Zotex-C Syrup

codeine phosphate, phenylephrine hydrochloride and pyrilamine maleate

Dosage Form: syrup
ZOTEX™-C Syrup

CV

Rx Only

Zotex-C Syrup Description

Zotex™-C Syrup is an antitussive decongestant and antihistamine available for oral administration as a syrup.

Each 5 mL (1 teaspoonful) of red-colored, cherry-flavored syrup contains:

Codeine Phosphate (WARNING-May be habit forming)	10 mg
Phenylephrine Hydrochloride	5 mg
Pyrilamine Maleate	5 mg

Inactive Ingredients: Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, FD&C Red #40, Cherry Flavor, Purified Water.

Codeine Phosphate is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white crystalline powder. It is affected by light. Its chemical name is Morphinan-6-ol, 7,8-didehydroxy-4,5-epoxy-3-methoxy-17-methyl- ,(5α,6α)-, phosphate (1:1) (salt), hemihydrate.

Its structure is as follows:

C12H21NO3 • H3PO4 • ½H2O                              M.W. 406.37

Phenylephrine Hydrochloride is a sympathomimatic amine decongestant which occurs as white or practically white, odorless crystals having a bitter taste. It is freely soluble in water and in alcohol. The chemical name is: Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-hydrochloride (R)-. Its structure is as follows:

C9H13NO2 • HCl                              M.W. 203.67

Pyrilamine Maleate is an antihistamine having the chemical name 2-[(2-Dimethylamino)ethyl)(p-methoxybenzyl)amino] pyridine maleate (1:1). Its structural formula is as follows:

C17H23N3O•C4H4O4                              MW 401.47

Zotex-C Syrup - Clinical Pharmacology

Codeine Phosphate is a centrally acting analgesic and antitussive which is well absorbed orally. Following absorption, codeine is metabolized by the liver and metabolic products are excreted in the urine.

Phenylephrine Hydrochloride is a sympathomimetic that acts predominantly on alpha receptors and has little action on beta receptors. Phylephrine Hydrochloride causes constriction of blood vessels, which shrinks swollen mucous membranes, reduces tissue hyperemia edema, nasal congestion and increases nasal airway patency. It, therefore, functions as an oral nasal decongestant while causing minimal central nervous system stimulation.

Pyrilamine Maleate is an antihistamine used in suppressing symptoms of allergic rhinitis. However, it is more prone to cause drowsiness than some other antihistamines.

Indications and Usage for Zotex-C Syrup

Zotex™-C Syrup is indicated for symptomatic relief of coughs and upper respiratory symptoms. Including nasal congestion, associated the common cold.

Contraindications

Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Do not use in newborn infants, premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heat disease, or in those receiving monoamine oxidase (MAO) inhibitors. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack. Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Do not exceed the recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

If a hypertensive crisis occurs, these drugs should be discontiued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.

Precautions

General

Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided. Because of its sympathomimetic component, Zotex™-C Syrup should be used with caution in patients with diabetes mellitus, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Patients should be cautioned to get up slowly from a lying or sitting position and to lie down if nausea occurs.

Drug Interactions

Patients receiving other narcotic analgesics, anti-psychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with this drug may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The concurrent use of anticholinergics with codeine may produce paralytic ileus. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g.; hypnotics, sedatives, tranquilizers, antianxiety agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Zotex™-C Syrup to assess the carcinogenic and mutagenic potential to the effect on fertility have not been performed.

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Zotex™-C Syrup. It is also not known whether Zotex™-C Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Zotex™-C Syrup should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether codeine is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from this product, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular. Zotex™-C Syrup is contraindicated in nusing mothers.

Pediatric Use

Not recommended for use in patients under 6 years of age.

Geriatric Use

The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly.

Adverse Reactions

The most frequent adverse reactions to Zotex™-C Syrup include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

General: urinary, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat.

Cardiovascular System: hypotension, headache, palpitations, tachycardia, extra systoles.

Dermatologic: urticaria, drug rash, photosensitivity, and pruritus.

Central Nervous System: sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, peuritus convulsions.

Gastrointestinal: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.

Genitourinary: urinary frequency, difficult urination, urinary retention, early mensea.

Respiratory: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Hematologic System: hemolytic anemia, thrombocytopenia, agranulocytosis.

Overdosage

Signs and Symptoms

Overdosage of Phenylephrine Hydrochloride may be associated with central nervous system stimulation, tachycardia, hypertension, and cardiac arrhythmias.

Toxic Doses

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out although in some instances tracheotomy may be necessary prior to lavage. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

DOSAGE AND ADMINISTRATION1

Adults and Children 12 years of age and older: 1-2 teaspoonfuls every 4-6 hours, not to exceed 12 teaspoonfuls in a 24 hour period.

Children 6 to 12 years of age: 1/2 to 1 teaspoonful every 4-6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.

1

In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

How is Zotex-C Syrup Supplied

Zotex™-C Syrup is a sugar free, alcohol free, cherry-flavored, red-colored syrup in 16 fl oz (473 mL) bottles.

