/kg per day range; the low dose caused a minor decrease in spermatocytes. This effect has not been observed in adult rats. Histologically the lesions were reversible at all but the highest dosage levels. However, these studies did not evaluate subsequent development of reproductive function in the rats. The relationship of these findings to humans is unknown.

Usage in Pregnancy

Pregnancy Category B

Reproduction studies have been performed in mice, rats, and monkeys at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Cefobid. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Usage in Nursing Mothers

Only low concentrations of Cefobid are excreted in human milk. Although Cefobid passes poorly into breast milk of nursing mothers, caution should be exercised when Cefobid is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established. For information concerning testicular changes in prepubertal rats (see Carcinogenesis, Mutagenesis, Impairment of Fertility).

Geriatric Use

Clinical studies of Cefobid (sterile cefoperazone sodium) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

In clinical studies the following adverse effects were observed and were considered to be related to Cefobid therapy or of uncertain etiology:

Hypersensitivity

As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.

Hematology

As with other beta-lactam antibiotics, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10.

Hepatic

Of 1285 patients treated with cefoperazone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during Cefobid therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After Cefobid therapy was discontinued, the patient's enzymes returned to pre -treatment levels and the symptomatology resolved. As with other antibiotics that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5–10% of the patients receiving Cefobid therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established.

Gastrointestinal

Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when cefoperazone therapy was stopped. Nausea and vomiting have been reported rarely.

Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibiotic therapy (see WARNINGS).

Renal Function Tests

Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted.

Local Reactions

Cefobid is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When Cefobid is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site.

Cefobid Dosage and Administration

The usual adult daily dose of Cefobid (sterile cefoperazone) is 2 to 4 grams per day administered in equally divided doses every 12 hours.

In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6–12 grams divided into 2, 3 or 4 administrations ranging from 1.5 to 4 grams per dose.

In a pharmacokinetic study, a total daily dose of 16 grams was administered to severely immunocompromised patients by constant infusion without complications. Steady state serum concentrations were approximately 150 mcg/mL in these patients.

When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

Solutions of Cefobid and aminoglycoside should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with Cefobid and an aminoglycoside is contemplated (see INDICATIONS) this can be accomplished by sequential intermittent intravenous infusion provided that separate secondary intravenous tubing is used, and that the primary intravenous tubing is adequately irrigated with an approved diluent between doses. It is also suggested that Cefobid be administered prior to the aminoglycoside. In vitro testing of the effectiveness of drug combination(s) is recommended.

RECONSTITUTION

The following solutions may be used for the initial reconstitution of Cefobid (sterile cefoperazone).

Table 1. Solutions for Initial Reconstitution
* Not to be used as a vehicle for intravenous infusion. † Preparations containing Benzyl Alcohol should not be used in neonates.
5% Dextrose Injection (USP)	0.9% Sodium Chloride Injection (USP)
5% Dextrose and 0.9% Sodium Chloride Injection (USP)	Normosol® M and 5% Dextrose Injection
5% Dextrose and 0.2% Sodium Chloride Injection (USP)	Normosol® R
10% Dextrose Injection (USP)	Sterile Water for Injection*
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP)*†

General Reconstitution Procedures

Cefobid (sterile cefoperazone) for intravenous or intramuscular use may be initially reconstituted with any compatible solution mentioned above in Table 1. Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization. Vigorous and prolonged agitation may be necessary to solubilize Cefobid in higher concentrations (above 333 mg cefoperazone/mL). The maximum solubility of Cefobid (sterile cefoperazone) is approximately 475 mg cefoperazone/mL of compatible diluent.

Preparation for Intravenous Use

General

Cefobid (sterile cefoperazone) concentrations between 2 mg/mL and 50 mg/mL are recommended for intravenous administration.

Preparation of Vials

Vials of Cefobid (sterile cefoperazone) may be initially reconstituted with a minimum of 2.8 mL per gram of cefoperazone of any compatible reconstituting solution appropriate for intravenous administration listed above in Table 1. For ease of reconstitution the use of 5 mL of compatible solution per gram of Cefobid is recommended. The entire quantity of the resulting solution should then be withdrawn for further dilution and administration using any of the following vehicles for intravenous infusion:

Table 2. Vehicles for Intravenous Infusion
5% Dextrose Injection (USP)	Lactated Ringer's Injection (USP)
5% Dextrose and Lactated Ringer's Injection	0.9% Sodium Chloride Injection (USP)
5% Dextrose and 0.9% Sodium Chloride Injection (USP)	Normosol® M and 5% Dextrose Injection
5% Dextrose and 0.2% Sodium Chloride Injection (USP)	Normosol® R
10% Dextrose Injection (USP)

The resulting intravenous solution should be administered in one of the following manners:

Intermittent Infusion

Solutions of Cefobid should be administered over a 15–30 minute time period.

Continuous Infusion

Cefobid can be used for continuous infusion after dilution to a final concentration of between 2 and 25 mg cefoperazone per mL.

Preparation for Intramuscular Injection

Any suitable solution listed above may be used to prepare Cefobid (sterile cefoperazone) for intramuscular injection. When concentrations of 250 mg/mL or more are to be administered, a lidocaine solution should be used. These solutions should be prepared using a combination of Sterile Water for Injection and 2% Lidocaine Hydrochloride Injection (USP) that approximates a 0.5% Lidocaine Hydrochloride Solution. A two-step dilution process as follows is recommended: First, add the required amount of Sterile Water for Injection and agitate until Cefobid powder is completely dissolved. Second, add the required amount of 2% lidocaine and mix.

