Noveril may be available in the countries listed below.
Dibenzepin hydrochloride (a derivative of Dibenzepin) is reported as an ingredient of Noveril in the following countries:
International Drug Name Search
ReFacto AF may be available in the countries listed below.
Coagulation Factor VIII , Human (rDNA) Moroctocog Alfa (a derivative of Coagulation Factor VIII , Human (rDNA)) is reported as an ingredient of ReFacto AF in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Roxarsone (BAN, USAN) is also known as Roxarsone (Rec.INN)
Lincomycin hydrochloride monohydrate (a derivative of Lincomycin) is reported as an ingredient of Roxarsone in the following countries:
Monensin is reported as an ingredient of Roxarsone in the following countries:
Narasin is reported as an ingredient of Roxarsone in the following countries:
Salinomycin sodium salt (a derivative of Salinomycin) is reported as an ingredient of Roxarsone in the following countries:
International Drug Name Search
Glossary
| BAN | British Approved Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Stadenace may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Stadenace in the following countries:
International Drug Name Search
Leoncol may be available in the countries listed below.
Letrozole is reported as an ingredient of Leoncol in the following countries:
International Drug Name Search
Regental may be available in the countries listed below.
Nimodipine is reported as an ingredient of Regental in the following countries:
International Drug Name Search
Nadis may be available in the countries listed below.
Furosemide is reported as an ingredient of Nadis in the following countries:
International Drug Name Search
PMS-Vitamin D3 may be available in the countries listed below.
Colecalciferol is reported as an ingredient of PMS-Vitamin D3 in the following countries:
International Drug Name Search
Metoprololtartraat CF may be available in the countries listed below.
Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Metoprololtartraat CF in the following countries:
International Drug Name Search
Chemmart Ranitidine may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Chemmart Ranitidine in the following countries:
International Drug Name Search
Glymacken may be available in the countries listed below.
Fructose is reported as an ingredient of Glymacken in the following countries:
Glycerol is reported as an ingredient of Glymacken in the following countries:
International Drug Name Search
Flumil Antidoto may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Flumil Antidoto in the following countries:
International Drug Name Search
Rec.INN
0029462-18-8
C17-H16-N2-O-S
296
Anxiolytic agent
Benzodiazepine derivative
Hypnotic agent
2H-[1]Benzothieno[2,3-e]-1,4-diazepin-2-one, 1,3,6,7,8,9-hexahydro-5-phenyl-
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Clorxima may be available in the countries listed below.
Lysozyme hydrochloride (a derivative of Lysozyme) is reported as an ingredient of Clorxima in the following countries:
International Drug Name Search
Metoprolol Sandoz may be available in the countries listed below.
Metoprolol succinate (a derivative of Metoprolol) is reported as an ingredient of Metoprolol Sandoz in the following countries:
Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Metoprolol Sandoz in the following countries:
International Drug Name Search
Triflusal Teva may be available in the countries listed below.
Triflusal is reported as an ingredient of Triflusal Teva in the following countries:
International Drug Name Search
Biotonus may be available in the countries listed below.
Mosapride is reported as an ingredient of Biotonus in the following countries:
International Drug Name Search
E-Moxclav may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of E-Moxclav in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of E-Moxclav in the following countries:
International Drug Name Search
Hexadent may be available in the countries listed below.
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Hexadent in the following countries:
International Drug Name Search
Bacivet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Bacitracin zinc salt (a derivative of Bacitracin) is reported as an ingredient of Bacivet in the following countries:
International Drug Name Search
Policor may be available in the countries listed below.
Cilostazol is reported as an ingredient of Policor in the following countries:
International Drug Name Search
Piridoxina Fmndtria may be available in the countries listed below.
Pyridoxine is reported as an ingredient of Piridoxina Fmndtria in the following countries:
International Drug Name Search
Velocef Inyectable may be available in the countries listed below.
Cefradine is reported as an ingredient of Velocef Inyectable in the following countries:
International Drug Name Search
Menostat may be available in the countries listed below.
Estrogens, conjugated is reported as an ingredient of Menostat in the following countries:
International Drug Name Search
Naloxone Cloridrato Galenica may be available in the countries listed below.
Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Naloxone Cloridrato Galenica in the following countries:
International Drug Name Search
Plitican may be available in the countries listed below.
Alizapride hydrochloride (a derivative of Alizapride) is reported as an ingredient of Plitican in the following countries:
International Drug Name Search
Madiprazole may be available in the countries listed below.
Omeprazole is reported as an ingredient of Madiprazole in the following countries:
International Drug Name Search
Oxazépam may be available in the countries listed below.
Oxazépam (DCF) is known as Oxazepam in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Nureflex may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Nureflex in the following countries:
International Drug Name Search
Vomitrol may be available in the countries listed below.
Metoclopramide is reported as an ingredient of Vomitrol in the following countries:
International Drug Name Search
Angoral may be available in the countries listed below.
Molsidomine is reported as an ingredient of Angoral in the following countries:
International Drug Name Search
Hostacillin may be available in the countries listed below.
Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Hostacillin in the following countries:
International Drug Name Search
Anvifen may be available in the countries listed below.
4-Amino-3-phenylbutyric acid is reported as an ingredient of Anvifen in the following countries:
International Drug Name Search
Furozénol may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Furosemide is reported as an ingredient of Furozénol in the following countries:
International Drug Name Search
Oxodil may be available in the countries listed below.
Formoterol fumarate dihydrate (a derivative of Formoterol) is reported as an ingredient of Oxodil in the following countries:
International Drug Name Search
Licarbium may be available in the countries listed below.
Lithium carbonate (a derivative of Lithium) is reported as an ingredient of Licarbium in the following countries:
International Drug Name Search
Piritinolo may be available in the countries listed below.
Piritinolo (DCIT) is also known as Pyritinol (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Orthonett Novum may be available in the countries listed below.
Ethinylestradiol is reported as an ingredient of Orthonett Novum in the following countries:
Norethisterone is reported as an ingredient of Orthonett Novum in the following countries:
International Drug Name Search
PMS-Pravastatin may be available in the countries listed below.
Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of PMS-Pravastatin in the following countries:
International Drug Name Search
Prostodin may be available in the countries listed below.
Carboprost tromethamine (a derivative of Carboprost) is reported as an ingredient of Prostodin in the following countries:
International Drug Name Search
Program Plus may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Lufenuron is reported as an ingredient of Program Plus in the following countries:
Milbemycin Oxime is reported as an ingredient of Program Plus in the following countries:
International Drug Name Search
Titos may be available in the countries listed below.
Tiemonium Methylsulfate is reported as an ingredient of Titos in the following countries:
International Drug Name Search
Monosorb may be available in the countries listed below.
Isosorbide Mononitrate is reported as an ingredient of Monosorb in the following countries:
International Drug Name Search
In the US, Dutasteride (dutasteride systemic) is a member of the drug class 5-alpha-reductase inhibitors and is used to treat Benign Prostatic Hyperplasia.
US matches:
Rec.INN
G04CB02
0164656-23-9
C27-H30-F6-N2-O2
528
Enzyme inhibitor, 5α-reductase
(4aR,4bS,6aS,7S,9aS,9bS,11aR)-N-(2,5-bis(trifluoromethyl) phenyl)-2,4a,4b,5,6,6a,7,8,9,9a,9b,10,11,11a-tetradecahydro-4a,6a-dimethyl-2-oxo-1H-indeno(5,4-f)quinoline-7-carboxamide
(5alpha,17beta)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-1-ene-17-carboxamide (USAN)
alpha,alpha,alpha,alpha',alpha',alpha'-Hexafluoro-3-oxo-4-aza-5alpha-androst-1-ene-17beta-carboxy-2',5'-xylidide (WHO)
N-[2,5-Bis(trifluormethyl)phenyl]-3-oxo-4-aza-5alpha-androst-1-en-17beta-carboxamid (IUPAC)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Fentanyl-Curamed may be available in the countries listed below.
Fentanyl citrate (a derivative of Fentanyl) is reported as an ingredient of Fentanyl-Curamed in the following countries:
International Drug Name Search
Teogrand may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Teogrand in the following countries:
International Drug Name Search
Oxybutynin-ratiopharm may be available in the countries listed below.
