Algopyrin may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Algopyrin in the following countries:
International Drug Name Search
Meksun may be available in the countries listed below.
Meloxicam is reported as an ingredient of Meksun in the following countries:
International Drug Name Search
Citalohexal may be available in the countries listed below.
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalohexal in the following countries:
International Drug Name Search
Nufacort may be available in the countries listed below.
Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Nufacort in the following countries:
Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Nufacort in the following countries:
International Drug Name Search
Immunine may be available in the countries listed below.
Coagulation Factor IX, Human is reported as an ingredient of Immunine in the following countries:
International Drug Name Search
Apo-Nifed may be available in the countries listed below.
Nifedipine is reported as an ingredient of Apo-Nifed in the following countries:
International Drug Name Search
Treating itchy eyes caused by allergies.
Bepotastine Eye Drops are an antihistamine eye drop. It works by blocking the release of histamine, which reduces the symptoms of an allergic reaction.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Bepotastine Eye Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Bepotastine Eye Drops. Because little, if any, of Bepotastine Eye Drops are absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Bepotastine Eye Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Bepotastine Eye Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Use Bepotastine Eye Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Headache; mild taste in the mouth; sore throat.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips or tongue); new or worsening eye irritation or redness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Bepotastine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Bepotastine Eye Drops upright in the refrigerator or at room temperature between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Keep the bottle tightly closed. Store away from heat, moisture, and light. Keep Bepotastine Eye Drops out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Bepotastine Eye Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Spirohexal may be available in the countries listed below.
Spironolactone is reported as an ingredient of Spirohexal in the following countries:
International Drug Name Search
Fareclox may be available in the countries listed below.
Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Fareclox in the following countries:
International Drug Name Search
Rx only
Desmopressin Acetate Injection, USP 4 mcg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:
Mol. Wt. 1183.31
Molecular Formula: C46H64N14O12S2 • C2H4O2 • 3H2O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
Desmopressin Acetate Injection, USP 4 mcg/mL is provided as a sterile, aqueous solution for intravenous or subcutaneous use. Each mL contains Desmopressin acetate, 4 mcg (equivalent to 0.004 mg of Desmopressin) and sodium chloride, 9 mg. May contain hydrochloric acid for pH adjustment. The pH range is 3.5 to 6.0.
Desmopressin Acetate Injection 4 mcg/mL contains as active substance, Desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (4 mcg) of Desmopressin acetate solution has an antidiuretic activity of about 16 IU; 1 mcg of Desmopressin acetate is equivalent to 4 IU.
Desmopressin acetate has been shown to be more potent than arginine vasopressin in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I.
Dose-response studies were performed in healthy persons, using doses of 0.1 to 0.4 mcg/kg body weight, infused over a 10-minute period. Maximal dose response occurred at 0.3 to 0.4 mcg/kg. The response to Desmopressin acetate of factor VIII activity and plasminogen activator is dose-related, with maximal plasma levels of 300 to 400 percent of initial concentrations obtained after infusion of 0.4 mcg/kg body weight. The increase is rapid and evident within 30 minutes, reaching a maximum at a point ranging from 90 minutes to two hours. The factor VIII related antigen and ristocetin cofactor activity were also increased to a smaller degree, but still are dose-dependent.
The biphasic half-lives of Desmopressin acetate were 7.8 and 75.5 minutes for the fast and slow phases, respectively, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone. As a result, Desmopressin acetate provides a prompt onset of antidiuretic action with a long duration after each administration.
The change in structure of arginine vasopressin to Desmopressin acetate has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.
When administered by injection, Desmopressin acetate has an antidiuretic effect about ten times that of an equivalent dose administered intranasally.
The bioavailability of the subcutaneous route of administration was determined qualitatively using urine output data. The exact fraction of drug absorbed by that route of administration has not been quantitatively determined.
The percentage increase of factor VIII levels in patients with mild hemophilia A and von Willebrand’s disease was not significantly different from that observed in normal healthy individuals when treated with 0.3 mcg/kg of Desmopressin acetate infused over 10 minutes.
Plasminogen activator activity increases rapidly after Desmopressin acetate infusion, but there has been no clinically significant fibrinolysis in patients treated with Desmopressin acetate.
The effect of repeated Desmopressin acetate administration when doses were given every 12 to 24 hours has generally shown a gradual diminution of the factor VIII activity increase noted with a single dose. The initial response is reproducible in any particular patient if there are 2 or 3 days between administrations.
Human Pharmacokinetics: Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose Desmopressin acetate (2 mcg) injection demonstrated a difference in Desmopressin acetate terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. See CONTRAINDICATIONS.
Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.
Desmopressin acetate will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.
Desmopressin acetate will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
Desmopressin acetate is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies. |
In certain clinical situations, it may be justified to try Desmopressin acetate in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand’s Disease (Type I): Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrand’s disease (Type I) with factor VIII levels greater than 5%. Desmopressin acetate will often maintain hemostasis in patients with mild to moderate von Willebrand’s disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.
