Monday, 8 October 2012

Phenylfenesin


Generic Name: guaifenesin/phenylephrine/phenylpropanolamine (gwye FEN e sin/fen ill EFF rin/fen ill proe pa NOLE a meen)

Brand Names: Ami-Tex, Banex, Dura-Gest, Duratex, Enomine, Entex, Fentex, Guaifenex, Phenylfenesin, Quintex


What is Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to ease breathing. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose, and throat), and increases the removal of mucous.


Phenylpropanolamine and phenylephrine are decongestants. They constrict (shrink) blood vessels (veins and arteries), which reduces the swelling of mucous membranes in areas such as the nose and sinuses.


Guaifenesin/phenylephrine/phenylpropanolamine is used to treat the symptoms of the common cold and of infections of your sinuses, your lungs, and your throat.


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Guaifenesin/phenylephrine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine)?


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine)?


Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have



  • high blood pressure or any other type of heart disease,




  • diabetes,




  • a peripheral vascular disorder (poor circulation),




  • glaucoma or increased pressure in the eyes,




  • an overactive thyroid, or




  • difficulty urinating or an enlarged prostate.



You may not be able to take guaifenesin/phenylephrine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Guaifenesin/phenylephrine/phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin/phenylephrine/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Guaifenesin/phenylephrine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin/phenylephrine/phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin/phenylephrine/phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine)?


Take guaifenesin/phenylephrine/phenylpropanolamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take guaifenesin/phenylephrine/phenylpropanolamine with food if stomach upset occurs. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

To ensure that you get a correct dose, measure the liquid form of guaifenesin/phenylephrine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Store guaifenesin/phenylephrine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a guaifenesin/phenylephrine/phenylpropanolamine overdose include vomiting, high blood pressure (headache, red face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.


What should I avoid while taking Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Guaifenesin/phenylephrine/phenylpropanolamine may cause dizziness. If you experience dizziness, avoid these activities.

Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine) side effects


No serious side effects from guaifenesin/phenylephrine/phenylpropanolamine are expected. Stop taking guaifenesin/phenylephrine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take guaifenesin/phenylephrine/phenylpropanolamine and talk to your doctor if you experience



  • dizziness or headache;




  • nervousness, restlessness, or insomnia;




  • nausea or stomach upset; or




  • difficulty urinating.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Phenylfenesin (guaifenesin/phenylephrine/phenylpropanolamine)?


Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin/phenylephrine/phenylpropanolamine.


Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin/phenylephrine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylephrine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.


Drugs other than those listed here may also interact with guaifenesin/phenylephrine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.



More Phenylfenesin resources


  • Phenylfenesin Drug Interactions
  • Phenylfenesin Support Group
  • 0 Reviews for Phenylfenesin - Add your own review/rating


  • Entacapone Monograph (AHFS DI)

  • Guaifenex Consumer Overview



Compare Phenylfenesin with other medications


  • Cough
  • Cough and Nasal Congestion
  • Hay Fever
  • Nasal Congestion
  • Sinusitis
  • Upper Respiratory Tract Infection


Where can I get more information?


  • Your pharmacist has additional information about guaifenesin/phenylephrine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Guaifenesin/phenylephrine/phenylpropanolamine is available with a prescription under the brand names Entex and Dura-Gest. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



  • Entex, 200 mg of guaifenesin, 5 mg of phenylephrine, and 45 mg of phenylpropanolamine--orange/white capsules




  • Entex Liquid, 100 mg of guaifenesin, 5 mg of phenylephrine, and 20 mg of phenylpropanolamine with 5% alcohol per 5 mL (1 teaspoon)-- orange-colored liquid




  • Dura-Gest, 200 mg of guaifenesin, 5 mg of phenylephrine, and 45 mg of phenylpropanolamine--gray/white capsules




Saturday, 6 October 2012

Dulcolax Pico Liquid





1. Name Of The Medicinal Product



Dulcolax® Pico Liquid, 5 mg / 5 ml, oral solution.


2. Qualitative And Quantitative Composition



Each 5ml of liquid contains 5 mg sodium picosulfate.



Dulcolax® Pico Liquid also contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol and the colouring agent sunset yellow FCF (E110).



For full list of excipients , see section 6.1.



3. Pharmaceutical Form



Oral solution.



Golden orange coloured liquid, with a fruit-like odour and taste.



4. Clinical Particulars



4.1 Therapeutic Indications



Pharmacy only and GSL:



Short term relief of constipation



Pharmacy only:



For the management of constipation of any aetiology.



4.2 Posology And Method Of Administration



For oral administration



Unless otherwise prescribed by the doctor, the following dosages are recommended:



Pharmacy only and GSL:



Adults and children over 10 years:



One to two 5 ml spoonfuls (5 - 10 mg) at night.



Pharmacy only:



Children under 10 years:



Not to be taken by children under 10 years without medical advice.



Children (4 - 10 years):



Half to one 5 ml spoonful (2.5 - 5 mg) at night.



Children under 4 years:



The recommended dosage is 250 micrograms per kilogram body weight.



In the management of constipation, once regularity has restarted dosage should be reduced and can usually be stopped.



