Octreotide Acetate (Sandostatin Lar Depot)

Trade Name : Sandostatin LAR Depot

Novartis Pharmaceuticals Corporation

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Octreotide Acetate (Sandostatin Lar Depot) which is also known as Sandostatin LAR Depot and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of per ml. Read more

Octreotide Acetate (Sandostatin Lar Depot) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.
SANDOSTATINu00a0LAR DEPOT is a somatostatin analogue indicated for:
Treatment in patients who have responded to and tolerated Sandostatinu00a0Injection subcutaneous injection for:

Acromegalyu00a0()n
Severe diarrhea/flushing episodes associated with metastatic carcinoid tumorsu00a0()n
Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ()

The following dosage regimens are recommended.
Patients Not Currently Receiving Sandostatin Injection Subcutaneously:
Patients Currently Receiving Sandostatin Injection Subcutaneously:
Renal Impairment, Patients on Dialysis:
Hepatic Impairment, Patients With Cirrhosis:

SANDOSTATINu00a0LARu00a0DEPOT is available in single-use kits for injectable suspension containing a 6-mL vial of 10 mg, 20 mg, or 30 mg strength, a syringe containing 2 mL of diluent, one vial adapter, and one sterile 1u00bdu201d 19 gauge safety injection needle. An instruction booklet for the preparation of drug suspension for injection is also included with each kit.
For injectable suspension: strengths 10 mg per 6 mL, 20 mg per 6 mL, or 30 mg per 6 mL vialsu00a0()

None.
None. ()

No data

Cholelithiasis and Complications of Cholelithiasis:
Glucose Metabolism:
Thyroid Function:
Cardiac Function:

The most common adverse reactions, occurring in u2265 20% of patients are:
nttttttttttTo report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .

Acromegaly:
Carcinoid Syndrome:

The following drugs require monitoring and possible dose adjustment when used with SANDOSTATINu00a0LAR DEPOT: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.u00a0()n n

Females and Males of Reproductive Potential:
8.3

Doses of 2.5 mg (2500 mcg) of Sandostatin Injection subcutaneously have caused hypoglycemia, flushing, dizziness, and nausea.
Contact Poison Control (1-800-222-1222) for latest recommendations.

Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1- (hydroxy-methyl) propyl]-, cyclic (2u21927)-disulfide; [R-(R*,R*)].
The molecular weight of octreotide is 1019.3 g/mol (free peptide, CHNOS) and its amino acid sequence is:
SANDOSTATINu00a0LARu00a0DEPOT is available in a vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability.
SANDOSTATINu00a0LARu00a0DEPOT is available as: sterile 6-mL vials in 3u00a0strengths delivering 10u00a0mg, 20u00a0mg, or 30u00a0mg octreotide-free peptide. Each vial of SANDOSTATINu00a0LARu00a0DEPOT delivers:

SANDOSTATINu00a0LARu00a0DEPOT is a long-acting dosage form consisting of microspheres of the biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer, containing octreotide. It maintains all of the clinical and pharmacological characteristics of the immediate-release dosage form Sandostatinu00a0Injection with the added feature of slow release of octreotide from the site of injection, reducing the need for frequent administration. This slow release occurs as the polymer biodegrades, primarily through hydrolysis. SANDOSTATINu00a0LARu00a0DEPOT is designed to be injected intramuscularly (intragluteally) once every 4u00a0weeks.

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SANDOSTATIN LAR DEPOT is available in single-use kits containing a 6-mL vial of 10 mg, 20 mg or 30 mg strength, a syringe containing 2 mL of diluent, one vial adapter, and one sterile 1u00bdu201d 19 gauge safety injection needle. An instruction booklet for the preparation of drug suspension for injection is also included with each kit.
Drug Product Kits
10u00a0mg kitnttu00a0u00a0u00a0u00a0u00a0ntNDCu00a00078-0811-81
20u00a0mg kitnttu00a0u00a0u00a0u00a0u00a0ntNDCu00a00078-0818-81
30u00a0mg kitnttu00a0u00a0u00a0u00a0u00a0ntNDCu00a00078-0825-81
Demonstration kitnttu00a0u00a0u00a0u00a0u00a0nttt0078-9825-81
For prolonged storage, SANDOSTATIN LAR DEPOT should be stored at refrigerated temperatures between 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) and protected from light until the time of use. SANDOSTATIN LAR DEPOT drug product kit should remain at room temperature for 30-60 minutes prior to preparation of the drug suspension. However, after preparation the drug suspension must be administered immediately.

Cholelithiasis and Complications of Cholelithiasis
Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis and pancreatitis) .
Carcinoid Tumors and VIPomas
Patients with carcinoid tumors and VIPomas should be advised to adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms .
Acromegaly
Patients with acromegaly should also be urged to adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels .
Pregnancy
Inform female patients that treatment with SANDOSTATIN LAR DEPOT may result in unintended pregnancy .
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2019-56

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 10n- mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0646-81
Sandostatinu00ae LAR Depot
(octreotide acetate for injectable suspension)
10 mg
For Intragluteal Injection

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 20n- mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0647-81
Sandostatinu00ae LAR Depot
(octreotide acetate for injectable suspension)
20 mg
For Intragluteal Injection

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 30n- mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0648-81
Sandostatinu00ae LAR Depot
(octreotide acetate for injectable suspension)
30 mg
For Intragluteal Injection

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 10n- mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0811-81
Sandostatinu00ae LAR Depot
(octreotide acetate for injectable suspension)
10 mg
For Intragluteal Injection

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 20n- mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0818-81
Sandostatinu00ae LAR Depot
(octreotide acetate for injectable suspension)
20 mg
For Intragluteal Injection

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 30n- mg
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0825-81
Sandostatinu00ae LAR Depot
(octreotide acetate for injectable suspension)
30 mg
For Intragluteal Injection

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Octreotide Acetate (Sandostatin Lar Depot)

Trade Name : Sandostatin LAR Depot

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Octreotide Acetate (Sandostatin Lar Depot)

Trade Name : Sandostatin LAR Depot

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

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