OCTREOTIDE ACETATE
OCTREOTIDE ACETATE · KIT · Mylan Institutional LLC
OCTREOTIDE ACETATE is a kit containing octreotide acetate. Manufactured by Mylan Institutional LLC.
Key Facts
- Brand Name
- OCTREOTIDE ACETATE
- Generic Name
- OCTREOTIDE ACETATE
- NDC Code (Product)
67457-762- Manufacturer
- Mylan Institutional LLC
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA216589
- Marketing Start
- 01/28/2026
Recall History
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Ben Venue Laboratories Inc
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Fresenius Kabi USA, LLC
Failed Impuities/Degradation Specifications
Fresenius Kabi USA, LLC
Failed Impuities/Degradation Specifications
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Octreotide Acetate Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. ( 1.3 ) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Octreotide Acetate Injection; these trials were not optimally designed to detect such effects. ( 1.4 ) 1.1 Acromegaly Octreotide Acetate Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Octreotide Acetate injection may be administered subcutaneously or intravenously. ( 2.1 ) Acromegaly : Recommended initial Octreotide Acetate injection dosage is 50 mcg three times daily during the initial 2 weeks of therapy. Maintenance dose 100 mcg to 500 mcg three times daily. ( 2.2 ) Carcinoid Tumors : Recommended dosage range of 100 mcg to 600 mcg daily in two to four divided doses during the initial 2 weeks of therapy. ( 2.3 ) VIPomas : Recommended dosage range of 200 mcg to 300 mcg daily in two to four divided doses during the initial 2 weeks of therapy. ( 2.4 ) 2.1 Dosage and Administration Overview Octreotide Acetate injection may be administered subcutaneously or intravenously. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Sites should be rotated in a systematic manner. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulates and/or discoloration are observed. Octreotide Acetate injection is not compatible in Total Parenteral Nutrition solutions because of the formation of a glycosyl o…
Contraindications
4 CONTRAINDICATIONS Sensitivity to this drug or any of its components. Sensitivity to this drug or any of its components. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The following drugs require monitoring and possible dose adjustment when used with octreotide acetate injection : cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. ( 7 ) Lutetium Lu 177 Dotatate Injection : Discontinue octreotide acetate injection at least 24 hours prior to each lutetium Lu 177 dotatate dose. ( 7.6 ) 7.1 Cyclosporine Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of octreotide acetate injection with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection. 7.2 Insulin and Oral Hypoglycemic Drugs Octreotide inhibits the secretion of insulin and glucagon. Therefore, blood glucose levels should be monitored when octreotide acetate injection treatment is initiated or when the dose is altered and anti-diabetic treatment should be adjusted accordingly. 7.3 Bromocriptine Concomitant administration of octreotide and bromocriptine increases the availability of bromocriptine. 7.4 Other Concomitant Drug Therapy Concomitant administration of bradycardia-inducing drugs (e.g.…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Complete Atrioventricular Block [see Warnings and Precautions (5.1)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.2)] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.3)] Thyroid Function Abnormalities [see Warnings and Precautions (5.4)] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.5)] Changes in Vitamin B12 Levels [see Warnings and Precautions (5.6)] Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism. In other patients, most common adverse reactions (incidence > 10%) are gallbladder abnormalities. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot …
Frequently Asked Questions
What is OCTREOTIDE ACETATE used for?
OCTREOTIDE ACETATE contains OCTREOTIDE ACETATE. It is a kit taken as directed. Consult your doctor for specific uses.
Is OCTREOTIDE ACETATE a controlled substance?
OCTREOTIDE ACETATE is not classified as a controlled substance by the DEA.
What is the generic name for OCTREOTIDE ACETATE?
The generic name for OCTREOTIDE ACETATE is OCTREOTIDE ACETATE. There are 10 other brand versions of OCTREOTIDE ACETATE.
What is the NDC code for OCTREOTIDE ACETATE ?
The NDC (National Drug Code) for OCTREOTIDE ACETATE is 67457-762, listed by Mylan Institutional LLC.
Other OCTREOTIDE ACETATE Dosages
Other Octreotide Brands
See all →- Octreotide Acetate1000 ug/mL25021-467
- Octreotide Acetate50 ug/mL71288-566
- Octreotide Acetate100 ug/mL0641-6175
- Octreotide Acetate1000 ug/mL0641-6178
- Sandostatin LAR Depot0078-0825
- Octreotide Acetate500 ug/mL68083-560
- Sandostatin50 ug/mL0078-0180
- Octreotide Acetate0480-9259
- Octreotide Acetate500 ug/mL0641-6176
- Sandostatin LAR Depot0078-0811
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)