Diluent: Can be diluted with purified water.



4.3 Contraindications



DULCOLAX is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.



DULCOLAX is also contraindicated in severe dehydration and in patients with known hypersensitivity to sodium picosulfate or any other component of the product.



4.4 Special Warnings And Precautions For Use



As with all laxatives, DULCOLAX should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.



Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.



DULCOLAX should not be taken by children under 10 years without medical advice.



Dulcolax® Pico Liquid contains 5.9 vol % ethanol (alcohol) i.e. up to 480 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose. Harmful for those suffering from alcoholism.To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.



Dulcolax® Pico Liquid contains the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate and the colouring agent sunset yellow FCF (E110) which may cause allergic reactions (possibly delayed).



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of DULCOLAX are taken.



Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.



Concurrent administration of antibiotics may reduce the laxative action of this product.



4.6 Pregnancy And Lactation



There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.



Clinical data show that neither the active moiety of sodium picosulfate (BHPM or bis-(p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.



Nevertheless, as with all medicines, DULCOLAX should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.



4.7 Effects On Ability To Drive And Use Machines



None stated.



4.8 Undesirable Effects



Adverse events have been ranked under headings of frequency using the following convention:



Very common (



Immune system disorders



Rare: Hypersensitivity including angioneurotic oedema and skin reactions.



Gastrointestinal disorders



Common: Abdominal discomfort, abdominal pain, abdominal cramps and diarrhoea.



Uncommon: Nausea, vomiting.



4.9 Overdose



Symptoms: If high doses are taken diarrhoea, abdominal cramps and a clinically significant loss of potassium and other electrolytes can occur.



Furthermore, cases of colonic mucosal ischaemia have been reported in association with doses of DULCOLAX considerably higher than those recommended for the routine management of constipation.



Laxatives when taken in chronic overdosage may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.



Therapy: Within a short time of ingestion, absorption can be minimised or prevented by inducing vomiting or by gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young.



Administration of antispasmodics may be of some value.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Sodium picosulfate is a locally acting laxative from the triarylmethane group, which after bacterial cleavage in the colon, has a dual-action with stimulation of the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis, with promotion of accumulation of water, and consequently electrolytes, in the colonic lumen. This results in stimulation of defaecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established.



5.2 Pharmacokinetic Properties



After oral ingestion, sodium picosulfate reaches the colon without any appreciable absorption. Therefore, enterohepatic circulation is avoided. The active laxative compound, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), is formed by bacterial cleavage in the intestine. Consequently, the onset of action of the preparation is usually between 6 - 12 hours, which is determined by the release of the active substance.



After oral administration, only small amounts of the drug are systemically available.



There is no relationship between the laxative effect and plasma levels of the active moiety.



5.3 Preclinical Safety Data



There are no pre-clinical 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



Sodium Carboxymethylcellulose



Methyl Parahydroxybenzoate (E218)



Propyl Parahydroxybenzoate (E216)



Glycerol



Aroma Tutti Frutti (flavouring)



Saccharin Sodium



FD & C Yellow 6 (E110) (colouring)



Ethanol 96%



0.1 M Sodium Hydroxide



Purified Water



6.2 Incompatibilities



None stated



6.3 Shelf Life



3 years



6.4 Special Precautions For Storage



Keep the container in the outer carton



6.5 Nature And Contents Of Container



Amber glass bottles with aluminium ROPP caps.



Pack sizes of 30, 40, 50, 60, 90, and 500 ml.



Amber glass bottles with polypropylene tamper-evident closure with expanded polyethylene (coated with LDPE) liner.



Pack sizes of 100, 250 and 300 ml.



Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Boehringer Ingelheim Limited



Ellesfield Avenue



Bracknell



Berkshire



RG12 8YS



Trading as Boehringer Ingelheim Self-Medication Division



8. Marketing Authorisation Number(S)



PL 00015/0249



9. Date Of First Authorisation/Renewal Of The Authorisation



16th September 2005



10. Date Of Revision Of The Text



September 2010



11. LEGAL CATEGORY


90, 100, 250, 300, 500 ml : P



30, 40, 50, 60 ml : GSL




Acidophilus Extra Strength


Generic Name: lactobacillus acidophilus (LAK toe ba SIL us AS sid OFF il us)

Brand Names: Acidophilus, Acidophilus Extra Strength, Bacid, Flora-Q 2, Novaflor, RisaQuad, RisaQuad 2, Superdophilus


What is Acidophilus Extra Strength (lactobacillus acidophilus)?

Lactobacillus acidophilus is a bacteria that exists naturally in the body, primarily in the intestines and the vagina. Lactobacillus acidophilus helps maintain an acidic environment in the body, which can prevent the growth of harmful bacteria.


Lactobacillus acidophilus has been used to treat or prevent vaginal yeast infections, yeast infections of the mouth, diarrhea caused by taking antibiotics, and urinary tract infections. Lactobacillus acidophilus may work by helping the body maintain normal consistency of bacteria in the stomach, intestines, and vagina.


Lactobacillus acidophilus has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Lactobacillus acidophilus has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of lactobacillus acidophilus may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


Lactobacillus acidophilus may also have be used for other purposes not listed in this product guide.