NDC 68025-037-16 and professional samples of 10 mL NDC 68025-037-10.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Manufactured for:

Vertical Pharmaceuticals, Inc.

Sayreville, NJ 08872

Iss. 09/08

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

NDC 68025-037-16

ZOTEX™-C

Syrup

Antitussive / Decongestant / Antihistamine

Cherry Flavor

Each teaspoonful (5 mL) for oral

administration contains:

Codeine Phosphate*	10 mg
*WARNING: May be habit-forming.
Phenylephrine HCl	5 mg
Pyrilamine Maleate	5 mg

Alcohol Free • Sugar Free

Rx Only

VERTICAL

PHARMACEUTICALS, INC.

16 fl oz (473 mL)

ZOTEX-C  codeine phosphate, phenylephrine hydrochloride and pyrilamine maleate  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68025-037 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 10 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   PROPYLENE GLYCOL   SORBITOL   CITRIC ACID MONOHYDRATE   SODIUM CITRATE   FD&C RED NO. 40   WATER

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68025-037-16 473 mL In 1 BOTTLE None 2 68025-037-10 10 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/10/2008

Labeler - Vertical Pharmaceuticals, Inc. (173169017)

Establishment
Name	Address	ID/FEI	Operations
Great Southern Laboratories		056139553	MANUFACTURE, PACK

Revised: 01/2010Vertical Pharmaceuticals, Inc.

More Zotex-C Syrup resources

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

Compare Zotex-C Syrup with other medications

• Cold Symptoms
• Cough and Nasal Congestion

Hygenic Cleansing Pad

Generic Name: glycerin and witch hazel topical (GLISS er in and WITCH hay zel TOP ik al)

Brand Names: A.E.R. Witch Hazel, Hemorrhoidal Hygiene Pads, Hygenic Cleansing Pad, Medi-Pad, Sani-Clens, Sani-pads with Aloe, Tucks

What is Hygenic Cleansing Pad (glycerin and witch hazel topical)?

Glycerin protects the skin and creates a protective barrier over hemorrhoids, allowing them to heal. Glycerin also prevents drying of these tissues and reduces itching.

Witch hazel is an astringent. It shrinks swollen tissue and provide relief from itching and irritation.

The combination of glycerin and witch hazel topical (for the skin) is used to relieve rectal pain, pressure, irritation, and mild bleeding caused by hemorrhoids. This medicine will not treat or cure a hemorrhoid, it will only relieve the symptoms.

Glycerin and witch hazel topical is also used to relieve vaginal discomfort after childbirth. This medication may also be applied to the diaper area of a baby.

Glycerin and witch hazel topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hygenic Cleansing Pad (glycerin and witch hazel topical)?

Do not take glycerin and witch hazel topical by mouth. It is for use only on your rectum. Stop using this medicine and call your doctor at once if you have bloody diarrhea or severe pain, bleeding, or irritation around your rectum.

Avoid using laxatives in combination with glycerin and witch hazel topical unless your doctor has told you to.

What should I discuss with my healthcare provider before using Hygenic Cleansing Pad (glycerin and witch hazel topical)?

You should not use this medication if you are allergic to glycerin or witch hazel. It is not known whether this medication will harm an unborn baby. Do not use glycerin and witch hazel topical without medical advice if you are pregnant. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use glycerin and witch hazel topical without medical advice if you are breast-feeding a baby.

How should I use Hygenic Cleansing Pad (glycerin and witch hazel topical)?

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.

It is best to use this medication after using the bathroom or having a bowel movement.

You may use a glycerin and witch hazel topical medicated pad up to 6 times per day.

After using the medicated pad, you may flush it down a toilet or septic system.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since glycerin and witch hazel topical is used as needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using glycerin and witch hazel topical .

What happens if I overdose?

An overdose of glycerin and witch hazel topical is not expected to be dangerous.

What should I avoid while using Hygenic Cleansing Pad (glycerin and witch hazel topical)?

Do not take glycerin and witch hazel topical by mouth. It is for use only on your rectum.

Avoid using laxatives in combination with glycerin and witch hazel topical unless your doctor has told you to.

Hygenic Cleansing Pad (glycerin and witch hazel topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using glycerin and witch hazel topical and call your doctor at once if you have a serious side effect such as:

• 
  

  bloody diarrhea; or

  
  


• 
  

  severe pain, bleeding, or irritation of the skin around your rectum.

  
  

Less serious side effects are more likely, and you may have none at all.

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 Hygenic Cleansing Pad (glycerin and witch hazel topical)?

There may be other drugs that can interact with glycerin and witch hazel topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Hygenic Cleansing Pad resources

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

Compare Hygenic Cleansing Pad with other medications

• Hemorrhoids

Where can I get more information?

• Your pharmacist can provide more information about glycerin and witch hazel topical.

See also: Hygenic Cleansing side effects (in more detail)

Trivaris Intravitreal ophthalmic

Generic Name: triamcinolone (ophthalmic) (trye am SIN oh lone off THAL mik)

Brand Names: Triesence, Trivaris Intravitreal

What is Trivaris Intravitreal (triamcinolone (ophthalmic))?