Oxybutynin hydrochloride (a derivative of Oxybutynin) is reported as an ingredient of Oxybutynin-ratiopharm in the following countries:
International Drug Name Search
Nevimune may be available in the countries listed below.
Nevirapine is reported as an ingredient of Nevimune in the following countries:
International Drug Name Search
Protebon may be available in the countries listed below.
Calcium Carbonate is reported as an ingredient of Protebon in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Rec.INN
G03GA05
0009002-68-0
Pituitary gonadotropin: Follicle stimulating hormone (FH)
Recombinant human follicle-stimulating hormone, glycoform α
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Dantrolene sodium for injection is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrolene sodium for injection is supplied in 65 mL vials containing 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 mL sterile water for injection USP (without a bacteriostatic agent).
Dantrolene sodium is classified as a direct-acting skeletal muscle relaxant. Chemically, dantrolene sodium is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl] methylene] amino]-2,4-imidazolidinedione sodium salt. The structural formula for the hydrated salt is:
The hydrated salt contains approximately 15% water (3.5 moles) and has a molecular weight of 399. The anhydrous salt (dantrolene) has a molecular weight of 336.
In isolated nerve-muscle preparation, dantrolene sodium has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, dantrolene sodium dissociates the excitation-contraction coupling, probably by interfering with the release of Ca++ from the sarcoplasmic reticulum. The administration of intravenous dantrolene sodium to human volunteers is associated with loss of grip strength and weakness in the legs, as well as subjective CNS complaints (see also PRECAUTIONS, Information for Patients). Information concerning the passage of dantrolene sodium across the blood-brain barrier is not available.
In the anesthetic-induced malignant hyperthermia syndrome, evidence points to an intrinsic abnormality of skeletal muscle tissue. In affected humans, it has been postulated that "triggering agents" (e.g. general anesthetics and depolarizing neuromuscular blocking agents) produce a change within the cell which results in an elevated myoplasmic calcium. This elevated myoplasmic calcium activates acute cellular catabolic processes that cascade to the malignant hyperthermia crisis.
It is hypothesized that addition of dantrolene sodium to the "triggered" malignant hyperthermic muscle cell reestablishes a normal level of ionized calcium in the myoplasm. Inhibition of calcium release from the sarcoplasmic reticulum by dantrolene sodium reestablishes the myoplasmic calcium equilibrium, increasing the percentage of bound calcium. In this way, physiologic, metabolic, and biochemical changes associated with the malignant hyperthermia crisis may be reversed or attenuated. Experimental results in malignant hyperthermia susceptible swine show that prophylactic administration of intravenous or oral dantrolene prevents or attenuates the development of vital sign and blood gas changes characteristic of malignant hyperthermia in a dose related manner. The efficacy of intravenous dantrolene in the treatment of human and porcine malignant hyperthermia crisis, when considered along with prophylactic experiments in malignant hyperthermia susceptible swine, lends support to prophylactic use of oral or intravenous dantrolene in malignant hyperthermia susceptible humans. When prophylactic intravenous dantrolene is administered as directed, whole blood concentrations remain at a near steady state level for 3 or more hours after the infusion is completed. Clinical experience has shown that early vital sign and/or blood gas changes characteristic of malignant hyperthermia may appear during or after anesthesia and surgery despite the prophylactic use of dantrolene and adherence to currently accepted patient management practices. These signs are compatible with attenuated malignant hyperthermia and respond to the administration of additional i.v. dantrolene (see DOSAGE AND ADMINISTRATION). The administration of the recommended prophylactic dose of intravenous dantrolene to healthy volunteers was not associated with clinically significant cardiorespiratory changes.
Specific metabolic pathways for the degradation and elimination of dantrolene sodium in humans have been established. Dantrolene is found in measurable amounts in blood and urine. Its major metabolites in body fluids are 5-hydroxy dantrolene and an acetylamino metabolite of dantrolene. Another metabolite with an unknown structure appears related to the latter. Dantrolene sodium may also undergo hydrolysis and subsequent oxidation forming nitrophenylfuroic acid.