What is the most important information I should know about Acidophilus Extra Strength (lactobacillus acidophilus)?


Lactobacillus acidophilus has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Lactobacillus acidophilus has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of lactobacillus acidophilus may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


Talk to your doctor before taking lactobacillus acidophilus if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Under certain conditions, it may be dangerous for you to take lactobacillus acidophilus.


Do not take lactobacillus acidophilus without first talking to your doctor if you are pregnant or may become pregnant during treatment. Do not take lactobacillus acidophilus without first talking to your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.

What should I tell my healthcare provider before taking Acidophilus Extra Strength (lactobacillus acidophilus)?


Talk to your doctor before taking lactobacillus acidophilus if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Under certain conditions, it may be dangerous for you to take lactobacillus acidophilus.


Do not take lactobacillus acidophilus without first talking to your doctor if you are pregnant or may become pregnant during treatment. Do not take lactobacillus acidophilus without first talking to your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take Acidophilus Extra Strength (lactobacillus acidophilus)?


When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.


Do not take more of this product than is directed.

If you choose to take lactobacillus acidophilus, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.


Lactobacillus acidophilus is available in capsule and tablet form. Powder or liquid forms may also be available. Some dairy products, especially yogurt, also contain lactobacillus acidophilus.


Do not use many different forms (such as tablets, topical formulations, and others) of lactobacillus acidophilus at the same time, unless your healthcare professional has told you to. You may get too much of this product if you use different forms together.

Store lactobacillus acidophilus in a sealed container as directed on the product label, away from moisture, heat, and light.


What happens if I miss a dose?


No information is available about missing a dose of lactobacillus acidophilus. Consult your doctor, pharmacist, or healthcare provider for instructions if you miss a dose.


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 taking Acidophilus Extra Strength (lactobacillus acidophilus)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using lactobacillus acidophilus.


Acidophilus Extra Strength (lactobacillus acidophilus) 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.

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


Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Acidophilus Extra Strength (lactobacillus acidophilus)?


There may be other drugs that can interact with lactobacillus acidophilus. Tell your healthcare provider 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 healthcare provider.



More Acidophilus Extra Strength resources


  • 0 Reviews for Acidophilus Extra Strength - Add your own review/rating


  • Lactobacillus Acidophilus Monograph (AHFS DI)

  • Acidophilus Natural MedFacts for Professionals (Wolters Kluwer)

  • Acidophilus Natural MedFacts for Consumers (Wolters Kluwer)

  • Acidophilus Consumer Overview



Compare Acidophilus Extra Strength with other medications


  • Clostridial Infection
  • Diarrhea
  • Irritable Bowel Syndrome
  • Oral Thrush
  • Traveler's Diarrhea
  • Urinary Tract Infection
  • Vaginal Yeast Infection


Where can I get more information?


  • Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.


antihemophilic factor-von Willebrand factor complex


Generic Name: antihemophilic factor-von Willebrand factor complex (an tee hee moe FIL ik FAK tor - von WIL e brand FAK tor)

Brand names: Alphanate, Humate-P, Wilstart, Dried Factor VIII Fraction Type 8Y, Haemate P, Optivate, Wilate


What is antihemophilic factor-von Willebrand factor complex?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot.


A lack of antihemophilic factor VIII is the cause of hemophilia A. A lack of an antihemophilic factor called von Willebrand factor is the cause of von Willebrand disease.


This medication works by temporarily raising levels of factor VIII or von Willebrand factor in the blood to aid in clotting.


Antihemophilic factor-von Willebrand factor complex is used to treat or prevent bleeding episodes in adults with hemophilia A. It is also used to treat injury-related bleeding episodes in adults and children with von Willebrand disease.


Antihemophilic factor-von Willebrand factor complex may also be used for purposes not listed in this medication guide.


What is the most important information I should know about antihemophilic factor-von Willebrand factor complex?


Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

Before using antihemophilic factor-von Willebrand factor complex, tell your doctor if you have ever had a stroke or a blood clot.


Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.


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.


Wear a medical alert tag or carry an ID card stating that you have hemophilia or von Willebrand disease in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Antihemophilic factor-von Willebrand factor complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.


What should I discuss with my health care provider before using antihemophilic factor-von Willebrand factor complex?


Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

To make sure you can safely use this medication, tell your doctor if you have ever had a stroke or a blood clot.


FDA pregnancy category C. It is not known whether antihemophilic factor-von Willebrand factor complex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether antihemophilic factor-von Willebrand factor complex 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.

Antihemophilic factor-von Willebrand factor complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.


Your doctor may want you to receive a hepatitis vaccination before you start using antihemophilic factor-von Willebrand factor complex.

How should I use antihemophilic factor-von Willebrand factor complex?


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


Antihemophilic factor-von Willebrand factor complex is injected into a vein through an IV. 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.


This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Antihemophilic factor-von Willebrand factor complex is usually given every 8 to 12 hours for up to 7 days, depending on the reason you are using the medication.


Always wash your hands before preparing and giving your injection.

Antihemophilic factor-von Willebrand factor complex must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.