Desmopressin acetate will usually stop bleeding in mild to moderate von Willebrand’s patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
Those von Willebrand’s disease patients who are least likely to respond are those with severe homozygous von Willebrand’s disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of Desmopressin acetate to ensure that adequate levels are being achieved.
Desmopressin acetate is not indicated for the treatment of severe classic von Willebrand’s disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. See WARNINGS.
Diabetes Insipidus: Desmopressin Acetate Injection 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus.
Desmopressin acetate is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
Desmopressin Acetate Injection 4 mcg/mL is contraindicated in individuals with known hypersensitivity to Desmopressin acetate or to any of the components of Desmopressin Acetate Injection 4 mcg/mL.
Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).
Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.
Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with Desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.
When Desmopressin Acetate Injection is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. See PRECAUTIONS, Pediatric Use and Geriatric Use. All patients receiving Desmopressin acetate therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.
Desmopressin acetate should not be used to treat patients with Type IIB von Willebrand’s disease since platelet aggregation may be induced.
Desmopressin acetate should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.
For injection use only.
Desmopressin Acetate Injection 4 mcg/mL has infrequently produced changes in blood pressure causing either a slight elevation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease.
Desmopressin Acetate Injection should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders, because these patients are prone to hyponatremia.
There have been rare reports of thrombotic events following Desmopressin Acetate Injection 4 mcg/mL in patients predisposed to thrombus formation. No causality has been determined; however, the drug should be used with caution in these patients.
Severe allergic reactions have been reported rarely. Anaphylaxis has been reported rarely with intravenous and intranasal Desmopressin acetate, including isolated cases of fatal anaphylaxis with intravenous Desmopressin acetate. It is not known whether antibodies to Desmopressin Acetate Injection 4 mcg/mL are produced after repeated injections.
Hemophilia A: Laboratory tests for assessing patient status include levels of factor VIII coagulant, factor VIII antigen and factor VIII ristocetin cofactor (von Willebrand factor) as well as activated partial thromboplastin time. Factor VIII coagulant activity should be determined before giving Desmopressin acetate for hemostasis. If factor VIII coagulant activity is present at less than 5% of normal, Desmopressin acetate should not be relied on.
von Willebrand’s Disease: Laboratory tests for assessing patient status include levels of factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII von Willebrand factor antigen. The skin bleeding time may be helpful in following these patients.
Diabetes Insipidus: Laboratory tests for monitoring the patient include urine volume and osmolality. In some cases, plasma osmolality may be required.
Although the pressor activity of Desmopressin acetate is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of Desmopressin acetate with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.
Desmopressin acetate has been used with epsilon aminocaproic acid without adverse effects.
Studies with Desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to Desmopressin acetate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Several publications of Desmopressin acetate’s use in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and Desmopressin acetate has been established. A fifteen year, Swedish epidemiologic study of the use of Desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, Desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the therapeutic advantages against the possible risks in each case.
There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable Desmopressin acetate in breast milk following an intranasal dose of 10 mcg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desmopressin acetate is administered to a nursing woman.
Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian. See WARNINGS. Desmopressin Acetate Injection 4 mcg/mL should not be used in infants less than three months of age in the treatment of hemophilia A or von Willebrand’s disease; safety and effectiveness in pediatric patients under 12 years of age with diabetes insipidus have not been established.
Clinical studies of Desmopressin Acetate Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min). See CLINICAL PHARMACOLOGY: Human Pharmacokinetics and CONTRAINDICATIONS.
Use of Desmopressin acetate injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient. See WARNINGS.
Infrequently, Desmopressin acetate has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasionally, injection of Desmopressin acetate has produced local erythema, swelling or burning pain. Occasional facial flushing has been reported with the administration of Desmopressin acetate. Desmopressin Acetate Injection has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall and a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with Desmopressin Acetate Injection.
See WARNINGS for the possibility of water intoxication and hyponatremia.
Post Marketing: There have been rare reports of thrombotic events (acute cerebrovascular thrombosis, acute myocardial infarction) following Desmopressin Acetate Injection in patients predisposed to thrombus formation, and rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutynin and imipramine.
Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. See WARNINGS. In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition.
There is no known specific antidote for Desmopressin acetate or Desmopressin Acetate Injection 4 mcg/mL.
An oral LD50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.
Hemophilia A and von Willebrand's Disease (Type I): Desmopressin Acetate Injection 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg Desmopressin acetate/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If Desmopressin Acetate Injection 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.
The necessity for repeat administration of Desmopressin acetate or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.
Fluid restriction should be observed. See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.
Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. Desmopressin Acetate Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.
The usual dosage range in adults is 0.5 mL (2 mcg) to 1 mL (4 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal Desmopressin acetate and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.
Fluid restriction should be observed. See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. See CLINICAL PHARMACOLOGY: Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS: Geriatric Use.