Triamcinolone is a steroid. It prevents the release of substances in the body that cause inflammation.

Triamcinolone ophthalmic (for the eyes) is injected into the eye to treat inflammation caused by disease or injury. Triamcinolone ophthalmic is usually given after steroid eye drops have been used without successful treatment of symptoms.

Triamcinolone ophthalmic is also used during a certain type of eye surgery.

Triamcinolone ophthalmic may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Trivaris Intravitreal (triamcinolone (ophthalmic))?

You should not receive this medication if you are allergic to triamcinolone, or if you have a fungal infection anywhere in your body. Do not use triamcinolone if you are pregnant. It could harm the unborn baby.

Before receiving triamcinolone ophthalmic, tell your doctor if you have any type of bacterial, fungal, or viral infection (including tuberculosis). Also tell your doctor if you have cataracts or glaucoma, herpes infection of your eye, diabetes, high blood pressure, congestive heart failure, a thyroid disorder, myasthenia gravis, a stomach or intestinal disorder, or a history of recent heart attack.

Before you receive any vaccine, talk with the doctor who is treating you with triamcinolone ophthalmic. Some vaccines may not work as well or could cause harmful side effects during treatment with steroid medicine.

Steroids can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles.

There are many other drugs that can interact with triamcinolone. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What should I discuss with my health care provider before receiving Trivaris Intravitreal (triamcinolone (ophthalmic))?

You should not receive this medication if you are allergic to triamcinolone, or if you have a fungal infection anywhere in your body.

To make sure you can safely receive triamcinolone, tell your doctor if you have any of these other conditions:

• 
  

  herpes infection of your eye;

  
  


• 
  

  eye conditions such as cataract or glaucoma;

  
  


• 
  

  diabetes;

  
  


• 
  

  high blood pressure, congestive heart failure;

  
  


• 
  

  any type of bacterial, fungal, or viral infection (including tuberculosis);

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  diverticulitis, stomach or intestinal ulcer, or recent stomach surgery; or

  
  


• 
  

  if you have recently had a heart attack.

  
  

FDA pregnancy category D. Do not receive triamcinolone if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Triamcinolone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medication can decrease bone formation which could lead to osteoporosis, especially with long-term use. Talk with your doctor about your specific risk of bone loss while receiving triamcinolone ophthalmic.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How is triamcinolone ophthalmic given?

Triamcinolone ophthalmic is given as an injection into your eye. Your doctor will use a medicine to numb your eye before giving you the injection. You will receive this injection in your doctor's office or other clinic setting.

For at least 30 minutes after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Long-term use of steroids can cause harmful effects on the eyes, such as glaucoma or cataracts. If you receive triamcinolone ophthalmic for longer than 6 weeks, your doctor may want you to have regular eye exams.

Steroids can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill, or from bacteria in a skin wound. Steroids can also slow the healing of skin wounds. Use caution to prevent illness, infection, or injury.

Your doctor may instruct you to limit your salt intake while you are receiving triamcinolone ophthalmic. You may also need to take potassium supplements. Follow your doctor's instructions.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using triamcinolone.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Trivaris Intravitreal (triamcinolone (ophthalmic))?

Do not receive a smallpox vaccine or any other "live" vaccine if you are being treated long-term with triamcinolone ophthalmic. Some vaccines may not work as well during treatment with steroid medicine at certain doses. Some vaccines may even cause dangerous side effects when used during steroid treatment. Before you receive any vaccine, talk with the doctor who is treating you with triamcinolone ophthalmic.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroids.

Trivaris Intravitreal (triamcinolone (ophthalmic)) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  problems with your vision, pain behind your eyes, or seeing halos around lights;

  
  


• 
  

  eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection);

  
  


• 
  

  large red or purple spots on your skin;

  
  


• 
  

  fast or slow heart rate;

  
  


• 
  

  feeling short of breath, swelling in your hands or feet;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure);

  
  


• 
  

  severe dizziness or nausea;

  
  


• 
  

  severe depression, changes in mood or behavior, seizures (convulsions); or

  
  


• 
  

  severe pain in your upper stomach.

  
  

Less serious side effects may include:

• 
  

  mild eye discomfort;

  
  


• 
  

  headaches, back aches, weakness;

  
  


• 
  

  bloating, appetite changes, weight gain;

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist), roundness in your face;

  
  


• 
  

  increased acne or facial hair;

  
  


• 
  

  menstrual problems (in women), impotence or loss of interest in sex (in men);

  
  


• 
  

  dry skin, thinning skin, changes in skin color;

  
  


• 
  

  bruising, sweating more than usual; or

  
  


• 
  

  any wound that will not heal.

  
  

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 Trivaris Intravitreal (triamcinolone (ophthalmic))?

Many drugs can interact with triamcinolone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  amphotericin B (Fungizone, AmBisome, Abelcet);

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  cholestyramine (Prevalite, Questran);

  
  


• 
  

  cyclosporine (Neoral, Gengraf, Sandimmune);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  insulin or an oral diabetes medication;

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

  
  


• 
  

  an antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), piroxicam (Feldene), and others;

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), quinidine (Quin-G), or verapamil (Calan, Covera, Isoptin, Verelan);

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nevirapine (Viramune), saquinavir (Invirase, Fortovase), ritonavir (Norvir, Kaletra), and others;

  
  


• 
  

  medications to treat dementia, such as donepezil (Aricept), rivastigmine (Exelon), galantamine (Razadyne), tacrine (Cognex); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others.

