Friday, September 30, 2016

Molipaxin 50mg and 100mg Capsules





1. Name Of The Medicinal Product



Molipaxin 100mg Capsules


2. Qualitative And Quantitative Composition



Trazodone hydrochloride 100mg per capsule.



For excipients see 6.1



3. Pharmaceutical Form



Capsules.



4. Clinical Particulars



4.1 Therapeutic Indications



Anxiety, depression, mixed anxiety and depression.



4.2 Posology And Method Of Administration



Route of administration: Oral.



DEPRESSION:



Adults:



Initially 150mg/day in divided doses after food or as a single dose on retiring.



This may be increased up to 300mg/day in a single or divided doses. The major portion of a divided dose to be taken on retiring. The dose may be further increased to 600mg/day in divided doses in hospitalised patients.



Elderly:



For very elderly or frail patients, the recommended initial starting dose is reduced to 100mg/day given in divided doses or as a single night-time dose. This may be incrementally increased, under supervision, according to efficacy and tolerance. In general, single doses above 100mg should be avoided in these patients. It is unlikely that 300mg/day will be exceeded.



Children:



There are insufficient data on safety to recommend the use of Molipaxin in children below the age of 18 years.



DEPRESSION ACCOMPANIED BY ANXIETY:



As for depression.



ANXIETY:



75mg/day increasing to 300mg/day as necessary.



A decrease in side-effects (increase of the resorption and decrease of the peak plasma concentration) can be reached by taking Molipaxin after a meal..



Hepatic Impairment:



Molipaxin undergoes extensive hepatic metabolism, see section 5.2, and has also been associated with hepatotoxicity, see sections 4.4 and 4.8. Therefore caution should be exercised when prescribing for patients with hepatic impairment, particularly in cases of severe hepatic impairment. Periodic monitoring of liver function may be considered.



Renal Impairment:



No dosage adjustment is usually necessary, but caution should be exercised when prescribing for patients with severe renal impairment (see also section 4.4 and 5.2).



4.3 Contraindications



Known sensitivity to trazodone and any of the excipients.



Alcohol intoxication and intoxication with hypnotics.



Acute myocardial infarction.



4.4 Special Warnings And Precautions For Use



Use in children and adolescents under 18



Molipaxin should not be used in children and adolescents under 18 years old. Suicidal behaviour (suicidal attempt and suicidal planning) and hostility (essentially aggressiveness, opposing behavior and anger) has been observed in a clinical study on children and adolescents treated with antidepressant more frequently than with placebo. Moreover, long-term safety data on children and adolescents regarding growth, maturation and cognitive and behavioral development are not available.



Suicide/suicidal thoughts or clinical worsening



Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.



Other psychiatric conditions for which Molipaxin is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.



Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.



Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.



To minimise the potential risk of suicide attempts, particularly at therapy initiation, only restricted quantities of Molipaxin should be prescribed at each occasion.



It is recommended that careful dosing and regular monitoring is adopted in patients with the following conditions:



• Epilepsy, specifically abrupt increases or decreases of dosage should be avoided



• Patients with hepatic or renal impairment, particulary if severe



• Patients with cardiac disease, such as angina pectoris, conduction disorders or AV blocks of different degree, recent myocardial infarction



• Hyperthyroidism



• Micturition disorders, such as prostate hypertrophy, although problems would not be anticipated as the anticholinergic effect of Molipaxin is only minor



• Acute narrow angle glaucoma, raised intra-ocular pressure, although major changes would not be anticipated due to the minor anticholinergic effect of Molipaxin



Should jaundice occur in a patient, Molipaxin therapy must be withdrawn.



Administration of antidepressants in patients with schizophrenia or other psychotic disorders may result in a possible worsening of psychotic symptoms. Paranoid thoughts may be intensified. During therapy with Molipaxin a depressive phase can change from a manic – depressive psychosis into a manic phase. In that case Molipaxin must be stopped.



Interactions in terms of serotonine syndrome/malignant neuroleptic syndrome have been described in case of concomitant use of other serotonergically acting substances like other antidepressants (e.g. tricyclic antidepressants, SSRI's, SNRI's and MAO-inhibitors) and neuroleptics. Malignant neuroleptic syndromes with fatal outcome have been reported in cases of coadministration with neuroleptics, for which this syndrome is a known possible adverse drug reaction. See Sections 4.5 and 4.8 for further information.



Since agranulocytosis may clinically reveal itself with influenza-like symptoms, sore throat, and fever, in these cases it is recommended to check haematology.



Hypotension, including orthostatic hypotension and syncope, has been reported to occur in patients receiving Molipaxin. Concomitant administration of antihypertensive therapy with Molipaxin may require a reduction in the dose of the antihypertensive drug



Elderly patients are often more sensitive to antidepressants, in particular to orthostatic hypotension and other anticholinergic effects.



Following therapy with Molipaxin, particularly for a prolonged period, an incremental dosage reduction to withdrawal is recommended, to minimise the occurrence of withdrawal syptoms, characterised by nausea, headache, and malaise.



There is no evidence that Molipaxin hydrochloride possesses any addictive properties.



As with other antidepressant drugs, cases of QT interval prolongation have been reported with Molipaxin very rarely. Caution is advised when prescribing Molipaxin with medicinal products known to prolong QT interval. Molipaxin should be used with caution in patients with known cardiovascular disease including those associated with prolongation of the QT interval.



Potent CYP3A4 inhibitors may lead to increases in trazodone serum levels. See section 4.5 for further information.



As with other drugs with alpha-adrenolytic activity, Molipaxin has very rarely been associated with priapism. This may be treated with an intracavernosum injection of an alpha-adrenergic agent such as adrenaline or metaraminol. However there are reports of Molipaxin -induced priapism which have required surgical intervention or led to permanent sexual dysfunction. Patients developing this suspected adverse reaction should cease Molipaxin immediately.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



General: The sedative effects of antipsychotics, hypnotics, sedatives, anxiolytics, and antihistaminic drugs may be intensified; dosage reduction is recommended in such instances.