The mean biologic half-life of dantrolene sodium after intravenous administration is variable, between 4 to 8 hours under most experimental conditions. Based on assays of whole blood and plasma, slightly greater amounts of dantrolene are associated with red blood cells than with the plasma fraction of blood. Significant amounts of dantrolene are bound to plasma proteins, mostly albumin, and this binding is readily reversible.
Cardiopulmonary depression has not been observed in malignant hyperthermia susceptible swine following the administration of up to 7.5 mg/kg i.v. dantrolene. This is twice the amount needed to maximally diminish twitch response to single supramaximal peripheral nerve stimulation (95% inhibition). A transient, inconsistent, depressant effect on gastrointestinal smooth muscles has been observed at high doses.
Dantrolene sodium for injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrolene sodium for injection should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).
Dantrolene sodium for injection is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.
None.
The use of dantrolene sodium for injection in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance.
Since the effect of disease state and other drugs on dantrolene sodium related skeletal muscle weakness, including possible respiratory depression, cannot be predicted, patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored.
If patients judged malignant hyperthermia susceptible are administered intravenous or oral dantrolene sodium preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible. These signs usually call for the administration of additional i.v. dantrolene.
Care must be taken to prevent extravasation of dantrolene sodium solution into the surrounding tissues due to the high pH of the intravenous formulation.
When mannitol is used for prevention or treatment of late renal complications of malignant hyperthermia, the 3 g of mannitol needed to dissolve each 20 mg vial of i.v. dantrolene sodium should be taken into consideration.
Based upon data in human volunteers, it will sometimes be appropriate to tell patients who receive dantrolene sodium for injection that decrease in grip strength and weakness of leg muscles, especially walking down stairs, can be expected postoperatively. In addition, symptoms such as "lightheadedness" may be noted. Since some of these symptoms may persist for up to 48 hours, patients must not operate an automobile or engage in other hazardous activity during this time. Caution is also indicated at meals on the day of administration because difficulty swallowing and choking has been reported. Caution should be exercised in the concomitant administration of tranquilizing agents.
Hepatotoxicity seen with dantrolene sodium capsules: Dantrolene sodium has a potential for hepatotoxicity, and should not be used in conditions other than those recommended. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. The incidence reported in patients taking up to 400 mg/day is much lower than in those taking doses of 800 mg or more per day. Even sporadic short courses of these higher dose levels within a treatment regimen markedly increased the risk of serious hepatic injury. Liver dysfunction as evidenced by blood chemical abnormalities alone (liver enzyme elevations) has been observed in patients exposed to dantrolene sodium for varying periods of time. Overt hepatitis has occurred at varying intervals after initiation of therapy, but has been most frequently observed between the third and twelfth month of therapy. The risk of hepatic injury appears to be greater in females, in patients over 35 years of age, and in patients taking other medication(s) in addition to dantrolene sodium. Dantrolene sodium should be used only in conjunction with appropriate monitoring of hepatic function including frequent determination of SGOT or SGPT.
Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.
Dantrolene sodium is metabolized by the liver, and it is theoretically possible that its metabolism may be enhanced by drugs known to induce hepatic microsomal enzymes. However, neither phenobarbital nor diazepam appears to affect dantrolene sodium metabolism. Binding to plasma protein is not significantly altered by diazepam, diphenylhydantoin, or phenylbutazone. Binding to plasma proteins is reduced by warfarin and clofibrate and increased by tolbutamide.
Cardiovascular collapse in patients treated simultaneously with verapamil and dantrolene sodium is rare. The combination of therapeutic doses of intravenous dantrolene sodium and verapamil in halothane/alpha-chloralose anesthetized swine has resulted in ventricular fibrillation and cardiovascular collapse in association with marked hyperkalemia. It is recommended that the combination of intravenous dantrolene sodium and calcium channel blockers, such as verapamil, not be used together during the management of malignant hyperthermia crisis until the relevance of these findings to humans is established.
Administration of dantrolene may potentiate vecuronium-induced neuromuscular block.
