Tamoxifeno Cinfa may be available in the countries listed below.
Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamoxifeno Cinfa in the following countries:
International Drug Name Search
Cloxagel may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cloxacillin benzathine (a derivative of Cloxacillin) is reported as an ingredient of Cloxagel in the following countries:
Cloxacillin benzathine and sodium (a derivative of Cloxacillin) is reported as an ingredient of Cloxagel in the following countries:
Cloxacillin sodium salt (a derivative of Cloxacillin) is reported as an ingredient of Cloxagel in the following countries:
Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Cloxagel in the following countries:
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Dextrométorphane may be available in the countries listed below.
Dextrométorphane (DCF) is known as Dextromethorphan in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Tabervol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Pyrethrin I is reported as an ingredient of Tabervol in the following countries:
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Syntolexin may be available in the countries listed below.
Cefalexin monohydrate (a derivative of Cefalexin) is reported as an ingredient of Syntolexin in the following countries:
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Marsthine may be available in the countries listed below.
Clemastine fumarate (a derivative of Clemastine) is reported as an ingredient of Marsthine in the following countries:
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Taxomedac may be available in the countries listed below.
Paclitaxel is reported as an ingredient of Taxomedac in the following countries:
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Vita Calcea may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Vita Calcea in the following countries:
Colecalciferol is reported as an ingredient of Vita Calcea in the following countries:
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Crorin may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Crorin in the following countries:
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Tragesik may be available in the countries listed below.
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Gabaran may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabaran in the following countries:
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Phemetabs may be available in the countries listed below.
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Drs. Foster and Smith Septi-Soothe Spray is a gentle antiseptic formula recommended for minor cuts, burns and scrapes. For dogs, cats, small pets, and horses.
Clean affected area thoroughly. Spray Septi-Soothe on affected area 2 to 3 times daily or as directed by your veterinarian. Let product, then area may be covered or bandaged.
0.05% Chlorhexidine Diacetate
Aloe Vera Gel, Bitter Extractives, Boric Acid, Fragrance, Glycerin, Isopropyl Alcohol, Propylene Glycol, Water.
For external use only. Avoid contact with eyes. Consult your veterinarian in cases of deep or puncture wounds, animal bites, serious burns or if redness and irritation persists or increases.
Store at room temperature.
For animal use only.
Keep out of reach of children and pets to prevent accidental ingestion.
For questions or to reorder:
1-800-562-7169 Drsfostersmith.com
Doctors
Foster and Smith
Veterinarian Formulated
Advanced Spray
Sept-
soothe
Spray
Gentle, Antiseptic Formula
8 fl oz (237 ml)
| DOCTORS FOSTER AND SMITH chlorhexidine spray | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/01/2001 | ||
| Labeler - Doctors Foster and Smith (122135148) |
| Registrant - United Pet Group (931135730) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| JUNGLE LABORATORIES CORPORATION | 032615270 | manufacture | |
Thiameron may be available in the countries listed below.
Tiquizium Bromide is reported as an ingredient of Thiameron in the following countries:
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Toza may be available in the countries listed below.
Nitazoxanide is reported as an ingredient of Toza in the following countries:
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Antimicotico may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Antimicotico in the following countries:
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Colpro may be available in the countries listed below.
Medrogestone is reported as an ingredient of Colpro in the following countries:
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Agrelid may be available in the countries listed below.
Anagrelide hydrochloride (a derivative of Anagrelide) is reported as an ingredient of Agrelid in the following countries:
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Gabapentina Generis may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentina Generis in the following countries:
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Pyritioxine Hydrochloride may be available in the countries listed below.
Pyritioxine Hydrochloride (JAN) is also known as Pyritinol (Rec.INN)
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Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Niltime may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Bendiocarb is reported as an ingredient of Niltime in the following countries:
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Lennamet may be available in the countries listed below.
Cimetidine is reported as an ingredient of Lennamet in the following countries:
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Rx only
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
ROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains:
Glycopyrrolate, USP 0.2 mg
Water for Injection, USP q.s.
Benzyl Alcohol, NF 0.9% (preservative)
pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.
For Intramuscular (IM) or Intravenous (IV) administration.
Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C19H28BrNO3 and the molecular weight is 398.33.
Its structural formula is as follows:
C19H28BrNO3 MW 398.33
Glycopyrrolate occurs as a white, odorless crystalline powder. It is soluble in water and alcohol, and practically insoluble in chloroform and ether.
Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. ROBINUL (glycopyrrolate) Injection is a clear, colorless, sterile liquid; pH 2.0– 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log10 P= -1.52) at ambient room temperature (24°C).
Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node,
the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions. Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced by cholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrast to atropine sulfate and scopolamine hydrobromide, which are highly non-polar tertiary amines which penetrate lipid barriers easily. With intravenous injection, the onset of action is generally evident within one minute. Following intramuscular administration, the onset of action is noted in 15 to 30 minutes, with peak effects occurring within approximately 30 to 45 minutes. The vagal blocking effects persist for 2 to 3 hours and the antisialagogue effects persist up to 7 hours, periods longer than for atropine.
Pharmacokinetics
The following pharmacokinetic information and conclusions were obtained from published studies that used nonspecific assay methods.
Distribution
The mean volume of distribution of glycopyrrolate was estimated to be 0.42±0.22L/kg.
Metabolism
Thein vivometabolism of glycopyrrolate in humans has not been studied.
Excretion
The mean clearance and mean T1/2 values were reported to be 0.54±0.14 L/kg/hr and 0.83±0.13 hr, respectively post IV administration. After IV administration of a 0.2 mg radiolabeled glycopyrrolate, 85% of dose recovered was recovered in urine 48 hours postdose and some of the radioactivity was also recovered in bile. After IM administration of glycopyrrolate to adults, the
mean T1/2 value is reported to be between 0.55 to 1.25 hrs. Over 80% of IM dose administered was recovered in urine and the bile as unchanged drug and half the IM dose is excreted within 3 hrs. The following table summarizes the mean and standard deviation of pharmacokinetic parameters from a study.
| Group | t 1/2 (hr) | Vss (L/kg) | CL (L/kg/hr) | Tmax (min) | Cmax (μg/L) | AUC (μg/L•hr) |
| (6μg/kg IV) | 0.83±0.27 | 0.42±0.22 | 0.54±0.14 | - | - | 8.64±1.49* |
| (8μg/kg IM) | - | - | - | 27.48±6.12 | 3.47±1.48 | 6.64±2.33* |
In Anesthesia
Robinul Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Robinul Injection may be used intraoperatively to counteract surgically or druginduced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.
In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, Robinul Injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
This drug should be used with great caution, if at all, in patients with glaucoma.
Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources. (see PRECAUTIONS, Pediatric Use). Robinul Injection may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with Robinul Injection would be inappropriate and possibly harmful.
General
Investigate any tachycardia before giving Robinul Injection since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac arrhythmias; hypertension; hyperthyroidism. Use with caution in patients with renal disease since the renal elimination of glycopyrrolate may be severely impaired in patients with
renal failure. Dosage adjustments may be necessary (seePharmacokinetics–Renal Impairment). Use ROBINUL with caution in the elderly and in all patients with autonomic neuropathy, hepatic disease, ulcerative colitis, prostic hypertrophy, or hiatal hernia, since anticholinergic drugs may aggravate these conditions. The use of anticholinergetic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying due to antral statis.
Information for the Patient
Because Robinul Injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug (seeWARNINGS). The patient also should be cautioned about the use of this drug during exercise or hot weather since overheating may result in heat stroke. The patient may experience a possible sensitivity of the eyes to light.
Drug Interactions
The concurrent use of Robinul Injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects. Concomitant administration of Robinul Injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.
Carcinogenesis and Mutagenesis and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.
Pregnancy
Teratogenic Effects– Pregnancy Category B.
Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum recommended daily human dose of 2 mg on a mg/m2 basis) and rabbits at intramuscular doses of up to 0.5 mg/kg/day (exposure was approximately 5 times the maximum recommended daily human dose on a mg/m2 basis). These studies produced no teratogenic effects to the fetus.Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Single-dose studies in humans found that very small amounts of glycopyrrolate passed the placental barrier.
Nonteratogenic Effects
Published literature suggest the following regarding the use of glycopyrrolate during pregnancy. Unlike atropine, glycopyrrolate in normal doses (0.004 mg/kg) does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. Concentrations of glycopyrrolate in umbilical venous and aterial blood and in the amniotic fluid are low after intramuscular
administration to parturients. Therefore, glycopyrrolate does not appear to penetrate through the placental barrier in significant amounts. In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rats of pup survival in a doserelated manner.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Robinul Injection is administered to a nursing woman. As with other anticholinergics, glycopyrrolate may cause suppression of lactation (seeADVERSE REACTIONS).
