Granisetron 1mg/ml Inj, 1ml

Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist. Chemotherapy and radiation therapy are associated with the release of serotonin from enterochromaffin cells of the small intestine, which then activates 5-HT3 receptors located on vagal afferent neurons to initiate the vomiting reflex. Granisetron selectively blocks this serotonin binding, 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 or seek immediate 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 belly
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 immediate medical attention 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 may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it is 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
Feeling dizzy, sleepy, tired, or weak
Diarrhea or constipation
Heartburn
Decreased appetite
* Trouble sleeping

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, any of 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. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage 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 alertness. This will help prevent any accidents or injuries that could occur due to drowsiness or impaired judgment.

Some formulations of this medication may contain benzyl alcohol. If you are administering this medication to a newborn or infant, it is crucial to avoid products containing 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. Consult your doctor to determine if the specific product you are using 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 this medication, taking into account the potential effects on both you and your baby.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, MAOIs, triptans, fentanyl, lithium, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
• Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones): Potential for additive QT prolongation, though granisetron's effect is generally minor.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease granisetron plasma concentrations.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase granisetron plasma concentrations.

• Headache
• Constipation
• Asthenia
• Diarrhea
• Fever
• Dizziness
• Anxiety
• Insomnia
• Signs of serotonin syndrome (agitation, hallucinations, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Signs of hypersensitivity reaction (rash, urticaria, dyspnea, swelling)

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. Granisetron is excreted in the milk of lactating rats. Because many drugs are excreted in human milk, caution should be exercised when granisetron is administered to a nursing woman. 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 in pediatric patients 2 years of age and older for the prevention of CINV. Dosing is weight-based. Not established for patients 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 adverse effects and clinical response.

• Granisetron is highly effective for preventing acute and delayed CINV and RINV.
• It is generally well-tolerated with common side effects being headache and constipation.
• Unlike some other 5-HT3 antagonists, granisetron has a relatively low risk of QT prolongation at recommended doses, but caution is still advised with other QT-prolonging drugs.
• Consider combination therapy with corticosteroids (e.g., dexamethasone) and/or NK1 receptor antagonists (e.g., aprepitant) for highly emetogenic chemotherapy regimens.
• IV administration should be slow (over 5 minutes) to minimize injection site reactions.

• Ondansetron (another 5-HT3 receptor antagonist)
• Palonosetron (another 5-HT3 receptor antagonist, longer half-life)
• Dolasetron (another 5-HT3 receptor antagonist)
• Netupitant/Palonosetron (fixed-dose combination of NK1 and 5-HT3 antagonist)
• Aprepitant/Fosaprepitant (NK1 receptor antagonists)
• Dexamethasone (corticosteroid)
• Olanzapine (atypical antipsychotic, off-label for CINV)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which can be a safe and convenient way to dispose of unwanted medications. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare providers deliver appropriate care.