Somatuline Depot label

Somatuline Depot

Somatuline Depot Recall

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Side Effects & Adverse Reactions

In pediatric patients, use with extreme caution. Excessive use in pediatric patients or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning. If this occurs, discontinue medication, and use appropriate therapy as outlined in “OVERDOSAGE” section.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.

History

There is currently no drug history available for this drug.

Other Information

Atropine Sulfate Ophthalmic Ointment USP, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula:

Structural Formula

(C17H23NO3)2•H2SO4•H2O
Mol. wt. 694.84

Chemical name:

Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-(3.2.1)oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate.

Each Gram Contains:

Atropine Sulfate Ophthalmic Ointment USP, 1%, contains in each gram of ointment: ACTIVE: Atropine Sulfate USP, 1% (10mg); INACTIVES: White Petrolatum, Mineral Oil, Lanolin Oil and Purified Water.

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Somatuline Depot Recall

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Somatuline Depot Manufacturers

Ipsen Biopharmaceuticals, Inc.
No Recall
Somatuline Depot | Bausch & Lomb Incorporated
ATROPINE SULFATE OINTMENT: A small amount in the conjunctival sac once or twice a day or as directed by a physician.

FOR OPHTHALMIC USE ONLY.
Beaufour Ipsen Pharma Sas
No Recall
Somatuline Depot | Beaufour Ipsen Pharma Sas
Patients should begin treatment with Somatuline Depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months.

After 3 months dosage may be adjusted as follows:
GH >1 to ≤ 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain Somatuline Depot dose at 90 mg every 4 weeks. GH > 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled, increase Somatuline Depot dose to 120 mg every 4 weeks. GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: reduce Somatuline Depot dose to 60 mg every 4 weeks.
Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and /or IGF-1 levels; and/or changes in symptoms of acromegaly.

Somatuline Depot should be injected via the deep subcutaneous route in the superior external quadrant of the buttock. The skin should not be folded and the needle should be inserted perpendicular to the skin, rapidly and to its full length. The injection site should alternate between the right and left side.

The starting dose in patients with moderate and severe renal or moderate and severe hepatic impairment should be 60 mg via the deep subcutaneous route, at 4 week intervals for 3 months followed by dose adjustment as described above [see Clinical Pharmacology (12.3)].
Ipsen Biopharmaceuticals, Inc.
No Recall
Somatuline Depot | Ipsen Biopharmaceuticals, Inc.
Patients should begin treatment with Somatuline Depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months.

After 3 months dosage may be adjusted as follows:
GH >1 to ≤ 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain Somatuline Depot dose at 90 mg every 4 weeks. GH > 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled, increase Somatuline Depot dose to 120 mg every 4 weeks. GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: reduce Somatuline Depot dose to 60 mg every 4 weeks.
Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and /or IGF-1 levels; and/or changes in symptoms of acromegaly.

Patients who are controlled on Somatuline Depot 60 mg or 90 mg may be considered for an extended dosing interval of Somatuline Depot 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.

Continued monitoring of patients response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

Somatuline Depot should be injected via the deep subcutaneous route in the superior external quadrant of the buttock. The skin should not be folded and the needle should be inserted perpendicular to the skin, rapidly and to its full length. The injection site should alternate between the right and left side.

The starting dose in patients with moderate and severe renal or moderate and severe hepatic impairment should be 60 mg via the deep subcutaneous route, at 4 week intervals for 3 months followed by dose adjustment as described above [see Clinical Pharmacology (12.3)].