Desmopressin Acetate Injection, USP 4 mcg/mL is available as a clear colorless sterile solution as follows:
NDC No. | Container | Concentration | Fill | Quantity |
0409–2265–01 | Ampul | 4 mcg/mL | 1 mL | 10 per Box |
KEEP REFRIGERATED AT 2° to 8°C (36° to 46°F).
Protect from light.
Keep out of the reach of children.
Revised: September, 2007
Printed in USA | EN-1599 |
Hospira, Inc., Lake Forest, IL 60045 USA | |
| Desmopressin ACETATE Desmopressin acetate injection, solution | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075220 | 10/19/2010 | |
| Labeler - Hospira, Inc. (141588017) |
Treating certain inflammatory conditions of the skin. The body oil is used to treat inflammation of the skin. The scalp oil is used to treat psoriasis of the scalp. Derma-Smoothe/FS Body Oil may also be used for other conditions as determined by your doctor.
Derma-Smoothe/FS Body Oil is a topical corticosteroid. Exactly how it works is unknown.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Derma-Smoothe/FS Body Oil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Derma-Smoothe/FS Body Oil. Because little, if any, of Derma-Smoothe/FS Body Oil is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Derma-Smoothe/FS Body Oil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Derma-Smoothe/FS Body Oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Derma-Smoothe/FS Body Oil.
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the scalp oil after topical use. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Cough; lightening of the skin; mild fever; nose or throat inflammation; runny nose.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Derma-Smoothe/FS Body Oil; thinning, softening, or discoloration of the skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Derma-Smoothe/FS Body side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.
Store Derma-Smoothe/FS Body Oil at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Derma-Smoothe/FS Body Oil out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Derma-Smoothe/FS Body Oil. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Abovis may be available in the countries listed below.
Aclatonium Napadisilate is reported as an ingredient of Abovis in the following countries:
International Drug Name Search
Veterinary For Oral Suspension
For use in DOGS only.
Biomox® (amoxicillin) is a broad-spectrum, semisynthetic antibiotic which provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Amoxicillin chemically is D-(-)a-amino-p-hydroxybenzyl penicillin trihydrate.
Cherry Flavor, Silicon Dioxide NF, FD&C Red #40, Polyoxyethylene-Polyoxypropylene Glycol, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sucrose.
Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial wall mucopeptides. Most strains of the following gram-positive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta-hemolytic streptococci, Streptococcus faecalis, Escherichia coli and Proteus mirabilis. Amoxicillin does not resist destruction by penicillinase; therefore, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Enterobacter and Klebsiella and all strains of Pseudomonas are resistant.
Amoxicillin may be given without regard to meals because it is stable in gastric acid. It is rapidly absorbed following oral administration and diffuses readily into most body fluids and tissues. It diffuses poorly into the brain and spinal fluid except when the meninges are inflamed. Most of the amoxicillin is excreted in the urine unchanged.
Biomox® (amoxicillin) for oral suspension is indicated in the treatment of the following infections in dogs when caused by susceptible strains of organisms:
BACTERIAL DERMATITIS due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and E. coli.
SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus, Streptococcus spp., E. coli, Proteus mirabilis and Staphylococcus spp.
As is true with all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.
Use of amoxicillin is contraindicated in animals with a history of an allergic reaction to penicillin.
Amoxicillin is a semisynthetic penicillin and, therefore, has the potential for producing allergic reactions. Epinephrine and/or steroids should be administered if an allergic reaction occurs.
For use in dogs only.
Until adequate reproductive studies are accomplished, Biomox (amoxicillin) for oral suspension should not be used in pregnant or breeding animals.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.
Add sufficient water to the bottle as indicated in the table below and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.
| Bottle Size | Amount of Water to Add for Reconstitution |
|---|---|
| 15 mL | 11 mL |
| 30 mL | 21 mL |
Note: When stored at room temperature or in refrigerator, discard unused portion of reconstituted suspension after 14 days.
Biomox® (amoxicillin) for oral suspension is supplied in bottles containing 0.75 g of amoxicillin activity in bottles of 15 mL or 1.5 g of amoxicillin activity in bottles of 30 mL. After reconstitution with the required amount of water, each mL will contain 50 mg of amoxicillin as the trihydrate.
Manufactured for:
Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161
1-800-338-3659
92515
05/08
Rev.-02
NDC-051311-300-15
Virbac
ANIMAL HEALTH
Biomox®
(amoxicillin)
VETERINARY FOR ORAL SUSPENSION
Equivalent to 0.75 g amoxicillin
When reconstituted, concentration is
50 mg/mL amoxicillin as the trihydrate
CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.
NADA # 65-495, Approved by FDA
15 mL (when mixed)
NDC-051311-300-30
Virbac
ANIMAL HEALTH
Biomox®
(amoxicillin)
VETERINARY FOR ORAL SUSPENSION
Equivalent to 1.5 g amoxicillin
When reconstituted, concentration is
50 mg/mL amoxicillin as the trihydrate
CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.
