Fentanyl (Citrate)

Fentanyl is used to manage breakthrough pain in adults and adolescents 16 years of age and older with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain . Oral transmucosal fentanyl preparations or fentanyl nasal spray are not for treating pain that is not cancer-related , such as migraine headaches or pain after surgery . Fentanyl skin patches may be used when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannot tolerate them. Fentanyl injection is used as a short-acting analgesic before, during, and after surgery and for anesthesia support in general or regional anesthesia or high-risk patients. Fentanyl is a strong prescription opioid pain medicine that is started only after you have been taking other opioid pain medicines and your body has become used to them ( you are opioid tolerant ). Do not use fentanyl if you are not opioid tolerant. An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. Fentanyl was first developed in 1959 and received its initial FDA approval on February 19, 1968. It is a prescription medicine classified as a Schedule II controlled substance under the Controlled Substances Act (CSA). Fentanyl sublingual sprays, sublingual/buccal tablets, nasal sprays, and transmucosal lozenges have been discontinued (both branded and generic versions). Fentanyl is only available as an injection and a transdermal patch.

Fentanyl is used to manage breakthrough pain in adults and adolescents 16 years of age and older with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain . Oral transmucosal fentanyl preparations or fentanyl nasal spray are not for treating pain that is not cancer-related , such as migraine headaches or pain after surgery . Fentanyl skin patches may be used when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannot tolerate them. Fentanyl injection is used as a short-acting analgesic before, during, and after surgery and for anesthesia support in general or regional anesthesia or high-risk patients. Fentanyl is a strong prescription opioid pain medicine that is started only after you have been taking other opioid pain medicines and your body has become used to them ( you are opioid tolerant ). Do not use fentanyl if you are not opioid tolerant. An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. Fentanyl was first developed in 1959 and received its initial FDA approval on February 19, 1968. It is a prescription medicine classified as a Schedule II controlled substance under the Controlled Substances Act (CSA). Fentanyl sublingual sprays, sublingual/buccal tablets, nasal sprays, and transmucosal lozenges have been discontinued (both branded and generic versions). Fentanyl is only available as an injection and a transdermal patch.

Do not take fentanyl if: You are not opioid tolerant. Opioid tolerance means that you are already taking other opioid pain medicines around-the-clock for at least one week or longer for your cancer pain, and your body is used to these medicines. You have severe asthma, trouble breathing, or other lung problems. You have a bowel blockage or a narrowing of the stomach or intestines. You are allergic to any of the ingredients in the formulation. You have short-term pain that you would expect to go away in a few days, such as: Pain after surgery Headache or migraine Dental pain. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Before taking fentanyl, tell your healthcare provider if you have a history of: Troubled breathing or lung problems such as asthma, wheezing, or shortness of breath Head injury, seizures Slow heart rate or other heart problems Low blood pressure Mental problems [including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)] Problems urinating Liver, kidney, thyroid problems Pancreas or gallbladder problems Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Diabetes and you are taking fentanyl OTFC (each OTFC unit contains about 1/2 teaspoon [2 grams] of sugar). Tell your healthcare provider if you are: Noticing your pain is getting worse . If your pain gets worse after you take OTFC, do not take more OTFC without first talking to your healthcare provider. Talk to your healthcare provider if the pain you have increases, if you feel more sensitive to pain, or if you have new pain after taking OTFC Pregnant or planning to become pregnant. Use of OTFC for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated Breastfeeding . Fentanyl passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs Living in a household where there are small children or someone who has abused street or prescription drugs Taking certain other prescription over-the-counter medicines, vitamins, or herbal supplements. Taking fentanyl with certain other medicines can cause serious side effects that could lead to death.

The possible side effects of Fentanyl are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, weakness, anxiety, depression, rash, and trouble sleeping. Call your healthcare provider if you have any of these symptoms and they are severe. Fentanyl may also decrease your blood pressure . This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down. Get emergency medical help or call 911 right away if you have: Trouble breathing or shortness of breath Fast heartbeat or chest pain Swelling of your face, tongue, or throat Extreme drowsiness Light-headedness when changing positions or feeling faint Agitation High body temperature Trouble walking Stiff muscles Mental changes such as confusion. These symptoms can be a sign that you have used too much fentanyl or that the dose is too high for you . These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not use any more fentanyl until you have talked to your healthcare provider. These are not all the possible side effects of fentanyl. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Because of the risks of addiction, abuse, and misuse, overdose, and death with opioids, which can occur at any dosage or duration and persist over the course of therapy, reserve: Transdermal fentanyl for use when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat pain well enough or are not tolerated Transmucosal and nasal fentanyl for use in cancer patients for whom alternative treatment options (such as non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Get emergency help or call 911 right away if you take too much fentanyl (overdose). When you first start taking fentanyl, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking fentanyl with other medicines that may make you sleepy, such as other pain medicines, gabapentinoids (gabapentin or pregabalin), antidepressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death. Never give anyone else your fentanyl. They could die from taking it . Selling or giving away fentanyl is against the law. Store fentanyl securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using fentanyl . You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.

Because of the risks of addiction, abuse, and misuse, overdose, and death with opioids, which can occur at any dosage or duration and persist over the course of therapy, reserve: Transdermal fentanyl for use when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat pain well enough or are not tolerated Transmucosal and nasal fentanyl for use in cancer patients for whom alternative treatment options (such as non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Get emergency help or call 911 right away if you take too much fentanyl (overdose). When you first start taking fentanyl, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking fentanyl with other medicines that may make you sleepy, such as other pain medicines, gabapentinoids (gabapentin or pregabalin), antidepressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death. Never give anyone else your fentanyl. They could die from taking it . Selling or giving away fentanyl is against the law. Store fentanyl securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using fentanyl . You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.

0.714 to 1.428 ug/kg (1.1 (1.071)) As recommended. IM — 30-60 Min before anaesthesia

1.7 to 3.3 ug/kg (2.5 (2.5)) As recommended. Intra Muscular — For Induction and Maintenance ,not safe below 2 Yrs.

Not safe under 2 Yrs of children ( ) —

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic , antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C. Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use: other narcotic medications - opioid pain medicine or prescription cough medicine; a sedative like Valium - diazepam , alprazolam , lorazepam , Ativan , Klonopin , Restoril , Tranxene , Versed , Xanax , and others; drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; cold or allergy medicines, bronchodilator asthma/ COPD medication, or a diuretic ("water pill"); medicines for motion sickness , irritable bowel syndrome , or overactive bladder ; drugs that affect serotonin levels in your body - medicine for depression , Parkinson's disease , migraine headaches, serious infections, or prevention of nausea and vomiting. This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins , and herbal products . Not all possible interactions are listed in this medication guide.

Inj Store Below 40°C. Protect from Sunlight and Moisture. Lozenges Store in a well closed container, Below 40°C. Do not Freeze. Protect from Sunlight and Moisture.