oxtriphylline

30/06/10

Generic Name: oxtriphylline (ox TRYE fi lin)
Brand Names: Choledyl, Choledyl SA

What is oxtriphylline?

Oxtriphylline is a bronchodilator. Oxtriphylline works in several ways: it relaxes muscles in your lungs and chest to allow more air in, decreases the sensitivity of your lungs to allergens and other substances that cause inflammation, and increases the contractions of your diaphragm to draw more air into the lungs.

Oxtriphylline is used to treat the symptoms of asthma, bronchitis, and emphysema.

Oxtriphylline may also be used for purposes other than those listed in this medication guide.


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

Do not crush or chew any extended-release formulation of oxtriphylline. Swallow the medication whole. It is specially formulated to release slowly in your body. If you do not know whether your medication is an extended-release formulation, ask your pharmacist.

Call your doctor right away if you experience nausea, vomiting, insomnia, restlessness, seizures, an increased heart rate, or a headache. These could be signs of too much oxtriphylline in your blood.

Do not start or stop smoking without your doctor’s knowledge. Smoking may affect your dosage.

Do not take more of this medicine than is prescribed without consulting your doctor. Seek medical attention if you are having increasing difficulty breathing.

Who should not take oxtriphylline?

Before taking this medication, tell your doctor if you have

  • a stomach ulcer;

  • seizures;

  • high blood pressure, a heart condition, or any type of heart disease;

  • fluid in your lungs;

  • a thyroid condition;

  • liver disease; or

  • kidney disease.

You may not be able to take oxtriphylline, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Oxtriphylline is in the FDA pregnancy category C. This means that it is not known whether oxtriphylline will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Oxtriphylline passes into breast milk and could affect a nursing baby. Do not take oxtriphylline without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from oxtriphylline. You may require a lower dose of this medication.


How should I take oxtriphylline?

Take oxtriphylline 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 each dose with a full glass of water. You can take oxtriphylline with food to lessen stomach upset.

Take your doses at the same time every day to keep a constant level of oxtriphylline in your blood.

Do not crush or chew any extended-release formulation of oxtriphylline. Swallow the medication whole. It is specially formulated to release slowly in your body. If you do not know whether your medication is an extended-release formulation, ask your pharmacist. Shake the liquid forms of this medication well before use. To ensure that you get a correct dose, measure the liquid with a dose-measuring cup or spoon, not a regular tablespoon. If a spoon or cup is not provided with the medication and you do not have one, ask your pharmacist where you can get one.

Do not switch to another brand or a generic form of oxtriphylline without the approval of your doctor.

Store oxtriphylline at room temperature away from moisture and heat.

See also: Oxtriphylline dosage in more detail

What happens if I miss a dose?

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


What happens if I overdose?

Seek emergency medical attention.

Symptoms of a oxtriphylline overdose include nausea, vomiting, headache, insomnia, tremor (shaking hands or twitching,), restlessness, seizures, and irregular heartbeats.

What should I avoid while taking oxtriphylline?

Use caution when driving, operating machinery, or performing other hazardous activities. Oxtriphylline may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Do not start or stop smoking without the approval of your doctor. Smoking changes the way your body uses oxtriphylline, and you may need a dose adjustment.

Avoid changing your dose or changing the time of your daily doses.

Do not change the brand, generic form, or formulation (tablet, capsule, liquid) of oxtriphylline that you are taking without the approval of your doctor. Different brands or formulations may require different dosages.

Avoid eating excessive amounts of grilled or char-broiled foods. Doing so may also change the dose of oxtriphylline that you need.

Avoid caffeinated beverages such as coffee, tea, and cola. Oxtriphylline is related chemically to caffeine, and you may experience some side effects if you consume too much caffeine.

Oxtriphylline side effects

If you experience any of the following serious side effects, stop taking oxtriphylline and seek emergency medical attention:

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

  • seizures;

  • increased or irregular heartbeats; or

  • severe nausea or vomiting.

Other, less serious side effects may occur although they are not common at appropriate doses. Continue to take oxtriphylline and talk to your doctor if you experience

  • slight nausea, decreased appetite, or weight loss;

  • restlessness, tremor, or insomnia; or

  • headache, lightheadedness, or dizziness.

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.

Oxtriphylline Dosing Information

Usual Adult Dose for Asthma — Maintenance:

4.7 mg/kg orally every 8 hours.

Usual Pediatric Dose for Asthma — Maintenance:

Child 1-9 years: 6.2 mg/kg orally every 6 hours.

Child 9-16 years: 4.7 mg/kg orally every 6 hours.

What other drugs will affect oxtriphylline?

Oxtriphylline interacts with many other drugs. Tell your doctor and pharmacist about all other medications that you are taking, including herbal remedies, vitamins, and other nonprescription items.