NADA # 65-495, Approved by FDA
30 mL (when mixed)
| Biomox amoxicillin suspension | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA65495 | 05/24/2010 | |
| Labeler - Virbac AH, Inc. (131568396) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Okasa PVT Ltd | 915793457 | MANUFACTURE | |
Class: Cathartics and Laxatives
ATC Class: A06AB02
VA Class: GA209
CAS Number: 603-50-9
Brands: Alophen Pills, Bisac-Evac, Carter’s Little Pills, Correctol, Dulcolax, Feen-A-Mint, Fleet Bisacodyl, Bisacodyl Uniserts, Fleet Bisacodyl Enema, Dulcolax Bowel Prep Kit, Fleet Prep Kit, LoSo Prep Kit, Tridrate Bowel Evacuant Kit
REMS:
FDA approved a REMS for bisacodyl to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Bisacodyl, a diphenylmethane laxative, is a stimulant laxative.b c e
Used as a stimulant laxative to relieve occasional constipation.a c e f g h i
Has a more pronounced laxative effect than mild laxatives (e.g., anthraquinones such as cascara sagrada [no longer commercially available in the US]) but less pronounced than the violent purgation produced by castor oil.c
Use of stimulant laxatives for simple constipation is seldom necessary or desirable.c
If a stimulant laxative is used, senna derivatives may be preferred.c
Used to treat constipation that occurs following prolonged bed rest or hospitalization.c
Used to treat chronic constipation associated with opiate therapy.e
Because bisacodyl may be distributed into milk, other laxatives usually are preferred for postpartum constipation.c
Stimulant laxatives have been used to treat constipation resulting from diminished colonic motor response in geriatric patients but, because this type of constipation is frequently due to psychological or physical laxative dependence, the bulk-forming laxatives are preferred.c
Stimulant laxatives are used to treat constipation occurring secondary to idiopathic slowing of transit time, to constipating drugs, or to irritable bowel or spastic colon syndrome.c
Stimulant laxatives have been used to treat constipation in patients with neurologic constipation.c
Used orally and/or rectally (as suppositories or enemas) to empty the bowel prior to surgery or radiographic, proctoscopic, or endoscopic (e.g., sigmoidoscopic, proctoscopic) procedures, when thorough evacuation is essential.a c e Oral therapy often is supplemented with rectal evacuants.b c k j
Used orally or rectally as a laxative for postoperative, antepartum, or postpartum care.i
Enemas are used to cleanse the colon postoperatively.c i
Suppositories may be used to cleanse the colon in pregnant women prior to delivery if they are given at least 2 hours before onset of the second stage of labor.c
Usually supplemented with administration of rectal evacuants, such as saline, stimulant, or soapsuds enemas, immediately before radiographic procedures.c
Bisacodyl tannex is added to barium sulfate enemas to aid in coating the intestinal mucosa and enhance colonic evacuation prior to radiographic examination of the colon.c
Has been used to facilitate flushing of colostomies†;c e may reduce or eliminate the need for irrigations.e
Administer orally as delayed-release (enteric-coated) tablets.a b f g i j k
Administer rectally as suspension enemas or as suppositories.b h i j k
Administered as a flush suspension† for colostomies.c e
Bisacodyl is administered orally.a b f g i
For occasional use as an oral laxative, administer the evening before a morning bowel movement is desired.b
To avoid gastric irritation and the possibility of vomiting, delayed-release (enteric-coated) tablets must be swallowed whole and not crushed, chewed, or taken within 1 hour of antacids or milk.a b e f g
Bisacodyl also is administered rectally as a suppository or enema.b h i j k
Remove the foil wrapper and insert the suppository well into the rectum, pointed end first, and retain for at least 15–20 minutes if possible.h j
Shake bisacodyl enemas well and remove the protective shield from the tip before inserting rectally.i Lie on left side with left knee slightly bent and the right leg drawn up or be in the knee-chest position and insert the enema tip into the rectum.i Squeeze the contents of the enema container into the rectum.j
Bisacodyl tannex is administered rectally as an enema.b
Rectal suppositories and enemas may be administered at the time a bowel movement is desired.b e h i
Stimulant laxatives generally avoided in children <6 years of age for occasional constipation,c unless otherwise directed by a clinician.a f g h i
Children 3–11 years of age: A single 5- to 10-mg (usually 5-mg) or 0.3-mg/kg dose daily.a b f g
Children ≥12 years of age: A single 5- to 15-mg (usually 10-mg) dose daily.a b e f g
Children ≥12 years of age: A single 10-mg (30-mL) dose daily.i
Children <2 years of age: A single 5-mg (½ suppository) dose daily.b e
Children 2–11 years of age: A single 5- or 10-mg (½ or 1 suppository, respectively) dose daily.b e h
Children ≥12 years of age: A single 10-mg (1 suppository) dose daily.b e h
Children ≥12 years of age: The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.r
Children ≥12 years of age: In the usual regimen, 300 mL of magnesium citrate solution (17.45 g of magnesium citrate) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository inserted at least 2 hours before the procedure.r
Children ≥12 years of age: The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.m