The metabolism of antidepressants is accelerated due to hepatic effects by oral contraceptives, phenytoin, carbamazepine and barbiturates. The metabolism of antidepressants is inhibited by cimetidine and some other antipsychotics.



In vitro drug metabolism studies suggest that there is a potential for drug interactions when Molipaxin is given with potent CYP3A4 inhibitors such as erythromycin, ketoconazole, itraconazole, ritonavir, indinavir, and nefazodone. It is likely that potent CYP3A4 inhibitors may lead to substantial increases in trazodone plasma concentrations with the potential for adverse effects. Exposure to ritonavir during initiation or resumption of treatment in patients receiving Molipaxin will increase the potential for excessive sedation, cardiovascular, and gastrointestinal effects. It has been confirmed in in- vivo-studies in healthy volunteers, that a ritonavir dose of 200 mg BID increased the plasma levels of Molipaxin by greater than two-fold, leading to nausea, syncope and hypotension. If Molipaxin is used with a potent CYP3A4 inhibitor, a lower dose of Molipaxin should be considered. However, the co-administration of Molipaxin and potent CYP3A4 inhibitors should be avoided where possible.



Carbamazepine reduced plasma concentrations of trazodone when coadministered. Concomitant use of carbamazepine 400 mg daily led to a decrease of plasma concentrations of Molipaxin and its active metabolite m-chlorophenylpiperazine of 76 % and 60 %, respectively. Patients should be closely monitored to see if there is a need for an increased dose of Molipaxin when taken with carbamazepine.



Molipaxin may enhance the effects of muscle relaxants and volatile anaesthetics, and caution should be exercised in such instances. Similar considerations apply to combined administration with sedative and anti-depressant drugs, including alcohol. Molipaxin intensifies the sedative effects of alcohol. Alcohol should be avoided during Molipaxin therapy. Molipaxin has been well tolerated in depressed schizophrenic patients receiving standard phenothiazine therapy and also in depressed parkinsonian patients receiving therapy with levodopa. Antidepressants can accelerate the metabolism of levodopa.



Tricyclic antidepressants: Concurrent administration should be avoided due to the risk of interaction. Serotonine syndrome and cardiovascular side effects should be bewared.



Fluoxetine: Rare cases have been reported of elevated Molipaxin plasma levels and adverse effects when Molipaxin had been combined with fluoxetine, a CYP1A2/2D6 inhibitor. The mechanism underlying a pharmacokinetic interaction is not fully understood. A pharmacodynamic interaction (serotonine syndrome) could not be excluded.



Possible interactions with monoamine oxidase inhibitors have occasionally been reported. Although some clinicians do give both concurrently, use of Molipaxin with MAOIs, or within two weeks of stopping treatment with these compounds is not recommended. The giving of MAOIs within one week of stopping Molipaxin is also not recommended.



Phenothiazines: Severe orthostatic hypotension has been observed in case of concomitant use of phenothiazines, like e.g. chlorpromazine, fluphenazine, levomepromazine, perphenazine.



Other



Concomitant use of Molipaxin with drugs known to prolong the QT interval may increase the risk of ventricular arrhythmias, including torsade de pointes. Caution should be used when these drugs are coadministered with Molipaxin.



Since Molipaxin is only a very weak inhibitor of noradrenaline re-uptake and does not modify the blood pressure response to tyramine, interference with the hypotensive action of guanethidine-like compounds is unlikely. However, studies in laboratory animals suggest that Molipaxin may inhibit most of the acute actions of clonidine. In the case of other types of antihypertensive drug, although no clinical interactions have been reported, the possibility of potentiation should be considered.



Undesirable effects may be more frequent when Molipaxin is administered together with preparations containing Hypericum perforatum (St Johns wort).



There have been reports of changes in prothrombin time in patients concomitantly receiving trazodone and warfarin.



Concurrent use with Molipaxin may result in elevated serum levels of digoxin or phenytoin. Monitoring of serum levels should be considered in these patients.



4.6 Pregnancy And Lactation



Pregnancy:



Data on a limited number (< 200) of exposed pregnancies indicate no adverse effects of Molipaxin on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. The safety of Molipaxin in human pregnancy has not been established. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development at therapeutic doses. On basic principles, therefore, its use during the first trimester should be avoided.



Caution should be exercised when prescribing to pregnant women. When Molipaxin is used until delivery, newborns should be monitored for the occurrence of withdrawal symptoms.



Lactation:



Limited data indicate that excretion of Molipaxin in human breast milk is low, but levels of the active metabolite are not known. Due to the paucity of data, a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Molipaxin should be made taking into account the benefit of breast-feeding to the child and the benefit of Molipaxin therapy to the woman.



4.7 Effects On Ability To Drive And Use Machines



Molipaxin has minor or moderate influence on the ability to drive and use machines.As with all other drugs acting on the central nervous system, patients should be cautioned against the risks of driving or operating machinery until they are sure they are not affected by drowsiness, sedation, dizziness, confusional states, or blurred vision.



4.8 Undesirable Effects



Cases of suicidal ideation and suicidal behaviours have been reported during Molipaxin therapy or early after treatment discontinuation (see section 4.4).



Molipaxin has had no effect on arterial blood pCO2 or pO2 levels in patients with severe respiratory insufficiency due to chronic bronchial or pulmonary disease.