Pediatric Use
Due to its benzyl alcohol content, Robinul Injection should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients below the age of 16 years have not been established. Safety and effectiveness in pediatric patients have not been established for the management of peptic ulcer. Dysrhythmias associated with the use of glycopyrrolate intravenously as a premedicant or during anesthesia have been observed in pediatric patients. Infants, patients with Down’s syndrome, and pediatric patients with spastic paralysis or brain damage may experience an increased response to anticholinergics, thus increasing the potential for side effects. A paradoxical reaction characterized by hyperexcitability may occur in pediatric patients taking large doses of anticholinergics including Robinul Injection. Infants and young children are especially susceptible to the toxic effects of anticholinergics.
Benzyl alcohol, a component of this drug product, has been associated with serious adverse events and death, particularly in pediatric patients. The“gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages greater than 99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hemotologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the“gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birthweight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.
Geriatric Use
Clinical Studies of Robinul 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 for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.
Anticholinergics, including Robinul Injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of
taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons. In addition, the following adverse events have been reported from post-marketing experience with ROBINUL: malignant hyperthermia; cardiac arrhythmias (including bradycardia, ventricular tachycardia, ventricular fibrillation); cardiac arrest; hypertension; hypotension; seizures; and respiratory arrest. Post-marketing reports have included cases of heart block and QTc
interval prolongation associated with the combined use of glycopyrrolate and an anticholinesterase. Injection site reactions including pruritus, edema, erythema, and pain have also been reported.
ROBINUL is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS-related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.
To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously in increments of 0.25 mg in adults. This dosage may be repeated every five to ten minutes until anticholinergic overactivity is reversed or up to a maximum of 2.5 mg. Proportionately smaller doses should be used in pediatric patients. Indication for repetitive doses of neostigmine should be based on close monitoring of the decrease in heart rate and the return of bowel sounds. If CNS symptoms (e.g., excitement, restlessness, convulsions, psychotic behavior) occur, physostigmine (which does cross the blood–brain barrier) may be used. Physostigmine 0.5 to 2 mg should be slowly administered intravenously and repeated as necessary up to a total of 5 mg in adults. Proportionately smaller doses should be used in pediatric patients. To combat hypotension, administer IV fluids and/or pressor agents along with supportive care. Fever should be treated symptomatically. Following overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis. In the event of a curare-like effect on respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.
NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS)
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Robinul Injection may be administered intramuscularly, or intravenously, without dilution, in the following indications.
Adults
Preanesthetic Medication
The recommended dose of Robinul Injection is 0.004 mg/kg by intramuscular injection, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.
Intraoperative Medication
Robinul Injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg and repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.
Reversal of Neuromuscular Blockade
The recommended dose of Robinul Injection is 0.2 mg for each 1.0 mg of neostigmine or 5.0 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.
Peptic Ulcer
The usual recommended dose of Robinul Injection is 0.1 mg administered at 4-hour intervals, 3 or 4 times daily intravenously or intramuscularly. Where more profound effect is required, 0.2 mg may be given. Some patients may need only a single dose, and frequency of administration should be dictated by patient response up to a maximum of four times daily.
Robinul Injection is not recommended for the treatment of peptic ulcer in pediatric patients (seePRECAUTIONS– Pediatric Use).
Pediatric Patients
(seePRECAUTIONS– Pediatric Use)
Preanesthetic Medication
The recommended dose of Robinul Injection in pediatric patients is 0.004 mg/kg intramuscularly, given 30 to 60 minutes prior to the anticipated time of induction of anesthesia or at the time the preanesthetic narcotic and/or sedative are administered.
Infants
(1 month to 2 years of age) may require up to 0.009 mg/kg.
Intraoperative Medication
Because of the long duration of action of Robinul Injection if used as preanesthetic medication, additional Robinul Injection for anticholinergic effect intraoperatively is rarely needed; in the event it is required the recommended pediatric dose is 0.004 mg/ kg intravenously, not to exceed 0.1 mg in a single dose which may be repeated, as needed, at intervals of 2 to 3 minutes. The usual attempts should be made to determine the etiology of the arrhythmia, and the surgical or anesthetic manipulations necessary to correct parasympathetic imbalance should be performed.