You may gently swirl the medicine and diluent to mix them, but do not shake the vial (bottle). Vigorous shaking can ruin the medicine. After mixing the medicine with a diluent, store at room temperature and use it within 3 hours. Do not refrigerate.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.


Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.


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.


Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.


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.


Wear a medical alert tag or carry an ID card stating that you have hemophilia or von Willebrand disease in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and diluent at room temperature, away from moisture and heat. Throw away any unused medicine after the expiration date on the label has passed.

What happens if I miss a dose?


Antihemophilic factor-von Willebrand factor complex is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


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 antihemophilic factor-von Willebrand factor complex?


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


Antihemophilic factor-von Willebrand factor complex 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. Call your doctor at once if you have a serious side effect such as:

  • easy bruising, increased bleeding episodes;




  • bleeding from a wound or where the medicine was injected;




  • low fever with skin rash, and joint pain, swelling, or stiffness;




  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with vision, speech, or balance;




  • black, bloody, or tarry stools;




  • coughing up blood or vomit that looks like coffee grounds; or




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • constipation;




  • swelling, stinging, or irritation where the injection was given;




  • skin rash or itching;




  • swelling in your hands or feet;




  • pain in your arms or legs;




  • chills; or




  • dizziness.



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.


Antihemophilic factor-von Willebrand factor complex Dosing Information


Usual Adult Dose for Hemophilia A:

Minor hemorrhage (early joint or muscle bleed or severe epistaxis): Loading dose 15 IU FVIII/kg to achieve FVIII plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the loading dose may be given once or twice daily for 1 to 2 days.

Moderate hemorrhage (advanced joint or muscle bleed, neck, tongue or pharyngeal hematoma (without airway compromise), tooth extraction, or severe abdominal pain): Loading dose 25 IU FVIII/kg to achieve FVIII plasma level of approximately 50% of normal, followed by 15 IU FVIII/kg every 8 to 12 hours for first 1 to 2 days to maintain FVIII plasma level at 30% of normal, and then the same dose once or twice a day for a total of up to 7 days, or until adequate wound healing.

Life-threatening hemorrhage (major operations, gastrointestinal bleeding, neck, tongue or pharyngeal hematoma with potential for airway compromise, intracranial, intraabdominal or intrathoracic bleeding, or fractures): Initially 40 to 50 IU FVIII/kg, followed by 20 to 25 IU FVIII/kg every 8 hours to maintain FVIII plasma level at 80 to 100% of normal for 7 days, then continue the same dose once or twice a day for another 7 days in order to maintain the FVIII level at 30 to 50% of normal.

Usual Pediatric Dose for von Willebrand's Disease:

Treatment of von Willebrand Disease:
Type 1 mild, if desmopressin is inappropriate (Baseline von Willebrand factor (VWF) activity typically greater than 30%):
Major Hemorrhage (e.g. severe or refractory epistaxis, GI bleeding, CNS trauma, or traumatic hemorrhage): Loading dose 40 to 60 IU/kg, then 40 to 50 IU/kg every 8 to 12 hours for 3 days to keep the trough level of VWF greater than 50%; then 40 to 50 IU/kg daily for a total of up to 7 days of treatment.
Type 1 moderate or severe (Baseline VWF activity typically less than 30%):
Minor (e.g. epistaxis, oral bleeding, menorrhagia): 40 to 50 IU/kg (1 or 2 doses)
Major (e.g. severe or refractory epistaxis, GI bleeding, CNS trauma, hemarthrosis or traumatic hemorrhage): Loading dose 50 to 75 IU/kg, then 40 to 60 IU/kg every 8 to 12 hours for 3 days to keep the trough level of VWF greater than 50%; then 40 to 60 IU/kg daily for a total of up to 7 days of treatment. Factor VIII levels should be monitored and maintained according to the guidelines for hemophilia A therapy.
Types 2 (all variants) and 3:
Minor (clinical indications above): 40 to 50 IU/kg (1 or 2 doses).
Major (clinical indications above): Loading dose of 60 to 80 IU/kg, then 40 to 60 IU/kg every 8 to 12 hours for 3 days to keep the trough level of VWF greater than 50%; then 40 to 60 IU/kg daily for a total of up to 7 days of treatment. Factor VIII levels should be monitored and maintained according to the guidelines for hemophilia A therapy.

In the case of emergency surgery, administer a loading dose of 50 to 60 IU/kg and, subsequently, closely monitor the trough coagulation factor levels.

Prevention of Excessive Bleeding During and After Surgery in VWD:
When possible, it is recommended that the incremental in vivo recovery (IVR) be measured and that baseline plasma VWF and FVIII be assessed in all patients prior to surgery. Measure IVR as follows:
1. Measure baseline plasma VWF.
2. Infuse 60 IU VWF/kg product intravenously at time 0.
3. At time +30 minutes, measure plasma VWF.
IVR = (Plasma VWF at time +30 min - Plasma VWF at baseline) / 60 IU kg.

Calculation of the loading dose requires four values: the target peak plasma VWF level, the baseline VWF level, body weight (BW) in kilograms, and IVR. When individual recovery values are not available, a standardized loading dose can be used based on an assumed VWF IVR of 2.0 IU/dL per IU/kg of VWF product administered.