The following symptoms, some of which are commonly reported in cases of untreated depression, have also been recorded in patients receiving Molipaxin therapy.








































MedDRA System Organ Class




Frequency not known (cannot be estimated from the available data)




Blood and the lymphatic system disorders




Blood dyscrasias (including agranulocytosis, thrombocytopenia, eosinophilia, leucopenia and anaemia)




Immune system disorders




Allergic reactions




Endocrine disorders




Syndrome of Inappropriate Antidiuretic Hormone Secretion




Metabolism and nutrition disorders




Hyponatraemia1, weight loss, anorexia, increased appetite,




Psychiatric disorders




Suicidal ideation or suicidal behaviours2, confusional state, insomnia, disorientation, mania, anxiety, nervousness, agitation (very occasionally exacerbating to delirium), delusion, aggressive reaction, hallucinations, nightmares, libido decreased, withdrawal syndrome




Nervous system disorders




Serotonin syndrome, convulsion, neuroleptic malignant syndrome, dizziness, vertigo, headache, drowsiness[3], restlessness, decreased alertness, tremor, blurred vision, memory disturbance, myoclonus, expressive aphasia, paraesthesia, dystonia, taste altered




Cardiac disorders




Cardiac arrhythmias4 (including Torsade de Pointes, palpitations, premature ventricular contractions, ventricular couplets, ventricular tachycardia), bradycardia, tachycardia, ECG abnormalities (QT prolongation)2




Vascular disorders




Ortostatic hypotension, hypertension, syncope




Respiratory, thoracic and mediastinal disorders




Nasal congestion, dyspnoea




Gastrointestinal disorders




Nausea, vomiting, dry mouth, constipation, diarrhoea, dyspepsia, stomach pain, gastroenteritis, increased salivation, paralytic ileus




Hepato-biliary disorders




Hepatic function abnormalities (including jaundice and hepatocellular damage)5 , cholestasis intrahepatic




Skin and subcutaneous tissue disorders




Skin rash, pruritus, hyperhidrosis




Musculoskeletal and connective tissue disorders




Pain in limb, back pain, myalgia, arthralgia




Renal and urinary disorders




Micturition disorderd




Reproductive system and breast disorders




Priapism6




General disorders and administration site conditions




Weakness, oedema, influenza-like symptoms, fatigue, chest pain, fever




Investigations




Elevated liver enzymes



1 Fluid and electrolyte status should be monitored in symptomatic patients.



2 See also Section 4.4.



3 Trazodone is a sedative antidepressant and drowsiness, sometimes experienced during the first days of treatment, usually disappears on continued therapy.



4 Studies in animals have shown that trazodone is less cardiotoxic than the tricyclic antidepressants, and clinical studies suggest that the drug may be less likely to cause cardiac arrhythmias in man. Clinical studies in patients with pre-existing cardiac disease indicate that trazodone may be arrhythmogenic in some patients in that population.



5 Adverse effects on hepatic function, sometimes severe, have been rarely reported. Should such effects occur, trazodone should be immediately discontinued.



6 See slso section 4.4.



4.9 Overdose



Features of toxicity



The most frequently reported reactions to overdose have included drowsiness, dizziness, nausea and vomiting. In more serious cases coma, tachycardia, hypotension, hyponatraemia, convulsions and respiratory failure have been reported. Cardiac features may include bradycardia, QT prolongation and torsade de pointes. Symptoms may appear 24 hours or more after overdose.



Overdoses of Molipaxin in combination with other antidepressants may cause serotonin syndrome.



Management



There is no specific antidote to trazodone. Activated charcoal should be considered in adults who have ingested more than 1 g trazodone, or in children who have ingested more than 150 mg trazodone within 1 hour of presentation. Alternatively, in adults, gastric lavage may be considered within 1 hour of ingestion of a potentially life-threatening overdose.



Observe for at least 6 hours after ingestion (or 12 hours if a sustained release preparation has been taken). Monitor BP, pulse and Glasgow Coma Scale (GCS). Monitor oxygen saturation if GCS is reduced. Cardiac monitoring is appropriate in symptomatic patients.



Single brief convulsions do not require treatment. Control frequent or prolonged convulsions with intravenous diazepam (0.1-0.3 mg/kg body weight) or lorazepam (4 mg in an adult and 0.05 mg/kg in a child). If these measures do not control the fits, an intravenous infusion of phenytoin may be useful. Give oxygen and correct acid base and metabolic disturbances as required.



Treatment should be symptomatic and supportive in the case of hypotension and excessive sedation. If severe hypotension persists consider use of inotropes, eg dopamine or dobutamine



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC code: N06A X05. Other antidepressants.



Molipaxin is a potent antidepressant. It also has anxiety reducing activity. Molipaxin is a triazolopyridine derivative chemically unrelated to known tricyclic, tetracyclic and other antidepressant agents. It has negligible effect on noradrenaline re-uptake mechanisms. Whilst the mode of action of Molipaxin is not known precisely, its antidepressant activity may concern noradrenergic potentiation by mechanisms other than uptake blockade. A central antiserotonin effect may account for the drug's anxiety reducing properties.



5.2 Pharmacokinetic Properties



Trazodone is rapidly absorbed from the gastro-intestinal tract and extensively metabolised. Paths of metabolism of trazodone include n-oxidation and hydroxylation. The metabolic m-chlorophenylpiperazine is active. Trazodone is excreted in the urine almost entirely in the form of its metabolites, either in free or in conjugated form. The elimination of Trazodone is biphasic, with a terminal elimination half-life of 5 to 13 hours. Trazodone is excreted in breast milk.



There was an approximate two-fold increase in terminal phase half-life and significantly higher plasma concentrations of trazodone in 10 subjects aged 65 to 74 years compared with 12 subjects aged 23 to 30 years following a 100mg dose of trazodone. It was suggested that there is an age-related reduction in the hepatic metabolism of trazodone.



In vitro studies in human liver microsomes show that trazodone is metabolised by cytochrome P4503A4 (CYP3A4) to form m-chlorophenylpiperazine. Whilst significant, the role of this pathway in the total clearance of trazodone in vivo has not been fully determined.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lactose



Magnesium stearate



Gelatin



Titanium dioxide E171



Erythrosine E127



Indigo Carmine E132



Red iron oxide E172



Yellow iron oxide E172



Ink (1028 (S-1-27794) or 1014 (SW-9008) Black)



6.2 Incompatibilities



None stated.



6.3 Shelf Life



60 months.



6.4 Special Precautions For Storage



Blister packs: Store below 30ºC in a dry place.