  
  

This list is not complete and there are many other drugs that can interact with triamcinolone. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Trivaris Intravitreal resources

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

Compare Trivaris Intravitreal with other medications

• Temporal Arteritis
• Uveitis

Where can I get more information?

• Your doctor can provide more information about triamcinolone ophthalmic.

See also: Trivaris Intravitreal side effects (in more detail)

carboprost

Generic Name: carboprost (KAR boe prost)

Brand Names: Hemabate

What is carboprost?

Carboprost is a form of prostaglandin (a hormone-like substance that occurs naturally in the body). Prostaglandins help to control functions in the body such as blood pressure and muscle contractions.

Carboprost is used to treat severe bleeding after childbirth (postpartum).

Carboprost is also used to produce an abortion by causing uterine contractions. It is usually given between the 13th and 20th weeks of pregnancy, but may be given at other times for medical reasons. Carboprost is often used when another method of abortion has not completely emptied the uterus, or when a complication of pregnancy would cause the baby to be born too early to survive.

Carboprost may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about carboprost?

Carboprost usually causes nausea, vomiting, and/or diarrhea. You may be given to control these things before you are given carboprost.

You should not receive this medication if you are allergic to carboprost, or have certain conditions such as pelvic inflammatory disease, a breathing disorder, heart disease, liver disease, or kidney disease. Serious side effects of carboprost may include severe pelvic cramping, vaginal bleeding, high fever, and severe vomiting or diarrhea.

Before you receive carboprost, tell your doctor if you have been treated with any other drugs that may cause contractions of the uterus. Carboprost can increase the effects of these other drugs, and they should not be used together.

Your cervix (opening of the uterus) will need to be checked after you receive carboprost. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated.

What should I discuss with my health care provider before receiving carboprost?

You should not receive this medication if you are allergic to carboprost, or have certain conditions. Tell your doctor if you have:

• 
  

  pelvic inflammatory disease;

  
  


• 
  

  a lung disorder or breathing problem;

  
  


• 
  

  heart disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  liver disease.

  
  

Before receiving carboprost, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  high or low blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  any scarring in your uterus;

  
  


• 
  

  a history of asthma; or

  
  


• 
  

  a history of heart, kidney, or liver disease.

  
  

If you have any of these conditions, you may not be able to receive carboprost, or you may need dosage adjustments or special tests during treatment.

If you are receiving this medication for purposes other than abortion or postpartum bleeding, tell your doctor if you are pregnant.

How is carboprost given?

Carboprost is given as an injection into a muscle. You will receive this injection in a clinic or hospital setting.

You may also be given medication to control nausea, vomiting, or diarrhea caused by carboprost.

To be sure this medication has been effective, your cervix (opening of the uterus) will need to be checked after the procedure. Do not miss any scheduled follow-up visits to your doctor.

In some cases, carboprost may not produce a complete abortion and the procedure must be repeated.

What happens if I miss a dose?

Since this medication is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine. An overdose of carboprost is unlikely to occur in a hospital or clinic setting.

What should I avoid while receiving carboprost?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive carboprost.

Carboprost 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  severe pelvic pain, cramping, or vaginal bleeding;

  
  


• 
  

  high fever;

  
  


• 
  

  feeling light-headed or short of breath;

  
  


• 
  

  severe nausea, vomiting, or diarrhea; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects include:

• 
  

  mild fever that may come and go;

  
  


• 
  

  chills, numbness, or tingly feeling;

  
  


• 
  

  mild nausea or diarrhea;

  
  


• 
  

  cough;

  
  


• 
  

  headache;

  
  


• 
  

  breast pain or tenderness;

  
  


• 
  

  menstrual type pain; or

  
  


• 
  

  ringing in your ears.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Carboprost Dosing Information

Usual Adult Dose for Abortion:

Initial dose: 250 mcg (1 mL) intramuscularly once. The dose should be administered deep into the muscle with a tuberculin syringe.

Subsequent doses of 250 mcg (1 mL) may be administered at 1.5 to 3.5 hour intervals depending on uterine response.

An optional test dose of 100 mcg (0.4 mL) may be administered initially. The dose may be increased to 500 mcg (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 mcg (1 mL).

The total dose of carboprost administered should not exceed 12 milligrams and continuous administration of the drug for more than 2 days is not recommended.

Abortion induced by carboprost may be expected to be incomplete in about 20% of cases (the same percentage as with spontaneous abortions).

While the incidence of cervical trauma is extremely small, the cervix should always be examined immediately postabortion.

Usual Adult Dose for Postpartum Bleeding:

Initial dose: 250 mcg (1 mL) administered deeply intramuscularly once.

Clinical trials have reported that 73% of cases responded to single injections.