Reversal of Neuromuscular Blockade
The recommended pediatric dose of Robinul Injection is 0.2 mg for each 1.0 mg of neostigmine or 5.0 mg of pyridostigmine. In order to minimize the appearance of cardiac side effects, the drugs may be administered simultaneously by intravenous injection and may be mixed in the same syringe.
Peptic Ulcer
Robinul Injection is not recommended for the treatment of peptic ulcer in pediatric patients (seePRECAUTIONS– Pediatric Use).
Diluent Compatibilities
Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer’s Injection.
Diluent Incompatibilities
Lactated Ringer’s solution
Admixture Compatibilities
Physical Compatibility
This list does not constitute an endorsement of the clinical utility or safety of co-administration of ROBINUL with these drugs. Robinul Injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium® (physostigmine salicylate); Benadryl® (diphenhydramine HCl); codeine phosphate, USP; Emete-Con® (benz-quinamide
HCl); hydromorphone HCl, USP; Inapsine® (droperidol); Levo-Dromoran® (levorphanol tartrate); lidocaine, USP; meperidine HCl, USP; Mestinon®/Regonol® (pyridostigmine bromide); morphine sulfate, USP; Nubain® (nalbuphine HCl); Numorphan® (oxymorphone HCl); procaine HCl, USP; promethazine HCl, USP; Prostigmin® (neostigmine methylsulfate, USP); scopolamine HBr, USP; Stadol® (butorphanol tartrate); Sublimaze® (fentanyl citrate); Tigan® (trimethobenzamide HCl); and Vistaril® (hydroxyzine HCl). Robinul Injection may be administered via the tubing of a running infusion of normal saline.
Admixture Incompatibilities
Physical Incompatibility
Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine Robinul Injection in the same syringe with Brevital® (methohexital Na); Chloromycetin® (chloramphenicol Na succinate); Dramamine® (dimenhydrinate); Nembutal® (pentobarbital Na); Pentothal® (thiopental Na); Seconal® (secobarbital Na); sodium bicarbonate (Abbott); Valium® (diazepam); Decadron® (dexamethasone Na phosphate); or Talwin® (pentazocine lactate). These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.
ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in:
1 mL single dose vials packaged in 25s (NDC 60977-155-01)
2 mL single dose vials packaged in 25s (NDC 60977-155-02)
5 mL multiple dose vials packaged in 25s (NDC 60977-155-03)
20 mL multiple dose vials in 10s (NDC 60977-155-06)
Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
Robinul is a registered trademark of Wyeth and used under license.
ESI logo is a registered trademark of Baxter International Inc., or its subsidiaries.
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)
MLT-00076/6.0
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA017558 | 08/01/2010 | |
| Labeler - General Injectables & Vaccines, Inc (108250663) |
Tenaxum may be available in the countries listed below.
Rilmenidine dihydrogen phosphate (a derivative of Rilmenidine) is reported as an ingredient of Tenaxum in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
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In the US, Urodol is a member of the drug class miscellaneous genitourinary tract agents and is used to treat Dysuria and Interstitial Cystitis.
Norfloxacin is reported as an ingredient of Urodol in the following countries:
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Treating mild to moderate dementia (eg, impairment of memory or judgement, abstract thinking, changes in personality) in patients with Alzheimer or Parkinson disease.
Rivastigmine Solution is a cholinesterase inhibitor. It works by increasing the amount of a certain substance (acetylcholine) in the brain, which may help reduce symptoms of dementia in patients with Alzheimer disease.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Rivastigmine Solution. 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 Rivastigmine Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Rivastigmine Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Rivastigmine Solution 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 Rivastigmine Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; headache; increased sweating; loss of appetite; nausea; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; bloody or black, tarry stools; chest pain; confusion; decreased coordination; decreased, increased, or painful urination; fainting; fever; new or worsening mental or mood changes (eg, depression); new or worsening tremor or uncontrolled muscle movements; new or worsening trouble walking; seizures; severe or persistent dizziness, tiredness, or weakness; severe or persistent diarrhea, nausea, stomach pain, or vomiting; severe or persistent loss of appetite or weight loss; slow or irregular heartbeat; trouble speaking or swallowing; twitching of the face or tongue; vomit that looks like blood or coffee grounds.
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: Rivastigmine 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 fainting; increased saliva production; loss of consciousness; muscle weakness; seizures; severe dizziness; severe nausea or vomiting; severely increased sweating; slow heartbeat; slow or shallow breathing.