Glass bottles and securitainers: Store below 30ºC.



6.5 Nature And Contents Of Container



i) Amber glass bottles with jay-cap closures: contents 100 capsules.



ii) PVdC coated 250μm PVC blisters sealed with 20μm aluminium foil: contents 56 and 100 capsules.



iii) Securitainers: contents 1000 capsules.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Sanofi-aventis



One Onslow Street



Guildford



Surrey



GU1 4YS



UK



8. Marketing Authorisation Number(S)



PL 04425/0180



9. Date Of First Authorisation/Renewal Of The Authorisation



26 August 2009



10. Date Of Revision Of The Text



27/09/2010



LEGAL STATUS


POM




Senatec


Generic Name: lidocaine topical (LYE doe kane TOP i kal)

Brand Names: AneCream, AneCream with Tegaderm, Anestacon, Bactine, LidaMantle, Lidocream, Lidoderm, Lidosense5, LMX 4, LMX 4 with Tegaderm, LMX 5, Medi-Quik Spray, Senatec, Solarcaine Aloe Extra Burn Relief, Solarcaine Cool Aloe, Uro-Jet, Uro-Jet AC, Xylocaine Jelly, Xylocaine Topical


What is Senatec (lidocaine topical)?

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.


Lidocaine topical (for use on the skin) is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, hemorrhoids, and burns.


Lidocaine topical may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Senatec (lidocaine topical)?


An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops). Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of lidocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


Keep both used and unused lidocaine skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens.

What should I discuss with my healthcare provider before using Senatec (lidocaine topical)?


An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Overdose is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography. Symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).


You should not use lidocaine topical if you are allergic to any other type of numbing medicine.

To make sure you can safely use lidocaine topical, tell your doctor if you have any of these other conditions:



  • liver disease; or




  • broken, swollen, or damaged skin.




FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Lidocaine topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Senatec (lidocaine topical)?


Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Lidocaine topical comes in many different forms for different uses. Lidocaine topical cream, lotion, spray, solution, film, and transdermal patch are generally for use on the skin only.


If your medication comes with patient instructions for safe and effective use, follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of lidocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


Lidocaine topical may be applied with your finger tips or a cotton swab. Follow your doctor's instructions.


Do not apply this medication to swollen skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion. Store at room temperature away from moisture and heat. Keep both used and unused lidocaine topical patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens.

What happens if I miss a dose?


Since lidocaine is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Lidocaine topical applied to the skin is not likely to cause an overdose unless you apply more than the recommended dose. Overdose may also occur if you apply heat, bandages, or plastic wrap to treated skin areas.

Improper use of lidocaine topical may result in death.


Overdose symptoms may include drowsiness, confusion, nervousness, ringing in your ears, blurred vision, feeling hot or cold, numbness, muscle twitches, uneven heartbeats, seizure (convulsions), slowed breathing, or respiratory failure (breathing stops).


What should I avoid while using Senatec (lidocaine topical)?


Do not allow this medication to come into contact with your eyes. If it does, rinse with water. Avoid touching the sticky side of a lidocaine skin patch while applying it.

Avoid using other topical medications on the affected area unless your doctor has told you to.


Senatec (lidocaine topical) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using lidocaine topical and call your doctor at once if you have any of these serious side effects:

  • uneven heartbeats;




  • drowsiness, confusion;




  • tremors, seizure (convulsions); or




  • blurred vision.



Less serious side effects include:



  • mild irritation, redness, or swelling where the medication is applied; or




  • numbness in places where the medicine is accidentally applied.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Senatec (lidocaine topical)?


Tell your doctor about all other medicines you use, especially:



  • quinidine (Quin-G);




  • disopyramide (Norpace);




  • flecainide (Tambocor);




  • mexiletine (Mexitil);




  • procainamide (Procan, Pronestyl);




  • tocainide (Tonocard); or




  • propafenone (Rythmol).



This list is not complete and other drugs may interact with lidocaine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Senatec resources


  • Senatec Side Effects (in more detail)
  • Senatec Use in Pregnancy & Breastfeeding
  • Senatec Support Group
  • 0 Reviews for Senatec - Add your own review/rating


  • Senatec Topical Advanced Consumer (Micromedex) - Includes Dosage Information

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  • LMX 5 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • LidaMantle Cream MedFacts Consumer Leaflet (Wolters Kluwer)

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  • Lidoderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)

  • Solarcaine Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • Solarcaine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Xylocaine Jelly Prescribing Information (FDA)

  • Xylocaine Jelly Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Xylocaine Viscous Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zingo Prescribing Information (FDA)

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Compare Senatec with other medications


  • Anal Itching
  • Anesthesia
  • Burns, External
  • Hemorrhoids
  • Pain
  • Pruritus
  • Sunburn


Where can I get more information?


  • Your pharmacist has information about lidocaine topical.

See also: Senatec side effects (in more detail)


Cuprimine


Pronunciation: PEN-ih-SILL-ah-meen
Generic Name: Penicillamine
Brand Name: Examples include Cuprimine and Depen

Cuprimine may cause serious side effects. Patients using Cuprimine should remain under the close supervision of their doctor. Tell your doctor immediately if you develop a rash, difficulty breathing or wheezing, chills, fever, sore throat, bruising, or bleeding.





Cuprimine is used for:

Treating Wilson disease (excess copper in the body), severe rheumatoid arthritis that has not responded to other treatments, and cystinuria (excess amino acids in the urine, which causes kidney stones). It may also be used for other conditions as determined by your doctor.


Cuprimine is a chelating agent. It works by removing excess copper in patients with Wilson disease, reducing excess cystine in patients with cystinuria, and reducing disease activity in patients with rheumatoid arthritis.


