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Generic Name: metformin (Oral route)
met-FOR-min hye-droe-KLOR-ide
Fortamet(R), Glucophage(R), Glucophage XR(R), Riomet(R): Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin hydrochloride; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with pathophysiologic conditions, including diabetes mellitus, characterized by significant tissue hypoperfusion and hypoxemia. The risk of lactic acidosis increases with renal impairment, increased age, congestive heart failure, and hepatic insufficiency. Treatment with metformin should not be initiated in patients 80 years old or older, unless measurement of creatinine clearance demonstrates that renal function is normal. Therapy should temporarily be discontinued prior to any intravascular radiocontrast study or surgical procedure. Excessive alcohol use should be avoided, because alcohol potentiates the effects of metformin on lactate metabolism. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .
Glumetza(R): Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with renal or hepatic impairment, acute congestive heart failure, sepsis, dehydration, and excess alcohol intake. Onset may be subtle and include nonspecific symptoms such as malaise, myalgia, respiratory distress, somnolence, and abdominal distress; laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If lactic acidosis is suspected, Glumetza(R) should be discontinued and the patient immediately hospitalized .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Hypoglycemic
Chemical Class: Metformin
Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using metformin alone, with a type of oral antidiabetic medicine called a sulfonylurea, or with insulin, will help to lower blood sugar when it is too high and help restore the way you use food to make energy.
Many people can control type 2 diabetes with diet and exercise. Following a specially planned diet and exercise will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of metformin you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet or exercise, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.
Metformin does not help patients does not help patients who have insulin-dependent or type 1 diabetes because they cannot produce insulin from their pancreas gland. Their blood glucose is best controlled by insulin injections.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, metformin is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of metformin oral solution and tablets in children 10 to 16 years of age. However, safety and efficacy of metformin extended-release tablets in the pediatric population have not been established.
Although appropriate studies on the relationship of age to the effects of metformin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of metformin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving metformin. This medicine is not recommended in patients 80 years of age and older who have kidney problems.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain metformin. It may not be specific to Riomet. Please read with care.
This medicine usually comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.
Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
Metformin should be taken with meals to help reduce stomach or bowel side effects that may occur during the first few weeks of treatment.
Swallow the extended-release tablet whole with a full glass of water. Do not crush, break, or chew it.
While taking the extended-release tablet, part of the tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
You may notice improvement in your blood glucose control in 1 to 2 weeks, but the full effect of blood glucose control may take up to 2 to 3 months. Ask your doctor if you have any questions about this.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.
This medicine may interact with the dye used for an X-ray or CT scan. Your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual. You may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
It is very important to carefully follow any instructions from your health care team about:
Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear, and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite; diarrhea; fast or shallow breathing; a general feeling of discomfort; severe muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.
If symptoms of lactic acidosis occur, you should get immediate emergency medical help.
Metformin can cause low blood sugar (hypoglycemia). However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take metformin with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.
Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. The members of your household also should know how to use it.
High blood sugar (hyperglycemia) is another problem related to uncontrolled diabetes. Symptoms of mild high blood sugar appear more slowly than those of low blood sugar. These may include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.
High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.
If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.
This medicine is only part of a complete program for controlling diabetes. It is important that you always eat a healthy diet, watch your weight, and get regular exercise.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Riomet side effects (in more detail)
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NADA 065-010, Approved by FDA
For use in Cattle, Sheep, Swine and Horses.
PENICILLIN G PROCAINE INJECTABLE SUSPENSION U.S.P.
READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT
Bactracillin G is a suspension of penicillin G procaine in 100, 250, and 500 mL multiple dose vials. Each mL is designed to provide 300,000 units of penicillin G as procaine in a stable suspension. Penicillin G procaine is an antibacterial agent which has activity against a variety of pathogenic organisms, mainly in the Gram-positive category.
Bactracillin G is indicated for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix rhusiopathiae in swine, and strangles caused by Streptococcus equi in horses.