Children ≥12 years of age: In the usual regimen, 18 g of magnesium citrate (1 packet dissolved in 240 mL water per manufacturer’s directions) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at least 2 hours before the procedure.m
Children >12 years of age: The regimen begins with a meal (i.e., clear liquids, chicken or turkey white meat sandwich without condiments, skim milk) at a prescribed time, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.o
Children >12 years of age: In the usual regimen, 300 mL of magnesium citrate solution is administered orally at 8 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at 10 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of the procedure.o
Children >12 years of age: The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.p
Children >12 years of age: In the usual regimen, 19 g of magnesium citrate (1 packet dissolved in 240 mL water per manufacturer’s directions) is administered orally in 2 divided doses at 6 p.m. and 6:15 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at bedtime (between 9 p.m. and midnight) the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of (at least 2 hours before) the procedure.p
Usually, 5–15 mg daily given as a single dose;a b f g some patients may require single daily doses up to 30 mg.e
A single 10-mg (30-mL) dose daily.i
A single 10-mg (1 suppository) dose daily.b e h
Up to 30 mg may be given orally when complete evacuation of the colon is required for special procedures.b
One of the following regimens can be used to clear the bowel prior to surgical, radiographic, or endoscopic procedures.j l m When available, provide patients with a copy of the manufacturers’ instructions, which detail the specific regimen to be employed.j l m n o p q
Give up to 30 mg of bisacodyl orally the night before the procedure, followed by a 10-mg bisacodyl rectal suppository 1–2 hours before the procedure.b Do not eat following administration of the tablets.b
Preparatory regimens using magnesium citrate, which acts mainly on the small intestine, in addition to administration of the usual oral (up to 30 mg) and rectal (10 mg) dose of bisacodyl also have been used.b
To cleanse the colon prior to delivery, a single 10-mg bisacodyl rectal suppository is administered at least 2 hours before onset of the second stage of labor.b
Bisacodyl tannex may be used prior to radiographic examinations or sigmoidoscopic or proctoscopic procedures.b
Give a residue-free diet the day before the procedure, followed by 30–60 mL of castor oil orally 16 hours before the examination or procedure.b
Prepare a cleansing enema by dissolving bisacodyl tannex equivalent to 1.5 mg of bisacodyl and 2.5 g of tannic acid (one packet of the commercially available bisacodyl tannex product) in 1 L of lukewarm water.b
When used as a radiopaque enema adjuvant, bisacodyl tannex equivalent to 1.5–3 mg of bisacodyl (1–2 packets of the commercially available product) is dissolved in 1 L of barium sulfate suspension.b The concentration of bisacodyl tannex should not exceed 0.5% (2 packets of the commercially available product per L).b
Administer the cleansing enema containing bisacodyl tannex the day of the procedure.b
If necessary, repeat the cleansing enema, but total dosage for one entire colonic examination (including the cleansing enema) should not exceed 4.5 mg of bisacodyl and 7.5 g of tannic acid (3 packets of the commercially available preparation), and no more than 6 mg of bisacodyl and 10 g of tannic acid (4 packets of the commercially available product) should be administered during a 72-hour period.b
The regimen begins with a liquid meal at a prescribed time, followed by periodic clear liquid intake throughout the day and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.k
In the usual regimen, 300 mL of magnesium citrate solution is administered orally at 4 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 6 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at 5:30 a.m. the morning of the procedure.k
Available in 2 kit combinations containing bisacodyl tablets, sodium phosphates oral solution, and either a bisacodyl suppository (Fleet Prep Kit 1) or a bisacodyl enema (Fleet Prep Kit 3).j
Each kit can be administered in regimens beginning 18 or 24 hours before the procedure; in most cases, the 24-hour regimen is followed.j s t
Each regimen begins with a light meal at a prescribed time, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of either a bisacodyl suppository or bisacodyl enema 1 hour before leaving for the procedure.s t
In the 24-hour regimen, 45 mL of sodium phosphates oral solution (Fleet Phospho-soda) is mixed with 360 mL of cold clear liquid (ginger ale, apple juice, Sprite, or 7-Up may help improve taste) and administered orally at 4 p.m. the day before the procedure with ≥360 mL (kit 1) or ≥240 mL (kit 3) of clear liquid, followed by 20 mg (or alternative dose per clinician) of bisacodyl orally at 9 p.m. the day before the procedure, and then by either a 10-mg bisacodyl rectal suppository (kit 1) or a 10-mg (30-mL) bisacodyl enema (kit 3) administered 1 hour before leaving for the procedure.s t
The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.r
In the usual regimen, 300 mL of magnesium citrate solution (17.45 g of magnesium citrate) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository inserted at least 2 hours before leaving for the procedure.r