Do NOT use Cuprimine if:


  • you are allergic to any ingredient in Cuprimine or to penicillin

  • you are pregnant or are breast-feeding

  • you have a history of aplastic anemia or agranulocytosis (decreased number of white blood cells) due to penicillamine use

  • you have a history of kidney problems (rheumatoid arthritis patients only), blood in the urine, or pemphigus (blistering skin disease)

  • you are taking gold therapy (eg, gold salts), antimalarial or cytotoxic medicines (eg, quinine, carboplatin), oxyphenbutazone, or phenylbutazone

Contact your doctor or health care provider right away if any of these apply to you.



Before using Cuprimine:


Some medical conditions may interact with Cuprimine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are planning to become pregnant

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you are scheduled for surgery

  • if you have Goodpasture syndrome, myasthenia gravis, aplastic anemia, or decreased blood platelets or white blood cells

Some MEDICINES MAY INTERACT with Cuprimine. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Antimalarial medicines (eg, atovaquone), cytotoxic medicines (eg, carboplatin, quinine), gold salts, oxyphenbutazone, or phenylbutazone because the risk of side effects, such as kidney problems and blood disorders, may be increased

  • Digoxin because its effectiveness may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cuprimine 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.


How to use Cuprimine:


Use Cuprimine as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Cuprimine on an empty stomach (1 hour before meals or 2 hours after meals).

  • Take Cuprimine at least 2 hours before or after other medicines containing aluminum or magnesium (antacids), iron, or vitamins that contain iron.

  • If you are taking Cuprimine for cystinuria, drink plenty of water while taking Cuprimine. Drink a pint (16 ounces [480 mL]) at bedtime and another pint during the night, unless directed otherwise by your doctor.

  • It may take 1 to 3 months for Cuprimine to work.

  • If you miss a dose of Cuprimine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cuprimine.



Important safety information:


  • Your doctor may prescribe a vitamin B supplement called pyridoxine while you are taking Cuprimine. Follow your doctor's instructions for taking this supplement.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Cuprimine.

  • LAB TESTS, including complete blood cell counts, platelet counts, liver and kidney function tests, urinalysis, and body temperature, may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Cuprimine with caution in the ELDERLY because they may be more sensitive to its effects.

  • Cuprimine is not recommended for use in CHILDREN with juvenile rheumatoid arthritis. Safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Cuprimine has been shown to cause harm to the fetus. If you become, discuss with your doctor the benefits and risks of using Cuprimine during pregnancy. It is unknown if Cuprimine is excreted in breast milk. Do not breast-feed while taking Cuprimine.


Possible side effects of Cuprimine:


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; loss of appetite; mild stomach pain; nausea; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding or bruising; blood in the urine; burning, itching, peeling, or redness of skin; changes in taste; chills; cough; dark urine; difficult urination; fever; general feeling of discomfort; joint pain; muscle weakness; severe stomach pain; shortness of breath; skin lesions; sore throat; swelling of the feet or legs; vision problems; weight gain; wheezing.



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: Cuprimine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Cuprimine:

Store Cuprimine at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cuprimine out of the reach of children and away from pets.


General information:


  • If you have any questions about Cuprimine, please talk with your doctor, pharmacist, or other health care provider.

  • Cuprimine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cuprimine. 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.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cuprimine resources


  • Cuprimine Side Effects (in more detail)
  • Cuprimine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Cuprimine Drug Interactions
  • Cuprimine Support Group
  • 0 Reviews for Cuprimine - Add your own review/rating


  • Cuprimine Prescribing Information (FDA)

  • Cuprimine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cuprimine Concise Consumer Information (Cerner Multum)

  • Penicillamine Professional Patient Advice (Wolters Kluwer)

  • Penicillamine Monograph (AHFS DI)

  • Depen Prescribing Information (FDA)



Compare Cuprimine with other medications


  • Cystinuria
  • Rheumatoid Arthritis
  • Wilson's Disease

Thursday, September 29, 2016

cyclophosphamide Oral, Intravenous


sye-kloe-FOS-fa-mide


Commonly used brand name(s)

In the U.S.


  • Cytoxan

  • Cytoxan Lyophilized

Available Dosage Forms:


  • Powder for Solution

  • Tablet

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Alkylating Agent


Chemical Class: Nitrogen Mustard


Uses For cyclophosphamide


Cyclophosphamide belongs to the group of medicines called alkylating agents. It is used to treat cancer of the ovaries, breast, blood and lymph system, nerves (found primarily in children), retinoblastoma (a cancer of the eye found primarily in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin).


Cyclophosphamide is also used for treatment of some kinds of kidney disease.


Cyclophosphamide may also be used for other conditions as determined by your doctor.


Cyclophosphamide interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by cyclophosphamide, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.


Before you begin treatment with cyclophosphamide, you and your doctor should talk about the good cyclophosphamide will do as well as the risks of using it.


Cyclophosphamide is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, cyclophosphamide is used in certain patients with the following medical conditions:


  • Cancer of the bladder

  • Cancer in the bones

  • Cancer of the cervix

  • Cancer of the endometrium

  • Cancers of the lungs

  • Cancer of the prostate

  • Cancer of the testicles

  • Cancer of the adrenal cortex (the outside layer of the adrenal gland)

  • Ewing's sarcoma (a certain type of bone cancer)

  • Germ cell tumors in the ovaries (a cancer in the egg-making cells in the ovary)

  • Gestational trophoblastic tumors (a certain type of tumor in the uterus/womb)

  • Soft tissue sarcomas (a cancer of the muscles, tendons, vessels that carry blood or lymph, joints, and fat)

  • Thymoma (a cancer in the thymus, a small organ beneath the breastbone)

  • Tumors in the brain

  • Waldenström's macroglobulinemia (a certain type of cancer of the blood)

  • Wilms' tumor (a cancer of the kidney found primarily in children)

  • Histiocytosis X (a certain type of cancer found primarily in children)

  • Organ transplant rejection (prevention)

  • Rheumatoid arthritis

  • Wegener's granulomatosis

  • Systemic lupus erythematosus

  • Systemic dermatomyositis or

  • Multiple sclerosis (a disease of the nervous system)

Before Using cyclophosphamide


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 cyclophosphamide, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to cyclophosphamide 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.


