Butrum-2mg Inj

BUTRUM-2MG Injection

Name:

• Common Name: Butorphanol Tartrate Injection.
• Brand Name: BUTRUM-2MG Injection (by Aristo Pharmaceuticals Pvt Ltd). Other brand names for Butorphanol in general include Stadol (discontinued) and Dolorex (veterinary use).

Composition: BUTRUM-2MG Injection contains Butorphanol (2 mg) as the active ingredient. Butorphanol is classified as an Opioid agonist/antagonist analgesic or narcotic analgesic. Each milliliter contains butorphanol tartrate 1 or 2 mg, along with sodium citrate dihydrate, citric acid hydrous, and sodium chloride.

Uses: BUTRUM-2MG Injection is primarily used for the management of moderate to severe pain. Specific conditions and uses include:

• Postoperative pain relief.
• Preoperative and pre-anesthetic medication, administered before surgical procedures.
• Supplement to balanced anesthesia.
• Relief of pain during early labor.
• Management of muscle pain and migraine-related headaches.
• Pain associated with conditions like toothache, rheumatoid arthritis, and osteoarthritis.
• It also acts as an antitussive (cough suppressant) and antiemetic (prevents vomiting).

Dosage and Administration: BUTRUM-2MG Injection is administered by a healthcare professional as an intravenous (IV) injection into the vein or an intramuscular (IM) injection into the muscle. It should not be self-administered. The dosage and duration are determined by the doctor based on the patient's age, body weight, disease condition, severity of pain, and response to treatment.

• For pain relief: The usual recommended single dose for IM administration is 2 mg, which may be repeated every 3 to 4 hours as necessary. The effective dosage range is 1 to 4 mg every 3 to 4 hours. For IV administration, the usual single dose is 1 mg, repeated every 3 to 4 hours, with an effective range of 0.5 to 2 mg every 3 to 4 hours.
• As preoperative/pre-anesthetic medication: The usual adult dose is 2 mg IM, administered 60-90 minutes before surgery.
• In balanced anesthesia: The usual dose is 2 mg IV shortly before induction and/or 0.5 to 1.0 mg IV in increments during anesthesia.
• For labor pain: A 1 to 2 mg dose IV or IM may be administered and repeated after 4 hours.
• Special populations: In patients with hepatic or renal impairment, the initial dose should generally be half the recommended adult dose (0.5 mg IV and 1.0 mg IM), with repeat doses no less than 6 hours apart.

Side Effects: Common side effects include:

• Excess sleepiness, drowsiness, dizziness, lethargy.
• Nausea and vomiting.
• Headache.
• Constipation.
• Injection site reactions (pain, redness, swelling).
• Nasal congestion.
• Anxiety, confusion, euphoria (feeling very happy), floating feeling, sleeplessness, nervousness, tremor.
• Dry mouth, stomach pain.
• Sweating, itching, blurred vision, ear pain, ringing sensation in ears, unpleasant taste.

Serious side effects can include:

• Respiratory depression, which can be life-threatening.
• Signs of severe hypertension (anxiety, blurred vision, chest pain).
• Signs of serotonin syndrome (agitation, confusion, dilated pupils).
• Neonatal opioid withdrawal syndrome in newborns if used during pregnancy.
• Low blood pressure, temporary loss of consciousness, abnormal dreams, agitation, dysphoria, hallucinations, hostility, withdrawal symptoms.
• Increased risk of seizures in patients with seizure disorders.

Precautions:

• Contraindications: Not recommended for patients with allergies to butorphanol tartrate, lung problems (such as respiratory depression, severe bronchial asthma), or gastrointestinal obstruction (e.g., paralytic ileus). It is also not recommended for children and adolescents under 18 years of age.
• Dependency: Butorphanol Tartrate is a Schedule IV controlled substance and carries risks of addiction, abuse, and misuse. Prolonged use may lead to physical dependence or tolerance. It is not recommended for patients dependent on narcotics due to its opioid antagonist properties, which can precipitate withdrawal symptoms.
• Pregnancy and Breastfeeding: Use with caution during pregnancy, only if necessary, as prolonged use may cause neonatal opioid withdrawal syndrome. It should be used with caution in breastfeeding women as it can pass into breast milk.
• Other Medical Conditions: Caution is advised in elderly patients (above 65 years). Inform your doctor if you have liver, kidney, or heart diseases, breathing problems, mood disorders, brain-related problems, gastrointestinal disorders, underactive thyroid (hypothyroidism), or drug addiction.
• Driving and Machinery: Avoid driving or operating machinery as the medicine can cause dizziness and drowsiness.
• Alcohol: Avoid alcohol consumption as it can worsen drowsiness, dizziness, and impaired mental function.
• Drug Interactions: Inform your doctor about all medications you are taking, including sedatives, hypnotics, anxiolytics, antidepressants (SSRIs, SNRIs, TCAs), muscle relaxants, general anesthetics, and other opioids, as interactions can lead to profound sedation, respiratory depression, coma, or serotonin syndrome.