The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.m
In the usual regimen, 18 g of magnesium citrate (1 packet dissolved in 240 mL water per manufacturer’s directions) is administered orally at 5:30 p.m. the day before the procedure, followed by 20 mg of bisacodyl orally at 7:30 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at least 2 hours before the procedure.m
The regimen begins with a meal (i.e., clear liquids, chicken or turkey white meat sandwich without condiments, skim milk) at a prescribed time, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.o
In the usual regimen, 300 mL of magnesium citrate solution is administered orally at 8 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at 10 p.m. the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of the procedure.o
The regimen begins with liquid meals at prescribed times, followed by scheduled clear liquid intake at various times and scheduled administration of oral laxatives, and concluding with rectal administration of a bisacodyl suppository.p
In the usual regimen, 19 g of magnesium citrate (1 packet dissolved in 240 mL water per manufacturer’s directions) is administered orally in 2 divided doses at 6 p.m. and 6:15 p.m. the day before the procedure, followed by 15 mg of bisacodyl orally at bedtime (between 9 p.m. and midnight) the day before the procedure, and concluding with a 10-mg bisacodyl rectal suppository at 7 a.m. the morning of (at least 2 hours before) the procedure.p
No specific dosage recommendations for bisacodyl in hepatic impairment.a b f g h i Minimally absorbed systemically following oral or rectal administration.b e
No specific dosage recommendations for bisacodyl in renal impairment.a b f g h i Minimally absorbed systemically following oral or rectal administration.b e
No specific geriatric dosage recommendations for bisacodyl.a
Acute abdominal pain, nausea, vomiting, or other symptoms of appendicitis or undiagnosed abdominal pain or rectal bleeding.c e
Intestinal obstruction.c
Bisacodyl tannex: Children <10 years of age.c
Do not use kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits) in patients with megacolon, GI obstruction, perforation, ileus, active inflammatory bowel disease, ascites, CHF, or clinically important renal function impairment or in patients <18 years of age.j s t
Habit-forming.c
Potentially serious toxicity with chronic use.c
Chronic use or overdosage may produce persistent diarrhea, hypokalemia, loss of essential nutritional factors, and dehydration.c
Laxative dependence, chronic constipation, and loss of normal bowel function could occur during long-term use.c
Factitious diarrhea (i.e., severe, chronic, watery diarrhea, frequently occurring at night and accompanied by abdominal pain, weight loss, nausea, and vomiting).e
Electrolyte disturbances including hypokalemia, hypocalcemia, metabolic acidosis or alkalosis, abdominal pain, diarrhea, malabsorption, weight loss, and protein-losing enteropathy may occur.c May require immediate medical intervention with appropriate fluid and electrolyte replacement.j
Electrolyte disturbances may produce vomiting and muscle weakness; rarely, osteomalacia, secondary aldosteronism, and tetany may occur.c
Pathologic changes including structural damage to the myenteric plexus, severe and permanent interference with colonic motility, and hypertrophy of the muscularis mucosae may occur with chronic use.c
Protein-losing enteropathy and steatorrhea can occur.e
“Cathartic colon” with atony and dilation of the colon, especially of the right side, has occurred with habitual use (often for several years) and often resembles ulcerative colitis.c
Some clinicians state that stimulant laxative suppositories or enemas should not be used in patients with abdominal cramps, anal or rectal fissures, or ulcerated hemorrhoids.c
Hepatotoxicity may result if sufficient tannic acid is absorbed from bisacodyl tannex laxatives.c
Bisacodyl tannex should be used with caution, if at all, in patients receiving multiple enemas or in those with extensive ulceration of the colon since increased tannic acid absorption may occur.c
Use with caution kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits) in patients with heart disease, acute MI, unstable angina, preexisting electrolyte disturbances, increased risk of electrolyte disturbances (e.g., dehydration, gastric retention, colitis, inadequate oral fluid intake, concomitant diuretics or other drugs that affect electrolytes), colostomy, or ileostomy, and in patients who are debilitated, elderly, on a low salt diet, at increased risk for underlying renal impairment, or taking drugs known to prolong the QT interval.j (See Specific Populations under Cautions.)
Risk of elevated sodium and phosphate concentrations and decreased calcium and potassium concentrations, with resultant risk of hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia, and acidosis.j Risk of renal failure and acute phosphate nephropathy.j
Do not give other sodium phosphate-containing preparations concomitantly.j
In at-risk patients, consider baseline and posttreatment measurement of sodium, potassium, calcium, chloride, bicarbonate, phosphate, BUN, and creatinine concentrations.j
When used in regimens with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.