In some selected cases, multiple dosing at intervals of 15 to 90 minutes was reported to have had a successful outcome.

The need for additional injections and the interval at which additional injections should be administered must be determined by the attending physician as dictated by the course of clinical events.

The total dose of carboprost should not exceed 2 mg (8 doses or 8 mL).

What other drugs will affect carboprost?

Before you receive carboprost, tell your doctor if you have been treated with any other drugs that may cause contractions of the uterus, such as:

• 
  

  dinoprostone (Prostin E2);

  
  


• 
  

  mifepristone (Mifeprex (RU-486)

  
  


• 
  

  misoprostol (Cytotec); or

  
  


• 
  

  oxytocin (Pitocin).

  
  

Carboprost can increase the effects of these other drugs, and they should not be used together.

This list it not complete and there may be other drugs that can affect carboprost. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More carboprost resources

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

• carboprost Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information


• Carboprost Tromethamine Monograph (AHFS DI)


• Hemabate Prescribing Information (FDA)

Compare carboprost with other medications

• Abortion
• Postpartum Bleeding

Where can I get more information?

• Your doctor or pharmacist can provide more information about carboprost.

See also: carboprost side effects (in more detail)

Co-codamol 8 / 500 Effervescent Tablets

1. Name Of The Medicinal Product

Co-codamol Effervescent Tablets

2. Qualitative And Quantitative Composition

Paracetamol Ph Eur 500mg

Codeine Phosphate Ph Eur 8mg effervescent

3. Pharmaceutical Form

Effervescent Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

For the short-term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone such as headaches, migraine, neuralgia, toothache, dysmenorrhoea and rheumatic pain.

4.2 Posology And Method Of Administration

For oral administration.

Adults the elderly and children over 12 years

Two tablets dissolved in a tumblerful of water. To be taken up to 4 times daily if required. Do not take for more than 3 days without medical review.

These doses should not be given more frequently than every 4 hours. No more than 4 doses should be given in any 24 hour period.

Children under 12 years:

Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to paracetamol, codeine phosphate or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the recommended dose. Do not take with any other paracetamol-containing products. If symptoms persist, consult your doctor. Keep out of the reach of children. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

The label will state:

Front of pack

• Can cause addiction

• For three days use only

• For pain relief

Back of pack

• For the short term treatment of acute moderate pain when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

• Headache, migraine, toothache, neuralgia, period pains and rheumatic pains

• If you need to take this medicine for more than 3 days you should see your doctor or pharmacist.

This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. If you take this medicine for headaches for more than 3 days it can make them worse

The leaflet will state:

Important things you should know about co-codamol

• This medicine can only be used the short term treatment of acute moderate pain when other painkillers have not worked

• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take this medicine for headaches for more than 3 days it can make them worse

Section 1: What co-codamol is and what it is used for

• It is an analgesic (painkiller) and is for the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

Section 2: Before you take co-codamol

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

• If you take a painkiller for headaches for more than 3 days it can make them worse

Section 3: How to take co-codamol

• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist

• This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Section 4: Possible side effects

This will appear immediately after the heading:

Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy.

This will appear at the end of section 4

How do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time

• You need to take more than the recommended dose

• When you stop taking this medicine you feel very unwell but you feel better if you start taking the medicine again

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the Caucasian population may be ultra-rapid metabolisers.

The leaflet will state in the "Pregnancy and breast-feeding" subsection of section 2 "Before taking your medicine":

Usually it is safe to take co-codamol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk.

If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dose. Codeine has been used for many years without apparent ill consequence and animal studies have not shown any hazard. Patients should follow the advice of their doctor regarding the use of this product.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and are unlikely to adversely affect the breast fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, drowsiness, confusion and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity. Tolerance and dependence can occur, especially with prolonged high dosage of codeine.

There have been very rare occurrences of pancreatitis.

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient:

• is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes, or

• regularly consumes ethanol in excess of recommended amounts, or

• is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines (see BNF overdose section).

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Codeine

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated characoal if an adult presents within one hour of ingestion of more than 350mg or a child more than 5mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a well established analgesic and antipyretic.

Codeine phosphate is a centrally acting analgesic and also has a weak cough suppressant activity.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma reaches a peak in 30-60 minutes. Plasma half-life is 1-4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids, plasma protein binding is variable.

Codeine phosphate is well absorbed after oral administration and is widely distributed. About 86% is excreted in the urine in 24 hours, 40-70% is free or conjugated morphine and 10-20% is free or conjugated Norcodeine.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sorbitol

Saccharin sodium

Sodium hydrogen carbonate (sodium bicarbonate)

Polyvidone (povidone)

Sodium lauryl sulphate

Anhydrous citric acid

Anhydrous sodium carbonate

Dimeticone (dimethicone)

6.2 Incompatibilities

None.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Individually packed into PPFP or Surlyn laminate strips in cardboard carton.

Pack sizes: 12, 16, 24, 30, 32.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Winthrop Pharmaceuticals UK Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

PL 17780/0072

9. Date Of First Authorisation/Renewal Of The Authorisation

17 November 2002

10. Date Of Revision Of The Text

02 February 2011

LEGAL CATEGORY

P

pamidronate

Generic Name: pamidronate (PAM i DROE nate)

Brand Names: Aredia

What is pamidronate?

Pamidronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body.

Pamidronate is used to treat high levels of calcium in the blood related to cancer (also called hypercalcemia of malignancy). Pamidronate is also used to treat Paget's disease of bone.

Pamidronate is used to treat bone damage caused by certain types of cancer such as breast cancer or bone marrow cancer. Pamidronate does not treat cancer. Use all other medications your doctor has prescribed for those conditions.

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

What is the most important information I should know about pamidronate?

Do not use pamidronate if you are pregnant. It could harm the unborn baby. You should not use this medication if you are allergic to pamidronate or to other bisphosphonates such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa).

Before using pamidronate, tell your doctor if you have kidney disease, a history of thyroid surgery, or low levels of platelets or red blood cells.

Some people using medicines similar to pamidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Pamidronate can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using pamidronate, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Serious side effects of pamidronate include high fever, severe bone pain, severe joint or muscle pain, urinating less than usual or not at all, swelling, rapid weight gain, eye pain, vision changes, confusion, uneven heart rate, extreme thirst, muscle weakness or limp feeling, or seizure.

What should I discuss with my healthcare provider before using pamidronate?

You should not use this medication if you are allergic to pamidronate or to other bisphosphonates such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa).

To make sure you can safely use pamidronate, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease;

  
  


• 
  

  a history of thyroid surgery; or

  
  


• 
  

  low levels of platelets or red blood cells.

  
  

Some people using medicines similar to pamidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category D. Do not use pamidronate if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether pamidronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is pamidronate given?

Pamidronate is injected into a vein through an IV. This medication must be given slowly, and the IV infusion can take up 2 to 24 hours to complete. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Pamidronate is sometimes given as a single dose only one time. It may also be repeated over 3 days in a row, or given once every 3 to 4 weeks. How often you receive this medication and the length of your infusion time will depend on the condition being treated. Follow your doctor's instructions.

You may need to mix pamidronate with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Never mix pamidronate with a solution that contains calcium (such as lactated Ringer's solution) or with other drugs in the same IV bag or line.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you do not have hypercalcemia, your doctor may want you to take calcium or vitamin D supplements by mouth while you are using pamidronate. Do not take any vitamin or mineral supplements that your doctor has not prescribed. To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly. Store unmixed pamidronate at room temperature away from moisture and heat. After mixing pamidronate with a diluent, store in the refrigerator and use it within 24 hours. Do not freeze. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of pamidronate.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using pamidronate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pamidronate 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  high fever;

  
  


• 
  

  severe joint, bone, or muscle pain;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  pain or burning when you urinate;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  eye pain, vision changes;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  
  


• 
  

  confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling, or jerking muscle movements.

  
  

Less serious side effects may include:

• 
  

  low fever;

  
  


• 
  

  stomach pain, loss of appetite, nausea, vomiting;

  
  


• 
  

  constipation; or

  
  


• 
  

  pain, redness, swelling or a hard painful lump under your skin around the IV needle.

  
  

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.

Pamidronate Dosing Information

Usual Adult Dose for Hypercalcemia of Malignancy:

60 to 90 mg as a single dose, intravenously by slow infusion over 2 to 24 hours one time. Longer infusions (i.e., > 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency. If significant hypercalcemia persists or recurs, a second dose, identical to the first, may be considered. A minimum of 7 days should elapse between doses. Response to subsequent doses may be diminished. Patients with frequent recurrences of hypercalcemia may require infusions of pamidronate every 2 to 3 weeks to maintain normocalcemia.

Usual Adult Dose for Paget's Disease:

30 mg intravenously as a 4 hour infusion on 3 consecutive days. A limited number of patients have received more than one treatment with the same dosage.

Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma:

90 mg intravenously as a 4 hour infusion given on a monthly basis for up to 9 months.

Usual Adult Dose for Osteolytic Bone Metastases of Breast Cancer:

90 mg intravenously as a 2 hour infusion given every 3 to 4 weeks.

Usual Pediatric Dose for Hypercalcemia:

> 1 year:

0.5 to 1 mg/kg intravenously by slow infusion over 24 hours one time. If significant hypercalcemia persists or recurs, a second dose, identical to the first, may be considered. A minimum of 7 days should elapse between doses.

What other drugs will affect pamidronate?

Pamidronate can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• 
  

  lithium (Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  
  


• 
  

  medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

This list is not complete and other drugs may interact with pamidronate. 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 pamidronate resources

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

• pamidronate Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Pamidronate MedFacts Consumer Leaflet (Wolters Kluwer)


• Pamidronate Prescribing Information (FDA)


• Aredia Monograph (AHFS DI)


• Aredia Prescribing Information (FDA)

Compare pamidronate with other medications

• Breast Cancer, Bone Metastases
• Hypercalcemia
• Hypercalcemia of Malignancy
• Osteolytic Bone Lesions of Multiple Myeloma
• Paget's Disease

Where can I get more information?

• Your pharmacist can provide more information about pamidronate.