Major Surgery: VWF Target Peak Plasma Level is 100 IU/dL and FVIII Target Peak Plasma Level is 80 to 100 IU/dL.
Calculation of Loading Dose (to be administered 1 to 2 hours before surgery): (Target peak plasma VWF - baseline plasma VWF x BW (kg) / IVR = IU VWF required.
If the incremental IVR is not available, assume an IVR of 2 IU/dL per IU/kg and calculate the loading dose as follows: (100 - baseline plasma VWF) x BW (kg) / 2.
Minor surgery VWF Target Peak Plasma Level is 50 to 60 IU/dL and FVIII Target Peak Plasma Level is 40 to 50 IU/dL.
Calculation of Loading Dose (to be administered 1 to 2 hours before surgery): (Target peak plasma VWF - baseline plasma VWF x BW (kg) / IVR = IU VWF required.

Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery:
Major surgery: VWF target level is greater than 50 IU/dL up to 3 days following surgery and greater than 30 IU/dL after day 3. FVIII target trough plasma level is greater than 50 IU/dL up to 3 days following surgery and greater than 30 IU/dL after day three. The minimum duration of treatment is 72 hours.
Minor surgery: VWF target level is greater than or equal to 30 IU/dL up to 3 days following surgery. FVIII target trough plasma level is greater 30 IU/dL after day three. The minimum duration of treatment is 48 hours.
Oral Surgery: VWF target level is greater than 30 IU/dL up to 3 days following surgery. FVIII target trough plasma level is greater than or equal to 30 IU/dL after day three. The minimum duration of treatment is 8 to 12 hours.

Usual Pediatric Dose for Hemophilia A:

Adequate and well-controlled studies with long-term evaluation of joint damage have not been done in pediatric subjects. Joint damage may result from suboptimal treatment of hemarthroses. For immediate control of bleeding for Hemophilia A, the general recommendations for dosing and administration for adults, as follows, may be referenced.

Minor hemorrhage (early joint or muscle bleed or severe epistaxis): Loading dose 15 IU FVIII/kg to achieve FVIII plasma level of approximately 30% of normal; one infusion may be sufficient. If needed, half of the loading dose may be given once or twice daily for 1 to 2 days.

Moderate hemorrhage (advanced joint or muscle bleed, neck, tongue or pharyngeal hematoma (without airway compromise), tooth extraction, or severe abdominal pain): Loading dose 25 IU FVIII/kg to achieve FVIII plasma level of approximately 50% of normal, followed by 15 IU FVIII/kg every 8 to 12 hours for first 1 to 2 days to maintain FVIII plasma level at 30% of normal, and then the same dose once or twice a day for a total of up to 7 days, or until adequate wound healing.

Life-threatening hemorrhage (major operations, gastrointestinal bleeding, neck, tongue or pharyngeal hematoma with potential for airway compromise, intracranial, intraabdominal or intrathoracic bleeding, or fractures): Initially 40 to 50 IU FVIII/kg, followed by 20 to 25 IU FVIII/kg every 8 hours to maintain FVIII plasma level at 80 to 100% of normal for 7 days, then continue the same dose once or twice a day for another 7 days in order to maintain the FVIII level at 30 to 50% of normal.


What other drugs will affect antihemophilic factor-von Willebrand factor complex?


There may be other drugs that can interact with antihemophilic factor-von Willebrand factor complex. 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 antihemophilic factor-von Willebrand factor complex resources


  • Antihemophilic factor-von Willebrand factor complex Side Effects (in more detail)
  • Antihemophilic factor-von Willebrand factor complex Dosage
  • Antihemophilic factor-von Willebrand factor complex Use in Pregnancy & Breastfeeding
  • Antihemophilic factor-von Willebrand factor complex Support Group
  • 1 Review for Antihemophilic factor-von Willebrand factor complex - Add your own review/rating


Compare antihemophilic factor-von Willebrand factor complex with other medications


  • Hemophilia A
  • von Willebrand's Disease


Where can I get more information?


  • Your pharmacist can provide more information about antihemophilic factor-von Willebrand factor complex.

See also: antihemophilic factor-von Willebrand factor complex side effects (in more detail)


Friday, 5 October 2012

procaine


Generic Name: procaine (PRO cane)

Brand names: Novocain, Mericaine


What is procaine?

Procaine is a local anesthetic. Procaine causes loss of feeling (numbness) of skin and mucous membranes.


Procaine is used as an injection during surgery and other medical and dental procedures.


Procaine may also be used for purposes other than those listed here.


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


Since there will be decreased sensation of the area where procaine is injected, use caution to avoid injury to the area during and following treatment.


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


Before using procaine, talk to your healthcare provider if you have


  • liver problems;


  • bleeding or blood clotting problems;




  • heart problems;




  • a neuromuscular disease such as myasthenia gravis; or




  • other serious medical conditions.



You may not be able to use procaine, or you may require a dosage adjustment or special monitoring during treatment.


It is not known whether procaine will be harmful to an unborn baby. Do not use procaine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether procaine passes into breast milk. Do not use procaine without first talking to your doctor if you are breast-feeding a baby.

How should I use procaine?