Sprague-Dawley female rats fed dantrolene sodium for 18 months at dosage levels of 15, 30 and 60 mg/kg/day showed an increased incidence of benign and malignant mammary tumors compared with concurrent controls. At the highest dose level (approximately the same as the maximum recommended daily dose on a mg/m2 basis), there was an increase in the incidence of benign hepatic lymphatic neoplasms. In a 30-month study in Sprague-Dawley rats fed dantrolene sodium, the highest dose level (approximately the same as the maximum recommended daily dose on a mg/m2 basis) produced a decrease in the time of onset of mammary neoplasms. Female rats at the highest dose level showed an increased incidence of hepatic lymphangiomas and hepatic angiosarcomas.
The only drug-related effect seen in a 30-month study in Fischer-344 rats was a dose-related reduction in the time of onset of mammary and testicular tumors. A 24-month study in HaM/ICR mice revealed no evidence of carcinogenic activity.
The significance of carcinogenicity data relative to use of dantrolene sodium in humans is unknown.
Dantrolene sodium has produced positive results in the Ames S. Typhimurium bacterial mutagenesis assay in the presence and absence of a liver activating system.
Dantrolene sodium administered to male and female rats at dose levels up to 45 mg/kg/day (approximately 1.4 times the maximum recommended daily dose on a mg/m2 basis) showed no adverse effects on fertility or general reproductive performance.
Dantrolene sodium has been shown to be embryocidal in the rabbit and has been shown to decrease pup survival in the rat when given at doses seven times the human oral dose. There are no adequate and well-controlled studies in pregnant women. Dantrolene sodium for injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In one uncontrolled study, 100 mg per day of prophylactic oral dantrolene sodium was administered to term pregnant patients awaiting labor and delivery. Dantrolene readily crossed the placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply. No neonatal respiratory and neuromuscular side effects were detected at low dose. More data, at higher doses, are needed before more definitive conclusions can be made.
Clinical studies of dantrolene sodium for 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 reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
There have been occasional reports of death following malignant hyperthermia crisis even when treated with intravenous dantrolene; incidence figures are not available (the pre-dantrolene mortality of malignant hyperthermia crisis was approximately 50%). Most of these deaths can be accounted for by late recognition, delayed treatment, inadequate dosage, lack of supportive therapy, intercurrent disease and/or the development of delayed complications such as renal failure or disseminated intravascular coagulopathy. In some cases there are insufficient data to completely rule out therapeutic failure of dantrolene.
There are rare reports of fatality in malignant hyperthermia crisis, despite initial satisfactory response to i.v. dantrolene, which involve patients who could not be weaned from dantrolene after initial treatment.
The administration of intravenous dantrolene sodium to human volunteers is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness.
The following adverse reactions are in approximate order of severity:
None of the serious reactions occasionally reported with long-term oral dantrolene sodium use, such as hepatitis, seizures, and pleural effusion with pericarditis, have been reasonably associated with short-term dantrolene sodium for injection therapy.
The following events have been reported in patients receiving oral dantrolene: aplastic anemia, leukopenia, lymphocytic lymphoma, and heart failure. (See package insert for dantrolene sodium capsules for a complete listing of adverse reactions.)
The published literature has included some reports of dantrolene sodium use in patients with Neuroleptic Malignant Syndrome (NMS). Dantrolene sodium for injection is not indicated for the treatment of NMS and patients may expire despite treatment with dantrolene sodium for injection.
Because dantrolene sodium for injection must be administered at a low concentration in a large volume of fluid, acute toxicity of dantrolene sodium could not be assessed in animals. In 14-day (subacute) studies, the intravenous formulation of dantrolene sodium was relatively non-toxic to rats at doses of 10 mg/kg/day and 20 mg/kg/day. While 10 mg/kg/day in dogs for 14 days evoked little toxicity, 20 mg/kg/day for 14 days caused hepatic changes of questionable biologic significance.
Symptoms which may occur in case of overdose include, but are not limited to, muscular weakness and alterations in the state of consciousness (e.g., lethargy, coma), vomiting, diarrhea, and crystalluria.
For acute overdosage, general supportive measures should be employed.
Intravenous fluids should be administered in fairly large quantities to avert the possibility of crystalluria. An adequate airway should be maintained and artificial resuscitation equipment should be at hand. Electrocardiographic monitoring should be instituted, and the patient carefully observed. The value of dialysis in dantrolene sodium overdose is not known.