See also: pamidronate side effects (in more detail)

Zinc

Dosage Form: injection, solution
Zinc

1 mg/mL

Zinc Chloride Injection, USP

FOR I.V. USE ONLY AFTER DILUTION

Plastic Vial

Rx Only

Zinc Description

Zinc 1 mg/mL (Zinc Chloride Injection, USP) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 2.09 mg Zinc chloride and 9 mg sodium chloride. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.354 m0smoL/mL (calc.).

Zinc Chloride, USP is chemically designated ZnCl2, a white crystalline compound freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.

The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The small amount of water vapor that can pass through the plastic container wall will not significantly alter the drug concentration.

Zinc - Clinical Pharmacology

Zinc is an essential nutritional requirement and serves as a cofactor for more than 70 different enzymes including carbonic anhydrase, alkaline phosphatase, lactic dehydrogenase, and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration, and the senses of taste and smell.

Zinc resides in muscle, bone, skin, kidney, liver, pancreas, retina, prostate and particularly in the red and white blood cells. Zinc binds to plasma albumin, α2-macroglobulin, and some plasma amino acids including histidine, cysteine, threonine, glycine, and asparagine. Ingested Zinc is excreted mainly in the stool (approximately 90%), and to a lesser extent in the urine and in perspiration.

Providing Zinc helps prevent development of deficiency symptoms such as: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly.

The initial manifestations of hypoZincemia in TPN are diarrhea, apathy and depression. At plasma levels below 20 mcg Zinc/100 mL dermatitis followed by alopecia has been reported for TPN patients. Normal Zinc plasma levels are 100 ± 12 mcg/100 mL.

Indications and Usage for Zinc

Zinc 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

Contraindications

None known.

Warnings

Direct intramuscular or intravenous injection of Zinc 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Zinc doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL (Zinc Chloride Injection, USP) should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Zinc from a bolus injection. Administration of Zinc in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Zinc are suggested as a guideline for subsequent Zinc administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Zinc 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

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 Zinc 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

See DOSAGE and ADMINISTRATION section.

Pregnancy Category C. Animal reproduction studies have not been conducted with Zinc chloride. It is also not known whether Zinc chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Zinc chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between 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

None known.

Drug Abuse and Dependence

None known.

Overdosage

Single intravenous doses of 1 to 2 mg Zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Zinc was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Zinc concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Zinc overdosage; patients receiving an inadvertent overdose (25 mg Zinc/liter of TPN solution, equivalent to 50 to 70 mg Zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Zinc was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Zinc toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Zinc level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Zinc toxicity.

Zinc Dosage and Administration

Zinc 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg Zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg Zinc/day (2.5 to 4 mL/day). An additional 2 mg Zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg Zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg Zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of Zinc.

For full term infants and children up to 5 years of age, 100 mcg Zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg Zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

How is Zinc Supplied

Zinc 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Revised: October, 2004

 

©Hospira 2004        EN - 0488        Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

RL-0577

Zinc  Zinc chloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-4090 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc CHLORIDE (Zinc) Zinc 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 9 mg  in 1 mL HYDROCHLORIC ACID   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-4090-01 1 TRAY In 1 CASE contains a TRAY 1 25 VIAL In 1 TRAY This package is contained within the CASE (0409-4090-01) and contains a VIAL, PLASTIC 1 10 mL In 1 VIAL, PLASTIC This package is contained within a TRAY and a CASE (0409-4090-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018959	08/11/2011

Labeler - Hospira, Inc. (141588017)

Revised: 08/2011Hospira, Inc.

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• Zinc Drug Interactions
• Zinc Support Group
• 0 Reviews · Be the first to review/rate this drug

Gengraf Solution

Pronunciation: SYE-kloe-SPOR-een
Generic Name: Cyclosporine
Brand Name: Examples include Gengraf and Neoral

Gengraf Solution suppresses the immune system, which may increase your risk of developing an infection or cancer. In kidney, liver, or heart transplant patients, Gengraf Solution may be used along with other medicines that suppress the immune system. Using these medicines together may further increase your risk of developing an infection or a certain type of cancer (lymphoma).

Gengraf Solution cannot be switched with other forms of cyclosporine (eg, Sandimmune) without your doctor's approval. If you are taking Gengraf Solution for a transplant or for rheumatoid arthritis, lab tests may be performed to monitor your progress or to check for side effects, such as toxicity.

If you are using Gengraf Solution for psoriasis and you are also using certain other forms of treatment (eg, psoralen ultraviolet A [PUVA] or ultraviolet B [UVB] therapy, medicines that suppress the immune system, coal tar, radiation therapy), you may be at an increased risk of developing skin cancer.

Gengraf Solution may cause high blood pressure or kidney problems. This risk may be increased with high doses or prolonged use of Gengraf Solution. Kidney function tests may be performed while you are taking Gengraf Solution to check for side effects.

Gengraf Solution is used for:

Preventing the rejection of organ transplants (kidney, liver, and heart). Gengraf Solution is also used to treat psoriasis and rheumatoid arthritis in certain patients. It may also be used for other conditions as determined by your doctor.