Pediatric


cyclophosphamide has been tested in children and has not been shown to cause different side effects or problems than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cyclophosphamide in the elderly with use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using cyclophosphamide.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking cyclophosphamide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using cyclophosphamide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using cyclophosphamide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Allopurinol

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Cyclosporine

  • Etanercept

  • Influenza Virus Vaccine, Live

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Nevirapine

  • Pentostatin

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • St John's Wort

  • Tamoxifen

  • Trastuzumab

  • Typhoid Vaccine

  • Varicella Virus Vaccine

  • Warfarin

  • Yellow Fever Vaccine

Using cyclophosphamide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Hydrochlorothiazide

  • Ondansetron

Interactions with Food/Tobacco/Alcohol


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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of cyclophosphamide. Make sure you tell your doctor if you have any other medical problems, especially:


  • Chickenpox (including recent exposure) or

  • Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

  • Gout (history of) or

  • Kidney stones (history of)—Cyclophosphamide may increase levels of uric acid in the body, which can cause gout or kidney stones

  • Infection—Cyclophosphamide can decrease your body's ability to fight infection

  • Kidney disease—Effects of cyclophosphamide may be increased because of slower removal from the body

  • Liver disease—The effect of cyclophosphamide may be decreased

  • Prior removal of adrenal gland(s)—Toxic effects of cyclophosphamide may be increased, dosage adjustment may be necessary

  • Tumor cell accumulation—Increased risk of tumor cells entering the bone marrow, due to bone marrow depression from high doses of cyclophosphamide

Proper Use of cyclophosphamide


Take cyclophosphamide only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.


Cyclophosphamide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.


While you are using cyclophosphamide, it is important that you drink extra fluids so that you will pass more urine. Also, empty your bladder frequently, including at least once during the night. This will help prevent kidney and bladder problems and keep your kidneys working well. Cyclophosphamide passes from the body in the urine. If too much of it appears in the urine or if the urine stays in the bladder too long, it can cause dangerous irritation. Follow your doctor's instructions carefully about how much fluid to drink every day. Some patients may have to drink up to 7 to 12 cups (3 quarts) of fluid a day.


Usually it is best to take cyclophosphamide first thing in the morning, to reduce the risk of bladder problems. However, your doctor may want you to take it with food in smaller doses over the day, to lessen stomach upset or help the medicine work better. Follow your doctor's instructions carefully about when to take cyclophosphamide.


Cyclophosphamide often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to use the medicine even if you begin to feel ill. Do not stop taking cyclophosphamide without first checking with your doctor. Ask your health care professional for ways to lessen these effects.


If you vomit shortly after taking a dose of cyclophosphamide, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.


Dosing


The dose of cyclophosphamide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cyclophosphamide. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


Missed Dose


If you miss a dose of cyclophosphamide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Call your doctor or pharmacist for instructions.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Store the oral solution form of cyclophosphamide in the refrigerator. Keep it from freezing.


Precautions While Using cyclophosphamide


It is very important that your doctor check your progress at regular visits to make sure that cyclophosphamide is working properly and to check for unwanted effects.


While you are being treated with cyclophosphamide, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Cyclophosphamide may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.


Before having any kind of surgery, including dental surgery, or emergency treatment, make sure the medical doctor or dentist in charge knows that you are taking cyclophosphamide, especially if you have taken it within the last 10 days.


Cyclophosphamide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

Before you have any medical tests, tell the medical doctor in charge that you are taking cyclophosphamide. The results of some tests may be affected by cyclophosphamide.


cyclophosphamide Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.



Check with your doctor immediately if any of the following side effects occur:


More common
  • Cough or hoarseness

  • fever or chills

  • lower back or side pain

  • missing menstrual periods

  • painful or difficult urination

With high doses and/or long-term treatment
  • Blood in urine

  • dizziness, confusion, or agitation

  • fast heartbeat

  • joint pain

  • shortness of breath

  • swelling of feet or lower legs

  • unusual tiredness or weakness

Less common
  • Black, tarry stools or blood in stools

  • pinpoint red spots on skin

  • unusual bleeding or bruising

Rare
  • Frequent urination

  • redness, swelling, or pain at site of injection

  • sores in mouth and on lips

  • sudden shortness of breath

  • unusual thirst

  • yellow eyes or skin

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:


More common
  • Darkening of skin and fingernails

  • loss of appetite

  • nausea or vomiting

Less common
  • Diarrhea or stomach pain

  • flushing or redness of face

  • headache

  • increased sweating

  • skin rash, hives, or itching

  • swollen lips

Cyclophosphamide may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although the new hair may be a slightly different color or texture.


After you stop using cyclophosphamide, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:


  • Blood in urine

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: cyclophosphamide Oral, Intravenous side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More cyclophosphamide Oral, Intravenous resources


  • Cyclophosphamide Oral, Intravenous Side Effects (in more detail)
  • Cyclophosphamide Oral, Intravenous Use in Pregnancy & Breastfeeding
  • Drug Images
  • Cyclophosphamide Oral, Intravenous Drug Interactions
  • Cyclophosphamide Oral, Intravenous Support Group
  • 4 Reviews for Cyclophosphamide Oral, Intravenous - Add your own review/rating


Compare cyclophosphamide Oral, Intravenous with other medications


  • Acute Lymphocytic Leukemia
  • Acute Nonlymphocytic Leukemia
  • Bladder Cancer
  • Brain Tumor
  • Breast Cancer
  • Bullous Pemphigoid
  • Cancer
  • Cervical Cancer
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Cogan's Syndrome
  • Dermatomyositis
  • Endometrial Cancer
  • Ewing's Sarcoma
  • Histiocytosis
  • Hodgkin's Lymphoma
  • IgA Nephropathy
  • Multiple Myeloma
  • Multiple Sclerosis
  • Mycosis Fungoides
  • Nephrotic Syndrome
  • Neuroblastoma
  • Non-Hodgkin's Lymphoma
  • Non-Small Cell Lung Cancer
  • Organ Transplant, Rejection Prophylaxis
  • Osteosarcoma
  • Ovarian Cancer
  • Pemphigoid
  • Pemphigus
  • Prostate Cancer
  • Rheumatoid Arthritis
  • Small Cell Lung Cancer
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • Testicular Cancer
  • Wegener's Granulomatosus
  • Wilms' Tumor

Cozaar



Generic Name: losartan (Oral route)

loe-SAR-tan

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .



Commonly used brand name(s)

In the U.S.


  • Cozaar

Available Dosage Forms:


  • Tablet

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Angiotensin II Receptor Antagonist


Uses For Cozaar


Losartan is used to treat high blood pressure (hypertension). High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Losartan works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, losartan relaxes blood vessels. This lowers blood pressure.


Losartan is also used to decrease the risk of stroke in patients with high blood pressure and a condition called left ventricular hypertrophy (LVH). LVH is an enlargement of the left pumping chamber of the heart and can cause problems with the way the heart pumps blood.


Losartan is also used to treat a condition called diabetic nephropathy. Diabetic nephropathy is a complication of type 2 diabetes which causes the kidneys to not work properly.


Losartan is available only with your doctor's prescription.


Before Using Cozaar


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:


Allergies


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.


Pediatric


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of losartan in children younger than 6 years of age with use in other age groups.


Geriatric


This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.


Pregnancy














Pregnancy CategoryExplanation
1st TrimesterCAnimal 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.
2nd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


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.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Benazepril

  • Enalapril

  • Enalaprilat

  • Lisinopril

  • Lithium

  • Moexipril

  • Perindopril

  • Quinapril

  • Ramipril

  • Trandolapril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Bromfenac

  • Celecoxib

  • Diclofenac

  • Diflunisal

  • Etodolac

  • Fenoprofen

  • Fluconazole

  • Flurbiprofen

  • Ibuprofen

  • Indomethacin

  • Ketoprofen

  • Ketorolac

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Nabumetone

  • Naproxen

  • Nepafenac

  • Oxaprozin

  • Piroxicam

  • Rifampin

  • Salsalate

  • Sulindac

  • Tolmetin

Interactions with Food/Tobacco/Alcohol


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.


Other Medical Problems


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:


  • Kidney disease or

  • Liver disease—Effects may be increased because of slower removal of losartan from the body

Proper Use of Cozaar


Make certain your health care professional knows if you are on any special diet, such as a low-sodium diet.


To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.


In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .


This medicine may be taken with or without food.


If you are unable to swallow tablets, ask your pharmacist about preparing an oral suspension for you.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—25 to 100 milligrams (mg) a day. The dose may be taken once a day or divided into two doses.

      • Children 6 years of age and older—Use and dose must be determined by your doctor.

      • Children younger than 6 years of age—Use and dose must be determined by your doctor.


    • For high blood pressure with left ventricular hypertrophy:
      • Adults—50 to 100 milligrams (mg) once a day. Your doctor may adjust your dose and add another medicine based on your blood pressure response.

      • Children 6 years of age and older—Use and dose must be determined by your doctor.

      • Children younger than 6 years of age—Use and dose must be determined by your doctor.


    • For diabetic neuropathy:
      • Adults—50 to 100 milligrams (mg) once a day. Your doctor may adjust your dose based on your blood pressure response.

      • Children 6 years of age and older—Use and dose must be determined by your doctor.

      • Children younger than 6 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Cozaar


Check with your doctor immediately if you think that you may be pregnant. Losartan may cause birth defects or other problems in the baby if taken during pregnancy.


It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.


Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.


Dizziness or lightheadedness may occur after the first dose of this medicine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.


Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.


Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.


Avoid alcoholic beverages until you have discussed their use with your doctor. Alcohol may make the low blood pressure effect worse and/or increase the possibility of dizziness or fainting.


Cozaar Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Rare
  • Hoarseness

  • swelling of face, mouth, hands, or feet

  • trouble in swallowing or breathing (sudden)

Incidence not known
  • Abdominal pain

  • black, tarry stools

  • bleeding gums

  • blood in urine or stools

  • coma

  • confusion

  • convulsions

  • decreased urine output

  • difficult breathing

  • fast or irregular breathing

  • headache

  • increased thirst

  • irregular heartbeat

  • large, flat, bluish patches on the skin

  • muscle pain or cramps

  • nausea or vomiting

  • painful knees and ankles

  • pinpoint red spots on skin

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • upper right abdominal pain

  • weakness or heaviness of legs

  • yellow eyes and skin

Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Cough, fever or sore throat

  • dizziness

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:


More common
  • Headache

Less common
  • Back pain

  • diarrhea

  • fatigue

  • nasal congestion

Rare
  • Cough, dry

  • leg pain

  • muscle cramps or pain

  • sinus problems

  • trouble in sleeping

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: Cozaar side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Cozaar resources


  • Cozaar Side Effects (in more detail)
  • Cozaar Dosage
  • Cozaar Use in Pregnancy & Breastfeeding
  • Drug Images
  • Cozaar Drug Interactions
  • Cozaar Support Group
  • 39 Reviews for Cozaar - Add your own review/rating


  • Cozaar Prescribing Information (FDA)

  • Cozaar Consumer Overview

  • Cozaar Monograph (AHFS DI)

  • Cozaar MedFacts Consumer Leaflet (Wolters Kluwer)

  • Losartan Prescribing Information (FDA)



Compare Cozaar with other medications


  • Diabetic Kidney Disease
  • High Blood Pressure

Cefotaxime IBI




Cefotaxime IBI may be available in the countries listed below.


Ingredient matches for Cefotaxime IBI



Cefotaxime

Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Cefotaxime IBI in the following countries:


  • Italy

International Drug Name Search

Crolom



cromolyn sodium

Dosage Form: ophthalmic solution
Crolom®

cromolyn sodium

ophthalmic solution USP, 4%

STERILE OPHTHALMIC SOLUTION

Rx only



DESCRIPTION:


Crolom® (cromolyn sodium ophthalmic solution USP, 4%) is a clear, colorless, sterile solution for topical ophthalmic use.


