Morphine Sulfate Oral Solution CII

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Overview

What is Morphine Sulfate Oral Solution CII?

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 pKa 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.

For the 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: anhydrous citric acid, edetate disodium, glycerin, sodium benzoate, sorbitol and water and if necessary sodium citrate to adjust pH.

What does Morphine Sulfate Oral Solution CII look like?

What are the available doses of Morphine Sulfate Oral Solution CII?

Oral Solution: For the 10 mg per 5 mL or 20 mg per 5 mL strengths, each mL contains 2 mg or 4 mg of morphine sulfate. For the 100 mg per 5 mL (20 mg/mL) strength, each mL contains 20 mg of morphine sulfate. ()

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

How should I use Morphine Sulfate Oral Solution CII?

Morphine sulfate solution are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Morphine sulfate solution (20 mg/mL) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. Patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer.

Morphine Sulfate Oral Solution is available in three concentrations: 10 mg per 5 mL, 20 mg per 5 mL and 100 mg per 5 mL (20 mg/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 the total dose in volume. Always use the enclosed calibrated oral syringe when administering Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) to ensure the dose is measured and administered accurately.

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 CII?

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What are the warnings of Morphine Sulfate Oral Solution CII?

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What are the precautions of Morphine Sulfate Oral Solution CII?

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What are the side effects of Morphine Sulfate Oral Solution CII?

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

Morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product.

Morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.

Morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

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

How should I store and handle Morphine Sulfate Oral Solution CII?

Store refrigerated between 2° and 8°C (36° and 46°F). Protect from light.Store refrigerated between 2° and 8°C (36° and 46°F). Protect from light.Morphine Sulfate Oral Solution10 mg per 5 mL Oral Solution20 mg per 5 mL Oral SolutionMorphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: NDC 70408-746-29 Bottle of 30 mL with an oral syringeNDC 70408-746-31 Bottle of 120 mL with an oral syringeStoragePROTECT 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 Solution10 mg per 5 mL Oral Solution20 mg per 5 mL Oral SolutionMorphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: NDC 70408-746-29 Bottle of 30 mL with an oral syringeNDC 70408-746-31 Bottle of 120 mL with an oral syringeStoragePROTECT 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 Solution10 mg per 5 mL Oral Solution20 mg per 5 mL Oral SolutionMorphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: NDC 70408-746-29 Bottle of 30 mL with an oral syringeNDC 70408-746-31 Bottle of 120 mL with an oral syringeStoragePROTECT 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 Solution10 mg per 5 mL Oral Solution20 mg per 5 mL Oral SolutionMorphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: NDC 70408-746-29 Bottle of 30 mL with an oral syringeNDC 70408-746-31 Bottle of 120 mL with an oral syringeStoragePROTECT 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 Solution10 mg per 5 mL Oral Solution20 mg per 5 mL Oral SolutionMorphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: NDC 70408-746-29 Bottle of 30 mL with an oral syringeNDC 70408-746-31 Bottle of 120 mL with an oral syringeStoragePROTECT 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 Solution10 mg per 5 mL Oral Solution20 mg per 5 mL Oral SolutionMorphine Sulfate Oral Solution 100 mg per 5 mL is a clear/colorless solution available in one strengths as follows: NDC 70408-746-29 Bottle of 30 mL with an oral syringeNDC 70408-746-31 Bottle of 120 mL with an oral syringeStoragePROTECT 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

Morphine sulfate, an opioid agonist, is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. In addition to analgesia, the widely diverse effects of morphine sulfate include drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting, and alterations of the endocrine and autonomic nervous system.

Effects on the Central Nervous System (CNS)

The principal therapeutic action of morphine sulfate is analgesia. Other therapeutic effects of morphine sulfate include anxiolysis, euphoria and feelings of relaxation. Although the precise mechanism of the analgesic action is unknown, specific CNS opiate receptors and endogenous compounds with morphine sulfate-like activity have been identified throughout the brain and spinal cord and are likely to play a role in the expression and perception of analgesic effects. In common with other opioids, morphine sulfate causes respiratory depression, in part by a direct effect on the brainstem respiratory centers. Morphine sulfate and related opioids depress the cough reflex by direct effect on the cough center in the medulla.

Morphine sulfate causes miosis, even in total darkness.

Effects on the Gastrointestinal Tract and on Other Smooth Muscle

Gastric, biliary and pancreatic secretions are decreased by morphine sulfate. Morphine sulfate causes a reduction in motility and is associated with an increase in tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm. The end result may be constipation. Morphine sulfate can cause a marked increase in biliary tract pressure as a result of spasm of the sphincter of Oddi. Morphine sulfate may also cause spasm of the sphincter of the urinary bladder.

Effects on the Cardiovascular System

In therapeutic doses, morphine sulfate does not usually exert major effects on the cardiovascular system. Morphine sulfate produces peripheral vasodilation which may result in orthostatic hypotension and fainting. Release of histamine can occur, which may play a role in opioid-induced hypotension. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes and sweating.

Endocrine System

Opioid agonists have been shown to have a variety of effects on the secretion of hormones. Opioids inhibit the secretion of ACTH, cortisol, and luteinizing hormone (LH) in humans. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon in humans and other species, rats and dogs. Thyroid stimulating hormone (TSH) has been shown to be both inhibited and stimulated by opioids.

Immune System

Opioids have been shown to have a variety of effects on components of the immune system in and animal models. The clinical significance of these findings is unknown.

Non-Clinical Toxicology

Morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product.

Morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.

Morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as dopamine. This interaction appears to be related both to pressor activity and to the beta adrenergic stimulating properties of these catecholamines, and may produce ventricular arrhythmias. Therefore, EXTREME CAUTION should be exercised when administering dopamine HCI to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine-induced ventricular arrhythmias during anesthesia can be reversed by propranolol.

Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who ave been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine should receive an initial dose of Dopamine HCl no greater than one-tenth (1/10) of the usual dose.

Concurrent administration of low-dose dopamine HCI and diuretic agents may produce an additive or potentiating effect on urine flow.

Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents.

Cardiac effects of dopamine are antagonized by beta-adrenergic blocking agents, such as propranolol and metoprolol. The peripheral vasoconstriction caused by high doses of dopamine HCI is antagonized by alpha-adrenergic blocking agents. Dopamine-induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.

Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopaminergic renal and mesenteric vasodilation induced with low-dose dopamine infusion.

The concomitant use of vasopressors, vasoconstrictor agents (such as ergonovine) and some oxytocic drug may result in severe hypertension.

Administration of phenytoin to patients receiving dopamine HCI has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine HCI, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.

Morphine Sulfate Oral Solution is available in 10 mg per 5 mL, 20 mg per 5 mL and 100 mg per 5 mL (20 mg/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. Always use the enclosed calibrated oral syringe when administering Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) to ensure the dose is measured and administered accurately.

Serious adverse reactions associated with morphine sulfate use include: respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.

The common adverse reactions seen on initiation of therapy with morphine sulfate are dose-dependent and are typical opioid-related side effects. The most frequent of these include constipation, nausea, and somnolence. Other commonly observed adverse reactions include: lightheadedness, dizziness, sedation, vomiting, and sweating. The frequency of these events depends upon several factors including clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. Anticipate and manage these events as part of opioid analgesia therapy.

Other less frequently observed adverse reactions expected from opioid analgesics, including morphine sulfate include:

Body as a Whole

Cardiovascular System

Digestive System

Endocrine:

Hemic and Lymphatic System

Metabolic and Nutritional Disorders

Musculoskeletal

Nervous System

Respiratory System

Skin and Appendages

Special Senses

Urogenital System

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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

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).

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