Targiniq ER

Targiniq ER is used for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and when other pain drugs are not working well enough or cannot be tolerated.

Oxycodone is a narcotic analgesic that acts on the central nervous system to relieve pain. Naloxone is used to treat an opioid emergency such as an overdose or a possible overdose of a narcotic medicine.

This drug is not indicated for short-term use or for the relief of mild pain, or in situations when the non-narcotic drug is effective. Prolonged use of this drug combination may cause mental or physical dependence. The fear of dependence should not hinder people who have continuing pain in taking this drug for relief.

Mental dependence is not likely to happen if this drug is used for clinical purposes. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly but it can be prevented by gradually reducing the dose over a period of time before treatment is stopped completely. This drug requires a prescription.

Before using Targiniq ER, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of oxycodone and naloxone combination have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of oxycodone and naloxone combination. Adjustments in the dose of the elderly may be required since they are more likely to have age-related lung, liver, or kidney problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

• Anticholinergics
• Diuretics
• Mixed Agonist/Antagonist Opioid Analgesics
• Inhibitors of CYP3A4 and 2D6
• Inducers of CYP3A4
• Muscle Relaxants
• CNS Depressants

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

• Alcohol abuse
• Brain tumor
• Breathing problems
• Chronic obstructive pulmonary disease
• Cor pulmonale
• Depression
• Drug dependence
• Gallbladder disease or gallstones
• Head injuries
• Weakened physical condition
• Asthma
• Liver disease
• Paralytic ileus
• Respiratory depression
• Stomach or bowel blockage
• Hypotension
• Pancreatitis
• Seizures
• Kidney or liver disease

Proper usage of Targiniq ER requires strict adherence to your doctor’s orders. Prolonged use of this drug may cause mental or physical dependence. The extended-release tablets must be swallowed whole. Breaking, crushing, cutting, chewing, or dissolving the drug is not recommended.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults who are not taking narcotic drugs with moderate to severe pain are initially given 10 milligrams of oxycodone and 5 mg of naloxone every 12 hours. Your healthcare professional may adjust your dose if necessary.

Use and dose in children must be determined by your healthcare professional. Adults who are taking regular oxycodone are given this drug every 12 hours. The total amount of milligrams per day is half of the total amount of regular oxycodone that is taken per day.

The total amount per day will be divided and given as 2 doses during the day. Your healthcare professional may adjust your dose if needed.

The dose must not exceed 80 mg of oxycodone and 40 mg of naloxone per day. Use and dose in children must be determined by your healthcare professional.

Adults switching from other narcotic drugs are given this drug every 12 hours. The total amount of milligrams per day will be determined by your healthcare professional and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. Your healthcare professional may adjust your dose if needed.

The dose must not exceed 80 mg of oxycodone and 40 mg of naloxone per day. Use and dose in children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

If you take Targiniq ER, your doctor should perform routine checkups and advise you in taking precautions.

Seek immediate medical attention if you have symptoms of anaphylaxis such as:

• Rash
• Itching
• Hoarseness
• Trouble breathing
• Trouble swallowing
• Any swelling of your hands, face, or mouth while you are using this drug

Call emergency medical services if any symptoms of an overdose such as:

• Extreme dizziness or weakness
• Slow heartbeat or breathing
• Seizures
• Trouble breathing
• Cold, clammy skin happen

This drug will potentiate the effects of alcohol and other CNS depressants such as:

• Antihistamines or drug for allergies or colds
• Sedatives, tranquilizers, or sleeping drug
• Other prescription pain drug or narcotics
• Drug for seizures or barbiturates
• Muscle relaxants, or anesthetics, including some dental anesthetics

Check with your healthcare professional before taking any of these drugs while you are using this drug. Do not use more than your prescribed dose of this drug may be habit-forming. This drug can cause dizziness, lightheadedness, or fainting especially when you get up suddenly from a lying or sitting position.

It is recommended to get up slowly to help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This drug may make you dizzy, drowsy, or lightheaded. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous.

Severe constipation has been associated with the prolonged use of this drug which can prevent by taking laxatives, increased fluid intake, or increase in the amount of fiber in your diet. Check with your healthcare professional before changing your dose or suddenly stop using it if you have been using this drug regularly for several weeks or longer.

Your healthcare professional may slowly taper the amount you are using before stopping it completely to help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as:

• Abdominal or stomach cramps
• Anxiety
• Fever
• Nausea
• Runny nose
• Sweating
• Tremors, or trouble sleeping

This drug has teratogenic potential. Inform your healthcare professional immediately if you think you are pregnant or if you plan to become pregnant while using this drug. Consult with your healthcare professional before you take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Targiniq ER. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

• Blurred vision
• Confusion
• Difficult or troubled breathing
• Dizziness
• Faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Irregular, fast or slow, or shallow breathing
• Pale or blue lips, fingernails, or skin
• Seizures
• Sweating
• Unusual tiredness or weakness, or symptoms of overdose such as bigger
• Dilated, or enlarged pupils
• Change in consciousness
• Chest pain or discomfort
• Cold
• Clammy skin
• Coughing that sometimes produces a pink frothy sputum
• Decreased awareness or responsiveness
• Difficult, fast, noisy breathing, sometimes with wheezing
• Increased sensitivity of the eyes to light
• Increased sweating
• Loss of consciousness
• Severe sleepiness
• Sleepiness or unusual drowsiness
• Slow or irregular heartbeat
• Swelling in the legs and ankles

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.