As soon as the malignant hyperthermia reaction is recognized, all anesthetic agents should be discontinued; the administration of 100% oxygen is recommended. Dantrolene sodium for injection should be administered by continuous rapid intravenous push beginning at a minimum dose of 1 mg/kg, and continuing until symptoms subside or the maximum cumulative dose of 10 mg/kg has been reached.
If the physiologic and metabolic abnormalities reappear, the regimen may be repeated. It is important to note that administration of dantrolene sodium for injection should be continuous until symptoms subside. The effective dose to reverse the crisis is directly dependent upon the individual's degree of susceptibility to malignant hyperthermia, the amount and time of exposure to the triggering agent, and the time elapsed between onset of the crisis and initiation of treatment.
Experience to date indicates that the dose of dantrolene sodium for injection for pediatric patients is the same as for adults.
Dantrolene sodium for injection and/or dantrolene sodium capsules may be administered preoperatively to patients judged malignant hyperthermia susceptible as part of the overall patient management to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia.
The recommended prophylactic dose of dantrolene sodium for injection is 2.5 mg/kg, starting approximately 1.25 hours before anticipated anesthesia and infused over approximately 1 hour. This dose should prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia provided that the usual precautions, such as avoidance of established malignant hyperthermia triggering agents, are followed.
Additional dantrolene sodium for injection may be indicated during anesthesia and surgery because of the appearance of early clinical and/or blood gas signs of malignant hyperthermia or because of prolonged surgery (see also CLINCAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS). Additional doses must be individualized.
Administer 4 to 8 mg/kg/day of oral dantrolene sodium in three or four divided doses for 1 or 2 days prior to surgery, with the last dose being given with a minimum of water approximately 3 to 4 hours before scheduled surgery. Adjustment can usually be made within the recommended dosage range to avoid incapacitation (weakness, drowsiness, etc.) or excessive gastrointestinal irritation (nausea and/or vomiting). See also the package insert for dantrolene sodium capsules.
Dantrolene sodium capsules, 4 to 8 mg/kg/day, in four divided doses should be administered for 1 to 3 days following a malignant hyperthermia crisis to prevent recurrence of the manifestations of malignant hyperthermia.
Intravenous dantrolene sodium may be used postoperatively to prevent or attenuate the recurrence of signs of malignant hyperthermia when oral dantrolene sodium administration is not practical. The i.v. dose of dantrolene sodium in the postoperative period must be individualized, starting with 1 mg/kg or more as the clinical situation dictates.
Each vial of dantrolene sodium for injection should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken until the solution is clear. 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection USP, and other acidic solutions are not compatible with dantrolene sodium for injection and should not be used. The contents of the vial must be protected from direct light and used within 6 hours after reconstitution. Store reconstituted solution at 20-25° C (68-77° F) [see USP Controlled Room Temperature] protected from direct light.
Reconstituted dantrolene sodium for injection should not be transferred to large glass bottles for prophylactic infusion due to precipitate formation observed with the use of some glass bottles as reservoirs.
For prophylactic infusion, the required number of individual vials of dantrolene sodium for injection should be reconstituted as outlined above. The contents of individual vials are then transferred to a larger volume sterile intravenous plastic bag. Stability data on file indicate commercially available sterile plastic bags are acceptable drug delivery devices. However, it is recommended that the prepared infusion be inspected carefully for cloudiness and/or precipitation prior to dispensing and administration. Such solutions should not be used. While stable for 6 hours, it is recommended that the infusion be prepared immediately prior to the anticipated dosage administration time.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Dantrolene sodium for injection (NDC 27505-001-66) is available in vials containing a sterile lyophilized mixture of 20 mg dantrolene sodium, 3000 mg mannitol, and sufficient sodium hydroxide to yield a pH of approximately 9.5 when reconstituted with 60 mL sterile water for injection USP (without a bacteriostatic agent).
Store unreconstituted product at 20-25° C (68-77° F) [see USP Controlled Room Temperature] and avoid prolonged exposure to light.
