

Inotad 100mg/5ml Injection (Irinotecan Injection IP)
Manufactured By
Adely
Pack Of
1
Salt Composition
Irinotecan Injection IP
Storage
Keep in cold place
ALL SUBSTITUTES
Overview
Inotad 100mg Injection is a prescription cytotoxic medicine containing irinotecan at 20mg/ml. Irinotecan Injection is a topoisomerase I inhibitor used mainly in gastrointestinal oncology, especially colorectal cancer, either in combination regimens or as later-line therapy. The 100mg/5ml vial is a concentration/presentation, not a patient dose. Irinotecan Injection IP dosing is protocol-specific and calculated using body surface area (mg/m²).
Dose selection depends on regimen, previous treatment, bilirubin/liver function, blood counts, toxicity and sometimes UGT1A1 genotype/phenotype considerations. However, Irinotecan 100mg Injection has two characteristic high-risk toxicities: diarrhea and myelosuppression. Early diarrhea can occur with an acute cholinergic syndrome during or shortly after infusion; late diarrhea can be prolonged, severe and life-threatening.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | inotad |
| Generic / Active Ingredient | Irinotecan Injection IP |
| Strength | 100 |
| Dosage Form | Injection |
| Manufacturer / Marketer | adely |
| Pack Size | 1 |
| Prescription Required | Yes |
| Therapeutic Categories | Cancer Medicines |
| Uses | Colorectal Cancer |
Uses and Indications
Inotad Injection should be used only for an appropriate specialist-directed indication. The exact treatment setting, combination regimen and duration depend on the diagnosis and current clinical guidance.
Metastatic colorectal cancer - combination therapy: Irinotecan 100mg is used with fluorouracil/leucovorin-based regimens as part of first-line or subsequent treatment strategies depending on the clinical setting.
Metastatic colorectal cancer after progression: Inotad 100mg Injection is indicated as single-agent treatment for patients whose disease has recurred or progressed after fluorouracil-based therapy under established labeling.
Other protocol uses: Irinotecan Injection is incorporated into specialist regimens in other cancers in some guidelines. Such uses should be described only when tied to the relevant disease protocol rather than generalized from the colorectal indication.
How Inotad 100mg/5ml Injection Works
Irinotecan 100 mg is converted into its active metabolite known as SN-38. This compound inhibits an enzyme known as topoisomerase I. Topoisomerase I normally assists in unwinding and repairing the DNA chain. When this process is inhibited, DNA is left damaged; thus, multiplication of cancerous cells becomes impossible and ultimately they die.
Clinical Evidence for Inotad 100mg/5ml Injection
- Irinotecan 100mg Injection has proven to be an efficient drug regimen in treating metastatic colorectal cancer through clinical trials. It can be used in combination with fluoropyrimidines or in the event that the cancer develops resistance after administration of fluorouracil therapy.
- Outcome of treatment varies depending on the type of regimen, nature of the cancer, treatment stage, and other medicines used.
- Contemporary treatment of colorectal cancer can also involve the use of targeted medicines or immunotherapy in patients with certain molecular characteristics.
- All the information provided pertains to irinotecan Injection and certain regimens, not to a specific clinical trial of the medicine vial.
Side Effects of Inotad 100mg/5ml Injection
Common or clinically relevant adverse effects can include:
- Early or late diarrhea
- Nausea
- Vomiting
- Neutropenia
- Anemia
- Fatigue
- Alopecia
- Abdominal cramping
- Loss of appetite
Serious adverse reactions can include:
- Life-threatening late diarrhea and dehydration
- Severe neutropenia/febrile neutropenia/sepsis
- Acute cholinergic syndrome
- Interstitial pulmonary disease
- Severe hypersensitivity
- Renal failure secondary to volume depletion
- Increased toxicity in patients with reduced UGT1A1 activity
Patients should receive medicine-specific instructions about symptoms that require urgent medical attention.
Critical Safety Warning
- Inotad Injection is a prescription medicine and should be given under the supervision of an appropriate specialist.