Store Rivastigmine Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rivastigmine Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Rivastigmine Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Toscamycin-R may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Toscamycin-R in the following countries:
International Drug Name Search
Tensoprel may be available in the countries listed below.
Captopril is reported as an ingredient of Tensoprel in the following countries:
International Drug Name Search
Losartan-Hormosan may be available in the countries listed below.
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan-Hormosan in the following countries:
International Drug Name Search
Teobag may be available in the countries listed below.
Theophylline is reported as an ingredient of Teobag in the following countries:
International Drug Name Search
Generic Name: benzoyl peroxide and salicylic acid topical (BEN zoe il per OX ide and sal i SIL ik A sid)
Brand names: Cleanse & Treat, Inova 4/1, Inova 8/2, Cleanse & Treat, Cleanse & Treat Plus
Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect that allows excess oil and dirt to be washed away.
Salicylic acid is a peeling agent that causes shedding of the outer layer of skin.
The combination of benzoyl peroxide and salicylic acid is used to treat severe acne.
Benzoyl peroxide and salicylic acid may also be used for purposes other than those listed in this medication guide.
This medication is not for use in treating mild forms of acne. The strength of benzoyl peroxide contained in this medication is higher than that used in many over-the-counter acne products. Severe skin irritation can result from improper use of this product.
Before using benzoyl peroxide and salicylic acid, tell your doctor if you are allergic to any drugs.
This medication is not for use in treating mild forms of acne. The strength of benzoyl peroxide contained in this medication is higher than that used in many over-the-counter acne products. Severe skin irritation can result from improper use of this product.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
Apply the medicated pad to clean, dry skin. Use only mild skin cleansers or those your doctor has prescribed.
If this medication causes skin irritation, apply a cool compress to your skin (such as a washcloth wet with cold water) and call your doctor.
Keep each medicated pad in its foil pouch until you are ready to use it.
Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.
Symptoms of a benzoyl peroxide and salicylic acid overdose may include scaly or peeling skin, redness, or swelling.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.
Less serious side effects may include dry skin or mild irritation.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Acne:
4% or 8% pad:
One application applied topically to the affected area once or twice a day. A thin film should be applied after washing, avoiding eyes, lips, and mucous membranes.
5% pad:
One application applied topically to affected area twice a day.
Usual Pediatric Dose for Acne:
5% pad:
Greater than or equal to 12 years:
One application applied topically to affected area twice a day.
There may be other drugs that can interact with benzoyl peroxide and salicylic acid. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: benzoyl peroxide and salicylic acid side effects (in more detail)
Amoxicilline/Acide Clavulanique Actavis Adultes may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilline/Acide Clavulanique Actavis Adultes in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilline/Acide Clavulanique Actavis Adultes in the following countries:
International Drug Name Search
Metrocev may be available in the countries listed below.
Metronidazole is reported as an ingredient of Metrocev in the following countries:
International Drug Name Search
Selen E-sol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sodium Selenate is reported as an ingredient of Selen E-sol in the following countries:
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Selen E-sol in the following countries:
International Drug Name Search
Aminofillina Hospira may be available in the countries listed below.
Aminophylline is reported as an ingredient of Aminofillina Hospira in the following countries:
International Drug Name Search
Captotec may be available in the countries listed below.
Captopril is reported as an ingredient of Captotec in the following countries:
International Drug Name Search
Neo-Panpur may be available in the countries listed below.
Pancreatin is reported as an ingredient of Neo-Panpur in the following countries:
International Drug Name Search
Generic Name: ibandronate (Intravenous route)
eye-BAN-droe-nate
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Calcium Regulator
Chemical Class: Bisphosphonate
Ibandronate injection is used to treat osteoporosis (thinning of the bone) in women after menopause.
This medicine is available only with your doctor's prescription.
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 have not been performed on the relationship of age to the effects of ibandronate injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibandronate injection in the elderly.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
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 ibandronate. It may not be specific to Bondronat. Please read with care.
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
This medicine is usually given once every 3 months. If you missed a dose, call your doctor to make another appointment as soon as possible.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). It is recommended that you receive calcium and vitamin D supplements while receiving this medicine.
It is important that you tell all of your health care providers that you are receiving ibandronate injection. If you are having dental procedures while using ibandronate injection, you may have an increased chance of getting a severe problem with your jaw.
Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
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 or nurse immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose 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: Bondronat side effects (in more detail)
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