Cromolyn sodium is represented by the following structural formula:



C23H14Na2O11                                                                                                           Mol. Wt. 512.34


Chemical Name: Disodium 5,5'- [(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]


Pharmacologic Category: Mast cell stabilizer.


EACH mL CONTAINS: ACTIVE: Cromolyn Sodium 40 mg (4%); INACTIVES: Edetate Disodium 0.1% and Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 - 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.



CLINICAL PHARMACOLOGY:


In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell.


Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of nonsensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators. Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.


Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or anti-inflammatory activity.


Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.


In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.



INDICATIONS AND USAGE:


Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.



CONTRAINDICATIONS:


Cromolyn sodium ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.



PRECAUTIONS:



General:


Patients may experience a transient stinging or burning sensation following application of cromolyn sodium ophthalmic solution.


The recommended frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION).



Information for Patients:


Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.


Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with cromolyn sodium ophthalmic solution.



Carcinogenesis, Mutagenesis, Impairment of Fertility:


Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m2 for mice, 47.2 mg/m2 for hamsters and 385.8 mg/m2 for rats. These doses correspond to approximately 6.8, 1.7, and 14 times the maximum daily human dose of 28 mg/m2.


Cromolyn sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.


No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m2) in males and 100 mg/kg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2.



Pregnancy:



Teratogenic effects:


Pregnancy Category B. Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m2) and 164 mg/kg (984 mg/m2), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m2) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m2 basis. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. 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.



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 cromolyn sodium ophthalmic solution is administered to a nursing woman.



Pediatric Use:


Safety and effectiveness in pediatric patients below the age of 4 years have not been established.



Geriatric Use:


No overall differences in safety or effectiveness have been observed between elderly and younger patients.



ADVERSE REACTIONS:


The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation.


The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributed to the drug:


Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes.


Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema, and rash.



DOSAGE AND ADMINISTRATION:


The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.


One drop contains approximately 1.6 mg cromolyn sodium.


Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.


Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.


If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.


FOR OPHTHALMIC USE ONLY



HOW SUPPLIED:


Crolom® (cromolyn sodium ophthalmic solution USP, 4%) is supplied in a plastic bottle individually cartoned with a controlled drop tip in the following sizes:


10 mL bottle (NDC 24208-300-10) - AB30709


DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.



Storage:


Store between 15°-30°C (59°-86°F). Protect from light – store in original carton. Keep tightly closed. Replace cap immediately after use.


KEEP OUT OF REACH OF CHILDREN.


Rx only



Bausch & Lomb Incorporated

Tampa, Florida 33637

©Bausch & Lomb Incorporated


XO50206 (Folded)

XM10005 (Flat)

R.1/04-83



Patient Instructions


PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS


Information for the Patient


Crolom®


(cromolyn sodium ophthalmic solution USP, 4%) Sterile


It is important to use Crolom® regularly, as directed by your physician.


1. Thoroughly wash your hands.


2. Remove safety seal (Figure 1).


3. Remove cap (Figure 2).


4. Sit or stand comfortably, with your head tilted back (Figure 3).


5. Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4).


6. Hold the Crolom® bottle upside down. Place dropper tip as close as possible to the lower eyelid and gently squeeze out the prescribed number of drops (Figure 5).


7. Do not touch the eye or eyelid with the dropper tip.


8. Blink a few times to make sure the eye is covered with the solution.


9. Close your eye and remove any excess solution with a clean tissue.


10. Repeat process in the other eye.


 



SPECIAL TIPS


1. Avoid placing Crolom® solution directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page.


2. To avoid contamination of the solution, do not touch dropper tip to the eye, fingers or any other surface. Replace cap after use. It is recommended that any remaining contents be discarded after the treatment period prescribed by your physician.


3. Store between 15°-30°C (59°-86°F). Protect from light – store in original carton. Keep tightly closed. Replace cap immediately after use.


4. Keep out of the reach of children.


5. Do not use with any other ocular medication unless directed by your physician. Do not wear contact lenses during treatment with Crolom®.


Bausch & Lomb Incorporated

Tampa, Florida 33637

©Bausch & Lomb Incorporated


XO50206 (Folded)

XM10005 (Flat)

R.1/04-83



Principal Display Panel



NDC 24208-300-10


Bausch & Lomb


Crolom


Cromolyn Sodium Ophthalmic Solution USP, 4%


[icon- eye]


STERILE


Rx only


10 mL









Crolom 
cromolyn sodium  solution/ drops










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)24208-300
Route of AdministrationOPHTHALMICDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CROMOLYN SODIUM (CROMOLYN)CROMOLYN SODIUM40 mg  in 1 mL














Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
HYDROCHLORIC ACID 
WATER 
SODIUM HYDROXIDE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
124208-300-101 BOTTLE In 1 CARTONcontains a BOTTLE, DROPPER
110 mL In 1 BOTTLE, DROPPERThis package is contained within the CARTON (24208-300-10)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07444301/30/1995


Labeler - Bausch & Lomb Incorporated (196603781)









Establishment
NameAddressID/FEIOperations
Bausch & Lomb Incorporated807927397MANUFACTURE
Revised: 03/2011Bausch & Lomb Incorporated




More Crolom resources


  • Crolom Side Effects (in more detail)
  • Crolom Dosage
  • Crolom Use in Pregnancy & Breastfeeding
  • Crolom Support Group
  • 0 Reviews for Crolom - Add your own review/rating


  • Crolom Advanced Consumer (Micromedex) - Includes Dosage Information

  • Crolom ophthalmic Concise Consumer Information (Cerner Multum)

  • cromolyn ophthalmic Concise Consumer Information (Cerner Multum)



Compare Crolom with other medications


  • Conjunctivitis, Allergic
  • Keratitis
  • Keratoconjunctivitis