- This treatment has important warnings for diarrhea and low blood cell counts. Severe diarrhea can be dangerous and needs quick medical treatment, which may include medicines such as loperamide and fluids to replace lost water and electrolytes.
- Early diarrhea can happen during or soon after the infusion. It may occur with symptoms such as stomach cramps, sweating, increased saliva, or a runny nose. Atropine may be used to prevent or treat these symptoms when considered appropriate by the healthcare team.
- Severe neutropenia, a major decrease in certain white blood cells, can increase the risk of serious infections such as sepsis. Regular CBC blood tests are needed, and the treatment may be delayed or the dose reduced depending on blood counts and side effects.
- Some patients with specific UGT1A1 gene variations may have higher levels of the active metabolite SN-38 and a greater risk of severe neutropenia. For patients known to have poor UGT1A1 metabolism, the current prescribing information supports considering a lower starting dose.
Inotad 100mg/5ml Injection Dosage and How To Take It
Inotad 100mg Injection is not self-administered. The 100mg/5ml (20mg/ml) presentation is used to prepare a protocol-calculated dose in a healthcare setting.
These are molecule-level examples/principles from regulatory labeling and are not instructions for self-dosing. The healthcare specialist determines the actual dose, duration, dose modifications and supportive treatment.
| Clinical situation | Dose |
|---|---|
| Combination schedule example | A dose of 125 mg/m² via IV infusion in 90 minutes weekly for four weeks, followed by a break, was part of some older protocols of fluurouracil/leucovorin therapy. |
| Every-3-week single-agent example | A dose of 350 mg/m² via IV infusion in 90 minutes every three weeks was part of some older protocols for colorectal cancer. |
| Modern combination protocols | Present protocols might require certain protocol-defined dosages, for example, dosages in FOLFIRI. The dosages should correspond to a certain cancer-treatment protocol. |
| 100mg/5ml vial context | There are 100 mg in 5 mL in the vial, corresponding to 20 mg/mL. The actual dosage will be calculated on the basis of body-surface area (mg/m²). |
Inotad 100mg/5ml Injection Missed Dose
Irinotecan Injection is administered on scheduled chemotherapy days. If an infusion is delayed or missed, the oncology team determines the revised cycle based on blood counts, diarrhea recovery, organ function and the treatment protocol. Patients should never attempt to compensate for a missed infusion.
Safety Advice for Inotad 100mg/5ml Injection
| Category | Status | Guidance |
|---|---|---|
| Diarrhea | High Caution | Report any instances of diarrhea as soon as possible. Delayed diarrhea is a serious condition that requires immediate treatment and proper hydration. |
| Blood counts | Monitor | The treatment may be delayed or its dose decreased in case of low neutrophil count and other blood cell count reductions. |
| Liver | Monitor | Elevated levels of bilirubin may enhance toxicity and thus should be assessed by a specialist to determine the correct dosage. |
| UGT1A1 | High Caution | Certain variants of UGT1A1 with reduced function can increase the risk of developing severe neutropenia. |
| Pregnancy | Avoid | Use of Irinotecan Injection poses risks to an unborn child, and contraception may be recommended during treatment. |
| Breastfeeding | Avoid | Irinotecan 100mg Injection is not recommended for use during breastfeeding periods. |
Monitoring During Inotad 100mg/5ml Injection Treatment
Monitoring is individualized according to the disease, regimen and patient risk factors. It may include:
- CBC with differential
- Diarrhea frequency/severity and hydration
- Electrolytes and renal function during significant diarrhea
- Liver tests and bilirubin
- Fever/infection
- Pulmonary symptoms
- UGT1A1 status when clinically appropriate
- Tumour response
Inotad 100mg/5ml Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Inotad |
| Molecule | Irinotecan |
| Strength | 100mg/5ml (20mg/ml) |
| Dosage form | Injection |
| Therapy type | Topoisomerase I inhibitor / cytotoxic chemotherapy |
| Route | Intravenous infusion |
| Prescription required | Yes |
| Dose principle | Indication/protocol-specific; do not infer patient dose from pack strength |
| Medical supervision | Required |
Inotad 100mg/5ml Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| OTC medicines, supplements and herbal products | They can impact the safety, exposure, or tolerance of Irinotecan 100mg. | Check the complete list of medications and supplements before undergoing any treatment. |
| Strong CYP3A4 inducers | Can lower levels of irinotecan and SN-38, which may influence effectiveness of therapy. | Take steps or modify the therapy based on the recommendations of experts. |
| Strong CYP3A4 inhibitors | Can affect irinotecan/SN-38 levels and increase toxicity risks. | Consider the particular combination and be vigilant. |
| Other myelosuppressive treatments | Might cause bone marrow toxicity and cytopenias. | Should be used with proper monitoring of blood counts and under expert guidance. |
| Chemotherapy and supportive-care regimen | Multiple medicines may contribute to overlapping toxicities or interactions. | Review the complete regimen before each treatment cycle. |
FAQs About Inotad 100mg/5ml Injection
What is Inotad 100mg Injection prescribed for?