Gengraf Solution is an immunosuppressant. Exactly how Gengraf Solution works is not known, but it may block certain white blood cells (lymphocytes).

Do NOT use Gengraf Solution if:

• you are allergic to any ingredient in Gengraf Solution


• you are taking bosentan, disulfiram, fluorouracil, metronidazole, orlistat, or a potassium-sparing diuretic (eg, spironolactone)


• you have psoriasis or rheumatoid arthritis and also have kidney problems, uncontrolled high blood pressure, or cancer


• you are using other therapies for psoriasis (eg, PUVA or UVB therapy, methotrexate or other medicines that suppress the immune system, coal tar, radiation therapy)


• you are going to be vaccinated with a live vaccine

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

Before using Gengraf Solution:

Some medical conditions may interact with Gengraf Solution. 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 liver, kidney, brain, or nerve problems; high blood potassium or uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; or problems absorbing food or medicine; or have had a recent vaccination


• if your diet contains a lot of potassium


• if you have a history of seizures


• if you are having phototherapy for psoriasis, or are having radiation treatment

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

• Many prescription and nonprescription medicines (eg, used for infections, inflammation, allergic reactions, asthma, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach and intestinal problems, endometriosis, HIV, seizures, blood clotting, weight loss, arthritis, psoriasis, depression, sleep, other conditions), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) may interact with Gengraf Solution. They may increase the risk of side effects or decrease the effectiveness of this or other medicines


• Potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased


• Bosentan because the risk of its side effects and toxic effects may be increased by Gengraf Solution


• Disulfiram, fluorouracil, or metronidazole because flushing, headache, fast or irregular heartbeat, shortness of breath, nausea, or vomiting may occur


• Orlistat because it may decrease Gengraf Solution's effectiveness

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

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

• Take Gengraf Solution on a regular schedule with regard to food and time of day.


• Do not eat grapefruit or drink grapefruit juice while you use Gengraf Solution.


• If you also take sirolimus, do not take it within 4 hours after taking Gengraf Solution. Check with your doctor if you have questions.


• Follow your doctor's instructions on how to dilute Gengraf Solution. Use a glass container to mix Gengraf Solution. To improve the flavor, Gengraf Solution may be mixed with room temperature orange or apple juice. Certain brands of Gengraf Solution should not be taken with apple juice; check with your doctor or pharmacist.


• Avoid frequently switching the liquid that you use to mix Gengraf Solution in. Stir well and drink right away (do not let it stand before drinking). Rinse glass with more liquid and drink again to make sure the entire dose is taken.


• Do not rinse the dosing syringe with water or other cleaning agents. This will affect the dose. If the syringe needs to be cleaned, it must be completely dry before it is used again.


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

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

Important safety information:

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


• Do not switch to another doseform or change brands of Gengraf Solution without talking to your doctor. Products made by other companies may not work as well for you.


• Gengraf Solution may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Gengraf Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor.


• Gengraf Solution may lower the ability of your body to fight infection and may increase the risk of severe infections. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.


• Some people treated with Gengraf Solution have developed severe kidney problems associated with the BK virus infection. Tell your doctor right away if you notice symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Discuss any questions or concerns with your doctor.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Gengraf Solution. Talk with your doctor before you receive any vaccine.


• Gengraf Solution may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Tell your doctor or dentist that you take Gengraf Solution before you receive any medical or dental care, emergency care, or surgery.


• Patients who are being treated for psoriasis will need to have careful skin and physical examinations, including blood pressure measurements, before starting this medication.


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


• Lab tests, including kidney and liver function; cyclosporine levels; and blood pressure, lipids, and electrolytes, may be performed while you use Gengraf Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Gengraf Solution with caution in the ELDERLY; they may be more sensitive to its effects.


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

Possible side effects of Gengraf Solution:

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:

Acne; burning sensation; coughing; dizziness; flushing; headache; increased hair growth; nausea; runny nose; sleeplessness; stomach discomfort; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; change in the appearance of a mole; chest pain; confusion; dark urine; diarrhea; fast or irregular heartbeat; gum disease or overgrowth; increased or decreased urination; loss of coordination; mental or mood changes; muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness; shortness of breath; symptoms of infection (eg, chills, cough, fever, painful urination, sore throat); tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes; wheezing; yellowing of the skin or eyes.

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

See also: Gengraf 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 Gengraf Solution:

Store Gengraf Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not refrigerate. Use the contents within 2 months of opening. If stored below 68 degrees F (20 degrees C), the solution may gel or become cloudy. This will not affect the product. If this occurs, bring it to room temperature (77 degrees F [25 degrees C]). Do not store in the bathroom. Keep Gengraf Solution out of the reach of children and away from pets.

General information:

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


• Gengraf Solution 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 Gengraf Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Gengraf resources

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

Compare Gengraf with other medications

• Crohn's Disease
• Idiopathic Thrombocytopenic Purpura
• Inflammatory Bowel Disease
• Organ Transplant, Rejection Prophylaxis
• Organ Transplant, Rejection Reversal
• Psoriasis
• Rheumatoid Arthritis
• Ulcerative Colitis