Address medical inquiries to US WorldMeds, LLC, 4010 Dupont Circle, Suite L-07, Louisville, KY 40207
| Mfg. by: | DSM Pharmaceuticals, Inc. Greenville, NC 27834 |
| Dist. by: | US WorldMeds, LLC Louisville, KY 40207 |
ISS 05-07
004624
| DANTROLENE SODIUM dantrolene sodium injection, solution | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
Depo-Promone may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Depo-Promone in the following countries:
International Drug Name Search
Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Pentazocine and Naloxone Hydrochloride in the following countries:
Pentazocine hydrochloride (a derivative of Pentazocine) is reported as an ingredient of Pentazocine and Naloxone Hydrochloride in the following countries:
International Drug Name Search
Denti-Care
Denti-Foam
Topical Fluoride Foam Orange
1.23 % Fluoride Ions
4.4 oz / 125 g
NDC 64778-1377-1
A topical anti-caries preparation
Directions (for professional use only):
1. Use after thorough prophylaxis
2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)
Note: fill tray(s) at one quarter full to allow foam to expand
3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the application
130 applications
Medicinal ingredients:
Warnings: KEEP OUT OF REACH OF CHILDREN
Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.
Do not use if seal is broken.
| DENTI-CARE TOPICAL FLUORIDE FOAM ORANGE fluoride ions aerosol, foam | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 05/01/2003 | ||
| Labeler - AR Medicom Inc (247876295) |
Glimepiride La Sante may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepiride La Sante in the following countries:
International Drug Name Search
Loisan may be available in the countries listed below.
Loratadine is reported as an ingredient of Loisan in the following countries:
International Drug Name Search
Fluminoc may be available in the countries listed below.
Flunitrazepam is reported as an ingredient of Fluminoc in the following countries:
International Drug Name Search
Prolax may be available in the countries listed below.
Glycerol is reported as an ingredient of Prolax in the following countries:
International Drug Name Search
Pulmicort Turbuhaler PharmaCoDane may be available in the countries listed below.
Budesonide is reported as an ingredient of Pulmicort Turbuhaler PharmaCoDane in the following countries:
International Drug Name Search
Papine may be available in the countries listed below.
Pancreatin is reported as an ingredient of Papine in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
Firocoxib is reported as an ingredient of Equioxx in the following countries:
International Drug Name Search
Coenzima Q-10 may be available in the countries listed below.
Ubidecarenone is reported as an ingredient of Coenzima Q-10 in the following countries:
International Drug Name Search
Terbinafin AbZ may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbinafin AbZ in the following countries:
International Drug Name Search
Epinephrine bitartrate (a derivative of Epinephrine) is reported as an ingredient of Bronitin Mist in the following countries:
International Drug Name Search
Topcort may be available in the countries listed below.
Desoximetasone is reported as an ingredient of Topcort in the following countries:
Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of Topcort in the following countries:
International Drug Name Search
Relieving breathing problems caused by bronchial asthma, chronic bronchitis, or emphysema.
Dilex-G Liquid is a bronchodilator and expectorant combination. It works by widening the air passages and making it easier to breathe, and by thinning the mucus for a more productive cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dilex-G Liquid. 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 Dilex-G Liquid. 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 Dilex-G Liquid 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 Dilex-G Liquid 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 Dilex-G Liquid.
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; nausea; upset stomach.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody vomit; diarrhea; dizziness; excitability; fast breathing; fast/irregular heartbeat; flushing; increased thirst or urination; irritability; muscle twitching; pounding in the chest; restlessness; seizures; stomach pain; trouble sleeping; vomiting.
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: Dilex-G 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 agitation; chest pain; dehydration; excessive sweating; excessive thirst; fever or chills; irregular heartbeat; loss of appetite; ringing in the ears; seizures; severe vomiting.
Store Dilex-G Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dilex-G Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dilex-G Liquid. 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.
Pericaina may be available in the countries listed below.
Mepivacaine hydrochloride (a derivative of Mepivacaine) is reported as an ingredient of Pericaina in the following countries:
International Drug Name Search
Paracold Extra may be available in the countries listed below.
Caffeine is reported as an ingredient of Paracold Extra in the following countries:
Paracetamol is reported as an ingredient of Paracold Extra in the following countries:
International Drug Name Search
