Granisetron 1mg/ml Inj, 4ml

Granisetron is a selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist. Chemotherapy and radiation therapy can cause the release of serotonin (5-HT) from enterochromaffin cells in the small intestine, which then stimulates 5-HT3 receptors located on vagal afferent neurons, initiating the vomiting reflex. Granisetron blocks this stimulation, both peripherally and centrally in the chemoreceptor trigger zone (CTZ), thereby preventing nausea and vomiting.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Shortness of breath
Stomach pain
Swelling of the abdomen
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Dizziness, sleepiness, tiredness, or weakness
Diarrhea or constipation
Heartburn
Decreased appetite
* Trouble sleeping

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
* If you are taking apomorphine, as this may interact with this medication.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to assess potential interactions and determine the safety of taking this medication with your other drugs and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure they are aware of any potential interactions or concerns.

Until you know how this medication affects you, it is recommended that you avoid driving and other activities that require your full attention. This will help prevent any accidents or injuries that could occur if the medication causes drowsiness or impaired alertness.

Some formulations of this medication may contain benzyl alcohol. If you are a parent or caregiver of a newborn or infant, it is crucial to avoid using products that contain benzyl alcohol whenever possible. Benzyl alcohol can cause serious side effects in children, particularly when used in combination with other medications that also contain benzyl alcohol. Be sure to consult with your doctor to determine if this medication contains benzyl alcohol.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor. This will enable you to make an informed decision about using the medication, taking into account the potential effects on both you and your baby.

• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, tricyclic antidepressants)
• Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - risk of serotonin syndrome

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease granisetron levels (clinical significance generally minor)
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) - may increase granisetron levels (clinical significance generally minor)

• Nausea
• Vomiting
• Headache
• Constipation
• Diarrhea
• Dizziness
• Fatigue
• Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
• Signs of hypersensitivity reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)

Granisetron is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from granisetron, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and efficacy have been established for the prevention of CINV in pediatric patients aged 2 to 16 years. Dosing is weight-based. Not recommended for children under 2 years of age.

No dosage adjustment is generally required based on age. However, elderly patients may have reduced renal or hepatic function, which could affect drug clearance. Monitor for comorbidities and polypharmacy, especially regarding QT prolongation risk.

• Granisetron is highly effective for preventing acute chemotherapy-induced nausea and vomiting (CINV) but may be less effective for delayed CINV.
• It is generally well-tolerated, with headache and constipation being the most common side effects.
• Administer IV granisetron slowly (over 5 minutes for 10 mcg/kg dose, or 30 seconds for 1 mg dose) to minimize injection site reactions.
• Caution should be exercised when co-administering with other drugs known to prolong the QT interval or with serotonergic agents due to the risk of serotonin syndrome.
• Ensure electrolyte abnormalities (especially hypokalemia and hypomagnesemia) are corrected before administration to reduce the risk of QT prolongation.

• Ondansetron (Zofran)
• Palonosetron (Aloxi)
• Dolasetron (Anzemet)
• Netupitant/Palonosetron (Akynzeo)
• Aprepitant (Emend)
• Fosaprepitant (Emend IV)
• Dexamethasone
• Prochlorperazine
• Metoclopramide

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.