Precautions and warnings

**Opioid REMS (Risk Evaluation and Mitigation Strategy)**

- The FDA now requires special safety measures (REMS) for extended-release (ER) and long-acting (LA) opioid painkillers.
- Doctors are strongly urged to take REMS-approved training and to talk to patients about how to safely use, store, and throw away these medications, as well as discuss their risks.

**Limitations on Use**

- ER/LA opioids should only be used for moderate-to-severe pain that requires continuous, long-term treatment.
- These medications are *not* meant for use “as needed”, for sudden or short-term pain, or after surgery—unless the patient is already on long-term opioids or is expected to have long-lasting pain after surgery.

**Risk of Abuse**

- These drugs are controlled substances and can be abused. Before prescribing, doctors should check the patient’s risk for opioid or alcohol abuse or addiction.
- Doctors should also check for mental health conditions (like depression).
- Patients should be monitored regularly for any signs of misuse, abuse, or addiction.

**Life-Threatening Breathing Problems**

- Serious or even fatal breathing problems can happen, even if the medication is used correctly. Safe dosing and careful monitoring by knowledgeable doctors are very important.
- ER/LA opioids should be swallowed whole—do not chew, crush, or dissolve them, as this can release a dangerous amount of the drug all at once.

**Accidental Exposure**

- Accidental swallowing—especially by children—can cause deadly overdose.

**Alcohol Warning**

- Patients must not drink alcohol or use other drugs containing alcohol while taking morphine (or similar opioids).
- Mixing alcohol with these opioids can lead to dangerously high levels of the drug in the body and possibly fatal overdose.

Drug Interactions

**Serious side effects can happen when taking MAOIs, especially if combined with other medicines that affect the brain. This includes drugs that increase serotonin, like triptans, SSRIs, SNRIs, lithium, sibutramine, fentanyl and similar drugs, tramadol, dextromethorphan, tapentadol, meperidine, methadone, pentazocine, or herbal supplements like St. John’s wort. Certain antibiotics, antipsychotics, or drugs such as linezolid, methylene blue, or tryptophan supplements can also raise serotonin levels, which can be dangerous.**

**There is a higher risk of heart rhythm problems (like QTc prolongation or ventricular arrhythmias) when taken with some antipsychotics or antibiotics.**

**MAOIs can also affect how other medicines work in your body:**
- **Indinavir levels may go down.**
- **Haloperidol levels may go up.**
- **Ketoconazole can increase the amount of this drug in your blood.**
- **Metoprolol levels go up, but its blood pressure-lowering effect may decrease.**
- **Risperidone levels may increase.**
- **Drugs that block CYP2D6 can slow down metabolism.**
- **Drugs that block CYP3A4 can increase venlafaxine levels.**

Contraindications

- Allergic reactions, such as anaphylaxis or swelling (angioedema)
- Serious trouble breathing
- Sudden or severe asthma attacks
- High levels of carbon dioxide in the blood if not being closely watched or if emergency equipment isn’t available
- Blockage in the intestines (paralytic ileus)
- Taking monoamine oxidase inhibitors (MAOIs) at the same time, or within the last 14 days

Mode of actions

This medication works by activating mu-opioid receptors, which block pain signals traveling up the nerves, changing how your body senses pain. As a result, it provides pain relief, can cause drowsiness, and may slow breathing. It also stops the reabsorption of norepinephrine, another way it helps block pain signals.

Dosage & Administration

Moderate-to-Severe Pain

Acute (immediate-release tablet or oral solution)

50-100 mg PO q4-6hr PRN; not to exceed 700 mg on day 1 and 600 mg/day thereafter.

Chronic (extended-release tablet)

50-250 mg PO q12hr PRN; not to exceed 500 mg/day.
Opioid-naive patients: 50 mg PO q12hr; titrated to optimal dosage as needed; not to exceed 500 mg/day

Diabetic Peripheral Neuropathy

Treatment of pain associated with diabetic peripheral neuropathy when continuous, around-the-clock opioid analgesic is needed for extended period

Extended release: 50 mg PO q12hr initially; titrated to balance individual tolerance with efficacy; typical range, 100-250 mg PO q12hr.

Renal impairment

CrCl >30 mL/min : Dosage adjustment not required
CrCl

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required despite potential risks.

Mothers with a newborn baby who have used this drug during the last 3 months of pregnancy may seldom create symptoms including drowsiness, muscle stiffness or shakiness, feeding or breathing troubles, constant crying. If you notice any of these symptoms of your baby's particularly during their first month, tell the doctor immediately.

This medicine passes into breast milk. Talk to your doctor before breastfeeding.

Pack Size & Price