	Final Cefoperazone Concentration	Step 1 Volume of Sterile Water	Step 2 Volume of 2% Lidocaine	Withdrawable Volume*†
* There is sufficient excess present to allow for withdrawal of the stated volume. † Final lidocaine concentration will approximate that obtained if a 0.5% Lidocaine Hydrochloride Solution is used as diluent.
1 g vial	333 mg/mL	2.0 mL	0.6 mL	3 mL
	250 mg/mL	2.8 mL	1.0 mL	4 mL
2 g vial	333 mg/mL	3.8 mL	1.2 mL	6 mL
	250 mg/mL	5.4 mL	1.8 mL	8 mL

When a diluent other than Lidocaine HCl Injection (USP) is used reconstitute as follows:

	Cefoperazone Concentration	Volume of Diluent to be Added	Withdrawable Volume*
* There is sufficient excess present to allow for withdrawal of the stated volume.
1 g vial	333 mg/mL	2.6 mL	3 mL
	250 mg/mL	3.8 mL	4 mL
2 g vial	333 mg/mL	5.0 mL	6 mL
	250 mg/mL	7.2 mL	8 mL

STORAGE AND STABILITY

Cefobid (sterile cefoperazone) is to be stored at or below 25°C (77°F) and protected from light prior to reconstitution. After reconstitution, protection from light is not necessary.

The following parenteral diluents and approximate concentrations of Cefobid provide stable solutions under the following conditions for the indicated time periods. (After the indicated time periods, unused portions of solutions should be discarded.)

Room Temperature (15°–25°C/59°–77°F)
24 Hours	Approximate Concentrations
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP)	300 mg/mL
5% Dextrose Injection (USP)	2 mg to 50 mg/mL
5% Dextrose and Lactated Ringer's Injection	2 mg to 50 mg/mL
5% Dextrose and 0.9% Sodium Chloride Injection (USP)	2 mg to 50 mg/mL
5% Dextrose and 0.2% Sodium Chloride Injection (USP)	2 mg to 50 mg/mL
10% Dextrose Injection (USP)	2 mg to 50 mg/mL
Lactated Ringer's Injection (USP)	2 mg/mL
0.5% Lidocaine Hydrochloride Injection (USP)	300 mg/mL
0.9% Sodium Chloride Injection (USP)	2 mg to 300 mg/mL
Normosol® M and 5% Dextrose Injection	2 mg to 50 mg/mL
Normosol® R	2 mg to 50 mg/mL
Sterile Water for Injection	300 mg/mL
Reconstituted Cefobid solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers.

Refrigerator Temperature (2°–8°C/36°–46°F)
5 Days	Approximate Concentrations
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP)	300 mg/mL
5% Dextrose Injection (USP)	2 mg to 50 mg/mL
5% Dextrose and 0.9% Sodium Chloride Injection (USP)	2 mg to 50 mg/mL
5% Dextrose and 0.2% Sodium Chloride Injection (USP)	2 mg to 50 mg/mL
Lactated Ringer's Injection (USP)	2 mg/mL
0.5% Lidocaine Hydrochloride Injection (USP)	300 mg/mL
0.9% Sodium Chloride Injection (USP)	2 mg to 300 mg/mL
Normosol® M and 5% Dextrose Injection	2 mg to 50 mg/mL
Normosol® R	2 mg to 50 mg/mL
Sterile Water for Injection	300 mg/mL
Reconstituted Cefobid solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers.

Freezer Temperature –20° to –10°C/–4°to 14°F)
3 Weeks	Approximate Concentrations
5% Dextrose Injection (USP)	50 mg/mL
5% Dextrose and 0.9% Sodium Chloride Injection (USP)	2 mg/mL
5% Dextrose and 0.2% Sodium Chloride Injection (USP)	2 mg/mL
5 Weeks
0.9% Sodium Chloride Injection (USP)	300 mg/mL
Sterile Water for Injection	300 mg/mL
Reconstituted Cefobid solutions may be stored in plastic syringes, or in flexible plastic parenteral solution containers. Frozen samples should be thawed at room temperature before use. After thawing, unused portions should be discarded. Do not refreeze.

How is Cefobid Supplied

Cefobid (sterile cefoperazone) is available in vials containing cefoperazone sodium equivalent to 1 g cefoperazone × 10 (NDC 0049-1201-83) and 2 g cefoperazone × 10 (NDC 0049-1202-83) for intramuscular and intravenous administration.

Cefobid (sterile cefoperazone) is available in 10 g (NDC 0049-1219-28) Pharmacy Bulk Package for intravenous administration.

Rx only

LAB-0033-5.0

Cefobid
cefoperazone powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0049-1201
Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
cefoperazone (cefoperazone)	Active	1 GRAM In 1 VIAL
sodium	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0049-1201-83	10 VIAL In 1 PACKAGE	None

Cefobid
cefoperazone powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0049-1202
Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
cefoperazone (cefoperazone)	Active	2 GRAM In 1 VIAL
sodium	Inactive

Friday, October 21, 2016

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Complete Natal

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