A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized in boiling water for 15 minutes). Before withdrawing the solution from the bottle, disinfect the rubber cap top with 70% alcohol. The injection site should be similarly disinfected with alcohol. Needles of 16 to 18 gauge and 1 to 1.5 inches long are adequate for intramuscular injections.
In livestock intramuscular injections should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle, such as rump, hip, or thigh region; avoid blood vessels and major nerves. Before injecting the solution, pull back gently on the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site.
Bactracillin G is administered by the intramuscular route. The product is ready for injection after warming the vial to room temperature and shaking to ensure a uniform suspension.
The daily dose of penicillin is 3,000 units per pound of body weight (1 mL per 100 lbs body weight). Continue daily treatment until recovery is apparent and for at least one day after symptoms disappear, usually in two to three days.
Treatment should not exceed four consecutive days.
No more than 10 mL should be injected at any one site. Rotate injection sites for each succeeding treatment.
The use of antibiotics in the management of diseases is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by penicillin-susceptible organisms, most animals treated with Bactracillin G show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be re-evaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian.
Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs and needless losses. Good housing, sanitation and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.
Exceeding the daily dosage of 3,000 units per pound of body weight, administering for more than four consecutive days, or exceeding the maximum injection site volume per injection site may result in antibiotic residues beyond the withdrawal time. Milk taken from treated dairy animals within 48 hours after the last treatment must not be used for food. Discontinue use of this drug for the following time period before treated animals are slaughtered for food:
Cattle – 14 days, Sheep – 9 days, Swine – 7 days.
A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
Do not use in horses intended for human consumption. Not for use in humans. Keep out of reach of children.
Intramuscular injection in cattle, sheep, and swine may result in a local tissue reaction which persists beyond the withdrawal period of 14 days (cattle), 9 days (sheep), or 7 days (swine). This may result in trim loss of edible tissue at slaughter.
Allergic or anaphylactic reactions, sometimes fatal, have been known to occur in animals hypersensitive to penicillin and procaine. Such reactions can occur unpredictably with varying intensity. Animals administered penicillin G procaine should be kept under close observation for at least one half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and call a veterinarian. If respiratory distress is severe, immediate injection of epinephrine or antihistamine following manufacturer's recommendations may be necessary.
As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs or symptoms suggest that an overgrowth of nonsusceptible organisms has occurred. In such instances, consult your veterinarian.
It is advisable to avoid giving penicillin in conjunction with bacteriostatic drugs such as tetracyclines.
Bactracillin G should be stored between 2 to 8°C (36 to 46°F).
Restricted Drug - California. Use Only as Directed.
Made in the UK.
Norbrook Laboratories Limited
Newry, Northern Ireland
Manufactured for:
Aspen Veterinary Resources,® Ltd.
Liberty, MO 64068, USA
LX-2484 Iss. 11/10
102628I01
NDC 46066-022-05 NADA 065-010, Approved by FDA
Bactracillin GTM
Sterile Penicillin G Procaine
Injectable Suspension U.S.P.
Injectable antibiotic in aqueous suspension 300,000 units per mL
ANTIBIOTIC
FOR INTRAMUSCULAR INJECTION ONLY
NET CONTENTS:
500 mL
Aspen®
VETERINARY RESOURCES,® Ltd.
| BACTRACILLIN G penicillin g procaine injection, suspension | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA065010 | 12/01/2010 | |
| Labeler - Aspen Veterinary (627265361) |
| Registrant - Norbrook Laboratories Limited (214580029) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Station Works | 214580029 | MANUFACTURE, ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Carnbane Industrial Estate | 211218325 | MANUFACTURE | |
A.S. COR may be available in the countries listed below.
Norfenefrine hydrochloride (a derivative of Norfenefrine) is reported as an ingredient of A.S. COR in the following countries:
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Papaverol NF may be available in the countries listed below.
Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Papaverol NF in the following countries:
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Pumpitor may be available in the countries listed below.
Omeprazole is reported as an ingredient of Pumpitor in the following countries:
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Agiolax Pico may be available in the countries listed below.
Sodium Picosulfate is reported as an ingredient of Agiolax Pico in the following countries:
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