Bisacodyl (base): Category B.e Bisacodyl tannex: Safety not established.c
May be distributed into the milk of nursing women but usually in amounts insufficient to produce a laxative effect.b c e
Stimulant laxatives generally avoided in children <6 years of age for occasional constipation,c unless otherwise directed by a clinician.a f g h i
Do not use bisacodyl enemas in children <12 years of age.i
Do not use kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits) in patients <18 years of age.j s t
Bisacodyl tannex: Because the possibility of tannic acid absorption has not been studied adequately in children <10 years of age, bisacodyl tannex is contraindicated in this age group.c
Use with caution kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits); consider baseline and posttreatment measurement of sodium, potassium, calcium, chloride, bicarbonate, phosphate, BUN, and creatinine concentrations.j (See Fleet Prep Kits under Cautions.)
Do not use kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits) in patients with ascites.j
Do not use kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits) in patients with clinically important renal impairment.j (See Fleet Prep Kits under Cautions.)
Some degree of abdominal discomfort, nausea, cramps, griping, and/or faintness with therapeutic doses.c
Diarrhea, GI irritation, and fluid and electrolyte depletion.c
Gastric irritation and the possibility of vomiting if enteric coating of tablets is disrupted.b (See Advice to Patients.)
Rectal administration of bisacodyl suspensions or suppositories may cause irritation and a sensation of burning of the rectal mucosa and mild proctitis.c e
Hepatotoxicity if sufficient tannic acid is absorbed from bisacodyl tannex.c
Risk of electrolyte disturbances with sodium phosphates in kits containing bisacodyl tablets, sodium phosphates oral solution, and bisacodyl suppositories or enemas (Fleet Prep Kits).j (See Fleet Prep Kits under Cautions.)
By increasing intestinal motility, can potentially decrease transit time of concomitantly administered oral drugs and thereby decrease their absorption.c
Drug or Food | Interaction | Comments |
|---|---|---|
Antacids | Administration of delayed-release (enteric-coated) tablets within 1 hour of antacids results in rapid erosion of the coatingb e | Do not take within 1 hour of antacids since gastric or duodenal irritation can occurb e |
Cimetidine | Administration of delayed-release (enteric-coated) tablets within 1 hour of cimetidine results in rapid erosion of the coatingb e | Do not take within 1 hour of cimetidine since gastric or duodenal irritation can occurb e |
Milk | Administration of delayed-release (enteric-coated) tablets within 1 hour of milk results in rapid erosion of the coatingb e | Do not take within 1 hour of milk since gastric or duodenal irritation can occurb e |
Famotidine | Administration of delayed-release (enteric-coated) tablets within 1 hour of famotidine results in rapid erosion of the coatingb e | Do not take within 1 hour of famotidine since gastric or duodenal irritation can occurb e |
Proton-pump inhibitors | Increased gastric pH results in rapid erosion of the coating of delayed-release (enteric-coated) tabletse | Gastric or duodenal irritation can occure |
Ranitidine | Administration of delayed-release (enteric-coated) tablets within 1 hour of ranitidine results in rapid erosion of the enteric coatingb e | Do not take within 1 hour of ranitidine since gastric or duodenal irritation can occurb e |
Absorption of bisacodyl or bisacodyl tannex is minimal following oral or rectal administration.b e
Tannic acid may be absorbed following rectal administration; very little is known about the degree of absorption and circumstances under which absorption may occur with bisacodyl tannex.b
Oral therapeutic dosages: evacuation is produced in 6–8 hours (range: 6–12 hours).a b e f g i
Rectally administered bisacodyl or bisacodyl tannex produces evacuation of the colon within 15 minutes to 1 hour.b e h i
Distributes into milk.
>99%.
In patients with renal impairment, possible altered protein binding and pharmacokinetics.
Any bisacodyl that is absorbed is metabolized in the liver.b
Any bisacodyl that is absorbed is excreted in the urine.b
Bisacodyl rectal suppositories and enteric-coated tablets should be stored at less than 30°C.b Reconstituted solutions of bisacodyl tannex should be used immediately following preparation.b
In well-closed containers at ≤30°C.b d
In well-closed containers at ≤30°C.b d
In unit-dose containers at ≤30°C.b d
Bisacodyl and bisacodyl tannex are diphenylmethane-derivative stimulant laxatives.b c e
Commonly thought that stimulant laxatives induce defecation by stimulating propulsive peristaltic activity of the intestine through local irritation of the mucosa or through a more selective action on the intramural nerve plexus of intestinal smooth muscle, thus increasing motility.c e
More recent evidence shows that stimulant laxatives alter fluid and electrolyte absorption, producing net intestinal fluid accumulation and laxation.c
Stimulant laxatives mainly promote evacuation of the colon;c action of bisacodyl on small intestine is negligible.e
Bisacodyl acts in the colon on contact with the mucosal nerve plexus.e
Colonic stimulation is segmented and axonal, producing contraction of the entire colon.e
Action is independent of intestinal tone.e
Tannic acid present in the bisacodyl tannex complex precipitates protein and its astringent effect decreases mucus secretion in the large intestine.c
Tannic acid also reportedly facilitates adherence of contrast media to mucous membranes, but this is disputed by some clinicians.c
Some reports that tannic acid increases evacuation of the colon, but other reports that its astringent effect produces constipation.c
Importance of swallowing delayed-release (enteric-coated) tablets whole and of not crushing, chewing, or taking within 1 hour of antacids or milk so that gastric irritation and the possibility of vomiting are avoided.a b f g h i
Patients who cannot swallow without chewing should not use the delayed-release (enteric-coated) tablets,f g unless otherwise directed by a clinician.g
Advise patients that prolonged use can cause excessive loss of fluids, electrolytes, and nutrients.e
Importance of not using laxative products for a period longer than 1 week unless directed by a clinician.a c f g h i
Importance of informing clinicians before use if abdominal pain, nausea, or vomiting is present or if a sudden change in bowel habits that persists over a period of 2 weeks has been noticed.a c f g h i
Importance of contacting a clinician if a bowel movement does not occura f g h i j within 12 hoursa or if rectal bleeding occurs since these may be signs of a serious condition.a f g h i j
Advise patient to open and read directions for bowel cleansing preparations at least 2 days in advance of examination.j s t Importance of following complete regimen for bowel cleansing preparations.m o r s t
Importance of adequate oral fluid intake when used for bowel cleansing.j k l m n o p q
Advise about risk of laxative abuse and potential serious consequences.c e (See Chronic Use or Overdosage under Cautions.)