Your healthcare provider will administer procaine as an injection.


What happens if I miss a dose?


Procaine is administered as an injection in a hospital or clinic setting. Missing a dose should not apply.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

What should I avoid while using procaine?


Since there will be decreased sensation of the area where procaine is injected, use caution to avoid injury to the area during and following treatment.


Procaine side effects


Stop using procaine and seek emergency medical attention or contact your doctor immediately if you experience any of the following rare but serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);




  • chest pain or slow or irregular heartbeats;




  • dizziness or drowsiness;




  • anxiety or restlessness;




  • nausea or vomiting; or




  • trembling, shaking, or seizures (convulsions).



Other less serious side effects such as numbness, tingling, or minor pain at or around the injection site are more likely to occur. Contact your healthcare provider if these effects seem excessive or prolonged.


Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect procaine?


Before using procaine, talk to your doctor if you are taking any of the following medicines:



  • warfarin (Coumadin);




  • a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);




  • mecamylamine (Inversine);




  • guanadrel (Hylorel) or guanethidine (Ismelin);




  • a medicine to treat high blood pressure; or




  • a medicine to improve muscle strength or tone for conditions such as myasthenia gravis.



You may not be able to use procaine, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.


Drugs other than those listed here may also interact with procaine. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More procaine resources


  • Procaine Drug Interactions
  • Procaine Support Group
  • 0 Reviews for Procaine - Add your own review/rating


  • Novocain Prescribing Information (FDA)

  • Novocain Monograph (AHFS DI)



Compare procaine with other medications


  • Local Anesthesia


Where can I get more information?


  • Your pharmacist has additional information about procaine written for health professionals that you may read.


Thursday, 4 October 2012

Cefdinir



Class: Third Generation Cephalosporins
Molecular Formula: C14H13N5O5S2
CAS Number: 91832-40-5
Brands: Omnicef

Introduction

Antibacterial; β-lactam antibiotic; aminothiazolyl derivative third generation cephalosporin.1 2 3 4 5 6


Uses for Cefdinir


Acute Otitis Media (AOM)


Treatment of AOM caused by S. pneumoniae (penicillin-susceptible strains only), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).1 12 37


Not a drug of first choice; considered a preferred alternative to amoxicillin or amoxicillin and clavulanate in patients with a history of non-type 1 hypersensitivity reactions to penicillin.37


Pharyngitis and Tonsillitis


Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci).1 6 25 Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.1 10 11 16 17 36


CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;10 16 17 36 oral cephalosporins and oral macrolides considered alternatives.10 16 17 36 Amoxicillin sometimes used instead of penicillin V, especially for young children.10 16


Respiratory Tract Infections


Treatment of acute maxillary sinusitis caused by susceptible Streptococcus pneumoniae (penicillin-susceptible strains only), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).1 7


Treatment of mild to moderate acute exacerbations of chronic bronchitis caused by susceptible S. pneumoniae (penicillin-susceptible strains only) or β-lactamase- and non-β-lactamase-producing H. influenzae, H. parainfluenzae, or M. catarrhalis.1 15


Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (penicillin-susceptible strains only) or β-lactamase- and non-β-lactamase-producing strains of H. influenzae, H. parainfluenzae, or M. catarrhalis.1 4 If an oral cephalosporin is used as an alternative to penicillin G or amoxicillin for treatment of CAP caused by penicillin-susceptible S. pneumoniae, ATS and IDSA recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.39


Skin and Skin Structure Infections


Treatment of uncomplicated skin and skin structure infections caused by S. aureus (including β-lactamase-producing strains) or S. pyogenes.1 5 24


Cefdinir Dosage and Administration


Administration


Oral Administration


Administer orally.1 4 5 6 7 12 15 24


Administration of cefdinir capsules or oral suspension with a high-fat meal decreases peak plasma concentration and AUC of cefdinir;1 28 manufacturer states this is not likely to be clinically important and the drug may be given without regard to meals.1


For most infections, may be administered once daily or in 2 divided doses every 12 hours; once-daily regimen not recommended for treatment of CAP or skin and skin structure infections.1


Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in 2 portions; invert bottle and shake after each addition.1


Reconstituted suspension contains 125 or 250 mg of cefdinir/5 mL.1


Shake suspension well prior to administration of each dose.1


Dosage


Pediatric Patients


Acute Otitis Media (AOM)

Oral

Children 6 months to 12 years of age weighing <43 kg: 14 mg/kg once daily for 10 days1 or 7 mg/kg every 12 hours for 5–10 days.1


Pharyngitis and Tonsillitis

Oral

Children 6 months to 12 years of age weighing <43 kg: 14 mg/kg once daily for 10 days1 or 7 mg/kg every 12 hours for 5–10 days.1


Children ≥13 year of age or weighing ≥43 kg: 600 mg once daily for 10 days1 or 300 mg every 12 hours for 5–10 days.1


Respiratory Tract Infections

Acute Sinusitis

Oral

Children 6 months through 12 years of age weighing <43 kg: 14 mg/kg once daily for 10 days1 or 7 mg/kg every 12 hours for 10 days.1


Children ≥13 years of age or weighing ≥43 kg: 600 mg once daily for 10 days1 or 300 mg every 12 hours for 10 days.1


Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥13 year of age: 600 mg once daily for 10 days1 or 300 mg every 12 hours for 5–10 days.1


Community-acquired Pneumonia

Oral

Children ≥13 year of age: 300 mg every 12 hours for 10 days.1


Skin and Skin Structure Infections

Oral

Children 6 months to 12 years of age weighing <43 kg: 7 mg/kg every 12 hours for 10 days.1


Children ≥13 year of age or weighing ≥43 kg: 300 mg every 12 hours for 10 days.1


Adults


Pharyngitis and Tonsillitis

Oral

600 mg once daily for 10 days1 or 300 mg every 12 hours for 5–10 days.1


Respiratory Tract Infections

Acute Sinusitis

Oral

600 mg once daily for 10 days1 or 300 mg every 12 hours for 10 days.1


Acute Exacerbations of Chronic Bronchitis

Oral

600 mg once daily for 10 days1 or 300 mg every 12 hours for 5–10 days.1


Community-acquired Pneumonia

Oral

300 mg every 12 hours for 10 days.1


Skin and Skin Structure Infections

Oral

300 mg every 12 hours for 10 days.1


Special Populations


Hepatic Impairment


No dosage adjustments required.1


Renal Impairment


Dosage adjustments recommended in patients with severe renal impairment (Clcr <30 mL/minute).1


Adults: 300 mg once daily if Clcr <30 mL/minute.1


Children: 7 mg/kg (maximum 300 mg) once daily if Clcr <30 mL/minute.1


Patients maintained on long-term hemodialysis: Recommended initial dosage is 300 mg every 48 hours in adults and 7 mg/kg (maximum 300 mg) every 48 hours in children.1 Administer a supplemental dose (300 mg in adults or 7 mg/kg in children) at the end of each dialysis period.1


Geriatric Patients


No dosage adjustments except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)


Cautions for Cefdinir


Contraindications



  • Known hypersensitivity to cefdinir or other cephalosporins.1



Warnings/Precautions


Warnings


Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged use.1 Careful observation of the patient is essential.1 Institute appropriate therapy if superinfection occurs.1


Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefdinir, and may range in severity from mild diarrhea to fatal colitis.1 Hyper toxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1


Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1


If CDAD is suspected or confirmed, the anti-infective may need to be discontinued.1 Some mild cases may respond to discontinuance alone.1 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1


Sensitivity Reactions


Hypersensitivity Reactions

Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis.1


If an allergic reaction occurs, discontinue cefdinir and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1


Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.1 10 20 21


Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.1 Cautious use recommended in individuals hypersensitive to penicillins:1 avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction 10 21 and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.a


General Precautions


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefdinir and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1


History of GI Disease

Use cephalosporins with caution in patients with a history of GI disease, particularly colitis.1 a (See Superinfection/Clostridium-difficile-associated Diarrhea and Colitis under Cautions.)


Diabetes Mellitus

Reconstituted oral suspension contains 2.86 g of sucrose per 5 mL.1


Specific Populations


Pregnancy

Category B.1


Lactation

Not detected in milk.26


Pediatric Use

Safety and efficacy not established in neonates and children <6 months of age.1


Use for treatment of acute maxillary sinusitis in children 6 months to 12 years of age is supported by evidence from studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adults and children, and data regarding the pharmacokinetics of cefdinir in children.1


Adverse effects reported in pediatric patients similar to those in adults.1 Increased incidence of diarrhea and rash in pediatric patients ≤2 years of age compared with older pediatric patients.1


Geriatric Use

Well tolerated in geriatric patients; incidence of adverse effects (including diarrhea) lower than in those in younger adults.1


Hepatic Impairment

Hepatic metabolism is negligible; dosage adjustments are not required.1


Renal Impairment

Increased plasma half-life and decreased total body clearance.1


Dosage adjustments necessary in those with severe renal impairment (Clcr <30 mL/minute).1 (See Renal Impairment under Dosage and Administration.)


Careful clinical observation and renal function tests recommended prior to and during cephalosporin therapy.a


Common Adverse Effects


GI effects (diarrhea, nausea) and rash.1


Interactions for Cefdinir


Specific Drugs and Laboratory Tests
























Drug or Test



Interaction



Comments



Antacids (aluminum- or magnesium-containing)



Decreased cefdinir absorption1



Administer cefdinir at least 2 hours before or after aluminum- or magnesium-containing antacids1



Iron supplements (multivitamin and mineral preparations containing iron)



Decreased cefdinir absorption1 8


Concomitant administration with iron-fortified infant formula (2.2 mg elemental iron/180 mL) has no effect on cefdinir pharmacokinetics1


Effect of iron-fortified food (e.g., iron-fortified breakfast cereal) has not been studied1


Possibility of reddish stools because of a nonabsorbable complex between cefdinir and iron in the GI tract



Administer cefdinir at least 2 hours before or after oral iron preparations1 8


Can be administered concomitantly with iron-fortified infant formula1



Nephrotoxic drugs



Potential for increased risk of nephrotoxicitya



Avoid concomitant use of nephrotoxic agents (e.g., aminoglycosides, colistin, polymyxin B, vancomycin) if possiblea