Inotad 100mg/5ml Injection is the brand name for irinotecan, and it is commonly prescribed as a chemotherapy drug in the treatment of colorectal cancer.
Does this mean that 100mg is the patient's dose?
Not exactly. 100mg/5ml refers to the concentration of the drug in the vial. The dose of Inotad Injection is calculated according to the patient's body surface area in mg/m².
What makes Irinotecan Injection work?
The active metabolite of Irinotecan 100mg Injection inhibits the enzyme, topoisomerase I. This causes damage to DNA replication, which in turn stops the growth of cancerous cells.
What is the reason for diarrhea as a critical precaution with Inotad 100mg?
This type of diarrhea may be late onset, dangerous, life-threatening due to dehydration.
What is early cholinergic diarrhea?
Diarrhea or stomach cramps can develop either during or immediately following the infusion. Cholinergic diarrhea can also present with sweating, excess saliva production, etc. Atropine may be employed where clinically indicated.
Why do blood counts have to be monitored during Inotad 100mg Injection?
The medication may result in severe neutropenia (a deficiency of some types of white blood cells). It increases the risk of infection or sepsis and should be monitored via blood counts.
What is UGT1A1?
UGT1A1 stands for uridine diphosphate glucuronosyltransferase 1 family, polypeptide A1. Some reduced-function variants of this gene increase the risk of SN-38 exposure and, consequently, severe neutropenia.
Can Irinotecan 100mg Injection be used for self-treatment?
No. Irinotecan Injection is an intravenous anti-cancer drug and must be prepared, administered and observed by healthcare professionals.
What is to be done if there is a missed Inotad 100mg infusion?
Depending upon the treatment regimen and clinical condition of the patient, the oncology department will determine the appropriate time for the rescheduling of the infusion.
What symptoms require immediate attention while undergoing treatment with Inotad Injection?
Diarrhea, fever, inability to take fluids, weakness, difficulty breathing, or infection symptoms are some of the conditions that require immediate medical intervention.
References
1. DailyMed. CAMPTOSAR (irinotecan hydrochloride) prescribing information, updated May 2026 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e518dfc6-7e93-4fee-a66c-51e1ab71c056
2. Current colorectal-cancer treatment guidelines and protocol-specific irinotecan regimens https://esmed.org/irnotecan-dose-adjustment-in-colorectal-cancer-treatment/
3. Current India-specific Inotad package insert before publication https://www.researchgate.net/publication/50434421_Package_Inserts_in_India_Need_for_a_Revision
4. Brand-specific Inotad prescribing information/package insert should remain the primary source for manufacturer, exact presentation, storage, pack configuration and India-specific approved labeling before publication https://www.researchgate.net/publication/312630060_Analysis_of_package_inserts_of_orally_administered_drugs_available_in_the_Indian_market
5. National Cancer Institute. Colon Cancer Treatment (PDQ®)–Health Professional Version. NCI https://www.cancer.gov/types/colorectal/hp/colon-treatment-pdq
Marketer Details
Adely
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