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c e i
Importance of informing patients of other important precautionary information. (See Cautions.)
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
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, delayed-release (enteric-coated) | 5 mg* | Alophen Pills | Numark |
Bisac-Evac | G&W | |||
Bisacodyl Enteric-coated Tablets | ||||
Carter’s Little Pills | Carter | |||
Correctol Caplets | Schering-Plough | |||
Correctol Tablets | Schering-Plough | |||
Dulcolax | Novartis | |||
Feen-A-Mint | Schering-Plough | |||
Fleet Bisacodyl | Fleet | |||
Rectal | Suppositories | 10 mg* | Bisac-Evac | G&W |
Bisacodyl Suppositories | ||||
Bisacodyl Uniserts | Upsher-Smith | |||
Dulcolax | Novartis | |||
Fleet Bisacodyl | Fleet | |||
Suspension | 10 mg/30 mL | Fleet Bisacodyl Enema | Fleet |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Kit | 4 Tablets, enteric-coated, Bisacodyl 5 mg (Dulcolax) 1 Suppository, rectal, Bisacodyl 10 mg (Dulcolax) | Dulcolax Bowel Prep Kit | Novartis | |
45 mL Solution, oral, Dibasic Sodium Phosphate 900 mg/5 mL and Monobasic Sodium Phosphate 2.4 g/5 mL (Fleet Phospho-soda) 4 Tablets, enteric-coated, Bisacodyl 5 mg (Fleet Bisacodyl) 1 Suppository, rectal, Bisacodyl 10 mg (Fleet Bisacodyl) | Fleet Prep Kit 1 | Fleet | ||
45 mL Solution, oral, Dibasic Sodium Phosphate 900 mg/5 mL and Monobasic Sodium Phosphate 2.4 g/5 mL (Fleet Phospho-soda) 4 Tablets, enteric-coated, Bisacodyl 5 mg (Fleet Bisacodyl) 30 mL Suspension, rectal, Bisacodyl 0.33 mg/mL (Fleet Bisacodyl Enema) | Fleet Prep Kit 3 | Fleet | ||
300 mL Solution, oral, Magnesium Citrate 4 Tablets, enteric-coated, Bisacodyl 5 mg 1 Suppository, rectal, Bisacodyl 10 mg | Liquid LoSo Prep Bowel Cleansing System | E-Z-EM | ||
For solution, oral, Magnesium Citrate 18 g as Magnesium Carbonate, Citric Acid, and Potassium Citrate 4 Tablets, enteric-coated, Bisacodyl 5 mg 1 Suppository, rectal, Bisacodyl 10 mg | LoSo Prep Bowel Cleansing System | E-Z-EM | ||
300 mL Solution, oral, Magnesium Citrate (Tridrate) 3 Tablets, enteric-coated, Bisacodyl 5 mg (Tridrate) 1 Suppository, rectal, Bisacodyl 10 mg (Tridrate) | Tridrate Bowel Evacuant Kit | Lafayette | ||
For solution, oral, Magnesium Citrate 19 g 3 Tablets, enteric-coated, Bisacodyl 5 mg (Tridrate) 1 Suppository, rectal, Bisacodyl 10 mg (Tridrate) | Tridrate Dry Bowel Evacuant Kit | Lafayette |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Bisac-Evac 10MG Suppositories (G & W LABS): 100/$18.97 or 300/$56.91
Bisacodyl 10MG Suppositories (PERRIGO): 100/$25.99 or 300/$65.97
Dulcolax 5MG Enteric-coated Tablets (BOEHRINGER INGELHEIM CONSUMER): 10/$13.99 or 30/$20.97
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'
