FDA LABEL RECORD
Octreotide Acetate
OCTREOTIDE ACETATE. FDA prescribing information for this product, as published on the retrieval date below.
AS THE LABEL RECORDS IT
Product details
| Brand name | Octreotide Acetate |
|---|---|
| Generic name | OCTREOTIDE ACETATE |
| Labeller | Teva Pharmaceuticals, Inc. |
| Route | INTRAMUSCULAR |
| Label version | 5 |
| Effective | 2024-07-30 |
| Retrieved by this site | 2026-10-03 |
| Full label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9739ea6-74de-4a41-a806-6e827a23cedb |
INDICATIONS AND USAGE
Quoted from the FDA label
1 INDICATIONS AND USAGE Octreotide acetate for injectable suspension 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated. Octreotide acetate for injectable suspension is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated octreotide acetate injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with metastatic carcinoid tumors ( 1.2 ) Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors ( 1.3 ) 1.1 Acromegaly Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal [see Clinical Studies ( 14 ), Dosage and Administration ( 2 )] . 1.2 Carcinoid Tumors Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. 1.3 Vasoactive Intestinal Peptide Tumors (VIPomas) Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors. 1.4 Important Limitations of Use In patients with carcinoid syndrome and VIPomas, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined.
What this page is
A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.
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