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Morphine Sulfate Oral Solution

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Overview

What is Morphine Sulfate Oral Solution?

Chemically, morphine sulfate is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate with a molecular mass of 758. Morphine sulfate occurs as a white to off-white crystalline solid. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pK is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).

For the 10 mg and 20 mg per 5 mL strengths: Each 5 mL of oral solution contains 10 or 20 mg of morphine sulfate, USP and the following inactive ingredients: anhydrous citric acid, edetate disodium, FD&C Green No. 3 (fast green), glycerin, sodium benzoate, sorbitol and water and if necessary sodium citrate to adjust pH.



What does Morphine Sulfate Oral Solution look like?



What are the available doses of Morphine Sulfate Oral Solution?

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What should I talk to my health care provider before I take Morphine Sulfate Oral Solution?

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How should I use Morphine Sulfate Oral Solution?

Morphine sulfate oral solution is available in two concentrations: 10 mg per 5 mL and 20 mg per 5 mL.

Take care when prescribing and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death.  Take care to ensure the proper dose is communicated and dispensed.  When writing prescriptions, include both the total dose in mg and total dose in volume. 

Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.


What interacts with Morphine Sulfate Oral Solution?

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What are the warnings of Morphine Sulfate Oral Solution?

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What are the precautions of Morphine Sulfate Oral Solution?

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What are the side effects of Morphine Sulfate Oral Solution?

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What should I look out for while using Morphine Sulfate Oral Solution?

Morphine sulfate oral solution is available in 10 mg per 5 mL and 20 mg per 5 mL concentrations.

Take care when prescribing and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death.  Take care to ensure the proper dose is communicated and dispensed.

Keep morphine sulfate oral solution out of the reach of children.  In case of accidental ingestion, seek emergency medical help immediately. 


What might happen if I take too much Morphine Sulfate Oral Solution?


How should I store and handle Morphine Sulfate Oral Solution?

Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. Do not freeze.Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. Do not freeze.Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C / 77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days. Do not freeze.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.Morphine Sulfate Oral SolutionMorphine sulfate oral solution is a blue-green solution available in two strengths as follows:10 mg per 5 mL Oral SolutionNDC 70408-358-31  Bottles of 100 mL with a dosing cupNDC 70408-358-35  Bottles of 500 mL with a dosing cup20 mg per 5 mL Oral SolutionNDC 70408-359-31  Bottles of 100 mL with a dosing cupNDC 70408-359-35  Bottles of 500 mL with a dosing cupStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.]PROTECT FROM MOISTURE.All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
Morphine sulfate oral solution is available in 10 mg per 5 mL and 20 mg per 5 mL concentrations.

Take care when prescribing and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death.  Take care to ensure the proper dose is communicated and dispensed.

Keep morphine sulfate oral solution out of the reach of children.  In case of accidental ingestion, seek emergency medical help immediately. 

Topiramate

Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the caucasian population (about 7 to 10% of Caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.

Monoamine oxidase inhibitors – see section. Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see section.

When amitriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.

Hyperpyrexia has been reported when amitriptyline is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.

Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride.

Morphine sulfate oral solution is available in 10 mg per 5 mL and 20 mg per 5 mL concentrations.  Use caution when prescribing, dispensing, and administering morphine sulfate oral solution to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Use caution to ensure the dose is communicated clearly and dispensed accurately.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).