The following drugs may increase the levels of oxtriphylline in your blood, leading to dangerous side effects:

  • alcohol;

  • cimetidine (Tagamet, Tagamet HB);

  • fluoroquinolone antibiotics such as enoxacin (Penetrex), lomefloxacin (Maxaquin), ciprofloxacin (Cipro), norfloxacin (Noroxin), and ofloxacin (Floxin);

  • clarithromycin (Biaxin) and erythromycin (Ery-Tab, E.E.S., E-Mycin, others);

  • disulfiram (Antabuse);

  • estrogens (Ogen, Premarin, and many other types);

  • fluvoxamine (Luvox);

  • methotrexate (Folex, Rheumatrex);

  • mexiletine (Mexitil) and propafenone (Rythmol);

  • propranolol (Inderal);

  • tacrine (Cognex);

  • ticlopidine (Ticlid); and

  • verapamil (Verelan, Calan, Isoptin).

The following drugs may decrease theophylline levels in your blood, leading to poor asthma control:

  • aminoglutethimide (Cytadren),

  • carbamazepine (Tegretol),

  • isoproterenol (Isuprel),

  • moricizine (Ethmozine),

  • phenobarbital (Luminal, Solfoton),

  • phenytoin (Dilantin),

  • rifampin (Rifadin), and

  • sucralfate (Carafate).

Drugs other than those listed here may also interact with oxtriphylline or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

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

What does my medication look like?

Many different formulations of oxtriphylline are available with a prescription under the brand name Choledyl and generically. Regular-release tablets, sustained-release tablets, a syrup, and an elixir are all available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 2/13/04 4:01:10 PM.

 

Oxoject

30/06/10

Generic Name: oxytocin
Dosage Form: FOR ANIMAL USE ONLY

Oxoject Injection Oxytocin ANADA 200-328

Product Titles

Oxoject

Oxytocin Injection

Purified Oxytocic Principle

(20 USP Units per mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Description

Oxoject (Oxytocin injection) is a sterile aqueous solution of highly purified oxytocic principle derived by synthesis or obtained from the posterior lobe of the putuitary gland of healthy domestic animals used for food by humans.  Oxoject (Oxytocin injection) contains 20 USP Units of oxytocin and less than 0.4 units of presser activity per mL.  Each mL of sterile solution also contains 0.9% w/v sodium chloride, 0.5% w/v chlorobutanol (as a preservative), with water for injection q.s. and pH adjusted to 3.0 to 5.0 with acetic acid.

Action

Oxytocin acts directly on the smooth musculature of the uterus in all species to induce rythmic contractions, although in some species the uterine cervix does not respond to oxytocin.  The responsiveness of the uterine musculature to oxytocin varies greatly with the stage of the reproductive cycle.  During the early phases of pregnancy the uterus is relatively insensitive to the effects of oxytocin, while in the late phases the sensitivity is markedly increased.  Most authorities attribute this varying response to the varying levels of estrogen and progesterone during the course of pregnancy.  Oxytocin also has been shown to exert a milk ejecting effect, occasionally referred to as the galactogogic effect.  The actual mechanism by which oxytocin stimulates the release of milk from the mammary glands is not known with certainty, but oxytocin injection is presumed to act on certain smooth muscle elements in the gland.

Indications

Because of the specific action of oxytocin upon the uterine musculature, it is recommended as an aid in the management of the following conditions:

1)  To precipitate labor

2)  To accelerate normal parturition

3)  Postpartum evacuation of uterine debris

4)  Postoperative contraction of the uterus following a cesarean section and control of uterine hemorrhage.

Oxytocin will contract the smooth muscle cells of the mammary gland to induce milk let-down if the udder is in a proper physiological state.




Contraindications

Do not use in dystocia due to abnormal presentation of the fetus until correction is accomplished.

Do not use in dystocia due to abnormal presentation of the fetus until correction is accomplished.

Precautions

Oxytocin is a potent preparation, accordingly, it should be administered with due caution.  For prepartum usage full dilation of the cervix should be accomplished either naturally or through the administration of estrogen prior to oxytocin therapy.

Dosage and Administration

Obstetrical Use: Inject aseptically by the intravenous, intramuscular or subcutaneous route as follows:

EWES, SOWS:

1.5 to 2.5mL……..30 to 50 USP Units

COWS, HORSES:

5.0mL……………..100 USP Units

These dosages are recommended, and may be repeated as indicated.

Milk Let-down:

Inject aseptically by the intravenous, intramuscular or subcutaneous route.

COWS:

0.5 to 1.0mL…………10 to 20 USP Units

SOWS:

0.25 to 1.0mL………..5 to 20 USP Units

These dosages are recommended and may be repeated as necessary.

Note:  Oxytocin will not induce milk let-down unless the udder is in the proper physiological state.

Caution

CAUTION:  Federal law restricts this drug to be used by or on the order of a licensed veterinarian.

How Supplied

100 mL multiple dose vials

Storage

Store at controlled room temperature.

Do Not Freeze.

Package Label Principle Display Panel

NDC # 11695-4015-1

Butler Animal Health Supply

Oxoject

Oxytocin Injection

Purified Oxytocic Principle

Sterile Aqueous Solution

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION:  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

ANADA # 200-328, Approved by FDA

Net Contents:  100mL (3.4 fl. oz)

Distributed Exclusively by:  Butler Animal Health Supply-Dublin, OH  43017

Oxoject 
oxytocin injection  injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 11695-4015
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxytocin (Oxytocin) Oxytocin 20 [USP'U]  in 100 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 11695-4015-1 100 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200328 10/15/2009

Labeler - Butler (017880659)

Revised: 12/2009Butler








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