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SUSTOL

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Overview

What is SUSTOL?

SUSTOL (granisetron) extended-release injection, contains granisetron, a serotonin-3 (5-HT) receptor antagonist. Granisetron is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is CHNO, with the following chemical structure:

Granisetron is a white to off-white crystalline solid that is insoluble in water.

SUSTOL is a sterile, clear, colorless to slightly yellow, viscous liquid supplied in a single-dose, pre-filled syringe. Each syringe contains 10 mg granisetron incorporated in an extended-release polymer formulation; the inactive ingredients are triethylene glycol poly(orthoester) polymer, 392 mg and polyethylene glycol monomethyl ether, NF, 98 mg.



What does SUSTOL look like?



What are the available doses of SUSTOL?

Extended-Release Injection: 10 mg/0.4 mL in a single-dose, pre-filled syringe. ()

What should I talk to my health care provider before I take SUSTOL?

How should I use SUSTOL?

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

Preparation

Administration


What interacts with SUSTOL?

Sorry No Records found


What are the warnings of SUSTOL?

Sorry No Records found


What are the precautions of SUSTOL?

Sorry No Records found


What are the side effects of SUSTOL?

Sorry No records found


What should I look out for while using SUSTOL?

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT receptor antagonists .


What might happen if I take too much SUSTOL?

There is no specific antidote for granisetron overdosage. In the case of overdosage, symptomatic treatment should be given. Overdosage of up to 38.5 mg of granisetron hydrochloride, as a single intravenous injection, has been reported without symptoms or with only the occurrence of headache.


How should I store and handle SUSTOL?

Store at 20°C to 25°C (68 °F to 77°F) [See USP Controlled Room Temperature]. Protect from light.SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06); each kit contains:StorageStore SUSTOL in the refrigerator at 2°C to 8°C (36°F to 46°F).SUSTOL can be placed back in the refrigerator after being kept at room temperature. SUSTOL can remain at room temperature for up to a maximum of 7 days.Protect from light. Do not freeze.SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06); each kit contains:StorageStore SUSTOL in the refrigerator at 2°C to 8°C (36°F to 46°F).SUSTOL can be placed back in the refrigerator after being kept at room temperature. SUSTOL can remain at room temperature for up to a maximum of 7 days.Protect from light. Do not freeze.SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06); each kit contains:StorageStore SUSTOL in the refrigerator at 2°C to 8°C (36°F to 46°F).SUSTOL can be placed back in the refrigerator after being kept at room temperature. SUSTOL can remain at room temperature for up to a maximum of 7 days.Protect from light. Do not freeze.SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06); each kit contains:StorageStore SUSTOL in the refrigerator at 2°C to 8°C (36°F to 46°F).SUSTOL can be placed back in the refrigerator after being kept at room temperature. SUSTOL can remain at room temperature for up to a maximum of 7 days.Protect from light. Do not freeze.SUSTOL extended-release injection is supplied in cartons of six kits (NDC 47426-101-06); each kit contains:StorageStore SUSTOL in the refrigerator at 2°C to 8°C (36°F to 46°F).SUSTOL can be placed back in the refrigerator after being kept at room temperature. SUSTOL can remain at room temperature for up to a maximum of 7 days.Protect from light. Do not freeze.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Granisetron is a selective 5-hydroxytryptamine (5-HT) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT, 5-HT, 5-HT, 5-HT; for alpha, alpha, or beta-adrenoreceptors; for dopamine-D; or for histamine-H; benzodiazepine; picrotoxin or opioid receptors.

Serotonin receptors of the 5-HT type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.

Non-Clinical Toxicology
SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT receptor antagonists .

Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of hyoscyamine sulfate. Administer hyoscyamine sulfate before meals; antacids after meals.

Infections

Infections at the injection site occurred in 0.4% (7 of 1814) of patients with cancer and 0.2% (1 of 412) of healthy subjects in clinical trials. Infections had a median onset of 9 days (range 7 to 16 days) following SUSTOL administration. One patient who was neutropenic at the time of the infection was hospitalized. All patients with infection were treated with antibiotics and had complete resolution.

Bruising and/or hematomas

Bruising and/or hematomas at the injection site occurred in 426 of 1131 (38%) patients treated with SUSTOL 10 mg with a median time to onset of 2 days. Bruising and/or hematomas with a delayed onset (onset 5 or more days following SUSTOL administration) were reported in 175 (15%) patients. Severe bruising or hematoma (e.g., greater than 4 cm bruise or hematoma) occurred in 3% of patients. Patients receiving concomitant anticoagulant and antiplatelet medications were at greater risk for severe injection site bruising and hematomas.

Bleeding

Bleeding at the injection site occurred in 70 of 1814 (4%) patients treated with SUSTOL. One patient required emergency management. Bleeding for longer than 5 days was reported in 23 (1%) patients.

Pain and Tenderness

In a clinical trial that collected information about injection site pain and tenderness from patient diaries, pain with or without tenderness at the injection site was reported by 91 of 456 (20%) of patients treated with SUSTOL 10 mg, and an additional 50 of 456 (11%) of patients reported tenderness without pain. Pain and/or tenderness severe enough to require taking pain medication, interfere with patient activity level, or cause significant discomfort at rest was reported in 2% of patients. Among all patients who reported pain and/or tenderness with SUSTOL 10 mg in clinical trials, the median duration was 5 days, and pain lasting longer than 7 days occurred in 6% of patients.

Nodules

Nodules at the injection site occurred in 203 of 1131 (18%) of patients treated with SUSTOL 10 mg. Nodules persisted for a median of 15 days and 73 patients (6%) had nodules with durations longer than 21 days.

Management of ISRs

The following clinically significant adverse reactions are described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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