Avinza Capsules and Night Sweats

Avinza side effects have a tendency to cause sweating, night sweats, nocturnal hydrosis and fevers along with many other side effects that make it difficult to get a good nights sleep. Here you will find the warnings, precautions, and side effects attributed to this capsule . We do not discuss if Oxycontin is stronger  here but you can read about them both. this information covers 120 and 30mg. This is a good source for medical information on this drug if you need more let us know and we will see if we can help

WARNING:

Avinza capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. CAPSULES ARE TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES SPRINKLED ON APPLESAUCE. THE CAPSULE BEADS ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

DESCRIPTION

Avinza (morphine sulfate extended-release capsules) 30, 60, 90, and 120 mg contain both immediate release and extended release beads of morphine sulfate for once daily oral administration.

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 weight of 758. Morphine sulfate occurs as white, feathery, silky crystals; cubical masses of crystal; or white crystalline powder. 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 _a is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).

Each Capsule contains either 30, 60, 90, or 120 mg of morphine sulfate, USP and the following inactive ingredients: ammonio-methacrylate copolymers, NF, fumaric acid, NF, povidone, USP, sodium lauryl sulfate, NF, sugar starch spheres, NF, and talc, USP. The capsule shell contains black ink, gelatin, titanium dioxide, D&C yellow No. 10 (30 mg), FC&C green No. 3 (60 mg), FD&C red No. 40 (90 mg), FD&C red No. 3 (120 mg), and FD&C blue No. 1 (120 mg).

PRECAUTIONS

General

This drug is intended for use in patients requiring continuous around-the-clock treatment with an opioid analgesic. It is not appropriate as a prn treatment for pain. As with any opioid, it is critical to adjust the dose of Avinza for each individual patient, taking into account the patient's prior experience with analgesics. (see DOSAGE AND ADMINISTRATION )

Use in Pancreatic/Biliary Tract Disease

Avinza should be used with caution in patients with biliary tract disease, including acute pancreatitis, as morphine may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.

Special Risk Groups

Avinza should be administered cautiously and in reduced dosages in patients with severe renal or hepatic insufficiency, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients. (see Geriatric Use and CLINICAL PHARMACOLOGY , Special Populations )

Caution should be exercised in the administration of morphine to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens, and seizure disorders.

Driving and Operating Machinery

Patients should be cautioned that Avinza could impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Patients should also be cautioned about the potential combined effects of Avinza with other CNS depressants, including other opioids, phenothiazines, sedative/hypnotics and alcohol. (see PRECAUTIONS , Drug Interactions )

Tolerance and Physical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION , Cessation of Therapy ).

Information for Patients

Patients receiving Avinza (morphine sulfate extended-release capsules) should be given the following instructions by the physician:

1. Patients should be advised that Avinza capsules contain morphine and should be taken once daily.
2. Avinza must be swallowed whole (not chewed, crushed, or dissolved) or Avinza may be opened and the entire bead contents sprinkled on a small amount of applesauce immediately prior to ingestion. The beads must NOT be chewed, crushed, or dissolved due to the risk of exposure to a potentially toxic dose of morphine.
3. The dose of Avinza should not be adjusted without consulting with a physician or other healthcare professional.
4. Patients should be advised that Avinza may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Patients started on Avinza or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected.
5. Patients should be advised that Avinza should not be combined with alcohol or other CNS depressants (e.g., sleep medications, tranquilizers). A physician should be consulted if other medications are currently being used or are added in the future.
6. Women of childbearing potential who become or are planning to become pregnant should consult a physician prior to initiating or continuing therapy with Avinza.
7. If patients have been receiving treatment with Avinza for more than a few weeks and cessation of therapy is indicated, they should be counseled on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. The physician should provide a dose schedule to accomplish a gradual discontinuation of the medication.
8. Patients should be advised that Avinza is a potential drug of abuse. They should protect it from theft. It should never be given to anyone other than the individual for whom it was prescribed.
9. Patients should be instructed to keep Avinza in a secure place out of the reach of children. When Avinza is no longer needed, the unused capsules should be destroyed by flushing down the toilet.

As with other opioids, patients taking Avinza should be advised of the potential for severe constipation; appropriate laxatives, and/or stool softeners as well as other appropriate treatments should be initiated from the onset of opioid therapy.

ADVERSE REACTIONS

In controlled and open label clinical studies, 560 patients with chronic malignant or non-malignant pain were treated with Avinza. The most common serious adverse events reported with administration of Avinza were vomiting, nausea, death, dehydration, dyspnea, and sepsis. (Deaths occurred in patients treated for pain due to underlying malignancy.) Serious adverse events caused by morphine include respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.

Adverse Events

The common adverse events seen on initiation of therapy with morphine are dose-dependent and are typical opioid-related side effects. The most frequent of these include constipation, nausea and somnolence. The frequency of these events depends upon several factors including the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. These events should be anticipated and managed as part of opioid analgesia therapy.

The most common adverse events (seen in greater than 10%) reported by patients treated with Avinza during the clinical trials at least once during therapy were constipation, nausea, somnolence, vomiting, and headache. Adverse events occurring in 5-10% of study patients were peripheral edema, diarrhea, abdominal pain, infection, urinary tract infection, accidental injury, flu syndrome, back pain, rash, sweating, fever, insomnia, depression, paresthesia, anorexia, dry mouth, asthenia and dyspnea. Other less common side effects expected from opioid analgesics, including morphine, or seen in fewer than 5% of patients taking Avinza in the clinical trials were:

Body as a Whole: malaise, withdrawal syndrome.

Cardiovascular System: bradycardia, hypertension, hypotension, palpitations, syncope, tachycardia.

Digestive System: biliary pain, dyspepsia, dysphagia, gastroenteritis, abnormal liver function tests, rectal disorder, thirst.

Hemic and Lymphatic System: anemia, thrombocytopenia.

Metabolic and Nutritional Disorders: edema, weight loss.

Musculoskeletal: skeletal muscle rigidity.

Nervous System: abnormal dreams, abnormal gait, agitation, amnesia, anxiety, ataxia, confusion, convulsions, coma, delirium, euphoria, hallucinations, lethargy, nervousness, abnormal thinking, tremor, vasodilation, vertigo.

Respiratory System: hiccup, hypoventilation, voice alteration.

Skin and Appendages: dry skin, urticaria.

Special Senses: amblyopia, eye pain, taste perversion.

Urogenital System: abnormal ejaculation, dysuria, impotence, decreased libido, oliguria, urinary retention.