Storage: Store BUTRUM-2MG Injection in a cool and dry place, away from direct sunlight, and out of reach of children. The recommended storage temperature is between 10ºC to 25ºC or below 30ºC. Discard any outdated medication.

BUTRUM-2MG INJ by ARISTO-MF 1 DIV is a medication containing Butorphanol, a synthetic opioid agonist-antagonist analgesic. It is primarily used for the management of moderate to severe pain.

Here are some frequently asked questions about Butorphanol injection:

What is Butorphanol injection used for?

Butorphanol injection is used to relieve moderate to severe pain that has not responded well to non-opioid medications. It is also used as a preoperative or pre-anesthetic medication, as a supplement to balanced anesthesia, and for pain relief during labor.

How does Butorphanol work?

Butorphanol works by interacting with opioid receptors in the central nervous system. It acts as a partial agonist at the mu-opioid receptor and an agonist at the kappa-opioid receptor, which helps to block pain signals and reduce the perception of pain.

What is the usual dosage?

For pain relief, the typical initial dosage for adults is 1 mg intravenously (IV) or 2 mg intramuscularly (IM), repeated every three to four hours as necessary. The effective dosage range can vary from 0.5 to 2 mg IV or 1 to 4 mg IM, repeated every 3 to 4 hours, depending on the severity of pain. For preoperative medication, the usual adult dose is 2 mg IM, administered 60 to 90 minutes before surgery. In patients with hepatic or renal impairment, the initial dose should generally be half the recommended adult dose (0.5 mg IV and 1 mg IM), with repeat doses determined by patient response and generally not less than 6 hours apart.

What are the possible side effects?

Common side effects of Butorphanol injection include drowsiness, dizziness, nausea, vomiting, headache, dry mouth, and constipation. More serious side effects can include profound sedation, respiratory depression (slow or shallow breathing), allergic reactions (rash, itching, swelling), low adrenal gland function, low blood pressure, and in rare cases, serotonin syndrome if used with certain other medications.

Is it safe during pregnancy or breastfeeding?

Butorphanol should be used during pregnancy only if the potential benefit justifies the potential risk to the infant, as there are no adequate and well-controlled studies in pregnant women before 37 weeks of gestation. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome in the newborn. Limited data indicate that small amounts of butorphanol pass into breast milk, and it is poorly absorbed orally by infants, making adverse effects unlikely. However, other agents may be preferred, especially for newborns or preterm infants, and infants should be monitored for drowsiness and adequate weight gain.

Can it be taken with other medications?

Butorphanol can interact with various medications. Concomitant use with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can lead to profound sedation, respiratory depression, coma, and death. It should also be used with caution with other opioids, certain antidepressants (especially those that increase serotonin levels, due to the risk of serotonin syndrome), antihistamines, muscle relaxants, and some antibiotics, antifungals, and seizure medications. It is crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, vitamins, and herbal products.

What precautions should be taken?

Butorphanol injection is a Schedule IV controlled substance due to its potential for addiction, abuse, and misuse. Patients should be assessed for risk factors before prescribing and regularly monitored. Respiratory depression is a serious risk, especially during initiation or dosage increases. Caution is advised in patients with lung or breathing diseases (e.g., asthma, COPD), head injuries, brain tumors, increased intracranial pressure, liver or kidney disease, and seizure disorders. It can also impair coordination and judgment, so driving or operating machinery should be avoided until its effects are known.

What happens if a dose is missed?

If Butorphanol injection is prescribed regularly and a dose is missed, it should be administered as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule continued. Do not double or take extra doses.

How should it be stored?

Butorphanol injection should be stored at room temperature, between 20°C to 25°C (68°F to 77°F). It should be protected from light and kept in its original container, tightly closed, and out of reach of children. Any outdated or no longer needed medication should be disposed of properly.