Probenecid



Decreased renal excretion of cefdinir and increased cefdinir serum concentrations and half-life1



Tests for glucose



Possible false-positive reactions in urine glucose tests using Clinitest, Benedict’s solution, or Fehling’s solution1



Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix, Tes-Tape)1



Tests for ketones



Possible false-positive reactions in urine ketone tests using nitroprusside; no effect on nitroferricyanide tests1


Cefdinir Pharmacokinetics


Absorption


Bioavailability


16–25%.1 Peak plasma concentrations attained 2–4 hours after an oral dose.1 23 27 28


Bioavailability of oral suspension is 120% of that reported with capsules.1


Food


Administration of cefdinir capsules or oral suspension with a high-fat meal decreases rate and extent of absorption;1 28 not considered clinically important.1


Special Populations


Peak plasma concentrations and AUC may be higher in geriatric patients than in younger adults.1


Distribution


Extent


Distributed into blister fluid, middle ear fluid, tonsils, sinus tissue, and bronchial mucosa and epithelial lining fluid in concentrations ranging from 15–48% of concurrent plasma concentrations.1 22 23


Not known whether distributed into CSF.1


Not detected in milk following a single 600-mg oral dose.1


Plasma Protein Binding


60–70% in adult and pediatric patients;1 binding is independent of concentration.1 23


Elimination


Metabolism


Not appreciably metabolized.1


Elimination Route


Eliminated principally by renal excretion;1 approximately 12–18% eliminated unchanged in urine.1


Half-life


Plasma elimination half-life 1.7–1.8 hours in adults with normal renal function.1 27


Special Populations


Pharmacokinetics not studied to date in hepatic impairment.1


Clearance decreased in renal impairment.1 Plasma elimination half-life 2 times higher in patients with Clcr 30–60 mL/minute and 5 times higher in those with Clcr <30 mL/minute compared with normal renal function.1


Stability


Storage


Oral


Capsules

25°C (may be exposed to 15–30°C).1


For Suspension

25°C (may be exposed to 15–30°C).1 Following reconstitution, store suspension in tight container at room temperature (25°C); discard after 10 days.1


Actions and SpectrumActions



  • Third generation cephalosporin1 2 3 4 5 6 with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.1 2 3 4 5 6 7 9 13 14




  • Usually bactericidal.1




  • Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.1 a




  • In vitro spectrum of activity includes many gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against anaerobic bacteria, fungi, and viruses.1 a




  • Usually less active in vitro against susceptible staphylococci than first generation cephalosporins,1 a however more active against susceptible staphylococci and streptococci than many other oral third generation cephalosporins (e.g., cefixime, cefpodoxime, ceftibuten).2 9 a




  • Gram-positive aerobes: Active in vitro and in clinical infections against S. pneumoniae (penicillin-susceptible strains only), S. pyogenes (group A β-hemolytic streptococci), and Staphylococcus aureus.1 Also active in vitro against S. agalactiae (group B streptococci), S. epidermidis (oxacillin-susceptible strains only), and viridans streptococci.1 Enterococci (e.g., Enterococcus faecalis)1 3 and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.1 3




  • Gram-negative aerobes: Active in vitro and in clinical infections against non-β-lactamase-producing and β-lactamase-producing strains of H. influenzae, H. parainfluenzae, and M. catarrhalis.1 Also active in vitro against Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.1 Inactive against most strains of Enterobacter and Pseudomonas aeruginosa.2 3




  • Stable in the presence of a wide variety of β-lactamases produced by gram-negative and gram-positive bacteria; may be hydrolyzed by certain plasmid-mediated extended-spectrum β-lactamases.9 13 14 19




  • Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to cefdinir, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.38



Advice to Patients



  • Advise patients that antibacterials (including cefdinir) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1




  • Importance of completing full course of therapy, even if feeling better after a few days.1




  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefdinir or other antibacterials in the future.1




  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1




  • Importance of taking cefdinir at least 2 hours before or after antacids containing aluminum or magnesium or iron supplements (including multivitamins containing iron).1




  • Importance of discontinuing cefdinir and informing clinician if an allergic reaction occurs.1




  • For patients with diabetes, importance of being informed of sucrose content of oral suspension.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, or concomitant illness.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name






































Cefdinir

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



300 mg*



Cefdinir Capsules



Omnicef



Abbott



For suspension



125 mg/5 mL*



Cefdinir for Suspension



Omnicef



Abbott



250 mg/5 mL*



Cefdinir for Suspension



Omnicef



Abbott


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Cefdinir 125MG/5ML Suspension (TEVA PHARMACEUTICALS USA): 60/$47.99 or 120/$85.98


Omnicef 125MG/5ML Suspension (ABBOTT): 100/$95.43 or 300/$273.32


Omnicef 300MG Capsules (ABBOTT): 20/$119 or 60/$337.71



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



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a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2003:125-39.



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Compare Cefdinir with other medications


  • Bronchitis
  • Otitis Media
  • Pneumonia
  • Sinusitis
  • Skin and Structure Infection
  • Skin Infection
  • Strep Throat
  • Tonsillitis/Pharyngitis